+ All Categories
Home > Documents > Project proponent: Auronext Pharma Pvt. Ltd.

Project proponent: Auronext Pharma Pvt. Ltd.

Date post: 16-Mar-2023
Category:
Upload: khangminh22
View: 0 times
Download: 0 times
Share this document with a friend
263
FINAL EIA-EMP REPORT FOR PROPOSED EXPANSION OF STERILE BULK DRUG & ITS INTERMEDIATED MANUFACTURING UNIT – 46.2 TPA, FILLING OF DRY POWDER VIALS 30 MILLION & LYOPIHILISED VIALS 6 MILLION BY AURONEXT PHARMA PVT. LTD. LOCATION: A-1128, RIICO INDUSTRIAL AREA PHASE-III, BHIWADI, DISTT.-ALWAR, RAJASTHAN. Project proponent: Auronext Pharma Pvt. Ltd. (“A” Category of 5 (f) column 4 of EIA Notification dated 14.06.2006 and its subsequent amendment dated 01.12.09 & 04.04.2011) The project attracts general condition that any project or activity specified under Category ‘B’ will be treated as Category A, if located in whole or in part within 10 km from the boundary of Inter-State boundary and International boundary. The Inter-state boundary (Haryana and Rajasthan) is 1.54 km towards ENE from the site. ENVIRONMENTAL CONSULTANT: ENKAY ENVIRO SERVICES PVT. LTD. (An ISO 9001:2008 Certified Firm) (Serial no. 44 as per the List of Accredited EIA Consultant Organizations) Corporate Office: L-G-6, Corporate Park, Gopal Bari, Ajmer Road, Jaipur Phone: - 0141-2363996, 4023996, Fax:-5118996 Email- [email protected], Website: www.enkayenviro.com
Transcript

FINAL EIA-EMP REPORT

FOR

PROPOSED EXPANSION OF STERILE BULK DRUG & ITS

INTERMEDIATED MANUFACTURING UNIT – 46.2 TPA,

FILLING OF DRY POWDER VIALS 30 MILLION &

LYOPIHILISED VIALS 6 MILLION BY AURONEXT PHARMA

PVT. LTD.

LOCATION: A-1128, RIICO INDUSTRIAL AREA PHASE-III,

BHIWADI, DISTT.-ALWAR, RAJASTHAN.

Project proponent:

Auronext Pharma Pvt. Ltd.

(“A” Category of 5 (f) column 4 of EIA Notification dated 14.06.2006 and its

subsequent amendment dated 01.12.09 & 04.04.2011)

The project attracts general condition that any project or activity specified under Category ‘B’

will be treated as Category A, if located in whole or in part within 10 km from the boundary of

Inter-State boundary and International boundary.

The Inter-state boundary (Haryana and Rajasthan) is 1.54 km towards ENE from

the site.

ENVIRONMENTAL CONSULTANT:

ENKAY ENVIRO SERVICES PVT. LTD.

(An ISO 9001:2008 Certified Firm) (Serial no. 44 as per the List of Accredited EIA Consultant Organizations) Corporate Office: L-G-6, Corporate Park, Gopal Bari, Ajmer Road, Jaipur

Phone: - 0141-2363996, 4023996, Fax:-5118996 Email- [email protected], Website: www.enkayenviro.com

Project: Auronext Pharma Pvt. Ltd. Document No.: EESPL/APPL/001/372-EC/IND.2014

i

PROPOSED EXPANSION OF STERILE BULK DRUG & ITS INTERMEDIATED

MANUFACTURING UNIT – 46.2 TPA, FILLING OF DRY POWDER VIALS 30

MILLION & LYOPIHILISED VIALS 6 MILLION BY AURONEXT PHARMA PVT.

LTD.

S. NO. CONTENTS PAGES

1. FORM-I 1-19

2. EIA-EMP REPORT 20-258

SECTION- I INTRODUCTION 20-49

1.1 PREAMBLE 21

1.2 GENERAL INFORMATION ON CEMENT INDUSTRIES 21

1.3 ENVIRONMENTAL CLEARANCE PROCESS 23

1.4 COMPLIANCE TO TERMS OF REFERENCE 25

1.5 GENERIC STRUCTURE OF ENVIRONMENTAL

IMPACT ASSESSMENT DOCUMENTS

44

1.6 POST ENVIRONMENTAL CLEARANCE MONITORING 45

1.7 IDENTIFICATION OF PROJECT PROPONENT 45

1.8 BRIEF DESCRIPTION OF THE PROJECT 46

1.9 LOCATION OF THE PROJECT 47

1.10 INFRASTRUCTURE 48

1.11 ENVIRONMENTAL IMPACT ASSESSMENT REPORT 48

1.12 SCOPE OF WORK 49

SECTION – II PROJECT DESCRIPTION 50-73

2.1 GENERAL 51

2.2 DESCRIPTION OF THE PROJECT 53

2.3 PLANT LAYOUT 55

2.4 RAW MATERIAL 57

2.5 SOURCE OF RAW MATERIAL 59

2.6 CAPACITY OF THE PROJECT 59

2.7 WATER REQUIREMENT 60

2.8 POWER 61

Project: Auronext Pharma Pvt. Ltd. Document No.: EESPL/APPL/001/372-EC/IND.2014

ii

2.9 SCHEDULE OF APPROVAL AND IMPLEMENTATION 61

2.10 MAN POWER 61

2.11 MANUFACTURING PROCESS 61

SECTION– III DESCRIPTION OF THE ENVIRONMENT 74-133

3.1 GENERAL 74

3.2 BASELINE DATA GENERATION 75

3.3 LAND USE STUDIE 75

3.4 SOIL CHARACTERISTICS 77

3.5 WATER ENVIRONMENT 79

3.6 AIR ENVIRONMENT 84

3.7 NOISE ENVIRONMENT 89

3.8 BIOLOGICAL ENVIRONMENT 90

3.9 SOCIO ECONOMIC ENVIRONMENT 122

SECTION – IV ANTICIPATED ENVIRONMENTAL IMPACTS &

& MITIGATION MEASURES

134-167

4.1 GENERAL 135

4.2 LAND ENVIRONMENT 135

4.3 AIR ENVIRONMENT 136

4.4 WATER ENVIRONMENT 148

4.5 SOLID WASTE 156

4.6 NOISE POLLUTION 158

4.7 SOCIO- ECONOMIC IMPACT 169

4.8 BIOLOGICAL ENVIRONMENT 166

SECTION– V ANALYSIS OF ALTERNATIVES (TECHNOLOGY

AND SITE)

168-1629

5.1 INTRODUCTION 169

SECTION– VI ENVIRONMENTAL MONITORING PROGRAMME 170-177

6.1 INTRODUCTION 171

6.2 ENVIRONMENTAL MONITORING AND

REPORTING PROCEDURE

171

6.3 ENVIRONMENTAL MONITORING CELL 172

6.4 MONITORING METHODS 176

Project: Auronext Pharma Pvt. Ltd. Document No.: EESPL/APPL/001/372-EC/IND.2014

iii

6.5 REPORTING SCHEDULES OF THE MONITORING

DATA

177

6.6 INFRASTRUCTURE FOR ENVIRONMENTAL

MONITORING

177

SECTION-VII ADDITIONAL STUDIES 178-216

7.1 PUBLIC CONSULTATION 179

7.2 RISK ASSESSMENT 179

7.3 HAZARD IDENTIFICATION 180

7.4 HAZARD ASSESSMENT AND EVALUATION 181

7.5 STORAGE AND HANDLING OF HAZARDOUS 190

7.6 DISASTER MANAGEMENT PLAN 193

7.7 OFF- SITE EMERGENCY PREPAREDNESS PLAN 205

7.8 OCCUPATIONAL HEALTH AND SAFETY 210

7.9 ENTERPRISE SOCIAL COMMITMENT 215

SECTION-VIII PROJECT BENEFITS 217-219

8.1 INTRODUCTION 218

8.2 IMPROVEMENT IN PHYSICAL INFRASTRUCTURE 218

8.3 IMPROVEMENT IN SOCIAL INFRASTRUCTURE 218

8.4 EMPLOYMENT POTENTIAL 218

8.5 OTHER TANGIBLE BENEFITS 218

SECTION-IX ENVIRONMENTAL COST BENEFITS ANALYSIS 219-221

9.1 ENVIRONMENTAL COST BENEFITS ANALYSIS 221

SECTION-X ENVIRONMENT MANAGEMENT PLAN 222-235

10.1 INTRODUCTION 223

10.2 ENVIRONMENT MANAGEMENT DEPARTMENT 223

10.3 ENVIRONMENTAL ACTION PROGRAMME 226

10.4 GREEN BELT DEVELOPMENT 232

SECTION-XI SUMMARY AND CONCLUSION 236-254

11.1 INTRODUCTION 237

11.2 DESCRIPTION OF THE PROJECT 239

11.3 ENVIRONMENTAL MONITORING 242

11.4 ANTICIPATED ENVIRONMENTAL IMPACTS AND

MITIGATION MEASURES

245

11.5 ENVIRONMENTAL MONITORING PROGRAMME 248

11.6 PROJECT BENEFITS 250

Project: Auronext Pharma Pvt. Ltd. Document No.: EESPL/APPL/001/372-EC/IND.2014

iv

11.7 ENVIRONMENT MANAGEMENT PLAN DURING

OPERATION PHASE

251

11.8 CONCLUSIONS 254

SECTION-XII DISCLOSURE OF CONSULTANT 255-258

LIST OF ANNEXURE

I COPY OF TERMS OF REFERENCE ISSUED BY MOEF

II DIC CERTIFICATE

III RECEIPT OF APPLICATION SUBMITTED TO CGWA

FOR EXTRACTION OF GROUND WATER

COPY OF TERMS OF REFERENCE ISSUED BY MOEF

IV COPY OF THE EC, CONSENT TO OPERATE AND

AUTHORIZATION.

V COPY OF NOC

VI COMPLIANCE TO THE CONDITIONS STIPULATED

IN THE NOC GRANTED BY SPCB

VI (A) DATA FOR THE STACK EMISSIONS, FUGITIVE

EMISSIONS

VI (B) WATER BALANCE CHART OF EXISTING UNIT

VI(C) TREATED EFFLUENT QUALITY REPORT

VII THE MAP INDICATING LOCATION OF THE PROJECT

VIII THE MAP INDICATING DISTANCE OF THE PROJECT

FROM SEVERELY POLLUTED AREA

IX RECEIPT OF APPLICATION SUBMITTED TO JVVNL

TO EXTEND THE POWER CONNECTION LOAD

X THE COPY OF THE LAND DOCUMENT

XI DETAILED (BASELINE MONITORING REPORT) :

ONE SEASON SITE-SPECIFIC MICRO-

METEOROLOGICAL DATA , AAQ DATA , WATER

AND NOISE MONITORING DATA

XII GEOLOGICAL AND GEO-HYDROLOGICAL REPORT

OF THE STUDY AREA

XIII MATERIAL SAFETY DATA SHEET

Project: Auronext Pharma Pvt. Ltd. Document No.: EESPL/APPL/001/372-EC/IND.2014

v

XIV AUTHORIZATION/MEMBERSHIP FOR THE

DISPOSAL OF SOLID/HAZARDOUS WASTE IN

TSDF HEARING

XV COMPLIANCE TO THE RECOMMENDATIONS

MENTIONED IN THE CREP GUIDELINES

XVI POLICY ON ENVIRONMENT HEALTH AND SAFETY

XVII HIERARCHICAL SYSTEM TO DEAL

ENVIRONMENTAL ISSUES

XVIII CERTIFIED COMPLIANCE OF ENVIRONMENTAL

CONDITIONS GRANTED BY MOEF

XIX OFFICE MEMORANDUM NO. J-11013/36/2014-IA-I

DATED 10.12.2014 REGARDING EXEMPTION FROM

PUBLIC CONSULTATION

XX PLANT LAYOUT

XXVI CSR ACTIVITES CARRIED OUT BY AURONEXT

PHARMA PVT LTD

************

1

Project: Auronext Pharma Pvt Ltd Form- 1

FORM-1

2

Project: Auronext Pharma Pvt Ltd Form- 1

APPENDIX I

(See Paragraph – 6)

FORM - 1

I Basic Information

S.

No.

Item : Details

1. Name of the Project/s : Auronext Pharma Pvt Ltd.

2. S. No. in the schedule : The proposed project is categorized under “B” of 5 (f)

{Synthetic organic chemicals industry (dyes & dye

intermediates; bulk drugs and intermediates excluding drug

formulations; synthetic rubbers; basic organic chemicals,

other synthetic organic chemicals and chemical

intermediates)} column 4 as per the amendment dated

01.12.09 and 04.04.2011 of the Gazette Notification of

Sept. 14th 2006.

But, as per the Gazette Notification mentioned above, the

project/activity falls under “A” Category because the project

attracts general condition that any project or activity

specified under Category ‘B’ will be treated as Category A, if

located in whole or in part within 10 km from the boundary

of Inter-State boundary and International boundary. The

Inter-state boundary (Rajasthan and Haryana) is 1.54 km

towards ENE from the site.

3. Proposed capacity/area/

length/tonnage to be

handled /command

area/lease area /number

of wells to be drilled

: The unit manufacture following sterile drugs:-

Sr. No. Product Quantity

(Kg/Year)

1a Meropenem Trihydrate Sterile 24000

1b Sodium Carbonate Sterile 4000

1(1a+1b) Meropenem for injection

(Sterile blend of Meropenem

& Sodium Carboante)

28000

2a Imipenem Monohydrate

Sterile

7000

2b Cilastatin Sodium Sterile 7200

2c Sodium Bicarbonate Sterile 1000

2

(2a+2b+

2c)

Imipenem & Cilastatin for

Injection (Sterile Blend of

Imipenem, Cilastatin Sodium

15200

3

Project: Auronext Pharma Pvt Ltd Form- 1

& Sodium Bicrbonate)

3.

Doripenem Monohydrate

Sterile

3000

4. Lyophiliz vials of Ertapenem for Injection 6

Millions Vials

5. Filling of vials of dry powder injection (Formulation)

30 Millions Vials

The total exiting land area is 10112 sq. m. No additional

land is required for the proposed modification.

4. New / Expansion /

Modernization

: Expansion

5. Existing capacity/Area etc. : The unit is manufacturing sterile bulk drug to tune of 38.4

TPA and vial filling to the tune of 30 million vials per

annum. Now, the unit is proposing to replace existing

product Ampicillin Sodium Sterile by a Carbapenem Sterile

bulk drugs (API).

6. Category of project i.e. 'A'

or 'B'

: ‘A’

7. Does it attract the general

condition? If yes, please

specify.

: Yes, Rajasthan-Haryana Interstate boundary at a distance

of 1.54 km towards ENE from the site.

8. Does it attract the specific

condition? If yes, please

specify.

: No

9. Location

Plot / Survey / Khasra no. : Plot no. A-1128, RIICO Industrial Area Phase-III

Village / Town : Bhiwadi

Tehsil : Tijara

District : Alwar

State : Rajasthan

10. Nearest Railway

station/Airport along with

distance in KM.

: S.N

o

Particular

s

Name Distance

(km)

Direction

1. Railway

station

Rewari

Railway

Station

24.22 W

2. Airport IGI Airport,

Delhi

46.16 NE

11. Nearest Town, City, : Nearest Town Harchandpur at a

4

Project: Auronext Pharma Pvt Ltd Form- 1

District Headquarters

along with distance in

kms.

distance of 0.40 Km.

Nearest City Bhiwadi at a distance of

2.47 km. towards W.

Nearest District

Headquarters

Alwar at a distance of 75

km towards SSW.

12. Village Panchayat, Zilla

Parishad, Municipal

Corporation, Local body

(Complete postal address

with telephone no. to be

given)

: Nagar Parishad (Local Body)

# Tijara, Alwar, Rajasthan- 301019

Nagar Vikas Nyas (U.I.T)

# Bhagat Singh Colony opp. Modern Public School,

Alwar by pass, Bhiwadi.

13. Name of the applicant : N.K. Jain

14. Registered address : Auronext Pharma Pvt Ltd.

A-1128, RIICO Industrial Area Phase-III’ Bhiwadi, Distt. -

Alwar, Rajasthan.

15. Address for correspondence:

Name : N.K. Jain

Designation (Owner/

Partner /CEO)

: Plant Head

Address : Correspondence Address:

Enkay Enviro Services Pvt. Ltd.

# LG 6, lower ground floor, corporate park, Gopal Bari,

Jaipur-302001

Plant & Office:

Auronext Pharma Pvt Ltd.

# A-1128, RIICO Industrial Area Phase-III’ Bhiwadi, Distt. -

Alwar, Rajasthan.

Pin Code : 301019

E-mail : [email protected]

[email protected]

[email protected]

Telephone no. : 01493-222339, 220334

Fax No. : --

5

Project: Auronext Pharma Pvt Ltd Form- 1

16. Details of alternative sites

examined, if any. Location

of these sites should be

shown on a Toposheet.

: No alternative site was examined as it constitute a part of

notified RIICO Industrial Area prior to 2006

17. Interlinked projects : There is no interlinked project

18. Whether separate

application of interlinked

project has been

submitted?

: Not applicable

19. If yes, date of submission : Not applicable

20. If no, reason : Not applicable

21. Whether the proposal

involves

approval/Clearance under:

if yes, details of the same

and their status to be

given.

(a) The Forest

(Conservation) Act,

(1980)?

(b) The Wildlife

(Protection) Act, 1972?

(c) The C.R.Z.

Notification, 1991?

: No

22. Whether there is any

Government Order/Policy

relevant/relating to the

site:

: No

23. Forest land involved

(hectares)

: No

24. Whether there is any

litigation pending against

the project and/or land in

which the project is

propose to be set up?

(a) Name of the Court

(b) Case No.

(c) Orders/directions of

No

6

Project: Auronext Pharma Pvt Ltd Form- 1

the court, if any and its

relevance with the

proposed project.

25. Expected cost of the

project

: The exiting capital cost of the project is Rs. 61.51 Crore,

and the estimated capital cost for the proposed Expansion

is Rs. 40.00 Crores.

*Capacity corresponding to sectoral activity (such as production capacity for manufacturing, mining

lease area and production capacity for mineral production, area for mineral exploration, length for linear

transport infrastructure, generation capacity for power generation etc.,)

II Activity

1. Construction, operation or decommissioning of the Project involving actions, which

will cause physical changes in the locality (topography, land use, changes in water

bodies, etc.)

S.

No.

Information/Checklist

confirmation

Yes

/

No

Details thereof (with approximate quantities

/rates, wherever possible) with source of

information data

1.1 Permanent or temporary

change on land use, land

cover or topography including

increase in intensity of land

use (with respect to local land

use plan)

No Land Use

• There is no change in land use as the land form is

industrial.

Land Cover

• The existing building area of 4550 sq. m will remain

unaltered and thus the impact will be negligible.

Topography

• No change in topography as the existing area will

remain unaltered.

1.2 Clearance of existing land,

vegetation and buildings?

No The proposed modification is coming up in exiting

project site premises. No clearing activity is envisaged.

Thus, there will no impact on the physical environment.

1.3 Creation of new land uses? No Not required for the proposed modification project.

1.4 Pre-construction investigations

e.g. bore houses, soil testing?

No The unit will utilize the existing building within the

exiting land and no additional construction is required.

Thus no preconstruction investigation is required.

1.5 Construction works? No No construction activities are envisaged for the

proposed modification project. Thus, there will be

negligible impact due to the same.

1.6 Demolition works? No No demolition work will be carried out

7

Project: Auronext Pharma Pvt Ltd Form- 1

1.7 Temporary sites used for

construction works or housing

of construction workers?

No Not required for the proposed project as no

construction activities is envisaged.

1.8 Above ground buildings,

structures or earthworks

including linear structures, cut

and fill or excavations

No No further above ground building, structure or

earthwork is envisaged for the proposed modification

project. Thus there will be negligible impact due to the

same.

1.9 Underground works including

mining or tunneling?

No Not applicable, it’s an industry project

1.10 Reclamation works? No Not Applicable

1.11 Dredging? No Not Applicable

1.12 Offshore structures? No Not Applicable

1.13 Production and manufacturing

processes?

No Presently the unit is manufacturing sterile bulk drug to

tune of 38.4 TPA and vial filling to the tune of 30 million

vials numbers per annum. Now, the unit is proposing to

replace existing product Ampicillin Sodium Sterile by a

Carbapenem Sterile bulk drugs (API) to tune of 46.2

TPA and lyophilization in vials Ertapenem for injection

of 6 millions vials. Thus, there will be no major change

in the production and manufacturing processes.

1.14 Facilities for storage of goods

or materials?

No Existing building area will be utilized for the storage of

goods and material. Therefore, no impacts are

envisaged.

1.15 Facilities for treatment or

disposal of solid waste or

liquid effluents?

No Liquid effluents:-

Water from boiler and cooling tower will be in

continuous loop during the process. The blow down

from boiler and cooling tower, and process wastewater

will be treated in ETP.

Domestic Wastewater generation 12 KLD, which will be

treated in STP (based on MBR) and treated water will

sent to ETP.

Industrial waste water generation will be 60 KLD & the

same will be treated in ETP

Solid waste generated as sludge from ETP will be send

to approved common dumping yard situated at UCCI,

Udaipur.

Spent Solvents / Mother Liquor generated in process

will be either recovered in house or sent to outside

8

Project: Auronext Pharma Pvt Ltd Form- 1

approved vendor for recovery & reuse or sold as such

1.16 Facilities for long term housing

of operational workers?

No There is no housing facility provided as locals will be

deployed as workers.

1.17 New road, rail or sea traffic

during construction or

operation?

No Not required for the proposed project

1.18 New road, rail, air waterborne

or other transport

infrastructure including new or

altered routes and stations,

ports, airports etc?

No There is no requirement of new rail, air borne transport

infrastructures for the project as the unit is coming up

in well established RIICO industrial area. .

1.19 Closure or diversion of existing

transport routes or

infrastructure leading to

changes in traffic movements?

No Due to the modification of project, there is no closure of

existing transport routes or infrastructures leading to

changes in traffic movements. Thus, no impact is

envisaged on physical environment.

1.20 New or diverted transmission

lines or pipelines?

No Exiting unit has contract demand of 1525 KVA and

transformer of 2000 KVA. After modification there will

be increase in contract demand to 2500 KVA &

Transformer to 2500 KVA will be installed.

No additional power transmission line is required for the

proposed modification of exiting plant. Hence, there will

be no impact on the physical environment of the area

due to the additional power demand.

1.21 Impoundment, damming,

culverting, realignment or

other changes to the

hydrology of watercourses or

aquifers?

No No such activity is taking place.

1.22 Stream crossings? No Not applicable

1.23 Abstraction or transfers of

water from ground or surface

waters?

Yes Daily fresh water demand after the proposed Expansion

project is 100 KLD. Water demand of the industry will

be met partially through RIICO water supply and

partially through ground water. The load on the ground

water will be balanced by constructing the rain water

harvesting structures. However, marginal impact is

envisaged due to the proposed project.

1.24 Changes in water bodies or

the land surface affecting

No There is no change in the land surface of the exiting

site as the unit will utilize the existing building area

9

Project: Auronext Pharma Pvt Ltd Form- 1

drainage or run-off? only.

There are no water bodies in the study area of 10 km

radius. Thus, no impact is envisaged.

1.25 Transport of personnel or

materials for construction,

operation or

decommissioning?

Yes Due to the proposed modification of project, there is

movement of material and manpower involving

movement of vehicles in and out of the plant. About 2-3

trucks/ day will go in out of the unit thus, contributing

to fugitive emissions and noise in the area. This will be

effectively managed by proper plantation and

maintenance of vehicle. Thus, insignificant impact is

envisaged on physical environment.

1.26 Long-term dismantling or

decommissioning or

restoration works?

No Not required for the proposed project.

1.27 Ongoing activity during

decommissioning which could

have an impact on the

environment?

No Not applicable

1.28 Influx of people to an area in

either temporarily or

permanently?

No The unit will employ local workers only. Thus, there will

be no influx of people either temporarily or

permanently.

1.29 Introduction of alien species? No None

1.30 Loss of native species or

genetic diversity?

No The species recorded in the project area are widely

distributed in the area and not restricted to certain

pockets. So there is no loss of native species or genetic

diversity as such.

1.31 Any other actions? No None

2. Use of Natural resources for construction or operation of the Project (such as land,

water, materials or energy, especially any resources which are non-renewable or in

short supply:

Information/checklist

confirmation

Yes

/

No

Details thereof (with approximate quantities

/rates, wherever possible) with source of

information data

2.1 Land especially undeveloped

or agricultural land (ha)

No No undeveloped and agricultural land is acquired for the

project. The proposed Expansionproject is coming up in

well established notified industrial area.

10

Project: Auronext Pharma Pvt Ltd Form- 1

2.2 Water (expected source &

competing users) unit: KLD

Yes Daily fresh water demand is 100 KLD. Water demand of

the industry will be met partially through RIICO water

supply and partially through ground water. The breakup

of the same is given as under:-

S.No. Purpose Quantity

KLD

1. Industrial Purpose 85

2. Domestic purpose 15

3 Daily fresh water 100

The application for NOC for abstraction of ground water

has been submitted to CGWA on 06/08/2015 and

receipt of the same is enclosed at Annexure-III.

2.3 Minerals (MT) No There is no use of minerals in the proposed Expansion

project.

2.4 Construction material – stone,

aggregates, sand / soil

(expected source – MT)

No --

2.5 Forests and timber (source –

MT)

No --

2.6 Energy including electricity

and fuels (source, competing

users) Unit: fuel (MT), energy

(MW)

Yes • Exiting unit has contract demand of 1525 kVA and

transformer of 2000 kVA. After modification there will

be increase in contract demand to 2500 kVA &

Transformer to 2500 kVA utilized.

• The unit has two D.G. set of 500 kVA. Further, the

unit will install either four D.G. set of 500 kVA or two

of 1000 kVA or two of 500 kvA & one of 1000 KVA.

2.7 Any other natural resources

(use appropriate standard

units)

No None

3. Use, storage, transport, handling or production of substances or materials, which

could be harmful to human health or the environment or raise concerns about actual

or perceived risks to human health.

S.

No.

Information/Checklist

confirmation

Yes

/

No

Details thereof (with approximate

quantities/rates, wherever possible) with source

of information data

11

Project: Auronext Pharma Pvt Ltd Form- 1

3.1 Use of substances or

materials, which are

hazardous (as per MSIHC

rules) to human health or the

environment (flora, fauna, and

water supplies)

No The storage, transport, handling, etc. of hazardous

substances is within the threshold limit as per MSIHC.

Thus there will be no harm to human health or the

environment.

3.2 Changes in occurrence of

disease or affect disease

vectors (e.g. insect or water

borne diseases)

No Proper housekeeping will be maintained to ensure that

no waste water stagnation occurs inside and outside the

plant premises. The wastewater generated from

industrial process will be treated in ETP.

The wastewater generated from domestic purpose will

be treated in the STP based MBR and Treated water

will be sent to common ETP.

3.3 Affect the welfare of people

e.g. by changing living

conditions?

Yes The socio-economic welfare of the people will be

through the proposed additional development in the

area contributing to employment opportunities and

enterprises social commitments. There will be positive

impact due to the proposed modifications as additional

man power of 100 number will be required for the

proposed modification.

3.4 Vulnerable groups of people

who could be affected by the

project e.g. hospital patients,

children, the elderly etc.,

No --

3.5 Any other causes No --

4. Production of solid wastes during construction or operation or decommissioning

(MT/Month)

S.No Information/Checklist

confirmation

Yes

/

No

Details thereof (with approximate

quantities/rates, wherever possible) with source

of information data

4.1 Spoil, overburden or mine

wastes

No Not applicable

4.2 Municipal waste (domestic and

or commercial wastes)

No --

4.3 Hazardous wastes (as per

Hazardous Waste Management

Rules)

Yes The details of hazardous wastes generated during

operation phase are as under :

12

Project: Auronext Pharma Pvt Ltd Form- 1

S.

No.

Hazardous

waste

Description

Category

as per

HWMR

rules

Qty

generated

/Annum

Unit Method of disposal

1. ETP sludge

a) Chemical

sludge from ETP

34.3 5 Ton

It will be sent to UCCI at

Udaipur for proper treatment

and disposal.

2. Spent Oil &

Used oil 5.1 & 5.2 1000 Lit

It will be disposed through

authorized disposer.

3. Process residue

and waste 28.1 1 Ton

It will be disposed in-house in

process effluent treatment

plant (Mixed with process

effluent)

4. Spent

catalyst/carbon 28.2 3.6 Ton

It will be sent to UCCI at

Udaipur for proper treatment

and disposal.

5. Off specification

products/raw

material

28.3 0.2 Ton

It will be sent to UCCI at

Udaipur for proper treatment

and disposal.

6. Expiry

drugs/medicines

28.4 0.25 Ton

It will be disposed in-house in

process effluent treatment

plant (Mixed with process

effluent)

7. Spent solvent

1500 Ton

It will be disposed/sale through

authorized Disposer

8. Liner/Packing

Material

/glass vials

2 Ton

It will be sent to UCCI at

Udaipur /for Inceneration for

Proper treatment

9. Lead Batteries

waste 2 Ton

It will be disposed/sale through

authorized Disposer

10. Electronic

,computer items 1 Ton

It will be disposed/sale through

authorized Disposer

11. CFL/Led etc

waste 1 Ton

It will be disposed/sale through

authorized Disposer

4.4 Other industrial process

wastes.

No --

4.5 Surplus product. Yes The manufactured intermediates drugs, after expiry

date need to be stored separately.

4.6 Sewage sludge or other sludge

from effluent treatment.

Yes ETP sludge will be produced to the tune of 5000

kg/annum which will be transported to CTDF Udaipur

(Raj.)

4.7 Construction or demolition No None

13

Project: Auronext Pharma Pvt Ltd Form- 1

wastes.

4.8 Redundant machinery or

equipment.

No None

4.9 Contaminated soils or other

materials.

No None

4.10 Agricultural wastes. No None

4.11 Other solid wastes. No None

5. Release of pollutants or any hazardous, toxic or noxious substances to air (Kg/hr)

S.

No.

Information/Checklist

confirmation

Yes

/

No

Details thereof (with approximate

quantities/rates, wherever possible) with source

of information data

5.1 Emissions from combustion of

fossil fuels from stationary or

mobile sources.

Yes There will be following source of emission after

modification:-

S.N

o

Source Management

1. Two D.G. set

of 500 kVA

each and

proposed four

D.G. set of

500 kVA-HSD

to the tune of

160 ltr/hr will

be required

for D.G. set.

The D.G. set will be provided

with adequate safe stack

height of 30 m proper

dispersion of pollutants.

2. Existing unit

has used

Boiler 2

Tonne. After

modification

there will be

increase in

Boiler

Capacities

4Tonne

Stack of 30 m height is

installed with Wet Scrubber.

5.2 Emissions from production

processes.

Yes The source of emissions from the proposed expansion

unit is as under:

S.No. Source Management

1 Boiler (4 TPH)

Emission are SPM,

CO, and SOX

Stack of Wet

Scrubber followed

by stack of 30 m

height

14

Project: Auronext Pharma Pvt Ltd Form- 1

2. D.G. Set- six DG sets

of 500 kVA each

The D.G. set will be

provided with

adequate safe

stack height of 4.5

m above the roof of

the D.G. house to

regulate the

emission within the

permissible norms

The reaction is conducted in closed reactors, and

filtration equipment. The transfer of materials will be

through closed pipelines

5.3 Emissions from materials

handling including storage or

transport

No The material handling and transportation may

contribute to fugitive emissions.

To control the fugitive emissions in proposed unit,

following measures will be adopted:-

Storage and material handling will be carried out in PUC

Certified trucks (1-2 trucks/day).

Ambient air quality and stack emissions will be

regularly monitored to ensure that the stipulated

standards are maintained.

5.4 Emissions from construction

activities including plant and

equipment

No No construction activities are involved.

5.5 Dust or odors from handling of

materials including

construction materials,

sewage and waste.

No During manufacturing process odour will be generated.

The unit will take mitigation measures to control the

same.

5.6 Emissions from incineration of

waste

No No such activity is proposed.

5.7 Emissions from burning of

waste in open air (e.g. slash

materials, construction debris)

No No such activity is proposed.

5.8 Emissions from any other

sources

No None

6. Generation of Noise and Vibration, and Emissions of Light and Heat:

15

Project: Auronext Pharma Pvt Ltd Form- 1

S.No. Information/Checklist

confirmation

Yes

/

No

Details thereof (with approximate

quantities/rates, wherever possible) with source

of information data

6.1 From operation of equipment

e.g. engines, ventilation plant,

crushers

No None

6.2 From industrial or similar

processes

No Operation of boiler, material handling (raw material &

product) is source of noise pollution.

Proper designed silencer and noise absorbent acoustic

paneling will be fitted between the source & receptor

(DG sets, machineries / equipments & pumps, fans,

compressors) to reduce noise levels.

6.3 From construction and

demolition

No No construction activities are involved.

6.4 From blasting or piling No Not applicable

6.5 From construction or

operational traffic

No During operation phase, raw material and products will

be transported at the peak time of the day.

PUC checked vehicle will be used for transportation

purposes.

33% of plant area will be under green cover with local

plant and trees species, the same will be maintained

after modifications.

6.6 From lighting or cooling

systems

No No, significant contribution of noise/vibration is from

cooling tower.

6.7 From any other sources No None

7. Risks of contamination of land or water from releases of pollutants into the ground or

into sewers, surface waters, groundwater, coastal waters or the sea:-

S.

No.

Information/Checklist

confirmation

Yes

/

No

Details thereof (with approximate

quantities/rates, wherever possible) with source

of information data

7.1 From handling, storage, use or

spillage of hazardous materials

No The raw materials viz Acetone and isopropyl Alcohol will

be used in the process are classified under MSIHC Rules

1989. The list of the same is given above point no. 3.1.

The chemicals handling will be done systematically.

Since, the use of these chemicals are confined, the risk

due to the same will also be limited.

16

Project: Auronext Pharma Pvt Ltd Form- 1

7.2 From discharge of sewage or

other effluents to water or the

land (expected mode and

place of discharge)

No The unit will be zero discharge unit. Thus, there will be

no discharge of sewage or other effluent to water or the

land.

7.3 By deposition of pollutants

emitted to air into the land or

into water.

No • The unit will have both point source as well as area

source emission.

• Process emission will be controlled by installing the

primary and secondary condensers with brine

circulation and handling of solvent will be through

flame proof pumps.

• Alkaline scrubber will be installed to control acidic

emissions from the process. Thus, there will be no

deposition of pollutant on land or water body.

7.4 From any other sources. No There are no other sources, which contaminates land

and water resources.

7.5 Is there a risk of long term

build up of pollutants in the

environment from these

sources?

No Adequate pollution control equipments will be installed

which will keep the emission within the level as per the

norms.

The plant will be equipped with air pollution control

equipments as discussed in previous sections.

However, there is always a risk of long term build up of

pollutants in the environment.

8. Risk of accidents during construction or operation of the project, which could affect

human health or the environment

S.

No.

Information/

Checklist confirmation

Yes

/

No

Details thereof (with approximate

quantities/rates, wherever possible) with source

of information data

8.1 From explosions, spillages,

fires etc from storage,

handling, use or production of

hazardous substances

No Various chemicals will be used in the process. These

chemical will be used by trained & skilled staff and

appropriate action as defined in material safety data

sheet will be followed.

8.2 From any other causes No --

8.3 Could the project be affected

by natural disasters causing

environmental damage (e.g.

floods, earthquakes,

landslides, cloudburst etc)?

No The project is located in seismic zone-IV, High damage

risk zone (MSK VIII), there are no reports of landslide

and earthquake in the area so far.

17

Project: Auronext Pharma Pvt Ltd Form- 1

9. Factors which should be considered (such as consequential development) which could

lead to environmental effects or the potential for cumulative impacts with other

existing or planned activities in the locality

S.

No.

Information/Checklist

confirmation

Yes

/

No

Details thereof (with approximate

quantities/rates, wherever possible) with source

of information data

9.1 Lead to development of

supporting cities, ancillary

development or development

stimulated by the project

which could have impact on

the environment e.g.:

Supporting infrastructure

(roads, power supply, waste

or waste water treatment,

etc.)

housing development

extractive industries supply

industries other

Yes The proposed project will generate growth of the

externalities in the surrounding area, for example-

demand for communication facilities; local commuting

taxis, etc. as there will be regular movement of

employees in the area. Thus, there will be positive

impact due the project.

9.2 Lead to after use of the site,

which could have an impact on

environment

No Not Applicable

9.3 Set a precedent for later

developments

Yes The proposed Expansion project shall provide value

chain addition in the similar kind of industries in the

industrial area, which will indirectly lead to further

development of the area. Thus, will have positive

impact.

9.4 Have cumulative effects due to

proximity to other existing or

planned projects with similar

effects

No The project is coming up in notified industrial area

II Environmental Sensitivity (within 15 km radius) –

S.

N

o

Areas Name/ Identity

Aerial distance (within 15 km)

proposed project location

boundary

1 Areas protected under

international conventions,

national or local legislation for

None --

18

Project: Auronext Pharma Pvt Ltd Form- 1

their ecological, landscape,

cultural or other related value

2 Areas which are important or

sensitive for ecological

reasons - Wetlands,

watercourses or other water

bodies, coastal zone,

biospheres, mountains,

forests

Rangla Reserve Forest 2.75km NNE

Chaupanki PF 8.20 km SE

Godhan PF 2.08 km S

Indauri Nala 5.66 km NE

3 Areas used by protected,

important or sensitive

species of flora or fauna for

breeding, nesting, foraging,

resting, over wintering,

migration.

None --

4 Inland, coastal, marine or

underground waters

None --

5 State, National boundaries Rajasthan-Haryana interstate

boundary

1.5 Km towards ENE.

6 Routes or facilities used by

the public for access to

recreation or other tourist,

pilgrim areas

None --

7 Defense installations None --

8 Densely populated or built-up

area

Bhiwadi Town 2.47 km towards W

9 Areas occupied by sensitive

man-made land uses

(hospitals, schools, places of

worship, community facilities)

Hospitals, recreational places,

temples, shops, educational

institution facilities are well

developed in Bhiwadi.

Within 2.0 km.

10 Areas containing important,

high quality or scarce

resources (ground water

resources, surface resources,

forestry, agriculture, fisheries,

tourism, minerals)

None --

11 Areas already subjected to

pollution or environmental

None --

19

Project: Auronext Pharma Pvt Ltd Form- 1

damage. (those where

existing legal environmental

standards are exceeded)

12 Areas susceptible to natural

hazard which could cause the

project to present

environmental problems

(earthquakes, subsidence,

landslides, erosion, flooding

or extreme or adverse

climatic conditions)

None The project is located in seismic

zone-IV, High damage risk zone

(MSK VIII), there are no reports

of landslide and earthquake in the

area so far.

"I hereby give undertaking that the data and information given in the application and

enclosure are true to the best of my knowledge and belief and I am aware that if any

part of the data and information submitted is found to be false or misleading at any

stage, the project will be rejected and clearance give, if any to the project will be

revoked at our risk and cost.

Date: 17/12/2015

Place: Bhiwadi

N.K. Jain

(Authorized Signatory)

Auronext Pharma Pvt Ltd.

A-1128, RIICO Industrial Area

Phase-III’ Bhiwadi,

Distt. Alwar, Rajasthan.

Project: Auronext Pharma Pvt Ltd. Section-I/ Introduction Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

20

SECTION-I

INTRODUCTION

INDEX

INTRODUCTION.................................................................................................... 20

1.1 PREAMBLE ...................................................................................................... 21

1.2 GENERAL INFORMATION ON PHARMACEUTICAL INDUSTRIES ................................ 21

1.3 ENVIRONMENTAL CLEARANCE PROCESS ............................................................. 23

1.4 COMPLIANCE TO TERMS OF REFERENCE ............................................................. 25

1.5 GENERIC STRUCTURE OF ENVIRONMENTAL IMPACT ASSESSMENT ........................ 44

1.6 POST ENVIRONMENTAL CLEARNCE MONITORING ................................................ 45

1.7 IDENTIFICATION OF PROJECT PROPONENT ......................................................... 45

1.8 BRIEF DESCRIPTION OF THE PROJECT ............................................................... 46

1.9 LOCATION OF THE PROJECT .............................................................................. 47

1.10 INFRASTRUCTURE ............................................................................................ 48

1.11 ENVIRONMENTAL IMPACT ASSESSMENT REPORT ................................................. 48

1.12 SCOPE OF WORK……………………………………………………………………………………………………. 49

*************

Project: Auronext Pharma Pvt Ltd. Section-I/ Introduction Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

21

INTRODUCTION

1.1 PREAMBLE

The word “Environment” is defined to include everything external to man /organism. It

covers the region, surroundings, or circumstances in which anything exists. Environment

is an important and essential part of the development. It plays an essential role in

overall development of the country. Development, which keeps environment with itself,

called sustainable development. Today, environment is degrading and exploiting by

many ways. Thus, the Ministry of Environment & Forest (MoE&F) had formulated its

policies & rules and made new policies & rules regarding operation of the industries to

achieve sustainable development and to prevent slapdash exploitation of natural

resources. Gazette Notification (14th Sept. 2006 and subsequent amendment) is the part

of it.

Preparation of Environment Impact Assessment report is now essential for similar kind of

pharmaceutical industry. An Environmental Impact Assessment (EIA) is an assessment

of the possible impact—positive or negative—that a proposed project may have on the

environment, together consisting of the natural, social and economic aspects

Environmental Impact Assessment (EIA) is a tool used to identify the environmental,

social and economic impacts of a project prior to decision-making. It is said to be the

instruments through which the environmental management tries to accomplish its

objective. It aims to predict environmental impacts at an early stage in project planning

and design, find ways and means to reduce adverse impacts, shape projects to suit the

local environment and present the predictions and options to decision-makers.

By using EIA both environmental and economic benefits can be achieved, such as

reduced cost and time of project implementation and design, avoided treatment/clean-

up costs and impacts of laws and regulations.

The key elements of an EIA are (a) Scoping: identify key issues and concerns of

interested parties; (b) Screening: decide whether an EIA is required based on

information collected; (c) Identifying and evaluating alternatives: list alternative

sites and techniques and the impacts of each; (d) Mitigating measures submitting

with uncertainty: review proposed action to prevent or minimize the potential adverse

effects of the project; and (e) Issuing environmental statements report the findings

of the EIA.

1.2 GENERAL INFORMATION ON PHARMACEUTICAL INDUSTRIES

The Indian Pharmaceutical Industry today is in the front rank of India’s science-based

industries with wide ranging capabilities in the complex field of drug manufacture and

technology. It ranks very high in the third world, in terms of technology, quality and

range of medicines manufactured. From simple headache pills to sophisticated antibiotics

and complex cardiac compounds, almost every type of medicine is now made

Project: Auronext Pharma Pvt Ltd. Section-I/ Introduction Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

22

indigenously. The pharmaceutical industry in India meets around 70% of the country's

demand for sterile bulk drugs, drug intermediates, pharmaceutical formulations,

chemicals, tablets, capsules, orals and injectibles.

Growth Scenario

The Indian pharmaceutical industry ranks third globally by volume of production and

accounts for around 10% of the global production. Low cost and skilled manpower are

key factors supporting growth of the Indian pharmaceutical industry. According to the

Department of Pharmaceuticals, the Indian pharmaceutical industry employs around

350,000 people. Pharmaceuticals Industry in India is expected to be worth US$ 55.39

billion by 2020. Indian pharmaceuticals market is expected to grow at a CAGR of 18% by

2020 driven by the aging and growing population, rising income levels, emerging

medical conditions and new diseases.

Fig 1.1: Growth of Indian Pharmaceutical industry

Future Growth

India will see the largest number of merger and acquisitions (M & A) in the

pharmaceutical and health care sector, according to consulting firm Grant Thornton. A

survey conducted across 100 companies has revealed that one-fourth of the respondents

were optimistic about acquisitions in the pharmaceutical sector. The growth of Indian

Pharma companies will also be driven by the fastest growing molecules in the diabetes,

skin care, and eye care segment.

Characteristics of Indian Pharmaceutical Industry

The Indian Pharmaceutical sector is highly fragmented with more than 20,000 registered

units. It has expanded drastically in the last two decades. The leading 250

pharmaceutical companies control 70% of the market with market leader holding nearly

Project: Auronext Pharma Pvt Ltd. Section-I/ Introduction Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

23

7% of the market share. It is an extremely fragmented market with severe price

competition and government price control.

1.3 ENVIRONMENTAL CLEARANCE PROCESS

The proposed expansion project is categorized under B of 5 (f) {Synthetic organic

chemicals industry (dyes & dye intermediates; sterile bulk drugs and

intermediates excluding drug formulations; synthetic rubbers; basic organic chemicals,

other synthetic organic chemicals and chemical intermediates)} column 4 as per the

amendment dated 01.12.09 and 04.04.2011 of the Gazette Notification of Sept. 14th

2006. But, as per the Gazette Notification mentioned above, the project/activity falls

under “A” Category because the project attracts general condition that any project or

activity specified under Category ‘B’ will be treated as Category A. The interstate

boundary of Rajasthan and Haryana 1.54 km towards ENE from the project site

The process for obtaining Environmental Clearance for the proposed projects as per EIA

Notification – 2006 is as under:-

Project: Auronext Pharma Pvt Ltd. Section-I/ Introduction Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

24

Figure No. 1.2

Environmental Clearance process chart

TOR approved by EAC

Draft EIA report to SPCB by project proponent

To proponent for submission of final EIA report/Supplementary

report to draft EIA

Approval by MOEF

Project Concept

Form 1, Pre-feasibility project report with proposed TOR to EAC

Scoping by EAC (site visit by sub group of EAC, if necessary)

EC- rejected by MOEF on the recommendation of EAC

Public consultation process by SPCB

Summary EIA and Form 1 – display on the website by SPCB

Proceedings of public consultation

Display at Panchayat, ZP, DM/ DC/ Dy. Com & on the

SPCB website

Appraisal and recommendation by EAC

Referred back to EAC under communication to the project

proponent

Post EC monitoring Submission of half yearly

compliance report to MoE&F/RO-MoE&F

Display of compliance report on RO-MOEF website

Rejected Approved Display on MOEF website & project proponent website

Project: Auronext Pharma Pvt Ltd. Section-I/ Introduction Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

25

1.4 COMPLIANCE TO TERMS OF REFERENCE

The application for the Terms of Reference for “Auronext Pharma Pvt. Ltd.” – a

proposed Sterile bulk drugs change in product mix in existing EC & expansion

manufacturing unit has been submitted to MoEF on dated 14.08.2014. The 26th meeting

of EAC considered the project during its meeting held on 29th October 2014. Based on

the consideration of the documents and presentation, MoEF, Delhi prescribed the Terms

of Reference. The copy of issued TOR is enclosed as Annexure-I. The point raised in the

TOR issued by MOEF&CC, New Delhi is attended as under:-

TOR POINTS

MENTIONED IN

TOR ISSUED BY

MOE&F

IMPLEMENTATION PLAN

1 Executive

summary of the

project

The executive summary is included in EIA/EMP report as

Section- XI.

2 Justification of the

project

Auronext Pharma Pvt. Ltd. is an existing pharmaceutical,

sterile bulk drugs (API) & formulations manufacturing plant

situated at A-1128, RIICO Industrial Area Phase-III,

Bhiwadi, Distt.-Alwar, Rajasthan. Presently, the unit is

manufacturing sterile bulk drug to tune of 38.4 TPA and vial

filling to the tune of 30 million vials numbers per annum.

Now, the unit is proposing to replace existing product

Ampicillin Sodium Sterile by a Carbapenem Sterile bulk

drugs (API) to tune of 46.2 TPA and lyophilization in vials

Ertapenem for injection of 6 millions vials. The proposed

capital investment for the Expansion is Rs. 40 Crores. The

modification will take place in the existing land area of

10112 sq. m. the unit will replace existing boiler of 2 TPH

with boiler of 4 TPH. The Inter-state boundary (Haryana

and Rajasthan) is 1.54 km towards ENE from the site.

Project: Auronext Pharma Pvt Ltd. Section-I/ Introduction Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

26

3 Promoters and

their back ground.

Aurobindo Pharma Ltd. had acquired M/s Deepharma Ltd.

about 20 yrs Old Unit which is located in Bhiwadi, Dist.

Alwar (Rajasthan), approximately 70 km away from Delhi.

M/s Deepharma Limited was holding Environmental

Clearance for MoEF for manufacturing of Sterile bulk drugs

38.4 Mt & 30 million vials. It is decided to rebuild the total

facility for it to produce 4th Generation Antibiotics - PENEMS

Category of Products for Regulated, Emerging Export

Markets and Domestic market. This Category of Products

are to be produced in dedicated facility, so to get approvals

in US, EU & ROW. This unit is launched on a new Name, M/s

AURONEXT. It is subsidiary of Aurobindo group. Unit was

planned to erected & commissioned in two phases.

4 Regulatory

framework

The Unit has obtained DIC certificate (IEM no

3002/SIA/IMO/2009 dated 23/11/2009 amended 16/05/14

– for Formulation of Dry Powder injection & Lyophlised vials

& 710/SIA/IMO/2010 dated 04/03/2010 amended on

16/05/2014 for Sterile Bulk Drugs /API from the Ministry of

Industry Department of Industrial Policy & promotion

secretariat of Industrial Assistance. Copy of the same is

enclosed at Annexure-II

The unit has already submitted application for obtaining

permission from CGWA for abstraction of ground water on

06/08/2015. The receipt of the same is enclosed as

Annexure III.

5 Environment

clearance for the

existing unit issued

by the Ministry

(reasons, if not

obtained), Consent

to Operate and

Authorization

accorded by the

RPCB.

The same has been already obtained from MOEF (Vide letter

no. dated) J-11012/69/95-IA.II (I) dated 22/05/1996

The copy of the EC, Consent to Operate and Authorization is

enclosed as Annexure IV

6 Copy of

NOC/Consent to

Copy of the same is enclosed as Annexure V

Project: Auronext Pharma Pvt Ltd. Section-I/ Introduction Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

27

Establish for the

existing unit.

7 Compliance to the

conditions

stipulated in the

NOC granted by

the SPCB.

Compliance of the same is enclosed as Annexure VI

8 Has the unit

received any

notice under the

Section 5 of

Environment

(Protection) Act,

1986 or relevant

Sections of Air and

Water Acts? If so,

compliance to the

notice(s).

NO

9 Data for the stack

emissions, fugitive

emissions; water

requirement and

water balance

chart; wastewater

generation, treated

effluent quality,

re-utilization and

disposal of

solid/hazardous

waste for the

existing unit.

Data for the stack emissions, fugitive emissions is enclosed

at annexure-VI –(A)

Water requirement : for the existing unit is 28 KLD and

water balance chart is enclosed at annexure-VI –(B)

Wastewater generation: 18 KLD from industrial process &

8 KLD from domestic uses. treated effluent quality report is

enclosed at annexure-VI(C)

Disposal of solid/hazardous waste for the existing unit:

Sr.

No

Types of

Hazardous waste

Category Qty Management

Sch Code

1 Spent

catalyst/spent

carbon

1 28.2 3600

kg/Yrs

CTDF Udaipur

2 Off

Specification product

1 28.3 125

kg/Yrs

CTDF Udaipur

3 Date expired

and discarded

and off specification

drug /medicines

1 28.4 150

kg/Yrs

CTDF Udaipur

Project: Auronext Pharma Pvt Ltd. Section-I/ Introduction Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

28

4 Discarded

containers/barrels/liners used

for hazardous waste

/chemicals

1 33.3 200

kg/Yrs

CTDF Udaipur

5 Chemical

sludge from WWT

1 34.3 1000

kg/Yrs

CTDF Udaipur

10 A map indicating

location of the

project and

distance from

severely polluted

area.

The map indicating location of the project is enclosed as

annexure-VII and distance from severely polluted area is

enclosed as Annexure VIII.

11 Project location

and plant layout.

Auronext Pharma Pvt. Ltd.

# A-1128, RIICO Industrial Area Phase-III, Bhiwadi, Distt.-

Alwar, Rajasthan.

The site falls in geological survey of India of toposheet No.

53D/15, 53D/16.Plant Layout is enclosed at Annexure-XX

NNW NNE

Latitude 28°12'2.66"N 28°12'2.14"N

Longitude 76°51'23.84"E 76°51'26.63"E

SSE SSW

Latitude 28°11'58.42"N 28°11'58.77"N

Longitude 76°51'25.92"E 76°51'23.05"E

12 Infrastructure

facilities including

power sources.

The project is a Sterile Bulk Drug & Formulation of Dry

powder filled & Lyophilised vials manufacturing unit –

Auronext Pharma Pvt. Ltd. situated up at A-1128, RIICO

Industrial Area Phase-III, Bhiwadi, Distt.-Alwar, Rajasthan.

RIICO Industrial Area has an established industrial base

comprising of many leading industries.

The RIICO assures uninterrupted power supply for

industries to be set up in the zone through its service

station within close proximity. The copy of the receipt is

enclosed as Annexure- IX.

There is also availability of semi-skilled/unskilled work force

from the vicinity at a relatively low rate.

13 Total cost of the The total capital cost for the proposed Expansion is Rs.

Project: Auronext Pharma Pvt Ltd. Section-I/ Introduction Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

29

project along with

total capital cost

and recurring

cost/annum for

environmental

pollution control

measures.

40.00 Crores

Total capital cost for environmental pollution control

measures is Rs. 259.0 lakhs and recurring cost /annum is

14.25 lakhs.

14 Project site

location along with

site map of 10 km

area and site

details providing

various industries,

surface water

bodies, forests etc.

Location of the project is given para 1.9 section- I of EIA

report.

15. Present land use

based on satellite

imagery for the

study area of 10

km radius. Details

of land availability

for the project

along with

supporting

document

Land use based on satellite imagery is given in Table 3.1

and landuse map is shown in figure 3.2 section –III of

EIA/EMP report.

The unit has acquired the land in RIICO Notified Industrial

Area. The copy of the land document is enclosed as

Annexure- X.

16 Location of

National Park/Wild

life

sanctuary/Reserve

forest within 10

km radius of the

project.

There are no national parks/Wild life sanctuaries within 10

km radius. The 10 km radius map is given in figure 1.2 of

section-I. The list of the reserve forest within the 15 km

radius is given below

Rangla Reserve Forest 3.0 km ENE

Tapkan PF 14.60 km ESE

Chaupanki PF 11.21 km SSE

Indaur RF 13.69 km SSE

Khori Kalan P.F. 11.00 km SSE

Godhan PF 4.0 km SSE

17 Permission from

the State Forest

Not applicable, as the proposed expansion is coming within

the notified Industrial area.

Project: Auronext Pharma Pvt Ltd. Section-I/ Introduction Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

30

Department

regarding the

impact of the

proposed plant on

the surrounding

reserve forests

18 Details of the total

land and break-up

of the land use for

green belt and

other uses.

Particulars Area (sq.

m)

Percentage

(%)

Plant Area, Office Area ( all

covered area)

4550.40 45

Paved Area ( Road,

Corridor, Parking and

drainage)

1213.40 12

Green Belt Area 3337 33

Open Area 1011.2 10

Total Plot area 10112 100

19 List of products

along with the

production

capacities.

S. No

Name of the

Product

Quantity

(Kg/ year)

1a Meropenem

Trihydrate Sterile

24000

1b Sodium Carbonate

Sterile

4000

Total 1(1a+1b) Meropenem for

Injection (Blend of

above product1a &

1b)

(Mixture of

Meropenem

Trihydrate Sterile &

Sod. Carbonate

Sterile)

28000

2a Imipenem

Monohydrate Sterile

7000

2b Cilastatin Sodium

Sterile

7200

2c Sodium Bicarbonate

Sterile

1000

Project: Auronext Pharma Pvt Ltd. Section-I/ Introduction Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

31

Total 2

(2a+2b+2c)

Imipenem & Cilastatin

for Injection (Blend of

above product2a, 2b

& 2c)

(Mixture of Imipenem

Monohydrate ,

Cilastatin Sodium &

Sodium Bi Carbonate

Sterile)

15200

3 Doripenem

Monohydrate Sterile

3000

Total (Worst case includes all Product ) 46200

4 Lyophilization in vials

of Ertapenem for

Injection

6 Millions

Vials

5 Filling of vials of dry

powder injection

(Formulation)

30 Millions

Vials

20 Detailed list of raw

material required

and source, mode

of storage.

List of raw material required and source, mode of storage.

are given para 2.4 of section II of EIA/EMP report.

21 Manufacturing

process details

along with the

chemical reactions

and process flow

chart.

Details are given in para 2.11 of section II of EIA report.

22 Action plan for the

transportation of

raw material and

products.

Action plan for the transportation of raw material and

products is given in section II of EIA-EMP report.

Project: Auronext Pharma Pvt Ltd. Section-I/ Introduction Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

32

23 Site-specific micro-

meteorological

data using

temperature,

relative humidity,

hourly wind speed

and direction and

rainfall is

necessary

Summary of the site specific meteorological data is given in

below.

Detailed of Site-specific micro-meteorological data(baseline

report) is enclosed as Annexure-XI

Month Temperature

(0C)

Relative

Humidity

(%)

Rainfall in

mm

Wind

Speed

mph

Max Min Max Min Max Total Max Min

December

- 2014 31.1 5.2 99.5 7.7 0 0 9.0 <1.0

January-

2015 29.5 2.7 99.5 9.4 0 0 9.0 <1.0

February

– 2015 30.8 5.8 86.3 6.8 0 0 8.0

<

1.0

24 Ambient air quality

monitoring at 6

locations within

the study area of 5

km., aerial

coverage from

project site as per

NAAQES notified

on 16th

September,

2009.Location of

one AAQMS in

downwind direction

Ambient air quality data of six locations within the study

area has been monitored for PM10, PM2.5, SO2, NOx, HC,

VOCs and details are given in para 3.5 of section- III. The

detailed (Baseline Report) is also enclosed as Annexure-

XI.

The details of the monitoring locations are given below:-

Location

Code

Location

Name Co-ordinates

AAQ- 1 Project Site Project Site N 28012’02.4” E

76051’24.4”

AAQ- 2 Belaheri Wahad S/o

Shadik pasha

N 28011’34.3” E

76052’10.0”

AAQ- 3 Bhiwari Ramesh S/o

Amarpal

N 28012’42.5” E

76050’26.9”

AAQ- 4 Milakpur Ranjith S/o

Jiayalal

N 28012’04.8” E

76049’38.2”

AAQ- 5 NH-71 Near BSNL Office N 28012’46.2” E

76051’42.4”

AAQ- 6 Khajuriwas Eshwar S/o

Bodanram

N 28010’37.6” E

76049’24.1”

Project: Auronext Pharma Pvt Ltd. Section-I/ Introduction Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

33

25. One season site-

specific micro-

meteorological

data using

temperature,

relative humidity,

hourly wind speed

and direction and

rainfall and AAQ

data (except

monsoon) for

PM2.5, PM10, SO2,

NOx, CO, NH3

including VOCs

shall be collected.

The monitoring

stations shall take

into account the

pre-dominant wind

direction,

population zone

and sensitive

receptors including

reserved forests.

Data for water and

noise monitoring

shall also be

included.

The detailed (baseline monitoring report): One season site-

specific micro-meteorological data, AAQ data for PM2.5,

PM10, SO2, NOx, CO, HC including VOCs & water and noise

monitoring data is enclosed as Annexure- XI.

26 Details of water

and air pollution

and its mitigation

plan

Details of water and air pollution and its mitigation plan are

given in para 4.3,& 4.4 of section IV

27 Air pollution

control measures

proposed for the

effective control of

gaseous/process

The details of the Air pollution control measures are given in

para 4.3 Section- IV of EIA-EMP report.

Project: Auronext Pharma Pvt Ltd. Section-I/ Introduction Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

34

emissions within

permissible limits.

28 An action plan

prepared by SPCB

to control and

monitor secondary

fugitive

emissions from all

the sources.

Not applicable

29. Determination of

atmospheric

inversion level at

the project site

and assessment of

ground level

concentration of

pollutants from the

stack emission

based on site

specific

meteorological

features. Air

quality modelling

for proposed plant.

Due to polar tropopause, ground inversion is common in

north of 200N after sunset and after sunrise. The lapse rate

is least (4°C km-1) at 850 mb and 700 mb. However, the

24 hrs windrose includes all the stability clauses and depict

the possibility of inversion if any. The lapse rate in the

entire north western India is governed by Siberian High and

influencing factors are upper air quality. Only IMD Pune has

the facility to do so. This is however required only at

elevated point emission sources only.

Assessment of ground level concentration of pollutants from

the stack emission based on site- specific micro

meteorological features are given in Section-IV vide item

no. 4.2.2 of the EIA/EMP Report.

30. Name of all the

solvents to be

used in the

process and details

of solvent recovery

system

Name of all the solvents to be used in the process are:

Methanol/ Ethanol, Isopropyl Alcohol, Acetone and recovery

system is mix solvent & water sold as such to approved

vendor or purified and reuse.

31. Design details of

ETP, incinerator, if

any along with

boiler,

scrubbers/bag

filters etc.

The details of air and water pollution are given in Para 4.4,

Section- IV of EIA/EMP report.

32. Action plan to The details of the same are given in Para 4.3.3 of Section-

Project: Auronext Pharma Pvt Ltd. Section-I/ Introduction Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

35

control ambient air

quality as per

NAAQS Standards

notified by the

Ministry on 16th

September, 2009.

IV of EIA/EMP report.

33. Source and

permission from

Competent

Authority for the

drawl of water.

Water balance

chart including

quantity of effluent

generated recycled

and reused and

effluent discharge

The unit had already submitted application for obtaining

permission from CGWA for abstraction of groundwater, The

receipt of the same is enclosed as Annexure III. Water

balance chart including quantity of effluent generated

recycled and reused and effluent discharge is given Para

2.7, section –II of EIA report.

34. Complete scheme

of effluent

treatment.

Characteristics of

untreated and

treated effluent to

meet the standard

Details are given in Para 4.4, Section IV of EIA/EMP report.

35. Zero discharge

effluent concepts

to be adopted

Zero waste water discharge

36. Ground water quality

monitoring minimum

at 6 locations shall

be carried out.

Geological features

and Geo-hydrological

status of the study

area and ecological

status (Terrestrial

and Aquatic).

Ground water was monitored at 6 locations and the results

are given in table 3.12 of section –III. Detailed geological

features and Geo-hydrological report of the study area is

enclosed at annexure-XII. Detailed ecological status

(Terrestrial and Aquatic) of the study area are given 3.8 of

section III.

37. The details of solid The details of solid and hazardous wastes generation,

Project: Auronext Pharma Pvt Ltd. Section-I/ Introduction Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

36

and hazardous

wastes generation,

storage, utilization

and disposal

particularly related

to the hazardous

waste calorific

value of hazardous

waste and detailed

characteristic of

the hazardous

waste.

storage, utilization and disposal are given below:

S.

No.

Haz.

waste

Descr

iption

Catego

ry as

per

HWMR

rules

Qty

gener

ated

/Ann

um

Unit Method of

disposal

1.

ETP

sludge

a)

Chemi

cal

sludge

from

ETP

34.3 5 Ton

It will be sent

to UCCI at

Udaipur for

proper

treatment and

disposal.

2.

Spent

Oil &

Used

oil

5.1 &

5.2 1000 Lit

It will be

disposed

through

authorized

disposer.

3.

Proces

s

residu

e and

waste

28.1 1 Ton

It will be

disposed in-

house in

process effluent

treatment plant

(Mixed with

process

effluent)

4.

Spent

cataly

st/car

bon

28.2 3.6 Ton

It will be sent

to UCCI at

Udaipur for

proper

treatment and

disposal.

5.

Off

specifi

cation

produc

ts/raw

materi

al

28.3 0.2 Ton

It will be sent

to UCCI at

Udaipur for

proper

treatment and

disposal.

6. Expiry

drugs/28.4 0.25 Ton

It will be

disposed in-

Project: Auronext Pharma Pvt Ltd. Section-I/ Introduction Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

37

medici

nes

house in

process effluent

treatment plant

(Mixed with

process

effluent)

7.

Spent

solven

t

1500 Ton

It will be

disposed/sale

through

authorized

Disposer

8.

Liner/

Packin

g

Materi

al

/glass

vials

2 Ton

It will be sent

to UCCI at

Udaipur /for

Inceneration for

Proper

treatment

9.

Lead

Batteri

es

waste

2 Ton

It will be

disposed/sale

through

authorized

Disposer

10.

Electro

nic

,comp

uter

items

1 Ton

It will be

disposed/sale

through

authorized

Disposer

11.

CFL/Le

d etc

waste

1 Ton

It will be

disposed/sale

through

authorized

Disposer

38. Material Safety

Data Sheet for all

Material Safety Data Sheet for all the Chemicals are

enclosed as Annexure- XIII

Project: Auronext Pharma Pvt Ltd. Section-I/ Introduction Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

38

the Chemicals are

being used/will be

used.

39. Authorization/Mem

bership for the

disposal of

solid/hazardous

waste in TSDF.

UCCI Member ship Attached at Annexure- XIV

40. Risk assessment

for storage for

chemicals/solvents

. Action plan for

handling & safety

system.

Risk assessment and disaster management plan is

discussed in section-VII

41. An action plan to

develop green belt

in 33 % area.

Layout plan for

green belt shall be

provided.

Details are given in para 10.4 Section X of EIA/EMP Report

42. Action plan for

rainwater

harvesting

measures at plant

site shall be

included to harvest

rainwater from the

roof tops and

storm water drains

to recharge the

ground water.

Details are given in para 4.9 of section –IV.

43. Details of

occupational

health

programme;

a) To which

chemicals, workers

The details of the same are given in para no 7.8 of Section-

VII of EIA/EMP report.

Project: Auronext Pharma Pvt Ltd. Section-I/ Introduction Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

39

are exposed

directly or

indirectly.

b) Whether these

chemicals are

within Threshold

Limit Values

(TLV)/Permissible

Exposure Levels as

per ACGIH

recommendation.

c) What measures

company have

taken to keep

these chemicals

within PEL/TLV.

d) How the

workers are

evaluated

concerning their

exposure to

chemicals during

pre-placement and

periodical medical

monitoring.

e) What are onsite

and offsite

emergency plan

during chemical

disaster.

f) Liver function

tests (LFT) during

pre-placement and

periodical

examination.

g) Details of

occupational

The details of the same are given in para no 7.8 of Section-

VII of EIA/EMP report.

Project: Auronext Pharma Pvt Ltd. Section-I/ Introduction Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

40

health surveillance

programme.

44. Socio-economic

development

activities shall be

in place.

The Socio-economic development activities are given in

point No 7.9 of section-VII,

45 At least 5 % of the

total cost of the

project should be

earmarked

towards the

Enterprise Social

Commitment

based on Public

Hearing issues and

item-wise details

along with time

bound action plan

should be prepared

and incorporated

The details of the same are given in para no 7.9 of Section-

VII.

46. Note on

compliance to the

recommendations

mentioned in the

CREP guidelines

The CREP guidelines for pharmaceuticals are enclosed as

Annexure XV of EIA-EMP Report.

47. Detailed

Environment

management Plan

(EMP) with specific

reference to details

of air pollution

control system,

water &

wastewater

management,

monitoring

frequency,

Detailed Environment management Plan (EMP) with specific

reference to details of air pollution control system, water &

wastewater management, monitoring frequency,

responsibility and time bound implementation plan for

mitigation measure shall be provided are given in Section X

of EIA/ETP report.

Project: Auronext Pharma Pvt Ltd. Section-I/ Introduction Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

41

responsibility and

time bound

implementation

plan for mitigation

measure shall be

provided

48. EMP shall include

the concept of

waste-

minimization,

recycle / reuse /

recover

techniques, Energy

conservation, and

natural resource

conservation.

Detailed Environment management Plan (EMP) with specific

reference to details of the concept of waste-minimization,

recycle / reuse / recover techniques, Energy conservation,

and natural resource conservation are given in Section IV

of EIA-EMPP report

49. Total capital cost

and recurring

cost/annum for

environmental

pollution control

measures.

EMP Capital Cost - Rs. 259.00 Lakhs

EMP Recurring Cost -Rs. 14.25 Lakhs

50.

a) .Does the

company have a

well laid down

Environment Policy

approved by its

Board of Directors?

If so, it may be

detailed in the EIA

report.

The Policy on Environment Health and safety is enclosed as

Annexure XVI of EIA-EMP Report.

Project: Auronext Pharma Pvt Ltd. Section-I/ Introduction Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

42

b).Does the

Environmental

Policy prescribe for

standard operating

Process/

procedures to

bring into focus

any infringement /

deviation /

violation of the

environmental or

forest norms /

conditions? If so, it

may be detailed in

the EIA report.

The hierarchical system to deal environmental issues is

given as Annexure XVII

c).What is the

hierarchical system

or Administrative

order of the

company to deal

with the

environmental

issues and for

ensuring

compliance with

the EC conditions.

Details of this

system may be

given.

The hierarchical system to deal environmental issues is

given as Annexure XVII

d).Does the

company have a

system of

reporting of non-

compliance /

violations of

environmental

norms to the

Company have a system of reporting noncompliance. Board

meeting is held six monthly bases. Hierarchical system and

policy to deal environmental issues is given as Annexure

XVII

Project: Auronext Pharma Pvt Ltd. Section-I/ Introduction Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

43

Board of Directors

of the company

and / or share

holders or

stakeholders at

large? This

reporting

mechanism should

be detailed in the

EIA report.

51. Any litigation

pending against

the project and/or

any direction/order

passed by any

Court of Law

against the

project, if so,

details thereof.

No litigation pending

Additional TOR

1. A separate chapter

on status of

compliance of

Environmental

Conditions granted

by State/Centre to

be provided. As

per circular dated

30th May, 2012

issued by MoEF, a

certified report by

RO, MoEF on

status of

compliance of

conditions on

existing unit to be

provided in EIA-

The same is given as Annexure XVIII

Project: Auronext Pharma Pvt Ltd. Section-I/ Introduction Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

44

EMP report.

2. Public hearing to

be conducted and

issues raised and

commitments

made by the

project proponent

on the same

should be included

in EIA/EMP Report

in the form of

tabular chart with

financial budget for

complying with the

commitments

made.

Not Applicable

As our project is coming up in the Notified Industrial Area,

(RIICO Industrial Area, Bhiwadi, Rajasthan), the same was

exempted from public hearing as per para 7 (i) III. Stage

(3) (i) (b) of EIA notification, 2006 (exemption from

public consultation is allowed for all projects or

activities located within the industrial estates or

parks approved by the concerned authorities and

which are not disallowed in such approvalsas

mentioned in the Gazette Notification of 2006and

subsequent amendment on dated 01.12.2009).Public

hearing has now again been exempted by MoEF&CC vide

your office memorandum No. J-11013/36/2014-IA-I dated

10.12.2014.(Annexure-XIX)

3. Permission from

the State Forest

Department

regarding the

impact of the

proposed project

on Reserve Forest

and Protected

Forest.

Not Applicable

1.5 GENERIC STRUCTURE OF ENVIRONMENTAL IMPACT ASSESSMENT

Environmental Impact Assessment (EIA) is a well planned process to predict the

environmental consequences of any kind of development, which is result of human

activities and to suggest appropriate measures in order to reduce adverse effects and

also to augment positive effects. The EIA procures a rational and ethical approach for

sustainable development. However, it is more scientific process because it not only tells

the past, present and the future consequences of going on development , but also

predicts the future events which likely to change due to some reasons.

Project: Auronext Pharma Pvt Ltd. Section-I/ Introduction Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

45

In terms of the EIA notification of the MOE&F dated 14th September 2006 and

subsequent amendment on 01.12.09 and 04.04.2011, the generic structure of EIA

documents shall be as under:-

• Introduction

• Project Description

• Description of the Environment

• Anticipated Environmental Impact & Mitigation Measures

• Analysis of Alternatives (Technology & Site)

• Environmental Monitoring Program

• Additional studies

• Project benefits

• Environmental Cost benefits Analysis (Only if recommended at scoping stage)

• EMP

• Summary & Conclusion

• Disclosure of Consultant Engaged

1.6 POST ENVIRONMENTAL CLEARNCE MONITORING

This is a expansion project; hence post-environmental clearance monitoring is

applicable. Although, the project management will submit half-yearly compliance reports

of the stipulated prior environmental clearance terms and conditions on 1st June and 1st

December of each calendar year.

1.7 IDENTIFICATION OF PROJECT PROPONENT

Established in 2009, Auronext Pharma Pvt. Ltd is a joint venture between Aurobindo

Pharma Ltd, and BR Sikri and Associates of Next Wave India. It is a dedicated facility to

manufacture penems range of products. Aurobindo Pharma Ltd is among the largest

'Vertically Integrated' pharmaceutical companies in India, Aurobindo has robust product

portfolio and has Global presence with own infrastructure, strategic alliances,

subsidiaries & joint ventures.. Their strength lies in logistics throughout the entire supply

chain, sourcing, warehousing and timely delivery.

Auronext is committed to its corporate ideals of providing innovative, world-class quality

of drugs and formulations, competitive pricing to an increasingly quality-determined

world, backed by its inherent strengths of dynamism, excellence, and modern

management principles.

Board of Directors

Mr. Kambam Nitya Nanda Reddy:

Project: Auronext Pharma Pvt Ltd. Section-I/ Introduction Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

46

Mr. K. Nityananda Reddy, holds a Master's Degree in Science (Organic Chemistry) and

has been associated with the Company from the initial days as a promoter, and is

versatile with the manufacturing technology. He supervises the overall affairs of the

Company.

Mr. Bodh Raj Sikri

Mr. B.R. Sikri, the Key promoter of ABS Group of companies dealing with

APIs/formulation. Group compnaies have trading, indenting, marketing, import export,

manufacturing of formulation and APIs etc. Also add that Mr.Sikri is associated in various

positions in almost all the pharma assocations such as, IDMA, BDMA, BDDA, PIAA,

HDMA, FOPE, Pharmexcil etc.

Bulk Drug Manufacturers Association ® Bulk Drug Dealers Association ® Joint Forum of

IDMA, FOPE, CIPI FOPE - Federation of Pharma Entrepreneurs (an organization of Tax-

Free zones) Himachal Drug Manufacturers Association

Mr. Anil Munjal:

Mr. Anil Munjal, holds a Master's Degree in Chemistry and has more than 30 years of

valuable experience in the pharmaceutical industry.

Mr. Penaka Sarath Chandra Reddy:

He is a graduate of Business Administration. He is a second generation entrepreneur and

has established his business acumen after he took over the management of Trident Life

Sciences Ltd, as Managing Director from Decemeber, 2005.

1.8 BRIEF DESCRIPTION OF THE PROJECT

The proposed project is categorized under “B” of 5 (f) columns 4 {Synthetic organic

chemicals industry (dyes & dye intermediates; sterile bulk drugs and intermediates

excluding drug formulations; synthetic rubbers; basic organic chemicals, other synthetic

organic chemicals and chemical intermediates)} But, as per the Gazette Notification

mentioned above, the project/activity falls under “A” Category because the project

attracts general condition that any project or activity specified under Category ‘B’ will be

treated as Category A, if located in whole or in part within 10 km from the boundary of

Inter-State boundary and International boundary. The Inter-state boundary (Haryana

and Rajasthan) is 1.54 km towards ENE from the site.

Project: Auronext Pharma Pvt Ltd. Section-I/ Introduction Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

47

The unit is proposing modification/expansion and change in the product mix by replacing

the existing product Ampicillin Sodium Sterile by a Carbapenem Sterile bulk drugs (API).

S. No

Name of the Product Product Type Quantity

(Kg/ year)

1a Meropenem Trihydrate Sterile Sterile Bulk

Drug

24000

1b Sodium Carbonate Sterile Sterile Bulk

Drug

4000

Total 1(1a+1b) Meropenem for Injection (Blending of

above product)

(Mixture of Meropenem Trihydrate

Sterile & Sod. Carbonate Sterile)

Mixture of

Sterile bulk

Drug

28000

2a Imipenem Monohydrate Sterile Sterile Bulk

Drug

7000

2b Cilastatin Sodium Sterile Sterile Bulk

Drug

7200

2c Sodium Bicarbonate Sterile Sterile Bulk

Drug

1000

Total 2

(2a+2b+2c)

Imipenem & Cilastatin for Injection

(Blending of above product)

(Mixture of Imipenem Monohydrate ,

Cilastatin Sodium & Sodium Bi

Carbonate Sterile)

Mixture of

Sterile bulk

Drug

15200

3 Doripenem Monohydrate Sterile Sterile Bulk

Drug

3000

Total (Worst case includes all Product ) 46200

4 Lyophilization in vials of Ertapenem

for Injection

6 Millions

Vials

5 Filling of vials of dry powder injection

(Formulation)

30 Millions

Vials

1.9 LOCATION OF THE PROJECT

The project is situated at A-1128, RIICO Industrial Area Phase-III, Bhiwadi, Distt.-Alwar,

Rajasthan. The site falls in geological survey of India of Toposheet No. 53D/15, 53D/16.

The geographical location of the project is-

NNW NNE

Latitude 28°12'2.66"N 28°12'2.14"N

Longitude 76°51'23.84"E 76°51'26.63"E

SSE SSW

Latitude 28°11'58.42"N 28°11'58.77"N

Longitude 76°51'25.92"E 76°51'23.05"E

Project: Auronext Pharma Pvt Ltd. Section-I/ Introduction Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

48

The plan clearly showing the project site and study area of 10 km radius is shown in

Figure 1.2 (i) and plant layout in Figure 1.3 (ii).

Figure No. 1.2

Topographical Map showing 10 km radius

1.10 INFRASTRUCTURE

The proposed site is located in the Industrial Area, which has all possible amenities that

are feasible for industrial projects viability.

• Railway Station: Rewari Railway station -24.22 km towards W from the site

• Airport: IGI Airport- 46.07 km towards NE from the site

• National Highway: NH-8 - 5.63 km towards W ; NH - 71 B - 7.01 km towards N

1.11 ENVIRONMENTAL IMPACT ASSESSMENT REPORT

Enkay Enviro Services Pvt. Ltd (EESPL) was assigned for the job of conducting and

preparation of Environment Impact Assessment (EIA) and Environmental Management

Plan (EMP) report for upcoming project of sterile bulk drug and its intermediates

manufacturing unit to the tune of 38.4 TPA proposed by “Auronext Pharma Pvt. Ltd.”

Project: Auronext Pharma Pvt Ltd. Section-I/ Introduction Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

49

The baseline data has been collected as per the TOR issued by Ministry of Environment &

Forests.

The baseline data collection involves the data on air quality, water quality, land use,

socio-economic profile of the study area, existing flora, fauna, prevailing noise levels,

along with the physiographical status and meteorological conditions of the area. The

current report is based on the information of the process technology, air emission,

effluent generation, discharge and solid waste management. An effective plan to

mitigate the adverse impacts and suggestive pollution control measures along with

environmental management plan has been summarized. The defined study period was

winter season (December 2014, January 2015 & February 2015).

1.12 SCOPE OF WORK

The scope of work of EIA/EMP studies of the proposed Expansion project of “Auronext

Pharma Pvt. Ltd.” for manufacturing of Sterile bulk drugs to the tune of 46.2 TPA , Filling

of Dry Powder vials 30 million & Lyopihilised vials 6 million is as under:-

The scope of the work includes detailed characterization of various environmental

components such as micro-meteorology, air, noise, water, land and socio economy

within 10 km radius from the proposed plant. The main objectives of the study are:-

• To assess the existing baseline status of air, water, noise, land and socio-

economic environment.

• To identify and quantify significant impacts due to various operations of the

proposed expansion of Sterile bulk drugs (API) on various environmental

components through prediction of impacts.

• To evaluate the beneficial and adverse impacts of the proposed plant.

• To evaluate and implement the Environmental Management Plan (EMP) detailing

control measures and its efficiency to minimize the pollution levels within the

permissible norms.

• To assess the probable risks, likely to occur in unit and suggest appropriate

measures to avoid the same.

• To design an occupational health & safety plan for the employees.

• To design post project monitoring plan for regulating the environmental quality

within the limits and help in sustainable development of the area.

****************

Project: Auronext Pharma Pvt. Ltd. Section-II/Project Description

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

50

SECTION-II

PROJECT DESCRIPTION

INDEX

PROJECT DESCRIPTION ................................................................................ 50

2.1 GENERAL ............................................................................................... 51

2.2 DESCRIPTION OF THE PROJECT ................................................................. 53

2.3 PLANT LAYOUT ........................................................................................ 55

2.4 RAW MATERIALS ..................................................................................... 57

2.5 SOURCE OF RAW MATERIAL ...................................................................... 59

2.6 CAPACITY OF THE PROJECT ....................................................................... 59

2.7 WATER REQUIREMENT ............................................................................. 60

2.8 POWER .................................................................................................. 61

2.9 SCHEDULE OF APPROVAL AND IMPLEMENTATION ......................................... 61

2.10 MAN POWER ........................................................................................... 61

2.11 MANUFACTURING PROCESS ...................................................................... 61

****************

Project: Auronext Pharma Pvt. Ltd. Section-II/Project Description

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

51

PROJECT DESCRIPTION

2.1 GENERAL

Auronext Pharma Pvt. Ltd. is a manufacturing sterile bulk drug to tune of 38.4 TPA and

vial filling to the tune of 30 million vials numbers per annum. Now, the unit is proposing

to replace existing product Ampicillin Sodium Sterile by a Carbapenem Sterile bulk drugs

(API) to tune of 46.2 TPA and lyophilization in vials Ertapenem for injection of 6 millions

vials. The expansion of unit is coming up at -1128, RIICO Industrial Area Phase-III,

Bhiwadi, Distt.-Alwar, Rajasthan. The proposed Expansion project is categorized under B

of 5 (f) column 4 {Synthetic Organic Chemicals Industry (dyes & dye

intermediates; sterile sterile bulk drugs and intermediates excluding drug

formulations; synthetic rubbers; basic organic chemicals, other synthetic

organic chemicals and chemical intermediates)} as per the Gazette Notification of

Sept. 14th 2006 and its subsequent amendment dated 01.12.09 and 04.04.2011.

But, as per the Gazette Notification mentioned above, the project/activity falls under “A”

Category because the project attracts general condition that any project or activity

specified under Category ‘B’ will be treated as Category A, if located in whole or in part

within 10 km from the boundary of Inter-State boundary and International boundary.

The Inter-state boundary (Rajasthan and Haryana) is 1.54 km towards ENE from the

site.

The project expansion is coming up on land area of 10112 Sq.m. The proposed project is

located in notified industrial area. The total green cover area will be approximately 3337

Sq.m (33%).The cost of existing project is Rs. 61.51 Crores and proposed expansion

project will be Rs. 40 Crores. About Rs. 259.0 lakhs are proposed for the environment

protection program and Rs. 14.25 Lakh as recurring cost. The unit will manufacture

following sterile bulk drugs, & its intermediates.

Table No. 2.1

List of Products with their Respective Production Capacity (After product mix

change and expansion)

S. No

Name of the Product Product

Type

Quantity

(Kg/ year)

1a Meropenem Trihydrate Sterile Sterile Bulk

Drug

24000

1b Sodium Carbonate Sterile Sterile Bulk

Drug

4000

Project: Auronext Pharma Pvt. Ltd. Section-II/Project Description

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

52

Total 1(1a+1b) Meropenem for Injection

(Blending of above product)

(Mixture of Meropenem

Trihydrate Sterile & Sod.

Carbonate Sterile)

Mixture of

Sterile Bulk

Drug

28000

2a Imipenem Monohydrate Sterile Sterile Bulk

Drug

7000

2b Cilastatin Sodium Sterile Sterile Bulk

Drug

7200

2c Sodium Bicarbonate Sterile Sterile Bulk

Drug

1000

Total 2

(2a+2b+2c)

Imipenem & Cilastatin for

Injection (Blending of above

product)

(Mixture of Imipenem

Monohydrate , Cilastatin

Sodium & Sodium Bi

Carbonate Sterile)

Mixture of

Sterile Bulk

Drug

15200

3 Doripenem Monohydrate Sterile Mixture of

Sterile Bulk

Drug

3000

Total 46200

4 Lyophilization in vials of

Ertapenem for Injection

6 Millions

Vials

5 Filling of vials of dry powder

injection (Formulation)

30 Millions

Vials

GENERAL INFORMATION ON PHARMACEUTICAL INDUSTRIES

Bulk pharmaceutical substances typically consist of structurally complex organic chemical

compounds, which are manufactured via a series of intermediate steps and reactions

under precise conditions. These substances are used in the manufacture of the dosage

form of a formulated pharmaceutical product and are manufactured by

(1) Chemical synthesis;

(2) Fermentation;

(3) Isolation/recovery from natural sources, or

(4) A combination of these processes.

Almost all pharmaceutical substances are manufactured utilizing “batch” processes. In a

batch process, particular substance or “intermediate” is manufactured in “campaign” for

periods ranging from a few days to several months until sufficient material is

Project: Auronext Pharma Pvt. Ltd. Section-II/Project Description

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

53

manufactured to satisfy the projected sales demand. At the end of the manufacturing

campaign, another pharmaceutical intermediate or substance is made. The same

equipment with potentially different configurations and the same operating personnel are

often used to make a different intermediate or substance, utilizing different raw

materials, executing different processes, and generating different waste streams.

2.2 DESCRIPTION OF THE PROJECT

Auronext Pharma Pvt. Ltd. is a manufacturing sterile bulk drug to tune of 38.4 TPA and

vial filling to the tune of 30 million vials numbers per annum. Now, the unit is proposing

to replace existing product Ampicillin Sodium Sterile by a Carbapenem Sterile bulk drugs

(API) to tune of 46.20 TPA and lyophilization in vials Ertapenem for injection of 6 millions

vials. The proposed site falls in Toposheet No. 53D/15, 53D/16 of geological survey of

India. The topographical map of 10 km study area is depicted in below figure no. 2.1.

Figure No. 2.1

Topographical Map Showing Study Area

The total land area occupied by the unit 10112 sq. m. the land use break up the unit is

as follows:

Project: Auronext Pharma Pvt. Ltd. Section-II/Project Description

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

54

Table No. 2.2

Land use breakup

S.NO Particulars Area (sq.

m)

Percentage

(%)

1. Plant Area, Office Area ( all covered area) 4550.40 45

2. Paved Area ( Road, Corridor, Parking and drainage) 1213.40 12

3. Green Belt Area 3337 33

4. Open Area 1011.2 10

5. Total Plot area 10112 100

Land Use Break Up

8.23.2

1.4

1.2

1st Qtr

2nd Qtr

3rd Qtr

4th Qtr

� The unit has acquired the land in RIICO Notified Industrial Area. The copy of the

land document is enclosed as Annexure-X.

� The unit has two D.G. set of 500 kVA. Further, the unit will install either four D.G.

set of 500 kVA or two of 1000 kVA or two of 500 kvA & one of 1000 KVA.

Project: Auronext Pharma Pvt. Ltd. Section-II/Project Description

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

55

� The unit will install condenser and reactors of different capacities.

2.3 PLANT LAYOUT

The total plot area acquired by the unit is 10112 Sq.m. The unit will consist of work

shed, godown, store room, parking area for vehicles as well as trucks, administrative

block etc. Plantation will be developed inside the unit in an area of 33%. The proposed

plant layout of unit is given in below figure:

Project: Auronext Pharma Pvt. Ltd.

Section-II/Project Description

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

56

Figure No. 2.2: Plant Layout

Project: Auronext Pharma Pvt. Ltd. Section-II/Project Description

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

57

2.4 RAW MATERIALS

The list of raw materials proposed to be used in unit is given below in table no. 2.3.

Table No. 2.3

List of Raw Material

For by product: Meropenem Trihydrate Sterile

Capacity: 28 MTPA

S. No. Name of Raw

material

Qty

(Kg/day)

Storage

Capacity Source

Mode of

transport

1 Meropenem Trihydrate

Non Sterile/ crude 85 2500 Domestic By Road

2 Activated Carbon 10 1000 Imported

By Air/

Sea

4 Water for injection 2975 In House In House

5 Methanol 3500 25000 Domestic By Road

6 Isopropyl Alcohol 3100 25000 Domestic By Road

For by product: Sodium Carbonate Sterile

Capacity: 4.0 MTPA

S.No. Name of Raw

material

Qty

(Kg/day)

Storage

Capacity Source

Mode of

transport

1 Sodium Carbonate

Non Sterile 13.87 1000 Domestic By Road

2 Methanol 91 25000 Domestic By Road

4 Carbon 1 1000 Imported

By Air/

Sea

5 Acetone 63 25000 Domestic By Road

6 WFI 49 In House In House

For by product: Imipenem Monohydrate Sterile

Capacity: 7.0 MTPA

S.No. Name of Raw material Qty

(Kg/day)

Storage

Capacity Source

Mode

of

transpo

rt

1 Imipenem Monohydrate

Non Sterile / crude

24.25 2500 Domestic By Road

2 Activated Carbon 4 1000 Imported

By Air/

Sea

4 Water for injection 1200 In House In House

5 Isopropyl Alcohol 2570 25000 Domestic By Road

6 Sodium Bicarbonate 4 1000 Domestic By Road

7 Glacial acetic acid 2 200 Domestic By Road

Project: Auronext Pharma Pvt. Ltd. Section-II/Project Description

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

58

For by product: Cilastatin Sodium Sterile

Capacity: 7.2 MTPA

S.No. Name of Raw material Qty

(Kg/day)

Storage

Capacity

Sour

ce

Mode of

transpor

t

1 Cilastatin Sodium Non

Sterile / crude

25 2500

Dome

stic By Road

2 Methanol 400 25000

Dome

stic By Road

4 Activated Carbon 1 1000

Impo

rted

By Air/

Sea

5 Ethanol 71 20000

Dome

stic By Road

6 Isopropyl Alcohol 791 25000

Dome

stic By Road

For by product: Sodium Bicarbonate Sterile

Capacity: 1.0 MTPA

S.No. Name of Raw

material

Qty

(Kg/day

)

Storage

Capacity Source

Mode of

transport

1 Sodium Bicarbonate

Non Sterile

4 1000 Domestic

By Road

2 Ethanol 50 20000 Domestic

By Road

4 WFI 30 In House In House

5 Carbon Dioxide Gas 20 250 Domestic By Road

For by product: Doripenem Monohydrate Sterile

Capacity: 3.0 MTPA

S. No. Name of Raw

material

Qty

(Kg/day

)

Storage

Capacity Source

Mode of

transport

1 Doripenem

Monohydrate Non

Sterile / crude

10.5

1000 Domestic By Road

2 Water for injection 420 In House In House

4 Carbon 1 1000 Imported

By Air/

Sea

5 Acetone 350 25000 Domestic By Road

1000 Domestic By Road

Project: Auronext Pharma Pvt. Ltd. Section-II/Project Description

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

59

2.5 SOURCE OF RAW MATERIAL

Largely the raw materials will be purchased from Indian market In case of unavailability

of raw from local market then the same will be imported from Germany, Belgium and

China. The solvents will be transported through trucks in closed barrels. The solvents

and the other raw material from international markets will be transported through

airways and sea route. The raw material will be transported in closed containers or in

closed packet.

2.6 CAPACITY OF THE PROJECT

Based on the plant and machinery of the unit, the total capital cost for the proposed

modification is Rs. 40.00 Crores (through continuous manufacturing process).

The proposed production capacity of unit after the modification/expansion with respect

to different products has been tabulate in above Table No 2.1

Sterile Bulk Drugs 46.2 TPA, Filling of Vials 30 million & lyophilizing of vials 6 million will

be manufactured. The list of Products is as follows:-

1). Meropenem Trihydrate Sterile

Meropenem is an ultra-broad-spectrum injectable antibiotic used to treat a wide variety

of infections. It is a beta-lactam and belongs to the subgroup of carbapenem, similar to

imipenem and ertapenem. It penetrates well into many tissues and body fluids including

the cerebrospinal fluid, bile, heart valves, lung, and peritoneal fluid.

2).Imipenem/cilastatin

Imipenem/ cilastatin is an antibiotic useful for the treatment of a number of bacterial

infections. It is a broad-spectrum beta-lactam containing equal quantities of imipenem

and cilastatin. It is related to the penicillin/cephalosporin family of antibiotics, but is

classified as belonging to the Carbapenem class.

Doripenem is a beta-lactam and belongs to the subgroup of Carbapenem. It is

particularly active against Pseudomonas aeruginosa. Doripenem can be used for bacterial

infections such as: complex abdominal infections, pneumonia within the setting of a

hospital, and complicated infections of the urinary tract including kidney infections with

septicemia. Doripenem decreases the process of cell wall growth, which eventually leads

to elimination of the infectious cell bacteria altogether.

Project: Auronext Pharma Pvt. Ltd.

Section-II/Project Description

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

60

2.7 WATER REQUIREMENT

Daily fresh water demand will be 100 KLD. Around 85 KLD water will be required for manufacturing purpose and 15 KLD for

domestic use. RIICO and ground water supply will meet this water demand.

Project: Auronext Pharma Pvt. Ltd. Section-II/Project Description

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

61

2.8 POWER

Existing unit has contract demand of 1525 kVA and transformer of 2000 kVA KVA which

will be supplied from JVVNL. After modification there will be increase in contract demand

to 2500 kVA & Transformer to 2500KVA. The unit has two D.G. set of 500 kVA. Further,

the unit will install either four D.G. set of 500 kVA or two of 1000 kVA or two of 500 kvA

& one of 1000 KVA. Following measures & ways will be taken to save the Electrical

Energy:-

• Energy efficient Fluorescent Lamp T5, CFL will be used which have higher output. 50%

of external landscaped street lights will be supplied through solar panel.

• Power factor will be maintained ~0.99 with the capacitor banks. All capacitors will be

provided with Harmonic Filters to avoid distortion in Voltage i.e. Clean Power will be

available.

• External lighting will be automatically controlled using timer contactor at external

lighting panel. Led type lights & Sodium vapor lights will be used for external lighting.

2.9 SCHEDULE OF APPROVAL AND IMPLEMENTATION

The expansion of the project has been planned for manufacturing sterile bulk drugs and

its intermediates to the tune of 46.2 TPA & Filling of Vials 30 million & lyophilizing of

vials 6 million will be manufactured. The entire development will take about 6 months for

completion. The construction activities will start after obtaining necessary approval from

Rajasthan State Pollution Control Board (RPCB).

2.10 MAN POWER

In the full fledge process of the plant, the total employment will be around 250 persons.

The man power employed in unit is given below:

Existing workers 150 persons

Proposed worker 100 persons

Total 250 persons

2.11 MANUFACTURING PROCESS

The company has planned to manufacture Antibiotics and their intermediates along with

research and development activities to develop new products. Research & Development

work and some activity of manufacturing Steroids on campaign basis on small scale (i.e.

Kilo Level) will be carried out.

Project: Auronext Pharma Pvt. Ltd. Section-II/Project Description

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

62

Manufacturing Process Details:

1. Meropenem Trihydrate sterile

Meropenem Trihydrate non sterile is dissolved in the water, Carbon is added , filtered

through sterile grade filters and crystallized by adding IPA followed by Methanol to get

Sterile Meropenem Trihydrate. This is filtered to separate Sterile Meropenem, which is

then dried, milled & packed in canisters/ bags. Finally Sterile Meropenem Trihydrate is

mixed with Sterile Sodium Carbonate and this mixture is packed in canister/ bags. This

canisters / bags are labeled & dispatched to Market/ used for captive consumption for

filling of vials of dry powder injection (Formulations).

Process Description for Meropenem Trihydrate Sterile Reaction Scheme

Molecular Weight: 437.5

Meropenem Trihydrate Non sterile

Water, Activated carbon

IPA and Acetone

Molecular Weight: 437.5

Project: Auronext Pharma Pvt. Ltd. Section-II/Project Description

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

63

Meropenem Trihydrate sterile

Process flow diagram

Meropenem Trihydrate NS

Water for injection Activated Carbon

Activated Carbon

Methanol

Isopropyl Alcohol (IPA) + Acetone Methanol+ IPA+ Water

Meropenem Trihydrate sterile (Pharma)

Table: 2.4 : Material Balance for Meropenem Trihydrate Sterile

Input

Quantity

(Kg/day)

Output Quantity

(Kg/day)

Remarks

Meropenem

Trihydrate Non

Sterile

85 Meropenem Trihydrate Sterile 66.7 Final

Product

Activated

Carbon

10 Activated Carbon waste 15 Organic

residue

Water for

injection

2975 Methanol + IPA + Water

Mixture (Sold as such to

approved vendor or Purified

and reused)

9565 Organic

Mother

liquor

Acetone 3500 Evaporation losses 23.3 Fugitive loss

Isopropyl

Alcohol

3100

Total Input 9670 Total Output 9670

Project: Auronext Pharma Pvt. Ltd. Section-II/Project Description

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

64

2. Sodium Carbonate Sterile

Non Sterile Sodium Carbonate is dissolved in the water; carbon is added, filtered

through sterile grade filters and crystallized by adding Methanol to get Sterile Sodium

Carbonate. This is filtered to separate Sterile Sodium Carbonate, which is then dried,

milled & packed in canisters/ bags. This is used for mixing with Meropenem Trihydrate.

Process Description for Sodium Carbonate Sterile Reaction Scheme

Molecular Weight: 116

Sodium Carbonate Non sterile

Water, Activated carbon

Methanol and Acetone

Molecular Weight: 116

Sodium Carbonate sterile

Process flow diagram

Sodium Carbonate NS

Water for injection Activated carbon

Activated Carbon

Methanol

Acetone Methanol+Acetone+ML Water

Sodium Carbonate sterile (Pharma)

Project: Auronext Pharma Pvt. Ltd. Section-II/Project Description

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

65

Table: 2.5 : Material Balance for Sodium Carbonate Sterile

Input

Quantity

(Kg/day)

Output Quantity

(Kg/day)

Remarks

Sodium

Carbonate

Non Sterile

13.87 Sodium Carbonate Sterile 11.1 Final

Product

Methanol 91 Activated Carbon waste 1.5 Organic

residue

Carbon 1 Acetone + Methanol + Water

Mixture (Sold as

such to approved vendor or

Purified and reused)

200 Organic

Mother

liquor

Acetone 63 Evaporation losses 5.27 Fugitive

loss

WFI 49

Total Input 217.87 Total Output 217.87

3. Imipenem Monohydrate Sterile

Imipenem Monohydrate non sterile is dissolved in the water, Carbon is added , filtered

through resin & sterile grade filters and crystallized by adding Isopropyl Alcohol to get

Sterile Imipenem Monohydrate. This is filtered to separate Sterile Imipenem

Monohydrate, which is then dried, milled & packed in canisters/ bags. Finally Sterile

Imipenem Monohydrate is mixed with Sterile Cilastatin Sodium & Sterile Sodium Bi

Carbonate and this mixture is packed in canister/ bags. This canisters / bags are labeled

& dispatched to Market/ used for captive consumption for filling of vials of dry powder

injection (Formulations).

Project: Auronext Pharma Pvt. Ltd. Section-II/Project Description

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

66

Process description for Imipenem Monohydrate Sterile Reaction Scheme

Molecular Weight: 317.36

Imipenem Monohydrate Non Sterile

Water, Activated carbon Acetic Acid, resin

N- Methyl Morphline and Acetone

Molecular Weight: 317.36

Imipenem Monohydrate Sterile

Process flow diagram

Imipenem Monohydrate

Water For injection

Activated Carbon

Activated Carbon

Sodium bicarbonate

Sodium Carbonate

Isopropyl Alcohol + Water ML

Acetic Acid

Isopropyl Alcohol

Imipenem Monohydrate Sterile (Pharma)

Project: Auronext Pharma Pvt. Ltd. Section-II/Project Description

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

67

Table: 2.6: Material Balance for Imipenem Monohydrate Sterile

Input

Quantity

(Kg/day)

Output Quantity

(Kg/day)

Remarks

Imipenem

Monohydrate

Non Sterile

24.25 Imipenem Monohydrate

Sterile

19.4 Final

Product

Activated

Carbon

4 Activated Carbon waste 5 Organic

residue

Water for

injection

1200 Acetone + Water+ Acetic acid

+ N-methyl Morpholine

Mixture (Sold as such to

approved vendor or Purified

and reused)

3759 Organic

Mother

liquor

Acetone 2570 Evaporation losses 20.85 Fugitive

loss

n methyl

morpholine

Glacial acetic

acid

2

Dowex resin 15 Dowex Resin (Recovered and

re used)

15 Inorganic

salt

Total Input 3819.25 Total Output 3819.25

4. Cilastatin Sodium Sterile

Cilastatin Sodium non sterile is dissolved in Methanol, Carbon is added , filtered through

sterile grade filters and crystallized by adding Isopropyl Alcohol to get Sterile Cilastatin

Sodium. This is filtered to separate Sterile Cilastatin Sodium, which is then washed by

ethanol & acetone, dried, milled & packed in canisters/ bags. Finally Sterile Cilastatin

Sodium is mixed with Sterile Imipenem Monohydrate & Sterile Sodium Bi Carbonate and

this mixture is packed in canister/ bags. This canisters / bags are labeled & dispatched to

Project: Auronext Pharma Pvt. Ltd. Section-II/Project Description

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

68

Market/ used for captive consumption for filling of vials of dry powder injection

(Formulations).

Process description for Cilastatin Sodium Sterile Reaction Scheme

Molecular Weight: 358.45

Cilastatin Sodium Non Sterile

Activated carbon,

Ethanol, Methanol and Acetone

Molecular Weight: 358.45

Cilastatin Sodium Sterile

Process flow diagram

Cilastatin Sodium NS

Activated Carbon

Activated Carbon

Methanol

Acetone

Ethanol +Acetone+

Cilastatin Sodium Sterile (Pharma)

Methanol+ Acetone

Methanol ML

Project: Auronext Pharma Pvt. Ltd. Section-II/Project Description

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

69

Table: 2.7 : Material Balance for Cilastatin Sodium Sterile

Input

Quantity

(Kg/day)

Output Quantity

(Kg/day)

Remarks

Cilastatin

Sodium Non

Sterile

25 Cilastatin Sodium Sterile 20

Final Product

Methanol 400 Activated Carbon waste 1.5 Organic

residue

Activated

Carbon

1 Acetone + Methanol + Ethanol

(Sold as such to approved

vendor or Purified and reused)

1252 Organic

Mother

liquor

Ethanol 71 Evaporation losses 14.5 Fugitive loss

Acetone 791

Total Input 1288 Total Output 1288

5. Sodium Bicarbonate Sterile

Non Sterile Sodium Bi Carbonate is dissolved in the water; carbon is added, filtered

through sterile grade filters (simultaneously carbon dioxide is added to stabilize pH) and

crystallized by adding Ethanol to get Sterile Sodium Bi Carbonate. This is filtered to

separate Sterile Sodium Bi Carbonate, which is then dried, milled & packed in canisters/

bags. This is used for mixing with Imipenem Monohydrate & Cilastatin Sodium. Non

Sterile Sodium Bi Carbonate is dissolved in the water; carbon is added, filtered through

sterile grade filters (simultaneously carbon dioxide is added to stabilize pH) and

crystallized by adding Ethanol to get Sterile Sodium Bi Carbonate. This is filtered to

separate Sterile Sodium Bi Carbonate, which is then dried, milled & packed in canisters/

bags. This is used for mixing with Imipenem Monohydrate & Cilastatin Sodium.

Process description for Sodium Bicarbonate Sterile Reaction Scheme:-

Project: Auronext Pharma Pvt. Ltd. Section-II/Project Description

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

70

Molecular Weight: 84.1

Sodium Bicarbonate Non sterile

Water, Ethanol

Carbon dioxide

Molecular Weight: 84.1

Sodium Bicarbonate Sterile

Process flow diagram

Sodium Bicarbonate NS

Ethanol

Carbon Dioxide gas Ethanol + Water ML

Sodium Bicarbonate Sterile (Pharma)

Project: Auronext Pharma Pvt. Ltd. Section-II/Project Description

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

71

Table: 2.8 : Material Balance for Sodium Bicarbonate Sterile

Input

Quantity

(Kg/day)

Output Quantity

(Kg/day)

Remarks

Sodium

Bicarbonate

Non Sterile

4 Sodium Bicarbonate

Sterile

2.7

Final Product

Ethanol 50 Water + Ethanol ML

(Sold as such to

approved vendor or

Purified and reused)

76 Organic

Mother liquor

WFI 30 Evaporation losses 5.3 Fugitive loss

Carbon

Dioxide Gas

20 Carbon Dioxide 20 Let into

Atmosphere

Total Input 104 Total Output 104

6. Doripenem Monohydrate Sterile

Doripenem Monohydrate non sterile is dissolved in the water, Carbon is added, filtered

through sterile grade filters and crystallized by adding Acetone to get Sterile Doripenem

Monohydrate. This is filtered to separate Sterile Doripenem Monohydrate, which is then

dried, milled & packed in canisters/ bags. These canisters / bags are labeled &

dispatched to Market/ used for captive consumption for filling of vials of dry powder

injection (Formulations).

Process description for Doripenem Monohydrate Sterile Reaction Scheme

Project: Auronext Pharma Pvt. Ltd. Section-II/Project Description

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

72

Molecular Weight: 420.5

Doripenem Monohydrate Non Sterile

Water, Activated carbon and IPA

Molecular Weight: 420.5

Doripenem Monohydrate Sterile

Process flow diagram

Doripenem Monohydrate

Water for injection Activated Carbon

Activated Carbon

Acetone Acetone+ Water ML

Doripenem Monohydrate Sterile (Pharma)

Project: Auronext Pharma Pvt. Ltd. Section-II/Project Description

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

73

Table: 2.9 : Material Balance for Doripenem Monohydrate Sterile

Input

Quantity

(Kg/day)

Output Quantity

(Kg/day)

Remarks

Doripenem

Monohydrate Non

Sterile

10.5 Doripenem Monohydrate Sterile 8.3 Final

Product

Water for injection 420 Activated Carbon waste 1.5 Organic

residue

Carbon 1 Acetone + Water Mixture

(Sold as such to approved

vendor or Purified and reused)

756 Organic

Mother

liquor

Acetone 350 Evaporation losses 15.7 Fugitive loss

Total Input 781.5 Total Output 781.5

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

74

SECTION – III

DESCRIPTION OF THE ENVIRONMENT

INDEX

DESCRIPTION OF THE ENVIRONMENT ................................................... 74

3.1 GENERAL ........................................................................................... 75

3.2 BASELINE DATA GENERATION ............................................................. 75

3.3 LAND USE STUDIES ............................................................................ 77

3.4 SOIL CHARACTERISTICS ..................................................................... 79

3.5 WATER ENVIRONMENT ...................................................................... 894

3.6 AIR ENVIRONMENT ........................................................................... 849

3.7 NOISE ENVIRONMENT ......................................................................... 97

3.8 BIOLOGICAL ENVIRONMENT………………………………………......................100

3.9 SOCIO ECONOMIC ENVIRONMENT ...................................................... 122

*************

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur

75

DESCRIPTION OF THE ENVIRONEMNT

3.1 GENERAL

The anthropogenic activities related to industrial sector cause impacts on environmental

components in and around the project site. However, the intensity of environmental impacts

vary from project to projects, depends upon several factors like- Physical, Chemical, & other

etc., Involved in the project, processing capacity (scale / size of the project), type and

extent of pollution control measures, project location surrounding geomorphology etc. To

assess environmental impacts from proposed project (specific), it is essential to monitor the

environmental quality prevailing in the surrounding area prior to implementation of the

proposed project. The environmental status (baseline status) within the study area is used

for prediction of anticipated environmental impact assessment study. The impacts from an

existing industrial project on its surrounding environment are due to the nature of

pollutants, their quantities discharged to the environment, existing environmental quality,

assimilative capacity of the surrounding environment and topography.

3.2 BASELINE DATA GENERATION

The baseline data generation for Auronext Pharma Pvt. Ltd was collected for December-

2014 to February 2015.The data of December 2014 to February 2015 is presented and

interpreted in this chapter.

3.2.1 Monitoring methodology

• Air

Fine Particulate Samplers (FPS) has been used for PM2.5 Sampling. Respirable Dust

Samplers (RDS) with gaseous attachment have been used for PM10 Sampling. RDS with

Gaseous attachment assembly is used for the collection of gaseous pollutants such as

SO2 & NOx.

• Meteorological Data

An auto weather monitoring station was installed during the study period to record

various meteorological parameters on hourly basis to understand the wind pattern,

Temperature variation, solar insulation and relative humidity variation etc.

• Water

Ground Water samples were collected in Pre sterilized sampling container. Chemical and

Metals analysis was carried out as per standard methods for ground water, Published by

AWWA, APHA, etc.

• Noise

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur

76

Instant sound level meter is used for the collection of data related to noise at an interval

of one hour per reading. Noise level for 24

hours was conducted during one week period at pre decided location.

• Soil

Representative soil sample was collected from project site for analysis of physico-

chemical characteristics. Standard procedures, as per BIS / CPCB and other published

methods were followed for sampling and analysis.

3.2.2 Location of monitoring station

Six monitoring stations including site were selected for monitoring of Ambient Air and Noise

while along with the above six location ground water samples has also been tested. Six

samples were tested for Soil quality. The monitoring period was from December-2014 to

February -2015 (winter). The monitoring stations were selected on the basis of surface

influence, demographic influence and meteorological influence. The topographical map

showing the monitoring locations is given below in Figure No. 3.1.

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur

77

Figure No. 3.1

Topographical Map Showing Monitoring Locations

3.3 LAND USE STUDIES

A digital classification of land use and land cover of the 10 km study area using IRS P6 data

(LISS-IV sensor) has been evolved to facilitate an appropriate assessment of all the land

use/ land cover classes as per NRSC, Hyderabad.

Following land use and land cover categories have been drawn:

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur

78

Table No. 3.1

LULC category with area and percentage

S.No. Name Area (Sq. M) Area (Ha.) Area (%)

1 Plantation 1569000.00 156.90 0.50

2 Waterbody 216800.00 21.68 0.07

3 Plantation + Residential 2178000.00 217.80 0.69

4 Forest - RF 1854000.00 185.40 0.59

5 Barren Hilly Terrain 1840000.00 184.00 0.59

6 Built-up - Transportation - Road 2829000.00 282.90 0.90

7 Forest - Protected 1917000.00 191.70 0.61

8 Fallow Land 3343000.00 334.30 1.06

9 Built-up - Industrial 13440000.00 1344.00 4.28

10 Open Scrub 1422000.00 142.20 0.45

11 Built-up - Residential 44040000.00 4404.00 14.02

12 Agriculture Land 239500000.00 23950.00 76.24

Total 314148800.00 31414.88 100.00

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur

79

Figure No. 3.2, LULC of Auronext Pharma Pvt Ltd

Land Use Analysis

LULC classification shows a healthy relation among the classes. The area is dominated by

built up land (settlement), forest land and agriculture land. Impact of the project will be

minimal. A well connected road network exists.

3.4 SOIL CHARACTERISTICS

3.4.1 Physiography

The Alwar District is situated in north-east Rajasthan between 270 04’ N and 280 04’ N

latitudes and 76o 07’ E and 77o 13’ E longitudes. It covers an area of 8,380 square

kilometers. The District occupies about 2.45% of the total area of the State. The District is

the 17th largest by area in the State. It is bounded on the north and north-east by Gurgaon

District of Haryana and Bharatpur District respectively. On the north-west, Alwar is bounded

by Rewari District of Haryana. Jaipur District bounds Alwar on the south-west and south.

Sawai Madhopur District surrounds Alwar on the south.

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur

80

3.4.2 Soil Quality

The soils of the District can broadly be divided in to three classes, viz., Older Alluvial Soils,

Red Grey-valley Soils and Red Sandy Soils. Older Alluvial Soils are found in Tijara tehsil,

large part of Lachhmangarh tehsil and some parts of Ramgarh, Kherli, Behror, Rajgarh,

Itarana and Kishangarh tehsils. Red Grey-valley Soils are found in large part of Alwar tehsil

and Thanagazi, small patches in Kishangarh and Ramgarh tehsils, north-east part of Rajgarj

and north-west part of Lachhmangarh tehsils. Red Sandy Soils are found in large part of

Bansur tehsil, mid part of Thangazi and some parts of Rajgarh.

3.4.3 Geology

Bhiwadi is situated at 28.21°N, 76.87°E. It is 65 km away from the New Delhi, 200 km

from Jaipur, 90 km from Alwar,22 km from Gurgaon(Manesar) and 60 km from Faridabad

(PROP Touch India Sec-49). It can be reached by National Highway NH8 (Delhi-Jaipur

highway) via Dharuhera, in 30 min from Hero Honda Chowk (Gurgaon) and in 40-45 min

from IGI Airport, New Delhi. It can also be reached by Gurgaon-Sohna-Taoru-Dharuhera

road.

The major group of rocks in Greater Bhiwadi is pre‐Aravalli comprising of schist, quartzite

and granite. Alwar group consists of quartzite and schist. Major minerals found in Alwar

district are Baryte, Building stones and Copper. District leads in the production of these

minerals. The rocks consist of schist and quartzite and intrusion of Granite. These are one of

the oldest reported formations dating back 2500 million years. The Baryte deposits are

mined about 2000 tonnes annually. Alwar district is the second richest in Rajasthan where

Copper ore is found. Other mineral deposits in the district are Asbestos, China clay,

Feldspar, Fine clay, Soap stone and Quartz.

3.4.4 Data Generation

For studying soil quality of the region, a sample was collected to assess the existing soil

conditions in and around the project area.

The sample was collected by ramming a core-cutter into the soil up to a depth of 90 cm.

The present study on the soil quality establishes the baseline characteristics and identifies

the incremental concentrations if any, due to the proposed project. The objective of the

sampling is:

• To determine the baseline soil characteristics of the study area;

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur

81

• To determine the impact of proposed activity on soil characteristics; and

• To determine the impact on soils more importantly from agricultural productivity point

of view

3.4.5 Soil quality of study area

The soil study was carried out to analyze the soil characteristics of the study area. For

studying soil quality of the region 6 samples (including site) were collected, description of

the same as follows:

Table 3.2

Monitoring Locations for soil quality testing

Soil Quality

Six soil samples in 10 km radius project Area was collected and analyzed. The analytical

results are given in below.

Table No. 3.3

Soil Quality Analysis Results

Sample

Code .NO

Location

Name

Details Direction w.r.t

Project Site

Co-ordinates

S-1 Project Site

Project Site -- N 28012’02.4” E

76051’24.4”

S-2 Belaheri Near Hanuman

Mandir

SE N 28011’23.4” E

76052’42.3”

S-3 Bhiwadi Near Govt

Hospital

NE N 28012’35.7” E

76050’42.5”

S-4 Milakpur Near Mataji

Mandir

W N 28011’32.2” E

76049’30.8”

S-5 NH-71

Near Main road NE N 28012’50.4” E

76051’32.3”

S-6 Khajuriwas Near Shivji

Mandir

SW N 28010’52.4” E

76049’13.2”

Sample Code .NO Location Name Date of sampling

S-1 Project Site 27.02.2015

S-2 Belaheri 27.02.2015

S-3 Bhiwadi 27.02.2015

S-4 Milakpur 27.02.2015

S-5 NH-71 27.02.2015

S-6 Khajuriwas 27.02.2015

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur

82

S.No PARAMETERES UNITS S1 S2 S3

1 Texture - Sandy Clay Sandy Clay Sandy Clay

2.

Particle size Distributions Sand

% 36 30 30

Silt % 14 16 22

Clay % 50 54 48

3. Appearance -- Brown Color Brown Color Brown Color

4. Sodium as Na mg/100grm 2.32 2.31 2.54

5. pH (10% Slurry) @ 25 oC - 7.52 7.56 7.36

6. Conductivity @25 oC µmhos/cm 252 214 226

7. Bulk density gram/cc 1.33 1.36 1.42

8. Porosity % v/v 26 28 20

9. Total Organic Matter(TOC) % 0.69 0.88 0.62

10. Nitrogen as N mg/100grm 184 199 172

11. Potassium as K mg/100grm 86 84 72

12. Phosphorus as P mg/100grm 34 43 48

13. Zinc as Zn mg/kg 2.12 2.61 1.96

14. Cadmium as Cd mg/kg <0.01 <0.01 <0.01

15. Chlorides as Cl mg/100grm 2.52 0.69 1.36

16. Alkali Metals mg/kg 2.0 0.31 1.8

17. Permeability Cm/h 4.2 2.6 5.1

18. Water holding capacity % 26.2 24.2 16.9

19. Copper as Cu mg/kg 0.02 0.09 0.07

20. Iron as Fe mg/kg 0.06 0.05 0.08

21. Lithium mg/kg <0.01 <0.01 <0.01

22. Moisture Content % <1.0 <1.0 <1.0

23. Boron as B mg/kg 0.09 0.08 0.07

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur

83

S.No PARAMETERES UNITS S4 S5 S6

1 Texture - Clay Sandy Clay Sandy Clay

2. Particle size Distributions

Sand % 36 34 36

Silt % 12 16 10

Clay % 52 50 54

3. Appearance -- Brown Color Brown Color Brown Color

4. Sodium as Na mg/100grm 2.33 2.62 2.33

5. pH (10% Slurry) @ 25 oC - 7.58 7.66 7.58

6. Conductivity @25 oC µmhos/cm 146 164 146

7. Bulk density gram/cc 1.54 1.65 1.54

8. Porosity % v/v 18 22 18

9. Total Organic Matter(TOC) % 0.72 0.75 0.72

10. Nitrogen as N mg/100grm 136 186 136

11. Potassium as K mg/100grm 68 88 68

12. Phosphorus as P mg/100grm 36 41 36

13. Zinc as Zn mg/kg 1.98 2.15 1.98

14. Cadmium as Cd mg/kg <0.01 <0.01 <0.01

15. Chlorides as Cl mg/100grm 1.48 0.58 1.48

16. Alkali Metals mg/kg 2.3 2.2 2.3

17. Permeability Cm/h 5.6 4.9 5.6

18. Water holding capacity % 14.5 15.2 14.5

19. Copper as Cu mg/kg 0.05 0.09 0.05

20. Iron as Fe mg/kg 0.09 0.08 0.09

21. Lithium mg/kg <0.01 <0.01 <0.01

22. Moisture Content % <1.0 <1.0 <1.0

23. Boron as B mg/kg 0.08 0.07 0.08

3.4.6 Results & Conclusions

The soil analysis results are presented in Table No. 3.3. The result obtained is compared

with the standard soil classification given Agriculture Soil Limits. It has been observed that

the soils are Sandy clay in texture and neutral in nature. The nutrient and organic matter

contents are medium and the soil is normally fertile.

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur

84

3.5 WATER ENVIRONMENT

3.5.1 Hydrogeology & Drainage

Ruparel, Sabi, Chunar Sidh and Landoha are the only rivers that flow through the District.

In the District there is no river which is perennial in its entire course. Several of the rivers

and their tributaries have been impounded at suitable sites, the water of which is used for

irrigation purposes.

There is no natural lake in the District. However, there are about 150 artificial lakes and

tanks. The history of some of these can be traced back to as far as the second century A.D.

Baghola Bund (tank) near Rajgarh is said to have been built by the Gujaras in 145 A.D. and

Bund Talao was built nearly 1,700 years ago. Another old bund is that of Deoti which was

built by Bar Gujar Chiefs of the place before the occupation of Deoti by Kachhawas of

Marwar. Some of the bunds like Babariya, Somasagar near Ajabgarh and Salim Sagar in

Alwar fort were constructed during the time of Mughals when Alwar forest was considered to

be a haunt of wild animals and the favourite Shikar Gah of the Mughal Emperors. Later on,

Maharaja Pratap Singh, the founder of the Alwar State built two Pratap bunds at Alwar and

Rajgarh. His successor Maharaja Vinay Singh constructed Siliserh, Baleta and Tijara tanks

during his time. District Environmental Atlas -2009 : Alwar 11 Inlaki and Thonsari bunds

were constructed during the period of Maharaja Balwant Singh of Tijara and Bakhtawar

Singh of Alwar respectively. The next stage of development of bunds was from 1891 to

1900 when Mr. Macdonald was the State Engineer. Nearly all the old bunds were renovated

and new bunds were constructed during the time of Maharaja Jey Singh.

The important among these are Hans Sarowar and Jey Samand (1910), Vijay Sagar

(1903), Training Bund (1922), and Mangalsar (1924).

3.5.2 Water Quality

To assess the present ground water condition six sampling location were selected for

ground water quality testing sampling. The monitoring is done during the winter season i.e.

December 2014 to February 2015. The details about the locations are given in the Table

No.3.4. The detailed analysis report of winter season is enclosed as Annexure- XI. The

results are presented in Table No. 3.5

The purpose of this study is to:

• Assess the water quality characteristics for critical parameters;

• Evaluate the impacts on agricultural productivity, habitat conditions, recreational

resources and aesthetics in the vicinity; and

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur

85

• Predict the likely impacts on water quality due to the proposed project and related

activities.

3.5.3 Methodology

The monitoring location has been finalized considering following points:-

• Drainage pattern of the regional area;

• Location of residential areas representing different activities/likely impact areas;

Ground water sources covering 10-km radial distance were examined for physico-chemical

parameters in order to assess the effect of industrial and other activities on the hydrosphere

resources. The samples were collected and analyzed as per the procedures specified in

'Standard Methods for the Examination of Water and wastewater' published by American

Public Health Association (APHA).

3.5.4 Water Sampling Locations

Six groundwater samples were collected as grab samples and were analyzed for various

parameters. The analyzed results were compared with the standards for drinking water as per

IS: 10500. The water sampling locations are listed below in Table No. 3.4.

Table No. 3.4

Water Quality Locations

Location

Code

Location

Name Details

Direction

w.r.t project

Site

Co-ordinates

GW-1 Project Site

Project site -- N 28012’02.4” E

76051’24.4”

GW-2 Belaheri Near Hanuman

Mandir

SE N 28011’31.2” E

76052’09.5”

GW-3 Bhiwadi

Near Govt Hospital NE N 28012’41.3” E

76050’19.5”

GW-4 Milakpur

Near Mataji Mandir W N 28011’53.5” E

76049’26.2”

GW-5 NH-71

Near Main road NE N 28012’45.3” E

76051’40.8”

GW-6 Khajuriwas

Near Shivji Mandir SW N 28010’16.2” E

76049’13.2”

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur

86

Table No. 3.5 (a)

Water quality of the study area

S.No Parameter Requireme

nt

(Desirable

Limits)

Permissibl

e Limits in

the

Absence

of

Alternate

Source

Unit

s

GW1

GW2

GW3

1 pH @25 OC 6.5 – 8.5 NR - 7.26 7.58 7.76

2 Color (Hazen

units)

< 5 < 25 Haze

n

<01 <01 <01

3 Taste Agreeable - - Agreeab

le

Agreeabl

e

Agreeab

le

4 Odor Unobjec-

tionable

- - Unobjec

-

tionable

Unobjec-

tionable

Unobjec

-

tionable

5 Conductivity@

25 OC

-- -- µS/c

m

1565 1426 1556

6 Turbidity (NTU) < 5 < 10 NTU 1.26 1.3 1.0

7 Total Dissolve

solids

< 500 < 2000 mg/L 1004 913 998

8 Total Hardness

as CaCO3

< 200 < 600 mg/L 560 510 540

9 Total Alkalinity < 200 < 600 mg/L 280 240 380

10 Calcium as Ca < 75 < 200 mg/L 120.0 112.0 112.0

11 Magnesium as

Mg

< 30 < 100 mg/L 62.4 55.2 62.4

12 Residual

Chlorine

< 0.2 - mg/L <0.02 <0.02 <0.02

13 Boron < 1 < 5 mg/L 0.03 0.036 0.039

14 Chloride as Cl < 250 < 1000 mg/L 205.1 180.1 195.1

15 Sulphate as

SO4

< 200 < 400 mg/L 182.6 193.8 101.0

16 Fluorides as F- < 1.0 < 1.5 mg/L 1.14 1.16 1.06

17 Nitrates as NO3 < 45 < 100 mg/L 13.2 10.7 10.7

18 Phenolic

Compounds

< 0.001 < 0.002 mg/L <0.001 <0.001 <0.001

19 Cyanide as CN < 0.05 NR mg/L <0.001 <0.001 <0.001

20 Anionic

Detergents

< 0.2 < 1.0 mg/L <0.001 <0.001 <0.001

21 Mineral Oil < 0.01 < 0.03 mg/L <0.001 <0.001 <0.001

22 Cadmium as

Cd

< 0.01 NR mg/L <0.001 <0.001 <0.001

23 Arsenic as As < 0.01 NR mg/L <0.001 <0.001 <0.001

24 Copper as Cu < 0.05 < 1.5 mg/L 0.059 0.012 0.039

25 Lead as Pb < 0.05 NR mg/L <0.001 <0.001 <0.001

26 Manganese as

Mn

< 0.1 < 0.3 mg/L 0.071 <0.001 <0.001

27 Iron as Fe < 0.3 < 1.0 mg/L 0.13 0.11 0.11

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur

87

S.No Parameter Requireme

nt

(Desirable

Limits)

Permissibl

e Limits in

the

Absence

of

Alternate

Source

Unit

s

GW1

GW2

GW3

28 Chromium as

Cr6+

< 0.05 NR mg/L <0.001 <0.001 <0.001

29 Zinc as Zn < 5 < 15 mg/L 0.039 0.064 0.079

30 Aluminum as

Al

< 0.03 < 0.2 mg/L <0.001 <0.001 <0.001

31 Mercury as Hg < 0.001 NR mg/L <0.0002 <0.000

2

<0.0002

32 Selenium as Se < 0.01 NR mg/L < 0.001 <

0.001

< 0.001

33 E-coli(Nos/100

ml)

Absent - - Not

detected

Not

detecte

d

Not

detected

34 Coliform

Organisms/100

mL

<10 -- MPN/

100 ml

Not

detected

Not

detecte

d

Not

detected

Table No. 3.5 (a)

Water quality of the study area

Sr.N

o

Parameter Requireme

nt

(Desirable

Limits)

Permissibl

e Limits in

the

Absence

of

Alternate

Source

Unit

s

GW4

GW5

GW6

1 pH @25 OC 6.5 – 8.5 NR - 7.81 8.06 7.66

2 Color (Hazen

units)

< 5 < 25 Haze

n

<01 <01 <01

3 Taste Agreeable - - Agreeab

le

Agreeab

le

Agreeabl

e

4 Odor Unobjec-

tionable

- - Unobjec

-

tionable

Unobjec

-

tionable

Unobjec

-

tionable

5 Conductivity@2

5 OC

-- -- µS/c

m

1794 832 1788

6 Turbidity (NTU) < 5 < 10 NTU 1.1 2.1 1.3

7 Total Dissolve

solids

< 500 < 2000 mg/L 1142 528 1142

8 Total Hardness

as CaCO3

< 200 < 600 mg/L 580 300 620

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur

88

Sr.N

o

Parameter Requireme

nt

(Desirable

Limits)

Permissibl

e Limits in

the

Absence

of

Alternate

Source

Unit

s

GW4

GW5

GW6

9 Total Alkalinity < 200 < 600 mg/L 550 200 460

10 Calcium as Ca < 75 < 200 mg/L 120.0 80.0 132.0

11 Magnesium as

Mg

< 30 < 100 mg/L 67.2 24.0 69.6

12 Residual

Chlorine

< 0.2 - mg/L <0.02 <0.02 <0.02

13 Boron < 1 < 5 mg/L 0.068 0.032 0.056

14 Chloride as Cl < 250 < 1000 mg/L 170.1 100.0 210.1

15 Sulphate as

SO4

< 200 < 400 mg/L 80.1 61.5 102.8

16 Fluorides as F- < 1.0 < 1.5 mg/L 1.16 0.64 1.36

17 Nitrates as NO3 < 45 < 100 mg/L 14.5 6.3 16.9

18 Phenolic

Compounds

< 0.001 < 0.002 mg/L <0.001 <0.001 <0.001

19 Cyanide as CN < 0.05 NR mg/L <0.001 <0.001 <0.001

20 Anionic

Detergents

< 0.2 < 1.0 mg/L <0.001 <0.001 <0.001

21 Mineral Oil < 0.01 < 0.03 mg/L <0.001 <0.001 <0.001

22 Cadmium as Cd < 0.01 NR mg/L <0.001 <0.001 <0.001

23 Arsenic as As < 0.01 NR mg/L <0.001 <0.001 <0.001

24 Copper as Cu < 0.05 < 1.5 mg/L 0.051 0.042 0.083

25 Lead as Pb < 0.05 NR mg/L <0.001 <0.001 <0.001

26 Manganese as

Mn

< 0.1 < 0.3 mg/L <0.001 0.006 <0.001

27 Iron as Fe < 0.3 < 1.0 mg/L 0.14 0.11 0.12

28 Chromium as

Cr6+

< 0.05 NR mg/L <0.001 <0.001 <0.001

29 Zinc as Zn < 5 < 15 mg/L 0.097 0.036 0.048

30 Aluminum as Al < 0.03 < 0.2 mg/L <0.001 <0.001 <0.001

31 Mercury as Hg < 0.001 NR mg/L <0.0002 <0.0002 <0.0002

32 Selenium as Se < 0.01 NR mg/L < 0.001 < 0.001 < 0.001

33 E-coli(Nos/100

ml)

Absent - - Not

detected

Not

detected

Not

detected

34 Coliform

Organisms/100

mL

<10 -- MPN/

100 ml

Not

detected

Not

detected

Not

detected

Results & Conclusions

The result indicates that the ground water quality values are below the permissible limits

and is suitable for drinking purpose. As per IS 10500 (Reaffirmed – 2012).

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur

89

3.6 AIR ENVIRONMENT

3.6.1 Climatology and Meteorology

The study area has particularly a dry climate. The three main seasons, summer, monsoon

and winter respectively, dominate the study area. Alwar weather is moderate and the

climate is not too hot. Throughout the year Alwar experience a dry climate, during the

summer season it is very hot, but far less than the other cities of Rajasthan. The summer

season spans between the months of April and June .The Aravalli hills that enclose Alwar

city protect it from the hot winds in the summers. May is the hottest month of the year

when the temperature raises up to 41° Celsius. Alwar weather comes across a cold winter

.The winters in Alwar are cool and pleasant spanning between November and February. The

temperature during the winter season approximately varies within the range of 23°C

(maximum) to 8°C (minimum).Alwar experience a very short monsoon. The annual rainfall

of tehsil tijara is around 359.0 mm (As per WRD, Raj. 2014). The average of humidity of

Alwar is 70% .The ideal time to visit the city is in the winter season in the month of

September to February.

3.6.2 Methodology

The methodology adopted for monitoring surface observations is as per the standard norms

laid down by Bureau of Indian Standards (IS: 8829) and India Meteorological Department

(IMD). Automatic Meteorological station has been installed near to the proposed project

site.

3.6.3 Meteorological data recorded at project site

An auto weather monitoring station was installed during the study period to record various

meteorological parameters on hourly basis to understand the wind pattern, Temperature

variation, solar insulation and relative humidity variation etc.

Percentage frequencies of wind in 16 directions have been computed from the recorded data

during the study period pre monsoon. The pictorial represents the summary of the wind

pattern is given blow of the study period.

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur

90

Table No. 3.6

Micro meteorological data for the study period at project site

Month Temperature

(0C)

Relative Humidity

(%)

Rainfall in

mm

Wind Speed

mph

Max Min Max Min Max Total Max Min

December -

2014 31.1 5.2 99.5 7.7 0 0 9.0 <1.0

January-

2015 29.5 2.7 99.5 9.4 0 0 9.0 <1.0

February –

2015 30.8 5.8 86.3 6.8 0 0 8.0 < 1.0

Wind pattern during the study period

The predominant wind direction during this Study period is observed to be blowing all

directions Wind speed during this period is 0.62 m/s. Calm wind during this period 52.59 %.

The recorded meteorological data for the study period at project site is given below.

Table No. 3.7: the Summary of the Wind Pattern is Given Below

S.No Wind Direction 0.5-2.1 Speed m/s >= 2.1

Speed m/s

Total

1. N 82 6 88

2. NNE 76 9 89

3. NE 90 8 85

4. ENE 41 4 98

5. E 79 11 45

6. ESE 39 10 90

7. SE 27 1 49

8. SSE 60 9 28

9. S 11 2 69

10. SSW 48 7 12

11. SW 97 11 54

12. WSW 53 5 110

13. W 41 8 58

14. WNW 55 11 49

15. NW 25 8 64

16. NNW 83 6 35

Sub-Total 1023

Calms 1136

Missing/Incomplete 1

Total 2160

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur

91

SITE SPECIFIC WIND ROSE

The predominant wind direction during this Study period is observed to be blowing all

directions Wind speed during this period is 0.62 m/s. Calm wind during this period 52.59 %.

The recorded meteorological data for the study period at project site is given below.

Figure No. 3.3

Windrose 24hrs

WRPLOT View - Lakes Environmental Software

PROJECT NO.:

M/s: AURONEXT PHARMA LTD

MODELER:

Vijay Kumar Reddy

COMPANY NAME:

Vison Labs

COMMENTS:WIND ROSE PLOT:

Station # 12 - M/s: AURONEXT PHARMA LTD,RIICO Industrial Area,Bhiwari,ALWAR, RT

Resultant Vector

26 deg - 11%

NORTH

SOUTH

WEST EAST

2%

4%

6%

8%

10%DATA PERIOD:

Start Date: 12/1/2014 - 00:00End Date: 2/28/2015 - 23:00

WIND SPEED (m/s)

>= 11.1

8.8 - 11.1

5.7 - 8.8

3.6 - 5.7

2.1 - 3.6

0.5 - 2.1

Calms: 18.89%

AVG. WIND SPEED:

1.72 m/s

CALM WINDS:

18.89%

TOTAL COUNT:

2159 hrs.

DISPLAY:

Wind SpeedDirection (blowing from)

3.6.4 Ambient Air Quality

The data was generated by Vison Labs, Hyderabad for the winter season December 2014-

Febraury 2015 for ambient air quality status within 10 km radius of the site.

The monitoring report (Baseline data) is enclosed as Annexure- XI. Six monitoring stations

(including project site) were installed at different locations during December 2014 to

February 2015 to assess the ambient air quality the summary of all the above location are

given below Table No.3.8.

I. Methodology adopted for Air Quality Survey

� Selection of Sampling Locations

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur

92

The baseline status of the air quality in the study area has been assessed through a

scientifically designed ambient air quality monitoring network. The design of monitoring

network in the air quality surveillance program has been based on the following

considerations:

• Meteorological conditions on synoptic scale;

• Topography of the study area;

• Representatives of regional background air quality for obtaining baseline status;

and

• Representatives of likely impact areas.

Ambient Air Quality Monitoring (AAQM) stations were set up at six locations during pre

monsoon season with due consideration to the above mentioned points. Table No. 3.8 gives

the details of environmental setting around each monitoring station and their distances with

reference to the proposed project.

Table No. 3.8

Location of air monitoring stations

Location

Code

Location

Name

Distance

(Km)

Direction Co-ordinates

AAQ- 1 Project Site Project Site - - N 28012’02.4”

E 76051’24.4”

AAQ- 2 Belaheri Wahad S/o

Shadik pasha

1.50 SE N 28011’34.3”

E 76052’10.0”

AAQ- 3 Bhiwadi Ramesh S/o

Amarpal

1.30 NE N 28012’42.5”

E 76050’26.9”

AAQ- 4 Milakpur Ranjith S/o

Jiayalal

2.30 W N 28012’04.8”

E 76049’38.2”

AAQ- 5 NH-71 Near BSNL Office 2.50 NE N 28012’46.2”

E 76051’42.4”

AAQ- 6 Khajuriwas Eshwar S/o

Bodanram

3.50 SW N 28010’37.6”

E 76049’24.1”

Ambient air quality monitoring has been carried out with a frequency of two days per week at

six locations covering one complete season except monsoon (CPCB guidelines). The ambient

air quality parameters along with their frequency of sampling are given in Table No. 3.9

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur

93

Table No. 3.9

Monitored Parameters and Frequency of Sampling

Parameters Sampling Frequency

Suspended Particulate Matter 24 hourly sample twice a week for a season except monsoon

Respirable Particulate Matter 24 hourly sample twice a week for a season except monsoon

Sulphur dioxide (SO2) 24 hourly sample twice a week for a season except monsoon

Oxides of Nitrogen (NOX) 24 hourly sample twice a week for a season except monsoon

II. Instruments used for sampling

Respirable Suspended Particulate Matter (RPM)/PM10 and gaseous pollutants like SO2, NOx.

And CO. APM 550 Fine Particle Sampler was used to monitor PM2.5.

III. Sampling and Analytical Techniques

PM2.5 and PM10 have been estimated by gravimetric method. Modified West and Gaeke

method (IS-5182 Part-II, 1969) has been adopted for estimation of SO2. Jacobs-Hochheiser

method (IS-5182 Part-IV, 1975) has been adopted for the estimation of NOx. NDIR

spectroscopy method will be adopted for carbon monoxide detection. The techniques used

for ambient air quality monitoring and its minimum detectable levels are given in Table No.

3.10.

Table No. 3.10

Techniques Used for Ambient Air Quality Monitoring

Particular

Testing Method to be Followed

Ambient Air Monitoring Parameter

A PM 10 IS-5182 (part – 23) 2006

B PM 2.5 RTI(Research Triangle Institute)

(Gravimetric Ana Revision-07 Aug14-2003)

C SO2 (Sulfur Dioxide) IS 5182 (Part – II) 2001, with Improved West

& Gaeke Method

D NO2 ( Oxides of Nitrogen) Modified Jacobs – Hochheiser Method /

Arsenite Method (IS 5182 Part IV)2011

E Carbon Monoxide NDIR Spectroscopy method

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur

94

Filter Paper details

APPRATUS MAKE SIZE SIZE PRODUCT

CATEGORY NO.

Filter Paper

(PM10)

M/S Whatmann

International Ltd.

203 x

254mm

GMF-S-10

Batch No-G015DO7

Filter Paper

(PM2.5)

M/S Whatmann

International Ltd.

47 mm Tuflon

IV. Presentation of Results

The analysis results for the study period are presented in detail in Annexure-XI. Various

statistical parameters like 98th percentile, average, maximum and minimum values have been

computed from the observed raw data for all the AAQ monitoring stations. The summary of

monitoring results for all the locations are presented in Table No.3.11 .These are compared

with the standards prescribed by Central Pollution Control Board (CPCB) for rural and

residential zone.

Table No. 3.11

Summary of Ambient Air Monitoring

Locations

PM10

(µg/m3)

PM2.5

(µg/m3)

SO2

(µg/m3)

NOx

(µg/m3)

CO

(µg/m3)

Max Min Avg Max Min Avg Max Min Avg Max Min Avg Max Min Avg

Project Site 90.4 69.9 80.15 53.6 38.5 92.1 9.7 6.8 8.25 34.5 21.9 28.2 1650 1054 1352

Belaheri 72 54.5 63.25 42.4 26.5 34.45 6.9 5.5 6.2 26.9 20.9 23.9 1324 986 1155

Bhiwadi 79 59.6 69.3 48.4 36.1 42.25 9.4 5.9 7.65 29.3 20.9 25.1 1452 986 1219

Milakpur 73.4 51.9 62.65 45.7 30.6 38.15 6.9 5.1 6 25.4 18.9 44.3 1245 785 1015

NH-71 88.3 65.8 77.05 51.4 34.2 42.8 9.1 7.0 8.05 35.6 24.8 30.2 1652 1098 1375

Khajuriwas 85.9 64.7 75.3 49.7 32.5 41.1 8.6 6.7 7.65 28.9 21.3 25.1 1411 986 1198.5

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur

95

Table No. 3.12 (a) CHEMICAL CHARACTERIZATION ANALYSIS OF PM10

Location Name : Project Site Date of Sampling : 20.01.2015

S.No Characteristics Units Project Site

1. Respirable Particulate Matter (PM10) µg/m3 71.5

2. Calcium as Ca µg/m3 2.36

3. Magnesium as Mg µg/m3 1.04

4. Sodium as Na µg/m3 0.08

5. Free Silica as Si µg/m3 12.3

6. Potassium as K µg/m3 <0.01

7. Chromium as Cr µg/m3 <0.01

8. Aluminum as Al µg/m3 <0.01

9. Lead as Pb µg/m3 <0.01

10. Zinc as Zn µg/m3 <0.01

11. Iron as Fe µg/m3 <0.01

12. Nickel as Ni µg/m3 <0.01

13. Barium as Ba µg/m3 <0.01

14. Cadmium as Cd µg/m3 < 0.01

15. Mercury as Hg µg/m3 <0.001

16. Arsenic as As µg/m3 <0.01

Table No. 3.12 (b): AMBIENT AIR QUALITY MONITORING

Location : : Project Site (A1)

Date

VOC

PPM

Hydro Carbons(HC) mg/m3

Methane Non-Methane

1. 09.12.2014 BDL BDL BDL

2. 16.12.2014 BDL BDL BDL

3. 22.12.2014 BDL BDL BDL

4. 29.12.2014 BDL BDL BDL

5. 05.01.2015 BDL BDL BDL

6. 12.01.2015 BDL BDL BDL

7. 19.01.2015 BDL BDL BDL

8. 26.01.2015 BDL BDL BDL

9. 03.02.2015 BDL BDL BDL

10. 10.02.2015 BDL BDL BDL

11. 17.02.2015 BDL BDL BDL

Arithmetic Mean BDL BDL BDL

Maximum BDL BDL BDL

Minimum BDL BDL BDL

50th percentile BDL BDL BDL

98th percentile BDL BDL BDL

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur

96

Note:-

1. VOC analyzed through VOC Analyzer

Model PhoCheck 1000

Handheld PID Detector for VOCs

Wide Detection Range : 0.1 to 4000 ppm

(BDL is <0.1ppm)

2. HC (Methane & Non- Methane (GC/FID)

In view of the use of this detector in methods 101,108 & 130. This expanded discussion is

provided here. A Flame Ionization Detector(FID) is a device which incorporate regulated fuel

air and sample delivery systems, an internal burner and associated electronics for

measuring the ion current produced by species introduced in to the flame. The FID is used

to sense and measure small amount of gases organic type components present in the

carrier gas stream leaving the column of a gas chromatography(GC) or to monitor methane

and / or total hydrocarbon concentrations in ambient air samples.

Range & sensitivity: 0.1-13mg/m3

BDL is < 0.1mg/m3

V. Results of monitoring

PM10: The maximum value for PM10 observed at Project site is 90.4 µg/m3 and minimum

value for PM10 observed at Belahari Village 72 µg/m3. The 24 hours applicable limit for

industrial, Residential Rural and Other Areas is 100 µg/m3.

PM2.5: The maximum value for PM2.5 observed at Project site 53.6µg/m3 and minimum value

for PM2.5 observed at Belahari Village 42.4µg/m3. The 24 hours applicable limit for industrial,

Residential Rural and Other Areas is 60 µg/m3.

SO2: The maximum value for SO2 observed at Project Site 9.7 µg/m3 and minimum value for

SO2 observed at Belahari Village 5.5 µg/m3. The 24 hours applicable limit for industrial,

Residential Rural and Other Areas is 80 µg/m3.

NO2: The maximum value for NO2 observed at NH- 71, 35.6µg/m3 and minimum value for

NO2 observed at Belahari Village 26.9 µg/m3. The 24 hours applicable limit for industrial,

Residential Rural and Other Areas is 80 µg/m3.

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur

97

CO: The maximum value for CO observed at NH71 1652µg/m3 and minimum value for CO

observed at Milakpur Village 785µg/m3. The 8 hours applicable limit for Industrial, Residential

Rural and other areas is 2000 µg/m3.

HC & VOCS: The values of HC & VOCs is foundBDL at Project site

Results and Conclusions

The results of the monitored data indicate that the ambient air quality of the region in general

is conformity with respect to norms of National Ambient Air Quality standards, at all locations

monitored.

3.7 NOISE ENVIRONMENT

The physical description of sound concerns its loudness as a function of frequency. Noise in

general is sound, which is composed of many frequency components of various types of

loudness distributed over the audible frequency range. The most common and universally

accepted scale is the A weighted scale, which is measured as dB (A). This is more suitable

for audible range of 20 to 20,000 Hz. The scale has been designed to weigh various

components of noise according to the response of human ear. The environmental impact of

noise can have several effects varying from Noise Induced Hearing Loss (NIHL) to

annoyance depending on loudness of noise.

The main objective of noise monitoring in the study area is to establish the baseline noise

levels and assess the impact of the total noise expected to be generated during the project

operations around the project site. The statistical analysis is done for measured noise levels

at seven locations in the study area. The parameters are analyzed for Leqday and Leqnight.

The statistical analysis results are given below:

3.7.1 Identification of Sampling Locations

A preliminary reconnaissance survey has been undertaken to identify the major noise

generating sources in the area. Noise at different noise generating sources has been identified

based on the residential, industrial and commercial activities in the area.

The noise monitoring has been conducted for determination of noise levels at six locations in

winter season. The noise levels at each location were recorded for 24-hrs. The environment

setting of noise monitoring location during winter season is given in Table No. 3.13 and

during

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur

98

Table No. 3.13

Location of monitoring station of Ambient Noise Levels in the Study Area

Location

Code

Location

Name Details

Direction w.r.t

project Site Co-ordinates

N – 1 Project Site

Project Site -- N 28012’02.4” E

76051’24.4”

N – 2 Belaheri Near Hanuman

Mandir

SE N 28011’34.3” E

76052’10.0”

N – 3 Bhiwadi Near Govt

Hospital

NE N 28012’40.8” E

76050’13.7”

N – 4 Milakpur Near Mataji

Mandir

W N 28012’02.7” E

76049’35.2”

N – 5 NH-71

Near Main road NE N 28012’46.2” E

76051’42.4”

N – 6 Khajuriwas Near Shivji

Mandir

SW N 28010’37.6” E

76049’24.1”

3.7.2 Method of Monitoring

Sound Pressure Levels (SPL) measurements were recorded at six locations. The readings were

taken for every hour for 24-hrs. The day noise levels have been monitored during 6am to 9

pm and night noise levels during 10 pm to 6 am at all the locations covered in the study area.

Measured noise level displayed as a function of time provides a useful scheme for describing

the acoustical climate of a community. Noise levels recorded at each station are computed

for equivalent noise levels. Equivalent noise level is a single number descriptor for

describing time varying noise levels. The equivalent noise level is defined as mathematically

Where L = sound pressure level a function of time dB (A)

T = Time interval of observations

Noise levels during the night time generally drop, therefore to compute Equivalent noise

levels for the night time, noise levels are increased by 10 dB (A) as the night time high

noise levels are judged more annoying compared to the day time.

3.7.3 Presentation of Results

10Log1/T ΣΣΣΣ (10Ln/10)

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur

99

The statistical analysis is done for measured noise levels at eight locations in the study area.

The parameters are analyzed for Lday, Lnight. The statistical analysis results are given in Table

No.3.14

Table-3.14

Ambient Noise Levels in The Study Area [dB(A)]

All the values are given in dB (A)

Sample code .NO Location Name Noise Monitoring Date

N-1 Project Site 21.02.2012

N-2 Belaheri 22.02.2015

N-3 Bhiwadi 24.02.2015

N-4 Milakpur 26.02.2015

N-5 NH-71 27.02.2015

N-6 Khajuriwas 28.02.2015

Time N1 N2 N3

N4

N5

N6

Day time

7.00 57.1 51.7 53.7 52.9 51.3 51.8

8.00 58.2 54.4 54.9 55.2 53.6 54.1

9.00 62.6 55.7 59.2 56.9 56.3 57.7

10.00 65.4 59.2 60.6 60.2 57.3 59.1

11.00 67.4 61.4 63.7 62.6 56.2 61.5

12 Noon 69.1 60.5 61.7 58.7 59.4 57.9

13.00 67.2 59.2 59.1 57.4 58.8 60.3

14.00 66.2 57.6 57.2 56.8 55.2 57.7

15.00 63.1 55.3 56.4 57.5 54.3 55.6

16.00 61.4 53.1 57.1 58.3 52.7 53.5

17.00 64.9 55.2 59.2 59.4 54.8 55.3

18.00 67.4 56.9 60.4 60.1 56.5 58.8

19.00 66.3 59.2 61.6 62.5 57.2 59.4

20.00 65.3 61.7 63.7 61.1 58.7 60.6

21.00 64.2 60.4 64.9 57.4 54.8 61.4

Night time

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur

100

3.7.4 Observation of Results

a) Day Time Noise Levels (Leqday)

Study Area

The daytime (Leqday) noise levels are observed to be in the range of 65.4 – 56.4

dB(A) which are within the prescribed limit of respective categories.

b) Night time Noise Levels (Leqnight)

Study Area

The nighttime (Leqnight) Noise levels are observed to be in the range of 45.4 – 47.7

dB(A) which are within the prescribed limit of respective categories.

3.8 BIOLOGICAL ENVIRONMENT

Documentation of biological components in a project area and its immediate surroundings is

imperative in the case of any developmental project, to ensure that the ecological setup of

the area does not degrade and in effect is improved. For understanding the impact of a

proposed project, it is better to prioritize the conservation issues, in terms of flora and

fauna, in addition to other base line parameters. Biodiversity study of the proposed project

area was carried out to understand the status of predominant floral and faunal groups i.e.

trees, shrubs, herbs, grasses, herpetofauna, avifauna and mammals. To collect data and

information on specific components of the ecological system and pertinent issues widely

22.00 61.1 56.2 56.4 55.3 52.1 51.7

23.00 57.2 51.3 53.3 53.2 49.3 49.7

24.00 55.2 49.1 51.5 51.3 48.7 49.5

1.00 53.1 48.5 49.2 48.8 46.2 46.4

2.00 49.0 47.4 47.4 46.9 45.3 45.8

3.00 48.3 46.8 46.2 46.7 44.7 45.2

4.00 49.6 45.7 45.3 45.6 43.9 44.5

5.00 53.8 45.9 47.5 47.4 44.4 45.4

6.00 55.3 47.1 51.9 50.2 47.2 48.3

Maximum 69.1 61.7 64.9 62.6 59.4 61.5

Minimum 48.3 45.7 45.3 45.6 43.9 44.5

LDay

equivalent 65.4 58.4 60.7 59.2 56.4 58.5

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur

101

used standard scientific methods were adopted. Rapid field surveys were undertaken during

december2014-fabruary2015 for collecting relevant data.

The objectives of the present study were as follows:

• To identify the floral and faunal diversity,

• To assess nature and distribution of the vegetation in the area,

• To identify the endangered species of flora and fauna, if any

• To prepare conservation plan for Schedule I fauna , if any

3.8.1 Methodology

Extensive literature review was carried out to indentify the representative spectrum of

threatened species, population and ecological communities listed by IUCN, WCMC, ZSI,

BSI and Indian wild Life Protection act, 1972. Biodiversity study of the proposed

project of Auronext Pharma Pvt Ltd coming up at RIICO Industrial Area, Bhiwadi, Distt.-

Alwar, Rajasthan , was carried out to understand the status of predominant floral and faunal

groups i.e. trees, shrubs, herbs, grasses, Herpetofauna, avifauna and mammals.

Table No. 3.15

Methods used for study of Flora & fauna

Taxa Sampling Methods

Plants Quadrate sampling and enumeration

Butterflies Transect, Visual encounter survey

Amphibians Visual encounter survey (search)

Reptiles Visual encounter survey (search)

Birds Point count, opportunistic observation

Mammals Tracks and signs, and visual encounter survey

Fauna

i. Avifauna

Species search and census: Standard methods were followed to survey the avifauna. Point

count method was followed for counting the birds. Opportunistic surveys were also carried

out with respect to avifaunal checklist. Identification by calls was also made for species

which were not directly encountered or were hidden in the vegetation or canopy. Secondary

data collected from the literature was also included in the present given list.

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur

102

ii. Herpetofauna

Amphibians and reptiles recorded during area searches were identified by visual

characteristics. Aquatic searches involved examining each type of aquatic habitat.

iii. Mammals

Presence of mammals was documented by using both direct sightings and indirect evidences

i.e. animal burrows/holes, scats, pellets, droppings and tracks Opportunistic sightings were

also included. Circular Plots were used to search indirect evidences.

Floristic studies were conducted during Dec-2014 Feb. 2015 to know the presence of any

endangered/threatened/endemic plant species study area of the existing industry (10-km

radius).

The data collected in the field was analyzed for secondary parameters such as density,

frequency and abundance following standard phyto-sociological methods. Shannon-Wiener

diversity index (Shannon and Wiener, 1963) was calculated for all life forms as follows:

Table No. 3.16: Estimation of phyto-sociological parameters

1 Frequency (%) = (No. of quadrats of occurrence of the species X 100) / Total No. of

quadrats sampled

2 Abundance = Total No. of individuals of the species / No. of quadrats of Occurrence

3 *Density = Total No. of individuals of the species / Total No. of quadrats sampled

4 Relative Frequency = (Frequency of the given species X 100) / Sum of all

frequencies

5 Relative Density = (Density of the given species X 100) / Sum of all densities

6 Relative Abundance = (Abundance of species X 100) / Sum of all abundances

7 Basal Area = (GBH)2 / 4Π

8 Dominance = Total Basal Area / Total area sampled

9 Relative Dominance = (Dominance of given species X 100) / Dominance of all

species

10 Important Value Index (I.V.I.) = Relative Density + Relative Frequency + Relative

Dominance

Note: *Density refers to the number of individuals per unit area of a site.

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur

103

3.8.2 Statistical Analysis

Shannon-Wiener diversity index (Shannon and Wiener, 1963) was calculated for all life

forms following:

Shannon- Wiener Information Function: D = -Σ pi ln pi

Where: i = an index for the number of species sampled, pi = ni/N =percentage of species i

in the entire sample (N) of individuals, and ln = natural log. Multiply the percentage (or

proportion) of each species in the sample times the natural log of that same value, sum the

products across all species, and then multiply by minus 1.

3.8.3 Biodiversity Profile of the Core Zone (PROJECT SITE:)

*Safeda (Eucalyptus globulus) and Subabool (Leucaena leucocephala) ware found along

with the boundary and within the site premises.

Table No. 3.17

Plants reported from Core Zone (Project site)

Trees

S.No. Common name Vernacular Name Family

1 Safeda Eucalyptus globulus Myrtaceae

2 Subabool Leucaena leucocephala Fabaceae (Mimosoideae)

Shrubs

1 Kaner Nerium oleander Apocynaceae

2 Peeli kaner Thevetia peruviana Apocynaceae

3 Chameli Jasminum sp. Oleaceae

Herbs

1 Pili Kantili Argemone mexicana Papaveraceae

2 Tarwar Cassia auriculata Caesalpinioideae

3 Dhatura Datura stramonium Solanaceae

Grass

1 Doob ghas Cynodon dactylon Poaceae

2 Sheda Grass Dichanthium annulatum Poaceae

3 Makra Dactyloctenium aegyptium Poaceae

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur

104

A. CORE ZONE

• Avifauna

A total of 5 species were recorded in the core zone (Project site) during the field survey. The

dominant species was Bank Myna (Acridotheres ginginianus) and House Crow (Corvus

splendens).

• Mammalia

A total of 2 species were observed in the core zone (Project site) during the field survey. i.e.

five stripped palm squirrel (Funambulus pennantii) and common house rat (Rattus rattus).

Table No. 3.18

Mammalian Species Recorded In Core Zone (Project Site: 8015 Sq.M)

S.

No.

Vernacular Name Scientific Name Family Category

Status

(IWPA)

IUCN

1 Five stripped palm

squirrel

Funambulus pennantii Sciuridae IV LC

2 Common House rat Rattus rattus Muridae V LC

• Amphibian

No species was reported during the field survey.

• Reptiles

Only one species was observed in the core zone (Project site) during the field survey. i.e

Oriental Garden Lizard.( Calotes versicolor).

Table No. 3.19

Reptiles recorded in core zone (Project Site)

S.No. Vernacular Name Scientific

Name

Family Category

Status

(IWPA)

IUCN

1. Oriental Garden Lizard Calotes

versicolor

Agamidae - -

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur

105

B. BUFFER ZONE (i.e. 10 km radius from the periphery of the project)

1.

Flora:

Table No. 3.20

Important Value Index (IVI) of Herb and Grass species in the buffer zone.

Vernacular Name

Scientific

Name

Total

No

of

quadrate

studied

#

@

F (%)

D

A

RF

RD

RA

IVI

Muktajhuri

Acalypha

indica

70

51

86

72.86

1.23

1.69

5.50

4.55

2.53

12.58

Latjira

Achyra

nth

es

aspera

70

25

88

35.71

1.26

3.52

2.70

4.65

5.29

12.64

Jangli chaulai

Am

ara

nth

us

spin

osus

70

39

92

55.71

1.31

2.36

4.21

4.87

3.55

12.62

Pili Kantili

Arg

em

one

mexicana

70

33

63

47.14

0.90

1.91

3.56

3.33

2.87

9.76

Janglimulli

Blu

mea lacera

70

21

45

30.00

0.64

2.14

2.27

2.38

3.22

7.87

Kasaundi

Cassia

occid

enta

lis

70

28

52

40.00

0.74

1.86

3.02

2.75

2.79

8.56

Charota

Cassia tora

70

36

51

51.43

0.73

1.42

3.88

2.70

2.13

8.71

Buffel grass

Cenchru

s

ciliarias

70

15

35

21.43

0.50

2.33

1.62

1.85

3.51

6.98

Hurhur

Cleom

e v

iscosa 70

18

47

25.71

0.67

2.61

1.94

2.49

3.92

8.35

Wild jute

Corc

horu

s

tridens

70

34

79

48.57

1.13

2.32

3.67

4.18

3.49

11.34

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur

106

Ban Tulsi

Cro

ton

bonplandianum

70

22

37

31.43

0.53

1.68

2.37

1.96

2.53

6.86

Unthkanta

Echin

ops

echin

atu

s

70

23

45

32.86

0.64

1.96

2.48

2.38

2.94

7.80

Shankhapushpi

Evolvulu

s

alsin

oides

70

22

33

31.43

0.47

1.50

2.37

1.75

2.25

6.37

Badi Dudhi

Euphorb

ia h

irta

70

41

102 58.57

1.46

2.49

4.42

5.39

3.74

13.56

Crown of Thorns

Euphorb

ia m

illi

70

7

16

10.00

0.23

2.29

0.76

0.85

3.44

5.04

Danda thor

Euphorb

ia

neriifolia

70

33

71

47.14

1.01

2.15

3.56

3.75

3.23

10.55

Gokhru

Indigofe

ra

cord

ifolia

70

36

81

51.43

1.16

2.25

3.88

4.28

3.38

11.55

Nili

Indigofe

ra

tincto

ria

70

16

56

22.86

0.80

3.50

1.73

2.96

5.26

9.95

Jangi gobi

Launaea

pro

cum

bens

70

41

53

58.57

0.76

1.29

4.42

2.80

1.94

9.17

Jharasi

Mollugo

cerv

iana

70

23

36

32.86

0.51

1.57

2.48

1.90

2.35

6.74

Tulsi

Ocim

um

am

ericanum

70

29

47

41.43

0.67

1.62

3.13

2.49

2.44

8.05

Gajar Ghas

Partheniu

m

hyste

rophoru

s

70

35

87

50.00

1.24

2.49

3.78

4.60

3.74

12.11

Bada gokhru

Pedalium

mure

x

70

17

41

24.29

0.59

2.41

1.83

2.17

3.62

7.63

Gulpankhi

Polygala

70

41

79

58.57

1.13

1.93

4.42

4.18

2.90

11.50

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur

107

eriopte

ra

Khareti

Sida cord

ifolia

70

28

53

40.00

0.76

1.89

3.02

2.80

2.84

8.67

Indian Cupscale Grass

Sacciolepis

indica

70

23

49

32.86

0.70

2.13

2.48

2.59

3.20

8.27

Kantakari

Solanum

xanth

ocarp

um

70

31

52

44.29

0.74

1.68

3.34

2.75

2.52

8.62

Sarphonk

Tephro

sia

purp

ure

a

70

44

102 62.86

1.46

2.32

4.75

5.39

3.48

13.62

Sarapunkha

Tephro

sia

villosa

70

27

59

38.57

0.84

2.19

2.91

3.12

3.28

9.32

Gokharu

Tribulu

s

terrestris

70

24

37

34.29

0.53

1.54

2.59

1.96

2.32

6.86

Ghamra

Tridax

pro

cum

bens

70

45

87

64.29

1.24

1.93

4.85

4.60

2.91

12.36

Chota dhtura

Xanth

ium

strum

arium

70

19

30

27.14

0.43

1.58

2.05

1.59

2.37

6.01

1324.29 27.014 66.53 100.00 100.00 100.00 300.00

#: Tota

l no o

f quadra

te in w

hich s

pecies o

ccurred, F: Fre

quency (%

), D

: Density, A: Abundance, RF: Relative F

requency, RD: Relative

Density, RA: Relative A

bundance, IV

I: Im

portant Valu

e Index S

hannon W

iener Divers

ity Index (H’) for herb

& g

rass w

as o

bserv

ed: 3.3

The herb & grass species commonly occurring in the study area were Tephro

sia purp

ure

a (Sarphonk), Partheniu

m

hyste

rophoru

s (Gajar ghas), Echin

ops echin

atu

s (Unthkanta

), Arg

em

one m

exicana (Pili Kantili), Acalypha in

dica (M

uktajhuri)

and A

chyra

nth

es a

spera

(Latjira). Among the herbs, highest IVI values w

ere seen for Tephro

sia p

urp

ure

a (13.62), E

uphorb

ia

hirta

(13.56), A

chyra

nth

es a

spera (12.64), A

calypha indica (12.58) and P

artheniu

m h

yste

rophoru

s (12.11) respectively.

Source: Published lecture of IUCN, WCMC, ZSI, BSI and Indian wild Life Protection act, 1972

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur

108

Table No. 3.21

Important Value Index (IVI) of Shrub species in the buffer zone.

Life Form:

Shrubs

(3x3m.)

Vernacula

r name

Scientific Name

Total No

of

quadrat

e

studied

#

@

F (%)

D

A

RF

RD

RA

IVI

Adusa

Justicia adhatoda

70

17

36

24.29

0.51

2.12

3.53

3.74

3.74

11.01

Aakda

Calotropis gigantea

70

33

39

47.14

0.56

2.29

6.85

4.05

4.05

14.95

Aak

Calotropis prosera

70

41

87

58.57

1.24

5.12

8.51

9.04

9.04

26.59

Kair

Capparis decidua

70

7

12

10.00

0.17

0.71

1.45

1.25

1.25

3.95

Karaunda

Carissa congesta

70

11

23

15.71

0.33

1.35

2.28

2.39

2.39

7.06

Awal,

Tarwar

Cassia auriculata

70

36

81

51.43

1.16

4.76

7.47

8.42

8.42

24.31

Dhatura

Datura stramonium

70

23

35

32.86

0.50

2.06

4.77

3.64

3.64

12.05

Vilayati

mehdi

Dodonaea viscosa

70

5

17

7.14

0.24

1.00

1.04

1.77

1.77

4.57

Gondhi

Grewia tenax

70

16

21

22.86

0.30

1.24

3.32

2.18

2.18

7.69

Behaya

Ipomoea carnea

70

28

72

40.00

1.03

4.24

5.81

7.48

7.48

20.78

Raimuniya

Lantana camara

70

52

11

5

74.29

1.64

6.76

10.79

11.95

11.95

34.70

Bander-Ki-

Rakhi

Mimosa hamata

70

27

39

38.57

0.56

2.29

5.60

4.05

4.05

13.71

Vilayati

Opuntia dillenii

70

3

10

4.29

0.14

0.59

0.62

1.04

1.04

2.70

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur

109

Babul

Nagphani

Prosopis juliflora

70

45

11

1

64.29

1.59

6.53

9.34

11.54

11.54

32.41

Dalme,

Dhani

Securinega virosa

70

7

17

10.00

0.24

1.00

1.45

1.77

1.77

4.99

Agasti

Sesbania sesban

70

28

38

40.00

0.54

2.24

5.81

3.95

3.95

13.71

Pili Kaner

Thevetia peruviana

70

24

41

34.29

0.59

2.41

4.98

4.26

4.26

13.50

Thor

Euphorb

ia caducifolia

70

19

40

27.14

0.57

2.35

3.94

4.16

4.16

12.26

Jharberi

Zizyphus nummularia

70

31

57

44.29

0.81

3.35

6.43

5.93

5.92

18.28

Arandi

Ricinus communis

70

29

71

41.43

1.01

4.18

6.02

7.38

7.38

20.78

688.5

7

13.7

4

56.5

9

100.0

0

100.0

0

100.0

0

300.0

0

#: Total no of quadrate in which species occurred, F: Frequency (%), D: Density, A: Abundance, RF: Relative Frequency, RD:

Relative Density, RA: Relative Abundance, IVI: Im

portant Value Index Shannon Wiener Diversity Index (H’) for shrubs was

observed: 2.7

The shrub species commonly occurring in the study area w

ere L

anta

na c

am

ara

, Pro

sopis juliflora

, Ip

om

oea c

arn

ea, Calotropis

pro

sera

, Cassia auriculata

, and Zizyphus num

mularia. Among the shrubs, highest IVI values were seen for

Lanta

na cam

ara

(34.70), P

rosopis juliflora

(32.41), C

alotropis p

rosera (26.59), Cassia auriculata

(24.31), Ipom

oea c

arn

ea (20.78) and Ricinus

com

munis (20.78) respectively.

Source: Published lecture of IUCN, WCMC, ZSI, BSI and Indian wild Life Protection act, 1972

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur

110

Figure No. 3.4

Common tree species observed in the buffer zone of the study area

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur

111

Figure No. 3.5

Common tree species observed in the buffer zone of the study area

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur

112

Table No. 3.22

Important Value Index (IVI) of tree species in the buffer zone.

Buffer Zone: Tree

(10x10m)

Scientific Name

Total No

of

quadrate

studied

#

Total no of

individual

F (%)

D

A

RF

RD

RA

IVI

Acacia leucopholea

70.0

12.0

27.0

17.1

0.4

2.3

3.5

4.9

7.6

16.0

Acacia nilotica

70.0

41.0

83.0

58.6

1.2

2.0

11.8

15.0

6.8

33.7

Acacia senegal

70.0

5.0

9.0

7.1

0.1

1.8

1.4

1.6

6.1

9.2

Albizia lebbeck

70.0

12.0

23.0

17.1

0.3

1.9

3.5

4.2

6.5

14.1

Azadirachta indica

70.0

33.0

43.0

47.1

0.6

1.3

9.5

7.8

4.4

21.7

Cassia fistula

70.0

39.0

67.0

55.7

1.0

1.7

11.3

12.1

5.8

29.2

Cordia dichotoma

70.0

22.0

28.0

31.4

0.4

1.3

6.4

5.1

4.3

15.7

Dalbergia sissoo

70.0

23.0

29.0

32.9

0.4

1.3

6.6

5.2

4.3

16.2

Dichrostachys cinerea

70.0

2.0

2.0

2.9

0.0

1.0

0.6

0.4

3.4

4.3

Leucaena leucocephala

70.0

11.0

15.0

15.7

0.2

1.4

3.2

2.7

4.6

10.5

Maytenus emarginata

70.0

11.0

28.0

15.7

0.4

2.5

3.2

5.1

8.6

16.8

Phoenix sylvestris

70.0

14.0

23.0

20.0

0.3

1.6

4.0

4.2

5.6

13.8

Pithecellobium dulce

70.0

24.0

36.0

34.3

0.5

1.5

6.9

6.5

5.1

18.5

Pongamia pinnata

70.0

33.0

49.0

47.1

0.7

1.5

9.5

8.9

5.0

23.4

Prosopis cineraria

70.0

7.0

18.0

10.0

0.3

2.6

2.0

3.3

8.7

14.0

Tamarindus indica

70.0

20.0

25.0

28.6

0.4

1.3

5.8

4.5

4.2

14.5

Tecomella undulata

70.0

9.0

13.0

12.9

0.2

1.4

2.6

2.4

4.9

9.8

Ziziphus m

auritiana

70.0

28.0

35.0

40.0

0.5

1.3

8.1

6.3

4.2

18.6

553.0

494.3

7.9

29.6

100.0

100.0

100.0

300.0

Source: Published lecture of IUCN, WCMC, ZSI, BSI and Indian wild Life Protection act, 1972.

The tree species commonly occurring in the study area were

Acacia nilotica,

Cassia fistu

la Dalberg

ia sissoo and Pongam

ia

pin

nata

. Among the tree, highest IVI values were seen for Acacia nilotica (33.7), Cassia fistu

la (29.2), Pongamia pinnata

(23.4), and Azadirachta indica (21.7) respectively.

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur

113

Figure No. 3.6

Common shrub species observed in the buffer zone of the study area

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur

114

Figure no. 3.7

Common herb & grass species observed in the buffer zone of the study area

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

115

3.8.4 Biodiversity profile of the buffer zone (10 km radius from the Periphery of the

project site)

1. Flora

Table No. 3.23

List of floral species recorded in the Buffer Zone

Trees

S.N

o.

Vernacular

Name

Scientific name Family Habitat

1. Ronjh Acacia leucopholea Fabaceae

(Mimosoideae)

Forest/Agriculture

2. Babool Acacia nilotica Fabaceae

(Mimosoideae)

Forest/Agriculture

3. Kumttha Acacia senegal Fabaceae

(Mimosoideae)

Forest

4. Bael Aegle marmelos Rutaceae

(Aurantioideae)

Forest/Agriculture

5. Siris Albizia lebbeck Mimosaceae Forest/Agriculture/

Sub Urban

6. Neem Azadirachta indica Meliaceae Agriculture/Sub

Urban

7. Kachnar Bauhinia purpurea Leguminosae Agriculture/Sub

Urban

8. Amaltash Cassia fistula Caesalpiniaceae Forest/Agriculture/

Sub Urban

9. lasoda Cordia dichotoma Boraginaceae Agriculture/Sub

Urban

10. Shesham Dalbergia sissoo Fabaceae

(Papilionaceae)

Agriculture/Sub

Urban

11. Gulmohar Delonix regia Caesalpiniaceae Agriculture/Sub

Urban

12. Kunali/khairi Dichrostachys

cinerea

Mimosaceae Forest

13. Safeda/ Eucalyptus Myrtaceae Agriculture/Sub

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

116

Sugandhapatra globolus Urban

14. Bargad Ficus benghalensis Moraceae Agriculture/Sub

Urban

15. Pipal Ficus religiosa Moraceae Agriculture/Sub

Urban

16. Subabul Leucaena

leucocephala

Fabaceae

(Mimosoideae)

Forest/Agriculture

17. Kankera Maytenus

emarginata

Celastraceae Forest/Agriculture

18. Shahtoot Morus alba Moraceae Forest/Agriculture

19. Khajoor Phoenix sylvestris Arecaceae (Palmae) Forest/Agriculture

20. Jangle Jalebi Pithecellobium

dulce

Fabaceae Forest/Agriculture

21. Karanj Pongamia pinnata Fabaceae

(Papilionaceae)

Forest/Agriculture

22. Khejari Prosopis cineraria Mimosaceae Forest/Agriculture/

Sub Urban

23. Jamun Syzygium cumini Myrtaceae Agriculture/Sub

Urban

24. Imli Tamarindus indica Fabaceae

(Leguminosae)

Agriculture/Sub

Urban

25. Sagon Tectona grandis Lamiaceae Forest

26. Ber Ziziphus

mauritiana

Rhamnaceae Forest/Agriculture/

Sub Urban

Shrubs

S.N

o.

Vernacular Name Scientific name Family

1 Aakra Calotropis gigantea Asclepiadaceae

2 Aak Calotropis procera Asclepiadaceae

3 Kair Capparis decidua Capparaceae

(Capparidaceae)

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

117

4 Behaya Ipomoea carnea Convolvulaceae

5 Kaner Nerium oleander Apocynaceae

6 Nag phani Opuntia elatior Cactaceae

7 Vilayati babool Prosopis juliflora Mimosaceae

8 Arandi Ricinus communis Euphorbiaceae

9 Kans Saccharum spontaneum Poaceae (Gramineae)

10 Munjh Saccharum munja Poaceae (Gramineae)

11 Jharberi Ziziphus nummularia Rhamnaceae

12 Champa Plumeria alba Apocynaceae

13 Dandathor Euphorbia caducifolia Euphorbiaceae

Herbs

1 Bui Aerva tomentosa Amaranthaceae

2 Pili Kantili Argemone mexicana Papaveraceae

3 Kala bhangra Anisomeles indica Lamiaceae

4 Jangli chaulai Amaranthus spinosus Amaranthaceae

5 Latjira Achyranthes aspera subsp.

argentea

Amaranthaceae

6 Latjira Achyranthes aspera subsp.

porphyristachya

Amaranthaceae

7 Muktajhuri Acalypha indica Euphorbiaceae

8 Punarnava Boerhavia diffusa Nyctaginaceae

9 Purple-Leaf Button

Weed

Borreria ocymoides Rubiaceae

10 Survali Celosia argentea Amaranthaceae

11 chitraa Citrullus colocynthis Cucurbitaceae

12 Jakhiya, Safed

hulhul

Cleome gynandra Cleomaceae

13 Kankus Commelina forskalei Commelinaceae

14 Ban Tulsi Croton bonplandianum Euphorbiaceae

15 kachari Cucumis melo ssp. agrestis Cucurbitaceae

16 Dhatura Datura metel Solanaceae

17 Latmahuria Digera muricata Amaranthaceae

18 Motha Cyperus rotundus Cyperaceae

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

118

19 Unthkanta Echinops echinatus Asteraceae

20 Oldman'S Cap Polycarpaea corymbosa Caryophyllaceae

21 Gulpankhi Polygala erioptera Polygalaceae

22 Laptuna Setaria verticillata Poaceae (Gramineae)

23 Baraira (bala) Sida acuta Malvaceae

24 Khareti Sida rhombifolia Malvaceae

25 Asiatic witchweed Striga asiatica Scrophulariaceae

26 Marigold Tagetes minuta Asteraceae

27 Yellow Bell Tecoma gaudichaudi Bignoniaceae

28 Sarphonk Tephrosia purpurea Fabaceae

(Papilionaceae)

29 Sarapunkha Tephrosia villosa Fabaceae

(Papilionaceae)

30 Peeli Kaner Thevetia peruviana Apocynaceae

31 Ashvagandha Withania somnifera Solanaceae

32 Badi Dudhi Euphorbia hirta Euphorbiaceae

33 Sunflower Helianthus annus Asteraceae

34 Gokhru Indigofera cordifolia Fabaceae

(Papilionaceae)

35 Nili Indigofera linnaei Fabaceae

(Papilionaceae)

36 Raimuniya Lantana camera Verbenaceae

37 Tikiokra Melochia corchorifolia Sterculiaceae

38 jharasi Mollugo pentaphylla Molluginaceae

39 shankhapushpi Evolvulus alsinoides Convolvulaceae

40 Dudhi Sonchus oleraceus Asteraceae

41 Damanpaper Oldenlandia corymbosa Rubiaceae

42 Gajar Ghas Parthenium hysterophorus Asteraceae

(Compositae)

43 Bada gokhru Pedalium murex Pedaliacae

44 Bilari Mukia maderaspatana Cucurbitaceae

45 Ashwagandha Withania somnifera Solanaceae

Grass

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

119

1 Jhuhi ghas Alysicarpus monilifer Fabaceae

(Papilionaceae)

2 Bristle grass Aristida adscensionis Poaceae (Gramineae)

3 Doob ghas Cynodon dactylon Poaceae (Gramineae)

4 Sheda Grass Dichanthium annulatum Poaceae (Gramineae)

5 Makra Dactyloctenium aegyptium Poaceae (Gramineae)

6 Panghas Eragrostis japonica Poaceae (Gramineae)

7 Small stink grass Eragrostis minor Poaceae (Gramineae)

8 Chinese Love Grass Eragrostis unioloides Poaceae (Gramineae)

9 Asian crab grass Digitaria bicornis Poaceae (Gramineae)

10 jangli-jowar Sorghum halepense Poaceae (Gramineae)

11 Okrich (Mauritania). Sporobolus helvolus Poaceae (Gramineae)

12 Thread Sprangletop Leptochloa panicea Poaceae (Gramineae)

13 Indian Cupscale

Grass

Sacciolepis indica Poaceae (Gramineae)

2. Fauna

Totally 31 species of the birds belonging to 21 families were recorded from the buffer zone

of the study area. All the bird species reported from the study area enlisted in the following

table:

Table 3.24

List of Avifauna Recorded in Buffer Zone (31398 ha)

S.No. Common Name Scientific name Family Status

(IWPA

1972)

1. Red-wattled lapwing Vanellus cinereus Charadriidae No mention

2. Baya weaver Ploceus philippinus Ploceidae Schedule IV

3. Grey francolin Francolinus

pondicerianus

Phasianidae Schedule IV

4. Common hoopoe Upupa epops Upupidae No mention

5. Indian Roller Coracias benghalensis Coraciidae Schedule IV

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

120

6. White-throated

kingfisher

Halcyon smyrnensis Alcedinidae Schedule IV

7. Green bee-eater Merops orientalis Meropidae No mention

8. Lesser coucal Centropus bengalensis Cuculidae Schedule IV

9. Rose-ringed

parakeet

Psittacula krameri Psittacidae Schedule IV

10. House swift Apus affinis sub sp.

affinis

Apodidae No mention

11. Rock Pigeon Columba livia Columbidae Schedule IV

12. Laughing dove Streptopelia senegalensis Columbidae Schedule IV

13. Eurasian Collared

dove

Streptopelia decaocto Columbidae Schedule IV

14. Red Collared dove Streptopelia

tranquebarica

Columbidae Schedule IV

15. Long-tailed shrike Lanius schach Laniidae No mention

16. Southern grey shrike Lanius meridionalis Laniidae No mention

17. House crow Corvus splendens Corvidae Schedule V

18. Black drongo Dicrurus macrocercus Dicruridae Schedule IV

19. White-bellied drongo Dicrurus caerulescens Dicruridae Schedule IV

20. Indian robin Saxicoloided fulicata Turdinae No mention

21. Brahminy starling Sturnus pagodarum Sturnidae Schedule IV

22. Asian Pied starling Sturnus contra Sturnidae Schedule IV

23. Common myna Acridotheres tristis Sturnidae Schedule IV

24. Bank myna Acridotheres ginginianus Sturnidae Schedule IV

25. Wire-tailed swallow Hirundo smithii Hirundinidae No mention

26. White-eared bulbul Pycnonotus leucotis Pycnonotidae Schedule IV

27. Red-vented bulbul Pycnonotus cafer Pycnonotidae Schedule IV

28. Large grey babbler Turdoides malcolmi Timaliinae Schedule IV

29. Jungle babbler Turdoides striatus Timaliinae Schedule IV

30. Purple sunbird Nectarinia asiatica Nectariniidae Schedule IV

31. House sparrow Passer domesticus Passerinae Schedule IV

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

121

Table 3.25

Common Mammal observed in the buffer zone of the study area

S.

No.

Vernacular

Name

Scientific Name Family Status

(IWPA)

1 Five stripped

palm squirrel

Funambulus

pennantii

Sciuridae IV

2 Common House

rat

Rattus rattus Muridae V

3 Grey Musk Shrew Suncus murinus Soricidae --

4 Indian Hare Lepus nigricollis Leporidae IV

5 Indian field

mouse

Mus booduga Muridae V

6 Nilgai Boselaphus

tragocamelus

Bovidae III

Table 3.26

List of amphibian species recorded in Buffer Zone

S. No. Vernacular Name Scientific Name Family

1 Indian Bullfrog Hoplobatrachus tigerinus Ranidae

2 Indain Skiper frog Euphlyctis cyanophlyctis Ranidae

3 Marbled Toad Bufo stomaticus Ranidae

Table 3. 27

List of reptiles recorded in Buffer Zone

S.No. Vernacular

Name

Scientific

Name

Family Status

(IWPA)

1 Common

House Gecko

Hemidactylus

frenatus

Gekkonidae No

mention

2 Oriental

Garden Lizard

Calotes

versicolor

Agamidae No

mention

3 Yellow-Bellied

House Gecko

Hemidactylus

flaviviridis

Agamidae No

mention

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

122

4 Indian sand

boa

Eryx johnii Boidae Schedule

IV

6 Cobra Naja Naja Elapidae Schedule

IV

7 - hemidactylus

brookii

Gekkonidae No

mention

Table 3.28

Butterflies recorded in Buffer Zone

S.no. Species Scientific Name Family

1 Common Rose Atrophaneura aristolochiae Papilionidae

2 Crimson Rose Pachliopta hector Papilionidae

3 Lime Butterfly Papilio polymnestor Papilionidae

4 Plain Orange Tip Colitis eucharis Pieridae

5 Yellow Orange Tip Lxias pyrene Pieridae

6 Yellow Pansy Junonia hierta Nymphalidae

7 Blue Pansy Junonia orithya Nymphalidae

8 Plain Tiger Danaus chrysippus Nymphalidae

9 Common Grass

Yellow

Eurema hecabe Pieridae

A total of 09 species of butterflies were recorded during the field survey. The dominant

family was Nymphalidae with 03 species with plain tiger as the dominant species.

3.9 SOCIO ECONOMIC ENVIRONMENT

METHODOLOGY

Objectives

The broad objectives of the socio-economic impact assessment are:

1. To study the socio-economic status of the people living in the study area.

2. To assess the impact on socio-economic environment due to the project concerned.

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

123

3. To evaluate the community development measures proposed to be taken up by the

Project Proponent, if any.

4. To suggest community development measures that needs to be taken for the study

area with stakeholder engagement.

The studies carried out are descriptive and exploratory in nature.

Collection of data:

The information analyzed for the project has been collected from various secondary sources,

which has been supported by the extensive site visits and field observations.

Secondary: Review of secondary data viz. Primary Census Abstract- Census of India 2011,

and latest available district statistical Hand Books with respect to population and occupational

structure. Various research papers of the concerned area.

Primary: A social survey for examination of the respective site and specific region in

reference to its general character. Primary data collected by Semi-structured Interviews /

discussions etc. in sample villages and households. Site visits and observations of the socio

economic environment.

Sampling method

The studies are conducted and inferences are drawn on the basis of observation and field

survey on the basis of non probability random sampling and convenience sampling with

access to the nearest habitation to the extent possible.

DEMOGRAPHIC ENVIRONMENT

Habitation

The study area comprises of, 74 village human settlement. The total area of the study area

is 314.0 Sq. km. The demographic study area is as following tables:

Population

The total number of households is 46,981 with an average household size of 5 people. There

are 2,35,466 people in the study area as per Census of India, 2011.

Population of the study area (10.0 k.m.):-

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

124

S.no. Name TRU

Household

s

Total

Population

Total

Males

Total

Females

1 Alampur Rural 371 2115 1148 967

2 Alawalpur Rural 76 452 232 220

3 Amala Rural 265 1619 859 760

4 Bahadari Rural 110 775 409 366

5 Bahado Khurd Rural 176 959 514 445

6 Banbeerpur Rural 335 1453 894 559

7 Bandapur Rural 546 2054 1334 720

8 Beelaheri Rural 302 1726 892 834

9 Bhiwadi (M) Urban 24449 104921 59712 45209

10 Bhooda Rural 570 3374 1758 1616

11 Bhoodli Rural 219 851 540 311

12 Bibipur Rural 181 1152 607 545

13 Bilaspur Rural 235 1699 869 830

14 Burera Rural 372 2075 1287 788

15 Chaupanki Rural 415 2287 1185 1102

16 Chhapar Rural 196 1154 599 555

17 Chhilodi Rural 376 2580 1340 1240

18 Daganheri Rural 157 841 443 398

19 Daroda Rural 354 2322 1241 1081

20 Dhanokhara Rural 67 498 259 239

21 Fakaruddinka Rural 199 1381 718 663

22 Fatehpur Rural 447 2629 1395 1234

23 Gadpur Rural 169 1338 721 617

24 Gandhola Rural 262 1870 998 872

25 Garhi Rural 705 4433 2386 2047

26 Ghatla Rural 472 2711 1438 1273

27 Gundbas Rural 173 993 515 478

28 Guwara Rural 187 1326 692 634

29 Haripura Rural 31 124 76 48

30 Husepur Rural 189 1235 642 593

31 Jhamoowas Rural 99 565 287 278

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

125

S.no. Name TRU

Household

s

Total

Population

Total

Males

Total

Females

32 Jhiwana Rural 969 5431 2818 2613

33 Joriya Rural 750 4167 2161 2006

34 Kalaka Rural 150 748 396 352

35 Kalwari Rural 573 3237 1691 1546

36 Karampur Rural 71 319 169 150

37 Karenda Rural 352 2155 1145 1010

38 Karendi Rural 195 1362 699 663

39 Khanpur Khurd Rural 97 591 310 281

40 Kharkhara Rural 326 1827 964 863

41 Kharkhari Rural 97 765 392 373

42 Khatiwas Rural 155 1054 539 515

43 Kheri Rural 332 1835 936 899

44 Khohri Kalan Rural 330 2179 1149 1030

45 Khohri Khurd Rural 182 1164 601 563

46 Ladiya Rural 171 961 523 438

47 Magarakha Rural 50 214 121 93

48 Mahesara Rural 253 1484 778 706

49 Malpur Rural 383 2051 1059 992

50 Mandhan Rural 712 3807 2014 1793

51 Mayapur Rural 255 1878 936 942

52 Milakpur Rural 491 3065 1632 1433

53 Nagliya Rural 107 644 347 297

54 Naharpur Rural 382 1825 958 867

55 Nangal Rural 42 313 148 165

56 Nizamnagar Rural 168 1084 587 497

57 Pathredi Rural 293 1704 950 754

58 Rajpur Rural 131 702 373 329

59 Rampura Rural 242 1308 698 610

60 Saidampur Rural 401 2237 1186 1051

61 Salarpur Rural 451 2424 1246 1178

62 Santhalka Rural 149 945 495 450

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

126

S.no. Name TRU

Household

s

Total

Population

Total

Males

Total

Females

63 Sare Kalan Rural 445 2928 1500 1428

64 Sare Khurd Rural 204 1294 690 604

65

Sedooka

Nangla Rural 91 548 290 258

66 Shahpur Rural 667 3691 1899 1792

67 Shekhpur Rural 395 2671 1362 1309

68 Shital Pur Rural 63 426 224 202

69 Sunari Rural 162 1049 567 482

70 Tatarpur Rural 1269 7171 3732 3439

71 Thana Rural 757 4497 2366 2131

72 Thara Rural 614 2228 1224 1004

73 Tolawas Rural 217 1295 665 630

74 Udaipur Rural 132 676 359 317

Total 46981 235466 128889 106577

*Census of India, 2011

Gender Ratio

Out of the total population, in the study area of 10.0 k.m. constitutes 54.73% of males and

45.27% of females. The gender ratio in study area is 826 is lower against the Alwar district

gender ratio (894) as per the Census of India 2011.

Literacy Rate

The Average literacy of 10.0 k.m. of the study area is 60.17%. The Male literacy with

respect to male population is 69.77% and the Female literacy with respect to female

population is 48.58%. The literacy gap is high 21.19% and the female literacy is low in the

study area as per the Census of India, 2011.

Literacy Profile:-

S.no. Name

Total

Literates Male Literates Female Literates

1 Alampur 1193 758 435

2 Alawalpur 240 148 92

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

127

S.no. Name

Total

Literates Male Literates Female Literates

3 Amala 896 586 310

4 Bahadari 340 242 98

5 Bahado Khurd 579 379 200

6 Banbeerpur 948 651 297

7 Bandapur 1144 942 202

8 Beelaheri 1156 686 470

9 Bhiwadi (M) 70120 44054 26066

10 Bhooda 1858 1205 653

11 Bhoodli 484 372 112

12 Bibipur 459 317 142

13 Bilaspur 630 438 192

14 Burera 1198 840 358

15 Chaupanki 907 654 253

16 Chhapar 482 312 170

17 Chhilodi 1338 844 494

18 Daganheri 405 249 156

19 Daroda 1390 911 479

20 Dhanokhara 267 160 107

21 Fakaruddinka 626 387 239

22 Fatehpur 1591 983 608

23 Gadpur 650 444 206

24 Gandhola 829 584 245

25 Garhi 2329 1532 797

26 Ghatla 1314 855 459

27 Gundbas 542 333 209

28 Guwara 652 413 239

29 Haripura 81 64 17

30 Husepur 595 408 187

31 Jhamoowas 369 230 139

32 Jhiwana 2644 1676 968

33 Joriya 2858 1727 1131

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

128

S.no. Name

Total

Literates Male Literates Female Literates

34 Kalaka 424 265 159

35 Kalwari 1913 1231 682

36 Karampur 226 140 86

37 Karenda 948 630 318

38 Karendi 490 366 124

39 Khanpur Khurd 315 204 111

40 Kharkhara 989 595 394

41 Kharkhari 400 244 156

42 Khatiwas 381 258 123

43 Kheri 1062 672 390

44 Khohri Kalan 924 666 258

45 Khohri Khurd 540 334 206

46 Ladiya 579 385 194

47 Magarakha 106 79 27

48 Mahesara 978 577 401

49 Malpur 1235 746 489

50 Mandhan 2747 1643 1104

51 Mayapur 796 505 291

52 Milakpur 1615 1053 562

53 Nagliya 355 223 132

54 Naharpur 930 583 347

55 Nangal 99 63 36

56 Nizamnagar 595 387 208

57 Pathredi 831 585 246

58 Rajpur 414 264 150

59 Rampura 839 550 289

60 Saidampur 1159 743 416

61 Salarpur 1664 981 683

62 Santhalka 547 344 203

63 Sare Kalan 1154 778 376

64 Sare Khurd 688 428 260

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

129

S.no. Name

Total

Literates Male Literates Female Literates

65 Sedooka Nangla 286 190 96

66 Shahpur 2356 1452 904

67 Shekhpur 1016 701 315

68 Shital Pur 273 171 102

69 Sunari 576 380 196

70 Tatarpur 4606 2742 1864

71 Thana 2764 1725 1039

72 Thara 1566 910 656

73 Tolawas 760 464 296

74 Udaipur 426 277 149

Total 141686 89918 51768

Census of India, 2011

OCCUPATIONAL STRUCTURE

The work participation rate is 43.62% of the study area. The non working population is

56.38% constituting male workers to be 25.52% and females with 30.86% population.

The main workers in the study area are 33.72% constituting 26.48% males and 7.24%

females. The marginal workers constitute 9.90%, among which the males constitute

2.73% and female workers constitute 7.15%.

Occupation Profile:

Main Workers Marginal Workers Non workers

Name Total Males Fem Total Males Fem Total Males Fem

Alampur 467 404 63 710 247 463 938 497 441

Alawalpur 48 38 10 81 65 16 323 129 194

Amala 758 395 363 1 1 0 860 463 397

Bahadari 177 156 21 239 63 176 359 190 169

Bahado Khurd 466 256 210 6 4 2 487 254 233

Banbeerpur 717 553 164 144 41 103 592 300 292

Bandapur 968 848 120 204 81 123 882 405 477

Beelaheri 495 430 65 392 62 330 839 400 439

Bhiwadi (M) 37595 32545 5050 2919 973 1946 64407 26194 38213

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

130

Main Workers Marginal Workers Non workers

Name Total Males Fem Total Males Fem Total Males Fem

Bhooda 1387 783 604 520 204 316 1467 771 696

Bhoodli 341 323 18 11 3 8 499 214 285

Bibipur 247 223 24 175 30 145 730 354 376

Bilaspur 411 347 64 525 137 388 763 385 378

Burera 906 828 78 236 44 192 933 415 518

Chaupanki 536 448 88 446 91 355 1305 646 659

Chhapar 339 274 65 230 31 199 585 294 291

Chhilodi 1323 699 624 6 6 0 1251 635 616

Daganheri 226 137 89 396 184 212 219 122 97

Daroda 668 515 153 448 82 366 1206 644 562

Dhanokhara 121 117 4 120 5 115 257 137 120

Fakaruddinka 557 284 273 80 20 60 744 414 330

Fatehpur 730 524 206 455 118 337 1444 753 691

Gadpur 398 249 149 218 63 155 722 409 313

Gandhola 447 402 45 204 46 158 1219 550 669

Garhi 1437 995 442 168 62 106 2828 1329 1499

Ghatla 733 549 184 561 188 373 1417 701 716

Gundbas 386 238 148 124 14 110 483 263 220

Guwara 606 330 276 150 62 88 570 300 270

Haripura 65 35 30 1 1 0 58 40 18

Husepur 367 219 148 162 38 124 706 385 321

Jhamoowas 17 17 0 360 172 188 188 98 90

Jhiwana 1624 1165 459 891 214 677 2916 1439 1477

Joriya 1015 872 143 1063 245 818 2089 1044 1045

Kalaka 316 183 133 46 28 18 386 185 201

Kalwari 911 755 156 735 146 589 1591 790 801

Karampur 83 78 5 9 6 3 227 85 142

Karenda 737 472 265 349 90 259 1069 583 486

Karendi 321 314 7 518 106 412 523 279 244

Khanpur Khurd 280 146 134 3 3 0 308 161 147

Kharkhara 532 389 143 310 65 245 985 510 475

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

131

Main Workers Marginal Workers Non workers

Name Total Males Fem Total Males Fem Total Males Fem

Kharkhari 267 152 115 58 24 34 440 216 224

Khatiwas 253 173 80 193 56 137 608 310 298

Kheri 696 391 305 174 73 101 965 472 493

Khohri Kalan 514 375 139 534 168 366 1131 606 525

Khohri Khurd 429 246 183 139 39 100 596 316 280

Ladiya 141 122 19 325 108 217 495 293 202

Magarakha 117 54 63 0 0 0 97 67 30

Mahesara 519 338 181 298 79 219 667 361 306

Malpur 471 402 69 554 122 432 1026 535 491

Mandhan 1195 893 302 656 151 505 1956 970 986

Mayapur 677 393 284 191 55 136 1010 488 522

Milakpur 912 746 166 423 73 350 1730 813 917

Nagliya 173 152 21 187 21 166 284 174 110

Naharpur 527 467 60 3 1 2 1295 490 805

Nangal 66 55 11 89 22 67 158 71 87

Nizamnagar 309 210 99 220 65 155 555 312 243

Pathredi 481 414 67 117 5 112 1106 531 575

Rajpur 326 164 162 7 4 3 369 205 164

Rampura 477 277 200 251 128 123 580 293 287

Saidampur 836 498 338 102 42 60 1299 646 653

Salarpur 920 557 363 452 125 327 1052 564 488

Santhalka 443 222 221 1 1 0 501 272 229

Sare Kalan 670 560 110 560 89 471 1698 851 847

Sare Khurd 394 327 67 376 77 299 524 286 238

Sedooka Nangla 162 113 49 14 14 0 372 163 209

Shahpur 1146 799 347 855 275 580 1690 825 865

Shekhpur 644 540 104 624 70 554 1403 752 651

Shital Pur 104 102 2 107 0 107 215 122 93

Sunari 357 270 87 268 75 193 424 222 202

Tatarpur 2518 1578 940 433 193 240 4220 1961 2259

Thana 1547 1036 511 385 146 239 2565 1184 1381

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

132

Main Workers Marginal Workers Non workers

Name Total Males Fem Total Males Fem Total Males Fem

Thara 837 749 88 202 18 184 1189 457 732

Tolawas 380 303 77 40 26 14 875 336 539

Udaipur 148 141 7 233 49 184 295 169 126

Total

7941

4

6235

4

1706

0 23287 6435 16852

13276

5

6010

0

7266

5

*As per Census of India, 2011

SOCIAL INFRASTRUCTURE AVAILABLE

The unit is located in the RIICO Industrial Area Bhiwadi. Bhiwadi town is located at a

distance of 2.0 km. towards W of the project site.

On the basis of the preliminary site visit, the infrastructure available was identified.

• EDUCATION FACILITIES: Rajkiya Prathmik Vidhyalya, Bhiwadi 1.5 km NE; Holy Faith

Public School (1.84 km. ESE), Lipin High School (2.74 km. ENE), UCSKM Public School

(1.09 km.), Gyan Deep Public School (1.38 km. W), Presidency the International School

(2.55 km. W), Naveen Shikshan Sansthan (2.29 km. WNW) and BS Memorial Secondary

School (2.49 km. WNW).

• MEDICAL FACILITIES: Government Hospital, Bhiwadi (2.24 km. NW), Gulati child

hospital (2.17 km. NW), City nursing home (2.27 km. NW), Shakuntala Hospital (3.14 km.

NW) and Santhigiri Ayurveda and Siddha Hospital (1.16 km. N)

• Post & Telegraph Offices: The facility of Post Office and Telegraph are available in the

nearby villages. Main Post Office Bhiwadi is 1.33 km. (NNE), Indian Post Office, Dharuhera,

Mao is 6.7 Km. (W) from the project site.

• TEMPLES: Lord Krishna temple (2.72 km W), Baba Mohan Ram Temple (2.0 km W), Shiv

Mandir (6.28 km NW), Hanuman Mandir (2.02 km. WSW), Utsav Temple (3.56 km. WNW)

and Rangoli Temple (3.77 km. WNW).

SOCIO ECONOMIC OBSERVATIONS

The proposed project is in the RIICO Industrial area, Bhiwadi. The nearest habitation include

Santhalka SW 700 m, Harchandpur 400 m NE.

Housing, Employment & Occupation

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

133

The habitation of Santhalka, Harchandpur is low income permanent with semi-permanent

houses including most of industrial workforce. The habitation resides in small size

households (mostly unorganized) and comprise of labours, skilled and semi skilled workers

of Industrial workers, Bhiwadi. The internal housing structure was nucleated with chaotic

agglomeration and there was interestingly no internal differentiation of the separated

quarters on the basis of castes.

Religion, Caste & Festivals.

Predominant castes in the housing are of Hindus and Muslims. Sikh, Gurjar, Jat and minor

immigrants in search of work from U.P. and M.P. were observed around the Industrial area

Bhiwadi.

Education

Primary, Secondry Education is available in the study area. Infrastructural facilities in

Education both public and private are available. For higher education youth commute to

Jaipur, Gurgaon or Delhi.

Hygiene, Drinking water & Sanitation:

Access to potable drinking water is drawn from Hand pumps. The major sources of water

supply are mix of borewells with more effluent classes in the Town and Tap- water, Wells,

Tanks, and Tankers.

Major bottlenecks in the study area:

• Malnutrition Camps for Mother and Child in the study area including drops /

supplements are required in the region.

• Rain water harvesting structure is required to make the schools and health centers

self sustainable with the water supply for drinking and bathrooms.

• As the proposed project is in Industrial Area, it requires certain livelihood

enhancement programmes for industrial workers including vocational job assistance

for differently-abled.

*********************

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

134

SECTION – IV

ANTICIPATED ENVIRONMENTAL IMPACTS & ENVIRONMENT MANAGEMENT MEASURES

INDEX

ANTICIPATED ENVIRONMENTAL IMPACTS & ENVIRONMENT MANAGEMENT

MEASURES……………………………………………………………………………………………………………………..134

4.1 GENERAL ..................................................................................................... 135

4.2 LAND ENVIRONMENT .................................................................................... 135

4.3 AIR ENVIRONMENT ....................................................................................... 136

4.4 WATER ENVIRONMENT .................................................................................. 148

4.5 SOLID WASTE .............................................................................................. 156

4.6 NOISE POLLUTION ........................................................................................ 158

4.7 SOCIO ECONOMIC IMPACT ............................................................................ 159

4.8 BIOLOGICAL ENVIRONMENT .......................................................................... 166

**********

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

135

ANTICIPATED ENVIRONMENTAL IMPACTS & ENVIRONMENT MANAGEMENT MEASURES

4.1 GENERAL

Various operations involved in proposed expansion pharmaceutical drug manufacturing plant

have been studied before implementation of project to identify, predict and evaluate impacts on

various environmental components as discussed below. This will help to avoid, minimize and

mitigate the pollution, which will be generated from the proposed project.

1. Land Environment

2. Air Environment

3. Water Environment

4. Noise Environment

5. Solid Waste

6. Biological Environment

7. Socio-Economic Environment

4.2 LAND ENVIRONMENT

4.2.1 Impact and Management

There is no change in land use as the land form is industrial. The existing building area of

4550.40 sq m will remain unaltered and thus the impact will be negligible. No change in

topography as the existing area will remain unaltered.

There are many changes after establish a new unit on a vacant land. The new construction

posses impact on surrounding environment and surrounding land use directly or indirectly. The

possible impact on topography and geology of the area will occur due to land grading, filling,

excavation of earthworks for making water reservoir/piling activities, making roads; work shed

related civil construction activities.

But there is minimum impact possess on environment as the modification is allowed for the

product only. The existing land is used for modification.

Following is the measures to minimize the impacts on land environment:-

• There will be no significant impact from changing the land use as the project is coming up in

well established industrial area.

• After construction, land use will be in consistent with the local land use plan.

• The site is not falling in the way of any stream. After construction, there will be no changes in

the topography as the drainage of the site and the nearby area will not be changed during

construction phase.

• There is no restricted area within the study area.

• 33% of the total plot area will be under green belt.

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

136

• Traffic load will be increased but approach roads are sufficient to support the extra traffic

load. However, proponent will co-operate with Govt. time to time in strengthening of approach

roads.

4.3 AIR ENVIRONMENT

Prediction of air pollution impacts is the most important component in the environmental impact

assessment studies. Several scientific techniques and methodologies are available to predict

impacts of developmental activities on physico, ecological and socioeconomic environments.

Such predictions are superimposed over the baseline (pre project) status of environmental

quality to derive the ultimate (post project) scenario of environmental conditions. The prediction

of impacts helps to identify the environmental management plan required to be executed during

and after commissioning the proposed project to minimize the adverse impacts on environmental

quality. Both gaseous organic and inorganic compounds, as well as particulates, may be emitted

during pharmaceutical manufacturing and formulation. The details of the emission during

construction phase and operation phase is given below.

4.3.1 Impact on Air Environment

A. During Construction Phase

Construction activities have the potential to generate a substantial amount of air pollution.

Construction activities that contribute to air pollution include: land clearing, operation of diesel

engines, burning, and working with toxic materials. Diesel is also responsible for emission of

carbon monoxide, hydrocarbons, nitrogen oxides and carbon dioxide. Noxious vapors from oils,

glues, thinners paints, treated woods, plastics, cleaners and other hazardous chemicals that are

widely used on construction sites, also contribute to air pollution. The dust generation during

construction will be suppressed through intensive water spraying. The proper maintenance of

equipment and transport vehicles will reduce generation of gases.

During construction phase fugitive dust emission sources will be as under:

I. Construction Operation:

Fugitive dust emission is the main pollution, generated from the construction activities.

Construction site generate high levels of dust (typically from concrete, cement, wood, stone,

silica). Construction dust is classified as PM10 - particulate matter less than 10 microns in

diameter, invisible to the naked eye. However, the impact on the air quality during construction

phase will be localized, temporary and reversible in nature Particulate dust emissions from the

construction are a function of total land disturbed and the volume of soil excavated. The ratio of

PM2.5 to PM10 is assumed to be 0.20.

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

137

The emissions factors vary from approximately 0.019 tons PM10/acre-month for initial

emissions estimate. The construction will take 18 months for completion. Thus,

emission will be 1.06 kg PM10 per day.

II. Particulate Emission from Transportation:

When a vehicle travel on the road, particulate emissions occur due to direct emissions from

vehicles in the form of exhaust. The level of the emission depends upon the condition of the road

(paved/unpaved) and condition of vehicles. PM dust emissions from road construction activities

are a function of acres disturbed during construction. As most of the vehicle used in plant are

trucks and heavy vehicle which are diesel vehicles. Diesel engines breathe only air, blow by

gases from the crankcase (consisting primarily of air and HC) are rather low. Due to its low

volatility, evaporative emissions from the fuel tank can also be ignored. The low concentration of

CO and un-burnt Hydro Carbons in the diesel exhaust are compensated by high concentration of

NOx.

B. During Operation Phase

I. Process Emissions

Process emissions are resulted from the manufacture of few products out of proposed products.

The major are VOC emissions from reactor vents, man ways, material loading and unloading,

acid gases (halogen acids, sulfur dioxide, nitrous oxides).

II. Point Source Emission

There will be following point source emissions from the proposed project

• Oil fired Boiler (4 TPH),

Stack Height Calculation Formula:

H= (Q)0.3 X 14

Where:

H= Height of Stack

Q= Emission of SO2 kg/hr.

Thus the emission of SO2 is = 17 kg/hr.

H = (17) 0.3 X 14

= 2.33 X 14

= 32.75 Say 33 m

• DG sets (kVA).

SO2 and NOx are the major pollutants generated from the above units.

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

138

S. No. Source Fuel Used Sulphur content

%

Chimney Height

Existing 10

1. D.G. Set 500x2 No’s H.S.D < 0.5

Proposed

2. D.G.Set 500x3 No’s H.S.D < 0.5 10

3. Boiler 4TPH Furnace oil 2-4% 33 m

III. Area Source (Fugitive Emission):-

a) Emission during the Transportation

Particulate emissions occur whenever vehicles travel over a paved or unpaved road. Particulate

emissions from the paved roads are due to direct emissions from vehicles in the form of exhaust,

brake wear and tear emissions and re- suspension of loose material on the road surface. The

quantity of dust emissions from a given segment of unpaved road varies linearly with the volume

of traffic. Dust emissions also depend on the source parameters that characterize the condition

of a particular road and the associated vehicle traffic.

b) Exhaust gas from the vehicles

During the transportation of the materials, exhaust gas also contributes in the air pollution. The

amount of the exhaust gas and the level of the air pollutants are depend upon the condition of

the vehicles. When a vehicle travel on the road, particulate emissions occur due to direct

emissions from vehicles in the form of exhaust.

4.3.2 Impact on Air Quality

The impact on air quality is assessed based on emissions of the oil fired boiler and truck

movement. PM10, PM2.5, SO2, NOx and CO will be the important pollutants emitting from the stack

and line sources.

Prediction of impacts on air environment has been carried out employing mathematical model based

on a steady state Gaussian plume dispersion model designed for multiple point sources for short

term. In the present case, Aermod View Version 7.1.0 dispersion model for different stability

state Gaussian plume dispersion, designed for multiple point sources for short term and developed

by United States Environmental Protection Agency [USEPA] has been used for simulations from

point and line sources.

Model Input Data

Point Source:

For the modeling purpose, all pollutants as described above are considered. The details of stack

emissions envisaged from the project are given in Table No.4.1.

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

139

Table No. 4.1: Stack Emission Details

Line Source:

Emission Source Emission rate

Line emissions PM10 – 2.7 x10-3 g/s/m

PM2.5 – 4 x 10-4 g/s/m

NOx – 2.8 x 10-4 g/s/m

CO – 1.05 x 10-3 g/s/m

Presentation of Results

In the present case, model simulations have been carried out for the study period. The Ground

level concentrations are computed for 24-hr average. Maximum Ground level concentrations of

PM10, PM2.5, SO2, NOx and CO for study period were 0.6 µg/m3, 0.3 µg/m3, 21 µg/m3, 11.7 µg/m3

and 7 µg/m3 respectively. The obtained GLC’s are well within the stipulated CPCB standards. The

incremental ground level concentrations for various pollutants are given in Table no. 4.2

S.No. Parameters Units Boiler (FO)

Stack-I

DG Sets 5x 500 kVA

Stack- II, III, IV, V & VI each

1 Stack Height m 34 10

2 Top diameter of flue m 0.5 0.2

3 Flue gas velocity m/sec 5.4 12

4 Exit Flue gas temperature oK 388 473

5 Flue gas flow rate m3/hr 9770 1357

6 Emission rate at stack exit

A PM10 emission rate g/s 0.08 0.24 g/Kw-hr

B PM2.5 emission rate g/s 0.05 0.15 g/Kw-hr

C SO2 @ 3.5% sulphur content g/s 3.75 --

D NOx g/s 0.57 9.2 g/Kw-hr

E CO g/s 0.16 3.5 g/Kw-hr

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

140

TABLE-4.2: Predicted 24-Hourly Short Term Maximum Incremental Concentrations

Resultant Concentrations after Implementation of the Project

The maximum incremental GLCs due to the proposed project for PM10, PM2.5, SO2, NOx and CO are

superimposed on the maximum baseline concentrations recorded during the study period. The

cumulative concentrations (baseline incremental) after implementation of the project are tabulated

below in Table-4.3. The predicted ground level concentration isopleths for various parameters

during study period is given in Figure No. 4.1 to 4.4.

Table-4.3

Details of incremental concentration of pollutants on sensitive locations like

habitations

Pollutant Concentration (µµµµg/m3)

Baseline

(Maximum)

Increment

al Resultant

Distance

(km) Direction

PM10

Project Site 90.4 0.3 90.7 - -

Belaheri 72 0.2 72.2 1.50 SE

Bhiwari 79 0.1 79.1 1.30 NW

Milakpur 73.4 0.1 73.5 2.30 W

NH-71 88.3 0.1 88.4 2.50 NE

Khajuriwas 85.9 0.1 86 3.50 SW

PM2.5

Project Site 53.6 0.15 53.8 - -

Belaheri 42.4 0.1 42.5 1.50 SE

Bhiwari 48.4 0.05 48.5 1.30 NW

Pollutant Maximum

Incremental

Concentration

(µµµµg/m3)

(X,Y)

coordinates

(m)

Towards

Direction

PM10 0.6 (0 , - 1000) S

PM2.5 0.3 (0 , - 1000) S

SO2 21 (0 , - 1000) S

NOx 11.7 (0 , - 1000) S

CO 7 (0 , - 1000) S

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

141

Pollutant Concentration (µµµµg/m3)

Baseline

(Maximum)

Increment

al Resultant

Distance

(km) Direction

Milakpur 45.7 0.05 45.8 2.30 W

NH-71 51.4 0.05 51.5 2.50 NE

Khajuriwas 49.7 0.05 49.8 3.50 SW

SO2

Project Site 9.7 4.7 14.4 - -

Belaheri 6.9 7.1 14 1.50 SE

Bhiwari 9.4 2.4 11.8 1.30 NW

Milakpur 6.9 2.4 9.3 2.30 W

NH-71 9.1 4.7 13.8 2.50 NE

Khajuriwas 8.6 2.4 11 3.50 SW

NO2

Project Site 34.5 2.6 37.1 - -

Belaheri 26.9 3.9 30.8 1.50 SE

Bhiwari 29.3 1.3 30.6 1.30 NW

Milakpur 25.4 0.05 25.5 2.30 W

NH-71 35.6 2.6 38.2 2.50 NE

Khajuriwas 28.9 1.3 30.2 3.50 SW

CO

Project Site 1650 1.6 1652 - -

Belaheri 1324 2.4 1326 1.50 SE

Bhiwari 1452 0.8 1453 1.30 NW

Milakpur 1245 0 1245 2.30 W

NH-71 1652 1.6 1654 2.50 NE

Khajuriwas 1411 0.8 1412 3.50 SW

It is seen from the above table, the resultant GLC’s obtained at various locations are well within

the CPCB standards (dated 18th November, 2009). Thus, there is no significant impact on air

quality due to the proposed project activities.

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

142

Figure no. 4.1

Isopleths Showing Maximum Incremental Ground Level Concentrations of PM10

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

143

Figure No. 4.2

Isopleths Showing Maximum Incremental Ground Level Concentrations of PM2.5

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

144

Figure no. 4.3

Isopleths Showing Maximum Incremental Ground Level Concentrations of SO2

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

145

Figure no. 4.3

Isopleths Showing Maximum Incremental Ground Level Concentrations of NOx

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

146

Figure no. 4.4

Isopleths Showing Maximum Incremental Ground Level Concentrations of CO

4.3.3 MANAGEMENT

I. During Construction Phase

The impacts of the construction phase will be temporary and localized phenomena except the

permanent change in local landscape and land use pattern at the project site.

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

147

• Dust pollution can be minimized at the source by water spraying and maintenance of road.

• Construction material will be stored in temporary storage yard.

• There will be no basement; hence quantity of the soil excavation will be comparatively less.

However, soil will be kept moist to reduce dust emission during excavation for piling.

• The excavated materials will be place only on the designated disposal areas.

• The construction area will be shielded with the help of tarpaulin from all the four sides to

contain the air emissions within the premises.

• Suitable covered skips and enclosed chats or other suitable measures will be provided in

order to minimize dust emission to the atmosphere when materials & waste will be removed

from the premises.

• Rapid cleanup of project related track out or material spills on paved road.

• Natural topography will be maintained to the greatest extent possible.

• Parking lot and paved road will be constructed first.

• Upwind portion of the project will be constructed first.

• During high wind condition, construction activities will be restricted, so that minimum flow of

dust particle takes place.

• The first and most important step towards emission control for the large in-use fleet of

vehicles is the formulation of an inspection and maintenance system. It is possible to reduce

30-40% pollution loads generated by vehicles through proper periodical inspections and

maintenance of vehicles

• All transportation vehicles will be suitably covered with tarpaulin & overloading of the vehicles

will be avoided.

• PUC certified vehicles will be used to avoid the exhaust emission.

II. During Operation Phase

� To control the fugitive emissions generated during various operations in the

industry, plant authorities will adopt following mitigation measures.

• Dedicated closed pipe lines for transfer of solvents from respective solvent storage tanks to

reactors in the production blocks.

All solvent storage tanks will be provided with vent condensers having chilled water and brine

circulation

All reactors will be provided by vapor condensers

Mechanical seals will be provided for all the reactors for improving emission control measures.

� To control the process emissions generated during various operations in the

industry, plant authorities will adopt following mitigation measures.

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

148

• The emission from furnace fired boiler of 4 TPH will be controlled by wet scrubber followed by

stack of 33 m for proper dispersion. The reactor will be connected to vapor condenser to collect

VOC emission from the process.

� To control the point source emissions generated during various operations in the

industry, plant authorities will adopt following mitigation measures.

The unit will install stack of appropriate height at the point sources:-

• D. G. Set

Two existing D.G.Set of 500 kVA and three proposed D.G.Set of 500 kVA. The adequate stack

height of the D.G. set will be provided as per the norms of the CPCB.

Height = 0.2X√500

= 4.4mabove the roof of the building. say 5m

• Boiler 4 TPH- a stack of 33 m height will be installed in association with wet scrubber.

4.4 WATER ENVIRONMENT

4.4.1 Impact

I. During Construction Phase:-

• Sewage will be the only source of water pollution.

• Un-captured run off from the site.

II. During Operation Phase:-

A. Waste water from industrial process

The total water demand is 150 KLD. Out of which daily fresh water and recycle/reused demand is

50 KLD. Around 85 KLD water will be required for manufacturing purpose and 15 KLD for

domestic use. Water demand of the industry will be met partially through RIICO water supply

and partially through ground water. Details of Waste water from industrial process will be as

under:

Table 4.4 : Waste water from industrial process

B. Domestic waste water from the different sections of building

Wastewater generated from domestic purpose will be to the tune of 12 KLD, which will be

treated in STP based on MBR and final treated water will be sent to common ETP.

Type of waste Quantity KLD Disposal

Process waste water 30 Will be treated in ETP

DM Reject/R.O. Reject 15 Will be treated in ETP

Boiler/Cooling Tower blow down 5+10 Will be treated in ETP

Total 60 KLD

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

149

4.4.2 Management

I. During construction Phase

• The construction site will be provided with sufficient and suitable toilet facilities for

workers to allow proper standards of hygiene. These facilities should preferably be

connected to a septic tank and maintained to ensure minimum environmental impact.

• Measures will be implemented to prevent seepage of liquid materials into ground where it

could contaminate groundwater;

• Ensure prompt cleaning up of accidental spillages

• Measures will be followed to prevent the contamination of hydrological features by diesel,

grease, oil, etc. derived from the working area.

• The machinery / equipment will be maintained in a good operating condition;

• Specially designated areas will be created for vehicle maintenance;

• Accidental spillages will be cleaned up promptly.

• Curing water will be sprayed and after liberal curing, all concrete structures will be

covered with gunny bags this will conserves water

• Provisions will be made to ensure the construction vehicles stick to the access track to

prevent mud & dirt being deposited on roads

• Fence will be constructed around the site to trap sediments whilst allowing the water to

flow through.

• All mud & dirt deposited on the roads from the construction activities will be cleaned.

Adopting good construction and engineering practices will help in mitigating the water pollution.

III. During Operation Phase

All mud & dirt deposited on the roads from the construction activities will be cleaned.

Adopting good construction and engineering practices will help in mitigating the water

pollution.

During operation:-

• The unit will manufacture manufacturing sterile bulk drug and Lyophilization batch wise.

Thus, characterization of waste water at this stage is difficult. The standard effluent

characteristic of drug manufacturing unit is given below in table no. 4.5. the treatment

scheme for effluent stream is given below:-

Table No. 4.5

Effluent waste water chararacteristics and treated water characteristics

Particular Effluent

chararacteristics

Treated Water characteristics

pH 6.0 to 8.5 7.5 to 8.5

BOD 1200 to 2000 mg/l Less than 30 mg/l

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

150

TSS 200 to 450 mg/l Less than 100 mg/l

COD 4000- 5000 mg/l Less than250 mg/l

Oil & grease up to 20 mg/l Less than10mg/l

WASTEWATER TREATMENT SCHEME

1. Double Acting Clarifier

Reduction of chemical consumption in physiochemical treatment process not only reduce the

operation cost as well as sludge quantity, we have proposed unique semi automatic Double

Acting Clarifier unit with air floatation arrangement which separate the major part of suspended

solids before chemical treatment. The Incoming effluent shall be treated with physiochemical

system to remove more than 95% suspended impurities and non bio degradable COD.We have

proposed a perfect chemical dosing system with solution preparation tank.

For efficient and economical treatment, the proposed system add measured quantity at

consistent flow rate and the unique system avoids typical handling of chemical on elevated level

as all the solution tanks shall be placed on ground level.

We will provide proper water filling system in solution tank through pipe / manifold with solenoid

valves & level controller to maintain the desired level and without overflow / drain.

In solution tank, the chemical is kept in proper soluble condition with air agitation.

2. Latest Photo Chemical Oxidation consisting of Ozonation and UV System for partial

Degradation of organics for efficient Physiochemical treatment to reduce chemical

consumption and Sludge Generation.

Effluents after photo-chemical oxidation get precipitated with oxidation and we have proposed

efficient oxidation system through ozone and UV. As a result, major part of organics gets

converted in suspended form. The Ozonation and ultra violet treatment is carried out in Stainless

Steel reaction chamber. For Ozonation, we have offered oxygen concentrator, Ozone Generator

& diffusion unit to produce and mix the ozone at negligible operation cost.

3. pH correction unit

To maintain the appropriate pH as per biological feed requirement, we have proposed auto pH

correction unit consisting of pH meter, prominent make metering pumps and acid solution tank.

4. Biological Treatment

Photochemical oxidation outlet flows to Biological chamber after fine flow filtration for

degradation of bio-degradable impurities by aeration and maintaining the desired level of MLSS.

Project: Project: Auronext Pharma Pvt Ltd. Section-III/Description of the Environment

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

151

The diffused aeration is conducted with Fine bubble diffusers. For perfect operation and

maintenance, all the diffusers are connected to top air header through SS air drop line. In case

of any defect, the

Particular diffuser can be taken out without decantation of biological chamber and treatment

process remains unaffected.

In biological system, the perfect results are achieved by maintaining the desired level of DO (1.5

to 3.0 mg/l). We have proposed on-line DO transmitter which monitor the working of air blowers

as per requirement. This maintain the perfect biological condition and saves considerable energy

also.

5. Latest MBR unit for Decantation and Ultra Filtration of Biological outlet

It is the MLSS level which degrades the organics and reduces the COD, BOD. In biological

chamber, MLSS remain in suspension condition with water. It is the decantation process which

enables to maintain the high MLSS in biological chamber and outlets desired quality clear water.

In conventional process, MLSS is maintained upto 5000 mg/l and clear water TSS remain 50 –

100 mg/l. obviously with conventional technology biological system, the outlet is filtered by sand

bed and pressurised ultra filtration technology for efficient operation of high recovery RO unit.

Membrane Bio Reactor Technology (MBR) is the latest technology for perfect decantation to

produce Ultra Filtered outlet and enables to maintain high MLSS upto 10000 mg/l. Thus, MBR

technologies ensure perfect biological treatment with appropriate minimum retention and

operation cost is also reduced. In MBR technology, most strong heavy duty reinforced PVDF

hollow fibre membranes are submerged in biological chamber and its outlet has perfect quality of

water through the suction of permeate pump. As the permeate pump is operated on low vacuum

pressure, the power consumption remain negligible for ultra filtration as compared to pressure

UF system. Hence in case of MBR, there is no requirement of sand bed filter and ultra filtration

which generate extra backwash water quantity for recycling in ETP, moreover pressurized UF

membranes are enclosed in PVC pressure tubes and can’t be cleaned mechanically in case of

typical clogging, while submerged MBR membranes can be cleaned chemically/mechanically by

taking out from the chamber.

Besides above, MBR is quite easy in operation and considerable space requirement is reduced as

there will be no requirement of sand bed filter and UF unit.

Figure No. 4.5: Scheme of Treatment

Project: Auronext Pharma Pvt. Ltd. Section-IV/ Anticipated Environmental Impacts &

Document No.: EESPL/APPL/001/372-EC/IND-2014 Environment Management

Enkay Enviro Services Pvt. Ltd., Jaipur,

152

Project: Auronext Pharma Pvt. Ltd. Section-IV/ Anticipated Environmental Impacts &

Document No.: EESPL/APPL/001/372-EC/IND-2014 Environment Management

Enkay Enviro Services Pvt. Ltd., Jaipur,

153

Domestic waste water

Wastewater generated from domestic purpose will be to the tune of 12 KLD, which will

be treated in STP based on MBR and treated water will be sent to ETP.

4.4.3 Rain water harvesting scheme

DESIGN BASIS FOR RAIN WATER CALCULATION

RUN – OFF [DISCHARGE]

Q = CIA

where

Q = run-off (discharge) in cubic meters per hour (m3/hour).

C = Co-efficient /Impermeability factor of the surface.

I = Intensity of rainfall = Taking 40 mm/hour

A = Total area in Hectare.

Table: 4.7

Co-efficient of Runoff/Impermeability Factor [C] :

S.No.

Description of Surface

Value of runoff coefficient /

Impermeability factor of the

surface

1. Terraces, Hard paved surface 0.85 – 0.90

2. Paved Surface, Roads 0.75 – 0.80

3. Natural ground, sloping ground 0.10 – 0.30

Conversion Factor

• 1 Hectare = 10,000 Sq.mt

• 1 Sq.mt = 1/10,000 Hectare

ROOFTOP RAIN WATER HARVESTING

Total rooftop area of plant is 4550 m2 that may be connected through pipes and drains

to Rainwater harvesting structures which has storage chamber and the percolation pits

as per sites having rooms for recharge in resonance with average rainfall, catchment

area and average rainfall intensity. Looking in to the average rainfall in this region, roof

top area of the building, rain water harvesting structures are designed in such a way that

even at peak rain fall intensity of 40 mm/hour, water does not spill over & the entire

rainwater falling over the total area goes in to the ground water body. Following

dimensional parameters are considered for design of

Rainwater harvesting system in the plant premises.

Total Rooftop area = 4550 m2

Project: Auronext Pharma Pvt. Ltd. Section-IV/ Anticipated Environmental Impacts &

Document No.: EESPL/APPL/001/372-EC/IND-2014 Environment Management

Enkay Enviro Services Pvt. Ltd., Jaipur,

154

Average rainfall = 415 mm = 0.415 m

Catchment factor for Roof top = 0.85 (as per C.G.W.A)

Total volume of water to be captured = 4550 x 0.415 x 0.85 = 1605.01 m3

The dimension of the structures to be designed for 40 mm/hour peak rainfall intensity.

Considering 15 minutes of peak rainfall, runoff volume in a single storm should be: 4550

m2 x 0.85 x 0.04 m/4 = 38.67 m3.

ROAD/PAVED AREA STORM WATER RUNOFF HARVESTING:

In road storm water harvesting system, drains may be made on both the sides of roads

with iron net filter of 5 mm opening at every 20 m. Rainwater falling on the road/paved

area is carried through these drains to rainwater harvesting structure and allow to

infiltered in groundwater regime. This will improve groundwater quality as well as

quantity in and around the plant premises. Following dimensional parameters are

considered for design of road storm water harvesting system in the plant premises.

Total Road/paved area = 1,213 m2

Average rainfall = 415 mm = 0.415 m

Catchment factor for Road/paved area = 0.75 (as per C.G.W.B.)

Total volume of water to be captured by road/paved area = 1213 x 0.415 x 0.75 m3 =

377.54 m3/annum

The dimension of the structures to be designed for 40 mm/hour peak rainfall intensity as

per published literatures. Considering 15 minutes of peak rainfall, runoff volume in a

single storm should be: 1213 m2 x 0.75 x 0.04m/4 = 9.09 m3.

GREEN/OPEN AREA RAINWATER HARVESTING:

The total green area of plant premises is 4348.20 m2 which may be connected through

pipes and drains to rainwater harvesting structures which has storage chamber and the

percolation pits as per sites having rooms for recharge in resonance with average

rainfall, catchment area and average rainfall intensity. Following dimensional parameters

are considered for design of open area rainwater harvesting system in the plant

premises.

Total open area = 4348.20 m2

Average rainfall = 415 mm = 0.415 m

Catchment factor for open area = 0.15 (as per C.G.W.A)

Total volume of water to be captured = 4348.20 x 0.415 x 0.15 = 270.67 m3

The dimension of the structures to be designed for 40 mm/hour peak rainfall intensity as

per published literatures. Considering 15 minutes of peak rainfall, runoff volume in a

single storm should be: 4348.20 m2 x 0.15 x 0.04 m/4 = 6.52 m3.

Project: Auronext Pharma Pvt. Ltd. Section-IV/ Anticipated Environmental Impacts &

Document No.: EESPL/APPL/001/372-EC/IND-2014 Environment Management

Enkay Enviro Services Pvt. Ltd., Jaipur,

155

The rain water harvesting systems will capture surface run-off from all areas and provide

annual recharge will be to tune of 2253.22 m3 /annum. It will help to improve the

ground water level. The total discharge from the area is calculated by considering the

maximum rainfall intensity of 40 mm/hr.

DESIGN OF RAINWATER HARVESTING STRUCTURES IN PLANT

PREMISES:

The total volume of water generated in project premises from rooftop,

road/paved & open area in a single storm on 40 mm peak rainfall intensity

would be:

Total generated storm water = Rooftop + Road/paved area + Open area

= 38.67 m3 + 9.09 m3 + 6.52 m3 = 54.28 m3.

It is revealed from recharge test that the aquifer would very well accept water of the

order of 137 m3/day @ 5.71 m3/hour continuously in long term through these recharge

structures. Considering the space availability, the individual design is made for

accumulation of 27 m3 of water i.e. 9 m3 of water in Desilting/settlement tank (1 m

water column above dead storage x 3 m length x 3 m width), 9 m3 in the filtration tank

(1 m water column above filtration media x 3 m length x 3 m width) and about 9 m3 in

the process of infiltration through filtration media of recharge well.

Hence, two recharge structures have been implemented in the plant premises and the

dimensional parameters of Desilting/Settlement chamber is 3 m (length) x 3 m (width) x

1.30 m (depth). In Desilting chamber, 0.30 m depth below outflow is kept for silt

deposition. The filtration tank dimension would be 3 m (length) x 3 m (width) x 3 m

(depth) with 0.15 m dia recharge well of 35 m depth depending upon the formation for

recharge in aquifer through vadose zone. Each structure will be capable of handling

rainwater volume @ 27 m3/day and such 2 structures can accommodate up to total

rainfall volume of 54 m3 in any rainfall event at peak rainfall occurrence.

Project: Auronext Pharma Pvt. Ltd. Section-IV/ Anticipated Environmental Impacts &

Document No.: EESPL/APPL/001/372-EC/IND-2014 Environment Management

Enkay Enviro Services Pvt. Ltd., Jaipur,

156

Figure No. 4.7

4.5 SOLID WASTE

4.5.1 Impact

I. During Construction Phase

• Construction waste likely to be generated during the site formation works include waste

wood from concrete form work; spent concrete; waste steel rebars from concrete

reinforcement activities; and material and equipment wrappings.

• Municipal wastes generated by site workers.

II. During Operation Phase

A. Hazardous waste

Bulk manufacturing processes in the pharmaceutical industry are typically characterized

by a low ratio of finished products to raw material resulting in significant quantities of

residual waste. Chemical synthesis processing generates wastes containing spent

solvents, reactants, aqueous or solvent liquors, still bottoms, as well as filter cakes

which may contain inorganic salts, organic by-products and metal complexes, filter

media, and small amounts of nutrients. Other sources of hazardous or potentially

hazardous wastes may include raw materials packaging waste, off specification products

expired products, laboratory wastes and sludge from the wastewater treatment process.

Project: Auronext Pharma Pvt. Ltd. Section-IV/ Anticipated Environmental Impacts &

Document No.: EESPL/APPL/001/372-EC/IND-2014 Environment Management

Enkay Enviro Services Pvt. Ltd., Jaipur,

157

The anticipated quantities of some major solid hazardous waste is given below in table

no. 4.10

Table No. 4.10

The anticipated quantities of solid waste are as follows

S.

No.

Hazardous

waste

Description

Category

as per

HWMR

rules

Qty

generated

/Annum

Unit Method of disposal

1. ETP sludge a) Chemical sludge from ETP

34.3 5 Ton It will be sent to UCCI at Udaipur for proper treatment and disposal.

2. Spent Oil & Used oil

5.1 & 5.2 1000 Lit It will be disposed through authorized disposer.

3. Process residue and waste

28.1 1 Ton

It will be disposed in-house in process effluent treatment plant (Mixed with process effluent)

4. Spent catalyst/carbon

28.2 3.6 Ton It will be sent to UCCI at Udaipur for proper treatment and disposal.

5. Off specification products/raw material

28.3 0.2 Ton It will be sent to UCCI at Udaipur for proper treatment and disposal.

6. Expiry drugs/medicines

28.4 0.25 Ton

It will be disposed in-house in process effluent treatment plant (Mixed with process effluent)

7. Spent solvent

1500 Ton It will be disposed/sale through authorized Disposer

8. Liner/Packing Material /glass vials

2 Ton

It will be sent to UCCI at Udaipur /for Inceneration for Proper treatment

9. Lead Batteries waste

2 Ton It will be disposed/sale through authorized Disposer

10. Electronic ,computer items

1 Ton It will be disposed/sale through authorized Disposer

11. CFL/Led etc waste

1 Ton It will be disposed/sale through authorized Disposer

4.5.2 Management

• The use of water based solvents will be preferred for waste reduction

• Continuous rather than batch operations will be in practice to reduce spillage and other

material losses.

Project: Auronext Pharma Pvt. Ltd. Section-IV/ Anticipated Environmental Impacts &

Document No.: EESPL/APPL/001/372-EC/IND-2014 Environment Management

Enkay Enviro Services Pvt. Ltd., Jaipur,

158

• The Spent solvent will be recycled and reuse, through distillation, evaporation,

decantation, centrifugation and filtration

• The inorganic salts will be recovered from chemical liquors produced during organic

synthesis operations.

• The hazardous waste will be collected in HDPE bags and will be sent to Common

Treatment, Storage & Disposal Facilities at UCCI Udaipur The unit will apply for the

membership from UCCI once the unit comes in a stage of commencement.

4.6 NOISE POLLUTION

4.6.1 Impact

I. During Construction Phase

Major sources of noise pollution are vehicular traffic, heavy moving machinery etc.

II. During Operation Phase

Major sources of noise pollution will be

• Operational machineries

• Pumps

• D.G. set

• Transportation

4.6.2 Management

I. During Construction Phase

• Complete construction work especially heavy work will be done during day time.

• Vehicular movement carrying raw materials will be avoided during night time.

• The vehicles will be regularly maintained and optimum use of the same will be made.

• Adequate PPE’s (ear plugs, ear muffs, helmet, mask etc) will be provided to the

workers.

• PUC certified vehicles will be used.

II. During operation phase

• All possible measures will be taken to minimize the noise.

• The insulation provided for prevention and loss of heat and personnel safety shall

also act as noise reducer.

• Foundations and structures will be designed to minimize vibrations and noise.

• Regular equipment maintenance and better work habits will be adopted.

• D.G. set is proposed to be housed in an inbuilt acoustic enclosure. The acoustic

enclosure will be designed for minimum 25dB (A) insertion loss for meeting the ambient

noise standards, whichever is on the higher side.

• Necessary safety and personal protective equipment such as ear plugs, ear muffs,

helmet etc will be provided to the workers.

Project: Auronext Pharma Pvt. Ltd. Section-IV/ Anticipated Environmental Impacts &

Document No.: EESPL/APPL/001/372-EC/IND-2014 Environment Management

Enkay Enviro Services Pvt. Ltd., Jaipur,

159

• Noise levels generated will be maintained to comply with the Factories Act & Rules

and will not exceed 75 dB (A) at 1 m distance.

• Implementation of green belt within the premises of plant will absorb the noise. Thus

will help to control the noise pollution.

• Proper lubrication and housekeeping will be usually done to avoid excessive noise

generation.

• Supervisor will be responsible to control the noise by maintaining conditions of

machineries and silencers.

• 33% of the total plot area will be under greenbelt.

4.7 SOCIO ECONOMIC IMPACT

4.7.1 IMPACT ON COMMUNITY DEMOGRAPHICS

S.no. Identification of

effects of

existing Socio-

economic Issues

:

Predict (adverse/ favorable)

impacts and magnitude

estimates. <reasons for

variations & bias of

representative data>

Mitigation measures.

In numbers

1. The core zone is in

the RIICO

Industrial Area

Phase-III, Bhiwadi,

Distt.-Alwar,

Rajasthan.

No habitation in the core zone.

Hence Zero (0) Loss of

habitation.

Rest rooms/recovery

rooms will be provided

to local workers to avoid

tiresome commuting to

their houses.

2. The nearest

habitation include

Santhalka 700 m

SW, Harchandpur

350 m NE.

The habitation comprises of

industrial household workers.

The wind direction is

predominantly in all directions

only minimum towards South

East. Though the wind direction

is more or less in all direction ,

not one specific habitation area

will be affected by the

cumulative impact of the

Industrial Area, Bhiwadi.

Regular health camps

(mainly in habitation of

Santhalka &

Harchandpur) to trace

the developments and

control any ill-

consequences due to

(bad odor) in future will

be done.

Periodic maintenance

and emission check of

vehicles shall be

ensured to restrict air

pollution.

Project: Auronext Pharma Pvt. Ltd. Section-IV/ Anticipated Environmental Impacts &

Document No.: EESPL/APPL/001/372-EC/IND-2014 Environment Management

Enkay Enviro Services Pvt. Ltd., Jaipur,

160

4.7.2 Occupation & Employment

S.no. Identification of

effects of

existing Socio-

economic Issues

:

Predict (adverse/ favorable)

impacts and magnitude estimates.

<reasons for variations & bias of

representative data.

Mitigation

measures. In

numbers

3. Long term and

stable employment

opportunities :

The proposed expansion project is long

term and and stable employment

generating project, aims to bring in

additional opportunities for income &

employment.

S.No Manpower for

Operation

Number

1 Existing workers 150

2 Proposed worker 100

3 Total after

modification

250

Local people will

be trained and

given

employment in

the expansion

phase:

A minimum of

approx. Rs.

62.00# lacs of

direct money

incomes could

be generated by

the local people

in the region

through

expasion of the

Industrial

operations.

4. The proposed

project is located

in RIICO Industrial

area, Bhiwadi with

the major district

road which is

permanent,

painted, and

cemented.

The main roads of

the Habitation,

around Santhalka

SW 700 m,

Indirect - Transportation, Supply Chains,

Wholesalers, agency employment in the

value chain.

From bringing raw materials to

dispatching of finished products (max.

of 10) trucks and further exports (C& F,

container and shipment services) will be

used. In each truck at least 3 people will

be employed as driver, cleaner and

navigator which will give further

employment to 30 people.

Indirect Employment:

Increase in supporting industries such

Traffic will be

restricted on the

National

Highway-71 B

(Connects

Shahpura to

Gurgaon)

Distance: 1.3 km

towards N

(aerially).

and will not

approach the

internal

Project: Auronext Pharma Pvt. Ltd. Section-IV/ Anticipated Environmental Impacts &

Document No.: EESPL/APPL/001/372-EC/IND-2014 Environment Management

Enkay Enviro Services Pvt. Ltd., Jaipur,

161

Harchandpur 400

m NE are

permanent but the

internal roads are

semi-permanent.

as packaging, printing etc.

Increase in Supply chain

Increase in Distribution Channel both-

State & International

Carrier goods and C& F agents

Chemist shops

Laboratory testing

Government of India Taxes

Minor increase in telecommunication,

couriers etc.

Other work opportunities such as

packaging, advertisement, supply chain,

wholesalers, retailers etc. will also be

created.

habitation road.

4.7.3 Impact on Working Population

S.no. Existing

variables/situations of

Socio-economic Issues :

Predict (adverse/

favorable) impacts

(reasons for variations &

bias of representative

data).

Mitigation

measures. In

numbers.

5. About Immigration

/Emigration of workers. Labour

migration from smaller

villagers to urban / developing

areas in search of work is a

general problem.

The labour immigration in

Alwar needs to be checked

through creating

employment opportunities

in the district. The proposed

project aims to control

emigration of 60* workers

at least.

The probable non

- emigrating

population, due

to the proposed

project,

contribute in the

regional growth.

Employment

Opportunity

No. *Minimum earnings

Proposed Manpower

for Expansion

100 62,70,000 for 300 days (Calculated at the minimum wage

rate for Skilled/day, Raj)

Total 250 1, 56, 75, 600/- per annum till the life of the project.

(Calculated at the minimum wage rate for Highly

Skilled/day, Raj)

Project: Auronext Pharma Pvt. Ltd. Section-IV/ Anticipated Environmental Impacts &

Document No.: EESPL/APPL/001/372-EC/IND-2014 Environment Management

Enkay Enviro Services Pvt. Ltd., Jaipur,

162

*Probability analysis of non – emigrating population

Hypothesis based on field study :

Migration chances are more among male workers as compared to women workers.

Migrartion among the women workers is dependent on the job shifts of their male

counterparts.

• Emigration of the illiterate population : With a likely occurence of 6 in every 10 illiterate

men migrate in search of skilled / semi skilled work

The proposed expansion project willl provide opportunities to 100 local people. Hence in

an experiment, to calculate the likely occurence of workers not leaving the study area

in search of work due to the opportunities provided by the proposed project = 60

approx.

4.7.4 Health & Related Impacts

S.no. Existing

variables/situations of

Socio-economic Issues :

Predict (adverse/

favorable) impacts

(reasons for variations

& bias of

representative data).

Mitigation measures.

In numbers.

6. Health impacts – on

mental, physical, and

social well being.

The proposed project will

not adversely impact the

mental, physical and

social well being.

Expectations in Fair

pay, employee care,

social responsibility

commitments etc. will

be timely met.

Greivance redressal

mechanism will be

made to handle

complaints from the

study area.

7. Loss/ gain of health &

fitness in short term (>1)

or long term (<1):

The proposed drug

manufacturing project is

in the RIICO Industrial

Area, Bhiwadi . The

deterioration in health &

fitness of the habitation

will be none. There could

be odour issues, but the

habitation in the major

Regular health camps

(mainly in village

Santhalka &

Harchandpur) to trace

the developments and

control any ill-

consequences in future

will be done. The

project aims to provide

Project: Auronext Pharma Pvt. Ltd. Section-IV/ Anticipated Environmental Impacts &

Document No.: EESPL/APPL/001/372-EC/IND-2014 Environment Management

Enkay Enviro Services Pvt. Ltd., Jaipur,

163

wind flowing direction is

at safe and comfortable

distance of 0.5 km .

medicines to the

villagers (of the nearest

study area) at nominal

or discounted rates

from the market price.

8.

Loss/gain of self esteem:

Less developed areas like

Santhalka & Harchandpur

etc. (in the district) have

low self esteem due to low

rate of economic growth in

the region.

A rise in the self esteem

due to contribution in the

rate of commercial

growth in the region.

Higher degree of self

satisfation and

contentment.

--

9.

Loss/gain of view by study

area inhabitants:

No, loss of view as the

project is located in the

RIICO Industrial Area,

Bhiwadi.

Plantation will be done,

Cleanliness will be

maintained in and

around the factory

premises.

10.

Loss/gain of culture and

religion: It is clearly stated

in as per the Human

Rights, that the obligation

of States is to promote

universal respect for, and

observance of, culture &

religion.

The proposed project will

follow universal respect

for, and observance and

protection of, human

rights and fundamental

freedoms for all.

The proposed project

will promote neither

selective, nor relative,

but universal respect

through contribution in

various festivities,

equal observance and

protection among

employees and

societies at large in all

CSR activities.

4.7.5 Impact On Industrialization Of State Economy

S.no Existing

observations/situations

of Socio-economic

Issues :

Predict (adverse/

favorable) impacts

(reasons for

variations & bias of

representative data).

Mitigation measures. In

numbers.

11. According to the (CII), State wise number of pharmaceutical

Project: Auronext Pharma Pvt. Ltd. Section-IV/ Anticipated Environmental Impacts &

Document No.: EESPL/APPL/001/372-EC/IND-2014 Environment Management

Enkay Enviro Services Pvt. Ltd., Jaipur,

164

there are around 8,000

small and medium

enterprises (SME) units,

accounting for about 70%

of the total number of the

pharma units in India.

Indian SMEs are also

opening up for emerging

opportunities in the

pharmaceutical industry in

the field of CRAMS, clinical

research etc. The Indian

government has been

making every attempt to

support SMEs through

several incentives.

manufacturing units in India

Source : Depratment of Pharmaceuticals

(2009), GoI

These would drive them to play a definitive role in

the transitional global pharmaceutical environment,

where a sizeable number of drugs are expected to go

off patent in the coming years. As Pharma in

Rajasthan is not among the major sterile bulk drug

producing states, it is the need of the hour to

propose SME like Auronext Pharma Pvt. Ltd. to

improve the state domestic production.

12. The Indian pharmaceutical

industry ranks among the

top five countries by

volume (production) and

accounts for about 10% of

global production.

According to the Depart.

of Pharmaceuticals, the

Indian pharmaceutical

industry employs about

340,000 people and an

estimated 400,000

doctors and 300,000

chemists.

The proposed project

will continue

contributing, though in

a small measures, in

bridging the gap

between the supply

and the demand of

high quality drugs and

drug intermediates in

the region and the

state of Raj. Minor

direct and indirect

gains in balance of

payments through

effective imports of raw

materials and export of

international quality

sterile bulk drugs and

intermediates.

The proposed project will

contribute in regional

economic growth through

expansion of key

industries.

Building social utility

permanent structures, in

the study area will

contribute in regional

upgradation. By production

of quality products the

enterprise is aims to fulfill

its foremost social

commitment and keep the

national prestige in

international market.

Project: Auronext Pharma Pvt. Ltd. Section-IV/ Anticipated Environmental Impacts &

Document No.: EESPL/APPL/001/372-EC/IND-2014 Environment Management

Enkay Enviro Services Pvt. Ltd., Jaipur,

165

13. The Economy of Bhiwadi

district is largely based on

industrial activity. There

have been lower induced

investments in basic

industries.

Sterile bulk drugs & its

Intermediates will be

manufactured, to

produce several

different types of

modern antibiotics, like

many industrialized

countries by the

proposed expansion

project.

It will further contribute

through various direct,

indirect taxes, duties like

sales, excise duty and

income from abroad etc.

These form a part of the

revenue and thus, will be

put in public expenditure.

14.

The activities indicate

ethical and good

standards of business

management required for

the region.

Proposed areas of

social commitments are

as follows :

Livelihood

enhancement for

differently abled.

Health and medical

Water & conservation

Enterprises’ commitment

towards social

responsibility will be

extended with active

participation in years to

come.

4.7.6 SWOT Analysis

The SWOT analysis of the Indian pharmaceutical industry in respect to its

internal and external environment.

Strengths

• Low cost of innovation, manufacturing

and operations

• Low cost of skilled manpower and

proven track record in design of high

technology manufacturing devices.

Weaknesses

• Stringent pricing regulations affecting the

profitability of pharma companies.

• Presence of more unorganized players versus

the organized ones, resulting in an increasingly

competitive environment, characterized by stiff

price competition.

Opportunities

• Opening of the health insurance

sector and increase in per capita

income - the growth drivers for the

pharmaceutical industry.

• India, a potentially preferred global

outsourcing hub for pharmaceutical

Threats

• Other low-cost countries such as China and

Israel affecting outsourcing demand for Indian

pharmaceutical products.

• Entry of foreign players (well equipped

technology-based products) into the Indian

market.

Project: Auronext Pharma Pvt. Ltd. Section-IV/ Anticipated Environmental Impacts &

Document No.: EESPL/APPL/001/372-EC/IND-2014 Environment Management

Enkay Enviro Services Pvt. Ltd., Jaipur,

166

products due to low cost of skilled

labour.

Source : Pharma Industry Overview, Department of Pharmaceuticals, GoI (2009)

The proposed project aims to meet the objectives, thereby encompassing technical and

social advantages.

4.8 BIOLOGICAL ENVIRONMENT

4.8.1 Impacts and Mitigation Measures

There is no development without impacts however efforts should be done to mitigate

them through proper management strategy. Though the proposed project site is already

located in the declared industrial area the some project activities impacted upon few

environmental parameters which are linked with the biodiversity of the surrounding area.

In this regard, special attention should be given towards the air pollution and gaseous

pollution. Therefore, this situation needs mitigation, which must be more of Eco-

management, where plants (greenbelt) play an important role. Presently, though the

study on the existing status and predicted likely impacts on ambient air quality are well

within the limit following impacts have been predicated and for these mitigation

measures have been suggested through green belt development in the management

plan. Mainly three impacts have been visualized due to the project on the surrounding

biological attributes and which are described below,

Impact 1: Impact on the flora-fauna of the buffer zone (operation phase)

Evaluation:

• Dust particles dispersal towards the surrounding vegetation and agriculture land due to

project activities (major impact)

• Impact of noise on the faunal species (particularly on avifauna and small mammals) due

to vehicle movement (minor impact)

• Impact of gaseous pollution on surrounding vegetation and agriculture due to different

project activities and vehicles (minor impact)

Mitigation: Development of multi layer plantation (green belt) around the proposed

project will help to mitigate dust, noise and gaseous pollution of the project area.

Species suggested in the greenbelt development are mainly dust capturing, some are

helpful in gas absorption and noise supersession also. Details about green belt

development have been described under the section “green belt development” of this

report.

Project: Auronext Pharma Pvt. Ltd. Section-IV/ Anticipated Environmental Impacts &

Document No.: EESPL/APPL/001/372-EC/IND-2014 Environment Management

Enkay Enviro Services Pvt. Ltd., Jaipur,

167

• Conclusion

All the floral and faunal species reported from the core zone are common and widely

distributed in the buffer zone also. So, it can be stated that the proposed project and

associated activities are unlikely to influence any floral and faunal components

significantly provided that the suggestions / recommendations in this report are

implemented. Strict implementations of EMP / mitigation measures are required to

ensure that the biodiversity of the study area should not impacted negatively.

**********

Project: Auronext Pharma Pvt Ltd. Section-V/ ANALYSIS OF ALTERNATIVES

Document No.: EESPL/APPL/001/372-EC/IND-2014 (TECHNOLOGY AND SITE)

Enkay Enviro Services Pvt. Ltd., Jaipur

169

SECTION - V

ANALYSIS OF ALTERNATIVES (TECHNOLOGY AND SITE)

INDEX

ANALYSIS OF ALTERNATIVES (TECHNOLOGY AND SITE) ............................... 168

5.1 INTRODUCTION ..................................................................................... 17069

***********

Project: Auronext Pharma Pvt Ltd. Section-V/ ANALYSIS OF ALTERNATIVES

Document No.: EESPL/APPL/001/372-EC/IND-2014 (TECHNOLOGY AND SITE)

Enkay Enviro Services Pvt. Ltd., Jaipur

170

ANALYSIS OF ALTERNATIVES (TECHNOLOGY AND SITE)

5.1 INTRODUCTION

The technology finalized for the expansion of the project is all latest and economically

best technology. The proposed site is already located in Industrial Area, thus no

alternative site was considered.

************

Project: Auronext Pharma Pvt Ltd. Section-VI Environmental Monitoring Programme

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur,

170

SECTION – VI

ENVIRONMENTAL MONITORING PROGRAMME

INDEX

ENVIRONMENTAL MONITORING PROGRAMME ............................................... 171

6.1 INTRODUCTION ........................................................................................ 171

6.2 ENVIRONMENTAL MONITORING AND REPORTING PROCEDURE ...................... 171

6.3 ENVIRONMENTAL MONITORING CELL ......................................................... 172

6.4 MONITORING METHODS ........................................................................... 176

6.5 REPORTING SCHEDULES OF THE MONITORING DATA ................................... 177

6.6 INFRASTRUCTURE FOR ENVIRONMENTAL MONITORING ................................ 177

************

Project: Auronext Pharma Pvt Ltd. Section-VI Environmental Monitoring Programme

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur,

171

ENVIRONMENTAL MONITORING PROGRAMME

6.1 INTRODUCTION

Regular monitoring of environmental parameters is of immense importance to assess the

status of environment during project operation. With the knowledge of baseline

conditions, the monitoring programme will serve as an indicator for any deterioration in

environmental conditions due to operation of the project, to enable taking up suitable

mitigatory steps in time to safeguard the environment. Monitoring is as important as

that of control of pollution since the efficiency of control measures can only be

determined by monitoring.

Usually, as in the case of the study, an impact assessment study is carried over short

period of time and the data cannot bring out all variations induced by the natural or

human activities. Therefore, regular monitoring programme of the environmental

parameters is essential to take into account the changes in the environmental quality.

6.2 ENVIRONMENTAL MONITORING AND REPORTING PROCEDURE

Monitoring will confirm that commitments are being met. This may take the form of

direct measurement and recording of quantitative information, such as amounts and

concentrations of discharges, emissions and wastes, for measurement against corporate

or statutory standards, consent limits or targets. It may also require measurement of

ambient environmental quality in the vicinity of a site using ecological/biological, physical

and chemical indicators. Monitoring may include socio-economic interaction, through

local liaison activities or even assessment of complaints.

The preventive approach to management may also require monitoring of process inputs,

for example, type and method used, resource consumption, equipment and pollution

control performance etc.

The key aims of monitoring are, first, to ensure that results/conditions are as forecast

during the planning stage, and where they are not, to pinpoint the cause and implement

action to remedy the situation. A second objective is to verify the evaluations made

during the planning process, in particular with risk and impact assessments and standard

& target setting and to measure operational and process efficiency. Monitoring will also

be required to meet compliance with statutory and corporate requirements. Finally,

monitoring results provide the basis for auditing.

6.2.1 Objectives of Monitoring

The objectives of monitoring are to:

• Verify effectiveness of planning decisions;

• Measure effectiveness of operational procedures;

Project: Auronext Pharma Pvt Ltd. Section-VI Environmental Monitoring Programme

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur,

172

• Conform statutory and corporate compliance; and

• Identify unexpected changes.

6.3 ENVIRONMENTAL MONITORING CELL

A centralized environmental monitoring cell will be established for monitoring of

important and crucial environmental parameters which are of immense importance to

assess the status of environment during operation of plant. With the knowledge of

baseline conditions, the monitoring program can serve as an indicator for any

deterioration in environmental conditions due to operation of the plant, and helps in

planning suitable mitigatory steps that could be taken in time to safeguard the

environment. Monitoring is as important as that of control of pollution since the

efficiency of control measures can only be determined by monitoring. The following

routine monitoring program will be implemented under the post-project monitoring as

per CPCB guidelines.

Environmental monitoring schedules are prepared covering various phases of project

advancement, such as constructional phase and regular operational phase.

6.3.1 Monitoring Schedule during Constructional Phase

The proposed expansion of the project envisages setting up of proposed sterile bulk drug

& its intermediated manufacturing. The construction or preoperational activities require

mobilisation of construction material and equipment. During construction phase the main

source will be fugitive emission from transportation of construction material and etc. As

such monitoring is not required during construction phase.

6.3.2 Monitoring Schedule during Operational Phase

During operational stage, Volatile organic compounds, acid gases, and particulates may

be emitted during pharmaceuticals manufacturing facilities from both point sources and

fugitive emissions. Along with the above the boiler, D.G. sets and reactors are also a

potential source of emission. Following attributes which merit regular monitoring based

on the environmental setting and nature of project activities are listed below:

• Source emissions and ambient air quality;

• Groundwater Levels and ground water quality;

• Water and wastewater quality (water quality, effluent & sewage quality etc);

• Soil quality;

• Noise levels (equipment and machinery noise levels, occupational exposures and

ambient noise levels);

• Ecological preservation and afforestation.

The following routine monitoring programme as detailed in as under will be

implemented at site. Besides to this monitoring, the compliances to all environmental

Project: Auronext Pharma Pvt Ltd. Section-VI Environmental Monitoring Programme

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur,

173

clearance conditions and regular permits from SPCB/MoEF will be monitored and

reported periodically.

Table No. 6.1

Environmental Monitoring During Operational Phase

S.

No

.

Potential

Impact

Action to be

Followed

Parameters

for

Monitoring

Frequency

of

Monitoring

Location

1 Air

Emissions

Ambient air quality

within the

premises of the

proposed unit and

nearby habitations

to be monitored.

PM10, PM2.5,

SO2, NOx CO,

VOC and HC

As per CPCB/

SPCB

requirement

or on weekly

basis

whichever is

earlier

At least two

locations

inside

premises;

four outside

premises

Exhaust from

vehicles to be

minimized by use

of fuel efficient

vehicles and well

maintained

vehicles having

PUC certificate.

Vehicle logs to

be maintained

-

Vehicle trips to be

minimized to the

extent possible

Vehicle logs Daily records Main gate

2 Noise Noise generated

from various plant

operations,

vehicular to be

optimized and

monitored

Spot Noise

Level

recording;

Leq(night),

Leq(day),

Leq(dn)

Periodic

during

operation

phase

Noise

measurement

at D.G Set,

Boilers and

main gate and

at least three

outside

premises

Generation of

vehicular noise

Maintain

records of

vehicles

Periodic

during

operation

-

Project: Auronext Pharma Pvt Ltd. Section-VI Environmental Monitoring Programme

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur,

174

S.

No

.

Potential

Impact

Action to be

Followed

Parameters

for

Monitoring

Frequency

of

Monitoring

Location

phase

3 Wastewater

Discharge

No untreated

discharge to be

made to surface

water,

groundwater or

soil.

No discharge

hoses in

vicinity of

watercourses.

Periodic

during

operation

phase

-

Take care in

disposal of

wastewater

generated such

that soil and

groundwater

resources are

protected

Discharge

norms for

effluents will be

maintained

Periodic

during

operation

phase

-

Compliance of

treated

wastewater

usage/discharge to

standards

pH, TSS, TDS,

BOD, COD,

phenol,

arsenic,

cadmium,

chromium and

Bio Assay

Testing .

Periodic

during

operation

phase

One location

(Treated

Wastewater)

Compliance of

treated sewage to

standards

Comprehensive

as per GSR

422(E)

Once in a

season

One location

(Treated

sewage)

4 Drainage

and effluent

Management

Ensure drainage

system and

specific design

measures are

working

effectively.

Design to

incorporate

Visual

inspection of

drainage and

records thereof

Periodic

during

operation

phase

-

Project: Auronext Pharma Pvt Ltd. Section-VI Environmental Monitoring Programme

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur,

175

S.

No

.

Potential

Impact

Action to be

Followed

Parameters

for

Monitoring

Frequency

of

Monitoring

Location

existing drainage

pattern and avoid

disturbing the

same.

5 Water

Quality and

Water Levels

Monitoring used

water quality &

groundwater

quality and levels

Comprehensive

monitoring as

per IS 10500

Groundwater

level bgl

Periodic

during

operation

phase

Three

locations

surrounding

project site

6 Energy

Usage

Energy usage for

air-conditioning

and other activities

to be minimized

Conduct annual

energy audit for

the buildings

Energy audit

report

Annual audits

and periodic

checks during

operational

phase

-

8 Emergency

preparednes

s, such as

fire fighting

Fire protection and

safety measures to

take care of fire

and explosion

hazards, to be

assessed and steps

taken for their

prevention.

Mock drill

records, on site

emergency

plan,

evacuation

plan

Periodic

during

operation

phase

9 Maintenance

of flora and

fauna

Vegetation,

greenbelt / green

cover development

No. of plants,

species

Periodic

during

operation

phase

-

10 Solid and

Hazardous

Waste

Management

Implement waste

management plan

that identifies and

characterizes

Records of

solid waste

generation,

treatment and

Periodic

during

operation

phase

Project: Auronext Pharma Pvt Ltd. Section-VI Environmental Monitoring Programme

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur,

176

S.

No

.

Potential

Impact

Action to be

Followed

Parameters

for

Monitoring

Frequency

of

Monitoring

Location

every waste

arising associated

with proposed

activities and

which identifies

the procedures for

collection, handling

& disposal of each

waste arising.

disposal

11 Soil quality Maintenance of

good soil quality

Physico-

chemical

parameters

and metals.

Periodical

monitoring

Plantation

areas

12 Health Employees and

migrant labour

health check ups

All relevant

parameters

including HIV

Regular check

ups

-

6.4 MONITORING METHODS

6.4.1 Air Quality Monitoring

I. Workspace Monitoring

The concentration of air borne pollutants in the workspace/work zone environment will

be monitored periodically. If concentrations higher than threshold limit values are

observed, the source of fugitive emissions will be identified and necessary measures

taken. If the levels are high, suitable measures as detailed in EMP will be initiated.

II. Ambient Air Quality Monitoring

The ground level concentrations of PM10, PM2.5, SO2, NOX, CO VOCs, HC in the ambient

air will be monitored at regular intervals. Any abnormal rise will be investigated to

identify the causes and appropriate action will be initiated. The ambient air quality data

should be transferred and processed in a centralised computer facility equipped with

required software. Trend and statistical analysis should be done.

6.4.2 Water and Wastewater Quality Monitoring

To ensure a strict control over the water consumption, flow meters will be installed for all

major inlets. All leakages and excess will be identified and rectified. In addition, periodic

water audits will be conducted to explore further possibilities for water conservation.

Project: Auronext Pharma Pvt Ltd. Section-VI Environmental Monitoring Programme

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur,

177

Methods prescribed in "Standard Methods for Examination of Water and Wastewater"

prepared and published jointly by American Public Health Association (APHA), American

Water Works Association (AWWA) are recommended.

I. Monitoring of Wastewater Streams

All the wastewater streams in the project area will be regularly analysed for flow rate

and physical and chemical characteristics. Such analysis is carried out for wastewater at

the source of generation, at the point of entry into the wastewater treatment plant and

at the point of final discharge. These data will be properly documented and compared

against the design values for any necessary corrective action.

II. Monitoring of Groundwater

The monitoring of groundwater is the most important tool to test the efficiency of plant

performance. It is suggested to collect water samples and analyse. Records of analysis

will be maintained.

6.4.3 Noise Levels

Noise levels will be monitored in the plant area. The frequency will be once in a month in

the work zone. Similarly, ambient noise levels near habitations will also be monitored

once in three months. Audiometric tests should be conducted periodically for the

employees working close to the high noise sources especially D.G. Set operations in this

case.

6.5 REPORTING SCHEDULES OF THE MONITORING DATA

It is proposed that voluntary reporting of environmental performance with reference to

the EMP should be undertaken.

The environmental monitoring cell will co-ordinate all monitoring programmes at site and

data thus generated will be regularly furnished to the State regulatory agencies.

The frequency of reporting will be on six monthly bases to the local state RSPCB officials

and to Regional office of MoE&F. The Environmental Audit reports will be prepared for

the entire year of operations and will be regularly submitted to regulatory authorities.

6.6 INFRASTRUCTURE FOR ENVIRONMENTAL MONITORING

The unit will outsource the monitoring instruments as and when required.

**************

Project: Auronext Pharma Pvt. Ltd. SECTION-VII/Additional Studies

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

178

SECTION-VII

ADDITIONAL STUDIES

INDEX

ADDITIONAL STUDIES ................................................................................... 179

7.1 PUBLIC CONSULTATION ........................................................................... 179

7.2 RISK ASSESSMENT ................................................................................... 179

7.3 HAZARD IDENTIFICATION ......................................................................... 180

7.4 HAZARD ASSESSMENT AND EVALUATION .................................................... 182

7.5 STORAGE AND HANDLING OF HAZARDOUS CHEMICALS ............................... 190

7.6 DISASTER MANAGEMENT PLAN ................................................................... 193

7.7 OFF-SITE EMERGENCY PREPAREDNESS PLAN ................................................ 205

7.8 OCCUPATIONAL HEALTH AND SAFETY .......................................................... 210

7.9 CORPORATE SOCIAL COMMITMENT .............................................................. 215

***********

Project: Auronext Pharma Pvt. Ltd. SECTION-VII/Additional Studies

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

179

ADDITIONAL STUDIES

7.1 PUBLIC CONSULTATION

As our project is coming up in the Notified Industrial Area , (RIICO Industrial Area,

Bhiwadi, Rajasthan), the same was exempted from public hearing as per the per EIA

Notification 2006, para 7 III stage (3) sub point B, (exemption from public

consultation is allowed for all projects or activities located within industrial

estates or park approved by the concerned authorities and which are not

disallowed in such approvals as mentioned in the Gazette Notification of 2006

and subsequent amendment on dated 01.12.2009).Public hearing has now again

been exempted by MoEF&CC vide your office memorandum No. J-11013/36/2014-IA-I

dated 10.12.2014. (Annexure-XIX)

7.2 RISK ASSESSMENT

7.2.1 Introduction

Hazard analysis involves the identification and quantification of the various hazards

(unsafe conditions) that exist in the proposed plant. On the other hand, risk analysis

deals with the recognition and computation of risks, the equipment in the plant and

personnel are prone to, due to accidents resulting from the hazards present in the plant.

Risk analysis follows an extensive hazard analysis. It involves the identification and

assessment of risks the neighboring populations are exposed to as a result of hazards

present. This requires a thorough knowledge of failure probability, credible accident

scenario, vulnerability of population etc. Much of this information is difficult to get or

generate. Consequently, the risk analysis is often confined to maximum credible accident

studies.

In the sections below, the identification of various hazards, probable risks in the proposed

plant, maximum credible accident analysis, consequence analysis are addressed which

gives a broad identification of risks involved in the plant. The Disaster Management Plan

(DMP) has been presented based on the risk estimation for storage of sulphuric acid,

hydrochloric acid, Sodium Hydroxide and Methanol only which are proposed to be installed.

7.2.2 Approach to the Study

Risk involves the occurrence or potential occurrence of some accidents consisting of an

event or sequence of events. The risk assessment study covers the following:

• Identification of potential hazard areas;

• Identification of representative failure cases;

Project: Auronext Pharma Pvt. Ltd. SECTION-VII/Additional Studies

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

180

• Visualization of the resulting scenarios in terms of fire (thermal radiation) and

explosion;

• Assess the overall damage potential of the identified hazardous events and the

impact zones from the accidental scenarios;

• Assess the overall suitability of the site from hazard minimization and disaster

mitigation point of view;

• Furnish specific recommendations on the minimization of the worst accident

possibilities; and

• Preparation of broad Disaster Management Plan (DMP), On-site and Off-site

Emergency Plan, which includes Occupational and Health Safety Plan.

Risk Analysis

7.3 HAZARD IDENTIFICATION

Identification of hazards in the modification of the existing plant is of primary significance in

the analysis, quantification and cost effective control of accidents involving chemicals and

process. A classical definition of hazard states that hazard is in fact the characteristic of

system/plant/process that presents potential for an accident. Hence, all the components of

a system/plant/process need to be thoroughly examined to assess their potential for

initiating or propagating an unplanned event /sequence of events, which can be termed as

an accident.

7.3.1 Classification of Major Hazardous Units

Hazard Identification

Hazard & Scenario Analysis

Likelihood Consequences

Risk

Project: Auronext Pharma Pvt. Ltd. SECTION-VII/Additional Studies

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

181

Hazardous substances may be classified into three main classes namely flammable

substances, unstable substances and toxic substances. The major hazardous materials to

be stored, transported, handled and utilized within the facility have been summarized in

the Table No. 7.1. The storage details and properties are given in Table No. 7.2 and

Table No. 7.3 respectively.

Table No. 7.1

Hazardous Materials Stored, Transported and Handled

S.No Materials Hazardous Properties

1. Methanol/Ethanol UN 1230 Dangerous Goods class 3 Flammable Liquid

2. Isopropyl Alcohol UN 1219 Dangerous Goods class 3 Flammable Liquid

3. Acetone UN 1090 Dangerous Goods class 3 Flammable Liquid

Table No. 7.2

Category Wise Schedule of Storage Tanks

Material Capacity (KL) Classification

Methanol/

Ethanol

25 Non-dangerous Petroleum

Isopropyl Alcohol 25 Non-dangerous Petroleum

Acetone 25 Non-dangerous Petroleum

Table No. 7.3

Properties of Materials Used in the Plant

Chemical Codes/Label TLV BP MP FP UEL LEL

°c %

Methanol Flammable 200 ppm 64.6 97.8 11-

12

36.0 6.7

Isopropyl Alcohol Flammable 400 ppm 82.5 - 88.5 12-13 12.7 2

Acetone Flammable 500 ppm 56.2 - 95.35 -18 12.8 2.6

TLV : Threshold Limit Value BP : Final Boiling Point

MP : Melting Point FP : Flash Point

UEL : Upper Explosive Limit LEL : Lower Explosive Limit

Project: Auronext Pharma Pvt. Ltd. SECTION-VII/Additional Studies

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

182

7.4 HAZARD ASSESSMENT AND EVALUATION

7.4.1 Methodology

An assessment of the conceptual design is conducted for the purpose of identifying and

examining hazards related to feed stock materials, major process components, utility and

support systems, environmental factors, proposed operations, facilities, and safeguards.

To minimize the risk of hazards, industry should maintain a management plan and the

process of Hazard management must involve the following four phases:

• Mitigation,

• Preparedness,

• Response,

• Recovery.

7.4.2 Preliminary Hazard Analysis (PHA)

A preliminary hazard analysis is carried out initially to identify the major hazards associated

with storages and the processes of the plant. This is followed by consequence analysis to

quantify these hazards. Finally, the vulnerable zones are plotted for which risk reducing

measures are deduced and implemented. Preliminary hazard analysis for storage area and

whole plant is given in Table No. 7.4 and Table No. 7.5.

Table No. 7.4

Preliminary Hazard Analysis for Storage Areas

Unit Capacity

(KL)

Hazard

Identified

Methanol/Ethanol 25 Fire/Explosion

Isopropyl Alcohol 25 Fire/Explosion

Acetone 25 Fire/Explosion

Table No. 7.5

Preliminary Hazard Analysis for the Whole Plant in General

PHA Category Description of

Plausible Hazard

Recommendation Provision

Environ-mental

factors

If there is any

leakage and

eventuality of source

of ignition.

-- All electrical fittings and

cables are provided as per

the specified standards. All

motor starters are flame

proof.

Project: Auronext Pharma Pvt. Ltd. SECTION-VII/Additional Studies

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

183

PHA Category Description of

Plausible Hazard

Recommendation Provision

Environ-mental

factors

Highly inflammable

nature of the liquid

Chemical may cause

fire hazard in the

storage facility.

A well designed fire

protection including

foam, dry powder,

and CO2

extinguisher should

be provided.

Fire extinguisher of small

size and big size are

provided at all potential

fire hazard places. In

addition to the above, fire

hydrant network is also

provided.

7.4.3 Maximum Credible Accident Analysis (MCAA)

Hazardous substances may be released as a result of failures or catastrophes, causing

possible damage to the surrounding area. This section deals with the question of how the

consequences of the release of such substances and the damage to the surrounding area

can be determined by means of models. Major hazards posed by flammable storage can be

identified taking recourse to MCA analysis. MCA analysis encompasses certain techniques to

identify the hazards and calculate the consequent effects in terms of damage distances of

heat radiation, toxic releases, vapour cloud explosion, etc. A host of probable or potential

accidents of the major units in the complex arising due to use, storage and handling of the

hazardous materials are examined to establish their credibility. Depending upon the

effective hazardous attributes and their impact on the event, the maximum effect on the

surrounding environment and the respective damage caused can be assessed. The reason

and purpose of consequence analysis are many folds like:

• Part of Risk Assessment;

• Plant Layout/Code Requirements;

• Protection of other plants;

• Protection of the public;

• Emergency Planning; and

• Design Criteria.

The results of consequence analysis are useful for getting information about all known and

unknown effects that are of importance when some failure scenario occurs in the plant and

also to get information as how to deal with the possible catastrophic events. It also gives

the workers in the plant and people living in the vicinity of the area, an understanding of

their personal situation.

• Selected Failure Cases

Project: Auronext Pharma Pvt. Ltd. SECTION-VII/Additional Studies

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

184

The purpose of this listing (refer Table 7.9) is to examine consequences of such

failure individually or in combination. It will be seen from the list that a vast range

of failure cases have been identified. The frequency of occurrence of failure also

varies widely.

• Damage Criteria

The chemical storage and unloading at the storage facility may lead to fire and

explosion hazards. The damage criteria due to an accidental release of any

hydrocarbon arise from fire and explosion. The vapors of these Chemical are not

toxic and hence no effects of toxicity are expected.

Tank fire would occur if the radiation intensity is high on the peripheral surface of

the tank leading to increase in internal tank pressure. Pool fire would

occur when chemicals are collected in the dyke due to leakage gets ignited.

• Fire Damage

A flammable liquid in a pool will burn with a large turbulent diffusion flame. This

releases heat based on the heat of combustion and the burning rate of the liquid. A

part of the heat is radiated while the rest is convicted away by rising hot air and

combustion products. The radiations can heat the contents of a nearby storage or

process unit to above its ignition temperature and thus result in a spread of fire.

The radiations can also cause severe burns or fatalities of workers or fire fighters

located within a certain distance. Hence, it will be important to know beforehand the

damage potential of a flammable liquid pool likely to be created due to leakage or

catastrophic failure of a storage or process vessel. This will help to decide the

location of other storage/process vessels, decide the type of protective clothing the

workers/fire fighters’ need, the duration of time for which they can be in the zone,

the fire extinguishing measures needed and the protection methods needed for the

nearby storage/process vessels. Table No. 7.7 tabulates the damage effect on

equipment and people due to thermal radiation intensity.

Table No. 7.7

Damage Due to Incident Radiation Intensities

Sr.

No.

Incident

Radiatio

n

(kW/m2)

Type of Damage Intensity

Damage to Equipment Damage to People

1 37.5 Damage to process equipment 100% lethality in 1 min. 1%

lethality

Project: Auronext Pharma Pvt. Ltd. SECTION-VII/Additional Studies

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

185

Sr.

No.

Incident

Radiatio

n

(kW/m2)

Type of Damage Intensity

Damage to Equipment Damage to People

in 10 sec.

2 25.0 Minimum energy required to ignite

wood at indefinitely long exposure

without a flame

50% Lethality in 1 min. Significant

injury in 10 sec.

3 19.0 Maximum thermal radiation

intensity allowed on thermally

unprotected adjoining equipment

--

4 12.5 Minimum energy to ignite with a

flame; melts plastic tubing

1% lethality in 1 min.

5 4.5 -- Causes pain if duration is longer

than 20 sec, however blistering is

un-likely (First degree burns)

6 1.6 -- Causes no discomfort on long

exposures

Source: Techniques for Assessing Industrial Hazards by World Bank.

The effect of incident radiation intensity and exposure time on lethality is given in

Table-7.8.

Table no. 7.8

Radiation Exposure and Lethality

Radiation

Intensity

(kW/m2)

Exposure

Time

(seconds)

Lethality

(%)

Degree of Burns

1.6 -- 0 No Discomfort even after

long exposure

4.5 20 0 1 st

4.5 50 0 1 st

8.0 20 0 1 st

8.0 50 <1 3 rd

8.0 60 <1 3 rd

12.0 20 <1 2 nd

12.0 50 8 3 rd

Project: Auronext Pharma Pvt. Ltd. SECTION-VII/Additional Studies

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

186

Radiation

Intensity

(kW/m2)

Exposure

Time

(seconds)

Lethality

(%)

Degree of Burns

12.5 Inst 10 --

25.0 inst 50 --

37.5 inst 100 --

7.4.5 Scenarios Considered for MCA Analysis

• Chemical Storage

The details of storages in the proposed plant are given Table-7.2 above. In case of

chemical released in the area catching fire, a steady state fire will occur. Failures in

pipeline may occur due to corrosion and mechanical defect. Failure of pipeline due to

external interference is not considered as this area is licensed area and all the work

within this area is closely supervised with trained personnel.

• Modeling Scenarios

Based on the storage and consumption of various chemicals the following failure

scenarios for the proposed plant have been identified for MCA analysis and the

scenarios are discussed in Table No. 7.9. The chemical properties considered in

modeling are given in Table No. 7.10.

Table No. 7.9

Scenarios Considered For MCA Analysis

Sr.

No.

Fuel/Chemical Total

Quantity

Scenarios

considered

1. Failure of Methanol Tank 25 KL Pool fire

2. Failure of Ethanol Tank 25 KL Pool fire

3. Failure of Isopropyl Alcohol Tank 25 KL Pool fire

4. Failure of Acetone Tank 25 KL Pool fire

Table-7.10

Properties of Chemicals Considered For Modeling

Sr.

No.

Fuel/substance Molecular

weight

Boiling Point

(°°°°C)

1 Methanol 34.04 64.6

2 Ethanol 46.06 78.37

3 Isopropyl Alcohol 60.1 82.5

4 Acetone 58.1 56.2

Project: Auronext Pharma Pvt. Ltd. SECTION-VII/Additional Studies

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

187

7.4.6 Pool Fire Models used for MCA Analysis

Heat Radiation program ‘RADN’ has been used to estimate the steady state radiation effect

from storage of fuel at different distances. The model is based on the equations compiled

from various literatures by Prof. J. P. Gupta, Department of Chemical Engineering, IIT

Kanpur.

7.4.7 Results and Discussion

The results of MCA analysis are tabulated indicating the distances for various damages

identified by the damage criteria, as explained earlier. Calculations are done for radiation

intensities levels of 37.5, 25, 12.5, 4.5 and 1.6-kW/m2, which are presented in Table-7.11

for different scenarios. The distances computed for various scenarios are from the center of

the pool fire.

Table-7.11

Occurrence of Various Radiation Intensities- Pool Fire

Thermal Radiation Level Damage Distance from the Centre of the pool

(M)

Methanol Isopropyl Alcohol Acetone

37.5 kW/m2 (100% lethality in 1

min)

12.9 8.9 13.1

25 kW/m2 (50% lethality in 1 min) 22.8 17.2 22.3

12.5 kW/m2 (1% lethality in 1 min) 45.9 36.7 43.7

4.5 kW/m2 (Causes 1st degree

burns on exposure more than 50

sec)

101.9 83.9 95.6

1.6 kW/m2 (Causes no discomfort

even after long exposure)

203.8 169.8 190.1

Pool Fire Due to Failure of Methanol Storage Tank

The maximum capacity of storage of Methanol will be 25 KL. The most credible

failure is the rupture of the largest pipe connecting to the storage tank. As the worst

case, it is assumed that the entire contents leak out into the dyke forming a pool,

which may catch fire on finding a source of ignition.

Project: Auronext Pharma Pvt. Ltd. SECTION-VII/Additional Studies

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

188

The radiation intensities have been computed using software based pool fire model

and the results are tabulated in Table 7.11.

A perusal of the above table clearly indicates that 37.5 kW/m2 (100% lethality)

occurs within the radius of the pool which is computed at 12.9 m tank on pool fire.

This vulnerable zone will damage all fuel storage equipment falling within the pool

radius. Similarly, 25 KW/m2 (50% lethality) occurs within the radius of the pool

computed at 22.8 m tank on pool fire. Similarly, the threshold limit with no

discomfort even after long exposure is 1.6 kW/m2, this zone is restricted to 203 m in

case tank on pool fire.

Pool Fire Due to Failure of Isopropyl Alcohol Storage Tank

The maximum capacity of storage of Isopropyl Alcohol will be 25 KL. The most

credible failure is the rupture of the largest pipe connecting to the storage tank. As

the worst case, it is assumed that the entire contents leak out into the dyke forming

a pool, which may catch fire on finding a source of ignition.

The radiation intensities have been computed using software based pool fire model

and the results are tabulated in Table 7.11.

A perusal of the above table clearly indicates that 37.5 kW/m2 (100% lethality)

occurs within the radius of the pool which is computed at 9 m tank on pool fire. This

vulnerable zone will damage all fuel storage equipment falling within the pool radius.

Similarly, 25 KW/m2 (50% lethality) occurs within the radius of the pool computed at

17 m tank on pool fire. Similarly, the threshold limit with no discomfort even after long

exposure is 1.6 kW/m2, this zone is restricted to 169 m in case tank on pool fire.

Pool Fire Due to Failure of Acetone Storage Tank

The maximum capacity of storage of Acetone will be 25 KL. The most credible failure

is the rupture of the largest pipe connecting to the storage tank. As the worst case, it

is assumed that the entire contents leak out into the dyke forming a pool, which may

catch fire on finding a source of ignition.

The radiation intensities have been computed using software based pool fire model

and the results are tabulated in Table 7.11.

A perusal of the above table clearly indicates that 37.5 kW/m2 (100% lethality)

occurs within the radius of the pool which is computed at 13 m tank on pool fire. This

Project: Auronext Pharma Pvt. Ltd. SECTION-VII/Additional Studies

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

189

vulnerable zone will damage all fuel storage equipment falling within the pool radius.

Similarly, 25 KW/m2 (50% lethality) occurs within the radius of the pool computed at

22 m tank on pool fire. Similarly, the threshold limit with no discomfort even after long

exposure is 1.6 kW/m2, this zone is restricted to 190 m in case tank on pool fire.

7.4.8 Hazardous Events with Greatest Contribution to Fatality Risk

The hazardous event scenarios likely to make the greatest contribution to the risk of

potential fatalities are summarized in Table No. 7.12. ‘Onsite facility’ refers to the

operating site at Udaipur, whereas ‘offsite facility’ refers to transport and handling

systems, which are away from the operating site.

Table-7.12

Hazardous events contributing to on-site facility risk

Hazardous Event Risk Rank Consequences of Interest

Onsite vehicle impact on

personnel

3 Potential for single fatalities, onsite

impact only

Entrapment/struck by

machinery

3 Potential for single fatalities, onsite

impact only

Fall from heights 3 Potential for single fatalities, onsite

impact only

Electrocution 3 Potential for single fatalities, onsite

impact only

Storage tank rupture 3 Potential for single fatalities, onsite

impact only

7.4.9 Risk Assessment Summary

The preliminary risk assessment has been completed for the proposed plant and

associated facilities and the broad conclusions are as follows:

• There will be no significant community impacts or environmental damage

consequences; and

• The hazardous event scenarios and risks in general at this facility can be adequately

managed to acceptable levels by performing the recommended safety studies as

part of detailed design, applying recommended control strategies and implementing

a Safety Management System.

7.4.10 Risk Reduction Opportunities

Project: Auronext Pharma Pvt. Ltd. SECTION-VII/Additional Studies

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

190

The process of bulk drug manufacturing activities is quite complex and has inherent risks

of

on-site and off-site environmental overheads.

The following opportunities will be considered as a potential means of reducing identified

risks during the detailed design phase:

• Buildings and plant structures designed for cyclone and seismic events (where

appropriate), to prevent structural collapse and integrity of weather (water)

proofing for storage of dangerous goods.

• Provision for adequate water capacity to supply fire protection systems and

critical process water

• Isolate people from load carrying/mechanical handling systems, vehicle traffic

and storage and stacking locations.

• Installation of fit-for-purpose access ways and fall protection systems to

facilitate safe access to fixed and mobile plant.

• Provision and integrity of process tanks, waste holding tanks and bounded

areas as per relevant standards

• Containment of hazardous materials.

• Security of facility to prevent unauthorized access to plant, introduction of

prohibited items, and control of onsite traffic; and

• Development of emergency response management systems commensurate

with site specific hazards and risks (fire, explosion, rescue and first aid).

• The industrial units using hazardous chemicals as raw materials in processes,

products and wastes with inflammable, explosive, corrosive, toxic and noxious

properties will be required to have onsite and offsite emergency plans in place

and put them to test by organizing regular mock drills.

• Industry should create a portfolio of disaster reduction actions, compiling best

practice and lessons learned from previous disasters, and a catalogue of

technologies for disaster reduction. The chemical industry should share well-

developed codes, translated into several languages and adapted to the different

environments in which we operate.

7.5 STORAGE AND HANDLING OF HAZARDOUS CHEMICALS

A storage and handling of hazardous chemical in a chemical industry is inevitable, land

they carry inherent characteristic risk to the employees due to the properties of

chemicals such as toxicity & flammability. Accident due to fire and explosion by

flammable substances are possible in process industry. The disastrous effect of fire,

Project: Auronext Pharma Pvt. Ltd. SECTION-VII/Additional Studies

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

191

explosion and release of toxic fumes in storage and production area, is due to

inappropriate design, improper storage, improper handling, poor maintenance or

deficiencies in the operation of the plant. Chemical in any form can be stored, handled

and used if their physical, chemical and hazardous properties are thoroughly understood

and necessary precautions are taken.

Each chemical has its specific character. Hence, chemicals do not co-exist. They need

their independent space, while storing. When two chemicals come in contact, they react

generating heat and by product gases. Ambient temperature and moisture can trigger

the reaction. Halogenated compounds acquire aggravated properties. It is only wise to

treat every chemical as Toxic.

Chemicals are potential enough to destroy the flesh and the skin is ultra sensitive to

chemicals. Chemicals on contact, the affected parts of the body should be washed

thoroughly with plenty of water for at least 15 minutes, to dilute the aggressive nature

of the chemical, as water is the only universal solvent and the best diluents. Then only

further treatment is to be followed.

Chemicals are handled in standard containers like MS, HDPE, GI Drums, PVC Carboys,

etc. All the chemicals are to be arranged and stored in accordance with their

compatibility, dry, well ventilated, with flameproof electrical equipments and lighting. All

the chemicals are to be provided with identification labels.

Eye wash/Drench shower is to be provided at a strategic location for emergency

purpose.

Chemical Safety Data Sheets and handling procedure, First Aid measures are to be

prepared and displayed for information and safety of the working personnel.

7.5.1 Hazards/ Exposure Control of Chemicals

The hazards involved and its control measures for the following chemicals which are being

handled / stored in the premises are given below:

I. METHANOL

Engineering controls:

Methanol is routinely stored in tank farms consisting of above-ground,

floating roof tanks and smaller, internally baffled floating baffle tanks. Tanks must

be grounded to avoid hazards associated with static discharge. Ignition control

may be by nitrogen padding, natural gas padding, or by designation of a hazard

zone with ignition control. Because methanol is commonly stored with other

solvents and feed stocks, all piping and valves subject to carrying methanol

should be consistently labeled, and direction of flow should be indicated. All

storage materials, including totes and drums, require berming and adequate

Project: Auronext Pharma Pvt. Ltd. SECTION-VII/Additional Studies

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

192

ventilation. Examples of engineering controls that can be used to prevent

exposure to methanol include:

• Installation of local ventilation hoods

• Ventilated enclosures around work processes (fume hoods, glove,boxes)

• Use of closed piping and storage systems

• Use of automatic systems to pump methanol from storage containers to

process systems or containers

Provide exhaust ventilation or other engineering controls to keep the airborne

concentrations of vapors below their respective threshold limit value. Ensure that

eyewash stations and safety showers are proximal to the work-station location.

Respiratory protection:

Emergency Use: Self-contained breathing apparatus (SCBA) or positive

pressure airline with full face mask with escape pack should be worn in areas of a

large release or unknown concentration.

Eye Protection: Safety glasses for handling cylinders, Chemical goggles with full

face shield for connecting, disconnecting or opening cylinders.

Skin Protection: Chemical-resistant gloves for handling cylinders. Chemical

resistant outer garment should be worn when connecting or disconnecting

cylinders. Total encapsulating chemical suit may be necessary in large release

area.

Other Protective Equipment: Safety shoes are recommended when handling

cylinders. Safety shower and eyewash fountain should be readily available.

Caution: Contact with eyes causes irritation, redness, pain and ingestion cause

Neurological, Gastro intestinal disorders.

II. ISOPROPYL ALCOHOL

Engineering controls

Provide exhaust ventilation or other engineering controls to keep the airborne

concentrations of vapors below their respective threshold limit value. Ensure that

eyewash stations and safety showers are proximal to the work-station location.

Eye/face protection:

Splash goggles. Lab coat. Vapor respirator. Be sure to use an approved/certified

respirator or equivalent. Gloves.

Skin protection:

In case of contact, Wash with soap and water. Cover the irritated skin with an

emollient. Get medical attention if irritation develops. Cold water may be used.

Protective Equipment

Project: Auronext Pharma Pvt. Ltd. SECTION-VII/Additional Studies

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

193

Gloves, Lab coat & Vapor respirator. Be sure to use an approved/certified

respirator or equivalent. Wear appropriate respirator when ventilation is

inadequate. Splash goggles.

III. ACETONE

Engineering controls

Provide exhaust ventilation or other engineering controls to keep the airborne

concentrations of vapors below their respective threshold limit value. Ensure that

eyewash stations and safety showers are proximal to the work-station location.

Eye/face protection:

Splash goggles. Lab coat. Vapor respirator. Be sure to use an approved/certified

respirator or equivalent. Gloves.

Skin protection:

In case of contact, immediately flush skin with plenty of water. Cover the irritated

skin with an emollient. Remove contaminated clothing and shoes. Cold water may

be used. Wash clothing before reuse. Thoroughly clean shoes before reuse. Get

medical attention.

Protective Equipment

Gloves, Lab coat & Vapor respirator. Be sure to use an approved/certified

respirator or equivalent. Wear appropriate respirator when ventilation is

inadequate. Splash goggles.

7.6 DISASTER MANAGEMENT PLAN

7.6.1 Introduction

A disaster is a catastrophic situation in which suddenly, people are plunged into

helplessness and suffering and, as a result, need protection, clothing, shelter, medical and

social care and other necessities of life.

Disasters can be divided into two main groups. In the first, are disasters resulting from

natural phenomena like earthquakes, volcanic eruptions, storm surges, cyclones, tropical

storms, floods, avalanches, landslides, forest fires. The second group includes disastrous

events occasioned by man, or by man's impact upon the environment. Examples are armed

conflict, industrial accidents, radiation accidents, factory fires, explosions and escape of

toxic gases or chemical substances, river pollution, mining or other structural collapses, air,

sea, rail and road transport accidents which can reach catastrophic dimensions in terms of

human loss.

There can be no set criteria for assessing the gravity of a disaster in the abstract since this

depends to a large extent on the physical, economic and social environment in which it

Project: Auronext Pharma Pvt. Ltd. SECTION-VII/Additional Studies

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

194

occurs. What would be consider a major disaster in a developing country, ill equipped to

cope with the problems involved, and may not mean more than a temporary emergency

elsewhere. However, all disasters bring in their wake similar consequences that call for

immediate action, whether at the local, national or international level, for the rescue and

relief of the victims. This includes the search for the dead and injured, medical and social

care, removal of the debris, the provision of temporary shelter for the homeless, food,

clothing and medical supplies, and the rapid re-establishment of essential services.

7.6.2 Objectives of Disaster Management Plan [DMP]

The Disaster Management Plan is aimed to ensure safety of life, protection of environment,

protection of installation, restoration of production and salvage operations in this same

order of priorities. For effective implementation of the Disaster Management Plan, it should

be widely circulated and personnel trained through rehearsals/drills.

The Disaster Management Plan should reflect the probable consequential severalties of the

undesired event due to deteriorating conditions or through 'Knock on' effects. Further the

management should be able to demonstrate that their assessment of the consequences

uses good supporting evidence and is based on currently available and reliable information,

incident data from internal and external sources and if necessary the reports of outside

agencies.

To tackle the consequences of a major emergency inside the plant or in the immediate

vicinity of the plant, a Disaster Management Plan has to be formulated and this planned

emergency document is called "Disaster Management Plan".

The objective of the Industrial Disaster Management Plan is to make use of the combined

resources of the plant and the outside services to achieve the following:

• Effect the rescue and medical treatment of casualties;

• Safeguard other people;

• Minimize damage to property and the environment;

• Initially contain and ultimately bring the incident under control;

• Identify any dead;

• Provide for the needs of relatives;

• Provide authoritative information to the news media;

• Secure the safe rehabilitation of affected area; and

• Preserve relevant records and equipment for the subsequent inquiry into the

cause and circumstances of the Emergency.

In effect, it is to optimize operational efficiency to rescue, rehabilitate and render medical

help and to restore normalcy.

Project: Auronext Pharma Pvt. Ltd. SECTION-VII/Additional Studies

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

195

7.6.3 Emergencies

I. General, Industrial, Emergencies

The emergencies that could be envisaged in the plant and fuel storage are as follows:

• A situation of fire at the tank farm of all storages;

• Slow isolated fires;

• Fast spreading fires;

• Structural failures;

• Contamination of food/water; and

• Sabotage/Social disorder.

II. Specific Emergencies Anticipated

• Fire and Explosion

Fire consequences can be disastrous, since they involve huge quantities of fuel

either stored or in dynamic inventory in pipe lines or in nearby areas. Preliminary

hazard analysis has provided a basis for consequence estimation. Estimation can be

made by using various pool fire, tank fire consequence calculations. During the

study of Risk Assessment, the nature of damages is worked out and probability of

occurrence of such hazards is also drawn up.

7.6.4 Emergency Organization

It is recommended to setup an Emergency Organization. A senior executive who has

control over the affairs of the plant should lead the Emergency Organization. He shall be

designated as Site Controller. General Manager [O & M] shall be designated as the Incident

Controller. In the case of stores, utilities, open areas, which are not under the control of the

Production Heads, Senior Executive responsible for maintenance of utilities would be

designated as Incident Controller. All the Incident Controllers would be reporting to the Site

Controller.

Each Incident Controller, for himself, organizes a team responsible for controlling the

incidence with the personnel under his control. Shift In-charge would be the reporting

officer, who would bring the incidence to the notice of the Incidence Controller and Site

Controller.

Emergency Co-ordinators would be appointed who would undertake the responsibilities like

fire fighting, rescue, rehabilitation, transport and provide essential and support services.

For this purposes, Security In-charge, Personnel Department, Essential services personnel

would be engaged. All these personnel would be designated as Key personnel.

Project: Auronext Pharma Pvt. Ltd. SECTION-VII/Additional Studies

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

196

In each shift, electrical supervisor, electrical fitters, pump house in-charge, and other

maintenance staff would be drafted for emergency operations. In the event of power or

communication system failure, some of staff members in the office/plant offices would be

drafted and their services would be utilized as messengers for quick passing of

communications. All these personnel would be declared as essential personnel.

I. Emergency Communication

Whoever notices an emergency situation such as fire, growth of fire, leakage etc

would inform his immediate superior and Emergency Control Center. A place nearer

to the Gate House Complex shall be identified as Emergency Control Center. The

person on duty in the Emergency Control Center would appraise the Site Controller.

Site Controller verifies the situation from the Incident Controller of that area or the

Shift In-charge and takes a decision about an impending On Site Emergency. This

would be communicated to all the Incident Controllers, Emergency coordinators.

Simultaneously, the emergency warning system would be activated on the

instructions of the Site Controller.

II. Emergency Responsibilities

The responsibilities of the key personnel are appended below:

Site Controller

On receiving information about emergency he would rush to Emergency Control

Center (ECC) and take charge of ECC and the situation. His responsibilities would be

as indicated below:

• Assesses the magnitude of the situation on the advice of Incident Controller and

decides;

� Whether the effected area needs to be evacuated;

� Whether personnel who are at assembly points need to be evacuated;

• Declares Emergency and orders for operation of emergency siren;

• Organizes announcement by public address system about location of

emergency;

• Assesses which areas are likely to be affected, or need to be evacuated or are to

be alerted;

• Maintains a continuous review of possible development and assesses the

situation in consultation with Incident Controller and other Key Personnel as to

whether shutting down the plant or any section of the plant is required and if

evacuation of persons is required;

Project: Auronext Pharma Pvt. Ltd. SECTION-VII/Additional Studies

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

197

• Directs personnel for rescue, rehabilitation, transport, fire, brigade, medical and

other designated mutual support systems locally available, for meeting

emergencies;

• Controls evacuation of affected areas, if the situation is likely to go out of control

or effects are likely to go beyond the premises of the factory, informs the District

Emergency Authority, Police, Hospital and seeks their intervention and help;

• Informs Inspector of Factories, Deputy Chief Inspector of Factories, RPCB and

other statutory authorities;

• Gives a public statement if necessary;

• Keeps record of chronological events and prepares an investigation report and

preserves evidence; and

• On completion of On Site Emergency and restoration of normalcy, declares all

clear and orders for all clear warning.

III. Incident Controller

• Assembles the incident control team;

• Directs operations within the affected areas with the priorities for safety to

personnel minimize damage to the plant, property and environment and

minimize the loss of materials;

• Directs the shutting down and evacuation of plant and areas likely to be

adversely affected by the emergency;

• Ensures that key personnel help is sought;

• Provides advice and information to the Fire and Security Officer and the Local

Fire Services as and when they arrive;

• Ensures that all non-essential workers/staff of the affected areas are evacuated

to the appropriate assembly points, and the areas are searched for casualties;

• Has regard to the need for preservation of evidence so as to facilitate any

inquiry into the causes and circumstances, which caused or escalated the

emergency;

• Co-ordinates with emergency services at the site;

• Provides tools and safety equipment to the team members;

• Keeps in touch with the team and advices them regarding the method of control

to be used; and

• Keeps the Site Controller of Emergency informed of the progress being made.

IV. Emergency Coordinator - Rescue, Fire Fighting

• On knowing about emergency, rushes to ECC;

Project: Auronext Pharma Pvt. Ltd. SECTION-VII/Additional Studies

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

198

• Helps the Incident Controller in containment of the emergency;

• Ensure fire pumps are in operating condition and instructs pump house operator

to ready for any emergency with standby arrangement;

• Guides the fire fighting crew i.e. firemen, trained plant personnel and security

staff;

• Organizes shifting the fire fighting facilities to the emergency site, if required;

• Takes guidance of the Incident Controller for firefighting as well as assesses the

requirements of outside help;

• Arranges to control the traffic at the gate and the incident area;

• Directs the security staff to the incident site to take part in the emergency

operations under his guidance and supervision;

• Evacuates the people in the plant or in the nearby areas as advised by Site

Controller;

• Searches for casualties and arranges proper aid for them;

• Assembles search and evacuation team;

• Arranges for safety equipment for the members of this team;

• Decides which paths the evacuated workers should follow; and

• Maintains law and order in the area, and if necessary seeks the help of police.

V. Emergency Coordinator-Medical, Mutual Aid, Rehabilitation, Transport and

Communication

• In the event of failure of electric supply and thereby internal telephone, sets up

communication point and establishes contact with the ECC;

• Organizes medical treatment to the injured and if necessary will shift the injured

to nearby hospitals;

• Mobilizes extra medical help from outside, if necessary;

• Keeps a list of qualified first aid providers for the plant and seeks their

assistance;

• Maintains first aid and medical emergency requirements;

• Makes sure that all safety equipment is made available to the emergency team;

• Assists Site Controller with necessary data to coordinate the emergency

activities;

• Assists Site Controller in updating emergency plan, organizing mock drills,

verification of inventory of emergency facilities and furnishing report to Site

Controller;

• Maintains liaison with Civil Administration;

• Ensures availability of canteen facilities and maintenance of rehabilitation center.

Project: Auronext Pharma Pvt. Ltd. SECTION-VII/Additional Studies

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

199

• Liaises with Site Controller/Incident Controller;

• Ensures transportation facility;

• Ensures availability of necessary cash for rescue/rehabilitation and emergency

expenditure;

• Controls rehabilitation of affected areas on discontinuation of emergency; and

• Makes available diesel/petrol for transport vehicles engaged in emergency

operation.

VI. Emergency Coordinator - Essential Services

• Assists Site Controller and Incident Controller;

• Maintains essential services like Diesel Generator, Water, Fire Water,

Compressed Air/Instrument Air, power supply for lighting;

• Plans alternate facilities in the event of power failure, to maintain essential

services such as lighting, etc;

• Organizes separate electrical connections for all utilities and emergency services

so that in the event of emergency or fires, essential services and utilities are not

affected;

• Gives necessary instructions regarding emergency electrical supply, isolation of

certain sections etc. to shift in-charge and electricians; and

• Ensures availability of adequate quantities of protective equipment and other

emergency materials, spares etc.

VII. General Responsibilities of Employees during an Emergency

During an emergency, which becomes more enhanced and pronounced when an

emergency warning is raised, the workers who are in-charge of process equipment

should adopt safe and emergency shut down and attend to any prescribed duty as

essential employee. Assessing the situation to determine whether an emergency

exists requiring activation of your emergency procedures. If no such responsibility is

assigned, he should adopt a safe course to assembly point and await instructions.

He should not resort to spreading panic. On the other hand, he must assist

emergency personnel towards meeting the objectives of DMP.

7.6.6 Emergency Facilities

I. Emergency Control Center (ECC)

The following information and equipment are to be provided at the Emergency Control

Center (ECC).

• Intercom, telephone;

Project: Auronext Pharma Pvt. Ltd. SECTION-VII/Additional Studies

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

200

• P and T telephone;

• Self contained breathing apparatus;

• Fire suit/gas tight goggles/gloves/helmets;

• Hand tools, wind direction/velocities indications;

• Public address megaphone, hand bell, telephone directories; (internal, P and T)

Plant layout, site plan;

• Emergency lamp/torch light/batteries;

• Plan indicating locations of hazard inventories, plant control room, sources of safety

equipment, work road plan, assembly points, rescue location vulnerable zones,

escape routes;

• Hazard chart;

• Emergency shut-down procedures;

• Nominal roll of employees;

• List of key personnel, list of essential employees, list of Emergency Co-ordinators;

• Duties of key personnel;

• Address with telephone numbers and key personnel, emergency coordinator,

essential employees; and

• Important address and telephone numbers including Government agencies,

neighboring industries and sources of help, outside experts, fuel fact sheets and

population details around the factory.

II. Assembly Point

Number of assembly points, depending upon the plant location, would be identified

wherein employees who are not directly connected with the disaster management would

be assembled for safety and rescue. Emergency breathing apparatus, minimum facilities

like water etc. would be organized.

In view of the size of plant, different locations would be ear marked as assembly points.

Depending upon the location of hazard, the assembly points are to be used.

III. Fire Fighting Facilities

First Aid and Firefighting equipment suitable for emergency should be maintained in each

section in the plant.This would be as per statutory requirements. However, fire hydrant

line covering major areas would be laid. It would be maintained as 6 kg/cm2 pressure. Fire

alarms would be located in the bulk storage areas. Do not block fire escape route .Keep all

fire doors closed. Know the escape routes in your environment. Know the locations of

break glass fire alarm buttons and firefighting equipment, and make sure they are easily

accessible. Fire officer will be the commanding officer of fire fighting services.

Project: Auronext Pharma Pvt. Ltd. SECTION-VII/Additional Studies

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

201

IV. Location of Wind Sock

Wind socks shall be installed at appropriate places in the plant to indicate direction of wind

for emergency escape.

V. Emergency Medical Facilities

Stretchers, gas masks and general first aid materials for dealing with chemical burns, fire

burns etc would be maintained in the medical center as well as in the emergency control

room. Medical superintendent of the medical center will be the head of the casualty services

ward. Private medical practitioners help would be also be sought. Government hospital

would be approached for emergency help.

Apart from plant first aid facilities, external facilities would be augmented. Names of

Medical Personnel, Medical facilities in the area would be prepared and updated. Necessary

specific medicines for emergency treatment of Patient’s Burns would be maintained.

Breathing apparatus and other emergency medical equipment would be provided and

maintained. Also, the help of nearby industries would be taken on mutual support basis.

VI. Ambulance

Availability of an ambulance with driver in all the shifts would be ensured to transport

injured or affected persons. Number of persons would be trained in first aid so that, in

every shift first aid personnel would be available.

7.6.7 Emergency Actions

I. Emergency Warning

The emergency would be communicated both to the personnel inside the plant and

the people outside. An emergency warning system shall be established for this

purpose.

II. Emergency Shutdown

There are number of facilities, which can be provided to help deal with hazardous

conditions, when a tank is on fire. The suggested arrangements are:

1. Stop feed;

2. Dilute contents;

3. Remove heat;

4. Deluge with water; and

5. Transfer contents.

Whether a given method is appropriate depends on the particular case.

Project: Auronext Pharma Pvt. Ltd. SECTION-VII/Additional Studies

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

202

III. Evacuation of Personnel

There could be a number of persons in the storage area and other areas in the

vicinity. The area would have adequate number of exits, staircases. In the event of

an emergency, unconnected personnel have to escape to assembly point. Operators

have to take emergency shutdown procedure and escape. Time Office shall maintain

a copy of deployment of employees in each shift, at ECC. If necessary, persons can

be evacuated by rescue teams.

IV. All Clear Signal

Also, at the end of an emergency, after discussing with Incident Controllers and

Emergency Co-ordinators, the Site Controller orders an all clear signal. When it

becomes essential, the Site Controller communicates to the District Emergency

Authority, Police, and Fire Service personnel regarding help required or development

of the situation into an Off-Site Emergency.

V. Employee Information

During an emergency, employees would be warned by raising siren in specific

pattern. Employees would be given training of escape routes and taking shelter.

Employees would be provided with information related to fire hazards, antidotes and

first aid measures. Those who would be designated as key personnel and essential

employees should be given training for emergency response.

VI. Public Information and Warning

The industrial disaster effects related to this plant may mostly be confined to the

plant area. The detailed risk analysis has indicated that the pool fire effects would

not be felt outside. However, as an abundant precaution, the information related to

Chemical in use would be furnished to District Emergency Authority for necessary

dissemination to general public and for any use during an offsite emergency. Plants

of this size and nature have been in existence in our country for a long time.

VII. Co-ordination with Local Authorities

Keeping in view of the nature of emergency, two levels of coordination are

proposed. In the case of an On Site Emergency, resources within the organization

would be mobilized and in the event extreme emergency local authorities help

would be sought.

Project: Auronext Pharma Pvt. Ltd. SECTION-VII/Additional Studies

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

203

In the event of an emergency developing into an offsite emergency, local authority

and District Emergency Authority (normally the Collector) would be appraised and

under his supervision, the Off Site Disaster Management Plan would be exercised.

For this purpose, the facilities that are available locally, i.e. medical, transport,

personnel, rescue accommodation, voluntary organizations etc. would be mustered.

Necessary rehearsals and training in the form of mock drills would be organized.

VIII. Mutual Aid

Mutual aid in the form of technical personnel, runners, helpers, special protective

equipment, transport vehicles, communication facility etc would be sought from the

neighboring industries.

IX. Mock Drills

Emergency preparedness is an important part of planning in Industrial Disaster

Management. Personnel would be trained suitably and prepared mentally and

physically in emergency response through carefully planned, simulated procedures.

Similarly, the key personnel and essential personnel would be trained in the

operations.

X. Important Information

Once the Plant goes on stream, important information such names and addresses of

key personnel, essential employees, medical personnel outside the plant,

transporters address, address of those connected with Off Site Emergency such as

Police, Local Authorities, Fire Services, District Emergency Authority would be

prepared and maintained. The on-site emergency organization chart for various

emergencies is shown in Fig:-

Pro

ject:

Au

ron

ext

Ph

arm

a P

vt.

Ltd

.

S

EC

TIO

N-V

II/

Ad

dit

ion

al S

tud

ies D

ocu

men

t N

o.:

EE

SP

L/

AP

PL/

00

1/

37

2-

EC

/IN

D.2

01

4

En

kay E

nvir

o S

ervic

es P

vt.

Ltd

., J

aip

ur.

20

4

Fig

ure

No. 7

.1.

On

-Sit

e E

mergen

cy O

rg

an

izati

on

Ch

art

Op

era

tor

Sh

ift

Inc

ha

rge

Sa

fety

Off

ice

r

Sit

e C

on

tro

ller

Ro

om

Em

erg

en

cy

Co

ntr

ol

Em

erg

en

cy

Co

ord

ina

ror

Em

erg

en

cy

Co

ord

ina

ror

(Me

dic

al,

Mu

tua

l,Aid

Re

ha

bili

tati

on

,Tra

ns

po

rta

nd

Co

mm

un

ica

tion

)

(Re

sc

ue

,Fir

e F

igh

ting

)

Ele

ctr

icia

n,

Fir

st

Aid

,T

ran

sp

ort

-Dri

ve

rT

ele

ph

on

e-O

pe

rato

r

Ele

ctr

icia

nP

um

p O

pe

rato

r

Em

erg

en

cy

Co

ord

ina

ror

(Es

se

nti

al

Se

rvic

es

)

Pu

mp

Op

era

tor

Sh

ift

Inc

ha

rge

Inc

ide

nt

Co

ntr

olle

r

Project: Auronext Pharma Pvt. Ltd. SECTION-VII/Additional Studies

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

205

7.7 OFF-SITE EMERGENCY PREPAREDNESS PLAN

If an accident takes place in chemical industry /unit and its effects are felt outside its

premises, the situation thus created is called an offsite emergency.

The task of preparing the Off-Site Emergency Plan lies with the District Collector; however

the off-site plan will be prepared with the help of the local district authorities. The proposed

plan will be based on the following guidelines.

7.7.1 Introduction

Off-site emergency plan would follow the on-site emergency plan. When the consequences

of an emergency situation go beyond the plant boundaries, it becomes an off-site

emergency. Off-site emergency is essentially the responsibility of the public administration.

However, the plant management will provide the public administration with the technical

information relating to the nature, quantum and probable consequences on the neighboring

population.

The off-site plan in detail will be based on those events, which are most likely to occur, but

other less likely events, which have severe consequence, will also be considered. Incidents

which have very severe consequences yet have a small probability of occurrence would also

be considered during the preparation of the plan. However, the key feature of a good off-

site emergency plan is flexibility in its application to emergencies other than those

specifically included in the formation of the plan.

The roles of the various parties who will be involved in the implementation of an off-site

plan are described below. Depending on local arrangements, the responsibility for the off-

site plan would either rest with the plant management or with the local authority. Either

way, the plan would identify an emergency co-ordinating officer, who would take the

overall command of the off-site activities. As with the on-site plan, an emergency control

center would be setup within which the emergency co-ordinating officer can operate.

An early decision will be required in many cases on the advice to be given to people living

"within range" of the accident - in particular whether they should be evacuated or told to go

indoors. In the latter case, the decision can regularly be reviewed in the event of an

escalation of the incident. Consideration of evacuation may include the following factors:

• In the case of a major fire but without explosion risk (e.g. an oil storage tank),

only houses close to the fire are likely to need evacuation, although a severe

smoke hazard may require this to be reviewed periodically; and

• If a fire is escalating and in turn threatening a store of hazardous material, it

might be necessary to evacuate people nearby, but only if there is time; if

insufficient time exists, people should be advised to stay indoors and shield

Project: Auronext Pharma Pvt. Ltd. SECTION-VII/Additional Studies

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

206

themselves from the fire. This latter case particularly applies if the installation at

risk could produce a fireball with very severe thermal radiation effects.

Although the plan will have sufficient flexibility built in to cover the consequences of

the range of accidents identified for the on-site plan, it will cover in some detail the

handling of the emergency to a particular distance from each major hazard works.

7.7.2 Aspects Proposed to be considered in the Off-Site Emergency Plan

The main aspects, which should be included in the emergency plan, are:

• Organization

Detail of command structure, warning systems, implementation procedures,

emergency control centers.

Names and appointments of incident controller, site main controller, their deputies and

other key personnel.

• Communications

Identification of personnel involved, communication center, call signs, network, list of

telephone numbers.

• Specialized Knowledge

Details of specialist bodies, firms and people upon whom it may be necessary to call

e.g. those with specialized fuel knowledge, laboratories.

• Voluntary Organizations

Details of organizers, telephone numbers, resources etc.

• Fuel Information

Details of the hazardous substances stored and a summary of the risk associated with

them.

• Meteorological Information

Arrangements for obtaining details of weather forecasts and weather conditions

prevailing at that time.

• Humanitarian Arrangements

Transport, evacuation centers, emergency feeding, treatment of injured, first aid,

ambulances and temporary mortuaries.

• Public Information

Arrangements for

(a) dealing with the media press office;

(b) informing relatives, etc.

• Assessment of Emergency Plan

Arrangements for:

(a) Collecting information on the causes of the emergency;

Project: Auronext Pharma Pvt. Ltd. SECTION-VII/Additional Studies

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

207

(b) Reviewing the efficiency and effectiveness of all aspects of the emergency

plan.

7.7.3 Role of the Emergency coordinating Officer

The various emergency services would be co-ordinated by an emergency co-ordinating

officer (ECO), who will be designated by the district collector. The ECO would liaison closely

with the site main controller. Again depending on local arrangements, for very severe

incidents with major or prolonged off-site consequences, the external control would be

passed to a senior local authority administrator or even an administrator appointed by the

central or state government. The ECO will be equipped with address and phone numbers of

important agencies.

7.7.4 Role of the Local Authority

The duty to prepare the off-site plan lies with the local authorities. The emergency planning

officer (EPO) appointed should carry out his duty in preparing for a whole range of different

emergencies within the local authority area. The EPO should liaison with the plant, to obtain

the information to provide the basis for the plan. This liaison should ensure that the plan is

continually kept upto date.

It will be the responsibility of the EPO to ensure that all those organizations which will be

involved off site in handling the emergency, know of their role and are able to accept it by

having for example, sufficient staff and appropriate equipment to cover their particular

responsibilities. Rehearsals for off-site plans should be organized by the EPO.

7.7.5 Role of Police

Formal duties of the police during an emergency include protecting life and property and

controlling traffic movements.

Their functions should include controlling bystanders, evacuating the public, identifying the

dead and dealing with casualties, and informing relatives of death or injury.

7.7.6 Role of Fire Authorities

The control of a fire should be normally the responsibility of the senior fire brigade officer

who would take over the handling of the fire from the site incident controller on arrival at

the site. The senior fire brigade officer should also have a similar responsibility for other

events, such as explosions. Fire authorities in the region should be apprised about the

location of all stores of flammable materials, water and foam supply points, and fire-

fighting equipment. They should be involved in on-site emergency rehearsals both as

participants and, on occasion, as observers of exercises involving only site personnel.

7.7.7 Role of Health Authorities

Project: Auronext Pharma Pvt. Ltd. SECTION-VII/Additional Studies

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

208

Health authorities, including doctors, surgeons, hospitals, ambulances, and so on, should

have a vital part to play following a major accident, and they should form an integral part

of the emergency plan.

For major fires, injuries should be the result of the effects of thermal radiation to a varying

degree, and the knowledge and experience to handle this in all but extreme cases may be

generally available in most hospitals.

Major off-site incidents are likely to require medical equipment and facilities additional to

those available locally, and a medical "mutual aid” scheme should exist to enable the

assistance of neighboring authorities to be obtained in the event of an emergency.

7.7.8 Role of Government Safety Authority

This will be the factory inspectorate available in the region. Inspectors are likely to satisfy

themselves that the organization responsible for producing the off-site plan has made

adequate arrangements for handling emergencies of all types including major emergencies.

They may wish to see well-documented procedures and evidence of exercise undertaken to

test the plan.

In the event of an accident, local arrangements regarding the role of the factory inspector

will apply. These may vary from keeping a watching brief to a close involvement in advising

on operations.

The action plan suggested for control of the off-site emergencies is given in Table No.

7.13.

Table No. 7.13

Off-Site Action Plan

S.

No.

Action required to be taken to

mitigate disaster by aid giving

agency

Responsible

agencies for

taking action

Equipments/material

facilities required at site to

mitigate emergency

A1 Arrangements for evacuation/rescue

of persons from zone of influence to

predetermined camps

Police

Department

Self Breathing apparatus with

spare cylinder

Chemical gas mask with spare

canister

Vehicle with PA system

Transportation for evacuation

of people

2 Caution to public by announcement

3 Traffic and Mob control by cordoning

of the area

4 Law & order

Project: Auronext Pharma Pvt. Ltd. SECTION-VII/Additional Studies

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

209

S.

No.

Action required to be taken to

mitigate disaster by aid giving

agency

Responsible

agencies for

taking action

Equipments/material

facilities required at site to

mitigate emergency

5 Request to railway authority for

keeping the nearest by railway gate

open & to stop the up & down trains

at the nearest railway station

Police

Department

B1 Control of fire District Fire

Brigade

Self breathing apparatus with

spare cylinders

Foam/water fire tenders

Gas mask with spare canisters

Lime water

Neck to toe complete asbestos

suit, PVC hand gloves,

gumboots, safety goggles

Mobile scrubbing system along

with suction arrangement.

1 Scrubbing of the flashed off gas cloud

with water curtain

2 To rescue trapped persons

3 If fire is big, keep surrounding area

cool by spraying water

4 Communication to TNEB to continue or

cut off electric supply

5 Communication to water supply

department for supplying water

C1 Medical facilities for affected persons

(first aid and treatment)

Hospital and

public health

Ambulance with onboard

resuscitation unit, first aid,

stretchers

D1 Identification of concentration of gas

in zone of influence

Pollution control

board

Gas detector

E1 Removal of debris and damaged

structures

Municipal

corporation

Provide bulldozers

Provide cranes

F1 Monitor the incoming and out going

transports

Transport

department

Provide traffic police at site

Provide emergency shifting

vehicles at site

Provide stock of fuel for

vehicles

2 Arrange emergency shifting of

affected persons and non affected

person to specified area

3 Arrange diesel/petrol for needed

vehicles

G1 Give all information related to

meteorological aspects for safe

handling of affected area for living

Meteorological

Department

Provide wind direction and

velocity instruments with

temperature measure

Project: Auronext Pharma Pvt. Ltd. SECTION-VII/Additional Studies

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

210

S.

No.

Action required to be taken to

mitigate disaster by aid giving

agency

Responsible

agencies for

taking action

Equipments/material

facilities required at site to

mitigate emergency

beings Mobile van for meteorological

parameter measurements

2 Forecast if any important weather

change

H1 Representatives of all departments are

in the local crisis group; therefore

they are expected to render services

available with them. Since it is a

group of experts with authority, the

mitigating measures can be

implemented speedily. The

representatives from locals are also

there so that communication with local

people is easy and quick.

Local Crises

Group

Must have all resources at

hand, specially disaster

management plan and its

implementation method.

All relevant information related

to hazardous industry are

generally available with crisis

group

News paper editor is a part of

the group so that right and

timely media release can be

done

2 The district emergency or disaster

control officer is the president and he

is used to mock drill etc. so action can

be taken in right direction in time

I1 Collector is the President of District

Crisis Group therefore all district

infrastructure facilities are diverted to

affected zone

District Crisis

group

All necessary facilities available

at district can be made

available at affected zone

Control of law and order

situation

2 All other functions as mentioned for

local crisis group

7.8 OCCUPATIONAL HEALTH AND SAFETY

For large industries, where multifarious activities are involved during construction, erection,

testing, commissioning, operation and maintenance, the men, materials and machines are

the basic inputs. Along with the boons, industrialization generally brings several problems

like occupational health and safety.

Project: Auronext Pharma Pvt. Ltd. SECTION-VII/Additional Studies

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

211

The industrial planner, therefore, has to properly plan and take steps to minimize the

impacts of industrialization and to ensure appropriate occupational health and safety

including fire plans. All these activities again may be classified under construction and

erection, and operation and maintenance.

7.8.1 Occupational Health

Occupational health needs attention both during construction and erection and operation

and maintenance phases. However, the problem varies both in magnitude and variety in

the above phases.

• Construction and Erection

The occupational health problems envisaged at this stage can mainly be due to

constructional accident and noise. To overcome these hazards, in addition to

arrangements to reduce it within TLV's, necessary protective equipments shall also

be supplied to workers.

• Operation and Maintenance

The problem of occupational health, in the operation and maintenance phase is

primarily due to noise which could affect hearing. The necessary personal protective

equipments will be given to all the workers. The working personnel shall be given

the following appropriate personnel protective equipments.

� Industrial Safety Helmet;

� Crash Helmets;

� Face shield with replacement acrylic vision;

� Zero power plain goggles with cut type filters on both ends;

� Zero power goggles with cut type filters on both sides and blue color

glasses;

� Welders equipment for eye and face protection;

� Cylindrical type earplug;

� Ear muffs;

� Canister Gas mask;

� Self contained breathing apparatus;

� Leather apron;

� Aluminized fiber glass fix proximity suit with hood and gloves;

� Boiler suit;

� Safety belt/line man's safety belt;

� Leather hand gloves;

� Asbestos hand gloves;

� Acid/Alkali proof rubberized hand gloves;

� Canvas cum leather hand gloves with leather palm;

Project: Auronext Pharma Pvt. Ltd. SECTION-VII/Additional Studies

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

212

� Lead hand glove;

� Electrically tested electrical resistance hand gloves; and

� Industrial safety shoes with steel toe.

Full-fledged hospital facilities will be available round the clock for attending emergency

arising out of accidents, if any. All working personnel will be medically examined at least

once in every year and at the end of his term of employment. This is in addition to the pre-

employment medical examination.

7.8.2 Safety Plan

Safety of both men and materials during construction and operation phases is of concern.

Safety plan shall be prepared and implemented in the proposed plant. The preparedness of

an industry for the occurrence of possible disasters is known as emergency plan. The

disaster in the plant is possible due to collapse of structures and fire/explosion etc.

Keeping in view the safety requirement during construction, operation and maintenance

phases, the plant would formulate safety policy with the following regulations:

• To allocate sufficient resources to maintain safe and healthy conditions of work;

• To take steps to ensure that all known safety factors are taken into account in

the design, construction, operation and maintenance of plants, machinery and

equipment;

• To ensure that adequate safety instructions are given to all employees;

• To provide wherever necessary protective equipment, safety appliances and

clothing and to ensure their proper use;

• To inform employees about materials, equipment or processes used in their

work which are known to be potentially hazardous to health or safety;

• To keep all operations and methods of work under regular review for making

necessary changes from the point of view of safety in the light of experience and

upto date knowledge;

• To provide appropriate facilities for first aid and prompt treatment of injuries and

illness at work;

• To provide appropriate instruction, training, retraining and supervision to

employees in health and safety, first aid and to ensure that adequate publicity is

given to these matters;

• To ensure proper implementation of fire prevention methods and an appropriate

fire fighting service together with training facilities for personnel involved in this

service;

• To organize collection, analysis and presentation of data on accident, sickness

and incident involving people injury or injury to health with a view to taking

Project: Auronext Pharma Pvt. Ltd. SECTION-VII/Additional Studies

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

213

corrective, remedial and preventive action;

• To promote through the established machinery, joint consultation in health and

safety matters to ensure effective participation by all employees;

• To publish/notify regulations, instructions and notices in the common language

of employees;

• To prepare separate safety rules for each type of occupation/processes involved

in a plant; and

• To ensure regular safety inspection by a competent person at suitable intervals

of all buildings, equipments, work places and operations.

7.8.3 General Safety Measures

• Proper ventilation system will be provided at storage and processing areas of

chemicals so that to maintain PEL valves of chemicals and solvents.

• Good housekeeping, disposal methods will be followed to control the fugitive

emissions of chemicals.

• In order to prevent the work men from facing the musculo -skeletal disorders,

backache, pain in minor and major joints etc, manual carrying of weights to the shop

floor from the ground floor will be avoided totally. All liquid raw materials/solvents

will be transferred through closed piping system either by pumping or by gravity, to

reduce the carrying load on work men against gravity. Safe carrying weights (up to

15 kgs ) only allowed to carry by work men. Stair cases with suitable gradient will be

constructed in the work sheds. Material handling trolleys will be provided to

carry/handle the solid materials from one place to other.

• Employees will be educated, trained and, informed about the chemicals and their

properties by displaying the material safety data sheets (MSDS) in the processing

areas.

• Awareness about potential hazards, work hazards, fire hazards, and health hazards

associated with the chemicals which are being used by the industry will be developed

among the employees.

Apart from the above, the following general safety precautions will be implemented in

the plant.

• Shielding guards will be provided to all belt pulleys, couplings and all moving parts of

the machinery.

• All electrical cables and electrical equipment will be properly grounded and earthed.

• Poster display regarding safety, health and environmental protection will be arranged

in the plant to make awareness of safety and health.

Project: Auronext Pharma Pvt. Ltd. SECTION-VII/Additional Studies

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

214

• All responsible employees will be educated and trained to handle the firefighting

equipment.

• NO SMOKING policy will be strictly implemented in the entire plant area.

• Emergency exits will be provided at the selected places.

• No employee will be allowed to expose to a noise level greater than 85dB(A) for a

period of more than 8 hours per day without hearing protection.

• Periodical health check up of employees will be held as a part of occupational health

surveillance.

• One shower type eye wash will be provided in the plant area.

• Fire extinguisher will be provided where ever is needed.

• All flammable chemicals and solvents will be kept away from ignition sources and

heat.

• Storage of chemicals will be as per their compatibility.

• Proper exhaust ventilation will be provided to the process area to maintain the

airborne concentrations and solvents below their TLV values.

7.8.3 Safety Organization

• Construction and Erection Phase

A qualified and experienced safety officer shall be appointed. The responsibilities of the

safety officer include identification of the hazardous conditions and unsafe acts of

workers and advice on corrective actions, conduct safety audit, organize training

programs and provide professional expert advice on various issues related to

occupational safety and health. He is also responsible to ensure compliance of Safety

Rules/ Statutory Provisions. In addition to employment of safety officer by CPC, every

contractor, who employs more than 250 workers, shall also employ one safety officer to

ensure safety of the worker, in accordance with the conditions of contract.

• Operation and Maintenance Phase

When the construction is completed the posting of safety officers shall be in accordance

with the requirement of Factories Act and their duties and responsibilities shall be as

defined thereof.

7.8.4 Safety Circle

In order to fully develop the capabilities of the employees in identification of hazardous

processes and improving safety and health, safety circles would be constituted in each

area of work. The circle would consist of 5-6 employees from that area. The circle normally

shall meet for about an hour every week.

Project: Auronext Pharma Pvt. Ltd. SECTION-VII/Additional Studies

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

215

7.8.5 Safety Training

A full-fledged training center shall be set up at the plant. Safety training shall be provided

by the Safety Officers with the assistance of faculty members called from Professional

Safety Institutions and Universities. In addition to regular employees, limited contractor

labors shall also be provided safety training. To create safety awareness safety films shall

be shown to workers and leaflets shall be distributed. Some precautions and remedial

measures proposed to be adopted to prevent fires are:

• Compartmentation of cable galleries, use of proper sealing techniques of cable

passages and crevices in all directions would help in localizing and identifying the area

of occurrence of fire as well as ensure effective automatic and manual fire fighting

operations;

• Spread of fire in horizontal direction would be checked by providing fire stops for cable

shafts;

• Reliable and dependable type of fire detection system with proper zoning and

interlocks for alarms are effective protection methods for conveyor galleries;

• Housekeeping of high standard helps in eliminating the causes of fire and regular fire

watching system strengthens fire prevention and fire fighting; and

• Proper fire watching by all concerned would be ensured.

7.8.6 Health and Safety Monitoring Plan

The health of all employees shall be monitored once in a year for early detection of any

ailment due to exposure to heat, fumes and noise.

7.9 CORPORATE SOCIAL COMMITMENT

The major positive impact of the Enterprises social responsibility will aim to strengthen

social inclusion by ensuring that both the excluded groups and intended beneficiaries are

included in the benefit stream and in access to opportunities created by the project.

*In Lacs

S.no. Activities Capital cost Recurring

Cost

I

Year

II

Year

III

Year

IV

Year

Project: Auronext Pharma Pvt. Ltd. SECTION-VII/Additional Studies

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

216

1. In association with local authorities

establishment of Rainwater storage

structure, making available potable

drinking water and construction of

toilets (4) for :

Rajkiya Prathmik Vidhyalya, Bhiwadi

1.0 km SE;

Public places and bus stands

Mahaniawas 500 m N, Akera 2.0 km

NE;

And other Government Schools in the

study area.

14 14 14 14 0.5

2. Regular Health check up camps and

Medicine distribution programme :

The proposed project aims to provide

Malnutrition checkup camps and

Access Treatment Programmes

through its Mobile Medical Van to

the nearest habitation of :

Mahaniawas 500 m N,

Akera 2.0 km NE;

Bhiwadi Town and

RIICO Indistrial Area, Bhiwadi.

13.34 13.34 5.32 5.32 0.5

3. Provisions of Medicines in the

study area at 30% less or at nominal

or discounted rates from the market

sale price.

19.82 19.82 19.82 19.82 0.5

4. Livelihood enhancement programmes

for industrial workers including

vocational job assistance for

differently-abled.

Periodic training to local villagers in

the premises and recruitment of local

workers from the study area.

6.0 6.0 6.7 6.7 0.5

Total 53.16 53.16 45.84 45.84 2.0

Capital Cost : 198.0 lacs

Recurring Cost: 2.0 lakhs.

Project: Auronext Pharma Pvt Ltd. Section-VIII/Project Benefits

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur,

217

SECTION-VIII

PROJECT BENEFITS

INDEX

PROJECT BENEFITS ........................................................................................ 218

8.1 INTRODUCTION ....................................................................................... 218

8.2 IMPROVEMENTS IN THE PHYSICAL INFRASTRUCTURE .................................. 218

8.3 IMPROVEMENTS IN THE SOCIAL INFRASTRUCTURE ..................................... 218

8.4 EMPLOYMENT POTENTIAL ......................................................................... 218

8.5 OTHER TANGIBLE BENEFITS ..................................................................... 218

************

Project: Auronext Pharma Pvt Ltd. Section-VIII/Project Benefits

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur,

218

PROJECT BENEFITS

8.1 INTRODUCTION

The proposed expansion of project of Auronext Pharma Pvt. Ltd, aims to manufacture

Carbapenem Sterile Bulk Drugs (API) - 46.2 TPA, Lyophilization in vials of Ertapenem for

Injection - 6 Millions Vials Filling of vials of dry powder injection (Formulation)- 30

Millions Vials Sterile bulk drugs & Filling of Vials 30 million. The unit proposes to

manufacture sterile bulk drugs & intermediates in its repetitive flow production. Like

many industrialized countries, several different types of modern antibiotics will be

produced by the modification of the existing project. Changing climate or falling of pollen

grains often increases the ratio of patients suffering from general fever, bacterial

infections (like Throat infection), asthma, and lifestyle diseases like Cholesterol, Heart

diseases etc. Few other reasons like stored water, uncovered litter, dirty places,

unhealthy living habits, unhealthy eating habits, pollution, water contamination and

more require Antibiotics. Thus the proposed production contributes in prevention, cure

and recovery of ailments and diseases.

8.2 IMPROVEMENTS IN THE PHYSICAL INFRASTRUCTURE

The modification of this drug manufacturing unit will have numerous induced impacts

on society such as supplies to hospitals and services to transport etc. It will also attract

other entrepreneur to establish their venture in the region.

8.3 IMPROVEMENTS IN THE SOCIAL INFRASTRUCTURE

There will be improvements in the social infrastructure like livelihood enhancement for

differently abled, Medical & health programes for local area and the Water storage

structures at various locations in the study area.

8.4 EMPLOYMENT POTENTIAL SKILLED, SEMI-SKILLED AND UNSKILLED

The present project provides direct employment to skilled workforce and the proposed

expansion aims for additional employment of 100 workers and indirect employment

(transport, services deliveries etc.) to semi-skilled and unskilled workers.

8.5 OTHER TANGIBLE BENEFITS

There will be social benefits from the proposed drug manufacturing project. The

underlying benefits through the proposed project are:

• The proposed modification of the project is for manufacturing of medical drugs and

intermediates contributing in prevention, cure and recovery of ailments and diseases.

• Looking at the health conditions around the globe due to various factors there is an

increasing demand for medicines in India and abroad.

Project: Auronext Pharma Pvt Ltd. Section-VIII/Project Benefits

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur,

219

• The growing number of population, geographical location utility, unhealthy living

habits etc often led to various health sufferings which increase the demand for

medicines. The proposed drugs also have an international demand.

• The end use of the medicine will add to an additional rise (though minorly) in

Healthcare status and medicinal availability.

• The proposed project will contribute to gains in national employment and in the gross

state domestic product.

• The proposed unit will provide full proof fire hydrant system & all kinds of fire

extinguishers to ensure the safe working environment on the shop floor. The workers

shall be provided with facemask, hand gloves, moreover the production halls shall be

fitted with exhaust fans etc. The organization will establish, implement & maintain

Occupational health & safety objectives as per norms, at relevant functions & levels

within the organization.

***************

Project: Auronext Pharma Pvt. Ltd Section-IX/ Environmental Cost Benefits

Document No EESPL/APPL/001/372-EC/IND- 2014 Analysis

Enkay Enviro Services Pvt. Ltd., Jaipur. 220

SECTION-IX

ENVIRONMENTAL COST BENEFITS ANALYSIS

INDEX

ENVIRONMENTAL COST BENEFITS ANALYSIS ........................................... 220

9.1 ENVIRONMENTAL COST BENEFITS ANALYSIS ........................................ 221

************

Project: Auronext Pharma Pvt. Ltd Section-IX/ Environmental Cost Benefits

Document No EESPL/APPL/001/372-EC/IND- 2014 Analysis

Enkay Enviro Services Pvt. Ltd., Jaipur. 221

9.1 ENVIRONMENTAL COST BENEFITS ANALYSIS

Not recommended at the Scoping stage

**********************

Project: Auronext Pharma Pvt. Ltd. SECTION–X/ Environnent Management Plan

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur. 222

SECTION-X

ENVIRONMENTAL MANAGEMENT PLAN

INDEX

ENVIRONMENTAL MANAGEMENT PLAN ........................................................... 222

10.1 INTRODUCTION ....................................................................................... 223

10.2 ENVIRONMENT MANAGEMENT DEPARTMENT ............................................... 223

10.3 ENVIRONMENTAL ACTION PROGRAMME ..................................................... 226

10.4 GREEN BELT DEVELOPMENT ...................................................................... 231

***************

Project: Auronext Pharma Pvt. Ltd. SECTION–X/ Environnent Management Plan

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur. 223

ENVIRONMENTAL MANAGEMENT PLAN

10.1 INTRODUCTION

The Environmental Management Plan (EMP) is a site specific plan developed to ensure

that the project is implemented in an environmental sustainable manner where all

contractors and subcontractors, including consultants, understand the potential

environmental risks arising from the proposed project and take appropriate actions to

properly manage that risk. It is required for formulation, implementation and monitoring

of environmental protection measures during and after commissioning of projects. The

plans should indicate the details as to how various measures have been or are proposed

to be taken including cost components as may be required. Cost of measures for

environmental safeguards should be treated as an integral component of the project cost

and environmental aspects should be taken into account at various stages of the

projects.EMP also ensures that the project implementation is carried out in accordance

with the design by taking appropriate mitigative actions to reduce adverse environmental

impacts during its life cycle. The plan outlines existing and potential problems that may

adversely impact the environment and recommends corrective measures where required.

Also, the plan outlines roles and responsibility of the key personnel and contractors who

are charged with the responsibility to manage the proposed plant.

The EMP is:

• Prepared in accordance with rules and requirements of the MoE&F and the State

Pollution Control Board;

• To ensure that the component of facility are operated in accordance with the design;

• A process that confirms proper operation through supervision and monitoring;

• A system that addresses public complaints during construction and operation of the

facility; and

• A plan that ensures remedial measures is implemented immediately.

10.2 ENVIRONMENT MANAGEMENT DEPARTMENT

10.2.1 Environmental department policies

The unit will ensure the following activity

a. Commitment & Policy

The proposed project management will strive to provide and implement the

Environmental Management Plan that incorporates all issues related to air, land and

water.

Project: Auronext Pharma Pvt. Ltd. SECTION–X/ Environnent Management Plan

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur. 224

b. Planning

This includes identification of environmental impacts, legal requirements and setting

environmental objectives. The various potential impacts are discussed under Section IV

of the EIA Report.

c. Implementation: This comprises of resources available to the proponents,

accountability of contractors, training of operational staff associated with environmental

control facilities and documentation of measures to be taken.

d. Measurement & Evaluation: This includes monitoring, corrective actions, and

record keeping.

10.2.2 Environnemental département structure

i. Environment management cell

• Organizational set-up

• linkage with other associated departments,

• reporting schedule to the regulating authorities

ii. Laboratory facility (in house / certified lab)

• Sampling,

• technique,

• analysis/monitoring practice followed,

• monitoring equipment/instrument available and

• schedule of monitoring

iii. Library

• Books on environment & monitoring

• Records/drawing

• Collection of standards/norms/guidelines/notification etc.

iv. Safety, health, fire services and security

• For the supervisors and workers

v. Training facility

• For the supervisors and workers

vi. Maintenance

Response time for emergency maintenance, spare availability and routine programme of

maintenance

• Disaster Management Plan (DMP)

• On-site Emergency Management Plan

• Risk Assessment (RA)

• Environmental Audit (EA)

Project: Auronext Pharma Pvt. Ltd. SECTION–X/ Environnent Management Plan

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur. 225

vii. Monitoring data

• Ambient air quality with meteorological data/information

• Ambient noise level

• Receiving water quality up-stream and down-stream of treated wastewater disposal

point (if any / applicable)

• Ground water quality in and around factory

• Storm water disposal facility inside & outside the factory

viii. Greenbelt development

• Plants selection

• Green belt covered area

• Future plan, if any

ix. Waste Management

• recovery,

• recycle and

• reuse

x. Performance study of waste management

• Identification of shortcomings

• Finding out proper remedial measures

• Implementation time frame

xi. Material balance

• Specific consumption of raw material per MT of product

• Design

• Actual

• Reason for difference

xii. Identification of hazardous installations

• list with details of hazardous installations

• measures, in case of unforeseen release of pollutants

• Was there any episode discharge of pollutants in past?

• experience

• remedial measures

• strategy to be adopted based on experience

xiii. Prepare an environment check list to review environmental safeguard

• House keeping

• Complaints

� Complaints received, if any

Project: Auronext Pharma Pvt. Ltd. SECTION–X/ Environnent Management Plan

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur. 226

� Accident occurred in last two years

• Compliance of standards

� Copy of water consent

� Copy of air consent

� Copy of authorization of hazardous wastes

• Comply with the standards, stipulations, guidelines etc.

• If not, indicate deviations with reasons for the same

• Find difficulty in complying with the conditions of consent letters.

10.3 ENVIRONMENTAL ACTION PROGRAMME

The management of “Auronext Pharma Pvt. Ltd.” is quite conscious of its responsibility

for maintaining clean and a healthy environment. The management is also keen to

modify and make more efficient measures towards suppression of pollution sources. Lot

of adequate funds for pollution control measures are provided as a part of overall project

financing to ensure the availability of proper treatment facilities before the

commissioning of the unit. The overall investment in the project is assumed to be 40.0

Crore. About Rs. 259.0 lakhs are proposed for the environment protection program. This

cost will be spending in phase wise along with the growth of project.

Table no. 10.1

Environment Management Budget

S. No. Particulars Capital Cost

( Lacs)

Recurring Cost in

(Lacs per annum)

1 Air Pollution Control 20.00 2.0

2 Water Pollution Control 200.0 5.00

3 Noise Pollution Control 5.00 0.50

4 Environment Monitoring and

Management

10.0 5.0

5 Occupational Health 15 0.75

6 Green Belt 4.00 0.50

7. Rain Water Harvesting 5.00 0.50

Total 259 14.25

The proposed Environment Management plan for the unit is summarized in the below

table

Project: Auronext Pharma Pvt. Ltd. SECTION–X/ Environnent Management Plan

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur. 227

Table no. 10.2

Environment Management Plan

Particulars Mitigation Measures

Air Environment

During

Construction Phase

• Dust pollution can be minimized at the source by water

spraying and maintenance of road.

• Construction material will be stored in temporary storage

yard.

• There will be no basement; hence quantity of the soil

excavation will be comparatively less. However, soil will be

kept moist to reduce dust emission during excavation for

piling.

• The excavated materials will be place only on the

designated disposal areas.

• The heights, from which materials will be dropped, will be

the minimum practical height to limit fugitive dust

generation.

• The construction area will be shielded with the help of

tarpaulin from all the four sides to contain the air emissions

within the premises.

• Dust or dusty material will not be swept without effectively

treating it with water or other substances in order to

minimize its dust emission.

• Suitable covered skips and enclosed chats or other suitable

measures will be provided in order to minimize dust

emission to the atmosphere when materials & waste will be

removed from the premises.

• Rapid cleanup of project related track out or material spills

on paved road.

• Natural topography will be maintained to the greatest

extent possible.

• Parking lot and paved road will be constructed first.

• Upwind portion of the project will be constructed first.

• During high wind condition, construction activities will be

restricted, so that minimum flow of dust particle takes

place.

• The first and most important step towards emission control

for the large in-use fleet of vehicles is the formulation of an

Project: Auronext Pharma Pvt. Ltd. SECTION–X/ Environnent Management Plan

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur. 228

Particulars Mitigation Measures

inspection and maintenance system. It is possible to reduce

30-40% pollution loads generated by vehicles through

proper periodical inspections and maintenance of vehicles

• All transportation vehicles will be suitably covered with

tarpaulin & overloading of the vehicles will be avoided.

• PUC certified vehicles will be used to avoid the exhaust

emission.

During Operation

Phase

To control the fugitive emissions generated during various

operations in the industry, plant authorities will adopt

following mitigation measures.

• Dedicated pipe lines for transfer of solvents from respective

solvent storage tanks to reactors in the production blocks.

• All solvent storage tanks will be provided with water jacket.

• Wherever required as and when reactors will be provided by

vapor condensers

• Mechanical seals will be provided for all the reactors for

improving emission control measures.

To control the process emissions generated during various

operations in the industry, plant authorities will adopt

following mitigation measures.

• The condenser is the first condenser located after the process

equipment and supports a vapour-to-liquid phase change for

the vapours produced in the process equipment. The primary

purpose of a condenser used as an air pollution control device

is to remove VOCs prior to venting. In this method, gas

streams from vents containing VOCs are cooled to below their

saturation temperatures, converting the gas into a VOC liquid.

This removes some VOCs from the gas, but some remains. The

amount of VOCs remaining in the gas depends on the

temperature and vapour-liquid equilibrium of the VOC.

• Emissions from boiler will be routed to stack of adequate height

through web scrubber.

• Regular post project air monitoring schedule will be planned

and record will be maintained to track any problem in Air

Pollution Control Equipments

Water • Measures will be implemented to prevent seepage of liquid

Project: Auronext Pharma Pvt. Ltd. SECTION–X/ Environnent Management Plan

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur. 229

Particulars Mitigation Measures

Environment

During

Construction Phase

materials into ground where it could contaminate

groundwater;

• Ensure prompt cleaning up of accidental spillages

• Measures will be followed to prevent the contamination of

hydrological features by diesel, grease, oil, etc. derived from

the working area.

• The machinery / equipment will be maintained in a good

operating condition;

• Specially designated areas will be created for vehicle

maintenance;

• Accidental spillages will be cleaned up promptly.

• Curing water will be sprayed and after liberal curing, all

concrete structures will be covered with gunny bags this will

conserves water

• Provisions will be made to ensure the construction vehicles

stick to the access track to prevent mud & dirt being

deposited on roads

• Fence will be constructed around the site to trap sediments

whilst allowing the water to flow through.

• All mud & dirt deposited on the roads from the construction

activities will be cleaned.

• Adopting good construction and engineering practices will

help in mitigating the water pollution.

During Operation

Phase

• Industrial waste water will be treated in ETP

• Domestic Waste water will be treated in common ETP

• Rain water harvesting structure will be installed in the unit.

• Regular ETP effluent monitoring will be done to track the

working of ETP.

• The unit will be shut in case of any problem in the ETP

working.

Solid Waste

During

Construction Phase

• Careful design, planning and good site management would

minimize waste of materials such as concrete, mortars and

cement grouts. The contractor will make inventory of all

types of solid waste that are expected during the

construction activity before starting the work.

• Complete excavated material from the earthworks will be re-

used on site as structural fill or for landscaping purposes by

Project: Auronext Pharma Pvt. Ltd. SECTION–X/ Environnent Management Plan

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur. 230

Particulars Mitigation Measures

balancing with cut & fill operations.

• Construction waste generated will be disposed off according

to the nature of the waste.

• Proper litter disposal and collection points will be established

around the all construction work sites.

• No solid waste will be kept in open spaces.

During Operation

Phase

• The use of water based solvents will be preferred for waste

reduction

• The inorganic salts will be recovered from chemical liquors

produced during organic synthesis operations.

• The hazardous waste will be collected in HDPE bags and will

be sent to CTDF site of UCCI Udaipur.

Noise Pollution

During

Construction Phase

• Complete construction work especially heavy work will be

done during day time.

• Vehicular movement carrying raw materials will be avoided

during night time.

• The vehicles will be regularly maintained and optimum use of

the same will be made.

• Adequate PPE’s (ear plugs, ear muffs, helmet, mask etc) will

be provided to the workers.

• PUC certified vehicles will be used.

During Operation

Phase

• All possible measures will be taken to minimize the noise.

• The insulation provided for prevention and loss of heat and

personnel safety shall also act as noise reducer.

• Foundations and structures will be designed to minimize

vibrations and noise.

• Regular equipment maintenance and better work habits will

be adopted.

• D.G. set is proposed to be housed in an inbuilt acoustic

enclosure. The acoustic enclosure will be designed for

minimum 25dB (A) insertion loss for meeting the ambient

noise standards, whichever is on the higher side.

• Necessary safety and personal protective equipment such as

ear plugs, ear muffs, helmet etc will be provided to the

workers.

• Noise levels generated will be maintained to comply with the

Project: Auronext Pharma Pvt. Ltd. SECTION–X/ Environnent Management Plan

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur. 231

Particulars Mitigation Measures

Factories Act & Rules and will not exceed 75 dB (A) at 1 m

distance.

• Implementation of green belt within the premises of plant will

absorb the noise. Thus will help to control the noise pollution.

• Proper lubrication and housekeeping will be usually done to

avoid excessive noise generation.

• Supervisor will be responsible to control the noise by

maintaining conditions of machineries and silencers.

• 33% of the total plot area will be under greenbelt.

Socio - Economy • Provisions of Medicines in the study area at 30% less or at

nominal or discounted rates from the market sale price.

• Periodic training to local villagers in the premises and

recruitment of local workers from the study area.

• Rest rooms/recovery rooms will be provided to local workers to

avoid tiresome commuting to their houses.

• The enroute will be restricted to the major roads State and

National highways.

• Regular health camps to trace the developments and control

any ill-consequences due to (bad odor) in future will be done.

• Periodic maintenance and emission check of vehicles shall be

ensured to restrict air pollution.

• The proposed project will promote neither selective, nor

relative, but universal respect through contribution in various

festivities, equal observance and protection among employees

and societies at large in all CSR activities.

Frequency of Environment Monitoring & Parameters to be tested.

S. No. Components Parameters for Monitoring

Frequency of Monitoring

Location

1 Air Emissions PM10, PM2.5,

SO2,

NOx, CO and

HC,VOCs

As per CPCB/

SPCB

requirement or

on weekly basis

whichever is

earlier

At least two

locations inside

premises; 4

locations outside

Project: Auronext Pharma Pvt. Ltd. SECTION–X/ Environnent Management Plan

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur. 232

S. No. Components Parameters for Monitoring

Frequency of Monitoring

Location

2 Noise Spot Noise Level

recording;

Leq(night),

Leq(day),

Leq(dn)

Periodic during

operation phase

Noise

measurements at

4 locations

3 Wastewater

Discharge

pH, TSS, TDS,

BOD, COD, AOX,

phenol, arsenic,

cadmium,

chromium and

Bio Assay Testing

Periodic during

operation phase

One location

(Treated

Wastewater)

pH, TSS, TDS,

BOD, COD, AOX,

phenol, arsenic,

cadmium,

chromium and

Bio Assay Testing

Periodic during

operation phase

One location

(Treated Sewage)

4 Water Quality

and Water Levels

Comprehensive

monitoring as per

IS 10500

Groundwater

level bgl

Periodic during

operation phase

Three locations

surrounding

project site

5 Waste

Management

Records of solid

waste generation,

treatment and

disposal

Periodic during

operation phase

-

6 Soil Quality Physico-chemical

parameters and

Metals.

Periodic during

operation phase

-

10.4 GREEN BELT DEVELOPMENT

The general consideration involved while developing the greenbelt are:

• Planting of trees should be undertaken in appropriate encircling rows around the

project site.

• Generally fast growing trees should be planted.

Local species will be planted under the greenbelt development plan. The list of plant

species suggested for plantation is presented below:

The plantation will be done in proper manner. Tall trees will be planted at the periphery

of the unit, than smaller trees in first row and bushes in second row. Care will be taken

to ensure that the plants in the second row should be staggered between the plants of

Project: Auronext Pharma Pvt. Ltd. SECTION–X/ Environnent Management Plan

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur. 233

the first row. There will be 3 m distance between each plant. Furthermore it helps in

reducing air pollution and increases the quality of nature besides helping in conservation

of top soil and maintaining the ecological balance. The unit has planted suggested

species in the premises and is continuously developing the landscape.

� Local/native trees growing up to 10 m or above in height with perennial foliage should be

planted around various appurtenances of the proposed project.

� Since, the tree trunk area is normally devoid of foliage up to a height of 3 m, it may be

useful to have shrubbery in front of the trees so as to give coverage to this portion.

The plantation of indigenous varieties such as Kikar, khair and other naturally occurring

trees such should be promoted, This may be done in conjunction with the forest

department. This step would go a long way in saving this eco-structure. Plantation of

carefully selected tree species should achieve attenuation of air and noise pollution,

increase wastewater reuse, recycling, and increase diversity of vegetation. The tree

plantation will be based on the following principals:-

The plant should be fast growing.

It should have thick canopy cover.

It should be perennial and evergreen.

� It should be efficient in absorbing pollutants without significant effect on plant growth.

Following plants will be planted in and around the proposed plant area.

Species for Plantation

Table no. 10.3

Peripheral plantation

S. No. Vernacular

Name

Scientific name Family Plantation

Year wise

plantation

1. Neem Azardirachta indica Meliaceae Peripheral First Year

2. Amaltas Cassia fistula Fabaceae Peripheral First Year

3. Sirish Albizzia lebbek Fabaceae Peripheral Second Year

4. Kachnar Bauhinia variegata Fabaceae Peripheral Second Year

5. Shesham Delbergia Sissoo Fabaceae Peripheral Second Year

Table no. 10.4

Plantation in 1st and 2nd row

S.

No.

Vernacular

Name

Scientific name Family Plantation Year

1 Bougainvillea Bougainvillea spectabilis Nyctaginaceae Row 1 Second

Year

2 Kaner Nerium oleander Apocynaceae Row 1 First

Project: Auronext Pharma Pvt. Ltd. SECTION–X/ Environnent Management Plan

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur. 234

Year

3 Gulmohar Delonix regia Fabaceae Row 1 First

Year

4 Bottle brush Callistemon citrinus Myrtaceae Row 1 First

Year

5 Gudhal Hibiscus rosa-sinensis

Linn.

Malvaceae Row 1 First

Year

6 Fishtail palm Caryota mitis Arecaceae Row 2 Second

Year

7 Rose periwinkle Catharanthus roseus Apocynaceae Row 2 First

Year

8 Marigold Tagetes patula Asteraceae Row 2 First

Year

Precautionary Measures:

• Plantation activity to be carried out in monsoon months

• The height of the plants should not be less than 1 ft and should be in polythene

bags and are not to be removed till the time of planting

• All plants supplied must be planted within three days of removal from the nursery

• The contractor will be required to water the area in case of insufficient rains after

planting

• 2 kg of compost /manure are suggested for each pit before plantation.

• To ensure better growth and survival of plants, surface should have sufficient

layer of good quality soil (up to 45 cm)

Green belt development plan budget

A capital cost provision of Rs. 4,00,000 has been kept for development of greenbelt as

given in Table No. 10.5 below The budget includes cost of digging of pits, fertilizers,

saplings and maintenance for 3 years.

Table No 10.5

Green belt development plan budget

Activity Sub

Activity

Unit

Physical Target Total

2015-

16

2016-

17

2017-

18

Green Belt

development

plan

Selection

of site

Year √

Selection

of Species

Year √ √ √

Project: Auronext Pharma Pvt. Ltd. SECTION–X/ Environnent Management Plan

Document No.: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur. 235

Plantation Number 150 150 100 400

Financial Target

2015-

16

2016-

17

2017-

18

Capital cost (In lacs.) 1.50 1.50 1.0 4,00,000

Recurring 40,000

*********************

Project: Auronext Pharma Pvt. Ltd. Section-XI/ Summary and Conclusions

Document No: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

236

SECTION – XI

SUMMARY AND CONCLUSION

INDEX

SUMMARY AND CONCLUSION ................................................................. 237

11.1 INTRODUCTION ........................................................................... 237

11.2 DESCRIPTION OF THE PROJECT ...................................................... 239

11.3 ENVIRONMENTAL MONITORING ...................................................... 241

11.4 ANTICIPATED ENVIRONMENTAL IMPACTS AND MITIGATION MEASURES 244

11.5 ENVIRONMENTAL MONITORING PROGRAMME ................................... 247

11.6 PROJECT BENEFITS ....................................................................... 250

11.7 ENVIRONMENT MANAGEMENT PLAN DURING OPERATION PHASE .......... 251

11.8 CONCLUSIONS ........................................................................... 253

Project: Auronext Pharma Pvt. Ltd. Section-XI/ Summary and Conclusions

Document No: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

237

SUMMARY AND CONCLUSION

11.1 INTRODUCTION

M/s. Auronext Pharma Pvt. Ltd. is proposed modified manufacturing unit of sterile bulk

drugs, & its intermediates to the tune of 38.4 TPA. Situated at A-1128, RIICO Industrial

Area Phase-III, Bhiwadi, Distt.-Alwar, Rajasthan. The proposed modifying project is

categorized under B of 5 (f) {Synthetic organic chemicals industry (dyes & dye

intermediates; sterile bulk drugs and intermediates excluding drug formulations;

synthetic rubbers; basic organic chemicals, other synthetic organic chemicals and

chemical intermediates)} column 4 as per the amendment dated 01.12.09 and

04.04.2011 of the Gazette Notification of Sept. 14th 2006 The project is situated on

land area of 10112 sq. m. The proposed modifying project is located in notified industrial

area. The total green cover area will be approximately 3337sq.m (33%). The estimated

of cost for the modification of the project is Rs.40.0 Crore. About Rs. 257.0 lakhs are

proposed for the environment protection program and Rs10.25 Lakh as recurring cost.

The detailed environmental settings is given in below table no. 11.1

Table 11.1

Details of Environmental Setting

S.

No.

Particulars Details

1 Location

A Village Bhiwadi

B Tehsil Tijara

C District Alwar

D State Rajasthan

E

Coordinates NNW NNE

Latitude 28°12'2.66"N 28°12'2.14"N

Longitude 76°51'23.84"E 76°51'26.63"E

SSE SSW

Latitude 28°11'58.42"N 28°11'58.77"N

Longitude 76°51'25.92"E 76°51'23.05"E

F Survey Nos. 53D/15, 53D/16

G Total Plant Area 10112 Sq. M.

2 Land use at the

project area

S.NO Particulars Area

(sq. m)

Percentage

(%)

Project: Auronext Pharma Pvt. Ltd. Section-XI/ Summary and Conclusions

Document No: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

238

1. Plant Area, Office Area (

all covered area)

4550.40 45

2. Paved Area ( Road,

Corridor, Parking and

drainage)

1213.40 12

3. Green Belt Area 3337 33

4. Open Area 1011.2 10

5. Total Plot area 10112 100

3 Nearest Habitation Bhiwadi- 2.48 km towards W

4 Nearest City/Town Bhiwadi- 2.48 km towards W

5 Nearest Highway National Highway-71 B (Connects Shahpura to Gurgaon) -

1.5 km towards N (aerially).

National Highway-8 (Connects Delhi to Mumbai)- 6.27 km

towards NNW (aerially).

6 Nearest Railway

Station from

Project site

Rewari railway station- 24.22 km towards W (aerially).

7 Nearest Airport IGI Airport – 44.1 km towards NNE (aerialy)

8 Nearest Tourist

places

None

9 Defence

installations

None

10 Archaeological

important

None

11 Notified Ecological

sensitive area

None within study area

12 Reserved/Protected

forest/National

Parks/Wildlife

Sanctuary (from

Project Site)

There are no National Park / Forest / Wildlife Sanctuaries in

the study area. Few reserve forest are located. The list of

the same is given as under:-

Reserve forest Distance from project

site

Rangla Reserve Forest 2.75 km NNE

Chaupanki PF 8.20 km SE

Godhan PF 2.08 km S

Indauri Nala 5.66 km NE

Project: Auronext Pharma Pvt. Ltd. Section-XI/ Summary and Conclusions

Document No: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

239

Figure 11.1

Map showing the project site and 10 km study area

11.2 DESCRIPTION OF THE PROJECT

The salient features of the proposed plant are given below:

SALIENT FEATURES OF PROPOSED PLANT

S.

no.

Particulars Details

1. Project Name Auronext Pharma Pvt. Ltd.

2. Location A-1128,RIICO Industrial Area Phase –III, Bhiwadi, Distt-Alwar,

Rajasthan

3. Production & its

Capacity

• Carbapenem Sterile Bulk Drugs (API) - 46.2 TPA

• Lyophilization in vials of Ertapenem for Injection 6 Millions

Vials

• Filling of vials of dry powder injection (Formulation)- 30 Millions

Vials

Project: Auronext Pharma Pvt. Ltd. Section-XI/ Summary and Conclusions

Document No: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

240

4. Land

requirement

10112 sq. m.

5. Source of

power

JVVNL, Jaipur

6. Water

Requirement

The total water requirement is 150 KLD. Daily fresh water demand will

be 100 KLD. 50 KLD water will be recycled in the industrial process.

7. Source of

Water

Water demand will meet met partially through RIICO water supply and

partially through ground water.

8. Manpower Existing workers- 150 persons, Proposed worker- 100 persons, Total

after modification- 250 persons

9. Wastewater

generation

Type of waste Quantity

KLD

Disposal

Process waste water 30 Will be treated in ETP

DM Reject/R.O.

Reject

15 Will be treated in ETP

Boiler/Cooling Tower

blow down

5+10 Will be treated in ETP

Domestic 12 will be treated in STP

based on MBR and sent to

ETP

Total 72 KLD

10. Solid waste generation

S.

No.

Hazardous

waste

Description

Category

as per

HWMR

rules

Qty

generated

/Annum

Unit Method of disposal

1. ETP sludge

a) Chemical

sludge from ETP

34.3 5 Ton

It will be sent to UCCI at

Udaipur for proper

treatment and disposal.

2. Spent Oil &

Used oil 5.1 & 5.2 1000 Lit

It will be disposed through

authorized disposer.

3. Process residue

and waste 28.1 1 Ton

It will be disposed in-house

in process effluent

treatment plant (Mixed

with process effluent)

4. Spent

catalyst/carbon 28.2 3.6 Ton

It will be sent to UCCI at

Udaipur for proper

treatment and disposal.

5. Off specification

products/raw 28.3 0.2 Ton

It will be sent to UCCI at

Udaipur for proper

Project: Auronext Pharma Pvt. Ltd. Section-XI/ Summary and Conclusions

Document No: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

241

material treatment and disposal.

6. Expiry

drugs/medicines

28.4 0.25 Ton

It will be disposed in-house

in process effluent

treatment plant (Mixed

with process effluent)

7. Spent solvent

1500 Ton

It will be disposed/sale

through authorized

Disposer

8. Liner/Packing

Material

/glass vials

2 Ton

It will be sent to UCCI at

Udaipur /for Inceneration

for Proper treatment

9. Lead Batteries

waste 2 Ton

It will be disposed/sale

through authorized

Disposer

10.Electronic

,computer items 1 Ton

It will be disposed/sale

through authorized

Disposer

11.CFL/Led etc

waste 1 Ton

It will be disposed/sale

through authorized

Disposer

11. Project Cost Rs. 40.0Crore

12. EMP costs EMP Capital Cost - Rs. 257.0 Lakhs

EMP Recurring Cost -Rs. 10.25 Lakh

13. Cost towards

CSR

Rs. 1.98Lacs Capital Cost

Rs. 0.02 lakhs per /annum

11.3 ENVIRONMENTAL MONITORING

For monitoring of the environmental parameters like meteorology, air, water, soil and

noise quality, the monitoring stations have been established at different locations in and

around the project area. The base line data has been collected in the winter season from

December 2014, January 2015 & February 2015.

Meteorology

The recorded meteorological data for the study period at project site is presented below:

Table No. 11.2

Micro meteorological data for the study period at project site

Project: Auronext Pharma Pvt. Ltd. Section-XI/ Summary and Conclusions

Document No: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

242

Month Temperature

(0C)

Relative

Humidity (%)

Rainfall in

mm

Wind Speed

mph

Max Min Max Min Max Total Max Min

December -

2014 31.1 5.2 99.5 7.7 0 0 9.0 <1.0

January- 2015 29.5 2.7 99.5 9.4 0 0 9.0 <1.0

February – 2015 30.8 5.8 86.3 6.8 0 0 8.0 < 1.0

Ambient Air Quality

Ambient air quality monitoring has been carried out with a frequency of two days per week

at six locations. The summary of these results for all the locations is presented below.

These are compared with the standards prescribed by Central Pollution Control Board

(CPCB) for rural and residential zone

Table No. 11.3

Summary of Ambient Air Quality for all the locations

Locations

PM10

(µg/m3)

PM2.5

(µg/m3)

SO2

(µg/m3)

NOx

(µg/m3)

CO

(µg/m3)

Max Min Avg Max Min Avg Max Min Avg Max Min Avg Max Min Avg

Project

Site 90.4 69.9 80.15 53.6 38.5 92.1 9.7 6.8 8.25 34.5 21.9 28.2 1650 1054 1352

Belaheri 72 54.5 63.25 42.4 26.5 34.45 6.9 5.5 6.2 26.9 20.9 23.9 1324 986 1155

Bhiwadi 79 59.6 69.3 48.4 36.1 42.25 9.4 5.9 7.65 29.3 20.9 25.1 1452 986 1219

Milakpur 73.4 51.9 62.65 45.7 30.6 38.15 6.9 5.1 6 25.4 18.9 44.3 1245 785 1015

NH-71 88.3 65.8 77.05 51.4 34.2 42.8 9.1 7.0 8.05 35.6 24.8 30.2 1652 1098 1375

Khajuriwas 85.9 64.7 75.3 49.7 32.5 41.1 8.6 6.7 7.65 28.9 21.3 25.1 1411 986 1198.5

Note: All values are represented in µµµµg/ m3

All values were found to be well within the latest national standards.

Observations:

PM10: The maximum value for PM10 observed at Project site 90.4 µg/m3 and minimum

value for PM10 observed at Belahari Village 72 µg/m3. The 24 hours applicable limit for

industrial, Residential Rural and Other Areas is 100 µg/m3.

Project: Auronext Pharma Pvt. Ltd. Section-XI/ Summary and Conclusions

Document No: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

243

PM2.5: The maximum value for PM2.5 observed at Project site 53.6µg/m3 and minimum

value for PM2.5 observed at Belahari Village 42.4µg/m3. The 24 hours applicable limit for

industrial, Residential Rural and Other Areas is 60 µg/m3.

SO2: The maximum value for SO2 observed at Project Site 9.7 µg/m3 and minimum value

for SO2 observed at Belahari Village 5.5 µg/m3. The 24 hours applicable limit for industrial,

Residential Rural and Other Areas is 80 µg/m3.

NO2: The maximum value for NO2 observed at NH 71 35.6µg/m3 and minimum value for

NO2 observed at Belahari Village 26.9 µg/m3. The 24 hours applicable limit for industrial,

Residential Rural and Other Areas is 80 µg/m3.

CO: The maximum value for CO observed at NH71 1652µg/m3 and minimum value for CO

observed at Milakpur Village 785µg/m3. The 8 hours applicable limit for Industrial, Residential

Rural and other areas is 2000 µg/m3.

HC & VOCs: The value of VOCs and HC found BDL at project site.

Results and Conclusions

The results of the monitored data indicate that the ambient air quality of the region in

general is conformity with respect to norms of National Ambient Air Quality standards, at all

locations monitored.

Ground water quality

To assess the present ground water condition six sampling location were selected for ground

water quality testing. The monitoring is done during the winter season i.e. December 2014

to February 2015.

The result indicates that the ground water quality values are below the permissible limits

and is suitable for drinking purpose. As per IS 10500 (Reaffirmed – 2012).

Noise Quality

The statistical analysis is done for measured noise levels at Six locations in the study area.

The parameters are analyzed for Leqday and Leqnight. The results obtained were compared with

the national standards and were found to be within limits.

Soil Quality

Six soil samples in Six villages around the project Area was collected and analyzed. The

Project: Auronext Pharma Pvt. Ltd. Section-XI/ Summary and Conclusions

Document No: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

244

result obtained is compared with the standard soil classification given Agriculture Soil Limits.

It has been observed that the soils are Sandy clay in texture and neutral in nature. The

nutrient and organic matter contents are medium and the soil is normally fertile.

Ecology

The project site is already surrounded by the urban environment and does not hold any

critical habitat/ecosystem as well as any threatened floral or faunal species. So project site

will not have any adverse impact on the environment.

Socio-Economic Aspects

The study area comprises of, 62 village human settlement. The total area of the study area

is 314.0 Sq. km. The total population of the study area is 2, 16, 327 with a 44,033 number

of households and an average household size of 5 people as per Census of India, 2011.Out

of the total population, in the study area of 10.0 k.m. constitutes 54.90% of males and

45.10% of females. The gender ratio in study area is 821 much lower against the Alwar

district gender ratio (894) as per the Census of India 2011The Average literacy of 10.0 k.m.

of the study area is 61.41%. The Male literacy with respect to male population is 70.76%

and the Female literacy with respect to female population is 50.03%. The literacy gap is

high 20.73% and the female literacy is low in the study area as per the Census of India,

2011.

11.4 ANTICIPATED ENVIRONMENTAL IMPACTS AND MITIGATION MEASURES

The summary of anticipated adverse environmental impacts due to the expansion of the

existing project and mitigation measures are given below.

11.4.1 Air Environment

The impact on air quality is assessed based on emissions of the oil fired boiler and truck

movement. PM10, PM2.5, SO2, NOx and CO will be the important pollutants emitting from

the stack and line sources.

Prediction of impacts on air environment has been carried out employing mathematical

model based on a steady state Gaussian plume dispersion model designed for multiple

point sources for short term. In the present case, Aermod View Version 7.1.0 dispersion

model for different stability state Gaussian plume dispersion, designed for multiple point

sources for short term and developed by United States Environmental Protection Agency

[USEPA] has been used for simulations from point and line sources.

Project: Auronext Pharma Pvt. Ltd. Section-XI/ Summary and Conclusions

Document No: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

245

Model Input Data

In the present case, model simulations have been carried out for the study period. The

Ground level concentrations are computed for 24-hr average.

Maximum Ground level concentrations of PM10, PM2.5, SO2, NOx and CO for study period

were 0.6 µg/m3, 0.3 µg/m3, 21 µg/m3, 11.7 µg/m3 and 7 µg/m3 respectively . The

obtained GLC’s are well within the stipulated CPCB standards. The incremental ground

level concentrations for various pollutants are given in Table No. 11.4.

Table No. 11.4

Predicted 24-Hourly Short Term Incremental Concentrations

Pollutant Maximum

Incremental

Concentration

(µµµµg/m3)

(X,Y)

coordinates

(m)

Towards

Direction

PM10 0.6 (0 , - 1000) S

PM2.5 0.3 (0 , - 1000) S

SO2 21 (0 , - 1000) S

NOx 11.7 (0 , - 1000) S

CO 7 (0 , - 1000) S

11.4.2 Water Environment

A. Waste water from industrial process

The unit will generate 60 KLD industrial waste water, out of which 30 KLD is Process

waste 10 KLD is from cooling tower blow down and 5 KLD from boiler and 15 KLD from

R.O/DM plant. The cooling tower blow down will be of HIGH TDS waste water while the

characteristic of industrial process waste water will be depend on the manufacturing

drug.

Management

The unit will install ETP for treatment of the waste water.

B. Domestic waste water

About 12KLD of waste water will be generated from domestic activities which will be

treated in STP based on MBR and sent to ETP.

11.4.3 Noise Environment

• D.G. set is proposed to be housed in an inbuilt acoustic enclosure. The acoustic

enclosure will be designed for minimum 25dB (A) insertion loss for meeting the

ambient noise standards, whichever is on the higher side.

Project: Auronext Pharma Pvt. Ltd. Section-XI/ Summary and Conclusions

Document No: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

246

• Necessary safety and personal protective equipment such as ear plugs, ear muffs,

helmet etc will be provided to the workers.

• Noise levels generated will be maintained to comply with the Factories Act & Rules and

will not exceed 75 dB (A) at 1 m distance.

11.4.4 Socio-Economic Environment

The requirement of unskilled manpower will be met from nearby villages during

construction and operational phase through training and development. The project will

also help in generation of the indirect employment apart from direct employment. This

will be a positive socio-economic development for the region. There will be a general

upliftment of standard of living in the region.

11.4.5 Solid Waste

The anticipated quantities of some major solid hazardous waste is given below in table

Table No. 11.5

The anticipated quantities of solid waste are as follows

S. No.

Hazardous

waste

Description

Category

as per

HWMR

rules

Qty

generated

/Annum

Unit Method of disposal

1. ETP sludge

a) Chemical

sludge from ETP

34.3 5 Ton

It will be sent to UCCI at

Udaipur for proper

treatment and disposal.

2. Spent Oil &

Used oil 5.1 & 5.2 1000 Lit

It will be disposed through

authorized disposer.

3. Process residue

and waste 28.1 1 Ton

It will be disposed in-house

in process effluent

treatment plant (Mixed with

process effluent)

4. Spent

catalyst/carbon 28.2 3.6 Ton

It will be sent to UCCI at

Udaipur for proper

treatment and disposal.

5. Off specification

products/raw

material

28.3 0.2 Ton

It will be sent to UCCI at

Udaipur for proper

treatment and disposal.

6. Expiry

drugs/medicines

28.4 0.25 Ton

It will be disposed in-house

in process effluent

treatment plant (Mixed with

process effluent)

Project: Auronext Pharma Pvt. Ltd. Section-XI/ Summary and Conclusions

Document No: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

247

S. No.

Hazardous

waste

Description

Category

as per

HWMR

rules

Qty

generated

/Annum

Unit Method of disposal

7. Spent solvent

1500 Ton

It will be disposed/sale

through authorized

Disposer

8. Liner/Packing

Material

/glass vials

2 Ton

It will be sent to UCCI at

Udaipur /for Inceneration

for Proper treatment

9. Lead Batteries

waste 2 Ton

It will be disposed/sale

through authorized

Disposer

10. Electronic

,computer items 1 Ton

It will be disposed/sale

through authorized

Disposer

11. CFL/Led etc

waste 1 Ton

It will be disposed/sale

through authorized

Disposer

* Common Treatment, Storage & Disposal Facilities at UCCI Udaipur.

Management

• The use of water based solvents will be preferred for waste reduction

• The Spent solvent will be recycled and reuse, through distillation, evaporation,

decantation, centrifugation and filtration

• The inorganic salts will be recovered from chemical liquors produced during organic

synthesis operations.

• The hazardous waste will be collected in HDPE bags and will be sent to Common

Treatment, Storage & Disposal Facilities at UCCI Udaipur The membership for the

same will be obtained soon.

11.5 ENVIRONMENTAL MONITORING PROGRAMME

Environmental Monitoring Cell

A centralized environmental monitoring cell will be established for monitoring of

important and crucial environmental parameters which are of immense importance to

assess the status of environment during mine operation.

The following routine monitoring programme as detailed in as under shall be

implemented at site. Besides to this monitoring, the compliances to all environmental

clearance conditions and regular permits from RPCB/MoEF shall be monitored and

reported periodically.

Project: Auronext Pharma Pvt. Ltd. Section-XI/ Summary and Conclusions

Document No: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

248

Table No. 11.6

Environmental Monitoring Programme

S.

No.

Potential

Impact

Action to be

Followed

Parameters

for

Monitoring

Frequency

of

Monitoring

Location

1 Air

Emissions

Ambient air quality

within the

premises of the

proposed unit and

nearby habitations

to be monitored.

PM10, PM2.5,

SO2, NOx CO,

VOC and HC

As per CPCB/

SPCB

requirement

or on weekly

basis

whichever is

earlier

At least two

locations

inside

premises;

four outside

premises

Exhaust from

vehicles to be

minimized by use

of fuel efficient

vehicles and well

maintained

vehicles having

PUC certificate.

Vehicle logs to

be maintained

-

Vehicle trips to be

minimized to the

extent possible

Vehicle logs Daily records Main gate

2 Noise Noise generated

from various plant

operations,

vehicular to be

optimized and

monitored

Spot Noise

Level

recording;

Leq(night),

Leq(day),

Leq(dn)

Periodic

during

operation

phase

Noise

measurement

at D.G Set,

Boilers and

main gate and

at least three

outside

premises

Generation of

vehicular noise

Maintain

records of

vehicles

Periodic

during

operation

phase

-

3 Waste

water

Discharge

No untreated

discharge to be

made to surface

water,

groundwater or

soil.

No discharge

hoses in

vicinity of

watercourses.

Periodic

during

operation

phase

-

Take care in

disposal of

wastewater

generated such

that soil and

groundwater

resources are

protected

Discharge

norms for

effluents will be

maintained

Periodic

during

operation

phase

-

Compliance of

treated

wastewater

usage/discharge to

standards

pH, TSS, TDS,

BOD, COD,

AOX, phenol,

arsenic,

cadmium,

Periodic

during

operation

phase

One location

(Treated

Wastewater)

Project: Auronext Pharma Pvt. Ltd. Section-XI/ Summary and Conclusions

Document No: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

249

S.

No.

Potential

Impact

Action to be

Followed

Parameters

for

Monitoring

Frequency

of

Monitoring

Location

chromium and

Bio Assay

Testing

Compliance of

treated sewage to

standards

Comprehensive

as per GSR

422(E)

Once in a

season

One location

(Treated

sewage)

4 Drainage

and

effluent

Manageme

nt

Ensure drainage

system and

specific design

measures are

working

effectively.

Design to

incorporate

existing drainage

pattern and avoid

disturbing the

same.

Visual

inspection of

drainage and

records thereof

Periodic

during

operation

phase

-

5 Water

Quality and

Water

Levels

Monitoring used

water quality &

groundwater

quality and levels

Comprehensive

monitoring as

per IS 10500

Groundwater

level bgl

Periodic

during

operation

phase

Three

locations

surrounding

project site

6 Energy

Usage

Energy usage for

air-conditioning

and other activities

to be minimized

Conduct annual

energy audit for

the buildings

Energy audit

report

Annual audits

and periodic

checks during

operational

phase

-

8 Emergency

preparedne

ss, such as

fire

fighting

Fire protection and

safety measures to

take care of fire

and explosion

hazards, to be

assessed and steps

taken for their

prevention.

Mock drill

records, on site

emergency

plan,

evacuation

plan

Periodic

during

operation

phase

9 Maintenanc

e of flora

and fauna

Vegetation,

greenbelt / green

cover development

No. of plants,

species

Periodic

during

operation

phase

-

10 Solid and

Hazardous

Waste

Manageme

nt

Implement waste

management plan

that identifies and

characterizes

every waste

arising associated

with proposed

activities and

Records of

solid waste

generation,

treatment and

disposal

Periodic

during

operation

phase

Project: Auronext Pharma Pvt. Ltd. Section-XI/ Summary and Conclusions

Document No: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

250

S.

No.

Potential

Impact

Action to be

Followed

Parameters

for

Monitoring

Frequency

of

Monitoring

Location

which identifies

the procedures for

collection, handling

& disposal of each

waste arising.

11 Soil quality Maintenance of

good soil quality

Physico-

chemical

parameters

and metals.

Periodical

monitoring

Plantation

areas

12 Health Employees and

migrant labour

health check ups

All relevant

parameters

including HIV

Regular check

ups

-

11.6 PROJECT BENEFITS

The proposed project of M/s. Auronext Pharma Pvt. Ltd aims to manufacture Bulk

Drugs & its Intermediates. The unit proposes to manufacture bulk drugs & intermediates

in its repetitive flow production. Like many industrialized countries, several different

types of modern antibiotics will be produced by the proposed project. Changing climate

or falling of pollen grains often increases the ratio of patients suffering from general

fever, bacterial infections (like Throat infection), asthma, and lifestyle diseases like

Cholesterol, Heart diseases etc. Few other reasons like stored water, uncovered litter,

dirty places, unhealthy living habits, unhealthy eating habits, pollution, water

contamination and more require Antibiotics. Thus the proposed production contributes in

prevention, cure and recovery of ailments and diseases.

• Use of antibiotics has now made it possible to treat many diseases that were fatal

prior to development of antibiotics.

• Antibiotics are also used to treat infectious diseases in animals and to control

bacteria and fungi that damage fruit and grain. Sometimes small amounts of

antibiotics are added to livestock feed to stimulate the animals' growth. Small

quantities of antibiotics are also used as food preservatives.

• Most antibiotics are affordable, easy to administer and effective against a wide

range of harmful bacteria. They also have wide applications, such as food

preservation, stimulation of growth and treating diseases that are caused by

animals, according to Wikipedia.

Project: Auronext Pharma Pvt. Ltd. Section-XI/ Summary and Conclusions

Document No: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

251

11.7 ENVIRONMENT MANAGEMENT PLAN DURING OPERATION PHASE

Environmental Management Plan (EMP) aims at the preservation of ecological system by

considering in-built pollution abatement facilities at the proposed site. Some of the major

criteria governing the environmental measures will be adopted, and the same is

described in ensuring paragraphs.

11.7.1 Air Pollution Management

� To control the fugitive emissions generated during various operations in

the industry, plant authorities will adopt following mitigation measures.

• Dedicated pipe lines for transfer of solvents from respective solvent storage tanks to

reactors in the production blocks.

• All solvent storage tanks will be provided with water jacket.

• Whenever required as and when reactors will be provided by vapor condensers

• Mechanical seals will be provided for all the reactors for improving emission control

measures.

� To control the process emissions generated during various operations in

the industry, plant authorities will adopt following mitigation measures.

� The condenser is the first condenser located after the process equipment and

supports a vapour-to-liquid phase change for the vapours produced in the process

equipment. The primary purpose of a condenser used as an air pollution control

device is to remove VOCs prior to venting. In this method, gas streams from vents

containing VOCs are cooled to below their saturation temperatures, converting the

gas into a VOC liquid. This removes some VOCs from the gas, but some remains. The

amount of VOCs remaining in the gas depends on the temperature and vapour-liquid

equilibrium of the VOC.

� Emissions from boiler will be routed to stack of adequate height through Wet

Scrubber .

� Regular post project air monitoring schedule will be planned and record will be

maintained to track any problem in Air Pollution Control Equipments

11.7.2 Water Pollution Management

• Industrial waste water will be treated in ETP.

• Domestic Waste water will be treated in STP based on MBR and treated water will be

sent to ETP.

• Rain water harvesting structure will be installed in the unit.

Project: Auronext Pharma Pvt. Ltd. Section-XI/ Summary and Conclusions

Document No: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

252

• Regular ETP effluent monitoring will be done to track the working of ETP.

• The unit will be shut in case of any problem in the ETP working.

11.7.3 Noise Pollution Management

• All possible measures will be taken to minimize the noise.

• The insulation provided for prevention and loss of heat and personnel safety shall

also act as noise reducer.

• Foundations and structures will be designed to minimize vibrations and noise.

• Regular equipment maintenance and better work habits will be adopted.

• D.G. set is proposed to be housed in an inbuilt acoustic enclosure. The acoustic

enclosure will be designed for minimum 25dB (A) insertion loss for meeting the

ambient noise standards, whichever is on the higher side.

11.7.4 Solid Waste Management

• Careful design, planning and good site management would minimize waste of

materials such as concrete, mortars and cement grouts. The contractor will make

inventory of all types of solid waste that are expected during the construction

activity before starting the work.

• Complete excavated material from the earthworks will be re-used on site as

structural fill or for landscaping purposes by balancing with cut & fill operations.

• Construction waste generated will be disposed off according to the nature of the

waste.

• The transportation of construction spoil will be allowed only to designated dumpsites

after obtaining permission of.

• Proper litter disposal and collection points will be established around the all

construction work sites.

• No solid waste will be kept in open spaces.

11.7.5 Socio-economic Aspects

The study area has been analyzed and surveyed Roads in main Bhiwadi town become

more unsafe between 10 pm and 9 am when policemen are not on the scene. Before 9

am, there is a lot of traffic on the road when school children are in a hurry to reach

school in time. Some effective road safety measures have to be devised so as to avoid

accidents during this crucial period.

• Healthcare facilities require improvement in the Industrial area.

Project: Auronext Pharma Pvt. Ltd. Section-XI/ Summary and Conclusions

Document No: EESPL/APPL/001/372-EC/IND.2014

Enkay Enviro Services Pvt. Ltd., Jaipur.

253

• Concerted effort on the part of the authorities and citizens of Bhiwadi town

are urgently needed to make the roads safer.

• Community development programme requires in the field of Education,

Employment and Water.

• Gender ratio of the study area is very low. Gender equality awareness

programme require in the study area. Need to increase female education

programme in villages.

The following CSR activities have been proposed for the people of the study area:

• Medical Mobile Van and Ambulance accompanied with qualified Doctor for

effective diagnosis of villagers in the study area.

• Industrial Training camps of local workers to upgrade skills of working in a

chemical factory. Training on precautions and safety (from industrial activities)

and awareness on Labour rights will be given to the villagers and nearby region

as most of the people are employed in the industrial area.

• Rainwater storage structure: In The nearest Government School, after

consultation & permissions from, Block development authority and the Gram

Panchayat:

11. CONCLUSIONS

It is predicted that socio-economic impact due to this project will positively increase the

employment opportunities for local inhabitants. There are no Resettlement and

Rehabilitation issues involved in this project. The contribution to the revenue of the State

Govt. will be put in public welfare and augment growth. The entire project area is devoid

of any endangered flora and fauna. Thus the proposed project is not likely to affect the

environment or adjacent ecosystem adversely

Project: Auronext Pharma Pvt Ltd Section-XII/ DISCLOSURE OF CONSULTANT ENGAGED

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur

254

SECTION XII

DISCLOSURE OF CONSULTANT ENGAGED

Project: Auronext Pharma Pvt Ltd Section-XII/ DISCLOSURE OF CONSULTANT ENGAGED

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur

255

DISCLOSURE OF CONSULTANT ENGAGED

Declaration by Experts contributing to the EIA of “Auronext Pharma Pvt Ltd” I, hereby,

certify that I was a part of the EIA team in the following capacity that developed the above EIA.

EIA Coordinator

Name Yashwant Bordia

Signature

Associate

EIA Coordinator

Sunita Mantri

Signature

Functional Area Experts: -

S.

No.

Functional

Areas

Name of the

Expert/s

Involvement

(Proposed)

(Period & Task)

Signature & Date

1 AP Dr. Yati Kachhawa

• Relevant

inventorization

• Prediction of air

pollution and its

management

2 WP Yashwant Bordia

Aakanksha

Rampuria(AFAE)

• Relevant

inventorization

• Data input in

report

• Prediction of

water

pollution and

its

management

.

• Water

Balance.

3 SHW Yashwant Bordia

Sunita Mantri

• Identification of

nature of waste,

categorization, and

quantity of

generated.

Project: Auronext Pharma Pvt Ltd Section-XII/ DISCLOSURE OF CONSULTANT ENGAGED

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur

256

4 SE Shubhangi Tibra

Vinod Verma

(AFAE)

• Primary and

secondary data

analysis.

• Socio Economic

Impact assessment

and

• CSR budget

allocation.

5 EB Dr. Yati Kachhawa

• Ecological and

biodiversity survey

• Identification of

species (flora and

fauna).

• Impact prediction

and Management

6 HG Vikrant Mahendran

• Field survey for

assessing the

regional and local

geology of the area.

7 GS Vikrant Mahendran

• Hydrogeological

survey for assessing

aquifer distribution

for the area.

• Water resource

evalution of the

area.

• Pre-monsoon &

post-monsoon

collection of water

level & quality data.

8 AQ Sunita Mantri

Aakanksha

Rampuria(AFAE)

• Inventorization of

source inputs

• Running of air

modelling

• Interpretation of

obtained results.

9 NV KN Sudershan Rao • Prediction of Noise

pollution.

• Mitigation measures

10 LU Vikrant Mahendran

• Satellite imaginary.

• Inference

11 RH Sunita Mantri • Assessment of risk

involved, if any.

• Management plan for

safety.

Project: Auronext Pharma Pvt Ltd Section-XII/ DISCLOSURE OF CONSULTANT ENGAGED

Document No.: EESPL/APPL/001/372-EC/IND-2014

Enkay Enviro Services Pvt. Ltd., Jaipur

257

• List of team members is enclosed

Declaration by the Head of the Accredited Consultant Organization

I, Sunita Mantri, hereby, confirm that the above mentioned experts prepared the EIA of “

Auronext Pharma Pvt Ltd”. I also confirm that I shall be fully accountable for any mis-leading

information mentioned in this statement.

LIST OF TEAM MEMBER ENGAGED

S.

No.

Functional Areas Name of the Expert/s Signature

1 AQ Prabhakar Sharma

2 AP Neha Bhargava

3 SHW Prabhakar Sharma

Aakanksha Rampuria

Yati Kachhawa

Neha Bhargava

4 NV Aakanksha Rampuria

5 WP & EB Ramsushil Mishra

Signature

Name Mrs. Sunita Mantri

Designation CMD

Name of the EIA Consultant Organization Enkay Enviro Services Pvt. Ltd.

NABET Certificate No. & Issue Date At serial no. 44 as per the List of

Accredited EIA Consultant Organizations as

on (A)/ July 6, 2015 (Rev. 32)


Recommended