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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 g eneric players in Japan and South Africa. . Tod ay, Lupin has emerged as the 5 th largest and the fastest growing t op 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 hono u rary Doctor of science (D.Sc.) with a aster’s degree in cheistry. 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 pharma ceuticals. 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 Sharm a is a graduate in chemic al engineering from the Indian I nstitute of Technology (IIT), Kanpur, with a post - graduate diploma in industrial management fr om Jamnalal Bajaj Institute of M anagement 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 manage ment 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 ( 2 49.3 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 rad ius 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 Lim ited (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 expan sion 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 12 th September 2011 2. TOR Presentation before the committee 15 th January 2013 3. TOR issuance by SEAC, Bhopal. 11 th 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 n ew 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 manage ment 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 m 3 /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 m 2 of land spread over 5 adjoining plots with distinctive number as 198,1 99, 200, 201, 202 from the developer of notified industrial area Ma dhya 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 man ufacturing 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 meas ures 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 o f 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 c onsumption shall increase by 90 m 3 /d after the proposed expansion. The proposed water requirement (fresh) for the industry for process, utilities , drinking and sanitation purpose is estimated as 90 m 3 /d. The proposed water requirement shall be made available from the supply of MPAKVN and through bore well in the factory p remises. 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 14 00 m 3 /d . The industry has an agreement with MPAKVN for supply of 600 m 3 /d of fresh water and a permission to withdraw up to 300 m 3 /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 p roposed expansion , effluent generation will be 6 30 m 3 /day . This includes process wastewater, boiler blow down, floor and equipment washing, cooling tower blow down and domestic wastewater. Lupin Limited, Mandideep has two efflu ent treatment plants followed by the recycling facility: RO , MEE and ATFD plant s, 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 aintain “Zero Liquid Discharge” conditions at the site. Lupin Limited Executive Summary Executive Summary 9 2.3.4 Man Power Requirement The e xisting manpower engaged in the production and other activities at Lupin, L imited , 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 bett er 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 Pitham pur, Dist. Dhar. The industry maintains manifest documents prepared in this regard and send s to Madhya Pradesh Pollution Control Bo ard, Bhopal on a regular basis. The industry has obtained the Membership of the CTSDF (Common Treatment, Storage and Disposa l Facility: Membership No. MPW MP - HzW - MDP - 277 dated 01.07.2008 which is valid up to 31.03.201 7 . The disposal of hazardous wastes is being done by the industry at CTSDF and an agreement has been executed for the financial year 201 4 - 15 as per rates, terms an d conditions agreed between the CTSDF operator and the industry. The same is revised as per the validity. 2.3.7 H azardous W astes 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 dispo sed to the common incinerator at approved C TSDF site at Pitham pur . Other Incinerable hazardous wastes E ffluent Treatment Plant sludge and ATFD solids are collected, stored, transported and disposed at common TSDF site at Pitham mpur . Recyclable hazardous wastes like used/ s pent oil, decontaminated discarded containers are collected, stored, transported & di sposed by selling to registered or approved rec yclers. Dedicated covered shed, with drain all around it, has been developed to store Haz ardous 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 a nd hand ling of hazardous wastes of additional waste generated after expansion. 2.3.8 Greenbelt Management Total plot area of Lupin Limited, Mandideep is 230447 m 2 . The total area under green cover is around 76500 m 2 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 plantatio n 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 com mon/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 A IR 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 (PM 10 & PM 2.5 ), Sulphur Dioxide (SO 2 ), Oxides of Nitr og en (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 ( I st March to 31 st 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 PM 10 (μg /m 3 ) PM 2.5 (μg/ 3 ) SO 2 (μg/ 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/ 3 ) CO(μg/ 3 ) NH 3 (μg/ 3 ) VOC (μg/ 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/ 3 ) Pb(μg/ 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 C 6 H 6 (μg/ 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 measur ing 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 an d underground water , within the study area and analysed. Analys is 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 saples were in range of 248.62 μs/c (Khanpura Village) to 487.6 μs/c (Ki rat 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 o f 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 fo llowed 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 colle cted. 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 stu dy. 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 are a 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 m ain tree species observed within the industrial area are Azadirachtaindica (Neem) Delbergiasissoo (Sisam), Syziziumcumini (Jamunl), Acacia nilotica (Babul), Mangiferaindica (Aam), Tacoma stans , Lucinaleaucociphala , Peltophorumpterocapum , Samaniasaman , Ponga miapinnata (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 a nd Endangered Fauna Species In The Study Area Wild Life (Protection) Act, 1972, amended on 17 th January 2003, is an Act to provide protection for wi ld 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 st udy 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 ( Vipera ruselli ) 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 sched ule IV of Wild Life Protection A ct 1972 where as, a ll Butterflies protected in Schedule IV and Rat sp ecies 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 z one (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 th e 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 A IR 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 [USEP A]. The model simulations deal with dispersion of three major pollutants viz., Sulphur Dioxide (SO 2 ), Oxides of Nitrogen (NO X ) and Particulate Matter (PM) emitted from the stacks. INCREMENTAL RISE IN CONCENTRATION (GLCs) OF PM 10 , SO 2 AND NO X (PROPOSED) Pollutant Maximum Incremental GLCs (  g/m 3 ) Distance (km) Direction PM10 0.65 1 km E, SE & SSE SO 2 18 1km E, SE & SSE NOx 10 1km E, SE & SSE CUMULATIVE CONCENTRATION LEVELS (AMBIENT + PROPOSED SCENARIO) Pollutant Maximum Baseline Concentration (  g/m 3 ) Incremental GLCs (  g/m3) Resultant Concentration (  g/m 3 ) Limits ( Industrial , Residential , Rural and other area) Concentration (  g/m 3 ) PM10 67.4 0.65 68.05 100 SO 2 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 equipent’s will be designed to coply 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 sou rces 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 w hich 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 - chemical ly good. Since there is no discharge from the Industry, impact on surface and ground water quality is not envisaged. WASTEWATER Effluent generated fr om the formulation units are identified as low COD streams and they are treated in E ffluent 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. E ffluent will be recycled through R everse Osmosis , M ulti E ffect E vaporator and A gitated 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 ENVIRONMEN T Any developmental project usually involve s acq uiring significant area of land and development of area . No additional land shall be acquired but activities like C learing 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 p roject . T here 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 co nstruction and operation p hases. 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. Consequentl y , damage to terrestrial ecology is ruled out. The project activity does not require tree s cutting during land clearing. Also, the study zone does not have any ecologically sensitive location and hence, the p roject activities are not expected to have any adverse impact on the ecology and biodiversity. Cons truction may cause minor disturbance due to noise and vibration for terrestrial fauna. As the site has Zero Liquid D ischarge F acility (RO, MEE and ATFD) to recover water from effluent for reuse , no discharge will take place . H ence , 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 antici pated. 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 ef fluent discharges as per Air and Water Pollution C ontrol Acts.  T o handle hazardous wastes as per Hazardous Material (Management, Handling and Trans boundary Movement) Rules 2008, as applicable.  To promote further affor estation 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 env ironmental 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 ASSESS MENT 7 .1 HAZARD IDENTIFICATION Appraisal of materials charact eristics fro “Material Safety D ata Sheet” for cheical 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 conseque nce 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 ex tent 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 release d 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 goo d 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 restric ted 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 sys tem coupled with the fire hydra nt system to be provided in o rder 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 spillag es 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 ipleentation of the syste . EHS Management Plan There is a full - fledged Environment, Health and Safety department to provide all types of inputs in the areas of Industr ial 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 c are 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 environment al m ana gement p lan (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 f ollowing 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. T rea ted effluent will be pass through RO, MEE, and ATFD for water recovery. Recovered water will be reused.  Process vents shall be equipped with scrubbers, wheneve r required, to ensure emissions within prescribed limits.  Stacks of adequate height will be provi ded 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 expansi on.  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 & trainin g, 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 be en 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 Cont ribution Regulation Act account f ounded in 1992, LHWRF is presently operating in 4 states (Rajasthan, Mah arashtra, Madhya Pradesh and Uttarak h and) over 9 districts in 600 villages. Its mainly focused atten tion 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 All eviation 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 agric ulture and animal husbandry.  Bank loan recovery rate 100% . M/s Lupin L imi t e d , 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 L imited, 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 p roposed activities will be within the existing premises and is proposed to cater to the increa sing demand of drugs in India and abroad. The project will have served the society further in a better way.