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Dasami Lab Pvt. Ltd. Sy.No DASAMI LAB PVT. LTD. SY.NO. 404, 405, 407, 408, 409 AND 410, VELIMINEDU VILLAGE, CHITYAL MANDAL, NALGONDA DISTRICT, TELANGANA RISK ASSESSMENT REPORT SUBMITTED TO MINISTRY OF ENVIRONMENT, FOREST AND CLIMATE CHANGE GOVERNMENT OF INDIA INDIRA PARYAVARAN BHAWAN, JOR BAGH ROAD, NEW DELHI Dasami Lab Pvt. Ltd. Environmental Impact Assessment Report 7.0 RISK ADDITIONAL STUDIES 7.0 Introduction This chapter presents the risk assessment study results for the plant operations, transport and storage of raw materials, and identifies maximum credible accident scenarios to draw the emergency management plan addressing various credible scenarios identified. 7.1. Objectives and Scope The production of Synthetic Organic chemicals (bulk drug and intermediates) involves usage of many chemicals which are both hazardous and toxic in nature. The risks associated with the chemical industry are commensurate with their rapid growth and development. Apart from their utility, chemicals have their own inherent properties and hazards. Some of them can be flammable, explosive, toxic or corrosive etc. The whole lifecycle of a chemical should be considered when assessing its dangers and benefits. In order to ensure the health and safety of persons at or near the facilities, Govt. has approved some regulations. The regulation requires Employers to consult with employees in relation to: - Identification of major hazards and potential major accidents - Risk assessment - Adoption of control measures - Establishment and implementation of a safety management system - Development of the safety report The involvement of the employees in identification of hazards and control measures enhances their awareness of these issues and is critical to the achievement of safe operation in practice. In order to comply with regulatory authorities, M/s Dasami Lab Pvt. Ltd., have entrusted Team Labs and Consultants, Hyderabad to review and prepare Hazard analysis and Risk assessment for their facility along with an approach to on-site emergency preparedness plan as required under the acts and rules. (Manual on emergency preparedness for chemical hazards, MOEF, New Delhi). In this endeavor, the methodology adopted is based on; 7-1 Team Labs and Consultants Dasami Lab Pvt. Ltd. Environmental Impact Assessment Report visualizing various probable undesirable events which lead to major accidents detailed and systematic assessment of the risk associated with each of those hazards, including the likelihood and consequences of each potential major accident event; and identifying the technical and other control measures that are necessary to reduce that risk to a level that is as low as reasonably practicable The strategy to tackle such emergencies, in-depth planning and person(s) or positional responsibilities of employees for implementation and coordination of timely and effective response measures are described in onsite detail in Emergency Plan. 7.2 Project Details The plant site is located at Survey No. 404, 405, 407, 408, 409 & 410, Veliminedu Village, Chityal Mandal, Nalgonda District, Telangana State. 43.875 acres of site is additionally acquired for the expansion to the existing 7.125 acres. The total site area for expansion is 51 acres. The site is located at the intersection of 17°13'27" (N) latitude and 79° 2'45" (E) longitude. The plant site elevation above mean sea level (MSL) is in the range of 329 - 338 m. The plant site is surrounded by open agricultural land in east and south directions, proposed site of Actero Pharma Pvt. Ltd., in west direction and Pittampalli village road connecting national highway in north direction. The nearest habitation from the plant is Pittampalli village located at a distance of 2.2 km in southwest direction. The main approach road NH-9 with pittamapalli village is adjacent to site in north direction. National Highway 9 - Hyderabad - Vijayawada is at a distance of 0.5 km in north direction. The nearest town Chityal is at a distance of 8.3 km in northeast direction. The nearest railway station Ramannapet is at a distance of 7.6 km in northeast direction and nearest airport is Rajiv Gandhi International Airport (Hyderabad) located at a distance of 65 km in northwest direction. Seasonal nala Chinna Vagu is flowing from northwest to southeast direction at a distance of 6.5 km in southwest direction. There are two reserve forests in the impact area of 10 km radius of the study area. Chityal RF at a distance of 6.0 7-2 Team Labs and Consultants Dasami Lab Pvt. Ltd. Environmental Impact Assessment Report km in east direction, Shivanenigudem RF at a distance of 9.0 km in northeast direction. There is no national park, wildlife sanctuary, ecologically sensitive area, biosphere reserve, tiger reserve, elephant reserve, critically polluted areas and interstate boundary within 10 km radius of the site. The manufacturing capacities of the proposed bulk drug and intermediates after expansion is presented in Table 7.1 and Table 7.2 Chemical inventory is presented in Table 7.3 Table 7.1 Manufacturing Capacity – After Expansion S.No Name of Product CAS No. Capacity TPM Kg/day 1 Amlodipine Besylate 111470-99-6 20 666.7 2 Aprimilast 608141-41-9 3 100 3 Bocepravir 394730-60-0 6 200 4 Bupropion HCl 31677-93-7 20 666.7 5 Carvedilol 72956-09-3 30 1000 6 Clopidogrel Hydrogen Bisulfate 135046-48-9 10 333.33 7 Colisevelam 182815-44-7 6 200 8 Dalfampridine 45498-20-2 17 566.7 9 Dex lansoprazole 138530-94-6 5 166.67 10 Divalproex Sodium 76584-70-8 15 500 11 Drotaverine HCl 985-12-6 3 100 12 Duloxetine HCl 136434-34-9 15 500 13 Esli Carbazapine 236395-14-5 2 66.7 14 Fexofenadine HCl 153439-40-8 10 333.3 15 Glimepride 93479-97-1 3 100 16 Lansoprazole 103577-45-3 8 266.67 17 Lomitapide 202914-84-9 2 66.7 18 Mesalamine 89-57-6 7 233.33 19 Nebumitone 42924-53-8 10 333.33 20 Omeprazole 73590-58-6 5 166.7 21 Piperquine Phosphate 4085-31-8 5 166.7 22 posacanazole 171228-49-2 7 233.3 23 Ramipril 87333-19-5 7 233.3 24 Ranolazine 95635-55-5 10 333.3 25 Sevelamir HCl 152751-57-0 29 966.67 26 Sparfloxacin 110871-86-8 20 666.7 27 Telapravir 402957-28-2 5 166.7 28 Ticagrelor 274693-27-5 1 33.3 29 Tramadol HCl 27203-92-5 12 400 30 Valacyclovir 124832-27-5 6 200 31 Valagancyclovir HCl 175865-59-5 2 66.7 32 Abiraterone Acetate 154229-18-2 1 33.3 33 Anastrozole 120511-73-1 2 66.7 7-3 Team Labs and Consultants Dasami Lab Pvt. Ltd. Environmental Impact Assessment Report 34 Bendamustine Hydochloride 3543-75-7 2.5 83.3 35 Bexarotene 153559-49-0 3 100 36 Bicalutamide 90357-06-5 5 166.7 37 Bortezomib 179324-69-7 0.5 16.7 38 Carboplatin 41575-94-4 5 166.7 39 Capecitabine 154361-50-9 2 66.7 40 Cisplatin 15663-27-1 2 66.7 41 Cyclophosphamide 50-18-0 2 66.7 42 Dasatinib 302962-49-8 2 66.7 43 Emtricitabine 143491-57-0 30 1000 44 Erlotinib HCl 183319-69-9 4 133.3 45 Gefitinib 184475-35-2 2 66.7 46 Gemcitabine HCl 122111-03-9 1 33.3 47 Imatinib Mesylate 220127-57-1 16 533.3 48 Irinotecan HCl 136572-09-3 14 466.7 49 Lapatinib Ditosylate Monohydrate 388082-78-8 2 66.7 50 Letrozole 112809-51-5 2.5 83.3 51 Nilotinib HCl 923288-90-8 2 66.7 52 Oxaliplatin 63121-00-6 4 133.3 53 Pazopanib Hydrchloride 635702-64-6 2 66.7 54 Pemetrexed Disodium 150399-23-8 0.5 16.7 55 Sorafenib Tosylate 475207-59-1 6 200 56 Temozolomide 85622-93-1 1 33.3 57 Sunitinib Malate 341031-54-7 6 200 Total 421 Total - Worst Case 27 Products on campaign basis 11566.7 Table 7.2 List of By-products – After Expansion S. No Name of Product Stage Name of By Product Quantity (Kg/day) 1 Amlodipine Besylate I Phthalic acid 195.2 2 Clopidogrel Hydrogen Sulphate I p-Toluene sulfonic acid 170.8 Tarataric acid 149 3 Duloxetine HCl I Sodium Phenyl Carbonate 239.9 Ethyl Acetate 131.9 4 Emtricitabine I Triethyl amine HCl 409.7 7-4 Team Labs and Consultants Dasami Lab Pvt. Ltd. Environmental Impact Assessment Report Table 7.3 List of Raw Materials and Inventory (Terms of Reference No. 3(iv) & (3(v)) S.No Name of the Raw Material Maximum Physical Type of Hazard Mode of Mode of storage Form Storage Transport (Kgs) 1 (1R,2S)-2-(3,4-Difluorophenyl)cyclopropanamine 192 Solid Corrosive Bags By Road mandalic acid salt 2 (1R,2S,5S)-6,6-Dimethyl-3-aza 693 Solid Corrosive Bags By Road bicyclo [3.1.0]hexane-2-carboxylic acid methyl ester hydrochloride 3 (1S,3aS,6aS)-ethyloctahydropentalenecarboxylate 645 Powder Flammable Bags By Road 4 (2-Thienyl)ethylpara-toulene sulphonate 2247 Solid Irritant Bags By Road 5 (3S)-3-amino-N-cyclopropyl-2-hydroxyl hexanamide 426 Crystalline Corrosive Bags By Road 6 (4,6-Dichloro-2-(propylsulfanyl)-5-pyrimidinamine 164 Solid Irritant Bags By Road 7 (5R-cis)-5-(2,4-difluorophenyl)-5-(1,2,4-triazol-1- 1498 Crystalline Irritant Bags By Road ylmethyl)tetrahydrofuran-3-methanol tosylate ester 8 (S)-1-(3-Ethoxy-4-methoxyphenyl)-2- 1009 Solid Corrosive Bags By Road (methylsulfonyl)ethan-1-amine acetyl-L-leucinate 9 (S)-2-((S)-2-cyclohexyl-2-(pyrazine-2- 1325 Solid Corrosive Bags By Road carboxamide)acetamido)-3,3-dimethylbutanoic acid 10 (S)-N-Methyl-N-phenyloxycarbonyl-3-(1-napthyloxy)- 5149 Solid Flammable Bags By Road 3-(2-thienyl)propylamine 11 [1,4]bipiperidinyl-1-carbonyl chloride hydrochloride 1550 Solid Corrosive Bags By Road 12 1-(2-hydroxyethyl)piperazine 218 Liquid Irritant Drums By Road 13 1(-3-dimethylaminopropyl)-3-ethylcarbodiimide (EDC) 315 Solid corrosive Bags By Road 14 1-(6-Methoxy-2-naphthyl)-1-ethanone 2650 Powder Irritant Bags By Road 15 1,3-Dibromopropane 364 Liquid Flammable Drums By Road 16 1,3-Dicyclohexyl carbodiimide 105 Solid Irritant Bags By Road 17 10 % Brine Solution 1575 Liquid Corrosive Drums By Road 18 1-Bromodecane 770 Liquid Toxic Drums By Road 19 1-Hydroxybenzotriazole 975 solid Flammable Bags By Road 20 1-Hydroxysuccinimide 35 Solid Non hazard Bags By Road 21 1R,2R(-)1,2-Diaminocyclohexane 498 Crystalline Corrosive Bags By Road 22 2(1S)-(1S,2S,3R,5S)-pinanediol-1-ammonium 237 Powder Flammable Bags By Road 7-5 Team Labs and Consultants Dasami Lab Pvt.
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