M/S. Sigma Life Science Plot No. 1032/16, Phase II, GIDC, Panoli, Dist: Bharuch (Guj.) ii Name of the Applicant Dr.

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1 SEAC, Gujarat: Page 1 of 19 Bulk Drug and Bulk Drug Intermediates 5(f) For appraisal - Environmental Clearance [EC] New Project 1. Basic Information of the Project: i Name & Address of the Project site (Complete details with plot no./survey no., Landmark etc. ) M/S. Sigma Life Science Plot No. 1032/16, Phase II, GIDC, Panoli, Dist: Bharuch (Guj.) ii Name of the Applicant Dr. Rajan Rudalal iii Address for correspondence M/S. Sigma Life Science Plot No. 1032/16, Phase II, GIDC, Panoli, Dist: Bharuch (Guj.) iv Contact no. and ID of the Applicant Mo. no. : rajanrudalal@yahoo.com v Aerial distance of nearest Habitat (KM) Ankleshwar: 4.5 Km vi vii viii Longitude & Latitude of the Project Site: (4 corners of the site) Category as per the Schedule to the EIA Notification 2006 i.e. 1(d), 2(b), 5(f) etc. Sub Category: i.e. Dyes, Dyes Intermediates, Specialty chemicals, Bulk Drugs etc. Applicability of General Conditions of EIA Notification 2006: i.e. Ensure that I. Protected areas notified under the Wildlife (Protection) Act, 1972; II. CEPI areas III. IV. Eco-sensitive areas and Inter-state boundaries and international boundaries; are not located within 5 km or 10 km (as the case may be) area from the boundary of the proposed site. Corner-1: longitude 72 59'11.85"E and latitude 21 33'24.61"N Corner-2: longitude 72 59'12.58"E and latitude 21 33'24.42"N Corner-3: longitude 72 59'12.96"E and latitude 21 33'26.05"N Corner-4: longitude 72 59'12.28"E and latitude 21 33'26.22"N 5 (f) Sub-Category: Bulk Drug and Bulk Drug Intermediates NA Page 1 of 19

2 SEAC, Gujarat: Page 2 of Online application & PH reg.: a) Date of EAC meeting for 28 FEB recommendation to grant TOR: b) Online application proposal no. : IA/GJ/IND2/62310/2017 c) Date online acceptance of EC application by EAC: 17 FEB d) TOR issued by EAC: Letter no&date. J-11011/35/2017-IA-II(I) e) Date of Public Hearing NA (If applicable): f) Date of presentation for Appraisal: -- Sr. No. 3. Product profile: Name of the Products CAS no. /CI no. Quantity MT/Month End-use of products Sulfonamido Phenyl Hydrazine Hydrochloride and It s Intermediates Celecoxib 2 4,4,4-trifluoro-1-[4-(methyl)phenyl]- butane-1,3-dione and It s Intermediates Celecoxib 3 2 Amino Phenyl phenyl Sulfide and It s Intermediates Quetiapine 4 Dibenzo[b,f][1,4]Thiazepin-11(10H)-One Quetiapine 2-Chloro-1,3- bis(dimentylamino)trimethinium hexafluorophosphate and It s Intermediates Etoricoxib 6 m Chloro Nitro benzene Tramadol 7 m Bromo Nitro benzene Tramadol 8 Chiral 2,3-Dibenzoyl-D-tartaric acid Resolution Agent 9 4 Methyl Acetophenone Celecoxib N-{2-[4-(aminosulfonyl)phenyl]ethyl}-3-ethyl-4- methyl-2-oxo-2,5-dihydro -1H-pyrrole-1- carboxamide and It s Intermediates 3-Ethyl-4-methyl-N-[2-(4-{[(trans-4-methyl cyclohexyl)carbamoyl] sulfamoyl} phenyl)ethyl]- 2-oxo-2,5-dihydro-1H-pyrrole-1-carboxamide Glimepiride Glimepiride 2,4 Difluoro Benzylamine and It s Intermediates Dolutegravir 13 P Methoxy Phenyl Acetonitrile and It s Intermediates Venlafaxine HCl Page 2 of 19

3 SEAC, Gujarat: Page 3 of Trifluoromethyl Cinnamic Acid and It s Cinacalcet Intermediates 15 Ethyltrifluoro Acetate Celecoxib 16 Anti Bupropion Hydrochloride and It s Intermediates Depression 5 17 Bronchodilat Doxofylline and It s Intermediates or TOTAL The project falls under the Category B of project activity 5(f) as per the schedule of EIA Notification Product wise Raw material consumption: Sr. no Name of the Products 4-Sulfonamido Phenyl Hydrazine Hydrochloride and It s Intermediates 4,4,4-trifluoro-1-[4- (methyl)phenyl]-butane-1,3- dione and It s Intermediates 2 Amino Phenyl phenyl Sulfide and It s Intermediates Dibenzo[b,f][1,4]Thiazepin- 11(10H)-One 2-Chloro-1,3- bis(dimentylamino)trimethini um hexafluorophosphate and It s Intermediates 6 m Chloro Nitro benzene Name of the Raw Materials CAS / CI no. of raw materials. Quantity MT/Month Sulfanilamide Sodium Nitrite Sodium bisulphite Conc HCl Sodium Methoxide Toluene Methylacetophenone Methyltrifluoroacetate Conc HCl Thio Phenol Nitro Chloro Benzene Caustic Flakes Raney Nickel Methanol Hydrogen gas M 3 Nitrogen M 3 2 Amino phenyl phenyl sulfide Poly Phosphoric Acid Ethyl Chloro formate Toluene Carbon Poly Phosphoric Acid HF Gas Dimethylformamide Chloroacetyl chloride Phosphorus Oxychloride Caustic Flakes Hexafluorophosphoric acid Nitro Benzene Chlorine Methanol m Bromo Nitro benzene Nitro Benzene Page 3 of 19

4 SEAC, Gujarat: Page 4 of ,3-Dibenzoyl-D-tartaric acid 9 4 Methyl Acetophenone Ethyl-4-methyl-N-[2-(4-{[(trans- 4-methyl cyclohexyl)carbamoyl] sulfamoyl} phenyl)ethyl]-2-oxo- 2,5-dihydro-1H-pyrrole-1- carboxamide 2,4 Difluoro Benzylamine and It s Intermediates P Methoxy Phenyl Acetonitrile and It s Intermediates 3-Trifluoromethyl Cinnamic Acid and It s Intermediates N-{2-[4- (aminosulfonyl)phenyl]ethyl}-3- ethyl-4-methyl-2-oxo-2,5-dihydro -1H-pyrrole-1-carboxamide and It s Intermediates Bromine Methanol Benzoyl Chloride D Tartaric Acid Toluene Acetyl Chloride Toluene Aluminum Chloride Conc HCl Ethyl-4-methyl-2-oxo- N-(2-phenylethyl)-2,5- dihydro-1h-pyrrole carboxamide (Amide Derivative) Chloro Sulfonic Acid Ammonia Solution EDC N-{2-[4- (aminosulfonyl)phenyl]e thyl}-3-ethyl-4-methyl-2- oxo-2,5-dihydro -1Hpyrrole-1-carboxamide (Solfonamide Derivative) Trans 4 methyl cyclohexyl isocyanate (Trans Iso Cyanate) Acetone Potassium Carbonate Methanol Conc HCl Carbon ,4 Difluoro Benzonitrile Methanol Nickel Catalyst Hydrogen gas M 3 Nitrogen M 3 4 Methoxy Benzaldehyde Nickel Catalyst Hydrogen gas M 3 Nitrogen M 3 Conc HCl Toluene Sodium Cyanide Sodium Chloride Trifluoromethyl Aniline Page 4 of 19

5 SEAC, Gujarat: Page 5 of Ethyltrifluoro Acetate Bupropion Hydrochloride and It s Intermediates Doxofylline and It s Intermediates Conc HCl Sodium Nitrite Acrylonitrile Caustic Flakes Conc Sulfuric Acid Trifluoro Acetic Acid Ethanol Sodium Carbonate Sulfuric Acid Toluene Chloro-2 -Bromo Propiophenone tert butyl amine % Methanolic HCl Iso Propyl Alcohol Carbon Theofylline Bromomethyl-1,3- dioxolane Sodium Carbonate Dimethyl Formamide (DMF) Carbon Salient features of the project including Water, Air and Hazardous waste management: Sr. Particulars Details no. A Total cost of Proposed Project (Rs. in Crores): 2.5 Crores 1. Capital cost for EMS (Environmental Management System): 35 Lakhs 2. Recurring cost towards the environmental protection measures: 5 Lakhs per Annum. B Total Plot area ( sq. meter) 1040 Sq. m. Green belt area,/tree Plantation area ( sq. meter) 312 Sq. m. C D i Employment generation 1. Direct 10 Employ 2. Indirect 10 Employ Total 20 Employ Water Source of Water Supply (GIDC Bore well, Surface water, Tanker supply r etc...) GIDC water supply Please refer Annexure 1 Status of permission from the concern authority. Page 5 of 19

6 SEAC, Gujarat: Page 6 of 19 ii Water consumption (KLD) Category Water Consumption KLD (A) Domestic 3.0 (B) Gardening 2.0 (C) Industrial Process 4.6 Washing 0.2 Boiler 3.7 Cooling 2.0 Others (Scrubber) 0.3 Industrial Total 10.8 Total (A + B + C) 15.8 Remarks 1) Total water requirement for the project: 15.8 KLD 2) Quantity to be recycle: 0.0 KLD 3) Total fresh water requirement: 15.8 KLD iii iv Waste water generation (KLD) - Category KLD Remarks (A) Domestic 2.0 (B) Industrial Process 8.5 Washing 0.2 Boiler 0.5 Cooling 0.2 Others 0.3 Total Industrial 9.7 waste water - Treatment facility with capacity ETP: 9.7 KL/Day (ETP, CETP, MEE, STP, Spray Dryeretc). v Mode of Disposal & Final meeting point Domestic: 2 KL/Day stream of domestic wastewater disposed through Septic Tank & Soak Pit Industrial: 9.7 KL/Day of effluent is treated in ETP and then send to Common MEE of M/s. ACPTCL for Disposal. vi In case of Common facility (CF) like CETP, Common Spray dryer, Common MEE etc., name of CF Common MEE of M/s. ACPTCL Membership of Common facility (CF) Please refer Annexure 2 Page 6 of 19

7 SEAC, Gujarat: Page 7 of 19 vii Reuse/Recycle details (KLD) -- E i ii iii Air Flue gas emission details No. of Boilers/TFH/Furnaces/DG sets etc. with capacities viz. TPH, Kcal/hr, MT/hr, KVA etc. - SR. no. 1 2 Source of emission With Capacity Thermic Fluid Heater (2 Lac Kcal) Steam boiler (1 TPH) Stack Height (meter) Type of Fuel Biocoal Biocoal 3 D G Set 11 HSD Quantity of Fuel MT/Day 84 MT/Mont h 6 MT/Mont h 20 Litre/Hr Type of emissions i.e. Air Pollutants PM SOx NOx PM SOx NOx PM SOx NOx - Process gas i.e. Type of pollutant gases (SO 2, HCl, NH 3, Cl 2, NO x etc.) - Sr. no. Source of emission Air Pollution Stack/Vent Type of Control Height emission Measures (meter) (APCM) HCL 11 Two Stage SO 2 Scrubber HBR 11 Two Stage Scrubber NH 3 11 Two Stage Scrubber 1. Process Vent 2. Process Vent 3. Process Vent - Fugitive emission details with its mitigation measures. Air Pollution Control Measures (APCM) Multi cyclone Separator with Bag Filter Multi cyclone Separator with Bag Filter -- As below: Following measures will be adopted to prevent and control fugitive emissions 1. Airborne dust at all transfers operations/ points will be controlled either by Page 7 of 19

8 SEAC, Gujarat: Page 8 of 19 spraying water or providing enclosures. 2. Care will be taken to store construction material properly to prevent fugitive emissions, if any. 3. Regular maintenance of valves, pumps, flanges, joints and other equipment will be done to prevent leakages and thus minimizing the fugitive emissions of VOCs. 4. Entire process will be carried out in the closed reactors with proper maintenance of pressure and temperature. 5. Periodic monitoring of work area will be carried out to check the fugitive emission. 6. Breather valves will be provided on solvent tanks. 7. Solvent tank vents will be connected to vent chillers. 8. To eliminate chances of leakages from glands of pumps, mechanical seal will be provided at all solvent pumps. 9. Close feeding system will be provided for centrifuges. Centrifuge and filtrate tank vents will be connected to vent chillers. 10. Minimum number of flanges, joints and valves in pipelines. 11. Enclosures to chemical storage area, collection of emission from loading of raw materials in particular solvents through hoods and ducts by induced draft, and control by scrubber / dust collector to be ensured. Nitrogen blanketing will be provided, besides special care needs to be taken for control in respect of odorous chemicals. F Hazardous waste (as per the Hazardous and Other Wastes (Management and Transboundary Movement) Rules i Sr. no. Type of Hazardous waste 1 Used Oil Source of generation Machinerie s Category and Schedule as per HW Rules. Quantity (MT/ Annum) Disposal Method Collection, Storage, Transportation Re-use or Sent to GPCB approved recycler 2 Discarded barrels/ containers/ liners Raw Materials and Products Collection, Storage, Transporta3tion, decontamination and Sent back to supplier / to GPCB approved Page 8 of 19

9 SEAC, Gujarat: Page 9 of ETP Sludge Distillation Residue Spent Carbon Spent Catalyst Spent solvents ETP Distillation Process Process Process Process Quantity of discarded containers must be in MT/Annum. 2 recycler Collection, Storage, Transportation and Sent to TSDF site of M/s. PSWML, Panoli or M/s. BEIL, Ankleshwar for secured land filling Collection, Storage, Transportation and sent to Cement Industries for Coprocessing or Disposal at Common Incineration Site of M/s. BEIL, Ankleshwar Collection, Storage, Transportation and sent for co-processing in cement industries or disposal at Common Incineration Site of M/s. BEIL, Ankleshwar Collection, Storage, Transportation and return back to manufacturer for regeneration or sell to end user. Collection, Storage, recovered through in house distillation or sent for distillation job work to authorized recycler. ii Membership details of TSDF, CHWIF etc. Please refer Annexure 3 ii G Details of Non-Hazardous waste & its disposal (MSW and others) Solvent management& VOC emissions etc. No non Hazardous Waste will be generated. i Details of Solvent recovery (As per respective ToR) Types of solvents, Details of Solvent recovery, % recovery. reuse of recovered Solvents All the solvents are directly distillate from product mix and purified in packed column with the help of reflux. The solvent distillation system is designed so as to achieve minimum 93% recovery of Page 9 of 19

10 SEAC, Gujarat: Page 10 of 19 solvent. Pure solvent, crude solvent and distilled (recovered) solvent shall be stored only in storage tanks and we shall not be using drums at any stage in the Solvent Management System. Wherever required, the solvents shall be directly pumped into day tanks from the storage tanks and shall be charged into the reactors without involving any manual handling. All the pumps shall be mechanical seal type to avoid any leakage of solvent. All necessary fire fighting systems shall be provided with alarm system. Flame proof wiring and flame proof electrical accessories shall be provided to avoid any mishap. All the storage tank and day tank shall be connected to a vent system through chilled water condensers to prevent loss of solvents in the atmosphere. All the distillation column vents are also connected to chilled water condensers for maximum possible recovery of the solvents. SOLVENT RECOVERY PATTERN Name of Solvent Total Input (Kg) Qty. of Recovered Solvent (Kg) Qty. Losses (Kg) of % Recover y % Losse s Toluene Methanol EDC Acetone IPA ii DMF VOC emission sources and its mitigation measures Volatile Organic Content Measures: Brief Process: Waste gas containing acidic components and volatile organic content (VOC) is released from process. The waste gas stream from process vessels is sucked in the alkaline scrubber. The main scrubber comprises of a packed tower with a sump, a circulation pump. The waste gases enter in the top of main scrubber. The gas first flow through a packing layer with the scrubbing liquid. The acidic gases are brought in contact with the circulating alkaline liquid (ph 8 12) on the large packing surface and are absorbed. The scrubbed exhaust gas enters the fan. The fan outlet is fed to RTO for VOC (solvent) control. Page 10 of 19

11 SEAC, Gujarat: Page 11 of Details of Environmental Consultant: Sr. Particulars Details no. i Name of the Consultant Aqua-Air Environnemental Engineers Pvt. Ltd. ii Contact no. and ID of the Consultant Mo. no. : aqua_eia@yahoo.com iii Accreditation for the categories and Validity Synthetic Organic Industry 5 (f) iv Any other details Details regarding EIA report: Sr. no. a b Particulars Details Page no., Section no. & chapter no. of EIA report Ensure that there is no change in EIA report w. r. t. ToR i.e. Form-1 & PFR Baseline environmental monitoring period c Baseline study area (km) 10 Km There is no change in EIA report w. r. t. ToR i.e. Form- 1 & PFR March, 2017 to May, , Section No , Chapter-3 of d e f No. of AAQM stations including project site Conclusion of the Monitoring (Baseline study) Air, Water & Land Parameters considered for AAQM including project specific parameters. 9 Nos. of AAQM 140, Section No , Chapter-3 of All parameters of Air, Water and Land are found within the limit. 247, Section No. 8.3, Chapter-8 of - Sr. no. Parameters Range of Remarks Concentrations (μg/m 3 ) 1 PM Results within limit 2 PM of NAAQS 3 SO NOx Page 11 of 19

12 SEAC, Gujarat: Page 12 of 19 g 5 O PB BDL 7 NH3 BDL CO C6H6 BDL 10 BaP BDL 11 As BDL 12 Ni HCl HC BDL 15 VOC Whether the results of AAQM is within the norms prescribed in NAAQS? If no, give reasons as per EIA report h Comments for AAQM results w. r. t. NAAQS i Software used for the mathematical Modelling for anticipated incremental GLCs (Ground Level Concentrations) j The resultant concentrations w. r. t. NAAQS and its conclusion. k Suggested mitigation measures w. r. t. Air l Conclusion of the Monitoring during baseline study of water m Suggested mitigation measures w. r. t. Water Results found within limit of NAAQS Results found within limit of NAAQS Industrial Source Complex Short Term (ISCST3) dispersion model is a steady-state Gaussian plume model After Proposed Project, Resultant concentrations found within Limits Multicyclone Separator with bag filter will be installed to boiler and thermic fluid heater. Scrubber will be process vent. Result found within drinking water standards Industrial waste water will be sent to common MEE facility, M/s. ACTPCL, Ankleshwar for further treatment and final disposal. Domestic waste water will be disposed through septic tank & soak pit. 140, Section No , Chapter-3 of 140, Section No , Chapter-3 of 201, Section No , Chapter-4 of 209, Section No , Chapter-4 of 234, Section No , Chapter-7 of 150, Section No , Chapter-3 of 232, Section No , Chapter-7 of n Conclusion of the Monitoring during Result found within limit Page 12 of 19

13 SEAC, Gujarat: Page 13 of 19 baseline study of Land o Suggested mitigation measures w.r. t. Land p Conclusion of the Monitoring during baseline study of Noise Seven categories of Hazardous/Solid Wastes will be generated. Treatment, Storage & Disposal mode shall be followed as per Hazardous/Solid Waste (Storage, Handling & Trans-boundary Movement) Rules, Noise level surrounding the plant found within Noise standard. 155, Section No. 3.5, Chapter-3 of 241, Section No , Chapter-7 of 145, Section No , Chapter-3 of 238, Section No , Chapter-7 of q Suggested mitigation measures w. r. t. Acoustic laggings, Noise enclosures and silencers will be provided wherever necessary for high noise generating equipment. Sound proof glass paneling will be provided for all operating stations/control rooms as well as for shift rooms at critical places. Strict implementation/compli ance of all statutory norms w.r.t. noise generation, occupational exposure is done. Use of personal protective devices such as ear-muffs and earplugs will be strictly enforced. Acoustic barriers /shelter will be developed in noisy workplaces. r Main issues in Public hearing (If Company is located in applicable) Notified Industrial Estate Panoli, So public hearing is not applicable. s Brief description of Public hearing (If applicable) - Company is located in Notified Page 13 of 19

14 SEAC, Gujarat: Page 14 of 19 Industrial Estate Panoli, So public hearing is not applicable. Main Issues raised by stake holders Commitments by Project proponent and action plan. t - Major hazardous chemicals and worst case scenario considered in Risk Analysis report. Comments/Suggestions/mitigation measures in brief Major hazardous chemicals and worst case scenario is incorporated in Risk Assessment Report and Scenario of Hazardous Chemicals is found within plant premises. 284, Section No , Chapter-10 of EIA Report. u An undertaking by the Project Proponent (PP) on the ownership of the EIA report as per the OM of MoEF&CC dated 05/10/2011 and an undertaking by the Consultant regarding the prescribed TORs have been complied with and the data submitted is factually correct as per the OM of MoEF&CC dated 04/08/2009. Please refer Index Page NO. 34 to 39. v Any other details: Name & designation of the Applicant: Dr. Rajan Rudalal General Instructions: Stamp &Signature of Applicant: Date: 14/02/2018 Format shall be in WORD Format (Font type- Arial, Font size- 11) Provide authenticated (with stamp & Signature) hard copy during presentation. Kindly send to : seacgujarat@gmail.com&uh-gpcb-seac@gujarat.gov.in Above data shall be as per application Form-1 & PFR. Incorporate relevant details in respective column in the Format. Do not attach Annexure except copy of Certificates etc. Page 14 of 19

15 SEAC, Gujarat: Page 15 of 19 Annexure 1 GIDC water supply Page 15 of 19

16 SEAC, Gujarat: Page 16 of 19 ANNEXURE 2 MEMBERSHIP CERTIFICATE FROM COMMON ENVIRONMENTAL INFRASTRUCTURE INCLUDING THE COMMON MEE COMMON MEE: Page 16 of 19

17 SEAC, Gujarat: Page 17 of 19 ANNEXURE 2 MEMBERSHIP CERTIFICATE FROM COMMON ENVIRONMENTAL INFRASTRUCTURE INCLUDING THE COMMON TSDF & CHWIF TSDF MEMBERSHIP: Page 17 of 19

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