SVL LIFE SCIENCE PVT. LTD. SY.NO

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SVL LIFE SCIENCE PVT. LTD. SY.NO. 45/1 TO 45/54 AND 46/1 TO 46/22, KOVVADA AGRAHARAM VILLAGE, PUSAPATIREGA MANDAL, VIZIANAGARAM DISTRICT, ANDHRA PRADESH EXECUTIVE SUMMARY SUBMITTED TO ANDHRA PRADESH STATE POLLUTION CONTROL BOARD, REGIONAL OFFICE, VIZIANAGARAM

EXECUTIVE SUMMARY Introduction M/s. SVL Life Science Pvt. Ltd., proposes to establish the unit in an area of 17.67 acres at Sy.No. 45/1 to 45/54 and 46/1 to 46/22, Kovvada Agraharam Village, Pusapatirega Mandal, Vizianagaram District, Andhra Pradesh. The capital cost of the project is Rs. 25 crores. Prior environmental clearance is mandated by Ministry of Environment, Forest and Climate Change (MoEFCC), vide SO 1533, dated September 14, 2006, for synthetic organic chemicals manufacturing activity. The project sought terms of reference for preparation of EIA report during February 2016, and the scoping of TOR was held in EAC meeting held in April 2016. The terms of reference for the environmental impact assessment studies was obtained from MoEFCC vide letter no. F.No. J-11011/83/2016-IA II (I) dated 21.06.2016 and the draft Environmental impact assessment (EIA) report is prepared in compliance of the TOR to conduct public hearing. Location of the Project: The project site is located at Sy.No. 45/1 to 45/54 and 46/1 to 46/22, Kovvada Agraharam Village, Pusapatirega Mandal, Vizianagaram District, Andhra Pradesh. The site is located at the intersection of 18 0 06 23.06 (N) latitude and 83 0 34 50.04 (E) longitude. The site elevation above mean sea level (MSL) is 53 m. The site is surrounded by open lands in all directions. The main approach road is NH 5 passing at a distance of 0.85 km from the plant site in northwest. The nearest habitation from the plant is Kovvada Agraharam village at a distance of 1.4 km in southwest direction. The nearest Town and Railway station is Vizianagaram at a distance of 19.5 km in east direction. The nearest airport is Visakhapatnam located at a distance of 56 km in southwest direction. There are three reserve forests in the study area; Kumili RF at a distance of 1.6 km in northwest direction, Amarsingi RF at a distance of 7.6 km in west direction and Konada RF at a distance of 7.8 km in south direction. Bay of Bengal is at a distance of 8 km in south direction. There are no ecologically sensitive areas like national parks, sanctuaries within 10 km radius of the site. E-1

Product Profile The manufacturing capacity of proposed products and by-products are presented in the following tables Manufacturing Capacity S.No Name of the Product CAS No. Capacity Kg/day TPM I. Bulk Drugs 1 Losartan Potassium 124750-99-8 200 6.0 2 Pregablin 148553-50-8 250 7.5 3 Flucanozole 86386-73-4 100 3.0 4 Ketorolac 74103-06-3 200 6.0 5 Ondansetron 99614-02-5 50 1.5 6 Atrovastatin Calcium 134523-03-8 100 3.0 7 Olanzapine 132539-06-1 70 2.1 8 Linezolide 165800-03-3 60 1.8 9 Sumatriptan Succinate 103628-46-2 100 3.0 10 Quetiamine Fumerate 111974-72-2 100 3.0 11 Dronedarone HCl 141625-93-6 30 0.9 Total - I (Worst case 6 Products on campaign basis) 950 28.5 II. Drug Intermediates 12 Cis Hydroxy Lactum 42399-49-5 200 6.0 13 Pramipexole HCl 104632-25-9 60 1.8 Total - II 260 7.8 III. Fine Chemicals 14 Sodium Methoxide 124-41-4 3000 90 Total - III 3000 90 IV. Nano Carbons 16 Kantera 13815-90-2 150 4.5 17 Graphene Oxide 7782-42-5 150 4.5 Total - IV 300 9 Grand Total (I+II+III+IV) 4510 135.3 List of By-Products S.No Name of Product Stage Name of By- product Capacity Kg/day TPM 1 Pregablin II Sodium Methoxide 58.4 1.75 2 III Ethyl Alcohol 44.2 1.32 3 Cis Hydroxy Lactum III 2-phenyl ethyl amine 94.7 2.84 4 Pramipexole HCl I Acetic Acid 33.4 1.67 5 Kantera III Pyridine HCl 56.7 1.7 E-2

Manufacturing Process Chemical synthesis produces the compounds for manufacture. Chemical synthesis consists of four steps - reaction, separation, purification, and drying. Large volumes of solvents are used during chemical synthesis, extractions, and solvent interchanges. The manufacturing process of the above mentioned molecules involve various types of reactions like acetylyzation, protection, deprotection, hydrolysis etc. The manufacturing process of all the compounds, reactions involved, material balance are presented in chapter 2 of EIA report. Utilities It is proposed to establish coal fired boilers of capacity of 10 TPH and 6 TPH. The required steam for process and ZLD system shall be drawn from 10 TPH boiler, while 6 TPH boiler shall be kept as standby. The DG sets requirement for emergency power during load shut down is estimated at 2000 KVA. Accordingly 2 x 1000 Kva and 1 x 500 Kva DG sets are proposed. The list of utilities is presented in the following Table. List of Utilities S.No Description Capacity 1 Coal Fired Boilers (TPH) 1 x 10 1 x 6* 2 DG Sets (KVA)# 2 x 1000 1 x 500 * Boiler shall be kept as standby. #DG sets will be used during load shut down by APTRANSCO. Water Requirement Water is required for process, scrubbers, washing, cooling tower makeup, steam generation and domestic purposes. The required water shall be drawn from bore wells within plant premises in addition to reuse of treated wastewater. The total water requirement is 257.7 KLD consisting of 146.7 KLD of fresh water and 111 KLD of recycled water. The water balance for daily consumption is presented in the following table; E-3

Water Balance Purpose INPUT (KLD) OUTPUT (KLD) Fresh Water Recycled Water Loss Effluent Process 57.7 61.7* Washings 12 12 Scrubber 7 7 Boiler Feed 40 35 5 Cooling Tower 10 111 106 15 RO/DM Plant 10 10 Domestic 5 0.5 4.5 Gardening 5 5 Gross Total 146.7 111 146.5 115.2 Total 257.7 261.7 * Process effluents contain soluble raw materials, byproducts, solvents etc. Baseline Environmental Data The baseline data was collected in the study area during March to June 2016. The baseline data includes collection of samples of ground water, surface water and soil, monitoring of ambient air quality, noise levels, ecological status and meteorological parameters. The analytical results show that the values are within the prescribed limits for air quality. The ground water quality is observed to be above the limits for potable purpose when compared to the prescribed standards of IS: 10500 2012 at few locations. Identification and Quantification of Impacts The potential effects due to interaction of environment with the pollution loads from the proposed industry are identified, quantified and assessed to select optimum mitigation and or management measures. The sources of pollution from the proposed plant are air emissions from utilities and process; liquid effluents from process, utilities and domestic usage; solid wastes from process, treatment systems and utilities; and noise pollution from utilities, and process equipment. Impacts on Air quality: The impacts on air quality shall be due to the emissions from Coal Fired Boilers and standby DG sets. The incremental ambient air quality concentrations due to these emissions are quantified using ISC-AERMOD model based on ISCST3 Algorithm. The results indicate marginal increase in ambient air quality concentration. The predicted values for PM, PM 10, PM 2.5, SO 2 and NO x are 5.54, 2.26, 0.99, 7.98 and 9.3 μg/m 3 respectively at a distance of 1.6 km in northeast direction. The cumulative concentrations of baseline air quality combined with predicted values are E-4

found to be within the prescribed limits of National Ambient Air Quality Standards. The proposed mitigation and control measures of air pollution shall ensure that the impact on air quality is local within the site area and its surroundings, with low magnitude, medium term duration, and an irreversible impact. The fugitive and diffuse emissions were quantified and the air borne concentrations were predicted using a box model, and the results indicate the work room concentrations were less than the threshold limit values (TLV) for various solvents. Impacts on Water: The water requirement is for process utilities and domestic use. The required water is abstracted from borewells and recycling of treated wastewater. The fresh water requirement is 146.7 KLD while the recycled water quantity is 111 KLD. No impact on water quality is expected due to the discharge of effluents as zero liquid discharge is envisagedensuring reuse of treated effluents for cooling tower makeup. There is no usage of treated wastewater for on land irrigation. The impact on hydrogeology shall be negative as it is proposed to utilize ground water resulting in impacts at regional level with medium magnitude for a medium term, continuous frequency, and is reversible in the long term. Impacts on Noise quality: The noise levels may increase due to motors, compressors, DG set and other activities. The major source of noise generation is DG sets which emit noise level of maximum 90 db (A) at a reference distance of 1m from the source. The predicted cumulative noise levels (as calculated by the logarithmic model without noise attenuation) ranged between 55 and 75 db(a) at distances of 8 to 12m. The increase in noise levels shall have neutral impact, restricted to within site area due to its low magnitude and occasional frequency. Impacts on Soil: The solid wastes generated from process, utilities and effluent treatment plant may have significant negative impacts if disposed indiscriminately. The total solid waste will be stored separately in Hazardous storage area. Solid waste will be sent to cements plants for co-incineration based on calorific value or sent to TSDF. The operational phase impacts shall be neutral due to effective implementation of mitigative measures in handling, storing and transferring of solid wastes, effluents and chemicals, and development of green belt. E-5

Impacts on Ecology: There are no endangered species of flora and fauna in the impact area. The impact on biological environment is neutral with the effect confined mainly to the site area with low magnitude for a medium term with isolated frequency. Impacts on Socio Economy: There is a potential for direct/indirect employment of about 30 people during construction phase and 120 during operation phase. The impact area will have positive benefits due to the project. The project shall have positive impact on socioeconomic environment due to provision of employment both direct and indirect and also due to propose CSR activities to be implemented by the proponent. Environment Management Plan (EMP) The management plan is drawn in consultation with project proponents and technical consultants after evaluating a number of technologies available for mitigation and control of pollution. The EMP is drawn to address the impacts monitored, identified and predicted. The impacts during construction stage are temporary and less significant, the management plan for impacts identified during operation stage is detailed below. Liquid Effluents The effluent generated is mainly from process, washings, scrubbers, cooling towers and boiler blow downs, Reverse osmosis/demineralization plant rejects from pre-treatment of water and domestic wastewater. The waste streams are segregated as high TDS and Low TDS streams. Total Effluent generated and mode of treatment is presented as follows: E-6

Total Effluent Generated and Mode of Treatment Description Quantity (KLD) Mode of Treatment HTDS Effluents Process 61.7 Sent to Stripper followed by MEE and ATFD. Stripper Washings 12 Scrubber Effluent 7 RO/DM rejects 10 Total - I 90.7 Condensate sent to Cement Plants for Co-Incineration. MEE and ATFD Condensate sent to Biological treatment plant followed by RO. RO rejects sent to MEE and permeate is reused in cooling towers makeup. LTDS Effluents Boiler Blow downs 5 Sent to Biological Treatment System followed by RO. Cooling Tower Blow down 15 Domestic 4.5 Total - II 24.5 Grand Total (I+II) 115.2 Effluent Treatment System RO permeate reused for cooling tower makeup. RO rejects sent to MEE. The Effluent management system is developed to ensure `Zero Liquid Discharge. Segregation of effluents is critical in effective treatment of various effluent streams. The effluents are segregated into two streams; High COD/ TDS and Low COD/ TDS streams. Effluents generated from process, washings, scrubbing effluent and rejects from pre-treatment of raw water are considered as High TDS, while utility blow downs and domestic wastewater are considered as Low TDS effluents. The High TDS/ COD Effluents The treatment system for treating High TDS/ COD effluents consists of equalization, neutralization, settling tank, stripper, multiple Effect Evaporator (MEE) followed by agitated thin Ffilm dryer (ATFD). The organic distillate from the stripper is sent to cement plants for co-incineration and aqueous bottom from stripper is sent to MEE followed by ATFD for evaporation. The condensate from the MEE and ATFD are sent to ETP (Biological). Salts from ATFD are disposed to TSDF. The Low TDS/ COD Effluents These effluents along with the condensate from MEE and ATFD are treated in primary treatment consisting of equalization, neutralization, and primary sedimentation followed by secondary biological treatment consisting of aeration tank and clarifier. The treated effluents after biological treatment are subjected to tertiary treatment in a reverse osmosis E-7

(RO) system. Permeate from RO is reused for cooling tower and boiler make-up and rejects are sent to MEE followed by ATFD. Sludge from various units of Biological treatment and effluent pretreatment is thickened in sludge handling system and sent to TSDF. Air Pollution The sources of air emission expected from the plant are coal fired boiler and DG sets. Bag filter will be provided as air pollution control equipment for 10 TPH and 6 TPH coal fired boilers. DG sets shall be provided with effective stack height based on the CPCB formula. The process emissions contain Ammonia, Carbon dioxide Hydrogen, Hydrogen Bromide, Hydrogen Chloride, Nitrogen, Oxygen and Sulfur dioxide. Ammonia, Hydrogen chloride, Hydrogen Bromide and Sulphur dioxide are sent to scrubber in series. Ammonium Chloride from ammonia scrubbing, Sodium chloride from HCl scrubbing, Sodium bromide from HBr Scrubbing and Sodium Bisulfite from Sulphur dioxide Scrubbing are sent to ETP. The other gases Carbon dioxide, Oxygen and Nitrogen are let out into atmosphere following a standard operating procedure, while Hydrogen gas is let out into atmosphere through a water column. Diffuse emissions are also released from various operations of manufacturing like centrifuge, drying, distillation, extraction etc. These emissions mainly contain volatile contents of the material used for processing. It is proposed to provide vent condensers in series to reactors, distillation columns, driers and centrifuge etc. to mitigate VOC emissions release. Solvent Use and Recycle Solvents are used for extraction of products and as reaction medium. Used solvents are recovered by distillation for reuse. Residues from distillation columns and mixed solvents shall be sent to TSDF for incineration or cement plants for co-incineration. If any of the distilled spent solvents are not reused due to statutory reasons the same shall be sold to other reusers. E-8

Solid Waste Solid wastes are generated from process, solvent distillation, effluent treatment system, DG sets and boilers. Stripper distillate, process residue and solvent residue are sent to cement plants for co-incineration based on acceptability as the same contain significant calorific value. If these wastes are not suitable for co-incineration, the same are sent to TSDF facility. The evaporation salts are sent to TSDF. Waste oil and used batteries from the DG sets are sent to authorized recyclers. Sludge from effluent treatment plant is considered hazardous and the same is sent to TSDF. Other solid wastes expected from the unit are containers, empty drums which are returned to the product seller or sold to authorized buyers after detoxification. Coal ash from boiler is sold to brick manufacturers. Noise Pollution Noise is anticipated from motors, compressors, centrifuges and DG sets. DG set shall be provided with acoustic enclosure. Motors and compressors shall be mounted properly to ensure reduction of noise and vibration. Employees working in noise generating areas shall be provided with appropriate personnel protective equipment. Occupational Safety and Health Direct exposure to organic chemicals or its raw materials may affect health of employees. Direct exposure to hazardous materials is eliminated by providing closed handling facilities. Personal Protective Equipment (PPE) i.e., hand gloves, safety goggles, safety shoes, safety helmets, respiratory masks etc. are provided to all the employees working in the plant. Company has a policy of providing PPEs to all personnel including contract workers. Periodic medical checkup in addition to checkup during recruitment is adopted to monitor health status of employees. Prevention, maintenance and operation of Environment Control Systems The pollution control equipment, and the effluent treatment systems is monitored periodically to estimate their efficiency and performance potential as part of adaptive management. Proactive maintenance and monitoring program for all equipment and machinery is adopted to identify the problems/under performance of the equipment. Necessary steps will be taken to rectify the identified problems/defects. The E-9

management agrees that the results of monitoring will be reviewed periodically to adopt new measures if necessary, for efficient pollution control. Transport systems All the raw materials and finished products are transported by road. Dedicated parking facility is provided for transport vehicles. The plant is located away from highway. Hence there will not be any unauthorized shop or settlements along the road connecting the plant site. There will be 10-12 truck trips per day to the factory for transporting raw materials and products. Traffic signage will be placed in the battery limit. The drivers of the vehicles will be provided with TREM cards of chemicals and materials to be transported, and will be explained the measure to be adopted during various emergencies Reduce, Recycle and Reuse A number of measures are proposed to achieve high yields and reduce generation of wastes. It shall be the endeavor of R&D team to improve yields through constant research and development activities. The solvents shall be recycled for reuse in the process after distillation. Mother liquors from the first crop shall be reused for process. The steam condensate shall be reused for boiler feed. Treated effluent shall be reused for cooling tower makeup. It is also proposed to explore recovery of various salts from MEE salts, and from process effluents to reduce effluent loads, and quantity of solid waste. Green Belt Development It is proposed to provide green belt in an area of 5.9 acres, covering the boundary of the site as part of environment management plan. Native species shall be identified for plantation and guidelines issued by CPCB for development of green belt shall be followed. The green belt shall enhance environmental quality through mitigation of fugitive emissions, attenuation of noise levels, balancing eco-environment, prevention of soil erosion, and creation of aesthetic environment. Post Project Monitoring Environmental monitoring for water, air, noise and solid waste quality shall be conducted periodically either by proponent or third party. The frequency of monitoring E-10

and the quality parameters shall be as suggested by the Ministry of Environment and Forests and Climate Change, Government of India. Environment Management Department The Environment Management Cell of the project shall be headed by Environment Engineer and shall be assisted by 4 nos. of operators, 4 nos. of chemists, 5 nos. of fitters and 2 nos. of horticultural staff. E-11