EXECUTIVE SUMMARY of M/s. STERMONE CHEMICALS PVT. LTD. BULK-DRUG MANUFACTURING UNIT Plot No.34/01, Paldi Golana Road, Village: Paldi, Tal: Khambhat, Dist; Anand, Gujarat, EMAIL: [email protected] (Project Area: 14,404 sq.m) PURPOSE: Production Expansion (From 0.405 MT/Month to 10.7475 MT/Month) CATEGORY “B” Prepared By: EXCEL ENVIRO TECH NABET Accredited EIA Consultant Organization Certificate No.: (NABET/EIA/1821/RA 0115) NABL Accredited Laboratory (certificate no. TC-5892) TF-2 , Sun House, Old High Court Lane Off Ashram Road, Ahmedabad – 380 009 Cell: +91-98255 88910.Office No: +91 9687611400 Email: [email protected] www.excelenviro.com Excel Enviro Tech Executive Summary EXECUTIVE SUMMARY A- 1 PROJECT BACKGROUND M/s. Stermone Chemicals Pvt. Ltd. located at Plot No. 34/01, Paldi, Golana Road, Tal: Khambhat, Dist: Anand, Gujarat. The proponent has already existing set-up in the Paldi. The unit is currently manufacturing bulk drug having capacity of 405 Kg/Month. Unit intends expand existing manufacturing capacity and intends to manufacture various life saving bulk drugs as hormones and steroids with a total capacity of 10,747.5 Kg/Month. Looking to the prospective market scenario and considering the large demand of the bulk drug in the market for various purposes and having established set-up, the proponent intends to expand the business at the same project site. The unit is holding Environmental Clearance vide letter no. F. No. J-11011/11/2008-IA II (I), dated 10/09/2009 for exising unit and consent order from GPCB Consolidated Consent & Authorization (CC &A) No. AWH-84821 dated 16/03/2017, valid up to 22/02/2022 the unit is complying with the required statutory conditions. The unit has also obtained the compliance certificate for existing Environmental Clearance dated 26/09/2018. The proposal of expansion by M/s. Stermone Chemicals Pvt. Ltd. falls under category 5(f) of schedule attached to EIA Notification 2006 and needs prior environmental clearance. It is stated that 5(f) industries located outside notified area are classified under category A and would be Ministry of Environment Forest & Climate Change. However, as per further amendment to notification dated 25th June 2014 mentioning that 5(f) industries can be classified under category B project if industry is fulfilling conditions as water consumption less that 25.0 m3/day, fuel consumption not to exceed 25.0 MT/day and storage of hazardous chemicals and fuels within premises not crossing the limits specified in MSIHC rules. The M/s. Stermone Chemicals Pvt. Ltd. Is fulfilling the three conditions and hence classified under Category B project. A-2 MAGNITUDE OF THE PROJECT The existing and proposed production capacity is given in Table-1. Table -1: The Existing And Proposed Production Capacity Sr. Name of Product Existing Proposed Total End Use of No. Capacity Change capacity Product (Kg/Month)* (Kg/Month) (Kg/Month) Existing 1. Beclomethasone Dipropionate 25 0 25 Healthcare 2. Betamethasone Diropionate 50 0 50 3. Betamethasone I.P. 5 0 5 4. Betamethasone Sodium 50 0 50 Phosphate 5. Betamethasone Valerate 50 0 50 6. Clobetasone Propionate 40 0 40 7. Clobetasone Butyrate 10 0 10 8. Dexamethasone and Sodium 50 0 50 Phosphate 9. Fluticasone Propionate 15 0 15 10. Hydrocortisone 20 0 20 11. Hydrocortisone Acetate 20 0 20 12. Mometasone Furoate 20 0 20 ES-1 M/s. Stermone Chemicals Pvt. Ltd. Excel Enviro Tech Executive Summary Sr. Name of Product Existing Proposed Total End Use of No. Capacity Change capacity Product (Kg/Month)* (Kg/Month) (Kg/Month) 13. Prednisolone Acetate 25 0 25 14. Prednisolone Sodium 25 0 25 Phosphate Proposed 1. Testosterone 0 2,260.5 2,260.5 Healthcare 2. Testosterone propionate 0 3. Testosterone Undecanoate 0 4. Testosterone Cypionate 0 5. Nandrolone Decanoate 0 6. Nandrolone Phenylpropionate 0 7. Trenbolone Acetate 0 8. Trenbolone Enanthate 0 9. Methandienone 0 10. Oxymetholone 0 11. Stanozolol 0 12. Tibolone 0 13. Hydroxyprogesterone 0 Caproate 14. Norathisterone Acetate 0 15. Norathisterone Enanthate 0 16. Levonorgestrel 0 17. Desogestrel 0 18. Drospirenone 0 19. Progesterone 0 20. Allylestrenol 0 21. Gestodene 0 22. Lynestrenol 0 23. Exemestane 0 24. Estradiol 0 25. Estrinol 0 26. Estradiol Cypionate 0 27. Ethinyl Estradiol 0 28. Mifepristone 0 29. Oxandrolone 0 30. Medroxy Progesterone 0 Acetate 31. Megestrol Aceate 0 32. Abiraterone acetate 0 33. Betamethasone 0 8,487 8,487 Healthcare 34. Betamethasone Acetate 0 35. Betamethasone Dipropionate 0 36. Betamethasone Valerate 0 37. Betamethasone Sodium 0 Phosphate 38. Clobetasol Propionate 0 39. Clobetasone Butyrate 0 40. Dexamethasone 0 41. Dexamethasone Sodium 0 ES-2 M/s. Stermone Chemicals Pvt. Ltd. Excel Enviro Tech Executive Summary Sr. Name of Product Existing Proposed Total End Use of No. Capacity Change capacity Product (Kg/Month)* (Kg/Month) (Kg/Month) Phosphate 42. Dexamethasone Acetate 0 43. Deflazacort 0 44. Hydrocortisone Acetate 0 45. Prednisolone 0 46. Prednislone Acetate 0 47. Prednisone 0 48. Prednisolone Sodium 0 Phosphate 49. Beclomethasone Dipropionate 0 50. Mometasone Furoate 0 51. Dutasteride 0 52. Halobetasol Propionate 0 53. Fluocinolone Acetonide 0 54. Fluocinonide 0 55. Triamcinolone 0 56. Triamcinolone Acetonide 0 57. Triamcinolone Hexaacetonide 0 58. Difluprednate 0 59. Methylprednislone 0 60. Methylprednisolone Acetate 0 61. Fluticasone Propionate 0 62. Fluromethonolone 0 63. Loteprednol Ethabonate 0 64. Diflucortolone Valerate 0 65. Desoximethasone 0 66. Eplerenone 0 67. Spironolactone 0 68. Hydrocortisone 0 Total 405.0 10,747.5 10,747.5 *The unit would enhance the manufacturing capacity of existing products and the same has been blended in proposed product list. ES-3 M/s. Stermone Chemicals Pvt. Ltd. Excel Enviro Tech Executive Summary A-3 SITE LOCATION The site details indicating the nearest landmarks and amenities are given in Table-2. Table-2: Aerial Distance of Nearest Landmarks Aerial Distance, km Particular Location Name (approx) Khambhat Taluka 5.93 Km SSE Khambhat City Anand District 43.32 Km, NE Anand City Village/Residential Zone Paldi 0.750 Km NNW Railway Station Khambhat Railway Station 6.28 Km SSE Airport Vadodara Airport 65.18 Km E Kheda – Khambhat 2.50 Km E Highway (National & state) SH- 89 5.70 Km SE Gulf of Khambhat 7.10 Km S Nearest major water body Natural Drain 0.6 Km E NECL (Nandesari Environment TSDF 52.0 Km E Control Ltd.) Hospital Cambay General Hospital 5.39 Km SSE Fire Station Sardargunj Fire Station Anand 43.81 Km NE Police Station Khambhat City police station 6.39 Km SSE The proposed expansion would be carried out within existing premises with expansion in existing building and another new building adjacent to the existing one. The existing land area is @14,404 sq.m. The choice of the land / Project confers several advantages, which are summarized below: The unit already exists and have procured applicable permissions for existing plant. Sufficient open space available for expansion within premises. No requirement of new land. The project proponent already possess ready infrastructure for existing capacity; where the product would be manufactured with required modifications. Uninterrupted availability of sufficient water (from GWSSB authority). Availability of Agro waste/Briquette as fuel from nearby source Uninterrupted supply of electricity No physical displacement of the members of the public. Connectivity of the site via road and train to procure the raw material and to despatch the products. A vicinity of habitation to get human resource to run the plant. A- 4 INVESTMENT OF THE PROJECT The total investment for the proposed expansion project would be INR 9.52 crore. The estimated capital cost to be incurred for environmental pollution control measures of the project are around INR 1.22 crore and operational cost to be incurred in future is INR 1.73 Crore / Annum say 14.41 Lacs/Month. ES-4 M/s. Stermone Chemicals Pvt. Ltd. Excel Enviro Tech Executive Summary A- 5 INFRASTRUCTURE & UTILITIES REQUIREMENT A.5.1 AREA REQUIREMENT The units is located in Khambhat, spread over a plot of 14,404 sq. meters, and are easily accessible by road and rail from all over India. Out of total land allotted for plant, approx. 33 % (4754 sq.m.) land will be allocated for green belt development. A.5.2 POWER REQUIREMENT The total power requirement is 1000 KVA and shall be obtained from MGVCL - Madhya Gujarat Vij Company Limited. Existing DG set of 125 KVA and proposed DG set of 500 KVA shall be utilized as stand-by power source after proposed expansion. A.5.3 FUEL REQUIREMENT Agrowaste / Briquette of @300 kg/hourand diesel of @60 Litre / hour shall be used as a fuel in boiler & DG Set respectively. A.5.4 MANPOWER REQUIREMENT Total 88 people shall be employed after proposed expansion. There are 43 existing and 45 proposed employees. A.5.5 WATER REQUIREMENT Water requirement for the project will be met from the GWSSB (Gujarat Water Supply and Sewarage Board) through pipeline. The total water requirement for the project would be 37 KL/day, out of which 23 KL/day will be fresh water and 14 KL/day will be recycled water. A.5.3 EQUIPMENTS & MACHINERIES After proposed expansion chilling tower, cooling tower, reactors, boiler, dryer, stripper, ETP, incinerator and MEE shall be installed. A-6 EMISSIONS, EFFLUENT GENERATION, WASTE GENERATION & SOLVENT RECOVERY A.6.1 ATMOSPHERIC EMISSIONS The existing and proposed flue gas emissions are given in Table-3. Table: 3 - Details of Flue Gas Stack (Existing & Proposed) Sr. Stack attached Height of Fuel APCM Fuel Parameter No. to Stack, m Consumption System Boiler Agro Waste Cyclone 1 (Existing) 1 TPH 13.0 100 kg/Hour / Briquette Separator Particulate Boiler Matter Agro Waste Cyclone 3 2 (proposed) 13.0 200 kg/Hour <150mg/NM / Briquette Separator 2 TPH SO2 < 100 ppm D.G.