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Page 1: Contents€¦ · Environment, Forest and Climate Change, Govt. of India, New Delhi. 1.1 Salient Features of the Project • Proposing expansion in the existing plant premises with
Page 2: Contents€¦ · Environment, Forest and Climate Change, Govt. of India, New Delhi. 1.1 Salient Features of the Project • Proposing expansion in the existing plant premises with

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Contents

S. No. Description Page No.

1.0 Executive Summary 1

1.1 Salient Features of the Project 2

2.0 Introduction 3 2.1 Identification of the Project and project proponent 3 2.2 Brief description of Nature of the Project 4

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

5

2.4 Demand and Supply Gap 5

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

6

2.6 Employment Generation 6

3.0 Project Description 6

3.1 Type of the project including interlinked and interdependent projects, if any 6

3.2 Location 6 3.3 Alternate sites 7 3.4 Size or magnitude of operation 7 3.5 Project description 8 3.6 Raw materials 9 3.7 Resources optimization / recycling and reuse 9 3.8 Availability of water and Energy 10

3.9 Quantity of Wastes Generation and their Management / Disposal

10

3.9.1 Water requirement and Wastewater generation and their Management / Disposal

10

3.9.2 Hazardous / 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

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S. No. Description Page No.

4.7 Climate data from Secondary sources 16 4.8 Social Infrastructure 16

5.0 Planning 16 5.1 Planning Concept 16 5.2 Population Projection 17 5.3 Land use planning 17 5.4 Assessment of Infrastructure Demand 17 5.5 Amenities/Facilities 17

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 18 6.8 Industrial Waste Management 18 6.8.1 Process Emissions Management 18 6.8.2 Fugitive emissions 19 6.8.3 Emissions–Utilities 20 6.8.4 Noise Environment 21 6.9 Hazardous / Solid Waste Management 21 6.10 Power Requirement & Supply / Source 21

7.0 Rehabilitation and Resettlement (R&R) Plan 21 8.0 Project Schedule & Cost Estimates 21

8.1 Time Schedule for the project construction 22 8.2 Estimated project cost 22

9.0 Analysis of proposal (Final Recommendations) 22 9.1 Budgetary allocation for Pollution Control Measures 22

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List of Tables

Table Title Page

1 Coordinates of all Corners of the Project Site 6

2 Permitted Products and their Capacities 8

3 Proposed Products, their Capacity and Therapeutic Category 8

4 Existing Water Requirement, Wastewater Generation and its Treatment 11

5 Proposed Water Requirement and Waste water Generation with Segregation 12

6 Effluent Treatment Flow as per segregation 12

7 Hazardous Waste Generation from the Existing (CFO) Products 13

8 Hazardous / Solid Waste Generation from the Proposed Products 14

9 Environmental Components Shortest distance from Project Periphery 15

10 Land Break-up details 17

11 Maximum Quantity of Process emission from Existing Products 19

12 Maximum Quantity of Process emission from Proposed Products 19

13 Stack Emission Details – Proposed 20

14 Budgetary allocation for pollution Control Measures 23

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LIST of Annexures

Annexure No.

Title Page

I First NOC from APPCB vide order No. 24262/PCB/NOC/AEE-V/93-

1477 dated 28-04-1993 24-27

II Second NOC vide order No. 2/PCB/RO/SRD/93-21 dated 06-09-1993 28

III APPCB issued renewal consent vide no. APPCB/PTN/132/RO/W/

2003/170-629 dated 12-02-2004 29-42

IV EC from MoEF vide order F.No. J-11011/79/2004-IA-II (I) dated 15-

07-2005 43-46

V PH Notification and PH minutes 47-55

VI Consent for operation as per EC permitted capacities vide consent

order no. APPCB/PTN/132/RO/ 2003/A/712-1060 dated 13-2-2006 56-71

VII Latest CFO from TSPCB vide order no.

TSPCB/RCP/CFO&HWM/HO/2016-2356 dated 24-11-2016 72-79

VIII GO. Ms. No. 239 dated 11-10-2016 regarding the formation /

reorganization of District, Revenue Divisions and Mandals in

Sangareddy District

80-84

IX CA Certificate 85

X General location of the Proposed Project 86

XI Specific Location of the Proposed Project 87

XII Google map showing the coordinates 88

XIII Plant Layout 89

XIV Typical process description & Flowchart for proposed products 90-108

XV Raw Materials required for the manufacture of Proposed products 109-117

XVI Hazardous chemicals list 118

XVII Ground water analysis Report 119

XVIII ETP Flow Scheme 120

XIX Schematic Flow Sheet for EIA Procedure 121-122

XX Topography Map – 10km radius 123

XXI Soil Analysis Report 124

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Harika Drugs Pvt. Ltd. Pre-Feasibility Report

1

Pre-Feasibility Report for Expansion of APIs Manufacturing Unit and R&D Facility

1.0 Executive Summary

M/s. Harika Drugs Pvt. Ltd. proposes to expand its Active Pharmaceutical Ingredients (APIs)

manufacturing unit with R&D facility in the existing plant premises with extended land area of 2.23

Ha. (22273.2 sq.m). The Unit is located in S.Nos. 165/A, 165/AA & 165/E, Gummadidala (V & M),

Sangareddy District, Telangana State (formerly Jinnaram (M), Medak Dist., Andhra Pradesh State).

The expansion proposal is to obtain Environmental Clearance (EC) from the Ministry of Environment,

Forests and Climate Change (MoEF&CC) to manufacture 6 campaign products at a time out of 19

APIs proposed products with a production capacity of 600.2 TPA and R&D products from existing

production capacity of 23.16 TPA.

Background:

Industry was established in the year 1989 and obtained first NOC from APPCB to

manufacture 5 bulk drugs with a total capacity of 7.5 TPD (2700 TPA) vide order No.

24262/PCB/NOC/AEE-V/93-1477 dated 28-04-1993 (Annexure-I) and second NOC vide order No.

2/PCB/RO/SRD/93-21 dated 06-09-1993 (Annexure-II). APPCB issued renewal consent vide no.

APPCB/PTN/132/RO/W/2003/170-629 dated 12-02-2004 (Annexure-III) with reduced quantities and

reduced products as per the production details submitted in the application.

Industry obtained Environmental Clearance from MoEF vide order F.No. J-11011/79/2004-IA-II (I)

dated 15-07-2005 (Annexure-IV) for 3 APIs with a capacity of 23.16 TPA. Public Hearing was

conducted under Ex-Post Facto Environmental Clearance on 11-4-2005 to 12-4-2005 (PH Notification

and PH minutes enclosed as Annexure-V). (However in EC order, mentioned as “Public hearing for

the project is not applicable since the unit is SSI and located in the notified industrial estate. Cost of

the project is 1.45 Crore”). Obtained the renewal Consent for operation as per Environmental

Clearance permitted capacities vide consent order no. APPCB/PTN/132/RO/ 2003/A/712-1060 dated

13-2-2006 (Annexure-VI). Industry is obtaining regular renewals for operation of the plant from time

to time. The Latest Consent for the Operation from TSPCB vide order no.

TSPCB/RCP/CFO&HWM/HO/2016-2356 dated 24-11-2016 (Annexure-VII) valid upto 31-12-2021.

Gummadidala Village is now formed as Mandal as per Telangana issued GO. Ms. No. 239 dated

11-10-2016 regarding the formation / reorganization of District, Revenue Divisions and Mandals in

Sangareddy District. (Annexure-VIII)

The proposed expansion project is to manufacture 19 products (including the permitted products with

increased capacities) along with R&D activity on campaign basis i.e. maximum 6 products at a time

with a production capacity of 600TPA + 0.2 TPA R&D activity with a total investment of Rs.36.97

Crores including the existing investment of Rs. 15.97 Crores (Annexure-IX).

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Harika Drugs Pvt. Ltd. Pre-Feasibility Report

2

The proposed expansion of APIs manufacturing unit (Synthetic Organic Chemical industry) falls under

Category 'A' project under 5 (f) of EIA Notification 2006 and will be apprised by the Ministry of

Environment, Forest and Climate Change, Govt. of India, New Delhi.

1.1 Salient Features of the Project

• Proposing expansion in the existing plant premises with extended land Area: 2.23 Ha.

• Total Greenbelt area is 0.7886 Ha (35.4%) of 2.23 Ha.

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

i. Adjacent to the road in E direction connecting Gummadidala and Kanukunta villages and 1.2 km to SH-6 (Hyderabad-Narsapur road) in SSW direction.

ii. Gummadidala village & Mandal at 0.9 km (SSW)

iii. Mambapur village at 2.2 km (SW)

iv. Dabilpur railway station at 10 km in SE direction. v. Hyderabad International Airport at 50 km in S direction. vi. Hyderabad ORR at 11.7 km (SSE) vii. Dundigal Air base at 1.5 km (SE)

• Total cost of the expansion is Rs. 36.97 Crores including existing investment of Rs. 15.97

Crores. Total capital cost allocated towards environmental pollution control measures is Rs.

6.04 Crores including existing investment of Rs. 2.44 Crores. Recurring cost after expansion will

be about Rs. 4.5 Crores per annum.

• The proposed power requirement of the plant is 1200 KVA (CMD) including existing 200 KVA

(CMD). Power will be met from Telangana State Power Distribution Corporation Limited.

• Total water requirement will be about 206.9 KLD of which fresh water requirement will be

141.4 KLD. Treated effluent of 65.5 KLD from ETP will be reused in cooling tower makeup.

Fresh water will be met from bore wells.

• Diesel of about 430 lit/hr will be used in the proposed D.G. sets of 2x1000 KVA, in addition to

existing 2 x 75 KVA DG sets. DG sets are used as standby during power failure. Existing 2 lakh

Kcal/hr diesel fired Thermic Fluid Heater will be standby in the proposed expansion.

• About 26.8 TPD of coal will be used in the proposed 2 & 4 TPH coal fired boilers along with

proposed 4 lakh Kcal/hr Coal fired Thermic Fluid Heater. Existing 0.5 TPH coal fired boiler will

be dismantled.

• About 239 employees including existing 114 employees will be benefitted due to the proposed

project. Out of which direct 85 and indirect 154 employees.

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• Industry will provide dual scrubbers based on the characteristics of process emissions. Multi-

cyclone separator & bag filter will be provided to Boilers to reduce the particulate emissions into

atmosphere.

• The wastewater generated from the plant will be about 73.2 KLD from process, washing,

utilities, Fresh water RO rejects, scrubber, Q.C, R&D and domestic wastewater.

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

neutralization then sent to upgraded ETP-ZLD of 75 KLD capacity within the premises.

• Domestic wastewater will be sent 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.

• Industry will upgrade the existing solvent recovery system for recovery of solvents from the

process. Primary and secondary condensers will continue to be provided with cooling water and

chilled brine circulation for effective recovery of solvents thereby reducing the solvent

emissions.

• 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 only. Built-in acoustic

enclosures provided for DG sets unit to minimize the noise levels. However, the workers in this

area will be provided with ear muffs.

Industry has prepared Form-I along with draft Terms of Reference (ToR) in the process of

obtaining ToR for preparation of EIA, in line with issue of Environmental Clearance. Hence, pre-

feasibility report highlighting the expansion project and the 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 established in 1989. M/s. Harika Drugs Pvt. Ltd. has obtained

Environmental Clearance (EC) from the Ministry of Environment and Forest (MoEF), New Delhi in

2005 for production quantity of 23.16 TPA vide order F.No. J-11011/79/2004-IA-II (I) dated 15-07-

2005. Public Hearing was conducted under Ex-Post Facto Environmental Clearance on 11-4-2005 to

12-4-2005. Industry proposes expansion of APIs with the production quantity of 600.2 TPA in the land

extent of 2.23 Ha at S.Nos. 165/A, 165/AA & 165/E, Gummadidala (V & M), Sangareddy District,

Telangana State.

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• Industry was established in the year 1989 and first NOC from APPCB to manufacture bulk drugs

vide order No. 24262/PCB/NOC/AEE-V/93-1477 dated 28-04-1993 and second NOC vide order

No. 2/PCB/RO/SRD/93-21 dated 06-09-1993 for a total capacity of 2700 TPA.

• APPCB issued renewal consent vide no. APPCB/PTN/132/RO/W/2003/170-629 dated 12-02-

2004 with reduced quantities and reduced products as per the production details submitted in the

application.

• Latest Consent for Operation from TSPCB vide order no. TSPCB/RCP/CFO&HWM/HO/2016-

2356 dated 24-11-2016 valid upto 31-12-2021.

Project Proponent

U.Amarnath:- A graduate in Pharmacy with 30 years’ experience in the Process development,

Production, Quality Control and Waste management of Active Pharmaceutical Ingredients. He is the

Managing Director of Harika Drugs Private Limited since 1993 and is involved in all Plant operations

on a day to day basis.

Mrs. U. Vijaya, Director: A graduate in Commerce, involved in Financial Operations of the Company

on a day to day basis.

A. V. Rama Krishna Rao, Director: A graduate in Management, involved in Marketing activities of the

company.

2.2 Brief Description of the Nature of the Project

This is an expansion of existing APIs manufacturing unit. The products manufactured are

used in API formulation industry and the therapeutic category of the products Anti-Inflammatory

Agents, Antihistamines, Oral antidiabetic agent, Skeletal Muscle Relaxant, antidepressant, Nutritional

supplement, Anticholinergic, Neuroleptic etc., which are applicable for human consumption around

the world after formulation activity.

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

processing extending to maximum of 4 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 adopt the

state of art technologies and dedicated team of environmental professionals for treatment and

recycling of effluents, operation and monitoring of all pollution control equipment. Industry has a

defined EHS policy and robust environmental management system supported by a well-defined

organizational structure to ensure the prevention of pollution and to protect the environment.

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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.

2.4 Demand and Supply Gap

The demand for APIs and API intermediates is a derived demand. It gets derived from the

demand for various medicinal formulations (final administrable drugs) for the formulation industry. The

APIs being manufactured by basic drug manufacturers are exported as such or used by domestic

formulators in their production processes. The formulation firms further produce final medicines and

export these as well as sell these in the domestic market.

There is a wide gap in the demand and availability of cheap and quality medicines in India

and the world over. Generic medicines and off patent drugs have significant potential to increase

access to cheap and effective medicines to poor people and in general to bridge the demand supply

gap. Indian basic drug manufacturers are playing a significant role in increasing access to affordable

off patent drugs.

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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. Most of imports are from

Chinese companies and thus India losing valuable foreign reserves to China. India imported APIs worth Rs. 13,853 Cr from China in 2015-16, or 65.29 % of the total API Imports of Rs. 21,216 Cr. 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 every year. This shows the

acceptability of the products produced in India. The formulations market has shown a tremendous

increase in the exports every year. 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. This information is sourced from Bulk Drug Manufacturers Association (BDMA) and Business-Standard.

2.6 Employment Generation

The expansion facility will generate direct and indirect employment. At present the company

has over 114 employees. About 239 employees including existing 114 employees will be benefitted

due to the proposed project, in that 85 nos. direct employment and 154 nos. of indirect employment.

3.0 Project Description

3.1 Type of the project including interlinked and interdependent projects, if any:

Proposed Expansion of APIs manufacturing industry (Synthetic Organic Chemical industry)

falls under Category-A project under 5 (f) of EIA Notification 2006 and its subsequent amendments.

The proposed unit is located in Gummadidala (V & M), Sangareddy District, Telangana State. There

is no interlink and interdependent project for this expansion project.

3.2 Location

The Unit is located S.Nos. 165/A, 165/AA & 165/E, Gummadidala (V & M), Sangareddy

District, Telangana State. Project site co-ordinates of all corners are presented in Table 1. The

project site is well connected by the State High Way.

Table 1: Co-ordinates of all corners of the Project site

Sl. No. Latitude Longitude Sl. No. Latitude Longitude 1 17°41'44"N 78°22'26"E 4 17°41'38"N 78°22'29"E 2 17°41'42"N 78°22'32"E 5 17°41'40"N 78°22'25"E 3 17°41'39"N 78°22'30"E 6 17°41'42"N 78°22'26"E

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The map showing general location, specific location, Google map showing the Co-ordinates

and Plant layout of the project showing existing and proposed facilities are presented at Annexures- X, XI, XII and XIII respectively.

3.3 Alternate Sites

This proposed expansion project is in the existing plant premises with extended land at

Gummadidala (V & M), Sangareddy District, Telangana State. Hence, Alternate sites are not

considered for the present expansion project.

Environmental considerations of this expansion project site.

• > 900 m away from human habitation

• Water Bodies

a) Pond Near Nawabpet at 3.3 km (NE) b) Pond Near Kanukunta at 2 km (E) c) Pond near Anantaram at 2 km (ESE) d) Pond Near Gummadidala at 1 km (SSE) e) Pond Near Bonthapally at 3.4 km (SSW) f) Erra Cheruvu Gummadidala at 0.7 km (SW), g) Pond near Mambapur at 1.7 km (SW) h) Pond Near Nallavalli at 2.2 km (NW)

• Reserve forests:

Narsapur Reserved Forest Block (Gottimukkula RF, Nallagutta RF, Naguvaram RF,

Royyapalli RF, Mangapet RF, Bonthapalli RF, Jinnaram RF, Mambapur RF, Nalavalli RF)

at 3 km (W)

Nawabpet RF at 2 km (N)

Kanukunta RF at 5.3 km (NE)

Bijilipur RF at 8.9 km (NE)

Dabilpur RF at 8.3 km (SE)

Wailal RF at 9.3 km (E)

• 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: 2.23 Ha.

Production Capacity: 600.2 TPA from 6 out of 19 products on campaign basis along with R&D

products (permitted production capacity: 23.16 TPA). The permitted and proposed products

with its production capacities are presented in Tables 2 & 3 respectively.

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Table 2: Permitted Products and their Capacities

S. No. Name of the product Quantity

(TPM) Quantity

(TPA) 1 Pheniramine Maleate 1 12 2 Promethazine Hydrochloride 0.67 8.04 3 Imipramine Hydrochloride 0.26 3.12

Total Production Quantity 23.16

Table 3: Proposed Products, their Capacity and Therapeutic Category

S. No. List of Products Quantity

kg/day Quantity

(TPA) CAS No. Therapeutic

Category 1. Benzydamine HCl 13.33 4.8 132-69-4 Anti- Inflammatory 2. Buclizine Dihydrochloride 25 9 129-74-8 Antihistamine 3. Carisoprodol 333.33 120 78-44-4 Muscle Relaxant 4 Chlorpheniramine Maleate 16.67 6 113-92-8 Antihistamine

5 Chromium Picolinate 83.33 30 14639-25-9 Nutritional supplement

6 Doxylamine Succinate 25 9 562-10-7 antihistamine 7 Gliclazide 200 72 21187-98-4 Oral antidiabetic

8 Hydroxyzine Dihydrochloride 66.67 24 2192-20-3 Antihistamine

9 Imipramine Hydrochloride 20 7.2 113-52-0 Antidepressant

10 Meclizine Dihydrochloride Monohydrate 25 9

1104-22-9 Antihistamine

11 Meloxicam 33.33 12 71125-38-7 Anti-inflammatory 12 Orphenadrine Citrate 333.33 120 4682-36-4 Anticholinergic

13 Oxomemazine Hydrochloride 13.33 4.8 4784-40-1 antihistamine

14 Oxomemazine 20 7.2 3689-50-7 antihistamine 15 Pheniramine Maleate 233.33 84 132-20-7 antihistamine 16 Prochlorperazine Maleate 26.67 9.6 84-02-6 Neuroleptic

17 Promethazine Hydrochloride 333.33 120 58-33-3 Antihistamine

18 Promethazine Theoclate 16.67 6 17693-51-5 Antihistamine 19 Sertraline Hydrochloride 233.33 84 113-92-8 Antidepressant

Total 6 products at time out of total 19products 1666.65 600

R & D Activity 1 R&D 0.5 0.2

Total 6 products at time out of total 19 products and R&D products

1667.2 600.2

Source: Harika Drugs Pvt. Ltd.

3.5 Project Description

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

processing extending to maximum of 4 stages involving different types of chemical reactions. Typical

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process description with process details for all 19 products is enclosed at Annexure-XIV. 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-XIII.

3.6 Raw Materials

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

chemicals/solvents and the fuel. The chemicals required for the process are mostly secured from the

local (indigenous) markets. Some of these raw materials will be imported from various countries.

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 APIs 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.

• About 26.8 TPD of coal will be used in the proposed 2 & 4 TPH coal fired boilers along with

proposed 4 lakh Kcal/hr Coal fired Thermic Fluid Heater. Existing 0.5 TPH coal fired boiler will

be dismantled.

• Diesel of about 430 lit/hr will be used in the proposed D.G. sets of 2x1000 KVA, in addition to

existing 2 x 75 KVA DG sets. Existing 2 lakh Kcal/hr diesel fired Thermic Fluid Heater will be

standby in the proposed expansion. DG sets are used as standby during power failure.

• The proposed power requirement of the plant is 1200 KVA (CMD) including existing 200 KVA

(CMD). Power will be met from Telangana State Power Distribution Corporation Limited.

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

at Annexure -XV and Hazardous chemicals list is presented at Annexure-XVI.

3.7 Resources Optimization / Recycling and Reuse

R&D facility in the unit is making 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 Proponent.

Improvement of yield of the products so as to reduce the waste generation during

manufacturing.

Industry uses zero liquid discharge plant to reuse all treated effluents as makeup water for

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

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

Organic residue, spent carbon, distillation residue will be sent to Authorized Cement Industries

to burn in Cement Kiln as an alternate fuel or TSDF in case of shut down of Cement

industries.

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10

Boiler ash will be sent to Brick manufacturing units.

ETP sludge / Evaporation salts will be sent to TSDF or Authorized Cement Industries based

on the calorific value of the waste.

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

drums will be disposed off to outside agencies after complete detoxification.

Spent catalyst will be sent back to suppliers

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

Optimum utilization of solar energy.

There is tremendous potential for implementation of clean technologies, recovery and reuse

techniques in this proposed APIs unit which will be explored and implemented after R&D process.

3.8 Availability of Water and Energy

Fresh water requirement is about 141.4 KLD which will be met from 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. Characteristics of Ground water are

enclosed at Annexure–XVII.

The proposed power requirement (Contract Power Demand) of the plant is 1200 KVA

including existing 200 KVA and it is sourced from the Telangana State Power Distribution Corporation

Limited. Coal and Diesel will be procured from the distribution sources closer to the project site.

3.9 Quantity of Wastes Generation and their Management /Disposal

3.9.1 Water requirement and Wastewater Generation and their Management / Disposal

The permitted water requirement and waste water generation with treatment is presented in

Tables 4. The proposed gross water requirement after expansion will be 206.9 KLD of which total

fresh water requirement will be 141.4 KLD. Treated effluent from ETP-ZLD of about 65.5 KLD will be

reused in utilities. Fresh water will be met from bore wells. Proposed Water Requirement and Waste

water Generation with Segregation is presented in Table 5. The sources of wastewater generation

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

waste. Total proposed wastewater will be 73.2 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 6.

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Table 4 : Existing Water Requirement, Wastewater Generation and its Treatment

Description Water

Requirement (KLD)

Wastewater Generation

in KLD Treatment

Process 2.5 0.3

Till the MEE system is installed: Shall be lifted to MEE system of M/s. JETL, Jeedimetla. After installation & Commissioning of the MEE system: • Shall be stripped of for organics recovery. • Stripper condensate for distillation for

separation of organic compounds followed by disposal to cement plants for co-processing. Distilled effluents shall be routed to LTDS effluents.

• Stripped effluents for Forced Evaporation in MEE followed by ATFD/ Nutch Filter

• Condensate from MEE & ATFD routed to LTDS Effluents

• Evaporation slats from ATFD/ Nutch Filter to TSDF

Cooling Tower 0.3

3.75 M/s. PETL, Patancheru after pre-treatment, along with MEE

Boiler Blow down 0.5

Domestic 1 washings 0.2 Gardening 3

Total 7.5 4.05

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Table 5: Proposed Water Requirement and Waste water Generation with Segregation

Description

Input (KLD) Output (KLD)

Fresh Water

Recycled Water

Evaporation / Handling

Loss Total

Wastewater Segregation type of

Wastewater

Process (6 products at a time) 16.9 -- (-1.3) 18.2 HTDS/HCOD

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

10 -- -- 10 LTDS/LCOD

Boiler (Proposed 2 + 4 boiler)

29 24 5 (3.4 % Blow

down) Utilities

(LTDS/LCOD)

(20 % Makeup) --

Cooling Tower 1800 TR 42.5 65.5 99 9

(Bleed) Fresh water RO rejects 12 -- -- 12 LTDS / LCOD

Scrubber 4 -- -- 4 HTDS / LCOD Q.C and R&D 5 -- -- 5 LTDS/LCOD Domestic (239 nos @50 lpcd) 12 -- 2 10 LTDS/LCOD

Greenbelt (1.9 acres @ 5KL/acre) 10 -- 10 - --

Total 141.4 65.5 133.7 73.2

Stripper condensate 0.5 KLD; Moisture in salt and ETP sludge is 0.5 KLD, Water loss in ETP 6.7 KLD (Total water loss is 7.7 KLD = 10.1 %) Reuse: 65.5 KLD 206.9 206.9

Table 6: Effluent Treatment Flow as per Segregation

Effluent Characteristics

Quantity (KLD) Treatment Flow

Stream -1 (Process & scrubber)

TDS > 5000 mg/l COD > 5000 mg/l

22.2

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

MEE & ATFD Condensate to ETP (Biological Treatment) along with domestic wastewater holding tank Pressure Sand Filter Activated Carbon Filter ETP RO system RO permeate water reuse in Cooling towers.

ETP RO rejects to MEE.

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

Stream- 2 (Process, Washings,

QC, R&D and Domestic)

TDS / COD < 5000 mg/l

39 Collection Equalization cum Neutralization ETP (Biological Treatment) along with MEE & ATFD Condensate

Stream 3 (Fresh water RO rejects) 12 Collection Tank ETP RO system

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Existing treatment system will be enhanced to meet the proposed effluent quantities. All the

proposed additional tanks in the ETP will be constructed / installed above the ground with water proof

lining. These individual effluents will be pumped to the RCC lined tanks for storage and neutralization

and then sent to upgraded ETP-ZLD of 75 KLD capacity within the plant premises. Effluent Treatment

Plant flow chart is enclosed as Annexure-XVIII.

ETP – ZLD facility consists of primary treatment (equalization and neutralization), thermal

treatment (stripper with MEE, ATFD), secondary treatment (biological) and tertiary treatment

(Pressure sand filter, Activated carbon filter & Reverse Osmosis) will be provided. Domestic

wastewater will be sent 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 or Authorized

Cement industries for safe disposal based on calorific value of the waste.

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 APIs manufacturing plant is presented in the Tables 7 & 8 respectively. Spillages such as wastewater / solid wastes / raw materials 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.

Table 7: Hazardous Waste Generation from the Existing (CFO) Products

S. No Description Quantity

(kg/month) Disposal

1 ETP Sludge 50 TSDF Dundigal, Rangareddy District for

secured land filling 2 Forced Evaporation salts 200

3 Process Waste (Sodium Chloride) 250

4 Spent Carbon 90 TSDF, Dundigal, Rangareddy District for Incineration / Authorised cement plants for

co-incineration 5 Distillation Bottom Residue 80

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Table 8: Hazardous / Solid Waste Generation from the Proposed Products

Sl. No. Description

Proposed Quantity

(TPD) Stream Handling

Method Disposal

1. Organic residue from Process 1.41 28.1 of

Schedule -I HDPE Drums

Sent to SPCB Authorized Cement

industries or to TSDF for Incineration

2. Distillation Bottom Residue (1% of spent solvents) 0.2 36.1 of

Schedule -I

3. Spent carbon 0.1 28.3 of Schedule -I

4. Inorganic & Evaporation salt (Process) (10% moisture) 2 28.1 of

Schedule -I HDPE Bags

Sent to SPCB Authorized Cement

industries or to TSDF for Incineration

5. Evaporation salt (Non-Process) 0.5 35.3 of

Schedule -I

6. ETP Sludge 0.3 35.3 of Schedule -I

7. Boiler ash 11 -- HDPE Bags

Sent to Brick Manufacturers

Other Hazardous Waste generation from the Plant

8.

a) Detoxified Container / Liners drums, HDPE Carboys, Fiber Drums,

100 Nos./ month

33.1 of Schedule-I Designated

covered area

Disposed to SPCB Authorized agencies

after complete detoxification b) PP Bags 100

Kg/month --

9. Spent solvents (17.2 KLD + 0.8 KLD water) 18 KLD 28.6 of

Schedule -I Tanks / Drums

Recovered within the premises

10.

Recovered Solvents from Spent solvents (85% recovery from spent solvents)

14.5 KLD 28.6 of

Schedule -I

Tanks / Drums

Reuse or sold to Recyclers

11. Spent Mixed solvents (unrecovered solvents) 2.7 KLD 28.6 of

Schedule -I Tanks/ Drums

Sent to SPCB Authorized agencies

12. Waste oils & Grease 3 KL/annum 5.1 of Schedule -I MS Drums

Sent to SPCB Authorized agencies for

reprocessing

13. Used Lead acid Batteries 50 Nos. / annum

A1160 of Schedule-III

Stored in Covered

shed

Sent to suppliers on buy-back basis.

14. Misc. Waste (spill control waste) L.S. -- Stored in

Drums TSDF 15. Rejects L.S. --

16. E- waste L.S. -- Designated covered

area

Authorized reprocessor or

TSDF

17. Waste papers & other types of packing scrap L.S. -- Sold to scrap venders

18. Canteen waste L.S. -- HDPE bags

Composted on site and reused for green belt

19 Bio Medical Waste LS. -- Color coded

containers

Sent to SPCB authorized Biomedical

waste incinerator Note: Hazardous / Solid waste quantities maximum on various combinations i.e., 6 products on campaign products at a point of time and R&D products

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3.10 Schematic Flow Sheet for EIA Procedure

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

4.0 Site Analysis 4.1 Connectivity

This proposed expansion project site is located at a distance (aerial) of 1.2 km (SSW) from

State Highway No. 6 (Hyderabad-Narsapur); about 0.9 km (SSW) from Gummadidala village &

Mandal; 10 km (SE) to Dabilpur railway station; 50 km (S) to Hyderabad International Airport.

4.2 Land Form, Land use and Land Ownership

The proposed expansion is in the existing manufacturing unit in the existing with extended

land. Total land is 2.23 Ha. Plain land and is in possession of Project Proponent.

4.3 Topography

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

4.4 Existing Land Use Pattern

The existing and proposed land use pattern of project area (core area) of 2.23 Ha is Industrial

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

are given in Table 9.

Table 9: Environmental Components shortest distance from Project periphery

S. No. Description Distance & Direction w.r.t. site 1. Water bodies • Pond Near Nawabpet at 3.3 km (NE)

• Pond Near Kanukunta at 2 km (E) • Pond near Anantaram at 2 km (ESE) • Pond Near Gummadidala at 1 km (SSE) • Pond Near Bonthapally at 3.4 km (SSW) • Erra Cheruvu Gummadidala at 0.7 km (SW), • Pond near Mambapur at 1.7 km (SW) • Pond Near Nallavalli at 2.2 km (NW)

2. Reserve Forests • Narsapur Reserved Forest (Dense mixed Jungle) Block (Gottimukkula RF, Nallagutta RF, Naguvaram RF, Royyapalli RF, Mangapet RF, Bonthapalli RF, Jinnaram RF, Mambapur RF, Nalavalli RF) at 3 km (W)

• Nawabpet RF (Fairly Dense Scrub) at 2 km (N) • Kanukunta RF (Dense Scrub) at 5.3 km (NE) • Bijilipur RF at (Fairly dense jungle) 8.9 km (NE) • Dabilpur RF (open scrub) at 8.3 km (SE) • Wailal RF (Dense Mixed Jungle) at 9.3 km (E)

3. National Parks/ Wild Life Sanctuaries/ Eco sensitive areas

Nil

4. Industries 1. Maha Sai Laboratories, 2. SKR Chemicals 3. Srivathsa Life Sciences P. Ltd., 4. Teckbond Laboratories P.Ltd., 5. Flemming Laboratories Ltd., 6. Luwis Chemicals

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7. Jay Ambe Gowri Chemicals, 8. Siris Crop Sciences 9. Vijetha Life Sciences Pvt. Ltd., 10. IDA Bontapally

5. Habitation Gummadidala village at 0.9 km (SSW) 4.5 Existing Infrastructure

Internal CC / Black top roads, Transportation facilities, water supply, In-house ETP facility

(pre-treatment), Power supply, Primary Health Centre, Conference halls, Fire hydrant system,

Telecommunication facility, canteen etc., are available.

4.6 Soil Classification

The soil in the study area is brownish in colour and sandy clay texture. Soil analysis report is

enclosed as Annexure-XXI.

4.7 Climate Data from Secondary Sources

The area enjoys pleasant, warm and dry climate. The coldest season is during December and

January, where the temperature touch a minimum of 13.6 - 15.8°C and warmest period is during the

month of April to May when the Mercury shoots up to 43 – 44.2°C.

The area experiences the maximum rainfall during the months of July to September and a

little rainfall during October, November and December due to North-East monsoon. Apart from these,

occasional rainfall is obtained from cyclonic storms and depression originating in the Bay of Bengal.

The normal annual rainfall of the area is around 951.7 mm. The rainfall is erratic and long period of

dry spells leading to drought conditions are frequent and periodic.

4.8 Social Infrastructure

Adjacent to the road connecting Gummadidala and Kanukunta villages, at 1.2 km (SSE) to

State Highway (SH-6); Road network, Transportation facilities, Private water supply, Power supply,

Fire station, Hospitals, Telecommunication facility, Schools, Community centers etc., are available at

Jeedimetla, Hyderabad located at a distance of 20 km (aerial distance) and also available in nearby

villages.

5.0 Planning

5.1 Planning Concept

Type of Industry: APIs & its Intermediate manufacturing industry with R&D products.

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

the project will be provided as per requirement.

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

expansion project is well connected to Road, Rail and Airways.

Town and Country Planning Classification: This is private land, converted to industrial use and is

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in possession of project proponent

5.2 Population Projection

Proposal is for expansion of the existing industry and there is a scope for increase in the

population in the vicinity as most of the skilled workers prefers to stay in the nearby locations to avoid

travelling from long distances. However semi skilled and indirect employment potential is from local

villages. Hence, there is a possibility of increase in population of the skilled and semi skilled. The

local unskilled villagers will be preferred for the unskilled jobs such as gardening, movement of

materials, etc. Educated youth will be employed as semi-skilled workers and training will be provided.

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 existing with extended area of about 2.23 Ha i.e.,

22273.02 sq.m. Total land is in the procession of the Proponent. The Break-up of the Land in

procession of the proponent is presented in Table 10.

Table 10: Land Break-up Details

S. No. Description

Existing Area

Additional Area

Total Area

(SQ.M) (SQ.M) (SQ.M) Percent (%)

1. Built-up area

11043 11230

5528.35 24.82 2. Roads 3750 16.84 3. Greenbelt 7886 35.40 4. Open Area 5108.67 22.94

Total 11043 11230 22273.02 100

5.4 Assessment of Infrastructure Demand

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

facility and Fire station requirement for the nearby villages of project area. Project site located in

Gummadidala village & mandal in Sangareddy District and is near to the state capital Hyderabad.

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 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

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• Seating facilities for those employees who do their work standing and ergonomically designed seating facilities for those who do their work seating

• 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, Utilities area, ETP upgradation has been proposed in the

existing and extended area of 2.23 Ha.

6.2 Residential Area

There will be no residential area within the project site.

6.3 Greenbelt

The existing Greenbelt of 35.4% i.e. 0.7886 Ha out of 2.23 Ha total area of the project.

6.4 Social Infrastructure

As Enterprise Social Commitment (ESC), 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 be provided to additional employees. The source of drinking water

is packaged drinking water.

6.7 Sewerage System

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

collection tank through pipelines and will be sent to ETP – ZLD system which needs to be upgraded

to meet the project demand.

6.8 Industrial Waste Management

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

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

techniques.

6.8.1 Process Emissions Management

Manufacturing of APIs will result in gaseous emissions. Maximum process emissions for

existing and proposed products are given in Tables 11 & 12 respectively. Proposed gaseous

emissions will be scrubbed in two stages with water and caustic solution based on the characteristics

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of gases. Proposed additional 6 scrubbers for the expansion project in addition to the existing 2

scrubbers to scrub the additional process emissions.

Table 11: Maximum Quantity of Process Emissions from Existing Products

Sl. No.

Process Emission

Maximum Quantity on various

combinations (kg/day)

Treatment

1. HCl 3.8 • Scrubber using caustic lye solution

2. NH3 4.7 • Scrubbed by using Chilled water / dil. H2SO4 solution

Table 12: Maximum Quantity of Process Emissions from Proposed Products

Sl. No.

Process Emission

Maximum Quantity on various combinations

(kg/day) Treatment

1. HCl 47.67 • Scrubbed by using water & CS lye sol.

2. SO2 301.4 • Scrubbed by using CS lye solution

3. NH3 60.9 • Scrubbed by using Chilled water / dil. H2SO4 solution.

4. H2 1.5 • Diffused with Flame Arrestor

6.8.2 Fugitive emissions

Solvents used in the APIs manufacturing process will be stored in drums and bulk quantities

will be stored in 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.

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

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Solvent Input Solvent in Solvent

Recovery Effluent Org. residue Handling loss 17.5 KLD

100% 0.019 KLD

0.108% 0.028 KLD

0.16% 0.271 KLD

1.55 % 17.19 KLD

98.18%

6.8.3 Emissions–Utilities

Boilers, Thermic fluid heater and DG sets are the main sources contributing to emissions from

the plant. Proposed 2 & 4 TPH coal fired boilers, 4 lac K.cal coal fired thermic fluid heater (TFH) are

in addition to the existing. Existing 0.5 TPH coal fired boiler will be dismantled and 2 lakh K. cal/hr

Diesel fired thermic fluid heater will be used as standby. Coal of about 26.8 TPD will be used in the

boiler & TFH.

Diesel about 430 lit / hr will be used at full operation load in the DG sets & Thermic Fluid

Heaters. Proposed D.G. sets are of 2 nos. of 1000 KVA, in addition to existing 2 nos. of 75 KVA DG

set. Existing 2 lakh Kcal/hr diesel fired TFH will be standby in proposed. DG sets will be used as

standby during power failure. The stack emissions from the boiler and DG sets are given in Table 13.

Table 13: Stack Emission Details – Proposed

Source Stack Height

(m)

Diameter (m)

Temperature (oC)

Flue Gas Flow rate

(m3/hr)

Exit Gas

Velocity (m/sec)

PM SO2 NOx

kg/hr

Coal Fired Boilers 4 TPH

(proposed) 30 0.5 150 10645 15.1 0.54 5.67 3.24

2 TPH (proposed) 30 0.3 150 5322 21.12 0.27 2.83 1.62

Thermic Fluid Heaters 4 lakh. K.cal/hr

(proposed – Coal fired)

30 0.28

150 1490 6.8 0.095 1.0 0.58

2 lakh K.cal/hr

(Existing– Diesel fired - standby)

150 768 3.5 0.004 0.088 0.094

Diesel Generator (DG) sets Proposed 1000 KVA 11 0.4 150 5645 12.5 0.06 1.25 1.34 1000 KVA 11 0.4 150 5645 12.5 0.06 1.25 1.34 Exisitng

75 KVA 6 0.1 150 425 14.8 0.005 0.09 0.1 75 KVA 6 0.1 150 425 14.8 0.005 0.09 0.1

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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.

Stack height will be based on Sulphur content in fuel as per CPCB guidelines

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

6.8.4 Noise Environment

• 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.

• 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, distillation

residue, boiler ash, spent mixed unrecoverable solvents and spent carbon.

• The organic residues, Spent carbon & Spent mixed unrecoverable solvents, distillation residue

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 TSDF.

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

6.10 Power Requirement & Supply / Source

The proposed power requirement (Contract Power Demand) of the plant is 1200 KVA

including existing 200 KVA. Proposed D.G. sets are 2 x 1000 KVA, in addition to existing 2 x 75 KVA

DG set. DG set which will be used as standby during power failure.

7.0 Rehabilitation and Resettlement (R&R) Plan

The proposed project is in the existing area with extended land and is completely in

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

this expansion project. The nearest habitation is away from >0.9 km away from the project site.

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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 April 2018 as it

is expected that the expansion project will be in a position to obtain Environmental Clearance for the

project and Consent to Establish from the State Pollution Control Board. In 2019 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. 36.97 Crores. Total capital cost allocated towards environmental pollution

control measures is Rs. 6.04 Crores including the existing Rs. 2.44 Cr. and the Recurring cost will be

about Rs. 4.5 Crores per annum.

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 239 members will be benefitted due to the

expansion project (including existing 114 nos.).

• Under the Enterprise Social Commitment, Industry will continue to develop a policy of

developing the surrounding 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 proposed and existing capital equipment for environmental

management include up-gradation of effluent treatment plant, pipelines and channels for wastewater

discharge, greenbelt development, air pollution control equipments and the environment laboratory.

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

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Table 14: Budgetary allocation for Pollution Control Measures

S. No. Description

Existing cost (in lakhs)

Proposed cost (in lakhs)

Capital *Recurring Capital *Recurring

1. Air Pollution Control a. Multicyclone / Bag filter with Stacks 9 6 20 10 b. Scrubbers 20 20

2. Water Pollution Control a. ETP Civil works, Steam stripper, MEE, ATFD, R.O. and mechanical equipment 90 60 170 175

3. Noise Pollution Control a. Silencers / acoustic enclosures 6 3 20 5

4. Solid Waste Management a. Covered Platform with leachate collection system 8 30 10 120**

5. Greenbelt Development 10 5 5 5 6. Occupation Health and Safety 16 15 20 20 7. Fire Management 35 5 30 5 8. Dyke walls and Storm water drains 8 5 5 5 9. Environmental Laboratory 18 20 40 30 10 Misc. 24 30 20 75

Total 244 179 360 450 *Recurring cost includes manpower, consumables, maintenance, energy charges per annum

** includes transportation, stabilization and handling charges to Cement industries / TSDF

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Annexures

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ANNEXURE - I

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ANNEXURE - VI

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ANNEXURE - VII

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GOVERNMENT OF TELANGANA ABSTRACT

District Administration – Formation/Reorganization of District, Revenue Divisions and Mandals in Sangareddy District – Final Notification - Orders – Issued.

REVENUE (DA-CMRF) DEPARTMENT

GO. Ms. No. 239: Date: 11.10.2016

Read:-

1) GO. Rt. No. 368 Revenue (DA-CMRF) Department dated 22-08-2016:

ORDER:- The appended notification will be published in an Extra-Ordinary Issue of Telangana Gazette, dated 11.10.2016 2. The Commissioner of Printing Stationery and Stores Purchase, Telangana State, Hyderabad is requested to publish the notification and furnish 100 copies of the Gazette notification for the use of the Government.

(BY ORDER IN THE NAME OF GOVERNOR OF TELANGANA)

K.PRADEEP CHANDRA SPECIAL CHIEF SECRETARY

To The Collectors concerned The Commissioner of Printing, Stationery & Stores Purchase, TS, Hyderabad The Chief Commissioner of Land Administration, T.S., Hyderabad SF/SC

//FORWARDED: BY ORDER// SECTION OFFICER

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N O T I F I C A T I O N Form II

In exercise of the powers conferred under Section 3 of the Telangana Districts (Formation) Act, 1974, the Governor of Telangana, in the interests of better administration and development of the area concerned, after taking into consideration of the objections and suggestions received from various people and public representatives, by altering the boundaries of existing District(s), i.e., as specified in Section 3 of the Central Act No. 6 of 2014 and its Revenue Divisions and Mandals and Villages, do hereby notify, the new District, Revenue Divisions and Mandals and Villages as specified in the Schedules below, with effect from 11.10.2016. Formation of new District, Revenue Divisions, Mandals and Villages will not have any effect on the existing elected bodies of Zilla Parishads, Mandal Parishads and Gram Panchayats and their jurisdiction over the areas covered by the existing districts, as specified in Section 3 of the Central Act No. 6 of 2014 till the new ZPs, MPs and GPs are constituted, in accordance with law.

ANNEXURE - VIII

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SCHEDULE-I Sangareddy District

Sl.No. Name of the District

Name of the Revenue including

New Revenue Division

Mandals in the District including

New Mandals

Name of the

Erstwhile District

Name of the

Erstwhile Revenue Division

1 2 3 4 5 6 1

Sangareddy

Sangareddy

Sangareddy

Medak

Sangareddy

2 Kandi * 3 Kondapur 4 Sadasivpet 5 Patancheru 6 Ameenpur * 7 Ramchandrapuram 8 Munipally Zaheerabad 9 Jinnaram

Medak

10 Gummadidala * 11 Pulkal 12 Andole 13 Vatpally * 14 Hathnoora 1

Zaheerabad

Zahirabad Zaheerabad 2 Mogudampally * 3 Nyalkal

Sangareddy 4 Jharasangam 5 Kohir 6 Raikode 1

Narayankhed

Narayankhed

Medak

2 Kangti 3 Kalher 4 Sirgapoor * 5 Manoor 6 Nagilgidda*

K. PRADEEP CHANDRA SPECIAL CHIEF SECRETARY

REVENUE DEPARTMENT

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Schedule-II

Reorganization of Mandals in Sangareddy District

Sl.No. Name of the Mandal Villages in the Mandal

Name of the Erstwhile

Mandal(s) from which the present Mandal is formed

1 2 3 4 1

Sangareddy

Irigipally

Sangareddy

2 Chintalpally 3 Kalabgoor 4 Tadlapally 5 Kulabgoor 6 Fasalwadi 7 Mohd.Shapur 8 Nagapur 9 Sangareddy (M )

10 Kalwakunta 11 Pothreddipally 12 Kothlapur 13 Ismailkhanpet 1

Kandi*

Arutla

Sangareddy

2 Chidruppa 3 Byathole 4 Erdanoor 5 Mamidipally 6 Kandi 7 Koulampet 8 Kashipur 9 Utharpally

10 Makthaalloor 11 Kalvemula 12 Topgonda 13 Julkal 14 Indrakaran 15 Cheriyal 16 Eddumailaram 1 Kondapur Garakurthi Kondapur 2 Aliabad

ANNEXURE - VIII

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8 Bandalguda 9 Ramachandrapuram 1

Jinnaram

Vailal

Jinnaram

2 Jinnaram 3 Palem (DP) 4 Mangampet 5 Ootla 6 Solakpally 7 Amdoor 8 Sivanagar 9 Kodakanchi

10 Puttaguda 11 Nalthur 12 Madaram 13 Khazipally 14 Kistaipally 15 Chetlapotharam 16 Gaddapotharam 17 Bollaram 1

Gummadidala*

Lakshmapur

Jinnaram

2 Kothapally 3 Pyaranagar 4 Nallavally 5 Mambapur 6 Antharam 7 Kanukunta 8 Dacharam 9 Gummadidala

10 Domadugu 11 Bonthapally 12 Annaram 1

Pulkal

Hunnapur (DP)

Pulkal

2 Manthoor 3 Raipahad 4 Peddareddipet 5 Seripeddareddipet (DP) 6 Singoor 7 Pocharam 8 Muddaipet 9 Pulkal

10 Baswapur 11 Mudimanikyam

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ANNEXURE -IX

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General Location Map

Telangana State

Gummadidala Mandal, Sangareddy District Project Site

ANNEXURE - X

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Project Site

Specific Location (Route Map) ANNEXURE - XI

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Google Image of the Proposed Project with Project Site Coordinates

Sl. No. Latitude Longitude Sl. No. Latitude Longitude 1 17°41'44"N 78°22'26"E 4 17°41'38"N 78°22'29"E 2 17°41'42"N 78°22'32"E 5 17°41'40"N 78°22'25"E 3 17°41'39"N 78°22'30"E 6 17°41'42"N 78°22'26"E

ANNEXURE - XII

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ANNEXURE - XIII

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Flow Chart

1-Bromo-3-ChloropropaneDimethylamine Hydrochloride Sol.RecoverySodium Hydroxide Evaporation LossToluene EffluentWater Organic Residue

Sol.RecoveryStage-1 Evaporation LossToluene EffluentWater Organic Residue

Benzydamine Sol.RecoveryHydrogen Chloride Evaporation LossIsopropyl Alcohol Organic ResidueActivated Carbon Spent Carbon

Process Emissions

Stage-2 : Stage-1 Compound is reacted with Sodium-1-Benzyl-1H-indazol-3-olate in the presence of Toluene asa solvent medium to yield Benzydamine base which is obtained after the solvent is distilled under vacuum.

Stage-3 : Benzydamine base is reacted with Hydrogen Chloride gas in presence of Isopropyl Alcohol as solventmedium followed by Carbon treatment to give Benzydamine Hydrochloride.

Benzydamine Hydrochloride

PRODUCT : Benzydamine Hydrochloride

Description :

Stage-1 : 1-Bromo-3-Chloropropane is reacted with Dimethylamine Hydrochloride in presence of SodiumHydroxide using Toluene as solvent medium to give Stage-1 Compound.

Sodium-1-Benzyl-1H-indazol-3-olate

Stage I

Stage II

Stage III

ANNEXURE - XIV

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Flow Chart

1-(4-Chlorobenzhydryl)piperazine4-tert-Butylbenzyl Bromide Sol.RecoverySodium Hydroxide Evaporation LossToluene EffluentWater Organic Residue

Buclizine Sol.RecoveryHydrogen Chloride Evaporation LossIsopropyl Alcohol Organic ResidueActivated Carbon Spent Carbon

Process Emissions

Stage-1 : 1-(4-Chlorobenzhydryl)piperazine is reacted with 4-tert-Butylbenzyl Bromide in presence of SodiumHydroxide using Toluene as solvent mdium to give Buclizine Base which is obtained after the solvent is distilled outunder vacuum.

Stage-2 : Buclizine base is reacted with Hydrogen Chloride gas in presence of Isopropyl Alcohol followed byCarbon treatment to give Buclizine Hydrochloride.

Buclizine Dihydrochloride

PRODUCT : Buclizine Dihydrochloride

Description :

Stage I

Stage II

ANNEXURE - XIV

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Flow Chart

Sol.RecoveryEvaporation Loss

Sodium Cyanate EffluentToluene Organic ResidueHydrogen Chloride Process EmissionsWater

Carisoprodol (Tech) Sol.RecoveryIsopropyl Alcohol Evaporation LossActivated Carbon Organic Residue

Spent Carbon

Carisoprodol

Isopropyl carbamic acid-2-Hydroxymethyl-2-methyl pentyl ester

Stage-1 : Isopropyl carbamic acid-2-Hydroxymethyl-2-methyl pentyl ester is reacted with Sodium Cyanate in thepresence of Hydrogen Chloride gas using Toluene as solvent medium to give Carisoprodol Technical.

Stage-2 : Carisoprodol Technical is dissolved in Isopropyl Alcohol as solvent medium followed by Carbontreatment to give Pure Carisoprodol.

PRODUCT : Carisoprodol

Description :

Stage I

Stage II

ANNEXURE - XIV

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Flow Chart

Chlorpheniramine Base Sol.RecoveryMaleic acid Evaporation LossIsopropyl Alcohol Organic ResidueActivated Carbon Spent Carbon

Chlorpheniramine Maleate

Stage-1 : Chlorpheniramine base is reacted with Maleic acid in presence of Isopropyl Alcohol as solventmedium followed by Carbon treatment to give Chlorpheniramine Maleate.

PRODUCT : Chlorpheniramine Maleate

Description :

Stage I

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Flow Chart

Picolinic acid

EffluentSodium HydroxideWater

PRODUCT : Chromium Picolinate

Description :

Stage-1 : Picolinic acid is reacted with Chlromium Chloride Hexahydrate in the presence of Sodium Hydroxideusing water as solvent medium to give Chromium Picolinate.

Chromium Picolinate

Chromium Chloride Hexahydrate Stage I

ANNEXURE - XIV

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Flow Chart

2-Dimethylamino Ethanol Sol.RecoveryThionyl Chloride Evaporation LossSodium Hydroxide Effluento-Xylene Organic ResidueWater Process Emissions

Stage-1

Sol.RecoverySodium Hydroxide Evaporation LossSodium Amide Effluento-Xylene Organic ResidueWater

Doxylamine Base Sol.RecoverySuccinic acid Evaporation LossAcetone Organic ResidueActivated Carbon Spent Carbon

Stage-1 : 2-Dimethylamino ethanol is reacted with Thionyl Chloride to give 2-Dimethylamino ethyl chlorideHydrochloride which is further reacted with Sodium Hydroxide in presence of o-Xylene as solvent medium to yieldStage-1 Compound.

Stage-2 : Methyl Phenyl Pyridyl Carbinol Hydrochloride is reacted with Sodium Hydroxide in the presence of oXylene as solvent medium to give Methyl Phenyl Pyridyl Carbinol. Stage-1 Compound is reacted with MethylPhenyl Pyridyl Carbinol in the presence of Sodium Amide using o -Xylene as a solvent to yield Doxylamine basewhich is distilled under vacuum.

Stage-3 : Doxylamine base is reacted with Succinic acid in presence of Acetone as solvent medium followed byCarbon treatment to form Doxylamine Succinate.

Doxylamine Succinate

Methyl Phenyl Pyridyl Carbinol Hydrochloride

PRODUCT : Doxylamine Succinate

Description :

Stage I

Stage II

Stage III

ANNEXURE - XIV

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Flow Chart

Sol.Recoveryp-Toluenesulfonyl Urea Evaporation LossToluene EffluentWater Organic Residue

Gliclazide (Tech) Sol.RecoveryIsopropyl Alcohol Evaporation LossActivated Carbon Organic Residue

Spent Carbon

Gliclazide

N-Amino-Azabicyclo Octane Hydrochloride

PRODUCT : Gliclazide

Description :

Stage-1 : N-Amino-Azabicyclo Octane Hydrochloride is reacted with p -Toluenesulfonyl Urea in presence ofToluene as solvent medium to get Technical grade Gliclazide.

Stage-2 : The Technical grade Gliclazide is dissolved in Isopropyl Alcohol solvent followed by Carbon treatmentto give Pure Gliclazide.

Stage I

Stage II

ANNEXURE - XIV

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Flow Chart

4-Chloro Benzhydryl Piperazine2-Chloroethoxy Ethanol Sol.RecoverySodium Hydroxide Evaporation LossToluene EffluentWater Organic Residue

Hydroxyzine Base Sol.RecoveryHydrogen Chloride Evaporation LossIsopropyl Alcohol Organic ResidueActivated Carbon Spent Carbon

Process Emissions

Stage-1 : 4-Chloro Benzhydryl Piperazine is reacted with 2-Chloroethoxy ethanol in presence of SodiumHydroxide using Toluene as solvent medium to give Hydroxyzine Base which is obtained after the solvent isdistilled out under vacuum.

Stage-2 : Hydroxyzine base is reacted with Hydrogen Chloride gas in presence of Isopropyl Alcohol as solventmedium followed by Carbon treatment to form Hydroxyzine Hydrochloride.

Hydroxyzine Dihydrochloride

PRODUCT : Hydroxyzine Dihydrochloride

Description :

Stage I

Stage II

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Flow Chart

1-Bromo-3-ChloropropaneDimethylamine Hydrochloride Sol.RecoverySodium Hydroxide Evaporation Losso-Xylene EffluentWater Organic Residue

Stage-1 Sol.RecoveryIminodibenzyl Evaporation LossSodium Amide Effluento-Xylene Organic ResidueWater Process Emissions

Imipramine Base Sol.RecoveryHydrogen Chloride Evaporation LossIsopropyl Alcohol Organic ResidueActivated Carbon Spent Carbon

Process Emissions

Imipramine Hydrochloride

Stage-1 : 1-Bromo-3-Chloropropane is reacted with Dimethylamine Hydrochloride in presence of SodiumHydroxide using o -Xylene as solvent medium to give Stage-1 Compound.

Stage-2 : Stage-1 Compound is reacted with Iminodibenzyl in the presence of Sodium Amide using o -Xylene as asolvent to yield Imipramine Base which is distilled under vacuum.

Stage-3 : Imipramine Base is dissolved in Isopropyl Alcohol, treated with Carbon and to the reaction mass isadded Hydrogen Chloride gas in Isopropyl Alcohol solvent medium to form Imipramine Hydrochloride.

PRODUCT : Imipramine Hydrochloride

Description :

Stage I

Stage II

Stage III

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Flow Chart

4-Chloro Benzhydryl Piperazine3-Methyl Benzyl Bromide Sol.RecoverySodium Hydroxide Evaporation LossToluene EffluentWater Organic Residue

Meclizine Base Sol.RecoveryHydrogen Chloride Evaporation LossIsopropyl Alcohol Organic ResidueActivated Carbon Spent CarbonWater Process Emissions

Meclizine Dihydrochloride Monohydrate

PRODUCT : Meclizine Dihydrochloride Monohydrate

Description :

Stage-1 : 4-Chloro Benzhydryl Piperazine is reacted with 3-Methyl Benzyl Bromide in presence of SodiumHydroxide using Toluene as solvent medium to give Meclizine Base which is obtained after the solvent is distilledout under vacuum.

Stage-2 : Meclizine Base is reacted with Hydrogen Chloride gas and Water in presence of Isopropyl Alcohol assolvent medium followed by Carbon treatment to obtain Meclizine Dihydrochloride Monohydrate.

Stage I

Stage II

ANNEXURE - XIV

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Flow Chart

Sol.RecoveryEvaporation Loss

2-Amino-5-methyl thiazole Organic Residueo-Xylene

4-Hydroxy-2-methyl-1,1-dioxo-1,2-dihydro-1-benzo[1,2] thiazine-3-carboxylic acid isopropyl ester

Stage-1 : 4-Hydroxy-2-methyl-1,1-dioxo-1,2-dihydro-1-benzo[1,2] thiazine-3-carboxylic acid isopropyl ester isreacted with 2-Amino-5-methyl thiazole using o -Xylene as solvent medium to form Meloxicam.

PRODUCT : Meloxicam

Description :

Meloxicam

Stage I

ANNEXURE - XIV

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Flow Chart

2-MethylbenzophenoneSodium BorohydrideSodium Hydroxide EffluentHydrochloric acid (35%) Process EmissionsWater

Stage-12-Dimethylamino ethanol Sol.Recoveryp-Toluenesulfonic acid Evaporation LossSodium Hydroxide EffluentToluene Organic ResidueWater

Orphenadrine Base Sol.RecoveryCitric acid Evaporation LossIsopropyl Alcohol Organic ResidueActivated Carbon Spent Carbon

Orphenadrine Citrate

Stage-1 : 2-Methylbenzophenone is reacted with Sodium Borohydride in the presence of Sodium Hydroxideusing water as solvent and subsequent neutralization with Hydrochloric acid to give Stage-1 Compound.

Stage-2 : Stage-1 Compound is reacted with 2-Dimethylamino ethanol in the presence of p -Toluenesulfonic acidas catalyst and Sodium Hydroxide using Toluene as a solvent medium to yield Orphenadrine Base which isdistilled under vacuum.

Stage-3 : Orphenadrine Base is reacted with Citric acid in presence of Isopropyl Alcohol as solvent mediumfollowed by Carbon treatment to give Orphenadrine Citrate.

PRODUCT : Orphenadrine Citrate

Description :

Stage I

Stage II

Stage III

ANNEXURE - XIV

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Flow Chart

Oxomemazine Sol.RecoveryHydrogen Chloride Evaporation LossIsopropyl Alcohol Organic Residue

Process Emissions

Oxomemazine Hydrochloride

Stage-1 : Oxomemazine is reacted with Hydrogen Chloride gas in presence of Isopropyl Alcohol as solventmedium to form Oxomemazine Hydrochloride.

PRODUCT : Oxomemazine Hydrochloride

Description :

Stage I

ANNEXURE - XIV

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Flow Chart

Sol.RecoveryDimethylamine Hydrochloride Evaporation LossSodium Hydroxide Effluento-Xylene Organic ResidueWater

Stage-1 Sol.RecoveryPhenothiazine Evaporation LossSodium Amide Effluento-Xylene Organic ResidueWater Process Emissions

Trimeprazine Base Sol.RecoveryHydrogen Peroxide (50%) Evaporation Losso-Xylene EffluentSodium Sulfate Organic ResidueWater Process Emissions

Oxomemazine (Crude) Sol.RecoveryIsopropyl Alcohol Evaporation LossActivated Carbon Organic Residue

Spent Carbon

1-Bromo-2-Methyl-3-Chloro Propane

Oxomemazine

Stage-1 : 1-Bromo-2-Methyl-3-Chloro Propane is reacted with Dimethylamine Hydrochloride in presence ofSodium Hydroxide using o -Xylene as solvent medium to give Stage-1 Compound.

Stage-2 : Stage-1 Compound is reacted with Phenothiazine in the presence of Sodium Amide using o -Xylen as solvent medium to yield Trimeprazine Base which is distilled under vacuum.

Stage-3 : Trimeprazine Base is reacted with Hydrogen Peroxide solution in presence of Sodium Sulfate using oXylene as solvent medium to form Oxomemazine Crude.

Stage-4 : The Crude Oxomemazine is dissolved in Isopropyl Alcohol solvent medium followed by treatment withCarbon to give Pure Oxomemazine.

PRODUCT : Oxomemazine

Description :

Stage I

Stage II

Stage III

Stage IV

ANNEXURE - XIV

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Flow Chart

2-Dimethylamino Ethanol Sol.RecoveryThionyl Chloride Evaporation LossSodium Hydroxide Effluento-Xylene Organic ResidueWater Process Emissions

Stage-1 Sol.RecoverySodium Amide Evaporation Loss2-Benzylpyridine Effluento-Xylene Organic ResidueWater Process Emissions

Pheniramine Base Sol.RecoveryMaleic acid Evaporation LossIsopropyl Alcohol Organic ResidueActivated Carbon Spent Carbon

Description :

Pheniramine Maleate

Stage-1 : 2-Dimethylamino Ethanol is reacted with Thionyl Chloride to give 2-Dimethylamino ethyl chlorideHydrochloride which is further reacted with Sodium Hydroxide in presence of o-Xylene as solvent medium toyield Stage-1 Compound.

Stage-2 : Stage-1 Compound is reacted with 2-Benzylpyridine in the presence of Sodium Amide using o -Xylene as solvent medium to yield Pheniramine Base which is distilled under vaccum.

Stage-3 : Pheniramine Base is reacted with Maleic acid in presence of Isopropyl Alcohol as solvent mediumfollowed by Carbon treatment to give Pheniramine Maleate.

PRODUCT : Pheniramine Maleate

Stage I

Stage II

Stage III

ANNEXURE - XIV

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Flow Chart

1-Bromo-3-Chloro PropaneN-Methyl Piperazine Sol.RecoverySodium Hydroxide Evaporation LossTetrabutylammonium Bromide EffluentToluene Organic ResidueWater

Stage-12-Chloro Phenothiazine Sol.RecoverySodium Hydroxide Evaporation LossToluene EffluentWater Organic Residue

Prochlorperazine BaseMaleic acid EffluentWater

Prochlorperazine Maleate

Stage-1 : 1-Bromo-3-Chloro Propane is reacted with N-Methyl Piperazine in the presence of Sodium Hydroxideand Tetrabutylammonium Bromide as a catalyst using Toluene as solvent medium to give Stage-1 Compound.

Stage-2 : Stage-1 Compound is reacted with 2-Chloro Phenothiazine in the presence of Sodium Hydroxide usingToluene as solvent medium to yield Prochlorperazine Base which is obtained after the solvent is distilled outunder vacuum.

Stage-3 : Prochlorperazine base is reacted with Maleic acid using Water as solvent to form ProchlorperazineMaleate.

PRODUCT : Prochlorperazine Maleate

Description :

Stage I

Stage II

Stage III

ANNEXURE - XIV

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Flow Chart

Dimethylamino-2-Propanol Sol.RecoveryThionyl Chloride Evaporation LossSodium Hydroxide Effluento-Xylene Organic ResidueWater Process Emissions

Stage-1 Sol.RecoveryPhenothiazine Evaporation LossSodium Amide Effluento-Xylene Organic ResidueWater Process Emissions

Promethazine Sol.RecoveryHydrogen Chloride Evaporation LossIsopropyl Alcohol Organic ResidueActivated Carbon Spent Carbon

Process Emissions

Stage-1 : Dimethylamino-2-Propanol is reacted with Thionyl Chloride to give Dimethylamino-2-propyl chlorideHydrochloride which is further reacted with Sodium Hydroxide using o -Xylene as solvent medium to yield Stage-1Compound.

Stage-2 : Stage-1 Compound is reacted with Phenothiazine in the presence of Sodium Amide using o -Xylene assolvent medium to yield Promethazine base which is distilled under vacuum.

Stage-3 : Promethazine base is dissolved in Isopropyl Alcohol, treated with Carbon and reacted with HydrogenChloride gas to give Promethazine Hydrochloride.

Promethazine Hydrochloride

PRODUCT : Promethazine Hydrochloride

Description :

Stage I

Stage II

Stage III

ANNEXURE - XIV

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Flow Chart

Promethazine Hydrochloride Sol.RecoverySodium Hydroxide Evaporation LossToluene EffluentWater Organic Residue

Promethazine Sol.Recovery8-Chloro Theophylline Evaporation LossIsopropyl Alcohol Organic ResidueActivated Carbon Spent Carbon

Stage-2 : Promethazine Base is reacted with 8-Chloro Theophylline using Isopropyl Alcohol as solvent mediumfollowed by Carbon treatment to give Promethazine Teoclate.

Promethazine Teoclate

PRODUCT : Promethazine Teoclate

Description :

Stage-1 : Promethazine Hydrochloride is dissolved in water and reacted with Sodium Hydroxide using Tolueneas solvent medium to give Promethazine Base.

Stage I

Stage II

ANNEXURE - XIV

107

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Flow Chart

Racemic Sertraline HydrochlorideAmmonia Solution (25%) Sol.RecoveryD-Mandelic acid Evaporation LossMethyl Isobutyl Ketone EffluentWater Organic Residue

Sertraline Mandelate Sol.RecoveryAmmonia Solution (25%) Evaporation LossMethyl Isobutyl Ketone EffluentWater Organic Residue

Sertraline Base Sol.RecoveryHydrochloric acid (35%) Evaporation LossMethyl Isobutyl Ketone EffluentActivated Carbon Organic Residue

Spent Carbon

Stage-3 : Sertraline Base is reacted with Hydrochloric acid using Methyl Isobutyl Ketone as solvent mediumfollowed by treatment with Carbon to give Sertraline Hydrochloride.

Sertraline Hydrochloride

PRODUCT : Sertraline Hydrochloride

Description :

Stage-1 : Racemic Sertraline Hydrochloride is reacted with Ammonia solution using Methyl Isobutyl Ketone assolvent medium to give Racemic Sertraline Base which is reacted with D-Mandelic acid using Methyl IsobutylKetone as solvent to give Sertraline Mandelate.

Stage-2 : Sertraline Mandelate is reacted with Ammonia solution using Methyl Isobutyl Ketone as solvent medium toyield Sertraline Base.

Stage I

Stage II

Stage III

ANNEXURE - XIV

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Raw Material

Consumption of Raw Material /

Batch of Product

Daily Consumption of

Raw Material

Kg Kg1-Bromo-3-Chloropropane = 225 30Activated Carbon = 10 1.33Dimethylamine Hydrochloride = 158 21.07Hydrogen Chloride = 20 2.67Isopropyl Alcohol = 670 89.33Sodium Hydroxide = 125 16.67Sodium-1-Benzyl-1H-indazol-3-olate = 150 20Toluene = 950 126.67

Raw Material

Consumption of Raw Material /

Batch of Product

Daily Consumption of

Raw Material

Kg Kg1-(4-Chlorobenzhydryl)piperazine = 65 19.124-tert-Butylbenzyl Bromide = 65 19.12Activated Carbon = 5 1.47Hydrogen Chloride = 21 6.18Isopropyl Alcohol = 470 138.24Sodium Hydroxide = 25 7.35Toluene = 330 97.06

PRODUCT : Benzydamine HydrochlorideLIST OF RAW MATERIALS

PRODUCT : Buclizine Dihydrochloride LIST OF RAW MATERIALS

ANNEXURE - XV

109

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Raw Material

Consumption of Raw Material /

Batch of Product

Daily Consumption of

Raw Material

Kg KgActivated Carbon = 5 16.67Hydrogen Chloride = 24 80Isopropyl Alcohol = 320 1066.67Isopropyl carbamic acid-2-Hydroxymethyl-2-methyl pentyl ester = 104 346.67

Sodium Cyanate = 35 116.67Toluene = 490 1633.33

Raw Material

Consumption of Raw Material /

Batch of Product

Daily Consumption of

Raw Material

Kg KgActivated Carbon = 5 0.67Chlorpheniramine Base = 100 13.33Isopropyl Alcohol = 900 120Maleic acid = 43 5.73

Raw Material

Consumption of Raw Material /

Batch of Product

Daily Consumption of

Raw Material

Kg KgChromium Chloride Hexahydrate = 36 60Picolinic acid = 49 81.67Sodium Hydroxide = 20 33.33

PRODUCT : Chlorpheniramine MaleateLIST OF RAW MATERIALS

PRODUCT : Chromium PicolinateLIST OF RAW MATERIALS

PRODUCT : CarisoprodolLIST OF RAW MATERIALS

ANNEXURE - XV

110

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Raw Material

Consumption of Raw Material /

Batch of Product

Daily Consumption of

Raw Material

Kg Kg2-Dimethylamino Ethanol = 26 13Acetone = 200 100Activated Carbon = 3 1.5Methyl Phenyl Pyridyl Carbinol Hydrochloride = 60 30

o -Xylene = 210 105Sodium Amide = 8 4Sodium Hydroxide = 29 14.5Succinic acid = 22 11Thionyl Chloride = 36 18

Raw Material

Consumption of Raw Material /

Batch of Product

Daily Consumption of

Raw Material

Kg KgActivated Carbon = 4 16Isopropyl Alcohol = 280 1120

N-Amino-Azabicyclo Octane Hydrochloride = 33 132

p -Toluenesulfonyl Urea = 51 204Toluene = 210 840

PRODUCT : GliclazideLIST OF RAW MATERIALS

PRODUCT : Doxylamine SuccinateLIST OF RAW MATERIALS

ANNEXURE - XV

111

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Raw Material

Consumption of Raw Material /

Batch of Product

Daily Consumption of

Raw Material

Kg Kg2-Chloroethoxy Ethanol = 34 45.334-Chloro Benzhydryl Piperazine = 43 57.33Activated Carbon = 4 5.33Hydrogen Chloride = 12 16Isopropyl Alcohol = 230 306.67Sodium Hydroxide = 16 21.33Toluene = 150 200

Raw Material

Consumption of Raw Material /

Batch of Product

Daily Consumption of

Raw Material

Kg Kg1-Bromo-3-Chloropropane = 55 22Activated Carbon = 5 2Dimethylamine Hydrochloride = 39 15.6Hydrogen Chloride = 8 3.2Iminodibenzyl = 64 25.6Isopropyl Alcohol = 250 100o -Xylene = 535 214Sodium Amide = 14 5.6Sodium Hydroxide = 35 14

PRODUCT : Hydroxyzine DihydrochlorideLIST OF RAW MATERIALS

PRODUCT : Imipramine HydrochlorideLIST OF RAW MATERIALS

ANNEXURE - XV

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Raw Material

Consumption of Raw Material /

Batch of Product

Daily Consumption of

Raw Material

Kg Kg3-Methyl Benzyl Bromide = 34 174-Chloro Benzhydryl Piperazine = 42 21Activated Carbon = 4 2Hydrogen Chloride = 12 6Isopropyl Alcohol = 260 130Sodium Hydroxide = 11 5.5Toluene = 170 85

Raw Material

Consumption of Raw Material /

Batch of Product

Daily Consumption of

Raw Material

Kg Kg2-Amino-5-methyl thiazole = 20 13.334-Hydroxy-2-methyl-1,1-dioxo-1,2-dihydro-1-benzo[1,2] thiazine-3-carboxylic acid isopropyl ester

= 47 31.33

o -Xylene = 370 246.67

PRODUCT : Meclizine Dihydrochloride MonohydrateLIST OF RAW MATERIALS

PRODUCT : MeloxicamLIST OF RAW MATERIALS

ANNEXURE - XV

113

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Raw Material

Consumption of Raw Material /

Batch of Product

Daily Consumption of

Raw Material

Kg Kg2-Dimethylamino ethanol = 35 116.672-Methylbenzophenone = 66 220Activated Carbon = 2 6.67Citric acid = 50 166.67Hydrochloric acid (35%) = 60 200Isopropyl Alcohol = 640 2133.33p -Toluenesulfonic acid = 100 333.33Sodium Borohydride = 5 16.67Sodium Hydroxide = 60 200Toluene = 660 2200

Raw Material

Consumption of Raw Material /

Batch of Product

Daily Consumption of

Raw Material

Kg KgHydrogen Chloride = 6 1.6Isopropyl Alcohol = 200 53.33Oxomemazine = 50 13.33

PRODUCT : Oxomemazine HydrochlorideLIST OF RAW MATERIALS

PRODUCT : Orphenadrine CitrateLIST OF RAW MATERIALS

ANNEXURE - XV

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Raw Material

Consumption of Raw Material /

Batch of Product

Daily Consumption of

Raw Material

Kg Kg1-Bromo-2-Methyl-3-Chloro Propane = 62 24.8Activated Carbon = 9 3.6Dimethylamine Hydrochloride = 43 17.2Hydrogen Peroxide (50%) = 88 35.2Isopropyl Alcohol = 470 188o -Xylene = 690 276Phenothiazine = 65 26Sodium Amide = 13 5.2Sodium Hydroxide = 39 15.6Sodium Sulfate = 10 4

Raw Material

Consumption of Raw Material /

Batch of Product

Daily Consumption of

Raw Material

Kg Kg2-Benzylpyridine = 95 221.672-Dimethylamino Ethanol = 57 133Activated Carbon = 3 7Isopropyl Alcohol = 210 490Maleic acid = 47 109.67o -Xylene = 630 1470Sodium Amide = 23 53.67Sodium Hydroxide = 30 70Thionyl Chloride = 80 186.67

PRODUCT : OxomemazineLIST OF RAW MATERIALS

PRODUCT : Pheniramine MaleateLIST OF RAW MATERIALS

ANNEXURE - XV

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Raw Material

Consumption of Raw Material /

Batch of Product

Daily Consumption of

Raw Material

Kg Kg1-Bromo-3-Chloro Propane = 40 21.332-Chloro Phenothiazine = 48 25.6Maleic acid = 58 30.93N-Methyl Piperazine = 28 14.93Sodium Hydroxide = 15 8Sodium Hydroxide = 25 13.33Tetrabutylammonium Bromide = 8 4.27Toluene = 670 357.33

Raw Material

Consumption of Raw Material /

Batch of Product

Daily Consumption of

Raw Material

Kg KgActivated Carbon = 15 13.33Dimethylamino-2-Propanol = 300 266.67Hydrogen Chloride = 75 66.67Isopropyl Alcohol = 1625 1444.44o -Xylene = 2500 2222.22Phenothiazine = 460 408.89Sodium Amide = 100 88.89Sodium Hydroxide = 150 133.33Thionyl Chloride = 400 355.56

PRODUCT : Prochlorperazine MaleateLIST OF RAW MATERIALS

PRODUCT : Promethazine HydrochlorideLIST OF RAW MATERIALS

ANNEXURE - XV

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Raw Material

Consumption of Raw Material /

Batch of Product

Daily Consumption of

Raw Material

Kg Kg8-Chloro Theophylline = 55 9.17Activated Carbon = 4 0.67Isopropyl Alcohol = 700 116.67Promethazine Hydrochloride = 85 14.17Sodium Hydroxide = 13 2.17Toluene = 210 35

Raw Material

Consumption of Raw Material /

Batch of Product

Daily Consumption of

Raw Material

Kg KgActivated Carbon = 20 18.67Ammonia Solution (25%) = 1470 1372D-Mandelic acid = 315 294Hydrochloric acid (35%) = 95 88.67Methyl Isobutyl Ketone = 3100 2893.33Racemic Sertraline Hydrochloride = 700 653.33

PRODUCT : Sertraline HydrochlorideLIST OF RAW MATERIALS

PRODUCT : Promethazine TeoclateLIST OF RAW MATERIALS

ANNEXURE - XV

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List of Hazardous Chemicals

AcetoneAmmonia Solution (25%)Dimethylamine HydrochlorideHydrochloric acid (35%)Hydrogen ChlorideHydrogen Peroxide (50%)Isopropyl AlcoholMaleic acidMethyl Isobutyl Ketoneo -Xylenep -Toluenesulfonic acidSodium CyanateSodium SulfateThionyl ChlorideToluene

ANNEXURE - XVI

118

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ANNEXURE - XVII

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Effluent Treatment Flow Scheme - ZLD

ANNEXURE - XVIII

120

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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 - XIX

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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 - XIX

122

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Topomap of 10 km Radius – M/s. Harika Drugs Pvt. Ltd.

ANNEXURE - XX

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ANNEXURE - XXI

124


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