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APPLICATION FOR PROPOSED TERMS OF REFERENCE (TOR) For Conducting Environment Impact Assessment (EIA) Study of Proposed Active Pharmaceutical Ingredients (API), Ingredients and Key Starting Materials (KSM) Manufacturing Facility At Plot No. N-26, MIDC additional Patalganga Industrial Estate, Tal. Panvel, Maharashtra By M/s. Cogent Lifescience Private Limited B-302, Shankardhan Plaza, J.N. Road, Opp. Mehul Theater, Mulund (W), Mumbai 400080 Prepared By M/s. Eco Foot Forward Environment Consultancy & Engineers Pvt. Ltd. D-318, Neelkanth Business Park, Vidyavihar (West), Mumbai 400 086, Maharashtra, India. Web: www.ecofootforward.com *Accredited by QCI/NABET for EIA consultancy services, (Certificate No. NABET/EIA/1720/IA0028)

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Page 1: M/s. Cogent Lifescience Private Limitedenvironmentclearance.nic.in/writereaddata/Online/TOR/16... · 2019. 10. 16. · Infinium Precious Resources Ltd. had only constructed building

APPLICATION FOR PROPOSED TERMS

OF REFERENCE (TOR)

For

Conducting Environment Impact Assessment (EIA) Study

of

Proposed

Active Pharmaceutical Ingredients

(API), Ingredients and Key Starting Materials (KSM)

Manufacturing Facility

At

Plot No. N-26, MIDC additional Patalganga Industrial Estate,

Tal. Panvel, Maharashtra

By

M/s. Cogent Lifescience Private Limited B-302, Shankardhan Plaza, J.N. Road, Opp. Mehul Theater, Mulund (W), Mumbai – 400080

Prepared By

M/s. Eco Foot Forward

Environment Consultancy & Engineers Pvt. Ltd. D-318, Neelkanth Business Park, Vidyavihar (West), Mumbai 400 086, Maharashtra, India.

Web: www.ecofootforward.com

*Accredited by QCI/NABET for EIA consultancy services, (Certificate No. NABET/EIA/1720/IA0028)

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Terms of Reference (TOR) for Proposed Active Pharmaceutical

Ingredients (API), Intermediates & Key Starting Materials (KSM)

Manufacturing Facility by M/s. Cogent Life Science Private Limited.

2 | P a g e

Table of Contents

List of Figures ........................................................................................................................................ 3

List of Tables ......................................................................................................................................... 4

List of Abbreviations ............................................................................................................................ 5

EXECUTIVE SUMMARY .................................................................................................................. 6

1. INTRODUCTION ......................................................................................................................... 7

1.1 Preamble: ................................................................................................................................ 7

1.2 Need of Project ............................................................................................................................. 8

1.3 Importance and Benefits ............................................................................................................... 8

2. PROJECT DISCRIPTION .......................................................................................................... 9

2.2 Layout maps of proposed unit and intended work areas ............................................................. 11

2.3 Products Manufacturing Process Description ............................................................................. 11

2.4 Typical Process Flow for Active Pharmaceutical Ingredients (APIs), KSM and Intermediates 12

2.5 Preliminary Environment and Health Hazard Identification and Safety Measures .................... 13

3. SITE DETAILS ........................................................................................................................... 15

3.1 Project Location .................................................................................................................... 15

3.2 Details of Alternative Sites and Justification of Site Selection ................................................... 19

4. FOREST AND WILDLIFE ISSUE ........................................................................................... 20

5. ENVIRONMENTAL STATUS .................................................................................................. 20

5.1 Meteorology: ............................................................................................................................... 21

5.2 Ambient Air Quality: .................................................................................................................. 21

5.3 Noise Monitoring: ....................................................................................................................... 22

5.4 Soil study: ................................................................................................................................... 23

5.5 Surface & Ground Water Quality: .............................................................................................. 24

5.6 Traffic Environment: .................................................................................................................. 26

5.7 Biological Environment: ............................................................................................................. 26

5.8 Socio-Economic Environment: ................................................................................................... 26

6. ENVIRONMENTAL IMPACT AND ENVIRONMENT MANAGEMENT PLAN ................. 27

7. OCCUPATIONAL HEALTH: ...................................................................................................... 28

8. CORPORATE ENVIRONMENT POLICY ............................................................................. 29

9. INFRASTURTURE FACILITY ................................................................................................ 29

10. ENVIRONMENT SOCIAL POLICY ....................................................................................... 29

11. ToR COMPLIANCE .................................................................................................................. 29

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Terms of Reference (TOR) for Proposed Active Pharmaceutical

Ingredients (API), Intermediates & Key Starting Materials (KSM)

Manufacturing Facility by M/s. Cogent Life Science Private Limited.

3 | P a g e

List of Figures

FIGURE 3. 1 PROPOSED PROJECT SITE LOCATION ................................................................ 15

FIGURE 3. 2 GPS COORDINATES OF PLOT BOUNDARY OF PROPOSED SITE ............................ 16

FIGURE 3. 3 MIDC PLOT AREA AND IDENTIFICATION .......................................................... 16

FIGURE 3. 4 SITE ANALYSIS & INFRASTRUCTURE SETUP ...................................................... 17

FIGURE 3. 5 PROPOSED SITE LOCATION 10 KM RADIUS .......................................................... 17

FIGURE 5. 1: AIR SAMPLING LOCATIONS AND WIND SPEED DETAILS .................................... 21

FIGURE 5. 2: NOISE SAMPLING LOCATIONS AND WIND SPEED DETAILS ................................ 22

FIGURE 5. 3: SOIL SAMPLING LOCATIONS ............................................................................. 24

FIGURE 5. 4 : SURFACE AND GROUND WATER SAMPLING LOCATIONS ................................. 25

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Terms of Reference (TOR) for Proposed Active Pharmaceutical

Ingredients (API), Intermediates & Key Starting Materials (KSM)

Manufacturing Facility by M/s. Cogent Life Science Private Limited.

4 | P a g e

List of Tables

TABLE 2. 1 PROJECT DETAILS .................................................................................................. 9

TABLE 2. 2 MASTER LAYOUT PLAN OF THE PROPOSED PROJECT ........................................ 11

TABLE 3. 1 SALIENT FEATURES OF THE PROJECT SITE ......................................................... 18

TABLE 5. 1 BASELINE DATA COLLECTION ............................................................................. 20

TABLE 5. 2: AMBIENT AIR QUALITY AND MONITORING DETAILS ......................................... 22

TABLE 5. 3: NOISE MONITORING DETAILS .............................................................................. 23

TABLE 5. 4: SOIL MONITORING DETAILS ................................................................................ 24

TABLE 5. 5: SURFACE AND GROUND WATER MONITORING DETAILS ..................................... 25

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Terms of Reference (TOR) for Proposed Active Pharmaceutical

Ingredients (API), Intermediates & Key Starting Materials (KSM)

Manufacturing Facility by M/s. Cogent Life Science Private Limited.

5 | P a g e

List of Abbreviations

APCD Air Pollution Control Devices

API Active Pharmaceutical Ingredients

BUA Built Up Area

CFM cubic feet per minute

c-GMP Common Good Manufacturing Practice

CHWTSDF Common Hazardous Waste Common Hazardous Waste Treatment,

Storage and Disposal Facilities

CMD Cubic Meters Per Day

CPCB Central Pollution Control Board

CTE Consent to Establish

D.G Diesel generator

EIA Environmental Impact Assessment

GPS Global Positioning System

HSD High Speed Diesel

KSM Key Starting Materials

KVA kilo-volt-ampere

MEE Multi Effect Evaporator

MIDC Maharashtra Industrial Development Corporation

MPCB Maharashtra Pollution Control Board

NABET National Accreditation Board for Education and Training

R&D Research and Development

RG Recreational Ground

RO Reverse Osmosis

TPM Tones Per Month

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Terms of Reference (TOR) for Proposed Active Pharmaceutical

Ingredients (API), Intermediates & Key Starting Materials (KSM)

Manufacturing Facility by M/s. Cogent Life Science Private Limited.

6 | P a g e

EXECUTIVE SUMMARY

M/s. Cogent Life Science Private Limited has envisaged production of Active Pharmaceutical

Ingredients (API), Key Starting Materials (KSM) and Intermediates with production capacity

of 100MT/M. The proposed project aims to manufacture 63 products of APIs, Intermediates &

KSM. The proposed project site is located at plot no. N- 26, MIDC additional Patalganga

Industrial Estate, Tal. Panvel, Maharashtra. Proposed project falls under the schedule 5(f)

category of EIA Notification and due to project site falls within the 10 km radius of Notified

Karnala Bird Sanctuary the ‘general conditions’ are applicable as per the amendment in EIA

notification, 2006 via. No. S.O.3067 dated 1.12.2009 and hence project category become the

“A”.

Proposed TOR is prepared as per the Model TOR issued by MoEF&CC published in April

2015 and collection of baseline data done as per OM issued by MoEF&CC dated 27.08.2017.

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Terms of Reference (TOR) for Proposed Active Pharmaceutical

Ingredients (API), Intermediates & Key Starting Materials (KSM)

Manufacturing Facility by M/s. Cogent Life Science Private Limited.

7 | P a g e

1. INTRODUCTION

1.1 Preamble:

M/s. Cogent Life Science Private Limited has proposed a new establishment for manufacturing

various APIs, KSM and intermediates with Quality Control facility with a production capacity

of 100 TPM.

Prior to proposal, M/s. Infinium Precious Resources Ltd. had obtained lease agreement via.

MIDC letter on 28.03.2014. Further, M/s. Infinium Precious Resources Ltd. had obtained

MPCB Consent to Establish (CTE) on 30.08.2016 and amended 21.09.2016 for “Distillation

of Solvents”. Meanwhile application for change of activity was approved by MIDC via letter

dated 25.01.2017 from “Engineering” to “Distillation of Solvents”. Post above approval M/s.

Infinium Precious Resources Ltd. had only constructed building shed after which proposal was

ceased by M/s. Infinium Precious Resources Ltd.

Further, M/s. Cogent Life Science Private Limited has purchased the plot under reference and

obtained the lease hold rights. The agreement of sale was executed on 17.05.2017. MIDC has

granted lease agreement transfer letter in favour of M/s. Cogent Life Science Private Limited

on 06.09.2017. MPCB has granted the amendment in consent by changing the name to M/s.

Cogent Life Science Private Limited on 24.11.2017.

Now, M/s. Cogent Life Science Private Limited proposes to manufacture Active

Pharmaceutical Ingredients (API), Intermediates and Key Starting Materials (KSM) with

production capacity of 100MT/month using the existing shed and adding new production-

utility blocks. Construction work for the proposed Manufacturing Facility will be carried out

as per MIDC approved letter OUTWARDS /MIDC /PATA1/ E&MDSDPTLGNGCIV/

A94524/2019 dated 13.03.2019. Enclosed as Annexure I. It involves construction of API

Block, Intermediate Plant, Utility Block & Admin/QC/Warehouse having total construction

BUA is 10489.95 sq.m.

Currently at the site, shed is existed having built-up area 1281.78 sq.m. which was constructed

by M/s. Infinium Precious Resources Ltd. and further construction will be done by M/s. Cogent

Life Science Private Limited once grant of environmental clearance and consent to establish

from state pollution control board.

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Terms of Reference (TOR) for Proposed Active Pharmaceutical

Ingredients (API), Intermediates & Key Starting Materials (KSM)

Manufacturing Facility by M/s. Cogent Life Science Private Limited.

8 | P a g e

1.2 Need of Project

The need of the project is justified through the intentions of the company to develop the drugs

in a non- infringing, novel and economical manner so that the drugs are available to the lower

community. The company aims to reduce the demand and supply gap by eliminating the cost

factor. It desires to manufacture and formulate the essential drugs so that it can tap the

international market along with the local merchandise taking into consideration the economic

factor & quality of the products. The project contemplates to serve the health sector worldwide

by producing qualitative & competitive products.

The objective of the company is to provide cost effective solutions for customer’s diverse

requirements & to reduce the demand and supply gap in national as well as international

market.

1.3 Importance and Benefits

Demand supply gap: The production capacity is proposed to reduce demand and supply gap of

animal grade and human grade API in the India as well as Asian and Latin American countries.

It is believed that the proposed project will try to meet the 12% requirement of API grade

chemicals in the country.

Imports vs. Indigenous manufacturing: Major raw materials required for additional production

are available in India and can be transported to the plant by road and railways. Animal grade

pharmaceutical products have large business potential as animal husbandry is major activity

done along with farming in India and demand for veterinary grade pharmaceuticals in

increasing constantly. Presently the demand has been met by importing the API in the country

and formulation is done in India. The activity will meet some of the demand of API which

reduces the cost of the medicines, save time for the availability which results in larger people

can afford the medication.

Export possibility: The veterinary grade API and human grade API both have huge market

potential in European and African countries. The pharmaceutical formulation done for

domestic purpose and have great export potential to US, South East Asia, African countries.

Employment generation: The proposed production activity of this project will create

employment opportunities for Technical, administration professionals also, skilled and non-

skilled labour. The semi-skilled and non-skilled labour can be employed from nearby area. This

can improve socio- economic condition of the surrounding area.

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Terms of Reference (TOR) for Proposed Active Pharmaceutical

Ingredients (API), Intermediates & Key Starting Materials (KSM)

Manufacturing Facility by M/s. Cogent Life Science Private Limited.

9 | P a g e

2. PROJECT DISCRIPTION

The proposed project of the company is a Green field Project. As per the Environment Impact

Assessment Notification 2006 & recent amendments till date, the project comes in

Schedule 5 (f) Category – A, under Synthetic Organic Chemicals Manufacturing Units. The

company has been classified as Medium Scale Industry and is categorized under Red category

industry by Maharashtra Pollution Control Board. Proposed setup aims to synthesis and

marketing an intermediate of APIs as per c-GMP guidelines

The total plot area of the plant is 10697 sq. m. Total production capacity of API, Intermediates

and KSM will be 100 MT/month. The estimated cost for proposed project would be around

45 Crore. The timelines for commencement of proposed construction activity immediate after

grant of Environmental Clearance from MoEF&CC. The commercial production is expected

to be commenced during F.Y. 2020-21.

The Salient features of the proposed project are summarized below in Table 2.1.

Table 2. 1 Project Details

Sr. No Components Details

1 Name of Proponent M/s. Cogent Life Science Private Limited.

2 Location

Plot No. N-26, MIDC additional Patalganga

Industrial estate, Tal-Panvel, Dist-Raigad, State-

Maharashtra

3 Product Type Active Pharmaceutical Ingredients (API),

Intermediates & KSM manufacturing facility.

4 Project Type New

5 Schedule (EIA Notification) 5 (f)

6 Category A

MPCB Consent Category Red category

MIDC approved letter OUTWARDS /MIDC / PATA1/ E& MDSDPTL

GNGCIV/A94524/2019 dated 13.03.2019

Area Details

Total Plot Area 10697 sq. m

Built Up Area 9540.67sq. m

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Terms of Reference (TOR) for Proposed Active Pharmaceutical

Ingredients (API), Intermediates & Key Starting Materials (KSM)

Manufacturing Facility by M/s. Cogent Life Science Private Limited.

10 | P a g e

7 Green Area 1139.95 sq. m

Parking Area 1490.81 sq. m

8 Production Capacity API, KSM, Intermediates 100 MT/month

9 Power Requirement Proposed Connected Load - 4624 KW

Proposed Demand - 1683.75 kVA

10 Water Requirement 80.5 CMD

Boiler water requirement 2000 lit/hr

11 Fuel for DG set Fuel Oil HSD 139 l/hr

Stack height 12 m from GL

12 D.G. set details 1000 KVA x 2 Nos

13 ETP Capacity 50 CMD

14 Scrubber 2* 200 CFM alkaline Scrubber

15 Effluent Generation 40 CMD (max.)

16 Man Power 50 persons (in three shifts)

17

Hazardous Waste Generation

details (Category) Proposed (TPM) Disposal

ETP Sludge (35.3) 5

CHWTSDF, Taloja Distillation Residue (20.3) 0.25

MEE Residue (35.3) 18.5

Spent carbon (28.3) 2.5 CHWTSDF, Taloja

Empty , carboys , bags etc.(33.1) 50 kg/month.

approx. Sell to MPCB authorized

recycler Drums (33.1) 100 nos. approx.

18

Non Hazardous Waste Proposed Disposal

Scrap Material 30 kg/month MPCB authorized scrap

recycler

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Terms of Reference (TOR) for Proposed Active Pharmaceutical

Ingredients (API), Intermediates & Key Starting Materials (KSM)

Manufacturing Facility by M/s. Cogent Life Science Private Limited.

11 | P a g e

2.2 Layout maps of proposed unit and intended work areas

The layout map proposed project manufacturing facility is shown in Figure 2.2.

Table 2. 2 Master Layout Plan of the Proposed Project

2.3 Products Manufacturing Process Description

The proposed unit is to manufacture various APIs, API intermediates and KSM products with

Quality Control facility with a production capacity of 100 TPM along with most

pharmaceutical substances are manufactured utilizing 'batch' process. The same equipment

with potentially different configurations and the same operating personnel are often used to

make a different intermediate or substance, utilizing different raw materials, executing different

processes, and generating different waste streams. Bulk pharmaceutical substances typically

consist of structurally complex organic chemical under precise conditions. These substances

are used in the manufacture of the dosage form of a formulated pharmaceutical product and are

manufactured by Chemical synthesis, Isolation/recovery from natural sources and/or

Combination of above.

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Terms of Reference (TOR) for Proposed Active Pharmaceutical

Ingredients (API), Intermediates & Key Starting Materials (KSM)

Manufacturing Facility by M/s. Cogent Life Science Private Limited.

12 | P a g e

2.4 Typical Process Flow for Active Pharmaceutical Ingredients (APIs), KSM and

Intermediates

Technology for manufacturing proposed products are available with the company as all

proposed products are permitted with enhanced quantities. The company will implement the

improved technologies of In-house R&D for the cost effective & environmentally friendly

practices.

Typical APIs, KSM & Intermediates process technology:

Most pharmaceutical substances are manufactured utilizing 'batch' process. In a batch process,

a particular substance or ‘intermediate’ is manufactured on a 'campaign' basis for periods

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

the projected sales demand. At the end of the manufacturing campaign, another pharmaceutical

intermediate or substance is made. The same equipment with potentially different

configurations and the same operating personnel are often used to make a different intermediate

or substance, utilizing different raw materials, executing different processes, and generating

different waste streams.

These substances are used in the manufacture of the dosage form of a formulated

pharmaceutical product and are manufactured by:

• Chemical synthesis

• Isolation/recovery from natural sources and/or

• Combination of above.

In the proposed project, APIs and API intermediates are manufactured using chemical synthesis

technology, which is described below, and a typical schematic process flow chart is depicted

in Figure. 2.3.

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Terms of Reference (TOR) for Proposed Active Pharmaceutical

Ingredients (API), Intermediates & Key Starting Materials (KSM)

Manufacturing Facility by M/s. Cogent Life Science Private Limited.

13 | P a g e

Figure 2. 3 Typical Manufacturing process of API’s, KSM & Intermediates

In a clean SS / GL reactor suitable solvent is taken. The reactants (solid, liquid or gas

Chemicals) being added maintaining desired operating conditions like Temperature, pressure,

pH conditions and at particular standard addition sequence predefined in master process

document to obtain the desired product.

The reaction completion is checked by monitoring the process using in-process quality checks

(like HPLC, GC, TLC, pH, LOD) to achieve & obtain desired crude product.

Once the product is obtained, it is further purified using chemical process or crystallization

techniques to obtain final product in its pure form meeting the desired quality attributes.

The purified intermediate product is being dried in suitable Drier and pulverized to obtain it in

uniform size distribution. It is then packed in suitable double polybag placed in suitable

container.

The API intermediate product is being finally analysed as per the standard specifications to

approve it for either for sale to API manufacturing customer or for next step processing in

house to convert it to new API intermediate. Product

2.5 Preliminary Environment and Health Hazard Identification and Safety Measures

Generally, the activities which may have adverse impact on the biotic environment during

operational phase may be due to deliberate/unforeseen release of treated/untreated effluent,

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Terms of Reference (TOR) for Proposed Active Pharmaceutical

Ingredients (API), Intermediates & Key Starting Materials (KSM)

Manufacturing Facility by M/s. Cogent Life Science Private Limited.

14 | P a g e

disposal of hazardous waste on the ground or in the water bodies in the study area. However,

the proposed project has made following provisions for the effluent & hazardous waste

management.

The treated effluent will be used for in house purpose such as chiller and onsite gardening after

treatment to reusable limit.

The only direct possible impacts due the proposed project may be from the following.

1. Air emissions from burning of fuel for operation of utilities like D.G set & manufacturing

process related emissions if at all escape the MIDC industrial estate.

Mitigation measures

In order to minimize the air emissions at the source itself, APCD’s such as Bag Filter is

proposed to be installed and for proper dispersion of pollutants in atmosphere stack with

appropriate height as per CPCB guidelines will be provided.

As a precautionary measure, best industry practice will ensure that at no point of time during

the operational phase of the project the concentrations of air emissions should not exceed the

prescribed standards.

In order to arrest the fugitive emissions within the plant premises & to minimize the noise

intensity propagating out of the factory premises, thick green belt comprising of native species.

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Terms of Reference (TOR) for Proposed Active Pharmaceutical

Ingredients (API), Intermediates & Key Starting Materials (KSM)

Manufacturing Facility by M/s. Cogent Life Science Private Limited.

15 | P a g e

3. SITE DETAILS

3.1 Project Location:

The proposed site is situated at Plot No. N-26, MIDC additional Patalganga industrial estate,

Taluka-Panvel, District-Raigad, State-Maharashtra. Site Coordinates 19°06.922’ N, E

072°53.530’

The location map indicating proposed site and its surroundings are depicted in Figure 3.1.

Figure 3. 1 Proposed Project Site Location

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Terms of Reference (TOR) for Proposed Active Pharmaceutical

Ingredients (API), Intermediates & Key Starting Materials (KSM)

Manufacturing Facility by M/s. Cogent Life Science Private Limited.

16 | P a g e

Figure 3. 2 GPS Coordinates of plot boundary of proposed site

Figure 3. 3 MIDC Plot Area and Identification

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Terms of Reference (TOR) for Proposed Active Pharmaceutical

Ingredients (API), Intermediates & Key Starting Materials (KSM)

Manufacturing Facility by M/s. Cogent Life Science Private Limited.

17 | P a g e

Site Photographs

Approach Road Towards New Patalganga

MIDC

Board Showing MIDC Area

Plot Area

Figure 3. 4 Site Analysis & Infrastructure setup

Figure 3. 5 Proposed site location 10 km radius

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Terms of Reference (TOR) for Proposed Active Pharmaceutical

Ingredients (API), Intermediates & Key Starting Materials (KSM)

Manufacturing Facility by M/s. Cogent Life Science Private Limited.

18 | P a g e

The salient features of the project site and study area are given below:

Table 3. 1 Salient Features of the Project Site

Sr.

No

Particulars Details

1 Location Plot No.N-26, MIDC additional Patalganga Industrial

Estate, Taluka-Panvel, District-Raigad, State-

Maharashtra

2 Geographical Locations 18°52’13.38” N, 73°10’05.52” E

3 Land use of Project site 100% Industrial Land

4 Infrastructure Setup : (Distances mentioned below are aerial distances)

Village / Habitation Nearest

Village

Karade 0.5 km

Town Khalapur : @ 12.0 Km

Panvel @15 km approx.

Highway National Highway No. 4 @ 5 km

Railway Station Apta @ 1.68 km,

Panvel @ 20 km

Nearest Sea Port JNPT @ 30 km approx.

Nearest Airport Chatrapati Shivaji Maharaj International Airport @

40.15 km

Nearest Hospitals Sampoorna Rege Hospital (SRH) @ 3.67 km

Nearest School/Colleges Z.P. School Washivali @ 3 km

5 Water Supply From MIDC

6 Power Supply From MIDC

7 Protected Area Buffer zone of Karnala Bird Wildlife Sanctuary at 2.62

km from project boundary.

8 Displacement of Population None

9 Availability of Raw

Material

All other raw materials will be procured from Local

Maharashtra.

10 Seismic Zone The area is falling in Zone- III

11 Soil Classification Reddish and laterite soil

12 Climatic Data Temperature variations: 38 °C – 17 °C

Avg. Wind speed : 2 m/s

Predominant wind direction : South West

Relative Humidity : 55% – 80%

Annual Rainfall : 2200 mm

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Terms of Reference (TOR) for Proposed Active Pharmaceutical

Ingredients (API), Intermediates & Key Starting Materials (KSM)

Manufacturing Facility by M/s. Cogent Life Science Private Limited.

19 | P a g e

3.2 Details of Alternative Sites and Justification of Site Selection

The proposed project site is located in the MIDC area and the said area is having number of

industrial estates, all basic infrastructure facilities like availability of water, electricity, fuel,

transport, telecommunication systems etc. MIDC plans to further develop the infrastructure in

the area.

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Terms of Reference (TOR) for Proposed Active Pharmaceutical

Ingredients (API), Intermediates & Key Starting Materials (KSM)

Manufacturing Facility by M/s. Cogent Life Science Private Limited.

20 | P a g e

4. FOREST AND WILDLIFE ISSUE

The proposed project is within the limits of the existing Patalganga MIDC and no forest area

envisage. Karnala Bird Wildlife Sanctuary (Notified ESZ) is at 2.62 km from proposed project

area therefore the project falls under category A as per amendment in EIA notification, 2006

via. No. S.O.3067 dated 1.12.2009.

5. ENVIRONMENTAL STATUS (BASELINE MONITORING)

The data for EIA study is being collected through field studies, literature review, and

interaction with concerned departments. The study area for the EIA study shall be the area

within the 10 km radius of the periphery of the project. Map of the study area clearly delineating

the location of various monitoring stations (air/ water / soil and noise) superimposed with

location of habitats shall be shown. Collection of primary baseline data done as per OM issued

by MoEF&CC dated 27.08.2017 for the period – March to May 2019 as per CPCB guidelines.

The baseline data collection is shown in Table 5.1.

Table 5. 1 Baseline Data Collection

Attribute Monitoring

Location

Parameters Frequency

Ambient Air

Quality 8 locations PM10, PM2.5, SOx, NOx, CO, O3, NH3, VOC. 24-hourly

twice a

week for one

season

Surface &

Ground Water

Quality

8 locations Class type (MPCB)

Important parameters as per drinking water

standards (IS:10500)

Once in a

month for

one season

Soil Quality 3 locations Soil type, textures, pH, EC, bulk density, porosity,

water holding capacity, Na, Ca, Mg, fertility (N,

P, K) etc.

Once in a

month for

one season

Ambient Noise

Quality

8 locations Day and night equivalent noise level (Leq) Once in a

fortnight

for one

season

Bio Diversity

study Within Study

Area

Flora & Fauna

Habitat Identification

& Survey (Line

transects)

During the

study period

Socio

Economic

Study

Within Study

Area

Demography,

employment status,

literacy rate & health

status

Census 2011 During the

study

Period Community level

survey

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The data/information on Environmental Baseline Status is collected as per the following

components.

5.1 Meteorology:

As a part of the EIA study, a micro-meteorological data is being collected by installing an

onsite meteorological station. The parameters include wind speed, wind direction, temperature,

and relative humidity. The collected data will be used for preparation of wind rose diagrams

and air quality modelling.

5.2 Ambient Air Quality:

An air quality monitoring network is designed for assessment of the baseline status of ambient

air quality. The monitoring was carried out as per NAAQS standards, 2009 CPCB. The

sampling stations were selected based on past information of prevailing wind direction that are

predominant in the area. The stations located at upwind, downwind, cluster contributor and on

site. Sampling locations and wind speed details are sown in the Figure 5.1. The Ambient Air

Quality and monitoring details are given in Table 5.2.

Figure 5. 1: Air Sampling Locations and windrose

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Table 5. 2: Ambient Air Quality and monitoring details

Code Approx. Arial distance from

project site (km)

Latitude & Longitude Wind

Direction

AP1 - 18°52'15.23"N, 73°10'5.50"E -

AP2 0.72 18°52'4.70"N, 73° 9'41.22"E Upwind

AP3 1.20 18°52'38.83"N, 73°10'34.26"E Cross Wind

AP4 1.65 18°52'14.53"N, 73° 9'9.56"E Upwind

AP5 1.70 18°53'3.85"N, 73°10'18.65"E Downwind

AP6 1.95 18°51'18.67"N, 73° 9'29.97"E Upwind

AP7 4.90 18°50'47.65"N, 73°12'28.74"E Downwind

AP8 7.80 18°50'17.38"N, 73° 6'8.27"E Cross Wind

5.3 Noise Monitoring:

Equivalent continuous noise level (Leq) (8 locations) in and around the project area is being

monitored. Construction equipment and road traffic are the major sources of noise. Baseline

data of noise at the project area and the neighbourhood habitat areas is ascertained. Daytime

and night time data is being collected.

Noise Sampling locations and wind speed details are sown in the Figure 5.2. Noise monitoring

details are given in Table 5.3.

Figure 5. 2: Noise Sampling Locations and windrose

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Table 5. 3: Noise monitoring details

Code Approx. Arial distance from

project site (km)

Latitude & Longitude

AP1 - 18°52'12.81"N, 73°10'4.78"E

AP2 0.12 18°52'16.30"N, 73°10'8.44"E

AP3 0.15 18°52'17.36"N, 73°10'2.19"E

AP4 0.35 18°52'21.32"N, 73°10'12.51"E

AP5 0.50 18°52'26.30"N, 73°10'13.91"E

AP6 0.40 18°52'6.94"N, 73°10'16.88"E

AP7 0.65 18°52'32.76"N, 73° 9'57.69"E

AP8 0.70 18°52'25.58"N, 73° 9'45.30"E

5.4 Soil study:

For studying soil profile of the region, sampling locations were selected to assess the existing

soil conditions in and around the site representing various land use conditions. The present

study of the soil profile establishes the baseline characteristics and this will help in future in

identifying the incremental concentrations if any, due to the operation of the project. The

sampling locations have been identified with the following objectives:

a) To determine the baseline soil characteristics of the study area

b) To determine the impact of proposed project on soil characteristics

Parameters such as pH, Organic Carbon, Moisture, Organic Matter, Iron, Lead, and Chromium

were determined in total 8 locations in and around the project site.

Soil Sampling locations are sown in the Figure 6.3. Soil monitoring details are given in Table

5.4.

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Figure 5. 3: Soil Sampling Locations

Table 5. 4: Soil monitoring details

Code Latitude & Longitude Approx. Arial Distance in KM

(Direction)

SC 1 18°52'14.96"N, 73°10'5.76"E -

SC 2 18°52'12.54"N 73°10'5.98"E -

SC 3 18°52'12.31"N 73°10'3.71"E -

SC 4 18°52'35.29"N 73° 9'37.43"E 1 (NW)

SC 5 18°51'1.57"N 73°13'19.31"E 6.03 (ESE)

SC 6 18°51'19.26"N 73° 6'7.26"E 7.08 (W)

SC 7 18°55'46.14"N 73°11'37.31"E 7.01 (NEN)

SC 8 18°48'6.41"N 73° 8'40.13"E 7.92 (SWS)

5.5 Surface & Ground Water Quality:

Baseline water quality from all sources such as ground water/ surface water and river water

were collected, analysed and compared to the water quality norms.

The monitoring was carried out for parameters prescribed in IS 10500.

Surface and Ground water sampling locations are sown in the Figure 5.4. Surface and Ground

water monitoring details are given in Table 5.5.

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Figure 5. 4 : Surface and Ground water Sampling Locations

Table 5. 5: Surface and Ground water monitoring details

Code Approx. Arial distance

from project site (km)

Latitude & Longitude Wind Direction

SW1 2.00 18°51'31.70"N,73°9'15.36"E River (Down Stream)

SW2 2.30 18°53'21.39"N, 73°10'15.24"E River (Up Stream)

SW3 0.90 18°52'36.81"N, 73° 9'42.97"E Water body

SW4 0.04 18°52'13.22"N, 73°10'7.73"E Water body

GW1 0.50 18°52'5.76"N, 73° 9'37.47"E Dug well

GW2 0.60 18°52'39.59"N, 73°10'36.18"E Dug well

GW3 1.00 18°52'37.82"N, 73° 9'36.10"E Dug well

GW4 1.60 18°52'43.95"N, 73° 9'17.16"E Dug well

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5.6 Traffic Environment:

Traffic study of the area at critical junction from project site to main entry point of Patalganga

MIDC will be conducted via. Visual traffic count, type of vehicles were noted as per the PCU

and will be computed to interpret impact of additional traffic due to proposed project.

5.7 Biological Environment:

As a part of the study the information on the following was collected through Gazetteer of

district, forest department and revenue offices:

a) Preparation of an inventory of major species of trees, herbs, shrubs and timber

trees in the area;

b) List of economically important plants, if any;

c) Presence of rare and endangered species, if any;

Terrestrial sampling survey is being carried out. The data on the availability of various floral

and faunal species in the study area already available with the Department of Forests was also

be collected and utilized as support to primary field survey.

5.8 Socio-Economic Environment:

The data on demographic profile in the study area is collected using secondary data sources.

The data is collected is as follows:

a) Demography

b) Caste profile

c) Literacy profile

d) Occupational profile

e) Health Status

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6. ENVIRONMENTAL IMPACT AND ENVIRONMENT

MANAGEMENT PLAN

This chapter provides Environmental Impact due to proposed activities and environment

management plan to minimise its impacts. With the knowledge of the baseline conditions,

Project characteristics, the intensity of construction activities, detailed projections shall be

made of the influence of planned project on all the areas of social, physical and biological

environment in the area during project construction and operation. Based on the predictions,

the critically affected environmental parameters will be identified for the proposed project.

This will help ensure effective management plan against negative environmental degradation.

Some features studied will be as follows:

Assessment of expected ground level concentration of pollutions from the stack emissions

and vehicular moment based on site –specific meteorological features. Since project is in

a hilly terrain AQIP modelling will be done using standard AerMOD software.

A note on treatment of waste water from different plant operations, extent recycled and

reused for different purpose shall be included. Complete scheme of effluent treatment

along with characteristic of untreated and treated effluent to meet the prescribed standards

of discharge under E (P) Rule.

Details of hazardous waste generation and their storage, utilization and management.

Membership with hazardous waste site will be taken.

Details of species will be studied within 10 km study area and an action plan for green belt

development within site premises will be designed and implemented. At present green belt

on project boundary and along entry-exit is envisaged.

Water conservation measures will be studied for minimization of domestic supply. At

present a rainwater harvesting facility is envisaged from rainwater diverted from rooftop

area, which will be supplemented for utilization of surface cleaning and gardening.

Onsite (anthropogenic or natural) risk will be studied which includes development of an

emergency response plan along with risk assessment of the propose development on

Operation Health and Safety.

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Based on size and capacity of pollution and safe operation control measures which will be

implemented a justifiable budget for Environment management system will be included in EIA

report along with its recurring cost/annum.

An environmental monitoring programme will be formulated based on findings to provide

scientifically defensible information for determining the status of the environmental quality of

the surrounding area of the project site and to check whether the levels of critical pollutants are

within the environmentally acceptable limits. This will help to obtain an early warning of

unacceptable environmental conditions so that control measures can be taken immediately.

7. OCCUPATIONAL HEALTH:

Best industry practices will be practiced on site to ensure the occupational health and safety.

The following aspect will be studied and covered in the EIA report.

A plan for effective training of best & safe work practices to be initiated will be

designed.

Indoor air quality and noise level will be periodically measured and an effective heath

management plan will be formulated to keep exposure limits within prescribed standards.

Awareness program for maintaining health and sanitation onsite will be designed.

Yearly health camps and checkup for workers will be initiated by proponent through tie-

up with competent agency and annual report on Occupational Health and Safety will be

designed and maintained at site.

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8. CORPORATE ENVIRONMENT POLICY

An Environment management cell will be formulated in administrative order of the company

to deal with environmental issues and for ensuring compliance with the environmental

clearance conditions. The formulated environment policy will be approved by the company’s

Board of Directors and complete scheme details will be included in the EIA report.

9. INFRASTURTURE FACILITY

Details regarding infrastructure facilities such as sanitation, clean drinking water facility,

restroom etc. will be provided to the labour force during construction as well as to the casual

workers including truck drivers during operation phase

10. ENVIRONMENT SOCIAL POLICY

As per stipulated condition of official letter F. No. 22-65/2017-IA-III appropriate budget (2%

of capital investment on project value ≤ 100 Cr.) will be provided for CER policy

implementation which may include schemes like development of infrastructure for clean drink

water supply, sanitation, skill development, solid waste management facility, solar lighting

system, rain water harvesting facility, avenue planation and plantation in community areas.

11. ToR COMPLIANCE

EIA report will be prepared as per the Model TOR issued by MoEF&CC published in April

2015 and A tabular chart with index for points wise compliance of TOR mentioned below will

be included in the EIA report.

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