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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 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
Lupin Limited Executive Summary
Executive Summary 2
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
Lupin Limited Executive Summary
Executive Summary 3
1.3.2 Site Map
Lupin Limited Executive Summary
Executive Summary 4
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
Lupin Limited Executive Summary
Executive Summary 5
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 12th
September 2011
2. TOR Presentation before the committee 15th
January 2013
3. TOR issuance by SEAC, Bhopal. 11th
March2013
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
Lupin Limited Executive Summary
Executive Summary 6
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
Lupin Limited Executive Summary
Executive Summary 7
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
Lupin Limited Executive Summary
Executive Summary 8
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.
Lupin Limited Executive Summary
Executive Summary 9
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
Lupin Limited Executive Summary
Executive Summary 10
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
(0
C)
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 %)
Lupin Limited Executive Summary
Executive Summary 11
Predominant Wind Direction Pre-monsoon season
Calm conditions (%) 8.13
Ambient Air Monitoring Results
STATION
CODE
LOCATION
PM10 (μg/m
3
) PM2.5 (μg/m
3
) SO2 (μg/m
3
)
MIN MAX AVG 98
TH
%TILE
MIN MAX AVG 98
TH
%TILE
MIN MAX AVG 98
TH
%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/m
3
) CO(μg/m
3
) NH3 (μg/m
3
) VOC (μg/m
3
)
MIN MAX AVG 98
TH
%
TILE
MIN MAX AVG 98
TH
%
TILE
MIN MAX AVG 98
TH
%
TILE
MIN MAX AVG 98
TH
%
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
Lupin Limited Executive Summary
Executive Summary 12
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/m
3
) Pb(μg/m
3
) Ni(ng/m
3
) BAP(ng/m
3
)
Min Max Avg 98
th
%tile
Min Max Avg 98
th
%tile
Min Max Av
g
98
th
%til
e
Min Max Avg 98
th
%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/m
3
) As(ng/m
3
)
Min Max Avg 98
th
%tile
Min Max Avg 98
th
%tile
AAQ 1 Project Site ND ND ND ND BDL BDL BDL BDL
AAQ2 Mandideep Village ND ND ND ND BDL BDL BDL BDL
Lupin Limited Executive Summary
Executive Summary 13
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
Lupin Limited Executive Summary
Executive Summary 14
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.
Lupin Limited Executive Summary
Executive Summary 15
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
Lupin Limited Executive Summary
Executive Summary 16
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 17th
January 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
Lupin Limited Executive Summary
Executive Summary 17
(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
Lupin Limited Executive Summary
Executive Summary 18
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.
Lupin Limited Executive Summary
Executive Summary 19
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.
Lupin Limited Executive Summary
Executive Summary 20
 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
Lupin Limited Executive Summary
Executive Summary 21
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.
Lupin Limited Executive Summary
Executive Summary 22
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
Lupin Limited Executive Summary
Executive Summary 23
 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
Lupin Limited Executive Summary
Executive Summary 24
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
Lupin Limited Executive Summary
Executive Summary 25
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.

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590lupinenglish.pdf

  • 1. 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
  • 2. Lupin Limited Executive Summary Executive Summary 2 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
  • 3. Lupin Limited Executive Summary Executive Summary 3 1.3.2 Site Map
  • 4. Lupin Limited Executive Summary Executive Summary 4 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
  • 5. Lupin Limited Executive Summary Executive Summary 5 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 12th September 2011 2. TOR Presentation before the committee 15th January 2013 3. TOR issuance by SEAC, Bhopal. 11th March2013 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
  • 6. Lupin Limited Executive Summary Executive Summary 6 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
  • 7. Lupin Limited Executive Summary Executive Summary 7 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
  • 8. Lupin Limited Executive Summary Executive Summary 8 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.
  • 9. Lupin Limited Executive Summary Executive Summary 9 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
  • 10. Lupin Limited Executive Summary Executive Summary 10 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 (0 C) 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 %)
  • 11. Lupin Limited Executive Summary Executive Summary 11 Predominant Wind Direction Pre-monsoon season Calm conditions (%) 8.13 Ambient Air Monitoring Results STATION CODE LOCATION PM10 (μg/m 3 ) PM2.5 (μg/m 3 ) SO2 (μg/m 3 ) MIN MAX AVG 98 TH %TILE MIN MAX AVG 98 TH %TILE MIN MAX AVG 98 TH %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/m 3 ) CO(μg/m 3 ) NH3 (μg/m 3 ) VOC (μg/m 3 ) MIN MAX AVG 98 TH % TILE MIN MAX AVG 98 TH % TILE MIN MAX AVG 98 TH % TILE MIN MAX AVG 98 TH % 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
  • 12. Lupin Limited Executive Summary Executive Summary 12 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/m 3 ) Pb(μg/m 3 ) Ni(ng/m 3 ) BAP(ng/m 3 ) Min Max Avg 98 th %tile Min Max Avg 98 th %tile Min Max Av g 98 th %til e Min Max Avg 98 th %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/m 3 ) As(ng/m 3 ) Min Max Avg 98 th %tile Min Max Avg 98 th %tile AAQ 1 Project Site ND ND ND ND BDL BDL BDL BDL AAQ2 Mandideep Village ND ND ND ND BDL BDL BDL BDL
  • 13. Lupin Limited Executive Summary Executive Summary 13 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
  • 14. Lupin Limited Executive Summary Executive Summary 14 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.
  • 15. Lupin Limited Executive Summary Executive Summary 15 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
  • 16. Lupin Limited Executive Summary Executive Summary 16 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 17th January 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
  • 17. Lupin Limited Executive Summary Executive Summary 17 (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
  • 18. Lupin Limited Executive Summary Executive Summary 18 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.
  • 19. Lupin Limited Executive Summary Executive Summary 19 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.
  • 20. Lupin Limited Executive Summary Executive Summary 20  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
  • 21. Lupin Limited Executive Summary Executive Summary 21 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.
  • 22. Lupin Limited Executive Summary Executive Summary 22 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
  • 23. Lupin Limited Executive Summary Executive Summary 23  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
  • 24. Lupin Limited Executive Summary Executive Summary 24 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
  • 25. Lupin Limited Executive Summary Executive Summary 25 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.