SMS PHARMACEUTICALS LIMITED, UNIT VII SY.NOS

Transcription

1 SMS PHARMACEUTICALS LIMITED, UNIT VII SY.NOS. 160, 161, 163 TO 168 AND 170 (KANDIVALASA VILLAGE), 72 (KOVVADA AGRAHARAM VILLAGE), PUSAPATIREGA MANDAL, VIZIANAGARAM DISTRICT, ANDHRA PRADESH FORM I Project No January 2018 SMS Pharmaceuticals Ltd., Plot No. 19 III, Opp. Bharatiya Viday Bhavan Public School, Road No. 71, Jubilee Hills, Hederabad Phone: , E mail ID: chandrashaker@smspharma.com STUDIES AND DOCUMENTATION BY TEAM Labs and Consultants B & 509, Annapurna Block, Aditya Enclave, Ameerpet, Hyderabad Phone: / , Telefax: SUBMITTED TO MINISTRY OF ENVIRONMENT, FORESTS AND CLIMATE CHANGE GOVERNMENT OF INDIA INDIRA PARYAVARAN BHAWAN, JOR BAGH ROAD, NEW DELHI

2 Unit VII APPENDIX I (See Paragraph 6) FORM I I) Basic Information S.No. Item Details 1 Name of the Project/s SMS Pharmaceuticals Limited, Unit VII 2 S. No in the Schedule 5 (f) A category (Synthetic Organic Chemicals) 3 Proposed capacity/area/length/tonnage to be handled/command area/lease area/number of wells to be drilled Area Existing: acres Capital cost for proposed expansion: 600 crores Existing Capacity: API Manufacturing TPM After Expansion: API Manufacturing TPM Captive Power Plant 2 x 2 MW 4 New/Expansion/Modernization Expansion 5 Existing Capacity/Area etc. Existing Capacity: TPM Area Existing: Acres 6 Category of Project i.e 'A' or 'B' A 7 Does it attract the general condition? If yes, No please specify 8 Does it attract the Specific condition? If yes, No please specify. 9 Location Plot/Survey/Khasra No. Sy.Nos. 160, 161, 163 to 168 and 170 (Kandivalasa Village), Sy. No. 72 (Kovvada Agraharam Village) Village Kandivalasa and Kovvada Agraharam Tehsil Pusapatirega Mandal District Vizianagaram District State Andhra Pradesh 10 Nearest railway station/airport along with distance in km. Railway Station: Vizianagaram 20.6 Km Airport: Vishakhapatnam 56 Km 11 Nearest Town, City, District Headquarters Vizianagaram 17 Km along with distance in kms. 12 Village Panchayats, Zilla Parishad, Municipal Kandivalasa Village Panchayat Corporation, Local body (complete postal address with telephone nos. to be given) 13 Name of the Applicant Ramesh Babu Potluri 14 Registered Address SMS Pharmaceuticals Limited, Unit XI Sy.Nos. 160, 161, 163 to 168 and 170 (Kandivalasa Village), Sy. No. 72 (Kovvada Agraharam Village), Pusapatirega Mandal, Vizianagaram District, Andhra Pradesh. Form I Page 1

3 Unit VII 15 Address for Correspondence: Name C. Chandra Shaker Designation(Owner/Partner/CEO) Head EHS Department Address Aurobindo Pharma Limited, SMS Pharmaceuticals Ltd. Plot No 19 III, Road No. 71, Opp. Bharatiya Vidya Bahavan Public School, Jubilee Hlls, Hyderabad, Telangana Pin Code E mail chandrashaker@smspharma.com Telephone Number Phone: Ext. 941 Mobile: Fax No / Details of alternative Sites examined, if any. Location of these sites should be shown on a Not Applicable, as the proposed expansion is for the existing unit topo sheet. 17 Interlinked Projects Not applicable 18 Whether separate application of interlinked Not applicable project has been submitted? 19 If yes, date of submission NA 20 If no, reason 21 Whether the proposal involves approval/clearance under: if yes, details of the same and their status to be given. (a) The Forest (Conservation) Act, 1980? (b) The Wildlife (Protection) Act, 1972? (c) The C.R.Z Notification, 1991? 22 Whether there is any Government Order/Policy relevant/relating to the site? 23 Forest land involved (hectares) No 24 Whether there is any location pending against the project and /or land in which the project is propose to be set up? (a) Name of the Court (b) Case No (c) Orders/directions of the Court, if any and its relevance with the proposed project. No CRZ, if necessary based on requirement of up gradation of existing off shore disposal system. No Form I Page 2

4 Unit VII (II) Activity 1. Construction, operation or decommissioning of the Project involving actions, which will cause physical changes in the locality (topography, land use, changes in water bodies, etc.) S.No. Information/Checklist confirmation Yes/No Details thereof (with approximate quantities /rates, wherever possible) with source of information data 1.1 Permanent or temporary change in land use, land cover or topography including increase in intensity of NO There will not be any change in land use. land use (with respect to local land use plan) 1.2 Clearance of existing land, NO vegetation and buildings? 1.3 Creation of new land uses? NO 1.4 Pre construction investigations e.g. YES Soil test done bore houses, soil testing? 1.5 Construction works? YES Construction activity involves creation of new production blocks, additional utilities like Chilling Plant, DG Set, etc and effluent treatment system. 1.6 Demolition works? NO No structures for demolition 1.7 Temporary sites used for construction works or housing of construction workers? 1.8 Above ground buildings, structures or earthworks including linear structures, cut and fill or excavations 1.9 Underground works including mining or tunneling? NO Construction labor from local villages shall be employed. YES Storage facilities shall be constructed. No major cut and fill or excavation is anticipated. NO 1.10 Reclamation works? NO 1.11 Dredging? NO 1.12 Offshore structures? NO 1.13 Production and manufacturing processes? YES 1.14 Facilities for storage of goods or YES materials? 1.15 Facilities for treatment or disposal of solid waste or liquid effluents? YES 1.16 Facilities for long term housing of NO operational workers? 1.17 New road, rail or sea traffic during NO No underground works like mining and tunneling. Enclosed in Annexure I Raw materials and solvents shall be stored with in factory premises. Materials in bags and drums will be stored in properly designed warehouse with adequate safe guards. Bulk quantities of raw materials will be stored in Bulk Storage tanks in the tank farms with retention dykes. Wastewater collection and storage facilities; guard ponds for storage of treated wastewater/utilities waster, storage bays for hazardous and other wastes will be created. Presented as Annexure II. No housing proposed Form I Page 3

5 Unit VII construction or operation? 1.18 New road, rail, air waterborne or NO other transport infrastructure including new or altered routes and stations, ports, airports etc? 1.19 Closure or diversion of existing NO transport routes or infrastructure leading to changes in traffic movements? 1.20 New or diverted transmission lines or NO pipelines? 1.21 Impoundment, damming, culverting, NO realignment or other changes to the hydrology of watercourses or aquifers? 1.22 Stream crossings? NO 1.23 Abstraction or transfers of water form ground or surface waters? YES 1.24 Changes in water bodies or the land NO surface affecting drainage or run off? 1.25 Transport of personnel or materials YES for construction, operation or decommissioning? 1.26 Long term dismantling or decommissioning or restoration works? 1.27 Ongoing activity during decommissioning which could have an impact on the environment? 1.28 Influx of people to an area in either temporarily or permanently? NO NO YES 1.29 Introduction of alien species? NO 1.30 Loss of native species or genetic NO diversity? 1.31 Any other actions? NO Total water required shall increase from 324 KLD to 2215 KLD out shall be met from ground water. The construction material shall be drawn from local sources within km. There is no transport of personnel, as the construction workers shall be drawn from local villages. The proposed project shall increase the employment potential and hence may lead to migration to surrounding villages. Form I Page 4

6 Unit VII 2. Use of Natural resources for construction or operation of the Project (such as land, water, materials or energy, especially any resources which are non renewable or in short supply): S.No. Information/checklist confirmation Yes/No Details thereof (with approximate quantities /rates, wherever possible) with source of information data 2.1 Land especially undeveloped or agricultural land (ha) 2.2 Water (expected source & competing users) unit: KLD No YES 2.3 Minerals (MT) NA 2.4 Construction material stone, aggregates, sand / soil (expected source MT) YES 2.5 Forests and timber (source MT) NO 2.6 Energy including electricity and fuels YES (source, competing users) Unit: fuel (MT), energy (MW) SMS Pharmaceuticals Limited, Unit XI Sy.Nos. 160, 161, 163 to 168 and 170 (Kandivalasa Village), Sy. No. 72 (Kovvada Agraharam Village), Pusapatirega Mandal, Vizianagaram District, Andhra Pradesh Total water required shall increase from 324 KLD to 2215 KLD out shall be met from ground water. (Water Balance Enclosed in Annexure III) Will be sourced from the local villages. The required energy shall be drawn from AP TRANSCO. The power shall be drawn from proposed captive power plant of 2 x 2 MW and DG sets during load shut downs. Backup DG sets of 7 x 1500 kva proposed in addition to existing DG set of 1 x 125 KVA to cater to energy requirement during load shut downs. High Pressure Coal fired boilers of 1 x 20 TPH capacity and Low pressure boiler of capacity for 1 x 12 and 2 x 10 are proposed in addition to existing 1 x 6 and 1 x 3 TPH boilers, to take care of process requirements and treatment system. Consumption of Coal for proposed boilers is 7 T/hr. 2.7 Any other natural resources (use appropriate standard units) NA It is proposed to establish Thermic Fluid heaters of 1 x 2 Lac K.cal/hr and 1 x 10 Lac K. Cal/hr. Consumption of Coal for proposed Thermic fluid heater boilers is 4.5 T/hr Form I Page 5

7 Unit VII 3. Use, storage, transport, handling or production of substances or materials, which could be harmful to human health or the environment or raise concerns about actual or perceived risks to human health. S.No. Information/Checklist confirmation Yes/No Details thereof (with approximate quantities/rates, wherever possible) with source of information data 3.1 Use of substances or materials, which are hazardous (as per MSIHC rules) to human health or the environment (flora, fauna, and water supplies) YES 3.2 Changes in occurrence of disease or NO affect disease vectors (e.g. insect or water borne diseases). 3.3 Affect the welfare of people e.g. by changing living conditions? YES 3.4 Vulnerable groups of people who could NO be affected by the project e.g. hospital patients, children, the elderly etc., 3.5 Any other causes NO Hazardous chemicals shall be used for manufacturing of Synthetic Organic Chemicals. MSIHC rules shall be followed during storage, transportation and handling of raw materials. Hazardous chemicals and solvent shall be stored and handled in closed systems. Shall increase the employment potential for locals and affect the living conditions for betterment. No sensitive receptors are present in the immediate vicinity of the site. The project shall not have any significant impact on vulnerable groups of people. 4. Production of solid wastes during construction or operation or decommissioning (MT/month) S.No. Information/Checklist confirmation Yes/No Details thereof (with approximate quantities/rates, wherever possible) with source of information data 4.1 Spoil, overburden or mine wastes NO 4.2 Municipal waste (domestic and or NO Wastes from canteen, other commercial wastes like commercial wastes) paper, empty containers etc. The canteen wastes and commercial wastes shall be in the range of 200 Kg/day after expansion (canteen and kitchen wastes) 4.3 Hazardous wastes (as per Hazardous Waste Management Rules) YES Hazardous waste generation during construction shall be limited to waste oils, batteries and containers of paints etc. The quantity of hazardous wastes generated during operation contain salts from evaporators, process residue, and solvent residues, ETP sludge and filtration media etc. 4.4 Other industrial process wastes YES Enclosed at Annexure IV 4.5 Surplus product NO 4.6 Sewage sludge or other sludge from effluent treatment YES Sludge from Effluent treatment plant, evaporation salts shall be sent to TSDF. 4.7 Construction or demolition wastes NO Construction activity involves creation of additional utilities like Chilling Plant, DG sets, etc and enhancement of effluent treatment system. 4.8 Redundant machinery or equipment NO 4.9 Contaminated soils or other materials NO Structures of all waste treatment facilities are made of concrete and also above ground to eliminate the possibility of any contamination due to seepage and for ease of maintenance Agricultural wastes NO 4.11 Other solid wastes YES Enclosed at Annexure IV Form I Page 6

8 Unit VII 5. Release of pollutants or any hazardous, toxic or noxious substances to air (Kg/hr) S.No. Information/Checklist confirmation Yes/No Details thereof (with approximate quantities/rates, wherever possible) with source of information data 5.1 Emissions from combustion of fossil fuels from stationary or mobile sources YES Coal Shall be used as fuel. Quantity of fuel and emissions details are enclosed in Annexure V 5.2 Emissions from production processes YES Gaseous emissions from process are Hydrogen Chloride, Sulfur dioxide, Carbon dioxide, Oxygen and Hydrogen. HCl and SO 2 are scrubbed in two stage scrubbers. Water is used as scrubbing media in primary scrubbers and caustic in secondary scrubbers. Sodium Chloride, Sodium bicarbonate solutions are sent to ETP. Hydrogen, Oxygen and carbon dioxide gases are let out into atmosphere by following standard operating procedure. Hydrogen gas is let out into atmosphere through water column. 5.3 Emissions from materials handling including storage or transport NO Material transfer takes place in closed pipeline systems using pumps with mechanical seals. 5.4 Emissions from construction activities YES Dust may rise during transport of material and including plant and equipment construction activity. The dust emissions shall be mitigated by water spraying on the roads within the premises. 5.5 Dust or odors from handling of materials including construction materials, sewage and waste NO 5.6 Emissions from incineration of waste NO 5.7 Emissions from burning of waste in NO open air (e.g. slash materials, construction debris) 5.8 Emissions from any other sources NO Necessary engineering or administrative controls will be put in place to address dust or odor. Form I Page 7

9 Unit VII 6. Generation of Noise and Vibration, and Emissions of Light and Heat: S.No. Information/Checklist confirmation Yes/No Details thereof (with approximate quantities/rates, wherever possible) with source of information data with source of information data 6.1 From operation of equipment e.g. engines, ventilation plant, crushers YES Turbine, material transport and construction equipment shall be source of noise, while transfer pumps, vacuum systems, DG sets are the sources of noise during operation. 6.2 From industrial or similar processes YES Turbine, DG sets controlled by providing Acoustic Enclosures. DG sets will be used in case of power failure from APPDCL. 6.3 From construction or demolition YES Noise during construction shall be due to construction equipment and emergency DG sets. 6.4 From blasting or piling NO 6.5 From construction or operational traffic NO The increased traffic shall not have any significant impact. 6.6 From lighting or cooling systems NO 6.7 From any other sources NO 7.Risks of contamination of land or water from releases of pollutants into the ground or into sewers, surface waters, groundwater, coastal waters or the sea: S.No. Information/Checklist confirmation Yes/No Details thereof (with approximate quantities/rates, wherever possible) with source of information data 7.1 From handling, storage, use or spillage of hazardous materials NO All the hazardous materials will be stored in MS/HDPE drums, in a covered shed and no contamination of soil is expected. 7.2 From discharge of sewage or other effluents to water or the land (expected mode and place of discharge) NO Trade effluent (process and utilities) will be subjected to segregation and subjected to physical, physicchemical and biological treatment and disposed to marine outfall conforming to norms. 7.3 By deposition of pollutants emitted to air into the land or into water NO 7.4 From any other sources NO 7.5 Is there a risk of long term build up of pollutants in environment from NO these sources? Domestic wastewater (canteen, sanitary, garment washing, etc) will be treated in STP and treated water will be used for gardening and/or will be disposed to marine outfall along with treated trade effluent. All the emissions from process are controlled by providing control equipment like scrubbers, Bag filters etc. Form I Page 8

10 Unit VII 8.Risk of accidents during construction or operation of the Project, which could affect human health or the environment S.No. Information/Checklist confirmation Yes/No Details thereof (with approximate quantities/rates, wherever possible) with source of information data 8.1 From explosions, spillages, fires etc from storage, handling, use or production of hazardous substances YES 8.2 From any other causes NA 8.3 Could the project be affected by natural disasters NO causing environmental damage (e.g. Floods, earthquakes, landslides, cloudburst etc)? All Inbuilt Safety precautions will be adopted and there will not be any damage to environment or human health 9.Factors which should be considered (such as consequential development) which could lead to environmental effects or the potential for cumulative impacts with other existing or planned activities in the locality S. No. Information/Checklist confirmation Yes/No Details thereof (with approximate quantities/rates, wherever possible) with source of information data 9.1 Lead to development of supporting. facilities, ancillary development or development stimulated by the project which could have impact on the environment e.g.: Supporting infrastructure (roads, power supply, waste or waste water treatment, etc.) housing development extractive industries supply industries other YES 9.2 Lead to after use of the site, which could haven NO impact on the environment 9.3 Set a precedent for later developments NO 9.4 Have cumulative effects due to proximity to other existing or planned projects with similar effects NO The project shall enhance the socio economic status of the area, improving the employment. There are no major support industries required for this plant. The baseline environmental status of the surrounding areas is within the prescribed limits as observed from the Secondary data. Form I Page 9

11 Unit VII (III) Environmental Sensitivity S.No. Areas Name/ Identity 1 Areas protected under international conventions, national or local legislation for their ecological, landscape, cultural or other related value 2 Areas which are important or sensitive for ecological reasons Wetlands, watercourses or other water bodies, coastal zone, biospheres, mountains, forests 3 Areas used by protected, important or sensitive species of flora or fauna for breeding, nesting, foraging, resting, over wintering, migration NA YES NA Aerial distance (within 15 km.) Proposed project location boundary Konada RF S 8 km Kumili RF NW 3.5 km Amarsingi RF NW 8.5 km Kandivalasa River NE 3.6 km (Flowing from NE to SE) Champavati River SW 6.5 km (Flowing from SW to S) 4 Inland, coastal, marine or underground waters NO 5 State, National boundaries NO 6 Routes or facilities used by the public for access to NO recreation or other tourist, pilgrim areas 7 Defense installations NO 8 Densely populated or built up area NO Nearest habitation from the site is Pusapatirega at a distance of 3.3 km in Southwest direction 9 Areas occupied by sensitive man made land uses NA (hospitals, schools, places of worship, community facilities) 10 Areas containing important, high quality or scarce NO resources (ground water resources, surface resources, forestry, agriculture, fisheries, tourism, minerals) 11 Areas already subjected to pollution or NO environmental damage. (those where existing legal environmental standards are exceeded) 12 Areas susceptible to natural hazard which could NO cause the project to present environmental problems (earthquakes, subsidence, landslides, erosion, flooding or extreme or adverse climatic conditions) Form I Page 10

12 Unit VII (IV) Proposed Terms of Reference for EIA studies Scope of Work of EIA The standard terms of reference (page ) issued by the Ministry of Environment Forest and Climate change shall be followed for preparation of EIA report. Any additional study proposed by the EAC shall also be completed. Ref: Standard Terms of Reference (TOR) for EIA/EMPO report for projects/activities requiring environmental clearance under EIA notification, 2006, MoEF & CC, GOI, April I hereby give the undertaking that data and information given in the application and enclosures are true to the best of my knowledge and belief and I am aware that if any part of the data and information submitted is found to be false or misleading at any stage, the project will be rejected and clearance given, if any to the project will be revoked at our risk and cost. Date: Place: Hyderabad Signature of the applicant With Name and Full Address (Project Proponent/Authorized Signatory) C. Chandra Shaker Head EHS Department SMS Pharmaceuticals Limited Plot No 19 III, Road No. 71, Opp. Bharatiya Vidya Bahavan Public School Jubilee Hlls, Hyderabad Phone: Ext. 941 Mobile : chandrashaker@smspharma.com Form I Page 11

13 SMS PHARMACEUTICALS LIMITED, UNIT VII SY.NOS. 160, 161, 163 TO 168 AND 170 (KANDIVALASA VILLAGE), 72 (KOVVADA AGRAHARAM VILLAGE), PUSAPATIREGA MANDAL, VIZIANAGARAM DISTRICT, ANDHRA PRADESH ANNEXURES SUBMITTED TO MINISTRY OF ENVIRONMENT, FORESTS AND CLIMATE CHANGE GOVERNMENT OF INDIA INDIRA PARYAVARAN BHAWAN, JOR BAGH ROAD, NEW DELHI

14 Form I Annexures Unit VII Location Map of SMS Pharmaceuticals Limited, Unit VII Page 1

15 ROOM SECURITY OFFICE GATE SECURITY POST MAIN GATE M WIDE ROAD 6M WIDE ROAD 6M WIDE ROAD 6M WIDE ROAD M WIDE ROAD CYCLE PARKING SHED GATE LIQUID RO AD NITROGEN TANK LIQUID DRIER N ITROGEN SOLID WASTE STORAGE PLATFORM SRB-2 STORAGE TANKS AREA FIRE PIT COAL SHED tr Cooling Tower 8500 COAL CONVEYOR FEED WATER TANK BOILER-2 (6TPH) BOILER-1 (3TPH) GATE Spare Tank Multi Effect Evaporator } Cooling Tower M WIDE ROAD 6M WIDE ROAD 6M WIDE ROAD M WIDE ROAD GATE FIRE HYDRANT TANK HT YARD 9000 Form I Annexures Unit VII S E W N GREENERY ROAD 5500 PROPOSED AREA FOR BOILERS BOILER HOUSE-1& CHIMMNY EFFLUENT TREATMENT PLANT MEE BLOCK Pipe line B ridge PROPOSED AREA FOR 500KLD ETP PROPOSED AREA FOR PHASE 2 ETP M WIDE ROAD GREENARY 6M WIDE ROAD SOLVENT YARD Bore well PRPOPSED SOLVENT YARD M WIDE ROAD GREENARY GREENARY GREENARY Bore well PROPOSED WAREHOUSE WAREHOUSE-2 GATE GATE HYDROGINATION BLOCK PRODUCTION BLOCK-D3 12 M WIDE ROAD SERVICE BLOCK-3 PRODUCTION BLOCK-B3 PRODUCTION BLOCK-D PRODUCTION BLOCK-C2 DEZ SHED 5M ROAD 5M ROAD GENERAL TOILETS GREENARY GREENARY 12 M WIDE ROAD PRODUCTION BLOCK - A1 PRODUCTION BLOCK - A2 GATE Bore well BT R O A D PRODUCTION BLOCK-D2 PRODUCTION BLOCK-B PRODUCTION BLOCK-C GREENARY PROPOSED PRODUCTION BLOCK-A3 H.T.YARD SERVICE BLOCK SRB GREENARY GREENARY SERVICE BLOCK AREA STATEMENT GENERATOR SHED POWER HOUSE FG STORE PRODUCTION BLOCK-B SRB GREENARY GREENARY GREENARY QC/QA BLOCK POWER HOUSE-1 OPERATIONAL BLOCKS AREA : SQM PROPOSED BLOCKS AREA : SQM GREENARY AREA : SQM GATE GARDEN AREA IS 54.5% IN TOTAL AREA E X I S T I N G BT R O A D TOILETS ENGG CANTEEN STORE Car Shed GREENARY ADMINISTRATION BLOCK FG STORE-1 B2 STORAGE TANKS AREA GREENARY WARE HOUSE ROADS & OTHER AREA : SQM TOTAL AREA : SQM NOTE : Mango Garden Mango Garden OPERATIONAL BLOCKS PROPOSED BLOCKS WATER SUMP WEIGH BRIDGE PLATFORM 12 M WIDE ROAD PROPOSED ADMIN BLOCK PROPOSED CAR SHED 12 M WIDE ROAD E X I S T I N G BT R O A D Canteen Block & Rest rooms Plant Layout of SMS Pharmaceuticals Limited, Unit VII GREENARY SMS PHARMACEUTICALS UNIT-VII,KANDIVALASA SITE LAYOUT Page 2

16 Form I Annexures Unit VII ANNEXURE - I M/s. SMS Pharmaceuticals Limited, Unit VII obtained Environment Clearance Vide file no. F. No. J-1011/361/2006-IA II (I) dated: The unit obtained CRZ clearance vide letter No /2007 IA. III dated from Ministry of Environment and Forest. The unit has valid consent for operation vide order no. APPCB/VSP/VZN/147/CFO/HO/2016 dated valid till It is proposed to expand the API manufacturing capacity from TPM to TPM and inclusion of captive power plant to 2 x 2 MW by using steam from proposed high pressure boiler in an existing area of acres. The capital cost for expansion is Rs. 600 crores, towards, additional production block, utilities, co-generation power plant and enhancement of treatment system at Sy.Nos. 160, 161, 163 to 168 and 170 (Kandivalasa Village), Sy. No. 72 (Kovvada Agraharam Village), Pusapatirega Mandal, Vizianagaram District, Andhra Pradesh. The proposed expansion has employment potential of 350 nos. Manufacturing capacity is presented in Table A-1. Table A-1 Manufacturing Capacity S.No Name of Product Capacity (TPM) Permitted After Expansion 1 Efavirenz Lopinavir Emtricitabine Tenofavir Atazanavir Valcyclovir Ritonavir Zidovudine Lamivudine Valsartan Abacavir TPN Base Pantoprazole Ranitidine Levetiracetam Temisartan Olmisartan Candesartan Page 3

17 Form I Annexures Unit VII 19 Ibresartan Itraconazole L-Carbocy-Stiene Sulfamide Gabapentin Valganociclovir Sitagliptin Vildagliptin 2 27 Briviracetam Amlodipine 5 29 Penciclovir 1 30 Arpiprazole 2 31 Rosiglitazone Canagliflozin 2 33 Dapagliflozin 2 34 Empagliflozin Ranolzine Lanoconazole Paliperidone Palmitate Mirabegron Solefinacin 1 40 Lamotrazine 5 41 Sumatriptan Famotidine 5 43 Almotriptan Ondansertan Zolmitriptan Rizatriptan Elitriptan Tadalafil Sildenafilcitrate 2 50 Lanthanum Carbonate 2 51 Luliconazole Verdinafil Raltegravir 5 54 Dolutegravir Darunavir Linagliptin Rivaroxaban 3 58 Apixaban 1 59 Sofosbuvir Trazadone 15 Total Co-generation Powe Plant x 2 MW Page 4

18 Form I Annexures Unit VII Process Description of Darunavir Reaction Schemes Process Description: Stage-I: 4-Amino-N- (2R,3S) (3-amino-2- hydroxy-4- phenyl -butyl)- N-isobutylbenzenesulfonamide is condensed with (3R,3aS,4aR)-hexahydrofuro[2,3-b]furan-3-ol in the presence of disucinimidyl carbonate to yield Darunavir Pharma. Schematic diagram of Darunavir is shown in Fig A-2 and material balance for Darunavir is presented in Table A- 2. Fig A-2 Process Flow Diagram of Darunavir Page 5

19 Form I Annexures Input Unit VII 4-Amino-N-(2R,3S)(3- amino-2-hydroxy-4- phenyl-butyl)-nisobutylbenzenesulfonamide (3R,3aS,6as)(3-amino- 2hydro-4-phenyl-butyl)- N-isobutyl-benzene sulfonamide Table A- 2 Material Balance for Darunavir Quantity Output Quantity Remarks (Kg/day) (Kg/day) 89.4 Darunavir 100 To stage II 30 1-Hydroxy pyrrolidine- 2,5-dione 42 Organic residue Disucinimidyl carbonate 58.5 MDC recovered 291 Recovered & Reused Sulphuric acid 3.5 MDC loss 2.4 Fugitive loss 2-Methyl2-Butanol 2 MDC in Residue 6.6 Solvent in residue Methylene 300 Cyclohexane recovered Recovered & Reused chloride(mdc) Cyclohexane 200 Cyclohexane loss 1 Fugitive loss Sodium sulphate 3.5 Cyclohexane in Residue 8.9 Solvent in residue Sodium hydroxide 2.9 Stage I Product 17.9 Organic Residue Activated carbon 4 Organic Residue 5.9 Organic Residue Water 500 Disucinimidyl carbonate 12 Organic Residue 2-Methyl2-Butanol 2 To wastewater Activated carbon 4 Spent carbon Sodium sulphate 8.6 To wastewater Water To wastewater Total Input Total Output Page 6

20 Form I Annexures Unit VII ANNEXURE II: Wastewater Treatment Facilities The effluent generated from the proposed expansion of M/s. SMS Pharmaceuticals Limited, Unit VII is mainly from process, washings, scrubbers, cooling towers & boiler blow downs, RO/DM rejects from pre-treatment of water and domestic effluent. It is proposed to treat all HTDS effluent in stripper followed by MEE, ATFD followed by Biological treatment plant. All LTDS effluent along with condensate from MEE & ATFD shall be treated in Biological treatment followed by disposed to sea by using marine outfall system. Total Effluent generated and mode of treatment before and after expansion is presented in Table A-3. Table A-3 Quantity of Effluent Generated and Mode of Treatment after Expansion - Tentative Description Quantity (KLD) Mode of Treatment Process 635 Sent to Stripper followed by MEE and ATFD. Washings 60 Stripper Condensate sent to Cement Plants for Co- Scrubber Effluent 40 Incineration. RO/DM rejects 80 MEE and ATFD Condensate sent to Biological treatment plant followed by Marine Outfall system. Total (I) - HTDS 815 Boiler Blow downs 45 Sent to Biological Treatment System followed by Cooling Tower Blow downs 210 Marine Outfall system Domestic 32 Total (II) - LTDS 287 Grand Total (I+II) 1102 Page 7

21 Form I Annexures Unit VII ANNEXURE III: Water Balance The total water requirement shall increase from 324 KLD to 2215 KLD shall be met by ground water supply and balance shall be recycled water. The water balance for daily consumption after expansion is presented in Table A-4. Table A-4 Total Water Balance After Expansion (Tentative) Purpose INPUT (KLD) OUTPUT (KLD) Loss Effluent Process Washings Scrubber Boiler Feed Cooling Tower RO/DM Regeneration Domestic Gardening Gross Total * Includes water formed during reaction and water in raw material Page 8

22 Form I Annexures Unit VII ANNEXURE IV: Solid Waste Generation and Mode of Disposal The total solid waste generated and mode of disposal is presented in Table A-5. Table A-5 Solid Waste Details After Expansion (Tentative) S.No Description Units Quantity Mode of Permitted After Expansion Treatment/Disposal 1 Process residue TPD Sent to TDSF/Cement Plants 2 Solvent Residue TPD 7.2 for Co-incineration 3 Spent Carbon Kg/day Evaporation TPD Sent to TSDF salts 7 ETP Sludge TPD Sent to TSDF 8 Inorganic Kg/day 410 Sent to TSDF Residue 9 Hyflow Kg/day 50 Sent to TSDF 10 Catalyst Kg/day 120 Sent to TSDF 11 Ash from Boiler TPH 75 Sold to Brick manufactures 12 Detoxified No.s/month 3200 Sold to authorized vendors containers & liners 14 Waste oil KLPA 7.2 Sent to Authorized Recyclers 15 Used batteries No.s/Yr 38 Sent to Authorized Recyclers Page 9

23 Form I Annexures Unit VII ANNEXURE V: Stack Emissions Details The sources of air pollution in the plant are from the existing 1 x 6 TPH, 1 x 3 TPH coal fired boilers and proposed 1 x 20 TPH, 1 x 12 TPH and 2 x 10 TPH Coal fired boiler. Proposed coal based thermic fluid heaters of capacity 1 x 2 lac and 1 x 10 lac k.cal. Backup DG sets of 7 x 1500 kva proposed in addition to existing DG set of 1 x 125 kva to cater to energy requirement during load shut downs. Bag Filters will be provided for proposed 20 TPH, 2 x 10, 12 TPH coal fired boilers and 1 x 2 lac and 1 x 10 lac k.cal thermic fluid heaters as air pollution control equipment. DG sets shall be provided with stack heights based on the CPCB formula for effective stack height. The emission rates of SPM, SO2, NOx and SPM from each stack are presented in Table A-6. S. No Stack Connected to Table A-7 Stack Emission Details Stack Ht (m) Dia of stack at top(m) Temp. of exhaust gases ( 0 C) Exit Velocity (m/sec) Pollutant Emission Rate (g/sec) PM SO 2 NO x Existing 1 1 x 6 TPH Coal fired Boiler * 2 1 x 3 TPH Coal Fired Boiler * 3* 1 x 125 kva DG set Proposed 1 1 x 20 TPH Coal Fired Boiler 2 1 x 12 TPH Coal fired Boiler * 3 2 x 10 TPH Coal Fired Boilers 4 1 x 10 Lakh Kcal Thermic Fluid Heaters 5 1 x 2 Lakh Kcal Thermic Fluid Heaters 6* 7 x 1500 kva DG sets *Standby. Page 10

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39 SMS PHARMACEUTICALS LIMITED, UNIT VII SY.NOS. 160, 161, 163 TO 168 AND 170 (KANDIVALASA VILLAGE), 72 (KOVVADA AGRAHARAM VILLAGE), PUSAPATIREGA MANDAL, VIZIANAGARAM DISTRICT, ANDHRA PRADESH STUDIES AND DOCUMENTATION BY TEAM Labs and Consultants QCI: MoE&F OM, List A-1, S.No (An ISO 9001:2008, ISO 14001:2004 & OHSAS 18001:2007 Certified Organization) B-115, Annapurna Block, Aditya Enclave Ameerpet, Hyderabad Phone: /616, Telefax: