SHIMOGA HEALTH CARE PLOT NO. 12, PHASE II, INDUSTRIAL PARK, MANDAL, DISTRICT,

FORM I

Project No. 0915‐21‐01 September 2015

STUDIES AND DOCUMENTATION BY Shimoga Health Care TEAM Labs and Consultants Flat No. 13‐1‐198/101, Mahalakshmi Classic, B‐115‐117 & 509, Annapurna Block, Mothi Nagar, Balaji swarnapuri Colony, Aditya Enclave, Ameerpet, Borabanda, Hyderabad – 500 018 Hyderabad‐500 038. Phone: +91 9423565743 Phone: 040‐23748 555/23748616, E‐mail: [email protected] Telefax: 040‐23748666

SUBMITTED TO STATE LEVEL ENVIRONMENT IMPACT ASSESSMENT AUTHORITY, ANDHRA PRADESH, GOVERNMENT OF Shimoga Health Care

APPENDIX – I (See Paragraph – 6) FORM I

I) Basic Information S.No. Item Details 1 Name of the Project/s Shimoga Health Care 2 S. No in the Schedule 5 f – B category 3 Proposed capacity/area/length/tonnage to Inclusion of be handled/command area/lease API’s (Synthetic Organic Chemicals) in existing area/number of wells to be drilled Herbal based products manufacturing unit. Capacity: 170 Kg/day (API’s: 150 Kg/day + R&D: 20Kg/day) Propose to manufacture 4 products respectively out of a total 16 products on campaign basis. 4 New/Expansion/Modernization Inclusion/Expansion 5 Existing Capacity/Area etc. Area: 2.75 acres Herbal Based products – 303 Kg/day 6 Category of Project i.e. 'A' or 'B' “B” 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. Plot No. 12, Phase II, Nadikudi Industrial Park, Village Nadikudi Village Tehsil Dachepalle Mandal District State Andhra Pradesh 10 Nearest railway station/airport along with Nadikudi (S.C Railways) 1.2 Km distance in kms. 11 Nearest Town, City, District Headquarters Guntur along with distance in kms. 12 Village Panchayats, Zilla Parishad, Nadikudi Village Municipal Corporation, Local body (complete postal address with telephone nos. to be given) 13 Name of the Applicant Dr. G. Venkateswara Rao 14 Registered Address Plot No‐ 12,Phase II, Nadikudi Industrial Park , Dachepalle Mandal, Guntur District, Andhra Pradesh.

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15 Address for Correspondence: Name Dr. G. Venkateswara Rao Designation(Owner/Partner/CEO) Proprietor Address Shimoga Health Care Flat No‐ 13‐1‐98/101, Mahalakshmi Classic, Mothinagar, Balaji Swarnapuri Colony, Borabanda, Hyderabad‐500018 Pin Code 500 018 E‐mail [email protected] Telephone Number +91‐9423565743 Fax No. 040‐23748666 16 Details of alternative Sites examined, if any. ‐NA‐ Location of these sites should be shown on a topo sheet. 17 Interlinked Projects ‐NA‐ 18 Whether separate application of interlinked No project has been submitted? 19 If yes, date of submission 20 If no, reason 21 Whether the proposal involves ‐NA‐ 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 No Order/Policy relevant/relating to the site? 23 Forest land involved (hectares) No 24 Whether there is any location pending No 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.

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Shimoga Health Care

(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 NO No additional land. The proposal is for land use, land cover or topography inclusion of API manufacturing unit in existing including increase in intensity of herbal based products manufacturing unit in land use (with respect to local land existing area. Total Land area is 2.75acres. use plan) 1.2 Clearance of existing land, vegetation NO Industrial and buildings? 1.3 Creation of new land uses? NO Existing – industrial 1.4 Pre‐construction investigations e.g. YES Soil test done and soil load bearing capacity bore houses, soil testing? established. 1.5 Construction works? YES Construction activity involves creation of new production blocks, additional utilities like Boilers, Chilling Plant etc and Zero Liquid Discharge (ZLD) system. 1.6 Demolition works? NO 1.7 Temporary sites used for NO Construction labor from local villages shall be construction works or housing of employed. construction workers? 1.8 Above ground buildings, structures or YES Storage facilities shall be constructed. No earthworks including linear major cut and fill or excavation is anticipated. structures, cut and fill or excavations 1.9 Underground works including mining NO or tunneling? 1.10 Reclamation works? NO 1.11 Dredging? NO 1.12 Offshore structures? NO 1.13 Production and manufacturing YES Enclosed in Annexure – I processes? 1.14 Facilities for storage of goods or NO Raw materials and solvents shall be stored materials? 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.

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Shimoga Health Care

1.15 Facilities for treatment or disposal of YES High TDS and low TDS effluents are treated solid waste or liquid effluents? with in the plant premises. Organic waste is sent to cement plants for co‐ incineration. Solid waste generated from Multiple Effect evaporators sent to TSDF. Details of waste treatment facilities presented in Annexure II. 1.16 Facilities for long term housing of NO Local people shall be employed. operational workers? 1.17 New road, rail or sea traffic during YES Construction materials shall be transported to construction or operation? the site. The traffic density of the existing connecting road is negligible. 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 YES Total water required shall increase from 30 form ground or surface waters? KLD to 84 KLD out of which 63 KLD shall be met from APIIC and the balance 21 KLD shall be recycled water. 1.24 Changes in water bodies or the land NO surface affecting drainage or run‐off? 1.25 Transport of personnel or materials YES The construction material shall be drawn from for construction, operation or local sources within 10 – 15 km. There is no decommissioning? transport of personnel, as the construction workers shall be drawn from local villages. 1.26 Long‐term dismantling or NO decommissioning or restoration works? 1.27 Ongoing activity during NO decommissioning which could have

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an impact on the environment? 1.28 Influx of people to an area in either YES The proposed project shall increase the temporarily or permanently? employment potential and hence may lead to migration to surrounding villages. 1.29 Introduction of alien species? NO 1.30 Loss of native species or genetic NO There are no major losses of tree/shrub diversity? species. 1.31 Any other actions? NO

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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 NO The proposal is for Inclusion of agricultural land (ha) API’s (Synthetic Organic Chemicals) in existing Herbal based products manufacturing unit. 2.2 Water (expected source & competing YES Total water required shall increase from 30 users) unit: KLD KLD to 84 KLD out of which 63 KLD shall be met from APIIC and the balance 21 KLD shall be recycled water. (Water Balance Enclosed in Annexure III) 2.3 Minerals (MT) NA 2.4 Construction material – stone, YES Shall be sourced from the local villages. aggregates, sand / soil (expected source – MT) 2.5 Forests and timber (source – MT) NO 2.6 Energy including electricity and fuels YES The required energy shall be drawn from (source, competing users) Unit: fuel APTRANSCO. DG set of 250 KVA shall be (MT), energy (MW) provided to cater to energy requirement during load shut downs.

The other energy source is steam, which will met from proposed Coal Fired Boiler of 1 x 3TPH in addition to existing 2TPH boilers. The required quantity of coal for proposed 3TPH boiler shall be 15.5TPD 2.7 Any other natural resources (use NA appropriate standard units)

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Shimoga Health Care

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 YES Solvents shall be used as reaction media. are hazardous (as per MSIHC rules) to MSIHC rules shall be followed during storage, human health or the environment transportation and handling of raw materials (flora, fauna, and water supplies) and hazardous chemicals. 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 YES Shall increase the employment potential for changing living conditions? locals and affect the living conditions for betterment. 3.4 Vulnerable groups of people who NO No sensitive receptors are present in the could be affected by the project e.g. immediate vicinity of the site. The project hospital patients, children, the elderly shall not have any significant impact on etc., vulnerable groups of people. 3.5 Any other causes NO

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 commercial wastes) wastes like paper, empty containers etc. The canteen wastes and commercial wastes shall be in the range of 3 kg/day 4.3 Hazardous wastes (as per Hazardous YES The quantity of hazardous wastes generated Waste Management Rules) during construction contains waste oils and batteries from DG set.

The quantity of hazardous waste generated during operation contain salts from evaporators, stripper distillate, process residue, and solvent residues, ETP sludge and filtration media etc. enclosed in Annexure – IV

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4.4 Other industrial process wastes YES Enclosed at Annexure IV 4.5 Surplus product NO 4.6 Sewage sludge or other sludge from YES Sludge from Effluent treatment plant and effluent treatment Salts from MEE & ATFD shall be sent to TSDF. 4.7 Construction or demolition wastes NO Construction activity involves creation of new production blocks, additional utilities like boilers, Chilling Plant etc and ZLD 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. 4.10 Agricultural wastes NO 4.11 Other solid wastes NO Enclosed at Annexure IV

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 YES Coal Shall be used as fuel. Quantity of fuel and fuels from stationary or mobile emissions details are enclosed in Annexure V sources 5.2 Emissions from production processes YES Enclosed in Annexure ‐ VI 5.3 Emissions from materials handling NO Material transfer takes place in closed including storage or transport 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 NO materials including construction materials, sewage and waste 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

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6. Generation of Noise and Vibration, and Emissions of Light and Heat: S.No. Information/Checklist Yes/No Details thereof (with approximate confirmation quantities/rates, wherever possible) with source of information data with source of information data 6.1 From operation of equipment YES Material transport and construction equipment e.g. engines, ventilation plant, shall be source of noise, while transfer pumps, crushers vacuum systems, DG sets are the sources of noise during operation. 6.2 From industrial or similar YES From DG sets, and controlled by providing Acoustic processes Enclosures. 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 NO The increased traffic shall not have any significant traffic 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 Yes/No Details thereof (with approximate confirmation quantities/rates, wherever possible) with source of information data 7.1 From handling, storage, use or NO All the hazardous materials will be stored in spillage of hazardous materials Tanks/MS drums, in a covered shed and no contamination of soil is expected 7.2 From discharge of sewage or NO All the wastes from domestic operations are sent other effluents to water or the to Biological treatment plant of ZLD system. land (expected mode and place of discharge) 7.3 By deposition of pollutants NO Air Pollutants generated are let out into emitted to air into the land or into atmosphere after meeting the prescribed water standards. 7.4 From any other sources NO 7.5 Is there a risk of long term build NO up of pollutants in environment from these sources?

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Shimoga Health Care

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 YES All Inbuilt Safety precautions will be storage, handling, use or production of adopted and there will not be any hazardous substances damage to environment or human health 8.2 From any other causes NA 8.3 Could the project be affected by natural NO disasters causing environmental damage (e.g? Floods, earthquakes, landslides, cloudburst etc)?

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. YES The project shall enhance the socio facilities, ancillary development or economic status of the area by development stimulated by the project which increasing the demand for housing, could have impact on the environment e.g.: improving the employment. There • Supporting infrastructure (roads, power are no major support industries supply, waste or waste water treatment, etc.) required for this plant. • housing development • extractive industries • supply industries • other 9.2 Lead to after‐use of the site, which could NO haven impact on the environment 9.3 Set a precedent for later developments NO 9.4 Have cumulative effects due to proximity to NO The baseline environmental status other existing or planned projects with similar of the surrounding areas is within effects the prescribed limits as observed from the Secondary data.

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(III) Environmental Sensitivity S.No. Areas Name/ Aerial distance (within 15 km.) Identity Proposed project location boundary 1 Areas protected under international NA conventions, national or local legislation for their ecological, landscape, cultural or other related value 2 Areas which are important or sensitive for YES Gamalapadu RF – N– 5.5Km, ecological reasons ‐ Wetlands, watercourses Madinapad RF – NE – 4Km or other water bodies, coastal zone, Daida RF – NW – 9.6Km biospheres, mountains, forests Nagaleru Vagu – SE – 4 Km 3 Areas used by protected, important or NA sensitive species of flora or fauna for breeding, nesting, foraging, resting, over wintering, migration 4 Inland, coastal, marine or underground NO waters 5 State, National boundaries NO 6 Routes or facilities used by the public for NO access to recreation or other tourist, pilgrim areas 7 Defense installations NO 8 Densely populated or built‐up area YES Dachepalle is at a distance of 1 KM in SE 9 Areas occupied by sensitive man‐made land NA uses (hospitals, schools, places of worship, community facilities) 10 Areas containing important, high quality or NO scarce 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 NO could cause the project to present environmental problems (earthquakes, subsidence, landslides, erosion, flooding or extreme or adverse climatic conditions)

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SHIMOGA HEALTH CARE PLOT NO. 12, PHASE II, NADIKUDI INDUSTRIAL PARK, DACHEPALLE MANDAL, GUNTUR DISTRICT, ANDHRA PRADESH

ANNEXURES

Project No. 0915‐21‐01 September 2015

STUDIES AND DOCUMENTATION BY Shimoga Health Care TEAM Labs and Consultants Flat No. 13‐1‐198/101, Mahalakshmi Classic, B‐115‐117 & 509, Annapurna Block, Mothi Nagar, Balaji swarnapuri Colony, Aditya Enclave, Ameerpet, Borabanda, Hyderabad – 500 018 Hyderabad‐500 038. Phone: +91 9423565743 Phone: 040‐23748 555/23748616, E‐mail: [email protected] Telefax: 040‐23748666

SUBMITTED TO STATE LEVEL ENVIRONMENT IMPACT ASSESSMENT AUTHORITY, ANDHRA PRADESH, GOVERNMENT OF INDIA Shimoga Health Care Form I Annexure

Location Map of Shimoga Health Care Shimoga Health of Map Location

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Shimoga Health Care Form I Annexure

ANNEXURE - I

M/s. Shimoga Health Care proposed to include Synthetic Organic Chemicals (Bulk Drugs & Intermediates) in existing herbal based products unit of area of 2.75 acres at Plot No. 12, Phase II, Nadikudi Industrial Park, Dachepalle Mandal, Guntur district, Andhra Pradesh. The proposed list of permitted and products and manufacturing capacity is presented in Table A-1 & A-2 respectively.

Table A-1 Manufacturing Capacity - Permitted S.No Name of the Product Capacity Kg/day TPM 1 Calcium Citrate 170 5.1 2 Calcium Hydroxy Citrate 100 3 3 Aloe Emodin 33 0.99 Total 303 9.09

Table A-2 Manufacturing Capacity S.No Name of the Product Capacity Kg/day TPM 1 Armodafinil 8.3 0.25 2 Candesartan 8.3 0.25 3 Clopidogrel 16.7 0.5 4 Duloxetine HCl. 8.3 0.25 5 Ezitimibe 8.3 0.25 6 Febuxostat 16.7 0.5 7 Fexofenadine 66.7 2 8 Rosuvastatin Calcium 50 1.5 9 Mesalamine 8.3 0.25 10 Phenylephrine HCl 66.7 2 11 Repaglinide 3.3 0.1 12 Sertraline HCl 16.7 0.5 13 Sumatriptan Succinate 8.3 0.25 14 Tamsulosin HCl 8.3 0.25 15 Telmisartan 8.3 0.25 16 Terbutaline Sulphate 16.7 0.5 Total (Worst Case 4 Products on campaign basis) 200 6.0 17 R&D Products 20 0.6 Grand Total 170 6.6

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Shimoga Health Care Form I Annexure

Process Description of Febuxostat Chemical Reaction of Febuxostat Stage I

H 3 C

O H O H 3 C H 3 C S O IPA S O OH H 3 C O H 3 C O H 3 C NaOH (M.Wt.=39.99) + N C H N C H 3 HCl (M.wt.=36.46) 3 N N Febuxostat M.wt=46.06 Ethyl-2-(3-Cyano-4-isobutoxyphenyl)-4- M.Wt=316.37 methyl-5-thiazolecarboxylate + Na Cl M.Wt.=344.428 M.wt=58.44 Stage II

Process Description for Febuxostat Stage I: Ethyl-2-(3-cyano-4-isobutoxyphenyl)-4-methyl-5-thiazolecarboxylate (NV07-3) is hydrolyzed with sodium hydroxide solution in isopropyl alcohol to furnish the product. The pH is adjusted with hydrochloric acid and solid is separated by filtration as febuxostat crude.

Stage II:Febuxostat (crude) is dissolved in acetone and charcoalized. After filtration, acetone is distilled out and solid is filtered to give febuxostat. The process flow diagram is presented in Fig A-1 and material balance is presented in Table A-3.

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Shimoga Health Care Form I Annexure

Wastewater Water NaOH NaCl HCl IPA Water Fugitive (solvent) loss Stage ‐I IPA Ethyl‐2‐(3‐cyano‐4‐ isobutoxyphenyl)‐4‐methyl‐5‐ thiazolecarboxylate Organic residue IPA Unreacted Ethyl‐2‐(3‐cyano‐4‐ isobutoxyphenyl)‐4‐methyl‐5‐ thiazolecarboxylate Dissolved Febu crude Methanol Recovered Solvents IPA

Febuxostat Crude

Fugitive (solvent) loss Acetone Organic residue Stage‐II Acetone Acetone Dissolved Febuxostat Activated carbon Spent carbon/celite Recovered Solvents Celite Acetone

Febuxostat

Fig A-1 Process Flow Diagram of Febuxostat

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Shimoga Health Care Form I Annexure

Table A-3 Material Balance for Febuxostat Stage I Input Quantity Output Quantity Remarks (Kg/day) (Kg/day) Ethyl-2-(3-cyano-4- 25.8 Febuxostat Crude 21.8 To Stage-II isobutoxyphenyl)-4- methyl-5- thiazolecarboxylate Sdoium Hydroxide 2.8 Ethanol 3.2 To wastewater Con. Hydrochloric acid 2.5 Sodium Chloride 4 To wastewater Isopropyl Alcohol 100 IPA Recovered 96.5 Recovery & reuse (IPA) Water 390 IPA Loss 0.5 Fugitive Loss IPA to Wastewater 1.5 To wastewater IPA to Residue 1.5 Solvent in Residue Ethyl-2-(3-cyano-4- 2.1 Organic Residue isobutoxyphenyl)-4- methyl-5- thiazolecarboxylate Water 390 To wastewater Total Input 521.1 Total Output 521.1 Stage II Input Quantity Output Quantity Remarks (Kg/day) (Kg/day) Febuxostat Crude 21.8 Febuxostat 16.7 Final Product Acetone 110 Acetone Recovered 106 Recovery & reuse Activated Carbon 1 Acetone Loss 0.5 Fugitive Loss Celite 1 Acetone to Residue 3.5 Solvent in Residue Febuxostat Crude 5.1 Organic Residue Activated Carbon 1 Organic Residue Celite 1 Organic Residue Total Input 133.8 Total Output 133.8

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Shimoga Health Care Form I Annexure

ANNEXURE – II: Wastewater Treatment Facilities

The effluent generated from the proposed inclusion of Synthetic Organic Chemicals manufacturing unit is mainly from process, washings, and scrubbers, cooling towers & boiler blow downs and domestic effluent. HTDS effluent sent to Stripper, Multiple Effect Evaporator followed by ATFD, Biological treatment and RO. LTDS effluent from cooling towers and boiler bow downs shall be sent to Biological treatment system followed by RO. The treated effluent reused for cooling towers make-up. Domestic effluent sent to septic tank followed by soak pit. Total Effluent generated and mode of treatment permitted and proposed is presented in Table A-4. Quantity and quality of effluent generated from process after expansion is presented in Table A-5.

Table A-4 Quantity of Effluent Generated and Mode of Treatment Description Quantity Mode of Treatment (KLD) Phase I: Herbal Based Products Process 4 Sent to Forced Evaporation and condensate Blow downs/Washings 3 recycled. Domestic 8 Total – Pahse I 15

Phase II: Active Pharma Ingredients HTDS Effluents (TDS & COD> 15000 mg/l) Process 8.4 Sent to Stripper followed by MEE and ATFD. Washings 2 Stripper Condensate sent to Cement Plants for QC and R&D 0.5 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 make-up. Scrubber Effluent 1 Sent to MEE followed by AFTD, Biological DM rejects 2 treatment plant and RO. Total - I 13.9 LTDS Effluents (TDS & COD< 15000 mg/l) Boiler Blow downs 2 Sent to Biological Treatment System followed by Cooling Tower Blow downs 3 RO. RO permeate reused for cooling tower Domestic 4 makeup. RO rejects sent to MEE. Total - II 9 Grand Total (I+II) 22.9

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Shimoga Health Care Form I Annexure

Table A-5 Quantity and Quality of Effluent Generated from Process (Tentative) S.No Name of the Product Quantity (Kg/Day) Concentration (mg/l) Water TDS COD Total COD TDS Input Effluent 1 Armodafinil 585 29 0 622 0 47426 2 Candesartan 615 55 7 675 10381 81499 3 Clopidogrel 355 11 8 373 21064 30669 4 Duloxetine HCl. 2860 81 72 3006 23910 26975 5 Ezitimibe 310 4 12 322 36062 12404 6 Febuxostat 390 4 7 399 17050 10092 7 Fexofenadine 1501 36 22 1630 13218 22365 8 Rosuvastatin Calcium 500 2 3 506 6431 3980 9 Mesalamine 380 31 9 421 20454 72728 10 Phenylephrine HCl 2225 95 0 2301 0 41118 11 Repaglinide 95 3 5 102 51831 26663 12 Sertraline HCl 330 6 5 344 14969 17826 13 Sumatriptan Succinate 530 53 13 594 22681 89326 14 Tamsulosin HCl 235 12 12 255 45700 48332 15 Telmisartan 50 2 0 53 2837 38972 16 Terbutaline Sulphate 18 0 0 18 0 0 Total (Worst 4 Products) 7201 284 119 7646 15503 37113 17 R&D Products 750 15 10 773 12937 19405 Grand Total 7951 299 129 8419 28440 56517

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Shimoga Health Care Form I Annexure

ANNEXURE – III: Water Balance

Water is required for process, scrubbers, washing, cooling tower makeup, steam generation and domestic purposes. The total water requirement after inclusion of Active Pharma Ingredients shall be 84 KLD, out of which 63 KLD shall be fresh water and balance 21 KLD shall be recycled water. The required water shall be drawn from ground water/APIIC (Industrial supply) in addition to reuse of treated wastewater. The water balance is presented in Table A-6.

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Shimoga Health Care Form I Annexure

Table A-6 Total Water Balance (Tentative) Purpose INPUT (KLD) OUTPUT (KLD) Fresh Water Recycled Water Loss Effluent Permitted Proposed Permitted Proposed Permitted Proposed Permitted Proposed Process 30 8.0 4 8.4* Washings 2 2 Scrubber 1 1 Boiler 10 8 2 DM/RO Rejects 2 2 QC & R&D 0.5 0.5 Cooling Tower 3 21 21 3 3 Domestic 4.5 0.5 8 4 Gardening 2 2 Gross Total 30.0 33 0.0 21 31.5 15 22.9 Total 63 21 31.5 37.9 * Process effluents contain soluble raw materials, byproducts, solvents etc.

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Shimoga Health Care Form I Annexure

ANNEXURE – IV: Solid Waste

Solid wastes are generated from process, solvent distillation, effluent treatment system, DG sets and boilers. The stripper distillate, process residue and solvent residue are sent to cement plants for co-incineration based on acceptability. If these wastes are not suitable for co-incineration, the same is sent to TSDF facility. The evaporation salts are sent to TSDF. Filter media like activated carbon and catalyst are sent to TSDF. Waste oil and used batteries from the DG sets are sent to authorized recyclers. The sludge from effluent treatment plant is considered hazardous and the same is sent to TSDF. The 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. The total solid waste generated and mode of disposal permitted and proposed is presented in Table A-7 & A-8.

Table A-7 Solid Waste Details (Tentative) - Permitted S.No Description Units Quantity Mode of Disposal 1 Organic Residue TPD 0.218 Sent to TDSF/Cement Plants for Co-incineration 2 FE Salts Kg/day 50 Sent to TSDF

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Shimoga Health Care Form I Annexure

Table A-8 Solid Waste Details (Tentative) - Proposed S.No Description Units Quantity Mode of Disposal 1 Ash from Boiler TPD 6.2 Sold to Brick manufactures 2 Solvent residue TPD 0.28 Sent to TDSF/Cement Plants for Co-incineration 3 Process Organic TPD 0.25 Sent to TDSF/Cement Plants for residue Co-incineration 4 Process Inorganic Kg/day 8 Sent to TSDF residue 5 Carbon Kg/day 23 Sent to TDSF/Cement Plants for Co-incineration 6 Hyflow Kg/day 12 Sent to TSDF 7 Catalyst Kg/day 21 Sent to TSDF 8 Mixed Solvents KLD 0.3 Sent to authorized recovery units/ Cement plants for co- incineration 9 Spent Solvents KLD 3.2 Recovered within the plant premises. 10 Stripper Distillate KLD 0.1 Sent to Cement Industries for Co-incineration. 11 Evaporation salts TPD 0.3 Sent to TSDF 12 ETP Sludge TPD 0.07 Sent to TSDF 13 Detoxified containers No.s/Yr 300 Sold to authorized vendors 14 Waste oil LPM 35 Sent to Authorized Recyclers 15 Used batteries No.s/Yr 4 Sent to Authorized Recyclers

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Shimoga Health Care Form I Annexure

ANNEXURE – V: Stack Emissions Details

The sources of air emission expected from the plant are gaseous emissions from existing 2TPH and proposed 3 TPH Coal fired boilers with Multicone Separators as control equipment and DG set of 250 KVA proposed as standby during load shut down. DG sets shall be provided with stack height 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- 9.

Table A-9 Stack Emission Details S.No Stack Attached to Stack Dia of Temp.of Exit Pollutant Emission Rate Height stack exhaust Velocity (g/sec) 0 (m) at top (m) gases ( C) (m/sec) PM SO2 NOx Existing 1 2 TPH Coal Fired 20 0.3 160 7 0.03 0.12 0.02 Boilers Proposed 1 3 TPH Coal Fired 30 0.5 180 8.5 0.09 0.14 0.35 Boilers 2 *DG Set 250 KVA 4 0.15 170 7 0.002 0.07 0.08 *DG sets will be used during load shut down by APTRANSCO.

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Shimoga Health Care Form I Annexure

ANNEXURE – VI: Process Emissions Details

Table A-11 Quantity of Process Emission Generated (Tentative) Product Name Stage Type of Quantity Mode of treatment emission (Kg/Day) Clopidogrel I Carbon dioxide 1.50 Let into atmosphere II Carbon dioxide 1.39 Let into atmosphere Duloxetine HCl. II Carbondioxide 1.10 Let into atmosphere Ezitimibe I Hydrogen gas 0.04 Let into atmosphere Fexofenadine II Carbondioxide 9.64 Let into atmosphere III Hydrogen 1.10 Let into atmosphere Rosuvastatin Calcium III Hydrogen 0.00 Safely released into atmosphere Mesalamine II Hydrogen 0.18 Safely released in to atmosphere Phenylephrine HCl I Hydrogen 2.09 Let out into atmosphere safely Repaglinide I Carbon Dioxide 0.35 Safely released in to atmosphere Sumatriptan I Ammonia 1.38 To Scrubber Succinate Carbon Dioxide 3.57 Safely Released into atmosphere Telmisartan I Hydrogen 2.30 To Scrubber Bromide

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Phones :2546217 I 218 ZOhIALOFFICE Fax:0866 -2546217 PLOTNO.41, OPP: SBH" SRI KANAKADURGA OFFICERS' e-mail:[email protected] COLONY.GURUNANAK ROAD. VIJAYAWADA. ap pc bzovja@rediff rna i l.co rn

BY REGD. POST WITHACK DUE CONSENTORDER FOR ESTABI.ISHMENT OrderNo : G-509/PCB/ZO-VJAJCFEi2014-I l38 Date:c6.09.2014 - -, Sub:- . PCB CFE - M/s. Shinroga Healtl'rCare, Guntur district Consent for Establishmentof the Board under Sec. 25 of Water (Prevention& Controlof Pollution)Act, 1974 and underSec.21 of Air (Prevention& Controlof Pollution) Act, 1981- lssued- Reg. R.ef:. 1. Industry'sCFE applicationreceived at RegionalOffice, Guntur on 14.O7.2014 throughGM, DlC, Guntur. 2. Additionalfee receivedon 23.07.2014 3. RO'sinspection report received alZO, Vijayawadaon24.07.2014. 4. CFE Committeemeeting lreld on Q7.08.2014. 5. ZO Lr.dt. 16.08.2014. 6. CFE Committeemeeting held on 21.08.2014

l. In the reference1" cited,an applicationwas submittedto the Boardseeking Consent for Establishment(CFE) to producethe productswith installedcapacities as mentionedbelour, with a projectcost of Rs.3.65Crores. CalciunrCitrate - 170 KPD Calcium l-lydroNyGitrate - 100 KPD Aloe EmodlEt- 33 KPD ll. As per the application,the above activityis to be locatedat Sy.No.127116,Plot No. 12, Nadikudi(V), Dachepalli (M), Guntur District. lll. The above site was inspectedby the AssistantEnvironmental Engineer, Regional Office, A.P.PollutionControl Board, Guntur on 18.07.2014 and found that the siteis surroundedby East. Few houses West. InternalRoad North: Vacantland South. M/s.Sushaa Labs Habitation: MangalagiriVillage is at a distanceof 200 mts. lV. The Board,after careful scrutiny of the applicatlonand verificationreport of RegionalOfficer, herebyissues CONSENT FOR ESTABLISHMENTto your unit underSection 25 of Water (Prevention& Controlof Pollution)Act, 1974 and under Section21 of Air (Prevention& Controlof Pollution)Act, 1981 and the rules made there under.This order is issued to manufacturethe products as mentionedat para ('tlonly. V. This ConsentOrder now issuedis subiectto the conditionsmentioned in Schedule'A' & Schedule'B'. Vl. This Orderis issuedfrom pollutioncontrol point of view only.Zoning and otherregulations are not considered.

Encl:- Schedule'A' & Schedule'B'

To M/s.Shimoga HealthCare, C/o. Sri Ch. Srinivas Rao, Flat No. 101,Mahalakshmi Classic Apartment, MotiNagar,BSPGolony, Hyderabad- 500 018"

Copyto JCEE(CFE) (UH-ll), Head Office, APPCB, Hyderabad for information. Copyto JCEE(CESS) (UH-l), Head Office, APPCB, Hyderabad for information. Copyto JCEE(HWM) (UH-lll), APPCB, Hyderabad for information. Copyto the EE, RO,APPCB, Guntur for informationand necessaryaction. Page 1 of 5 SCHEDI.,!LE-A

1) Progress on implementationof the projectshall be reportedto the concernedRegional Office,A.P. PollutionControl Board once in six months.

2) Separate energy meters shall be providedfor Efiluent Treatment plant (ETp) and Air PollutionControl equipments to recorclenergy consumed.

3) The proponent shallobtain Consents for operation(CFo) fromAppCB, as requiredunder Section 25126 of the Water (P&C of P) Act, 1974 and under Section 21t22 of the Air (P&c of P) Act, 1981,before commencemeni of the activity. 4) Notwithstanding anythingcontained in this conditionalletter or consent,the Boardhereby reserves its right and power under Section 27(2) of Water (Prevention& Control of Pollution)Act, 1974 andunder Section 21@) of Air (Prevention& Controlof pollution)Act, 1981to review any or all the conditionsimposed herein and to make such alternationas deemedfit andstipulate any additionalconditions by the Board. 5) The Consentof the Boardshall be exhibitedin the factorypremises at a conspicuousplace for the informationof the inspectingofficers of differentdepartments.

6) Compensation paid is to be for any environmentaldamage caused by it, as fixed by the Collectorand DistrictMagistrate as civilliability.

7) Floorwashing shallbe admittedinto the effluentcollection system only and shallnot be allowedto find theirway in stormdrains or openareas. The industrysrrilt maintain a good housekeeping' pipe All valves, sewers,drains shall be Ieat

8) Rain Water. Harvesting(RWH) structure(s) shall be establishedon the plant site. - proponent The shallensure that effluentshall not enterthe RainWaler harvestingstructure. 9) The rules and regulationsnotified by Ministryof Lawand Justice,Gol, regardingthe public LiabilityInsurance At, 1991shall be followed.

10) If the proponent is aggrievedby this order made by A.P. pollutionControl Board under Sec. 25 of Water (Prevention& Control of Pollufion)Act' lgli ana Sec. 21 of Air (Prevention & Controlof Pollution)Act' 1981"he mayVithin 30 days from the date on receipt of the order prefer an appeal to AppellateAuthority locatej at H.No.6-1-69/211 Lakdi-ka-pool,Hyderabad -5OO 004.

11) This order is validfor a periodof FIVEyears from the date of issue.

SCHEDUI-E . B Water:

1) The source of water is bore well and the maximumpermitted water consumptionis 30.0KLD.

2) The Effluent TreatmentPlant (ETlr) shall be.constructedand commissionedalong with the commissioningof the activity. All the units of the ETP shall be impervioustJ prevent groundwater pollution.

3) The effluentsshall be treatedto the on land for irrigationstandards, stipulated under Environment(Protection) Rules, 1986, notified and puOtisfreOby Minisiryoi Environment and Forests,Government of India as specifiedin scheduleVl viOe C.S.n.42Z (i), dt.19'05.1993and its amendmentsthereof, and additionalstandards / conditionsstipulaied byAPPCB. 4) The maximumWaste Water Generation (KLD) shall rrot exceed the followinq:

st. Source WastewaterGeneration No. {KLD) a) Process 4.0 b) Coolinq/ Makeup& Washinqs 3.0 c) Domestic 8.0 Total 15.0

Effluent Source Standardsto be complied Mode of final disposal Trade effluents pH-5.5-9 0; TSS- 200mg/ltr.; Flced Evaporator and TDS-2100 mglltr.;BOD-"1 00 condensateto be recycled. mq/ltr.;Oil & Grease- 10mq/ltr Domestic Septictank followed by soakpit.

5) During transferof materials,spillages shall be avoided and garland drains shall be constructedto avoidmixing of accidentalspillages with domestic waste and stormdrains. 6) Separatemeters with necessarypipe-line shall be providedfor assessingthe quantityof waterused for eachof the purposesmentioned below. a) lndustrialcooling, spraying in rninepits or boilerfeed. b) Domesticpurposes. c) Processing,whereby water gets polluted and pollutantsare easilybio-degradable. d) Processing,whereby water gets pollutedand the pollutantsare not easily bio- degradable. 7) The industryshall provide magnetic flow meterswith totaliserswith recordingfacility at inlet of settlingtank and at intake point to processseparately for auto recordingof effluents generatedand reused. Air:

8) The proponentshall cbmply with the followingfor controllingair pollution.

st. Source Capacity Control Equipment No. a) Boiler 2 TPH Cyclonefollowed by bagfilters or any othersuitable air pollutioncontrol equipment such that the stack emissionsconforms to the followinglimit, SPM- 11Smg/Nm3. Stackheight - 30 mts. b) Processemissions Scrubber

9) A samplingport with removabledummy of not lessthan 15 cm diametershall be provided in the stack at a distanceof 8 times the diameterof the stack from the nearestconstraint such as bends etc. A platformwith suitableladder shall be providedbelow 1 meterof samplingport to accommodatethree personswith instruments.A 15 AMP 250 V plug pointshall be providedon the platform. 10) The industryshall provide interlocking system between the processand scrubbersso that the feeding of raw materialwould be automaticallystopped whenever the scrubbing system fails to work or the conceirtrationfluorine levels from the stack exceeds the prescribedstandard. 11) The industryshall providethe monitoringsystem to all the stacks/ vents in the plant. Regularmonitoring shall be carriedout and reportshall be submittedto the Regional Officer. 12) The industryshall controlfugitive emissions by providingclosed room operations. prone tJ/ Fugitiveemissions from raw materialscrushing, grinding and other air pollution areas shall be containedat source ancl housed completely.Dust extractionsystem connectedto bag filtersand scrubbersshall be providedto complywith the prescribed emissionsstandards. 14) The industryshall not causeodour nuisance in the surroundings. 15) The generatorshall be installedin a closed area with a silencerand spitablenoise absorptionsystems. The ambientnoise level shall not exceed75 dB(A)during day time and 70 dB(A)during night time. 16) The industryshall not exceedthe followingAmbient Air Qualitystandards measured at the peripheryof the industry: - - Soz - BO;,rg/m3, No* - 80 prg/m3,PMr. 60 prg/m3,PMro 100prg/m3, Noiselevels : Daytime (6 AM to 10 PM) - 75 dB(A) Nighttime (10 FM to 6 AM) - 70 dB(A) 17) The Air Pollutioncontrol equipment shall be installedalong with the commissioningof the activity.

Solic!Waste:

18) The proponentshall comply with the following

sx. Solid Waste Quantity Methodof Disposal No. qeneratedfrom {Kq/dav) 1. Organic 0.218TPD Proposedto disposeto outsideparties or can be usedas fuelto the boiler. 2. FE Salts s0 (gs/dry_ TSDF,Dindigal.

1g) The proponentshall place the chemicalclrums and / any drumsin the concreteplatform only. The Platformshall be providedwith sufficientdyke wall and effluentconnection system. 20) Container& Containerliners shall be cletoxifiedat the specifiedcovered platform with dyke wallsand the washwaste water shall be routedto effluentcollection tank. 21) The followingrules and regulationsnotified by the MOE&F,GOI shallbe implemented. a) HazardousWaste (Management,Handling & TransboundaryMovement) Rules, 2008 and itsAmendments thereof. b) Manufacture,Storage and lmportof HazardousChemicals Rules, 1989. c) Rules for manufacture,use, import, export and storage of Hazardousmicro- organisms/ genetically engineered organisms or cells,1989. d) Batteries(Management 8. Handling) Rules,2010- e) E-Waste(Managemenf B. Handling) Rules,2012-

Other Conditions:

22) Greenbelt shallbe developedall alongthe boundaryof the industryto maintain33 % of total project area. Green belt developmerrtshall be started along with the construction activity. 23) Systemof leak detectionand repairof pump/ pipelineshall be installedin the plantand immediateresponse team shall be identifiedfor preventivemaintenance. 24) The proponentshall ensure that thereshall not be any changein the processtechnology, source& compositionof raw materialsand scopeof workingwithout prior approval from the Board. 25) The proponentshall comply with all the direciionsissued by the Boardfrom time to time' 26) Concealingthe factualdata or submissionof false information/ fabricateddata and failure to complywith any of the conditionsmentioned in thisorder may resultin withdrawalof this orderand attractaction under the provisionsof relevantpollution controlAcls. 27) The Board reserves its right to modify above conditionsor stipulate qny additional conditionsincluding revocation of this order in the interestof environmentprotection. 28) The order is issued without prejudiceto the righis and contentionsof this Board in any courtof law.

To M/s.Shimoga HealthCare, C/o. Sri Gh. Srinivas Rao, Flat No. 101,Mahalakshmi Glassic,Apartn'rent, %" MotiNagar,BSPColony, Hyderabad- 500 018. SHIMOGA HEALTH CARE PLOT NO. 12, PHASE II, NADIKUDI INDUSTRIAL PARK, DACHEPALLE MANDAL, GUNTUR DISTRICT, ANDHRA PRADESH

STUDIES AND DOCUMENTATION BY TEAM Labs and Consultants QCI: MoE&F OM, List A‐1, S.No.25. (An ISO 9001:2008, ISO 14001:2004 & OHSAS 18001:2007 Certified Organization) B‐115, Annapurna Block, Aditya Enclave Ameerpet, Hyderabad‐500 038. Phone: 040‐23748 555/616, Telefax: 040‐23748666 Email: [email protected]