CHAPTER - IVenvironmentclearance.nic.in/writereaddata/Online/TOR/0_0_17_Feb_2… · Title Page No....

PRE-FEASIBILITY REPORT

(Proposed Expansion of Inorganic Chemical Manufacturing unit to APIs, API intermediates &

Inorganic chemical Manufacturing Unit with R&D)

of

M/s. Bhagyanagar Chlorides Pvt. Limited Sy. No. 54/1,

Saggonda (V), Gopalapuram (M), West Godavari District, Andhra Pradesh

February 2016

Contents

S. No. Description

Page No.

1.0 Executive Summary 1

1.1 Salient Features of the Project 1

2.0 Introduction 3

2.1 Identification of the Project and project proponent 3

2.2 Brief description of Nature of the Project 3

2.3 Need for the Project and its importance to the country and or region

4

2.4 Demand and Supply Gap 5

2.5 Imports Vs. Indigenous production, Export Possibility, Domestic/Export Markets

5

2.6 Employment Generation due to the proposed expansion project 6

3.0 Project Description 6

3.1 Type of the project 6

3.2 Location 6

3.3 Alternate sites 6

3.4 Size or magnitude of operation 7

3.5 Project description 9

3.6 Raw materials 9

3.7 Resources optimization / recycling and reuse 10

3.8 Availability of water and Energy 10

3.9 Quantity of Wastes Generation and their Management /

Disposal 11

3.9.1 Water requirement and Wastewater generation and their

Management / Disposal 11

3.9.2 Solid Waste Generation, Handling and their Disposal 13

3.10 Schematic flow sheet for EIA procedure 15

4.0 Site Analysis 15

4.1 Connectivity 15

4.2 Land Form, Land use and Land ownership 15

4.3 Topography 15

4.4 Existing Land use pattern 15

4.5 Existing Infrastructure 16

4.6 Soil Classification 16

4.7 Climate data from Secondary sources 16

S. No. Description

Page No.

4.8 Social Infrastructure 16

5.0 Planning 17

5.1 Planning Concept 17

5.2 Population Projection 17

5.3 Land use planning 17

5.4 Assessment of Infrastructure Demand 17

5.5 Amenities/Facilities 18

6.0 Proposed Infrastructure 18

6.1 Industrial Area 18

6.2 Residential Area 18

6.3 Green Belt 18

6.4 Social Infrastructure 18

6.5 Connectivity 18

6.6 Drinking Water management 18

6.7 Sewerage System 19

6.8 Industrial Waste Management 19

6.9 Solid Waste Management 22

6.10 Power Requirement & Supply / Source 22

7.0 Rehabilitation and Resettlement (R&R) Plan 22

8.0 Project Schedule & Cost Estimates 22

8.1 Time Schedule for the project construction 22

8.2 Estimated project cost 22

9.0 Analysis of proposal (Final Recommendations) 23

9.1 Budgetary allocation for Pollution Control Measures 23

List of Tables

Table Title Page No.

1 Coordinates of all Corners of the Project Site 6

2 Permitted (Existing) Products and their Capacities 7

3 Proposed Products, their Capacity and Therapeutic Category 8

4 Permitted and Proposed Products, their quantities and its Status

9

5 Existing Water Requirement, Wastewater Generation and its Treatment 11

6 Proposed Water Balance and segregation and Treatment Method 12

7 Effluent Quantity and Treatment Flow as per segregation 13

8 Solid Waste Generation from the Existing Products 14

9 Solid Waste Generation from the Proposed Products 14

10 Environmental Components Shortest distance from Project Periphery 15

11 Breakup of proposed landuse Pattern 17

12 Maximum Quantity of Process emission for Proposed Products 19

13 Stack Emission Details – Proposed 21

14 Budgetary allocation for pollution Control Measures 24

LIST of Annexures

Annexure No.

Title Page No.

I Certificate of Incorporation 25

II CFE from APPCB vide No. 3335/PCB/ZO-Vsp/Tech/2007 dated 17-08-2007

26

III CFO from APPCB vide order no. 3335/APPCB/ZO-VSP/Tech./2013

dated 24-10-2013

30

IV General location of the Proposed Project 34

V Specific Location of the Proposed Project 35

VI Google map showing the coordinates 36

VII Plant Layout 37

VIII Typical Manufacturing description & Flowchart for proposed products 38

IX Raw Materials required for the manufacture of Proposed products 53

X Hazardous chemicals list 60

XI Ground Water analysis report 61

XII Proposed Effluent Treatment Plant Flow Diagram 62

XIII Schematic Flow Sheet for EIA Procedure 63

XIV Topography Map – 10km radius 65

XV Soil Analysis Report 66

Other Annexure

XVI Seismic Map of India 67

M/s Bhagyanagar Chlorides Pvt. Ltd. Pre-Feasibility Report

1

Pre-Feasibility Report for Expansion of Inorganic Chemical Manufacturing unit to APIs, API intermediates & Inorganic chemical

Manufacturing Unit with R&D facility

1.0 Executive Summary

M/s. Bhagyanagar Chlorides Pvt. Ltd. proposes to expand its Inorganic Chemical

manufacturing unit to Active Pharmaceutical Ingredients (APIs), API Intermediates & Inorganic

chemical manufacturing Unit with R&D facility located at Sy. No.: 54/1, Saggonda (V),

Gopalapuram (M), West Godavari District, Andhra Pradesh with a total investment of Rs.

54 Crores including the existing investment of Rs. 14 Crores.

The proposed expansion project falls under the Category ‘A’, project or activity 5(f)

according to the EIA Notification 2006.

1.1 Salient Features of the Project:

• The existing unit was established in 2007 and obtained CFE from APPCB in 2007.

• Proposing expansion in the existing area with extended land from 2.17 Ha to 4.3 Ha.

• The proposed expansion project is to manufacture 10 products with R&D activity on

campaign basis i.e., 2 regular and 3 campaign products at a time with a production capacity

of 15845 TPA (existing 10800 TPA).

• Total Greenbelt area is 1.46 Ha (34%).

• Industry obtained CFE for manufacturing Inorganic Chemicals from APPCB vide order

no. 3335/PCB/ZO-Vsp/Tech/2007 dated 17-08-2007. Latest CFO was issued by APPCB vide

order no. 3335/APPCB/ZO-VSP/Tech./2013-723 dated 24-10-2013 valid upto 31-05-2016.

• This proposed expansion project site is located at an aerial distance of

i. 21 km to NH16 at Kovvur in SE direction which connects to Rajamundry, Chennai in South and Vishakapatnam, Bhubaneshwar, Jharpokharia in NE

ii. Gopavaram village at 1 km in W direction

iii. Kovvur railway station at 23 km in SE direction

iv. Gopalapuram (Mandal Headquarters) at 10 km in SW

v. Eluru (District Headquarters) at 72 km in SW direction

vi. Rajamundry Airport at 23 km in SE direction.

• Total cost of the expansion is Rs. 54 Crores. Total capital cost allocated towards

environmental pollution control measures is Rs. 6.92 crores including existing investment of

Rs. 0.97Crores. Recurring cost after expansion will be about Rs. 6. crores per annum.


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• Total water requirement will be about 250 KLD of which fresh water requirement will be 163

KLD and balance 87 KLD will be recycled water from ETP. Fresh water will be met from

Groundwater from existing Bore wells.

• The proposed power requirement of the plant is 1120 KVA including existing 120 KVA. DG

sets are used as standby during power failure. Diesel of about 220 lit/hr will be used in the

proposed 500 KVA and 2 x 250 KVA DG sets along with existing DG sets of 62.5 KVA & 20

KVA.

• Total 130 employees including existing 60 nos. will be benefitted due to the proposed

expansion project. Out of which direct 110 and indirect 20 employees.

• Coal of about 40 TPD (with 4000 Kcal) / husk of about 50 TPD (with 3000 Kcal)/ Briquettes of

about 40 TPD (with 4000 Kcal) will be used in the proposed 2 x 5 TPH coal/husk/Brickets

(Ground nut Briquettes) fired boilers. Diesel of about 20 lph will be used for Proposed 2 lakh

Kcal./hr Thermic Fluid Heater.

• Industry will provide additional dual scrubbers based on the characteristics of process

emissions. Boilers will be provided with multi-cyclone separator & bag filter to reduce the

particulate emissions into atmosphere.

• The wastewater generated from the plant will be about 99 KLD from process, washing,

utilities, DM regeneration, scrubber, Q.C, R&D and domestic wastewater.

• The effluent will be pumped to the above ground level R.C.C lined tanks for storage and

neutralization then sent to proposed upgraded ETP-ZLD of 120 KLD capacity within the

premises.

• Domestic wastewater will be sent to septic tank and the overflow to ETP - ZLD.

• Hazardous waste will be segregated and collected in the HDPE drums / bags as appropriate

and will be stored in the covered and raised platform with provision of leachate collection

system.

• Solid waste like boiler ash will be sent to cement brick manufacturers.

• Compressors, Boilers and DG sets will be the major noise generating units in the plant. Out

of these, the generator will be functioning at the time of power failure. Built-in acoustic

enclosures provided for D.G. set unit to minimize the noise levels. However the workers in

this area will be provided with ear muffs.

Industry has uploaded for Form-I along with draft Terms of Reference (ToR) in MoEF&CC

website, in the process of obtaining ToR for preparation of EIA, in line with issue of Environmental

Clearance. Hence, a technical pre-feasibility report highlighting the expansion project and the


3

various operations including waste generation and mitigation measures are prepared & submitted

to the Environmental Appraisal Committee (EAC) for issuing ToR.

2.0 Introduction

2.1 Identification of the Project and Project Proponent

The present unit was originally established in 2007. M/s. Bhagyanagar Chlorides Pvt. Ltd.

ROC copy is enclosed as Annexure-I. Industry proposed to expand its Inorganic Chemical

manufacturing unit to Active Pharmaceutical Ingredients (APIs) and API Intermediates

manufacturing with R&D facility in the total area of 4.30 Ha (incl. existing 2.17 Ha) located at

Saggonda Village, Gopalapuram Mandal, West Godavari, Andhra Pradesh. The proposal is to

obtain Environmental Clearance from the Ministry of Environment, Forests and Climate Change

(MoEF&CC) and Consent for Establishment from APPCB.

• Industry’s first obtained CFE from APPCB vide No. 3335/PCB/ZO-Vsp/Tech/2007 dated

17-08-2007 (Annexure-II).

• Latest CFO was issued by APPCB vide order no. 3335/APPCB/ZO-VSP/Tech./2013 dated

24-10-2013 valid upto 31-05-2016 (Annexure-III).

• Total investment for the proposed project is about Rs.54 Crores including existing investment

of Rs.14 Crores.

• Total production capacity is 15845 TPA (existing 10800 TPA), from 2 Regular and 3 campaign

at a time will be manufactured with R&D activity.

Project Proponent:

The Bhagyanagar Chlorides is promoted by Shri A.V.S. Prasad, Managing Director having

more than 25 years of experience in the same field. His vision and hard work were the key

factors for the growth of the company.

Shri P. Srinivasa Rao, Jt. Managing Director joined the industry in 2007. He has B. Tech

(Mechanical Engg.) from Bangalore University, and has over 31 years of experience in varied

aspects of business including technology transfer, SCM, Business Development and Finance.

2.2 Brief Description of Nature of the Project

The project proponent proposed to expand existing Inorganic Chemical manufacturing unit.

As per EIA Notification 2006, the project is 5 (f) Synthetic Organic Chemical Industry (Bulk Drug

(API) & Intermediates). The products manufactured are used in API formulation industry and the

therapeutic category of the products is Antifungal, Antiulcerative, Antibacterial, Bronchodilator,

Antihypertensive etc., which are applicable for human consumption around the world after

formulation activity.


4

The manufacturing process of APIs consists of chemical synthesis and multiple stage of

processing extending to maximum of Ten stages involving different types of chemical reactions.

The entire process operations are operated by various technical, skilled and unskilled persons with

due care to be met various standards prescribed by authorities.

Technology for manufacturing the products listed under proposed expansion is available

from in-house R&D & private consultants and proposes to adopt new technologies and techniques

that are continuously refined in every stage of manufacturing to meet global standards. Industry

will implement the proven technologies in the R&D for the cost effective & environment friendly

practices.

2.3 Need for the Project and its Importance to the Country and or Region

The Indian pharmaceutical industry valued at $16 billion has portrayed tremendous

progress with reference to infrastructure development, technology base creation and a

wide range of production. India has achieved an eminent global position in pharma

sector. The Indian pharmaceuticals market is third largest in terms of volume and thirteen

largest in terms of value, as per a pharmaceuticals sector analysis report by equity master.

The market is dominated majorly by branded generics which constitute nearly 70% to 80%

of the market. The Indian pharmaceutical industry is estimated to grow at 20% compound

annual growth rate (CAGR) over the next five years, as per India Ratings. The domestic

pharma growth rate was 11.9% in October 2015.

It is estimated that by the year 2015, the Indian pharmaceutical industry has the potential to

achieve over Rs.2,00,000 Crore in formulations and bulk drug production. The industry now

produces bulk drugs belonging to all major therapeutic groups requiring complicated

manufacturing process and has also developed Good Manufacturing Practices (GMP)

facilities for the production of different dosage forms.

The pharma industry exports APIs and pharmaceuticals worth over $ 14.9 billion in 2013-

14. It ranks 17th in terms of export value of bulk activities and dosage. Indian exports cover

more than 200 countries including the highly regulated markets of USA, Europe, Japan and

Australia.

At a growth rate of 12% per year, the pharmaceutical industry in India is well set for rapid

expansion. As a result of the expansion, the Indian pharmaceutical and healthcare market

is undergoing a spurt of growth in its coverage, services, and spending in the public and

private sectors.


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2.4 Demand and Supply Gap

The products manufacture by the proponent has demand from China, Japan, Middle East,

Latin American countries and other Asian countries etc. In addition, the products are consumed in

domestic market by Dr. Reddy labs, Mylan etc. It is reported that there is increase in the

consumption of these products by about 5-6% every year. As Indian industries are importing from

neighbouring countries and western countries, indicates the gap in the demand and supply of the

products in the domestic markets.

2.5 Imports vs. Indigenous production, Export Possibility, Domestic/Export Markets

Presently China is dominating in the API (bulk drug) market the world over. India is

importing all major intermediate chemicals required for manufacturing lifesaving drugs i.e., Anti-

Cancer Drugs, Anti ulcerative, etc. We are importing from China – the Third generation Antibiotics

mainly Cephalosporin intermediates that are of very high value. Most of our imports are from

Chinese companies and thus we are losing our valuable foreign reserves to China. As mentioned

above the imports have gone up from $ 2.9 billion in 2011 to about $ 4.6 billion in 2012 on account

of APIs, Pharmaceuticals and fine chemicals. During the same period the imports of formulations

has also doubled. The Chinese, American and European markets play a very vital role in the

supply of these products to our country. This clearly indicates that there is tremendous scope for

developing the indigenous products by reducing the imports and thus saving the foreign exchange

reserves of the country. This potential can be utilized to the fullest extent possible by increasing

the production capacity of the existing industries or by establishing new industries to meet the

market demand of the products.

As it is a well known fact that Indian products are well accepted abroad for its quality and

marketing flexibility. The exports from the Indian companies to other foreign countries such as

Europe, America, Japan and other African countries has been increasing from Rs.8007 in 2005 to

Rs.16565 Crores in 2009. This shows the acceptability of the products produced in India. The

formulations market has shown a tremendous increase in the exports from about Rs.9500 to

Rs.23700 Crores during the same period. However, the basic raw material for formulations is

APIs. Hence, this sector has a tremendous potential of indigenous market as well as export market

and the promotion of such projects will not only help by way of generation of employment but also

by generation of foreign currency reserves for the country. The figures mentioned above are

sourced from BDMA.


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2.6 Employment Generation due to the Proposed Project

The following Table shows the manpower requirement after expansion of the proposed

project:

Type Existing (No. of persons)

Proposed (No. of persons)

Total after Expansion

Direct 60 50 110 Indirect - 20 20 Total 60 70 130

3.0 Project Description

3.1 Type of the project

Proposed expansion project of APIs & API intermediates falls under category ‘A’ as per EIA

Notification 2006 under the item No. 5 (f). There are no interlinked projects.

3.2 Location

The unit is located at 54/1, Saggonda (V), Gopalapuram (M), West Godavari District,

Andhra Pradesh. The proposed project expansion site has coordinates of all corners is presented

in Table 1. The study area represents Rural Environment.

Table 1: Coordinates of all corners of the Project site

Sl. No. Latitude Longitude

1. 17°10'22"N 81°36'12"E 2. 17°10'32"N 81°36'12"E 3. 17°10'32"N 81°36'18"E 4. 17°10'26"N 81°36'18"E

The map showing general location, specific location, Google map showing the Coordinates

and plant layout of the Total Project and existing project is enclosed at Annexures IV, V, VI & VII

respectively.

3.3 Alternate sites

This proposed expansion project is in the existing and additional plant area at Saggonda

village. Hence no alternate sites were considered.

Environmental considerations of this expansion project site.

This expansion site is in existing industry with additional plain land.

> 1 km away from human habitation,

The Andhra Sugars Limited industry is located at 1.4 km in NE which is a major raw material of

Chlorine supplier.

4.2 km (W) away from canal near Rampalem


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5 km (E) away from Godavari river.

There are 5 reserve forests.

• Polavaram RF (Mixed Jungle) 8 km N

• Gopavaram RF (Dense Jungle) 2.5 km SW

• Vinjaram RF (Mixed Jungle) 8.3 km NNW

• Gangolu RF (Dense mixed Jungle) 3.5 km NW

• Karakapadu RF (Mixed Jungle) 9.2 km W

Exist Transportation and Communication network

There are no rare or endangered or endemic or threatened (REET) species of animals or birds.

3.4 Size or magnitude of operation

Project Area: 4.30 Ha. (incl the existing 2.17 Ha)

Production Capacity: 15845 TPA from 5 out of 10 products on regular and campaign basis.

Products: The permitted and proposed products along with its production capacities are

presented in Tables 2 and 3 respectively.

Table 2: Permitted (Existing) and their Capacities

SI. No. Product Existing Products

Quantity Regular Product (kg/day) (TPA) 1. Aluminum Chloride anhydrous 30000 10800

By products 1. Hydro Chloric Acid 83.3 Liters 30 KL 2. Sodium Hypo Solution 83.3 Liters 30 KL

Source: M/s. Bhagyanagar Chlorides Pvt. Ltd.


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Table 3: Proposed Products, their Capacity and Therapeutic Category

Sl. No.

Product name Quantity (Kg/day)

Quantity (TPA)

Therapeutic Category / Intermediate /

Chemical

Regular Products

1. Aluminum Chloride anhydrous 30000 10800 Inorganic raw material

2. Benzo Trichloride 6666.67 2400 Raw Material for Acetyl Chloride &

Chloro acetyl chloride

Campaign Products

3. Fluconazole 333.33 120 Antifungal

4. Pantoprazole Sodium 233.33 84 Antiulcerative

5. Ciprofloxacin Hydrochloride 666.67 240 Antibacterial

6. Salbutamol Sulfate 333.33 120 Bronchodilator

7. Ramipril 300 108 Antihypertensive

8. N,N-Diethyl cyanoacetamide 200 72 Entacapone intermediate

9. Acetyl chloride 3333.33 1200 Raw material for APIs

10. Chloro acetyl chloride 3333.33 1200 Raw material for APIs

Production (Maximum 5 Products at a time)

44000 15840

R&D 13.88 5

Total Production with R&D (Maximum 5 Products at a time)

44013.88 15845

Source: M/s. Bhagyanagar Chlorides Pvt. Ltd.

List of By-products

SI. No. Name of the By-Product Quantity

(KL/day) Quantity (KL/A) Name of the Product

1. Hydro Chloric Acid (25%) 9 3240 KL

Benzotrichloride, Chloro acetyl chloride,

Salbutamol Sulfate Fluconozole

Aluminum Chloride anhydrous

2 Sodium Hypo Solution 83.3 Liters 30 KL Aluminum Chloride anhydrous


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Table 4: Permitted and Proposed Products, their quantities and its Status

Sl. No.

Product name Permitted

(TPA) Proposed

(TPA)

Total After Expansion

(TPA) Status

Regular Products

1. Aluminum Chloride anhydrous 10800 -- 10800 Existing

2. Benzo Trichloride -- 2400 2400 New

Campaign Products 3. Fluconazole -- 60 60 New

4. Pantoprazole Sodium -- 36 36 New

5. Ciprofloxacin Hydrochloride -- 120 120 New

6. Salbutamol Sulfate -- 60 60 New

7. Ramipril -- 60 60 New

8. N,N-Diethyl cyanoacetamide -- 36 36 New

9. Acetyl chloride -- 1200 1200 New

10. Chloro acetyl chloride -- 1200 1200 New

3.5 Project Description with Process Details

The manufacturing process of APIs consists of chemical synthesis extending to maximum

of 10 stages of processing involving different types of chemical reactions. Typical process

description with process details is enclosed at Annexure-VIII. These drugs are mainly used for

human Medication after Formulation activity for various diseases. Industry will implement the

proven technologies in the R&D for the cost effective & environment friendly practices. The plant

layout showing existing and proposed components of the project is enclosed at Annexure-VII.

3.6 Raw Materials

The raw materials required for the manufacture of proposed products are the chemicals

and the fuel.

• The APIs & API Intermediates manufacturing involve the use of various chemicals and

organic solvents either directly as reactant or for extraction of a product of interest from the

reaction mixture.

• Coal / Husk / Briquettes consumption will be 40 / 50 / 40 TPD for the proposed 2 x 5 TPH

coal/husk/Briquettes fired boilers.

• About 240 lit/hr diesel will be used at full operation load in the proposed 500 KVA and

2 x 250 KVA DG sets along with existing DG sets of 62.5 KVA & 20 KVA DG sets. and 2

lakh Kcal/hr Thermic fluid heater.

• The total power requirement of the proposed plant is 1120 KVA including existing 120 KVA.


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• Mode of transportation of all raw materials and finished products from the project site is by

road to local markets and by road / rail / sea if exported.

The chemicals (raw materials) required for the manufacture of proposed products is

presented at Annexure – IX and Hazardous chemicals list is presented at Annexure – X.

3.7 Resources Optimization / Recycling and Reuse

R&D facility in the unit is taking all efforts to recycle the wastes / reuse wherever possible.

However, R&D is a continuous process, where improvements in the processes adopted by the

industry, waste minimization etc. will be worked out as the project progresses. Following are some

of the recycle options proposed by the industry.

Industry is proposing for Zero liquid discharge plant to reuse all treated effluents as makeup

water for utilities like Cooling Tower. This will reduce the fresh water consumption.

Industry is proposing dedicated reactors for few products there by reducing the reactor

washings.

All solvents are recovered to the extent possible and reused in the process.

Organic residue and spent carbon will be sent to Authorized Cement industries to burn in

Cement Kiln as an alternate fuel.

Boiler ash will be sent to Cement Brick manufacturing units.

Waste / Used oil will be sent to Authorized Waste / Used oil Reprocessing units.

Container & container liners of hazardous chemicals, Polythene / HDPE Bags, broken plastic

drums shall be disposed of to outside agencies after complete detoxification.

Spent catalyst will be sent back to supplies

Waste Lead acid batteries will be sent back to suppliers on buy back basis.

Optimum utilization of solar energy.

Recycling and reuse of by-products, solvents generated during the process will also be

planned properly thereby implementing the clean manufacturing techniques.

3.8 Availability of Water and Energy

The total fresh water requirement is about 163 KLD which will be met from Groundwater

from existing bore wells. The proposal is to minimize the effect on the level of water table by

practicing reuse / recycling of the treated water wherever possible thereby reducing the fresh

water requirement. Water analysis report of the raw water at project is enclosed as

Annexure – XI.

The total power requirement will be met from Andhra Pradesh State Power Distribution

Corporation Limited (APSPDCL). Coal and Diesel will be procured from the distribution sources

closer to the project site.


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3.9 Quantity of Wastes Generation and their Management/ Disposal

3.9.1 Water requirement and Wastewater Generation and their Management/ Disposal

The permitted, proposed water requirement and wastewater generation with its proposed

treatment is presented in Tables 5 & 6 respectively. The sources of wastewater generation are

from the process, floor & reactor washes, utilities, Q.C, R&D, scrubber and plant domestic waste.

Total proposed wastewater will be 99 KLD, which will be segregated into HTDS/HCOD &

LTDS/LCOD and collected by gravity into a collection tank separately. This individual effluent will

be pumped to the above ground level R.C.C lined tanks for storage and neutralization then sent to

ETP-ZLD. The effluents segregated quantity, characteristics and treatment flow is briefly

presented in Table 7.

Table 5: Existing Water Requirement, Wastewater Generation and its Treatment

Description Water

Requirement (KLD)

Wastewater Generation

(KLD) Treatment Method

Process & Washings 0.5 0

Gardening / Irrigation 4 0

Domestic 2 2 Septic tank followed by soak pit.

Total 6.5 2


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Table 6: Proposed Water Balance, Segregation and Treatment Method

Description Input (KLD) Output (KLD)

Fresh Water

Recycled Water

Evaporation / Handling Loss

Total Wastewater

Segregation type of Wastewater

Process (5 products at a time)

44 -- 0 44 (46.5 Tons) HTDS/HCOD

Washings (reactor, centrifuges, nutch filters, containers, floor, etc.,)

10 - -- 10 LTDS/LCOD

Boiler (2 x 5 TPH)

57 (24 %

Makeup) 0

38 (16% loss)

8 (3% Blow

down) Utilities

(LTDS/LCOD)

11 (5 % - MEE

Steam condensate)

Cooling Tower 1500 TR

3 87 82.5 7.5

(Bleed)

DM Regeneration 5 -- - 5 HTDS / LCOD

Scrubber 12 - 9 3 HTDS / LCOD

Q.C and R&D 5 -- - 5 LTDS/LCOD

Domestic (130 nos @50 lpcd) 7 -- 1.5 5.5 LTDS/LCOD

Greenbelt (4 acres @ 5 KL/acre)

20 -- 20 - --

Total

163 87 151 99

Reuse: Stripper condensate 0.5 KLD; Moisture in salt and ETP sludge is 2 KLD, Water loss in ETP 9.5 KLD (Total water loss is 12 KLD = 12 %)

250 250

Note: 44 KLD is 46.5 Tons consists of 43.95 KLD liquid effluent and 2.6 Tons of salts (Max. on

various combinations) as per material balance.


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Table 7: Effluent Treatment Flow for as per Segregation

Effluent Characteristics

Quantity (KLD) Treatment Flow

Process, DM & Scrubber

HTDS/HCOD & (HTDS)

HTDS > 5000 mg/l HCOD > 5000 mg/l

52

Collection Equalization Neutralization Settling Holding Steam stripper MEE along with HTDS effluent Condensate to ETP (biological treatment) Concentrate to ATFD

ATFD Condensate to ETP (Biological Treatment) along with domestic wastewater (septic tank overflow) Pressure Sand Filter Activated Carbon Filter R.O R.O rejects to MEE.

R.O Permeate & MEE Condensate to cooling tower

ATFD Salts to TSDF and stripped solvents to SPCB authorized cement industries

Washings, Boiler, Cooling Tower, QC &

R&D LTDS / LCOD

LTDS < 5000 mg/l LCOD < 5000 mg/l

41.5 Collection Equalization Neutralization ETP (Biological Treatment) along with MEE Condensate

Domestic 5.5 Septic tank Overflow to ETP (Biological Treatment)

Proposing 120 KLD Effluent Treatment Plant system and flow chart is enclosed as

Annexure-XII. All the treatment tanks etc., will be constructed / installed above the ground with

water proof lining. This individual effluent will be pumped to the above ground level R.C.C lined

tanks for storage and neutralization then sent to ETP-ZLD.

ETP – ZLD facility consists of primary (equalization and neutralization), secondary (stripper

with MEE, ATFD & biological) and tertiary treatment (PSF, ACF & R.O) will be provided. Domestic

wastewater will be sent to septic tank and the overflow to ETP (biological treatment). Concentrate

from MEE system will be sent to ATFD and the salts from the evaporation system will be collected

and sent to TSDF for safe disposal.

3.9.2 Hazardous / Solid Waste Generation, Handling and their Disposal

Hazardous/ Solid waste will be segregated, detoxified and collected in the HDPE Drums /

Bags and will be stored in the covered and raised platform with Leachate collection system. The

existing and proposed solid waste and other waste generated, handling and disposal method from

the various stages of manufacturing plant is presented in the Table 8 & 9 respectively. Spillages

such as wastewater / solid wastes / raw material are possible and the risk of this would be limited

to within the premises of the manufacturing facility. A precautionary measure like spillage control

management is practiced in the industry.


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Table 8: Permitted Hazardous Waste Generation from the Existing Products

Sl. No. Source Permitted

Quantity (kg/day) Disposal Option

1. Used oil/ Waste lubricant oil 100 LPA Sent to Authorized Reprocessors/

Recyclers

Table 9: Proposed Hazardous / Solid Waste Generation from the Proposed Products

Sl. No. Source

*Proposed Quantity

(TPD) Handling Method Disposal

1. Organic residue 2.02

HDPE Drums

Sent to SPCB Authorized Cement industries / TSDF

2. Spent Carbon 0.12

3. Distillation Bottom Residue (1% of spent solvents)

0.4

4. Inorganic & Evaporation salt (Process) 3.13

HDPE Bags 5. Evaporation salt (Non-Process) 0.5

6. ETP Sludge with 50% moisture 0.6

7. Boiler Ash 16 Stored in covered area

Sold to Cement Brick Manufacturers

Other Hazardous Waste generation from the Plant

8.

a) Detoxified Container / Liners drums b) HDPE Carboys c) Fiber Drums d) PP Bags

300 Nos./ month

100

Kg/month

Designated covered area

Disposed to SPCB Authorized agencies after

complete detoxification

9. Spent solvents (with moisture) (solvents 35.5+water 1.5)

37 KLD Stored in Drums / Tanks

Recovery within the premises duly sending the residue to

Authorized agencies

10. Recovered Solvents from spent solvents 32 KLD

Stored in Drums / Tanks

Reuse in process / Send to authorized recyclers

11. Spent Mixed solvents (3.5 from SRS + 1 from ETP)

4.5 KLD Stored in Drums / Tanks

Sent to SPCB Authorized agencies

12. Waste oils & Grease 1.5 KL/A Stored in Drums

Sent to SPCB Authorized agencies for reprocessing /

recycling.

13. Used Lead acid Batteries

50 Nos. / annum

Designated covered area

Sent to suppliers on buy-back basis.

14. Misc. Waste (spill control waste) 12 TPA Stored in

Drums TSDF

15. Spent Catalyst (Raney Nickel) 24 TPA Stored in

Drums Sold to suppliers on buy-back

basis / auth. reprocessers. 16. Spent Piperazine HCl 1405 TPA * Solid waste quantities maximum on 5 products at a point of time


15

3.10 Schematic Flow Sheet for EIA Procedure

The schematic flow sheet for EIA procedure is depicted as Annexure -.XIII.

4.0 Site Analysis

4.1 Connectivity

The proposed expansion project site is connected to NH16 at Kovvur in SE direction at a

distance of 21 km aerial distance, which connects to Rajamundry, Chennai in South and

Vishakapatnam, Bhubaneshwar, Jharpokharia in NE. Approach road also connecting to NH 42 at

Chityala which connect to Khammam in West and Kovvur in SE. Gopavaram village at 1 km (W);

The Andhra Sugars Limited (Major Raw material supplier) is at 1.4 km NE, Gopalapuram (Mandal

Headquarters) at 10 km (SW); Eluru (District Headquarters) at 72 km (S); Kovvur railway station at

23 km (SE) and Rajamundry Airport at 23 km (SE).

4.2 Land Form, Land use and Land Ownership

Total land is 4.30 Ha. is in possession of Project Proponent.

4.3 Topography

The Topography map with a 10 km radius is enclosed as Annexure-XIV.

4.4 Existing Land Use Pattern

The existing and proposed land use pattern of project area (core area) 4.3 Ha. Industrial

land and shortest distance of environmental components in buffer area from the project periphery

is given in Table 10.

Table 10: Environmental Components Shortest distance from Project Periphery

S. No.

Particulars Details (Distance & Direction w.r.t. site)

1. Water bodies • Canal near Rampalem – 4.2 km (W) • Godavari river – 5 km (E) • Pond near Kommy gudem – 6.3 km (N) • Pond near Bhimolu– 4.8 km (SW) • Canal near Bhimolu – 3.4 km (S) • Kovvada Kalva (Canal) - 4.3 km (N)

2. Reserve Forests No high quality or scarce resources are present in the buffer zone. Following Reserved forest blocks are present such as • Polavaram RF (Mixed Jungle) 8 km N • Gopavaram RF (Dense Jungle) 2.5 km SW • Vinjaram RF (Mixed Jungle) 8.3 km NNW • Gangolu RF (Dense mixed Jungle) 3.5 km NW • Karakapadu RF (Mixed Jungle) 9.2 km W

3. National Parks/ Wild Life Sanctuaries/ Eco

Nil


16

sensitive areas 4. Agricultural land Adjacent 5. Non-Agricultural land Adjacent 6. Habitation Gopavaram Village

4.5 Existing Infrastructure

Internal CC roads, approach road connecting to NH16 at Kovvur in SE direction at a

distance of 21 km aerial distance, which connects to Rajamundry, Chennai in South and

Vishakapatnam, Bhubaneshwar, Jharpokharia in NE. Approach road also connecting to NH 42 at

Chityala which connect to Khammam in West and Kovvur in SE. Transportation facilities, water

supply, Power supply, Occupation Health Centre, Conference hall, Telecommunication facility etc.,

are available.

4.6 Soil Classification

The soil in the project site is Red and in the study area is mostly red in colour, containing

32.56% sand, 34.58% silt and 32.86% clay . The soil analysis report of the project site is enclosed

as Annexure-XV.

4.7 Climate Data from Secondary Sources

The tropical climate conditions with extreme hot summer and cold winter prevail in this

district. April to June are the hottest months with high temperature in May. The monsoon usually

breaks in the middle of June and brings good rains upto middle of October. The normal rainfall of

this district is 1077 mm. (Source: District Hand Book)

The climate of the district is moderate and characterized by tropical rainy climate with

aggressive summer. The period from December to middle of February is generally the season of

fine weather. The summer season is from March to May. This is followed by monsoon period from

June to September, the post monsoon from October to December and the winter season from

January to February.

4.8 Social Infrastructure

National Highway no. 16 (Chennai – Bhubaneshwar) is at 21 km (SE), road network,

transportation facilities, power supply, fire station and other basic amenities such as

telecommunication facility, education centre, hospitals, community halls are available at

Gopalapuram at 10 km (SW).


17

5.0 Planning

5.1 Planning Concept

Type of Industry: The proposed expansion project is of Inorganic Chemical manufacturing unit to

APIs, API intermediates & Inorganic chemical Manufacturing Unit with R&D facility.

Facilities: Industry proposed for expansion at existing and additional land and facilities required

for the project will be provided as per requirement.

Transportation: Transportation of raw material and final products is done via roads as the

proposed project is well connected with roads, rail and airways.

Town and Country Planning Classification: This is existing industry land and additional land is

private land, converted to industrial use and is in possession of project proponent.

5.2 Population Projection

There is a scope for increase in the population from the proposed expansion project.

Skilled workers prefer to stay in the nearby locations to avoid travelling from long distances. Local

Non-technical villagers will be preferred for the unskilled jobs such as gardening, movement of

materials, etc. Local / Non local educated youth will be employed as semi-skilled workers and

training will be provided. Hence, there is a possibility of increase in population of the skilled and

semi-skilled. However, on the whole there is a possibility of little increase in population of the area.

5.3 Land use Planning

The expansion unit has been proposed in the existing and additional land. Land use

pattern of the Project area is given in Table 11.

Table 11: Break up of proposed land use pattern

S. No.

Purpose

Existing Area

Proposed Area Total Area

% Sq.m Sq.m Sq.m 1. Built up area 1775.5 4682.92 6458.42 15.01 2. Roads 560 5380.46 5940.46 13.81 3. Green belt 10000 4642.47 14642.47 34.05 4. Open area

7909 8067.4 15661.29 36.4

5. Truck Parking Area 315.11 0.73

Total 20244.5 22773.25 43017.75 100

5.4 Assessment of Infrastructure Demand

On assessment of infrastructure demand near the project area Hospital with Ambulance

facility and Fire station is requirement for the nearby villages of project area.


18

5.5 Amenities/Facilities

Industry will continue to provide and upgrade the following amenities / facilities in the

proposed expansion project.

• Canteen • Potable drinking water • Training block • Laying of Black top / Concrete internal roads • Fire hydrant facility • Eye/body wash showers • First Aid kits at all prominent places. • Head nurse for emergency medication. • Rest Room for employees • Seating facilities for those employees who do their work standing and ergonomically

designed sitting facilities for those who do their work sitting • Pre-employment and routine medical examinations and the necessary follow up actions • Communication systems like Phone, Internet with safety measures, etc. • Security system at the entrance etc.

6.0 Proposed Infrastructure

6.1 Industrial Area

Additional production blocks, administration facilities, utility area, ETP area are been

proposed in the expansion area.

6.2 Residential Area :

There will be no residential area within the project site.

6.3 Greenbelt

The expansion unit has been proposed in existing with extension area about 4.30 Ha i.e.,

43017.75 sq.m. Out of which about 1.46 Ha i.e.14642.47 sq.m is allocated for Greenbelt area

which is equivalent to 34% of the total area.

6.4 Social Infrastructure

As a Corporate / Entrepreneur Social Responsibility (ESR), Industry will contribute for

development of village social infrastructure.

6.5 Connectivity

There is no change in connectivity compare to existing facility.

6.6 Drinking Water Management

Potable drinking water will continue to be provided to all employees. The source of drinking

water is Groundwater.


19

6.7 Sewerage System

Sewage will be generated from the Canteen and Toilets, which will be collected into

sewage collection tank through pipelines and septic tank respectively. Overflow of these tanks will

be sent to ETP – ZLD system which needs to be upgraded to meet the expansion project demand.

6.8 Industrial Waste Management

Existing storage system needs to enhance to meet the expansion project demand. The

management of these wastes is to be handled very sensitively and by adopting proper segregation

techniques.

Liquid Waste Management: The liquid wastes from the various industrial activities will continue to

be segregated and send to ETP-ZLD.

Process Emissions Management:

Manufacturing of APIs and API intermediates will result in gaseous emissions. Maximum

Process emissions from proposed products are given in Table 12 respectively. Proposed gaseous

emissions will be scrubbed in two stage scrubbers with water or other liquid based on the

characteristics of gases.

Table 12: Maximum Quantity of Process Emission for Proposed Products

Sl. No.

Process Emission

Maximum Quantity on various combinations

(kg/day) Treatment Method

1. HCl 2686.5 Scrubber with water / caustic sol.

2. NH3 7.17 Scrubbed by using Chilled water

3. H2 23.77 Diffused with flame arrestor

4. CO2 252.73 Dispersed into atmosphere

5. SO2 49 Scrubber using caustic sol.

6. N2 6.67 Dispersed into atmosphere

Fugitive emissions Management:

Solvents used in the APIs & API intermediates manufacturing process will be stored in drums and bulk quantities will be stored in underground/ above ground storage tanks.

Solvents are handled in closed conditions thereby reducing the losses in the form of evaporation.

Proper earthing will be provided to all the electrical equipment and the joints / connections wherever solvent handling is done.

Reactor and solvent handling pump will have mechanical seals to prevent leakage.


20

The industry will take measures for reduction of fugitive emissions and for further reduction industry will provide vent condensers to the tanks.

Chilled brine circulation will be carried out to condensate the solvent vapour and to the receivers of the solvent vapors which ensures the maximum recovery.

Solvent vapours from the Centrifuge and Catch pots will be connect to vent condensers.

The height of the solvent receiver tank vent is above production block roof level and the diameter is 20 mm.

Flame proof fitting / equipments / pumps / lighting will be used wherever solvents are used. The solvent storage tanks will be provided with breather valve to prevent losses.

Combination Solvent

Input

Solvent Loss in Effluent

Solvent Loss in

Org. residue

Solvent Loss

(Handling)

Solvent Recovery

Solvent Recovery

(KLD) (KLD) (KLD) (KLD) (KLD) (%) 1 37.6 0.13 0.9 1.75 35.3 94 2 25.5 0.16 0.29 1.34 23.71 93 3 35.9 0.15 0.43 1.76 33.63 94

Maximum on various combination 37.6 0.16 0.43 1.76 35.3 94

Emissions from Utilities Management:

Boilers and DG sets are the two main sources contributing to emissions from the plant. The

proposed coal/ husk/ Briquettes fired boilers will be used for 2 x 5 TPH Boilers. Diesel will be used

for 2 lakh Kcal./hr TFH and Proposed 2 x250 KVA and 500 KVA DG Sets, existing 20 KVA & 62.5

KVA. DG Sets will be used as standby power during power failures. The emissions from the boiler

are given in Table 13.


21

Table 13: Stack Emission Details

Source Stack Height

(m)

Diameter (m)

Temperature

( oC)

Flue Gas Flow rate

(m3/hr)

Exit Gas Velocity (m/sec)

PM SO2 NOx

kg/hr

Proposed Boilers

5 TPH 30 0.62 150 13104 12.88 0.747 7.47 5.22

5 TPH 30 0.62 150 13104 12.88 0.747 7.47 5.22

Proposed Diesel fired thermic fuel heater

2 lakh Kcal/hr

TFH 30 0.3 150 867.61 3.4 0.004 0.087 0.093

Proposed D.G sets

500 KVA 9 0.3 150 2822.4 11.10 0.031 0.625 0.671

250 KVA 8 0.2 150 1411.2 12.48 0.015 0.312 0.335

250 KVA 8 0.2 150 1411.2 12.48 0.015 0.312 0.335

Existing D.G sets 62.5 KVA 6 0.08 150 352.8 19.54 0.003 0.078 0.083

20 KVA 5 0.06 150 111.6 11.10 0.001 0.025 0.026

The various measures proposed to minimize the pollution from the boiler are as follows:

Multi-cyclone separator followed by Bag filter will be installed to control the particulate (PM)

emissions within statutory limit of 115 mg/Nm3. To facilitate wider dispersion of pollutants,

30m height stack each will be installed.

The NOx emissions from the boilers will be controlled by controlling combustion measures,

which will be approached by way of low NOx burners or by air stagging in boiler. The NOx

emissions will be restricted to below 500 mg/Nm3.

Stacks will be provided to proposed D.G sets as per CPCB / SPCB Guidelines.

Fugitive dust will be controlled by adopting dust extraction and dust suppression measures

and development of greenbelt along the periphery of the proposed Boiler area.

Noise Management:

• Compressors, Boilers and DG sets will be the major noise generating units in the plant.

• The noise levels of the DG sets will be well within the limits as these will be installed with

acoustic enclosures. Workers will always be provided with ear muffs.


22

• All the equipment in the plant would be designed to have a total noise level not exceeding

85-90 dB(A) as per the requirement of OSHA (Occupational Safety and Health

Administration) standards.

6.9 Hazardous / Solid Waste Management

• Solid waste mainly segregated into process organic residues, inorganic salts, boiler ash

spent mixed unrecoverable solvents and spent carbon.

• The organic residues, Spent carbon & Spent mixed unrecoverable solvents can be

disposed off to Cement plants as recommended by CPCB for use as alternate fuels either

in the solid or liquid form.

• Boiler ash will be sold to brick manufacturers.

• Inorganic salts are to be sent for landfill at HWMP – TSDF.

Solid waste will be segregated, stored and disposed as mentioned in the Table 8

6.10 Power Requirement & Supply / Source

Power supply of 1120 KVA will be drawn from the nearby sub-station of APPDC. D.G. set

will be used as alternate arrangement in case of failure in power supply. Proposed 2 x 250 KVA &

500 KVA D.G. sets in addition to the existing 62.5 KVA and 20 KVA DG sets.

7.0 Rehabilitation and Resettlement (R&R) Plan

The proposed additional land is plain land adjacent to the existing land and is in

possession of project proponent. Therefore Rehabilitation and Resettlement plan is not applicable

to this expansion project site. The nearest habitation is away from 1 km away from the project site.

8.0 Project Schedule & Cost Estimates

8.1 Time Schedule for the project construction

The timelines for commencement of proposed construction activity will be from

December 2016 as it is expected that the expansion project will be in a position to obtain

Environmental Clearance & Consent for Establishment for the project. In 2017-18 the commercial

production is expected to be commenced.

8.2 Estimated project cost

Overall estimated cost involved in the total project (existing and proposed) like land,

building, plant & machinery is Rs. 54 Crores including existing Rs. 14 Crores. Total capital cost

allocated towards environmental pollution control measures is Rs. 5.95 Crores and the Recurring

cost will be about Rs. 6 crores per annum.


23

9.0 Analysis of proposal (Final Recommendations)

• The proposed expansion project will result in growth of surrounding area by generating direct

and indirect employment to local people. Around 130 members will be benefitted due to the

expansion project (incl. existing 60 nos.).

• Under the Corporate Social Responsibility the Industry will continue to develop a policy of

developing the villages in the vicinity by identifying the requirements.

• No adverse effect on environment is envisaged as proper mitigation measures will be taken

up.

• Industry will strengthen the existing Safety, Health & Environment Department and also

continue to engage recognized laboratories to carry out all necessary monitoring parameters

for its activities.

• The segregated (HTDS / LTDS) wastewater will regularly analyzed before and after

treatment in ETP-ZLD.

• Qualified staff will be appointed for the purpose of Operation and Maintenance of the

pollution control facilities.

• Stand-by facilities will be provided to all the pumps so as to ensure fail proof treatment,

handling and disposal.

•

9.1 Budgetary allocation for Pollution Control Measures

The management will set aside adequate funds in its budget to fully meet the stated

objectives of the environmental policy. The existing and proposed capital equipment for

environmental management include effluent treatment plants, pipelines and channels for

wastewater discharge, greenbelt development, environment laboratory, fire, occupational health

etc., The break-up of budgetary allocation for various control measures is presented in Table 14.


24

Table 14: Budgetary allocation for Pollution Control Measures

S. No. Description

Existing cost (in lakhs)

Proposed cost (in lakhs)

Capital Capital *Recurring

Air Pollution Control

1. Multicyclone& Bag filter with Stacks 2 30

10 2. Scrubbers 50 50 3. Vent condensers 50 Water Pollution Control

3. ETP Civil works, Steam stripper, MEE, ATFD, R.O. and mechanical equipment

5 250 300

Noise Pollution Control

4. Silencers / acoustic enclosures 1 10 5

Solid Waste Management

5. Covered Platform with leachate collection system 5 10 170

6. Greenbelt Development 5 5 5

7. Occupation Health and Safety 4 10 10

8. Fire Management 10 60 5

9. Dyke walls and Storm water drains 5 20 5

10. Environmental Laboratory 5 50 10 11. Misc. 5 50 80

Total 97 595 600 *Recurring cost includes manpower, consumables, maintenance, energy charges per

annum

ANNEXURES

Annexure -I

25

Annexure-II

26

Annexure-II

Annexure-II

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Annexure-II

27

Annexure-II

28

Annexure-IIAnnexure-III

29

Annexure-III

30

Annexure-III

31

Annexure-III

32

Annexure-III

33

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Annexure-VI

36

Annexure-VII

37

Flow Chart

Aluminium Chlorine Process Emissions

Aluminum Chloride Anhydrous

Description :

Aluminium is heated to its melting temperature and maintained in a pool. Chlorine in gaseous form is fed intoAluminum pool in the reactor. Aluminum Chloride Anhydrous vapors are formed and collected in to an air-cooled condensor, where the Aluminum Chloride Anhydrous vapors sublime to form crystalline power. This isfurther collected in bins and sent for grading and packing.

PRODUCT : Aluminum Chloride Anhydrous

Stage I

Annexure-VIII

38

Flow Chart

Toluene Chlorine gas

Benzo trichloride

Stage-1 : Chlorine gas is passed into boiling toulene in the presence of chlorine chlorinated activating light, amixture of different product is obtained. The principle product being substitued with chlorine molecule. This is acontinuous process.

Description :

Recovery and Reuse Process Emissions-Recovery

PRODUCT : Benzo trichloride

Stage I

Annexure-VIII

39

Flow Chart

1,3-Difluoro benzeneChloroacetyl Chloride Sol.Recovery4-Amino-1,2,4-Triazole Evaporation LossIsopropyl Alcohol EffluentHydrochloric Acid (35%) Organic ResidueSodium Nitrite Process EmissionsAmmonia (25%) soln.Water

Stage-1TMSI Sol.Recovery1,2,4-Triazole Evaporation LossPotassium Hydroxide EffluentMethylene Dichloride Organic ResidueWater

Fluconazole (Crude)Hydrochloric Acid (35%) EffluentAmmonia (25%) soln Spent CarbonCarbonHyflowWater

Stage-1 : 1,3-Difluro Benzene reacts with Chloroacetyl Chloride and condence with 4-Amino-1,2,4-Triazole inpresence of Sodium Nitrite in Isopropyl Alcohol solvent media to get Stage-1(2,4-Difluoro-1H-1YL-1,2,4-Triazole Acetophenone).

PRODUCT : Fluconazole

Fluconazole

Description :

Stage-2 : Stage-1 Compound is reacted with TMSI and condence with 1,2,4-Triazole in presence ofPotassium Hydroxide in Methylene Dichloride solvent media to get crude Fluconazole.

Stage-3 : Crude Fluconazole disolved in water and Hydrochloric Acid charge carbon and filter pH adjust withAmmonia solution to get Final Product of Fluconazole Pharma.

Stage I

Stage II

Stage III

Annexure-VIII

40

Stage-5 : Stage-4 Compound is reacted with Sodium Methoxide in presence of Methanol to get Stage-5Compound.

Stage-6 : Stage-5 Compound is reacted with Acetic Anhydride to get Stage-6 Compound.

Stage-7 : Stage-6 Compound is reacted with Sodium Hydroxide in presence of Methylene Dichloride to getStage-7 Compound.

Stage-8 : Stage-7 Compound is reacted with Thionyl Chloride in presence of Toluene and Acetone to getStage-8 Compound.

Stage-9 : Stage-8 Compound is reacted with (5-Difluoromethoxy)-2-mercapto Benzimidazole and SodiumHydroxide in presence of Toluene to get Stage-9 Compound.

Stage-10 : Stage-9 Compound is reacted with Sodium Hypochlorite and Sodium Hydroxide in presence ofAcetone and Toluene solvent media to get Pantoprazole Sodium.

Stage-2 : Stage-1 Compound is reacted with Ammonium Carbonate in presence of Toluene to get Stage-2Compound.

Stage-3 : Stage-2 Compound is reacted with Phosphorus Oxychloride in presence of Ethylene Dichloride toget (Stage-3) Compound

Description :

Stage-1 : Maltol is reacted with Diemthyl Sulfate in presence of Potassium Carbonate in Acetone solventmedia to get (Stage-1) Compound.

Stage-4 : Stage-3 Compound is reacted with Hydrogen Peroxide in presence of Methylene Dichloride and n-Hexane to get Stage-4 Compound.

PRODUCT : Pantoprazole Sodium

Annexure-VIII

41

Flow Chart

Maltol Sol.RecoveryDimethyl Sulfate Evaporation LossPotassium carbonate Organic ResidueAcetone Inorganic Solid Waste

Process Emissions

Stage-1 Sol.RecoveryAmmonium Carbonate Evaporation LossWater EffluentToluene Organic Residue

Process Emissions

Stage-2 Sol.RecoveryPhosphorus Oxychloride Evaporation LossWater EffluentSodium Hydroxide Organic ResidueEthylene Dichloride

Stage-3Hydrogen peroxide (50%) Sol.RecoveryAcetic acid Evaporation LossSodium hydroxide EffluentWater Organic ResidueMethylene Dichloriden-Hexane

Stage-4 Sol.RecoverySodium Methoxide Evaporation LossMethanol Organic Residue

Inorganic Solid Waste


Stage I

Stage II

Stage III

Stage IV

Stage V

Annexure-VIII

42

Stage-5 Sol.RecoveryAcetic Anhydride Evaporation Loss

Organic Residue

Stage-6 Sol.RecoverySodium Hydroxide Evaporation LossMethylene Dichloride EffluentWater Organic Residue

Stage-7 Sol.RecoveryThionyl Chloride Evaporation LossToluene Organic ResidueAcetone Process Emissions

Stage-8Sol.Recovery

Evaporation LossSodium Hydroxide EffluentWater Organic ResidueToluene

Stage-9Sodium Hypochlorite (4%) Sol.RecoveryAcetone Evaporation LossCarbon EffluentSodium Hydroxide Organic ResidueToluene Spent CarbonWater


Pantoprazole Sodium

5-Difluoromethoxy-2-mercapto benzimidazole

Stage VI

Stage VII

StageVIII

Stage IX

Stage X

Annexure-VIII

43

PRODUCT : Ciprofloxacin Hydrochloride

Description :

Stage-1 : Toluene was used as a solvent. Initially, Toluene was taken in the reactor (M.C.0.1 below), (take allsafety precautions before charging SH, Nitrogen blanketing is maintained (purging) through out up to complexmaintenance), to which sodium hydride added at RT, after that Dimethyl Carbonate addn, these mixture was

heated to 55oC. Acetophenone solution (acp+toluene) addition overall period of 4hrs at 60-65oC. after that

maintained another 4 hrs, the reaction mass was checked for completion of reaction. Then cooled to 15-20o

Acetic Acid was added within 2hrs at 15-20oC & maintained 30 minutes at 20oC.After that complex added

slowly at 20-30oC with in 2 hrs and maintained 10hrs at 30-35oC.the reaction mass was checked for completionof reaction. The reaction mass filtered to separate salt & organic layer. These organic layer taken and cooled to

0-5oC. The added CPA at 0-5oC and maintained 4 hrs completion of the reaction was checked. The solvent

removed upto70%. Then cooled to 5 to -2oC, centrifuge the mass & washed with chilled toluene.

Stage-3 : Methanol was used as a solvent. Initially solvent was taken into the reactor, piperazine and Q-Acid

material added. Then heated to 120-125oC.Reaction mass was maintained 15hrs at 125-130oc. Completion ofthe reaction mass checked. Then Base pure ml's (as a water input) was added to the mass and distill out thesolvent completely. Adjust the pH was neutral (6.9 to 7.2) by using hydrochloric acid and centrifuge the materialand washed with hot water.

Stage-2 : Initially, toluene was charged into the reactor & added stage-I material, heated up to reflux andremove water Azeotropically. Then CS flakes were added lot wise, collected water completely. Then the masswas maintained 2 hrs and the mass was checked for completion of reaction. Then solvent toluene can be

removed completely. After that water & C.S.lye charge & heated to 80-95oC. Maintained 4 hrs and checkedthe mass for completion of reaction. Hydrochloric acid was used to adjust pH 3-3.5 of reaction mass. Thencentrifuged the mass collect the material of Q-Acid.

After that water charged into the reactor and added that material. Then adjust the pH up to 4.2 to 4.5 by usingacetic acid, added carbon, EDTA, hyflo maintained 30 minutes filtered and collect the clear filtrate and adjust

pH neutral (6.9 to 7.2) by using ammonia solution at 55 to 60oC. Then centrifuge the mass at 55-60oC andwashed with hot water. Collect the material.

Stage-4 : Initially, required quantity of Methanol was taken in the reactor at RT and added stage-3 material.

Then adjust pH 2 to 2.5 by using cp HCl. Heated the reaction mass to 60-65oC. Maintained 3 hrs with in 60-

65oC. Then the mass was cooled to 10-15oC, maintained 1 hr at 10-15oC. The mass was centrifuded toseparate Methanol ml's and technical grade of Ciproflaxacin Hydrochloride.

Annexure-VIII

44

Flow Chart

2,4-Dichloro-5-Fluoro AcetophenoneDimethyl Carbonate Sol.RecvoerySodium Hydride (60%) Evaporation LossDimethyl Sulfate EffluentDimethylformamide Organic ResidueCyclopropyl amine Inorganic Solid WasteAcetic acid Process EmissionsTolueneWaterHydrochloric Acid (35%)

Stage-1Sodium Hydroxide Sol.RecoveryHydrochloric Acid (35%) Evaporation LossWater EffluentToluene Organic Residue

Stage-2PiperazineHydrochloric Acid (35%)Acetic acid Sol.RecvoeryAmmonium Hydroxide (25%) Evaporation LossCarbon Send to Auth. PartyEDTA Spent CarbonHyfloWaterMethanol

Ciprofloxacin Base Pure (470 + 370) Sol.RecoveryHydrochloric acid (35%) Evaporation LossMethanol EffluentWater Organic Residue

PRODUCT : Ciprofloxacin Hydrochloride

Ciprofloxacin Hydrochloride

Stage III

Stage IV

Stage I

Stage II

Annexure-VIII

45

Description :

PRODUCT : Salbutamol Sulfate

Stage-3 : Stage-2 Compound is oxidised with Selenium Dioxide in presence of 1,4-Dioxane to gove oxidesedcompound. It is further condenced with tert-Butylamine in presence of Methanol solvent media to give Stage-3Compound.

Stage-4 : Stage-3 Compound is reduction with Sodium Borohydride in presence of Lithium Bromide in Diglymeand Ethylene Dichloride solvent media to give Stage-4 Compound.

Stage-5 : Stage-4 Compound under goes deprotenation with Hydrogen in presence of Raney Nickel catalyst innitrogenic condition in Methanol solvent media to give Salbutamol base. It is further salt formation with Sulfuricacid to give Salbutamol Sulfate.

Stage-2 : Stage-1 Compound is condenced with Benzylchloride in presence of Potassium Carbonate,Dimethylsulfoxide, TEBAC and Methanol solvent media to give Stage-2 Compound.

Stage-1 : Methyl Salicylate is acylated with Acetyl Chloride in presence of Aluminum Chloride and EthyleneDichloride solvent media to Stage-1 Compound.

Annexure-VIII

46

Flow Chart

Methyl SalicylateAcetyl ChlorideAluminum Chloride Sol.RecoverySodium Bicarbonate Evaporation LossEthylene Dichloride EffluentIce Process EmissionsHydrochloric Acid (10%)Water

Stage-1DimethylsulfoxidePotassium Carbonate Sol.RecoveryBenzylchloride Evaporation LossTEBAC EffluentMethanol Process EmissionsWater

Stage-2 Byproduct1,4-Dioxane Sol.RecoverySelenium Dioxide Evaporation Losstert-Butylamine Organic ResidueMethanol

Stage-3DiglymeSodium Borohydride Sol.RecoveryLithium Bromide Evaporation LossAcetic Acid EffluentSodium Hydroxide Organic ResidueEDTA Spent CarbonEthylene DichlorideCarbonWater

Stage-4Methanol Sol.RecoveryRaney Nickel Evaporation LossHydrogen Organic ResidueNitrogen Process EmissionsSulfuric Acid

Salbutamol Sulfate

PRODUCT : Salbutamol Sulfate

Stage I

Stage II

Stage III

Stage IV

Stage V

Annexure-VIII

47

Stage-6 : 2-Azabicyclo-(3,3,0)-octane-3-Carboxylic acid benzyl ester reacts with ECPP Alanine in presenceof Toluene and Acetone gives Ramipril Benzyl ester.

Stage-7 : Ramipril Benzyl ester on hydrogenation with Hydrogen on Palladium Carbon in presence ofMethanol gives Ramipril.

Stage-2 : Methyl-β-chloro-α-acetamido propionate reacts with Cyclopentanone in presence of PotassiumCarbonate and Toluene gives 1-Acetylamino-2-(2-oxocyclopentyl) propionic acid methyl ester.

Stage-3 : 1-Acetylamino-2-(2-oxocyclopentyl) propionic acid methyl ester cyclises in presence ofHydrochloric acid and water give 2-Azabicyclo-(3,3,0)-octene-3-Carboxylic acid.

Stage-4 : 2-Azabicyclo-(3,3,0)-octene-3-Carboxylic acid on hydrogenation with Hydrogen on Palladiumcarbon in presence of Methanol gives 2-Azabicyclo-(3,3,0)-octane-3-Carboxylic acid.

Stage-5 : 2-Azabicyclo-(3,3,0)-octane-3-Carboxylic acid reacts with Benzylalcohol in presence of Sulfuricacid and Toluene gives 2-Azabicyclo-(3,3,0)-octane-3-Carboxylic acid benzyl ester.

Stage-1 : L-Serine methylester.HCl reacts with Acetic Anhydride in presence of Potassium Carbonate,Hydrochloric acid and Toluene gives Methyl-β-chloro-α-acetamido propionate.

Description :

PRODUCT : Ramipril

Annexure-VIII

48

Flow ChartL-Serine methylester.HCl Sol.RecoveryAcetic Anhydride Evaporation LossToluene EffluentPotassium Carbonate Organic ResidueHydrochloric Acid (35%) Process EmissionsWater

Stage-1 Sol.RecoveryCyclopentanone Evaporation LossToluene EffluentPotassium Carbonate Organic ResidueWater Process Emissions

Stage-2 Sol.RecoveryHydrochloric Acid (35%) Evaporation LossXylene EffluentWater Organic Residue

Stage-3 Sol.RecoveryPalladium Carbon Evaporation LossMethanol EffluentHiflo Organic ResidueHydrogen Spent CarbonWater Process Emissions

Stage-4Benzylalcohol Sol.RecoverySulfuric Acid Evaporation LossToluene EffluentWater

Stage-5ECPP Alanine Sol.RecoveryPara Toluene sulfonic acid Evaporation LossToluene EffluentAcetone Organic ResidueWater

Stage-6 Sol.RecoveryPalladium Carbon Evaporation LossMethanol EffluentHiflo Organic ResidueHydrogen Spent CarbonWater Process Emissions

PRODUCT : Ramipril

Ramipril

Stage I

Stage II

Stage III

Stage IV

Stage V

Stage VI

Stage VII

Annexure-VIII

49

Flow Chart

Ethyl cyanoacetate Sol.RecoveryDiethylamine Evaporation LossWater Effluent

Process Emissions

N,N-Diethyl cyanoacetamide

PRODUCT : N,N-Diethyl cyanoacetamide

Description :

Stage-1 : Ethyl cyanoacetate is condensed with Diethylamine in water media to gives N,N-Diethylcyanoacetamide compound.

Stage I

Annexure-VIII

50

Flow Chart

Acetyl chloride Recovery and Reuse Benzo trichloride Effluent Caustic Organic Residuewater

Acetyl chloride

Description :

Stage-1 : Acetic anhydride reacts with Benzo trichloride in presence of Caustic to form Acetyl chloride

PRODUCT : Acetyl chloride

Stage I

Annexure-VIII

51

Flow Chart

Chloro acetic acid Recovery and Reuse Benzo trichloride Organic ResidueWater for Serabbing Process Emissions-Recovery

Chloroacetyl chloride

Description :

Stage-1 : Chloro acetic acid reacts Benzo trichloride to form Chloroacetyl chloride

PRODUCT : Chloroacetyl chloride

Stage I

Annexure-VIII

52

Raw Material

Consumption of Raw Material /

Batch of Product

Daily Consumption of

Raw Material

Kg KgAluminium = 202.2 6066Chlorine = 803 24090

Raw Material


Batch of Product


Raw Material

Kg KgToluene = 543 3147.83Chlorine gas = 1259 7298.55

PRODUCT : Aluminum Chloride AnhydrousLIST OF RAW MATERIALS

PRODUCT : Benzo trichlorideLIST OF RAW MATERIALS

Annexure-IX

53

Raw Material


Batch of Product


Raw Material

Kg Kg1,2,4-Triazole = 76 63.31,3-Difluoro benzene = 110 91.74-Amino-1,2,4-Triazole = 90 75.0Ammonia (25%) soln = 298 248.3Carbon = 20 16.7Chloroacetyl Chloride = 110 91.7Hydrochloric Acid (35%) = 457 380.8Hyflow = 8 6.7Isopropyl Alcohol = 1310 1091.7Methylene Dichloride = 730 608.3Potassium Hydroxide = 88 73.3Sodium Nitrite = 76 63.3TMSI = 190 158.3

PRODUCT : FluconazoleLIST OF RAW MATERIALS

Annexure-IX

54

Raw Material


Batch of Product


Raw Material

Kg Kg5-Difluoromethoxy-2-mercapto benzimidazole = 70 70Acetic acid = 40 40Acetic Anhydride = 40 40Acetone = 1650 1650Ammonium Carbonate = 65 65Carbon = 10 10Dimethyl Sulfate = 45 45Ethylene Dichloride = 360 360Hydrogen peroxide (50%) = 40 40Maltol = 85 85Methanol = 415 415Methylene Dichloride = 715 715n-Hexane = 400 400Phosphorus Oxychloride = 35 35Potassium carbonate = 55 55Sodium Hydroxide = 84 84Sodium Hypochlorite (4%) = 507.5 508Sodium Methoxide = 23 23Thionyl Chloride = 39 39Toluene = 2405 2405

PRODUCT : Pantoprazole SodiumLIST OF RAW MATERIALS

Annexure-IX

55

Raw Material


Batch of Product


Raw Material

Kg Kg2,4-Dichloro-5-Fluoro Acetophenone = 380.5 253.7Acetic acid = 218 145.3Ammonium Hydroxide (25%) = 250 166.7Carbon = 16 10.7Cyclopropyl amine = 105 70.0Dimethyl Carbonate = 322.5 215.0Dimethylformamide = 183 122.0Dimethyl Sulfate = 316 210.7EDTA = 1 0.7Hydrochloric Acid (35%) = 697 464.7Hyflo = 4.5 3.0Methanol = 1897.5 1265.0Piperazine = 327.5 218.3Sodium Hydride (60%) = 146.5 97.7Sodium Hydroxide = 177 118.0Toluene = 3550 2366.7

PRODUCT : Ciprofloxacin HydrochlorideLIST OF RAW MATERIALS

Annexure-IX

56

Raw Material


Batch of Product


Raw Material

Kg Kg1,4-Dioxane = 465 1550Acetic Acid = 30 100Acetyl Chloride = 40 133.3Aluminum Chloride = 40 133.3Benzylchloride = 62 206.7Carbon = 6 20.0Diglyme = 167 556.7Dimethylsulfoxide = 10 33.3EDTA = 4 13.3Ethylene Dichloride = 766 2553.3Hydrochloric Acid (10%) = 200 666.7Hydrogen = 1.8 6Lithium Bromide = 27 90Methanol = 829 2763.3Methyl Salicylate = 62 206.7Nitrogen = 1 3.3Potassium Carbonate = 37.5 125Raney Nickel = 10 33.3Selenium Dioxide = 53 176.7Sodium Bicarbonate = 10 33.3Sodium Borohydride = 19 63.3Sodium Hydroxide = 25 83.3Sulfuric Acid = 10 33.3TEBAC = 2.5 8.3tert-Butylamine = 29 96.7

PRODUCT : Salbutamol SulfateLIST OF RAW MATERIALS

Annexure-IX

57

Raw Material


Batch of Product


Raw Material

Kg KgAcetic Anhydride = 40 66.7Acetone = 265 441.7Benzylalcohol = 112 186.7Cyclopentanone = 31 51.7ECPP Alanine = 77 128.3Hiflo = 4 6.7Hydrochloric Acid (35%) = 51 85Hydrogen = 3 5.0L-Serine methylester.HCl = 60 100Methanol = 525 875.0Palladium Carbon = 3 5.0Para Toluene sulfonic acid = 5 8.3Potassium Carbonate = 60 100Sulfuric Acid = 1 1.7Toluene = 1800 3000Xylene = 300 500

PRODUCT : RamiprilLIST OF RAW MATERIALS

Annexure-IX

58

Raw Material


Batch of Product


Raw Material

Kg KgDiethylamine = 168 258.5Ethyl cyanoacetate = 70 107.7

Raw Material


Batch of Product


Raw Material

Kg KgChloro acetic acid = 930 3100.00Benzo trichloride = 1925 6416.67

Raw Material


Batch of Product


Raw Material

Kg KgAcetyl chloride = 750 2500.00Benzo trichloride 1450 4833.33Caustic = 145 483.33

PRODUCT : N,N-Diethyl cyanoacetamideLIST OF RAW MATERIALS

PRODUCT : Acetyl ChlorideLIST OF RAW MATERIALS

PRODUCT : Chloroacetyl ChlorideLIST OF RAW MATERIALS

Annexure-IX

59

LIST OF HAZARDOUS RAW MATERIALS

Raw Material

1,4-DioxaneAcetic acidAcetic AnhydrideAcetoneAcetyl chlorideAluminium Aluminum ChlorideAmmonia (25%) solnAmmonium Hydroxide (25%)ChlorineChloroacetyl ChlorideDiethylamineDimethyl SulfateEthylene DichlorideHydrochloric Acid (10%)Hydrochloric Acid (35%)HydrogenHydrogen peroxide (50%)Isopropyl Alcoholn-HexaneNitrogenPhosphorus OxychlorideSulfuric AcidThionyl ChlorideToluene

Annexure-X

60

Annexure-XI

61

Colle

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Equa

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Tank

Solv

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for R

ecov

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Co

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Hold

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Neu

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tion

Aera

tion

Ta

nk

Stor

age

Tank

Du

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med

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filte

r

Steam Stripper

ATFD

Pre

aera

tion

ta

nk

Condenser R.

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Prod

uct w

ater

to

Util

ities

ACF

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COD

Efflu

ent i

nlet

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age

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Cond

ensa

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Cond

ensa

te

Pre aeration tank

Filtrate

Slud

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ter/

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sludg

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Annexure-XII

62

Schematic flow Sheet for EIA Procedure

Time schedule for obtaining the EC from MOEF

Submission of application by proponent (Form 1, Pre-feasilibility report and Draft Terms of Reference)

Scrutiny by EAC

Scoping an communication of Terms of Reference for EIA Studies to the Proponent for EIA preparation

Submission of proceedings of the public hearing by the SPCB / PCC to EAC

Conducting public hearing by SPCB / PCC or any other public Agency / authority engaged by regulatory authority

Submission of Draft EIA / Summary EIA / Application for Public consultation

Appraisal by EAC

Submission of final EIA by the proponent after improving EIA / EMP

Decision of MoEF

Decision of MoEF

Specific Concerns

Yes NO Rejection

Issuing clearance to project proponent

60 days

45 days

60 days

Scop

ing

Publ

ic C

onsu

ltanc

y De

cisio

n M

akin

g Ap

prai

sal

Reservation on the proposal conveyed to EAC

EAC views on reservations sent to MoEF

45 days

60 days

30 days

Category A Project

Preparation of FORM I Application & Prefeasibility report

30 days on obtaining information from industry

as per check list

Preparation of Draft EIA report 120 days minimum other than monsoon period of 120 days

30 days for preparation of Final REIA Maximum

Annexure-XIII

63

Environmental Baseline Monitoring (To Establish quality of the

Environment)

Application of Impact Prediction Tools (Quantitative Significance Analysis)

Identification of Likely Impacts (Quantitative Significance Analysis

(Ref: Impact Matrix)

EIA Team

Social Impact Assessment

Risk Assessment

Project Features (Pre-feasibility Report,

Form1)

Valued Environment Components

Mitigation Measures

Environmental Management Plan

Reporting

Approach of EIA Study – 4 months other than monsoon period after obtaining TOR copy from MOEF

Annexure-XIII

64

Annexure-XIV

65

Annexure-XV

66

Seismic Map of India

Annexure-XVI

67

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