1.0 introduction 1.1 about lupin limited - म.प्र ...mppcb.nic.in/pdf/590lupinenglish.pdf ·...

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Lupin Limited Executive Summary Executive Summary 1 1.0 INTRODUCTION 1.1 ABOUT LUPIN LIMITED Indian drug maker, Lupin Limited, head quartered in Mumbai, India, is the fastest growing, top 3 pharmaceutical players in India and the fastest growing top 10 generic players in Japan and South Africa. . Today, Lupin has emerged as the 5 th largest and the fastest growing top 5 company in the U.S (by prescriptions), the only Asian company to achieve that distinction. 1.2 ABOUT PROJECT PROPONENT Dr. Desh Bandhu Gupta's vision and dream to fight life threatening infectious diseases and to manufacture drugs of the highest social priority led to the formation of Lupin in the year 1968. Dr. Desh Bandhu Gupta is the Chairman of the company. He is an honourary Doctor of science (D.Sc.) with a master’s degree in chemistry. Dr. Gupta, in his early career was an Associate Professor at Birla Institute of Science and Technology, Pilani, Rajasthan. Dr. Gupta has steered Lupin towards the forefront of India pharmaceuticals. In recent years, he has spearheaded the restructuring of Lupin's operations, and the research and innovation programs in new drug research and novel drug delivery systems. Dr. Kamal K Sharma is the Vice Chairman of the company. Dr. Kamal K Sharma is a graduate in chemical engineering from the Indian Institute of Technology (IIT), Kanpur, with a post-graduate diploma in industrial management from Jamnalal Bajaj Institute of Management Studies, Mumbai, and a Ph.D in economics from IIT, Mumbai. He has also completed an advanced management program from Harvard Business School, Boston. In a career spanning more than three decades, Dr. Sharma has held a range of senior management positions managing projects, corporate development and general management in the pharmaceuticals and chemicals industries. Mr Nilesh Gupta is the Managing Director. He is a Chemical Engineer from the University Department of Chemical Technology (UDCT), Mumbai, and a graduate with honours from the Wharton School, University of Pennsylvania, USA, where he specialized in healthcare, strategic management and finance. 1.3 ABOUT THE PROJECT AND THE PROJECT SITE 1.3.1 Project Site Details Sr. No. Particular Details 1 Plant Location Plot 198-202, New Industrial Area, Mandideep. Village Mandideep (2.4 km, NW) Tehsil Goharganj District Raisen State Madhya Pradesh 2 2 Coordinates Latitude 23°4’59.34"N and Longitude

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Page 1: 1.0 INTRODUCTION 1.1 ABOUT LUPIN LIMITED - म.प्र ...mppcb.nic.in/pdf/590lupinenglish.pdf · Lupin Limited Executive Summary Executive Summary 1 1.0 INTRODUCTION 1.1 ABOUT

Lupin Limited Executive Summary

Executive Summary

1

1.0 INTRODUCTION

1.1 ABOUT LUPIN LIMITED

Indian drug maker, Lupin Limited, head quartered in Mumbai, India, is the fastest

growing, top 3 pharmaceutical players in India and the fastest growing top 10 generic

players in Japan and South Africa. . Today, Lupin has emerged as the 5th largest and

the fastest growing top 5 company in the U.S (by prescriptions), the only Asian

company to achieve that distinction.

1.2 ABOUT PROJECT PROPONENT

Dr. Desh Bandhu Gupta's vision and dream to fight life threatening infectious

diseases and to manufacture drugs of the highest social priority led to the formation

of Lupin in the year 1968. Dr. Desh Bandhu Gupta is the Chairman of the company.

He is an honourary Doctor of science (D.Sc.) with a master’s degree in chemistry.

Dr. Gupta, in his early career was an Associate Professor at Birla Institute of Science

and Technology, Pilani, Rajasthan. Dr. Gupta has steered Lupin towards the

forefront of India pharmaceuticals. In recent years, he has spearheaded the

restructuring of Lupin's operations, and the research and innovation programs in new

drug research and novel drug delivery systems.

Dr. Kamal K Sharma is the Vice Chairman of the company. Dr. Kamal K Sharma is a

graduate in chemical engineering from the Indian Institute of Technology (IIT),

Kanpur, with a post-graduate diploma in industrial management from Jamnalal Bajaj

Institute of Management Studies, Mumbai, and a Ph.D in economics from IIT,

Mumbai. He has also completed an advanced management program from Harvard

Business School, Boston. In a career spanning more than three decades, Dr.

Sharma has held a range of senior management positions managing projects,

corporate development and general management in the pharmaceuticals and

chemicals industries.

Mr Nilesh Gupta is the Managing Director. He is a Chemical Engineer from the

University Department of Chemical Technology (UDCT), Mumbai, and a graduate

with honours from the Wharton School, University of Pennsylvania, USA, where he

specialized in healthcare, strategic management and finance.

1.3 ABOUT THE PROJECT AND THE PROJECT SITE

1.3.1 Project Site Details

Sr. No.

Particular Details

1 1

Plant Location Plot 198-202, New Industrial Area, Mandideep.

Village Mandideep (2.4 km, NW)

Tehsil Goharganj

District Raisen

State Madhya Pradesh

2 2 Coordinates Latitude 23°4’59.34"N and Longitude

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Sr. No.

Particular Details

77°32’0.45"E

3 Elevation 527 m

4 Nearest representative IMD station

Bairagarh, Bhopal, 35 km (North-West) away from project site

5 Nearest highway NH-12 (0.5km) South-West

6 Nearest railway station Mandideep (5 km ) North-West from project site

7 Nearest airport Bairagarh, Bhopal (35 Km) North-West from project site

8 District Headquarters Mandideep (District- Raisen) (50km)

9 Nearest State/National boundaries

Maharashtra (249.3 km, WNW)

10 Seismic Zone Zone II as per the 2002 Bureau of Indian Standards (BIS)

11 Nearest major city with 2,00,000 population

Bhopal ,35 KM

12 Nearest village Mandideep

13 Villages within 1 km radius Nayapura

14 Hills/valleys None

15 Nearest tourist place Bhojpur 4.9 km (ENE), Bhimbethka 17.2 km ( SSW), Saanchi 49.6 (NE)

16 Archaeologically important

places Bhojpur 4.9 km (ENE), Bhimbethka 17.2 km ( SSW), Saanchi 49.6 (NE)

17

Protected areas as per Wildlife Protection Act,1972 (Tiger reserve, Elephant reserve, Biospheres, National parks, Wildlife sanctuaries, community reserves and conservation reserves)

None

18 Forests land There is an open mixed forest at SSW within 10 km radius of the project site

19 Defence Installations None

20 List of Industries

Vardman Yarns (2.2 km), Dawat Food (2.43 km), Crompton Greaves (2.75 km), Nahar Spinning Mills (3.58 km), Proctor & Gamble Industries (3.25 km), HEG (1.8 km), Andritz Hydro Pvt Ltd (3.72 km), Bhaskar Industries Limited (3.72 km), Makson Health care (3.57 km), EicherTactors (3.62 km).

21 Notified ECO- Seismicity None in 10km radius

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1.3.2 Site Map

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Site Map Showing Project Location at Mandideep, Raisen

M/s Lupin Limited, Mandideep, has proposed expansion of its product spectrum and

manufacturing capacity, within the existing factory premises at village Mandideep,

Tehsil Goharganj, District Raisen.

Raisen district is situated at Latitude 23°4’59.34"N and Longitude 77°32’0.45"E. The

site address is Plot 198-202, Sector-II, New Industrial area, Mandideep, District,

Raisen, Madhya Pradesh, India. The project site is located in notified industrial area

of Madhya Pradesh Audyogik Kendra Vikas Nigam (MPAKVN).

1.4 BRIEF DESCRIPTION OF PROJECT

1.4.1 Regulatory Framework

According to the EIA Notification 2006 and its subsequent amendments, the

proposed project comes under the project activity of 5 (f), Synthetic Organic

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Chemicals industry under category B and is located in a notified industrial area.

Lupin Limited, Mandideep has therefore initiated the process of Environmental

Clearance.

Sl. No. Description of Process Date

1. Submission of Form I to SEIAA, Bhopal 12thSeptember 2011

2. TOR Presentation before the committee 15thJanuary 2013

3. TOR issuance by SEAC, Bhopal. 11thMarch2013

1.4.2 Proposed Product Details

Sl. No.

Product Name (Bulk Drugs) Production Capacity (in MTPA)

Existing Additional Proposed

Total

1 Cephalexin 1000 0 1000

2 Cefadroxil 120 0 120

3 Cefazolin Sodium 20 0 20

4 Cephradine 10 0 10

5 Cefuroxime Axetil 20 30 50

6 Cefaclor 120 180 300

7 Ceftriaxone Di Sodium 25 0 25

8 Cefotaxime Sodium 25 0 25

9 Ceftazidime 25 0 25

10 Cefipime 10 0 10

11 Cefixime Trihydrate 15 0 15

12 Cefpodoxime Proxetil 12 8 20

13 Ceftiofur Sodium 10 0 10

14 Cefprozil Monohydrate 10 15 25

15 Cefdinir 24 26 50

16 Lisinopril 100 50 150

17 Benazapril 10 0 10

18 Perindopril 10 0 10

19 Trandolapril 5 0 5

20 Quinapril 20 0 20

21 Ramipril 15 0 15

22 Brimonidine Tartrate 0 1 1

23 Pitavastatin 0 1 1

24 Amlodipine 0 10 10

25 Donepezil HCl 0 1 1

26 Ceftaroline Fosamil Monoacetate 0 5 5

27 Tolterodine Tartrate 0 1 1

28 Candesartan Cilexetil 0 1 1

29 Rosuvastatin Calcium 0 8 8

30 Pilot Plant ( R & D and Trial Run Products) 1 9 10

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By Product

1 Recovered Solvent 7000 0 7000

Formulation Product (Injectable/Oral) Existing Additional Proposed

Total

1 Cefazoline Sodium (Vials) 14 0 14

2 Ceftriazone Disodium (Vials) 12.5 0 12.5

3 Cefotaxime Sodium (Vials) 12.5 0 12.5

4 Tablets (In Crores/Annum) 20 0 20

5 Capsules (In Crores/Annum) 24 0 24

6 Syrups (In Crores/Annum) 1.5 0 1.5

7 Injections (In Lacs/Annum) 12 0 12

8 Infusions (In Lacs/Annum) 6 0 6

9 Ointments (In lacs/Annum) 5 0 5

1.4.3 Project cost

The proposed expansion project is for capacity enhancement of six existing products

and inclusion of eight new products, at the existing manufacturing unit. The project

activity does not involve procurement of land or construction of new buildings. The

overall project will involve provision of plant and machinery, utilities, expansion of

ETP and recycling unit. Total project cost for the proposed expansion is estimated to

be Rs. 2000 lakhs including Rs. 650 lakhs on environment management facilities

and measures.

The budgetary allocation towards pollution control arrangements for the proposed project is as follows:

Sl.

No

Area of Expenditure Capital Cost

( Rs. Lacs)

Recurring Cost

( Rs. Lacs

/annum)

1. Air Pollution Control 20 5.00

2. Water Pollution Control 570 3.00

3. Hazardous Wastes Management 15 1.00

4. Environment Monitoring and

Management 20

1.50

5. Rain Water Harvesting 20 1.00

6. Greenbelt 5 0.50

Total 650 12.00

2.0 PROJECT DESCRIPTION

2.1 TYPE OF PROJECT

This is a synthetic organic chemicals industry project manufacturing bulk drugs.

Organic chemicals are manufactured through industrial synthesis generally by

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chemical process. The manufacturing of pharmaceutical compounds using chemical

synthesis involves a complex process including many intermediate stages and

chemical reactions performed in step by step.

2.2 MAGNITUDE OF OPERATION

M/s Lupin Limited, Mandideep, proposed for expansion of drug manufacturing

capacity and introduction of new drugs. The details regarding resources availability

with cost of the project are presented in Table.

DETAILS OF THE PROPOSED PROJECT

Sr. No.

Parameter Description

1 Land Requirement

The proposed expansion project activities will be carried out in the existing manufacturing facilities at the existing site and therefore no additional land is required/ proposed to be acquired by the project proponent.

2 Land use Notified Industrial Area

3 Water Requirement

90 m3/day

4 Source of Water

Municipal Water supply from AKVN

5 Power Requirement

7200 KVA, addition DG of 1010 KVA is proposed

6 Source of Power

The industry has an existing power supply from Madhya Pradesh State Electricity Board (MPSEB)

7 Employment The additional manpower will be 200 for the proposed project

8 Project Cost Rs.2000 Lakhs

2.3 BASIC REQUIREMENTS FOR PROPOSED EXPANSION PROJECT

2.3.1 Land requirement

MP AUDYOGIK KENDRA VIKAS NIGAM (BHOPAL) Ltd. has been entrusted the

responsibility of Industrial promotion through development of Industrial Growth

Centers in selected areas of its jurisdiction in the State of Madhya Pradesh.

The project proponent acquired 230447 m2 of land spread over 5 adjoining plots with

distinctive number as 198,199, 200, 201, 202 from the developer of notified industrial

area Madhya Pradesh, Audyogik Kendra Vikas Nigam (MPAKVN). This land was

acquired during the year 1986 and the commercial production for the first API

product was commended in Dec 1988. Proposed expansion project activities will be

carried out in the existing manufacturing facilities at the existing site and therefore no

additional land is required/ proposed to be acquired by the project proponent.

2.3.2 Power requirement

The industry has an existing power supply from Madhya Pradesh State Electricity

Board (MPSEB) with a maximum contract demand of 8040 KVA. The actual power

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consumption at current level of operations is around 7200 KVA. Since various

energy conservation measures are being adopted by the industry, it is expected that

further enhancement of maximum contract demand will not be required even after

the proposed project expansion. Accordingly, the existing power supply to the unit is

adequate even after execution of the expansion project.

Source of Power and Backup

In order to have 100% power back-up, DG sets have been installed at the site with

an installed capacity of 11000 KVA with all the DG sets put together. Keeping in

view the efficiencies of the DG sets and power factor, it is proposed to install one

additional DG set of 1010 KVA capacity so as to ensure 100% power back up after

execution of the expansion project.

Sources Existing KVA Additional KVA Total KVA Fuel Type

MPSEB 8040 _ 8040 _

DG Set

550 X 02 = 1000

1010 X1= 1010 12040 HSD

750 X 02 = 1500

1000 X 0 3= 3000

1010 X 03 = 3030

1250 X 02 = 2500

2.3.3 Water

Source of Water Supply and Requirement

Total fresh water consumption shall increase by 90m3/d after the proposed

expansion. The proposed water requirement (fresh) for the industry for process,

utilities, drinking and sanitation purpose is estimated as 90 m3/d. The proposed water

requirement shall be made available from the supply of MPAKVN and through bore

well in the factory premises.

The recovered water obtained from the effluent shall also be used / recycled in the

factory premises to reduce the fresh water requirement. The total water (fresh and

recycled together) required shall be 1400 m3/d.

The industry has an agreement with MPAKVN for supply of 600 m3/d of fresh water

and a permission to withdraw up to 300 m3/d has been obtained from Central

Groundwater Board (CGWB) through bore wells at site.

Wastewater and Zero Liquid Discharge Facility

It is estimated that with the proposed expansion, effluent generation will be 630

m3/day. This includes process wastewater, boiler blow down, floor and equipment

washing, cooling tower blow down and domestic wastewater. Lupin Limited,

Mandideep has two effluent treatment plants followed by the recycling facility: RO,

MEE and ATFD plants, to recover water for recycling and reuse. The additional

effluent generated shall be treated in the ETP II and will further get processed in the

recycling facility. Lupin Limited, Mandideep has proposed expansion of ETP II and

the recycling facility to maintain “Zero Liquid Discharge” conditions at the site.

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2.3.4 Man Power Requirement

The existing manpower engaged in the production and other activities at Lupin,

Limited, Mandideep is about 2750. It is expected that additional 200 manpower shall

be engaged after the proposed expansion.

2.3.5 Air Emissions

Major sources of emissions are from process and utility areas. These include boilers,

DG sets and process vents attached to the scrubbers. Furnace oil and high speed

diesel will be used as fuel in boilers and DG sets, respectively. Sulphur di oxide,

oxides of nitrogen and particulate matter are the main pollutants in the emissions.

Adequate stack height is provided for better dispersion of pollutants.

2.3.6 Solid Waste Generation

The industry has obtained an authorization under the Hazardous Wastes

(Management, Handling & Trans-boundary Movement) Rules 2008 from the Madhya

Pradesh Pollution Control Board vide letter No. 1376/HOPCB/HSMD/BR-31/2011;

and compliance of conditions of authorization are well maintained by the industry.

The disposal of hazardous wastes generated by the industry in different categories is

executed as per the authorization for Common TSDF at Pithampur, Dist. Dhar. The

industry maintains manifest documents prepared in this regard and sends to Madhya

Pradesh Pollution Control Board, Bhopal on a regular basis.

The industry has obtained the Membership of the CTSDF (Common Treatment,

Storage and Disposal Facility: Membership No. MPWMP-HzW-MDP-277 dated

01.07.2008 which is valid up to 31.03.2017. The disposal of hazardous wastes is

being done by the industry at CTSDF and an agreement has been executed for the

financial year 2014-15 as per rates, terms and conditions agreed between the

CTSDF operator and the industry. The same is revised as per the validity.

2.3.7 Hazardous Wastes Storage Facility

M/s Lupin Limited, Mandideep has dedicated areas for storage of Hazardous & non

Hazardous waste. The hazardous wastes generated include both incinerable and

non-incinerable wastes. Incinerable hazardous wastes like process residues and

wastes, spent carbon, spent organic solvent and off-specification drugs are

collected, stored, transported and disposed to the common incinerator at approved

CTSDF site at Pithampur.

Other Incinerable hazardous wastes Effluent Treatment Plant sludge and ATFD

solids are collected, stored, transported and disposed at common TSDF site at

Pithammpur. Recyclable hazardous wastes like used/ spent oil, decontaminated

discarded containers are collected, stored, transported & disposed by selling to

registered or approved recyclers.

Dedicated covered shed, with drain all around it, has been developed to store

Hazardous waste. This prevents chances of contamination of land and water. With

the proposed expansion, quality of Hazardous Waste being generated shall

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increase. Authorisation will be amended accordingly. All necessary precautions is

being taken during management and handling of hazardous wastes of additional

waste generated after expansion.

2.3.8 Greenbelt Management

Total plot area of Lupin Limited, Mandideep is 230447 m2. The total area under

green cover is around 76500 m2 i.e ~33.196% of the plot area. Around 18000 trees

of native species have been planted within and all along the perimeter of the factory

premises. Besides this, about 10000 trees have also been planted on the AKVN plot,

in-between the factory premises & National Highway 12. The plantation along the

highway, has been done not only for the purpose to maintain ecological balance, but

also because it will act as a sink for the gases released by vehicles and industries

operating in the nearby area. The greenbelt will also be act as barrier for propagation

of noise, reducing air pollution and further development of greenbelt for improvement

in environmental quality. Selected plant species are adopted for plantation based on

CPCB guideline.

M/s Lupin Limited, Mandideep, proposes to identify a common/public land in the

vicinity of the proposed plant and develop plantation on the said land in association

with appropriate local authority

3.0 DESCRIPTION OF ENVIRONMENT

3.1 AIR ENVIRONMENT

Ambient air quality monitoring has been carried out in the study area, with a

frequency of two days per week at 14 locations covering one complete season. The

parameters monitored are Particulate Matter (PM10 & PM2.5), Sulphur Dioxide (SO2),

Oxides of Nitrogen (NOx), Carbon Monoxide (CO) and Volatile Organic Carbons

(VOCs) using standard methods. The results were compared with the NAAQMS,

2009, prescribed by CPCB for Industrial, Residential, Rural and Other areas.

Meteorology

The study area has dry climate in the southwest monsoon season. Mandideep has a

tropical climate. In winter there is much more rainfall in Mandideep than in summer.

Meteorological data was collected at the site during the pre monsoon season of 2013

(Ist March to 31st May) and is summarized as follows:

Month Temperature (0C)

Relative Humidity (%)

Rainfall (mm)

Atmospheric Pressure (hpa)

Min Max Min Max Min Max

March 2013 11 36 6 92 0.0 1003 1019

April 2013 18 42 5 77 0.0 950 1011

May 2013 23 44 5 48 0.0 994 1100

Range 11-44 5-92 0.0 994-1100

Predominant Wind Direction Pre-monsoon season

First Predominant Wind Direction WNW (23.14 %)

Second Predominant Wind Direction W (11.22 %)

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Predominant Wind Direction Pre-monsoon season

Calm conditions (%) 8.13

Ambient Air Monitoring Results

STATION CODE

LOCATION

PM10 (μg/m3) PM2.5 (μg/m

3) SO2 (μg/m

3)

MIN MAX AVG 98TH

%TILE

MIN MAX AVG 98TH

%TILE

MIN MAX AVG 98TH

%TILE

AAQ 1 Project Site 42.7 67.4 53.8 66.9 17.2 28.1 21.4 26.7 5.2 8.9 6.5 8.7

AAQ2 Mandideep Village

51.8 64.8 57.8 64.0 15.4 22.1 18.1 21.9 5.7 8.1 6.9 8.1

AAQ3 Hajli Village 39.0 54.0 48.2 53.5 9.5 18.2 14.4 18.2 5.2 8.4 6.6 8.3

AAQ4 Pipliya Village 46.0 64.8 55.5 63.5 10.8 22.1 17.6 21.9 5.7 8.2 7.1 8.2

AAQ5 Nayapura Village

45.0 57.0 51.5 56.5 11.8 19.2 17.1 19.2 5.9 9.5 8.2 9.5

AAQ6 Bangarsiya

Village

44.0 56.0 51.1 55.6 10.8 18.9 15.7 18.7 5.8 8.2 7.4 8.2

AAQ7 Bamulia Village 48.0 63.0 57.0 63.0 12.7 20.2 15.7 20.1 6.2 9.7 8.5 9.6

AAQ8 Suiraya Nagar 43.7 64.3 54.6 64.1 13.8 22.6 17.6 22.4 5.4 8.2 6.5 7.8

AAQ9 Rasalpur Village 43.0 57.3 48.1 56.1 11.7 18.5 16.0 18.5 5.2 8.3 6.5 8.2

AAQ 10 Nurganj Village 44.0 56.0 51.1 55.5 10.8 18.9 15.9 18.7 5.8 8.2 7.4 8.2

AAQ11 Sarakiya 50.8 62.2 56.6 62.0 14.9 19.4 16.6 19.1 5.3 9.8 7.0 9.7

AAQ12 Bersiya 54 65 59.0 64.1 14.3 17.7 16.0 17.6 5.1 9.7 7.5 9.6

AAQ13 Kiratnagar 51.3 65.8 57.8 64.0 14.3 19.8 16.8 19.5 5.6 8.1 6.5 7.9

AAQ14 Khanpura 54.6 65.3 60.6 65.3 15.6 19.6 17.8 19.6 5.4 7.3 6.4 7.3

Range 39-67.4 9.5-28.1 5.1-9.8

Ambient Air Quality Standards

100(24 hr) 60 (24 hr) 80 (24 hr)

STATION CODE

LOCATION

NOx(μg/m3) CO(μg/m

3) NH3 (μg/m

3) VOC (μg/m

3)

MIN MAX AVG 98TH

% TILE

MIN MAX AVG 98TH

% TILE

MIN MAX AVG 98TH

%

TILE

MIN MAX AVG 98TH

%

TILE

AAQ 1 Project Site 11.1 22.8 14.2 22.3 86.0 139.0 116.5 136.5 BDL BDL BDL BDL BDL BDL BDL BDL

AAQ2 Mandideep Village

11.0 22.9 17.6 22.6 94.0 134.0 111.7 134.0 BDL BDL BDL BDL BDL BDL BDL BDL

AAQ3 Hajli Village

9.2 16.8 14.3 16.8 41.0 87.0 58.3 84.0 BDL BDL BDL BDL BDL BDL BDL BDL

AAQ4 Pipliya Village

8.2 22.9 15.2 22.4 81.0 119.0 95.7 118.0 BDL BDL BDL BDL BDL BDL BDL BDL

AAQ5 Nayapura Village

8.7 15.9 12.1 15.9 58.0 122.0 84.7 120.6 BDL BDL BDL BDL BDL BDL BDL BDL

AAQ6 Bangarsiya Village

8.6 15.3 11.6 15.1 68.0 109.0 82.7 107.7 BDL BDL BDL BDL BDL BDL BDL BDL

AAQ7 Bamulia Village

10.3 19.8 15.5 19.7 71.0 112.0 83.4 108.3 BDL BDL BDL BDL BDL BDL BDL BDL

AAQ8 Suiraya Nagar

8.6 23.3 17.8 23.1 84.0 124.0 99.3 122.7 BDL BDL BDL BDL BDL BDL BDL BDL

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AAQ9 Rasalpur Village

9.3 21.9 14.8 21.6 61.0 107.0 75.1 105.6 BDL BDL BDL BDL BDL BDL BDL BDL

AAQ 10

Nurganj Village

8.6 19.3 12.7 19.0 61.0 102.0 78.3 101.5 BDL BDL BDL BDL BDL BDL BDL BDL

AAQ11 Sarakiya 9.6 22.9 16.4 22.2 92 122 109.1 121.6 BDL BDL BDL BDL BDL BDL BDL BDL

AAQ12 Bersiya 14.3 19.6 17.0 19.6 87 108 96.6 106.6 BDL BDL BDL BDL BDL BDL BDL BDL

AAQ13 Kiratnagar 14.9 19.5 17.6 19.4 92 118 105.0 116.5 BDL BDL BDL BDL BDL BDL BDL BDL

AAQ14 Khanpura 14.6 23.9 17.6 22.1 102 124 112.5 123.5 BDL BDL BDL BDL BDL BDL BDL BDL

Range 8.2-23.9 41-139 BDL BDL

Ambient Air Quality Standards

80 (24 hr) 2000 (8 hr) 400 (24hr)

STATI

ON

CODE Location

OZONE (μg/m3) Pb(μg/m

3) Ni(ng/m

3) BAP(ng/m

3)

Min Max Avg 98th

%tile

Min Max Avg 98th

%tile

Min Max Av

g

98th

%til

e

Min Max Avg 98th

%tile

AAQ 1 Project Site 12.9 32 19.3 31.8 0.11 0.19 0.1 0.18 7.3 11.2 9.5 11.0

5

ND ND ND ND

AAQ2 Mandideep

Village

12.9 21.6 17.6 21.1 0.12 0.17 0.1 0.2 7.7 10.9 9.4 10.8 ND ND ND ND

AAQ3 Hajli Village 15.3 25.6 19.1 24.35 0.12 0.18 0.1 0.18 8.2 11.1 9.6 11 ND ND ND ND

AAQ4 Pipliya

Village

14.6 22.3 18.3 22.3 0.12 0.18 0.2 0.18 7.7 10.9 9.3 10.8 ND ND ND ND

AAQ5 Nayapura

Village

13.5 22.9 18.4 22.8 0.12 0.19 0.1 0.2 7.4 11.1 9.5 11.0 ND ND ND ND

AAQ6 Bangarsiya

Village

13.1 23.1 18.4 23.0 0.12 0.18 0.1 0.2 8.1 10.7 9.4 10.6 ND ND ND ND

AAQ7 Bamulia

Village

16.2 30.6 19.9 30.0 0.11 0.18 0.1 0.2 8.2 10.7 9.3 10.6 ND ND ND ND

AAQ8 Suiraya

Nagar

17.2 25.1 20.5 24.9 0.13 0.18 0.2 0.2 7.6 10.5 8.9 10.3 ND ND ND ND

AAQ9 Rasalpur

Village

16.3 27.6 22.1 26.5 0.14 0.18 0.2 0.2 7.6 10.2 8.8 10.0 ND ND ND ND

AAQ

10

Nurganj

Village

14.8 25.3 19.7 25.2 0.13 0.19 0.2 0.2 7.1 10.1 8.8 10.0 ND ND ND ND

AAQ11 Sarakiya 15.2 24.2 18.9 23.5 0.14 0.19 0.2 0.2 7.7 10.9 9.4 10.8 ND ND ND ND

AAQ12 Bersiya 16.3 21.3 19.3 21.1 0.14 0.17 0.2 0.2 7.3 9.9 8.8 9.8 ND ND ND ND

AAQ13 Kiratnagar 12.2 20.9 18.3 20.8 0.11 0.17 0.2 0.2 8.2 10.1 9.2 9.9 ND ND ND ND

AAQ14 Khanpura 13.6 21.9 18.5 21.8 0.14 0.18 0.2 0.2 7.5 9.4 8.5 9.3 ND ND ND ND

Range 12.9-32 0.11-0.19 7.1-11.2 ND

Ambient Air Quality

Standards

100 (8 hr) 1 (24 hr) 20 (Annual) 1 (Annual)

STATION

CODE LOCATION

C6H6(μg/m3) As(ng/m

3)

Min Max Avg 98th

%tile

Min Max Avg 98th

%tile

AAQ 1 Project Site ND ND ND ND BDL BDL BDL BDL

AAQ2 Mandideep Village ND ND ND ND BDL BDL BDL BDL

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AAQ3 Hajli Village ND ND ND ND BDL BDL BDL BDL

AAQ4 Pipliya Village ND ND ND ND BDL BDL BDL BDL

AAQ5 Nayapura Village ND ND ND ND BDL BDL BDL BDL

AAQ6 BangarsiyaVillage ND ND ND ND BDL BDL BDL BDL

AAQ7 Bamulia Village ND ND ND ND BDL BDL BDL BDL

AAQ8 Suiraya Nagar ND ND ND ND BDL BDL BDL BDL

AAQ9 Rasalpur Village ND ND ND ND BDL BDL BDL BDL

AAQ 10 Nurganj Village ND ND ND ND BDL BDL BDL BDL

AAQ11 Sarakiya ND ND ND ND BDL BDL BDL BDL

AAQ12 Bersiya ND ND ND ND BDL BDL BDL BDL

AAQ13 Kiratnagar ND ND ND ND BDL BDL BDL BDL

AAQ14 Khanpura ND ND ND ND BDL BDL BDL BDL

Range ND BDL

Ambient Air Quality

Standards

5 (Annual) 6 (Annual)

3.2 NOISE ENVIRONMENT

The statistical analysis was done for measuring noise levels at 8 locations during

pre-monsoon season 2013. The day time noise levels location in residential and

industrial area, were observed to be well within the prescribed limit of CPCB

standards. The night time noise levels was well within the prescribed limit of CPCB

standard, in the study area.

Noise Level Results:

SI. NO. LOCATION Leq Day (dB A) Leq Night (dB B)

1 Project Site 64 59

2 Mandideep Village 49 43

3 Satlapur Village 51 42

4 Pipliya Village 47 39

5 Nayapura Village 49 42

6 Manddheri Village 52 43

7 Bamulia Village 46 38

8 Narvada Nagar 53 42

Range 46 - 64 38 – 59

CPCB Standards

Industrial Area (dBA) 75 70

Residential Area (dBA) 55 45

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3.3 WATER ENVIRONMENT

The area does not come under semi-critical, critical or over-exploited areas as

defined by CGWA. Mandideep is coming under safe zone. Ground water samples

were collected at different locations within the study area and analysed. Analysis

results of the samples were compared with the drinking water standards as per

APHA/IS: 10500. The results show acceptable limit of parameters at project site and

sampling location. Betwa River is the main surface water body in the study area.

Surface water samples were collected from both river and underground water, within

the study area and analysed. Analysis results of the samples were compared with

the drinking water standards as per IS: 10500/2012.

3.4 LAND ENVIRONMENT

3.4.1 Soil Characteristics

Soil samples were collected within the study area to know the quality of soil. The

results indicated the following:

Porosity of soil samples were in the range of 7.29% (Bamulia Village) to 25.42

% (Satlapur village).

Water Holding Capacity of soil samples were in range of 34.01% (Mandideep

village) to 62.64% (Satlapur village).

Bulk density of Soil samples were in range of 1.08 g/cc (Satlapur village) to

1.52 g/cc (Mandideep village).

Electrical Conductivity of soil samples were in range of 248.62 μs/cm

(Khanpura Village) to 487.6 μs/cm (Kirat Nagar village)

The texture of soil is observed to be mainly Sandy Loam in the study area

based on analysis of the samples collected.

3.4.2 Land Use of The Study Area

The land-use & land cover map of the 10 km radial study area from the project site

has been prepared using Geo EYE satellite image with reference to Geo Eye and

additional satellite Image, Herndon. Land use pattern of the study area, as well as

the catchment area was carried out by standard methods of analysis of remotely

sensed data and followed by ground truth collection and interpretation of satellite

data.

Remote Sensing (RS) and Geographic information system (GIS) was used to detect

the Land use pattern within 10 km radius around plant. Data on ground reality

verification was also collected. Agriculture has been a major occupation for the

residents hence it contributes to the largest portion of the study area land use. No

reserve forest or any other notified ecologically sensitive features in the study area

were identified during the study. The area is well connected to the other parts of the

country by roads and railways. National highway 12 passes through the heart of the

study area, thus giving it an excellent connectivity with the rest of the state.

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LAND USE PATTERN Of STUDY AREA

Sr. No. Village Name Total Land

Forest land

Irrigated land

Un irrigated land

Cultivable waste land

Area not available for cultivation

0-2 km, Goharganj taluka, Raisen district

1. Moijpura 114.00 34.00 21.00 20.00 31.00 8.00

2. Jhalar Kalan 123.00 47.00 2.00 0.00 0.00 74.00

3. Khamkheda 200.00 0.00 122.00 47.00 5.00 26.00

Sub Total 437.00 81.00 145.00 67.00 36.00 108.00

3-5 km, Goharganj taluka, Raisen district

4. Satlapur 390.00 0.00 220.00 12.00 147.00 11.00

5. Pipliya Gajju 326.00 0.00 36.00 272.00 18.00 0.00

6. Bamuliya Pawar 343.00 0.00 115.00 200.00 5.00 23.00

7. Mundla 170.00 0.00 129.00 27.00 0.00 14.00

8. Hameeri 192.00 0.00 147.00 35.00 2.00 8.00

9. Itaya Khurd 181.00 0.00 121.00 33.00 9.00 18.00

10. Sarakiya 675.00 28.00 275.00 293.00 24.00 55.00

11. Shobhapur 111.00 0.00 79.00 26.00 0.00 6.00

12. Simrai 379.00 0.00 159.00 160.00 20.00 40.00

13. Itaya Kalan 377.00 0.00 269.00 59.00 6.00 43.00

14. Nayapura Mewati 194.00 23.00 51.00 28.00 13.00 79.00

15. Semra 110.00 0.00 47.00 49.00 7.00 7.00

16. Bersiya 161.00 0.00 88.00 52.00 21.00 0.00

17. Khanpura 239.00 0.00 18.00 177.00 12.00 32.00

18. Pipaliya Korka 718.00 0.00 435.00 210.00 67.00 6.00

19. Tilakhedi 189.00 0.00 157.00 28.00 4.00 0.00

20. Mendua 633.00 219.00 218.00 101.00 37.00 58.00

21. Kiratnagar 610.00 186.00 154.00 195.00 70.00 5.00

22. Bhojpur 556.00 216.00 136.00 98.00 14.00 92.00

Sub Total 6554.00 672.00 2854.00 2055.00 476.00 497.00

Huzur Taluka, Bhopal district

23. Kotra 162.00 0.00 87.00 57.00 9.00 9.00

24. Pipaliya Rani 163.00 0.00 72.00 43.00 11.00 37.00

25. Samarda Kaliyasot 323.00 0.00 176.00 57.00 52.00 38.00

26. Samarda 107.00 0.00 24.00 58.00 19.00 6.00

Sub Total 755.00 0.00 359.00 215.00 91.00 90.00

Grand Total 7746.00 753.00 3358.00 2337.00 603.00 695.00

Source: Village Directory 2001, District Raisen & Bhopal, State Madhya Pradesh

On the basis above study percentage of Land use of the study area summarized as:

Total Land

Forest land Irrigated

land Un irrigated

land Cultivable waste land

Area not available for cultivation

Grand Total

7746 753 3358 2337 603 695

Percentage of Land use of the Study area

10% 43% 30% 8% 9%

3.5 BIOLOGICAL ENVIRONMENT

3.5.1 National Park, Sanctuaries, Reserve Forest and Protected Forest

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As per satellite imagery, ground truth and available secondary literature, it was

observed that there is no National Park, Sanctuary or biosphere reserve within the

study area. The proposed industry is located in a notified Mandideep industrial area.

The main tree species observed within the industrial area are Azadirachtaindica

(Neem) Delbergiasissoo (Sisam), Syziziumcumini(Jamunl), Acacia nilotica (Babul),

Mangiferaindica (Aam), Tacoma stans, Lucinaleaucociphala,

Peltophorumpterocapum, Samaniasaman, Pongamiapinnata (Karanj), Cassia

siamea (Kashid), Albizzialebbek, etc.

3.5.2 Rare, Endangered, Threatened Plant Species

The IUCN Red List is the world's most comprehensive inventory document showing

the status of plant and animal species. Threatened species are those found only in

small numbers or those which are on the verge of extinction. India has a list of

threatened species published by Botanical Survey of India/Zoological Survey of

India. As per the survey conducted in the study area, there is no any threatened,

vulnerable or endangered species reported as mentioned in the Red Data Book.

3.5.3 Rare and Endangered Fauna Species In The Study Area

Wild Life (Protection) Act, 1972, amended on 17thJanuary 2003, is an Act to provide

protection for wild animals, birds and plants ensuring the ecological and

environmental security of the country. Some of the sighted fauna are given

protection under Indian Wild Life (Protection) Act, 1972 by including them in different

schedules. Among the birds in the study area, Pea fowl (Pavocristatus), is included

in schedule I, while many other birds are included in schedule IV except Jungle crow

(Corvusmacrorhynchos), which is included in Schedule V.

Among the reptiles, Indian Cobra (Najanaja), Russel’s viper (Viperaruselli) are

provided protection as per Schedule-II and common krait (Bungaruscaeruleus),

Dhaman (Dendrelaphispictus), (Gongylophisconicus), (LycodenAulicus) & Black

earch bee (Eryxjohni) and Indian Starred tortoise (Testudoelegaus) provided in

Schedule IV.

Among mammals; Mongoose (Herpestesedwardsi), Jackal (Canisaureus), Jungle cat

(Felischaus), and Rhesus macaque (Macacamulata) are schedule –II animals.

Spotted deer (Axis axis), Wild boar (Susscrofa) and Boselaphustragocamelus (Blue

bull), Striped hyaena (Hyaenahyaena) is protected as Schedule-III animal and

common Indian hare & striped palm squirrel are protected in schedule IV of Wild Life

Protection Act 1972 where as, all Butterflies protected in Schedule IV and Rat

species protected in Schedule V. No Rare, Endemic, Endangered, Vulnerable

species are reported in the study area.

3.6 SOCIO-ECONOMIC ENVIRONMENT

Demography

The zone wise distribution of villages indicates that total 27 villages are within 5 km

radius of the project site. Out of 27 villages, 03 villages fall within the 0 -2 Km radius

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(first zone) including all the 3 villages from Goharganj taluka. The second zone (3-5

Km) incorporates 24 villages from 2 Districts (Raisen & Bhopal) including 20 villages

from Goharganj taluka of Raisen district and 4 villages from Huzur taluka of Bhopal

district.

Census 2001: With a total household 13836, total population in the 0-5 km

study area is 63000. In 0-6 age group total populations were 11872; SC & ST

population was 7032 and 4806 accordingly.

Census 2011: In 2011 overall population has increased. Total household in

the study area is 22605 with a total population of 95984. Under the 0-6 age group

total population is 14551.SC population is 12733 and ST population is 5646.

4.0 ANTICIPATED ENVIRONMENTAL IMPACTS AND MITIGATION

MEASURES

4.1 AIR ENVIRONMENT

Prediction of impacts on air environment was carried out by employing a

mathematical model. In the present case, Industrial Source Complex 3 (ISC3)

dispersion model based on a steady state Gaussian plume dispersion, designed for

multiple point sources for short term has been used for predicting the ground level

concentrations and developed by United States Environmental Protection Agency

[USEPA].

The model simulations deal with dispersion of three major pollutants viz., Sulphur

Dioxide (SO2), Oxides of Nitrogen (NOX) and Particulate Matter (PM) emitted from

the stacks.

INCREMENTAL RISE IN CONCENTRATION (GLCs) OF PM10, SO2 AND NOX

(PROPOSED)

Pollutant Maximum Incremental GLCs (g/m3) Distance (km) Direction

PM10 0.65 1 km E, SE & SSE

SO2 18 1km E, SE & SSE

NOx 10 1km E, SE & SSE

CUMULATIVE CONCENTRATION LEVELS (AMBIENT + PROPOSED

SCENARIO)

Pollutant Maximum Baseline

Concentration

(g/m3)

Incremental GLCs

(g/m3)

Resultant Concentration

(g/m3)

Limits (Industrial, Residential, Rural

and other area) Concentration

(g/m3)

PM10 67.4 0.65 68.05 100

SO2 9.8 18 27.8 80

NOx 23.9 10 33.9 80

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4.2 NOISE ENVIRONMENT

Noise generated by equipment’s will be designed to comply the MP Factories Rules

stipulations and will not exceed 75 dB(A) at plant boundary. During construction,

there shall be noise generated due to the use of earth moving equipment, vehicle

movement and construction equipment. The workers will be provided ear plug/ ear

muffs, wherever required. The noise level will be localized and will be intermittent

during construction stage and hence no significant impact is envisaged.

During operations, the main sources of noise generation are DG sets, blowers and

compressors. DG set will be provided with acoustic enclosures. Equipment like

blowers, etc will be mounted on rubber pads or any other noise absorbing materials,

wherever practical. Equipment balance will be maintained so that noise level does

not increase due to improper maintenance. Besides, workers working in high noise

areas will be provided PPEs like ear plug and ear muffs, wherever required.

Greenbelt will be maintained around periphery of the plant which shall act as a

barrier for propagation of noise from the plant premises. It is expected that noise

level at the plant boundary will be within the prescribed norms of CPCB due to the

operation of the proposed project and no significant impact on noise environment is

expected.

4.3 WATER ENVIRONMENT

IMPACT ON WATER QUALITY

There are one surface water sources within the study area. Surface water samples

were collected from river Betwa which is the nearest source of water. It was

observed that, water quality of this river is physic-chemically good. Since there is no

discharge from the Industry, impact on surface and ground water quality is not

envisaged.

WASTEWATER

Effluent generated from the formulation units are identified as low COD streams and

they are treated in Effluent Treatment Plant I. The effluent from the bulk

manufacturing units has been identified as high COD streams and they are treated in

Effluent Treatment Plant II. The treated effluent is then processed through Reverse

Osmosis units.

The project proponent has proposed to expand Effluent Treatment Plant -II and the

Recycling facility. Effluent will be recycled through Reverse Osmosis, Multi Effect

Evaporator and Agitated Thin Film Dryer for recovery of water and reuse. Part of the

treated effluent of Effluent Treatment Plant-I shall be used for chemical preparation

in Effluent Treatment Plant-II area and for gardening purpose, if required.

4.4 LAND ENVIRONMENT

Any developmental project usually involves acquiring significant area of land and

development of area. No additional land shall be acquired but activities like Clearing

of the site, soil excavation and other activities, will be done for the proposed project.

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Secondary impacts are those of induced development related to the project, which

would place a stress on the land use.

For the proposed expansion, construction will be carried out in the existing premises

and additional land will not be acquired for proposed project. There will not be any

change in land use due to proposed expansion. Consequently, impacts on land and

soil will be negligible. During construction, top soil generated from various activities

like excavation etc. will be stored and preserved to use it during restoration period as

far as possible. There will be no disposal of wastewater on land. Hazardous wastes

will be stored at the dedicated Hazardous Waste shed constructed in the factory

premises with provision of garland drain for control of leach or spill, going on to the

land and thus preventing land and soil contamination. Hazardous wastes will be

disposed as per the Hazardous Waste Rules. No impact is likely to occur on the

land/ soil quality during construction and operation phases.

4.5 BIOLOGICAL/ECOLOGY ENVIRONMENT

Based on the study conducted for ecology in the study area, no rare or endangered

terrestrial and aquatic flora/ fauna were noted in the study area. Consequently,

damage to terrestrial ecology is ruled out. The project activity does not require trees

cutting during land clearing. Also, the study zone does not have any ecologically

sensitive location and hence, the project activities are not expected to have any

adverse impact on the ecology and biodiversity.

Construction may cause minor disturbance due to noise and vibration for terrestrial

fauna. As the site has Zero Liquid Discharge Facility (RO, MEE and ATFD) to

recover water from effluent for reuse, no discharge will take place. Hence, no

adverse impact on ecology is envisaged.

4.6 SOCIO-ECONOMIC IMPACTS

The proposed expansion is within the existing premises hence there shall be no

displacement of population. The activities to be carried out during the planning and

construction phases will require skilled, semi-skilled and un-skilled labours, hence

creating temporary as well as permanent employment for the local people. There will

be direct and indirect job opportunities created by the project during both the

construction as well as the operation phases. The local economy will receive a

stimulus in the form of greater economic growth and avenues for income generation

with the arrival of the project. Hence, the short-term positive impacts on socio-

economic conditions of the area is anticipated. These products also have export

potential and hence possibility of earning foreign exchange is expected.

5.0 ENVIRONMENTAL MANAGEMENT PLAN

5.1 PURPOSE OF THE ENVIRONMENTAL MANAGEMENT PLAN

The main objectives in formulating this environmental management plan are:

To treat all the pollutants viz. liquid and gaseous that contributes to the

degradation of the environment with appropriate technology.

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To comply with all regulations stipulated by the Central / Madhya Pradesh

Pollution Control Boards related to air emissions and liquid effluent discharges

as per Air and Water Pollution Control Acts.

To handle hazardous wastes as per Hazardous Material (Management,

Handling and Trans boundary Movement) Rules 2008, as applicable.

To promote further afforestation in the surrounding areas of the industry to

create good working conditions for employees / workers.

To reduce fire and accident hazards.

Perspective budgeting and allocation of funds for environment management

expenditure.

Continuous development and search for innovative technologies for a cleaner and

better environment.

5.2 COST OF ENVIRONMENTAL MANAGEMENT SYSTEM

The investment for the proposed project is as below:

5.3 ENERGY CONSERVATION MEASURES

Lupin Limited has taken several initiatives towards energy conservation. Following

measures shall be adopted further to contribute towards energy conservation:

Steam generation and distribution

Chilled brine generation and distribution

Cooling towers

Power Consumption in dedicated facility

Solvent recovery system

Control on impurities

Control on Fugitive Emissions

5.4 ENVIRONMENTAL MONITORING PROGRAMME

5.4.1 IMPLEMENTATION AND MONITORING

Sl. No.

Area of Expenditure Capital Cost ( Rs. Lacs)

Recurring Cost ( Rs. Lacs /annum)

1. Air Pollution Control 20 5.00

2. Water Pollution Control 570 3.00

3. Hazardous Wastes Management 15 1.00

4. Environment Monitoring and Management

20 1.50

5. Rain Water Harvesting 20 1.00

6. Greenbelt 5 0.50

Total 650 12.00

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The various components of the environment needs to be monitored on regular basis

as per the requirements of regulating agencies as well as for trend monitoring of the

pollutants levels in various environmental conditions. To review the effectiveness of

environmental management system during and after the project, in line with ISO-

14001 & ISO-18001/IS-18001 and to monitor the effectiveness of Environmental

Management Programs implementation for the project, Lupin Limited, Mandideep

has initiated ISRS system of DNVGL.

ENVIRONMENTAL MONITORING PROGRAM

The program followed shall be as below:

SL No.

Description of parameters Schedule & duration of monitoring

1. AIR QUALITY

A

Ambient Air Quality Monitoring for parameters as per the conditions of in consent given by Madhya Pradesh Pollution Control Board.

Once every month or as prescribed by MPPCB/CPCB/MoEF.

B

Emission from Stack for parameters as per the conditions of in consent given by Madhya Pradesh Pollution Control Board.

Once every month or as prescribed by MPPCB/CPCB/MoEF.

C Work place monitoring for fugitive emissions

Quarterly

2. WATER QUALITY

A

Waste Water Quality monitoring at inlet and outlet of the Effluent Treatment Plant as per the conditions in consent given by Madhya Pradesh Pollution Control Board.

Daily (on working days) or as prescribed by MPPCB/CPCB/MoEF.

B Ground Water Quality monitoring for TDS, pH, COD, Hardness and microbial parameters as per IS:10500: 2012

Weekly

3. NOISE LEVEL

Ambient noise level and as per conditions given by Madhya Pradesh Pollution Control Board in consent

Once a month as prescribed by MPPCB/CPCB/MoEF.

4. SOIL QUALITY

Soil analysis for pH, conductivity, sulfates, calcium and magnesium etc.

Every year or as prescribed by MPPCB/CPCB/MoEF.

5.5 OCCUPATIONAL HEALTH & SAFETY

Occupational health needs attention both during construction, erection, operation

and maintenance phases. Lupin Limited, Mandideep has a full flagged Occupational

Health and Safety system at site.

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6.0 ANALYSIS OF ALTERNATIVES

As the proposed project is an expansion within the premises of existing bulk drug

manufacturing facility and no additional land is proposed to be acquired, alternatives

were not analyzed. Since Lupin Limited, Mandideep is adopting its own processes

for manufacturing of drugs through their in house R & D and know-how, hence no

other processes are feasible for the manufacturing of related drugs.

7.0 RISK ASSESSMENT

7.1 HAZARD IDENTIFICATION

Appraisal of materials characteristics from “Material Safety Data Sheet” for chemical

and other materials used in Lupin Limited, Mandideep, indicate that material used

are toxic and highly inflammable with moderate to high explosive hazards. It is

observed that Methylene chloride, Hexane, Ethyl Acetate, Acetone and Methyl

Alcohol are hazardous chemicals being used in bulk.

Hazard control and safety procedure

Generally mode of approach for consequence analysis is to select few most likely

incidents (failure cases) and then to conduct consequence analysis for these failure

cases. The purpose of listing of failure cases is to examine the consequence on

people or equipment individually or in combination. Those incidents which shall give

maximum credible accident scenario are generally selected for quantitative risk.

Control Measures

The possibility of cascade effect of tank fire is reduced to an extent by providing

bund to each tank.

The centre of effective distances of Maximum Credible Loss Scenarios of

Catastrophic rupture (worst case scenario) of tank which is released into

environment, such as MDC, IPA, Methanol, Toluene, Cyclohexane, Acetone,

Hexane, Acetic Acid, , Ethyl Acetate etc. is marginally crossing the site boundary

The risk contour of late explosion (Overpressure) of tank, which is release into

environment, such as MDC, IPA, Methanol, Toluene, Cyclohexane, Acetone,

Hexane, Acetic Acid,, Ethyl Acetate etc on site layout clearly indicates that the

centre of explosion is lying within the site or any neighbouring industrial facility,

the explosion centre of worst case scenarios marginally crossing the site

boundary

A concrete wall of a good fire rating capacity will be erected along the site

boundary and development of greenbelt along the site periphery is also

envisaged which will result in restriction of radiation within site boundary.

Mitigation Measures Suggested

The following are the available and suggested mitigation measures:

All pumps will be double mechanical seal to avoid any leakage chances

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Regular work place monitoring to check the level of pollutants and to detect the

leakages

All volatile solvents will be stored under restricted premises storage tanks, with

breather valves away from source of ignition.

All equipment, pumps, pipe lines containing the volatile material to be properly

ground through earth pits and jumper clips.

All sections in the plant will have fire escape routes (Emergency Exits) as per the

Rules.

The layout of the Plant has been done in such a way so as to keep away the

Tank Farm from all possible sources of ignition.

The sprinkler arrangement system coupled with the fire hydrant system to be

provided in order to reduce the solvent vapour emission.

Intermediate lower bund walls to be there to divide tanks in to groups to contain

any accidental leakage & to minimize the surface area of any spillage.

The floor of the bund to be sloped to prevent minor spillages remaining below

tank. Provision to be made for the removal.

Recommendations

Following Recommendations are suggested to minimize the risk in the facility:

Ensure periodical checking of gaskets and monitoring of emergency response

system.

Provide blinds end flanges, wherever there are flanges, blinds shall be provided.

Proper ventilation shall be ensured to prevent any build-up of flammable vapours

which may lead to Vapor cloud explosion.

No ignition source shall be located within 50 meter radius of the Flammable

chemicals.

The SOPs’ to be followed strictly for effective implementation of the system.

EHS Management Plan

There is a full-fledged Environment, Health and Safety department to provide all

types of inputs in the areas of Industrial Safety, Health & Environment. Safety &

Health department has strength of around seven persons and is headed by a Sr.

Manager – Safety. All references, data sheets and information which may be

required in the event of an emergency is readily available with the Safety

Department. Besides other related functions of the department, this team provides

valuable and comprehensive inputs in terms of training to the employees.

Environment Department has about fifty people working, who take care of operation

and regulatory standards.

An Environment Management Plan has been prepared for mitigation / management

of the adverse impacts and strengthening positive impacts during proposed

expansion. The industry will adopt a comprehensive environmental management

plan (EMP) which will cover several environmental protection measures, not only for

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abatement of environmental pollution resulting from the proposed expansion but also

for further improvement following will be adopted:

All the necessary controls w.r.to management of liquid / hazardous / gaseous

pollutants shall be exercised.

For liquid effluents, effluent treatment plant consisting of primary, secondary and

tertiary treatment shall be expanded / upgraded to ensure adequate treatment.

Treated effluent will be pass through RO, MEE, and ATFD for water recovery.

Recovered water will be reused.

Process vents shall be equipped with scrubbers, whenever required, to ensure

emissions within prescribed limits.

Stacks of adequate height will be provided in boilers and DG sets for better

dispersion of pollutants.

DG sets will be provided with acoustic enclosure.

Hazardous wastes will be handled as per Hazardous Waste (Management,

Handling and Trans boundary Movement) Rules, 2008 and amendment thereof.

Work place monitoring shall be carried out regularly.

An environment monitoring program has been prepared and will be followed after the

proposed expansion.

8.0 PROJECT BENEFITS

Following are the benefits expected from the proposed expansion:

There will be positive impact on the socio-economic condition of the area in terms

of direct and indirect employment due to the proposed project.

There will be employment opportunity for local people during construction and

operation phase of the proposed expansion.

The proposed expansion will provide quality product at lower cost to the users.

Country will save valuable foreign exchange by import of these drugs.

New developed technologies will be adopted in country.

8.1 CORPORATE SOCIAL RESPONSIBILITY

Under Corporate Social Responsibility, the M/s Lupin is committed to work towards

improvement in the living conditions of local population near the project, particularly

in the areas of health & hygiene, civic amenities, infrastructure, education & training,

water supply etc. For this purpose, M/s Lupin Limited, Mandideep, has formed Lupin

Human Welfare & Research Foundation (LHWRF), an independent entity of Lupin

Limited, Mandideep, to implement Lupin CSR activities all over India. This

organization has been registered under Societies Act/ Trust act and exempted under

35 AC and 80 G. LHWRF is also entitled to take foreign funding through its Foreign

Contribution Regulation Act account founded in 1992, LHWRF is presently operating

in 4 states (Rajasthan, Maharashtra, Madhya Pradesh and Uttarakhand) over 9

districts in 600 villages. Its mainly focused attention is on Poverty Alleviation. Major

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Programme includes Micro Finance, Irrigation Development, Agriculture

development, Animal husbandry development & Self-employment.

In the state of Madhya Pradesh, LHWRF operates in about 100 villages of District

Raisen, District Vidisha and in District Dhar. The highlights are:

Over 4000 families covered under various program.

The main programme include:

a. Poverty Alleviation

b. Irrigation Development

c. Agricultural Advancement

d. Community Health Care

e. Buffalo Breed Improvement.

A loan amount of Rs. 4.5 Crores is made available for 2500 families in

collaboration with Indian Bank to take up self-employment in areas of

agriculture and animal husbandry.

Bank loan recovery rate 100%.

M/s Lupin Limited, Mandideep, shall incur expenditure equivalent to 0.2% of the

net profit being generated by the project. The allocated fund shall be cumulative

in nature regardless of expenditure made.

9.0 ENVIRONMENTAL COST BENEFIT ANALYSIS

Mandideep is well connected to Railways, Roadways and Airways as it is a region of

state capital Bhopal. M/s Lupin Limited, Mandideep, got approval for setting up drug

manufacturing unit in Mandideep Industrial area in 1988.

The project has got number of intangible benefits like minimum emissions of the

greenhouse gases, no adverse impact on environment, socio economic benefits to

the local people and the region and enhancement of the economy for the country.

The establishment of drug manufacturing unit at Mandideep site, when operated will

provide significant supply of drugs to the consumers in India and abroad and help to

increase the economic status of the country.

10.0 SUMMARY AND CONCLUSIONS

The proposed activities will be within the existing premises and is proposed to cater

to the increasing demand of drugs in India and abroad. The project will have served

the society further in a better way.