FORM 1 (Amended) APPENDIX I (See paragraph – 6) (I) Basic Information S.No Item Details

1. Name of the Project M/S. MICRO LABS LIMITED, API Division, ML-15, Plot.No.43-45, KIADB Industrial Area, Bommasandra-Jigani Link Road, Phase-IV, Anekal Taluk, 560105.

“Change In Product Mix And Enhancement Of Plant Facilities” 2. S. No. in the Schedule 5(f)

3. Proposed Existing Capacity: 36445 Kg/A Capacity/area/length/tonnage to be Proposed Capacity: No Change. handled/command area/lease Total Nos of AIPs: 93. area/number of wells to be drilled. However there are changes in product mix as per the details given in Annexure 1.

4. New/Expansion/Modernization Same facility with additional block will be constructed.

5. Existing capacity/Area etc Existing Nos of APIs: 65. Existing Capacity: 36445 Kg/A. Details given in Annexure 1.

6. Category of Project i.e. ‘A’ or ‘B’ Though the project site is located in KIADB industrial area, as per the MoEF&CC Notification No. S.O.804 (E) 14th March, 2017 it has been Categorized as ‘A’ and Schedule 5(f).

7. Does it attract the general No. condition? If yes please specify.

8. Does it attract the specific Yes condition? If yes please specify. The site is located in Jigani, Bommasandra Industrial Area of KIADB

9. Location M/S. MICRO LABS LIMITED, API Division ML-15, Plot.No. 43, 44 & 45. KIADB Industrial Area, Bommasandra-Jigani Link Road, Phase-IV, Anekal Taluk, Bangalore 560105

Plot/survey/khasra No. 43, 44 & 45

Village Bommasandra

Tehsil Anekal

District Bangalore

State

10. Nearest Railway station/Airport Railway Station: along with the distance in Kms. Heelalige: 6.7 Kms Anekal Road: 9. 00 Kms Airport : Bangalore Airport: 46 Kms

11. Nearest town, city, District Head Town: Anekal -8.9 Kms quarters along with distance in kms. City: Bangalore- 21.5 Kms

12. Village Panchayats, Zilla Parishad, M/S. MICRO LABS LIMITED, Municipal Corporation, Local Body API Division, ML-15, (complete postal addresses with Bommasandra Gram Panchayat, phone nos. to be given) Anekal Taluk, Bommasandra Industrial Area, Bangalore – 560105, Karnataka. Phone : 08110-415647/48

13. Name of the applicant Mr. N. B. Shenoy, Vice President (T & O)

14. Registered Address M/S. MICRO LABS LIMITED, #No. 27, Race Course Road, Bangalore- 560 001

15. Address for Correspondence M/S. MICRO LABS LIMITED, API Division, ML-15. Plot.No.43-45, KIADB Industrial Area, Bommasandra-Jigani Link Road, Phase-IV,Anekal Taluk, Bangalore 560105, Karnataka.

Name Mr. N. B. Shenoy

Designation (Owner/Partner/CEO) Vice President (T & O)

Address M/S. MICRO LABS LIMITED, API Division (ML15). Plot No. 43-45, KIADB Industrial Area, Bommasandra,Jigani Link Road, Phase-IV,Anekal Taluk, Bangalore-560105, Karnataka.

Pin Code Bangalore- 560 105

E – mail [email protected], [email protected]

Telephone No. Tel: 08110-415647/48 N. B. Shenoy- 09449851251. S. S.Yadav- 09663202181.

16. Details of Alternative sites Modification in existing facilities. examined, if any. Location of these sites should be shown on a toposheet.

17. Interlinked Projects No

18. Whether separate application of Not Applicable interlinked project has been submitted. 19. If yes, date of submission Not Applicable

20. If no, reason Not Applicable

21. Whether the proposal involves Not Applicable 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 forest land is involved.

24. Whether there is any litigation No pending 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. 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. Information / Checklist Yes/ Details thereof (with approximate quantities/ rates, wherever No confirmation No possible) with source of information data 1.1 Permanent or temporary No Existing. change in land use, land The present land use in KIABD industrial area. cover or topography Land possession certificate is attached as Annexure 2. including increase in intensity of landuse (with respect to local landuse plan)

1.2 Clearance of existing land, No NA Site is in KIABD industrial area vegetation and buildings?

1.3 Creation of new land No NA Site is in KIABD industrial area uses? 1.4 Pre-construction No NA investigations e.g. bore houses, soil testing?

1.5 Construction works? Yes Modification in existing production block.

Construction Blocks: Modification to connect Production Block A to form Production Block-D, which will have two (G+Maz+1) floors. Proposed Production Block built-up Area is 810 Sq.m. 1.6 Demolition works? No Some demolition work will be involved. Appropriate approval from local authority will be obtained.

1.7 Temporary sites used for No The local labors will be utilized for the construction purpose. construction works or housing of construction workers? S. Information / Checklist Yes/ Details thereof (with approximate quantities/ rates, wherever No confirmation No possible) with source of information data 1.8 Above ground buildings, Yes Above ground works as below will be implemented: structures or earthworks Construction Blocks: including linear structures, Modification to connect Production Block A to form Production cut and fill or excavations Block-D, which will have two (G+Maz+1) floors. Proposed Production Block built-up Area is 810 Sq.m.

1.9 Underground works No Not Applicable. including mining or tunneling?

1.1 Reclamation works? No Not Applicable 0 1.1 Dredging? No Not Applicable 1

1.1 Offshore structures? No Not Applicable 2

1.1 Production and Yes There will be production of APIs. The process description is 3 manufacturing processes? enclosed in Annexure 3.

1.1 Facilities for storage of Yes Storage facilities:

4 goods or materials? S.No Description Capacity

Existing Proposed Total

1. Solvent Yard Capacity 180 KL 60 KL 240 KL

2. Powder storage 33600 kg - 33600 kg (Solid Storage WA)

3. Haz Storage Room 5280 kg - 5280 kg

4. Primary Packing Storage 1800 kg - 1800 kg

5. Secondary Packing Storage 3200 kg - 3200 kg

6. Drum Yard Storgae Capacity 88880 kg - 88880 kg

7. API Storage capacity 1800 kg - 1800 kg S. Information / Checklist Yes/ Details thereof (with approximate quantities/ rates, wherever No confirmation No possible) with source of information data

1.1 Facilities for treatment or Yes a. Solid Waste: 5 disposal of solid waste or Operation phase liquid effluents? Type Kg/day Disposal method Organic Municipal bin (including food 115.2 (Food waste to waste) cattle feed) KSPCB authorized Inorganic 124.8 recyclers Total 240 for total 480 Employees Hazardous waste Hazardous waste materials are properly disposed as per the Hazardous waste management rule2008 and amendment in 2008. Agreement between Ramky Enviro Engineer Limited and Micro Labs for collection, transport, storage, treatment and disposal is enclosed as Annexure 4. Agreement with Gomti Incinco for Incineration is given in Annexure 5.

Hazardous Quantity Waste Method of waste Category handling Generated Existing Proposed Total Collected in leak proof containers and 1.5 1 2.5 disposed only 5.1 Used Oil KL/A KL/A KL/A to KSPCB registered Authorized re- processor

0.1 0.9 1 Stored in Oil soaked 5.2 MT/A MT/A MT/A secure manner cotton waste and handed over to Pharmaceutical 05 05 10 KSPCB residues 28.1 MT/A MT/A MT/A Authorized (Process incinerator. residues) Stored in secure manner and handed 7.2 2.8 10 over to MT/A MT/A MT/A 28.2 Spent Catalyst KSPCB Authorized TSDF 06 15 21 Stored in 28.6 Spent solvent MT/A MT/A MT/A secure manner and handed over to 5000 5000 Discarded KSPCB 33.1 Nos/A - Nos/A containers Authorized recycler Stored in secure manner and handed 100 100 Sludge from - over to 35.3 MTA MTA ETP & MEE KSPCB Authorized TSDF S. Information / Checklist Yes/ Details thereof (with approximate quantities/ rates, wherever No confirmation No possible) with source of information data KSPCB authorization for Existing facilities TSDF Annexure 6.

b. Liquid waste management

Sewage and effluent generated from process and washings are taken to combined Effluent and sewage Treatment Plant and two stages RO and Multiple Effect Evaporator of 36 KLD capacity. The treated waste water of 25 KLD will be reused for Boiler and Chiller. Zero liquid discharge system will be maintained.

ETP/MEE sludge will disposed to M/s Ramky Enviro Engineers Ltd.

Schematic of ETP cum Reverse Osmosis Plant, Annexure 7 1.1 Facilities for long term No Local labors will be utilized. Hence no housing facilities are required for the workers. 6 housing of operational worker

1.1 New road, rail or sea No The existing Bommasandra-Jigani link road will be utilized. 7 traffic during construction or operation?

1.1 New road, rail, air The existing Bommasandra-Jigani link road will be utilized. 8 waterborne or other transport infrastructure No including new or altered routes and stations, ports, airports etc?

1.1 Closure or diversion of 9 existing transport routes or infrastructure leading to No Not applicable changes in traffic movements? S. Information / Checklist Yes/ Details thereof (with approximate quantities/ rates, wherever No confirmation No possible) with source of information data 1.2 New or diverted 0 transmission lines or No Not applicable pipelines? 1.2 Impoundment, damming, 1 culverting, realignment or other changes to the No Not applicable hydrology of watercourses or aquifers

1.2 Stream crossings? No Not applicable 2 1.2 Abstraction or transfers of No Not applicable. 3 water form ground or Water will be procured from Tanker. surface waters? An agreement is made with Ragavendra water supply, Annexure 8.

1.2 Changes in water bodies 4 or the land surface No Not applicable affecting drainage or runoff?

1.2 Transport of personnel or Yes The existing roadways/facilities will be used for the transport of materials and personnel. 5 materials for construction, operation or Through public transports only. decommissioning?

1.2 Long-term dismantling or 6 decommissioning or No Not applicable restoration works? 1.2 Ongoing activity during 7 decommissioning which No Not applicable could have an impact on the environment? S. Information / Checklist Yes/ Details thereof (with approximate quantities/ rates, wherever No confirmation No possible) with source of information data 1.2 Influx of people to an

8 area in either temporarily Yes Operation phase: or permanently? Permanent Contractual Total Existing 300 Nos 120 Nos 420 Nos Proposed 50 Nos 10 Nos 60 Nos Total 350 130 480 Nos

Construction Phase: 50 Nos temporarily 1.2 Introduction of alien No Not envisaged 9 species?

1.3 Loss of native species or No Not envisaged 0 genetic diversity?

1.3 Any other actions? No - 1

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. Information / Checklist Yes/ Details thereof (with approximate quantities/ rates, No. confirmation No wherever possible) with source of information data 2.1 Land especially undeveloped or No The land is earmarked for Industrial use. agricultural land (ha) S. Information / Checklist Yes/ Details thereof (with approximate quantities/ rates, No. confirmation No wherever possible) with source of information data 2.2 Water (expected source & Yes The total water requirement will be 98KLD. competing users) unit: KLD Requirement Existing Proposed Total (KLD) (KLD) (KLD) Process 18 00 18 Washing 08 00 08 Boiler Feed 24 00 24 Cooling 20 05 25 Tower Domestic 05 010 15 Others 03 05 08 Total 78 20 98 Required water will be sourced from tankers. An agreement is made with M/s Raghavendra Water Supply and the same is attached in Annexure 8.

Minerals (MT) No Not applicable

2.4 Construction material-stone, Yes Construction Blocks: aggregates, sand/ soil (expected Modification to connect Production Block-A and source-MT) Production Block-B to form Production Block-C which will have two (G+3) floors, etc. Construction Materials: S. No Description Qty 1. Cements 4000 bags 2. Sand 22500 CFT 3. Cement Block 10000 Nos 4. Steel 200 T 5. RMC 700 M3 6. Jelly 15000 CFT

2.5 Forests and timber (source–MT) No Doors used will be flush doors or paned doors/laminated timbers. Aluminum frame windows will be used. S. Information / Checklist Yes/ Details thereof (with approximate quantities/ rates, No. confirmation No wherever possible) with source of information data 2.6 Energy including electricity and Yes Power requirement. fuels (source, competing users) Details Capacity (KVA) Source Unit: fuel (MT), energy (MW) Existing Proposed Total Power 1300 400 1700 BESCOM Requirement Power Back 750x3= DG Sets 750x2 750x1 2250 Up

Fuel Oil 2 2 HPCL & Nil KLD. KLD IOL.

2.7 Any other natural resources (use No Not applicable appropriate standard units) 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. Details thereof (with approximate S. Information / Checklist Yes/ quantities/rates, wherever possible) with source No. confirmation No of information data 3.1 Use of substances or materials, Yes This is a Pharmaceutical Ingredients (API) which are hazardous (as per MSIHC manufacturing process and solvents will be used in rules) to human health or the the process. A separate storage facility is provided environment (flora, fauna, and water for the storage of solvents and Raw materials. supplies) Materials will be handled as per MSDS guidelines. MSDS of some of the new APIs’ and their Raw Materials are given as Annexure. (Raw materials MSDS, Annexure 9 and APIs MSDS, Annexure 10).

3.2 Changes in occurrence of disease or No Not such impacts are envisaged. affect disease vectors (e.g. insect or water borne diseases) 3.3 Affect the welfare of people e.g. by No Systems are already in place. changing living conditions? Employment generation for local people.

3.4 Vulnerable groups of people who NA could be affected by the project No e.g. hospital patients, children, the elderly etc.,

3.5 Any other cause No Not applicable. 4. Production of solid wastes during construction or operation or decommissioning (MT/month) Information / S. Yes/ Details thereof (with approximate quantities/rates, wherever Checklist No. No possible) with source of information data confirmation 4.1 Spoil, overburden or No Not applicable. mine wastes

4.2 Municipal waste Yes Type Kg/day Disposal method (domestic and or Organic (including Municipal bin (Food 115.2 food waste) waste to cattle feed) commercial wastes) KSPCB authorized Inorganic 124.8 recyclers Total 240 Information / S. Yes/ Details thereof (with approximate quantities/rates, wherever Checklist No. No possible) with source of information data confirmation 4.3 Hazardous wastes (as Yes Hazardous Waste Hazardous waste will be properly disposed as per the Hazardous waste per Hazardous Waste Management rule 2008 and amendment in 2016. Management Rules) Hazardous Quantity Waste Method of waste Category handling Generated Existing Proposed Total Collected in leak proof containers and 1.5 1 2.5 disposed only 5.1 Used Oil KL/A KL/A KL/A to KSPCB registered Authorized re- processor

0.1 0.9 1 Stored in Oil soaked 5.2 MT/A MT/A MT/A secure manner cotton waste and handed over to Pharmaceutical 05 05 10 KSPCB residues 28.1 MT/A MT/A MT/A Authorized (Process incinerator. residues) Stored in secure manner and handed 7.2 2.8 10 over to MT/A MT/A MT/A 28.2 Spent Catalyst KSPCB Authorized TSDF 06 15 21 Stored in 28.6 Spent solvent MT/A MT/A MT/A secure manner and handed over to 5000 5000 Discarded KSPCB 33.1 Nos/A - Nos/A containers Authorized recycler Stored in secure manner and handed 100 100 Sludge from - over to 35.3 MTA MTA ETP & MEE KSPCB Authorized TSDF

KSPCB authorization of TSDF Annexure 6 4.4 Other industrial No Not applicable process wastes

4.5 Surplus product No Not applicable Information / S. Yes/ Details thereof (with approximate quantities/rates, wherever Checklist No. No possible) with source of information data confirmation 4.6 Sewage sludge or Yes ETP Sludge Generation from CETP. other sludge from Existing 100 MTA effluent treatment Proposed - Total 100 MTA

Agreement between Ramky Enviro Engineer Limited and Micro Labs for collection, transport, storage, treatment and disposal is enclosed as Annexure 4. Agreement with Gomti Incinco for Incinneration is given in Annexure 5.

4.7 Construction or Yes Garbage waste to Landfill. demolition wastes Steel waste to scrap dealer. Cement bags to scrap dealer.

4.8 Redundant machinery Construction machinery will be taken back by the contractor. or equipment Yes Any redundant items during operation will be periodically sold as per the norms to the approved vendors. 4.9 Contaminated soils or Yes Construction waste and cement contaminated soil will be used for other materials land fill-up.

4.10 Agricultural wastes No Not applicable.

4.11 Other solid waste No Not applicable. 5. Release of pollutants or any hazardous, toxic or noxious substances to air (Kg/hr) S. Information / Checklist Yes/ Details thereof (with approximate quantities/rates, No. confirmation No wherever possible) with source of information data

5.1 Emissions from Yes Construction Phase: combustion of fossil fuels Movement from construction vehicles like lorries, Trucks, from stationary or mobile Dumpers, Roller, Excavator and HVM etc will result in air sources pollution. All vehicles need to be used will have PUC certificate. Operation Phase: The movement of the vehicle around the project site also increases the emission load. DG sets are attached to the building, adequate DG stack height above GL will be provided for safe emission of the flue gases

5.2 Emissions from production Yes All the reactors have condensers to condense the solvent vapors. processes The reactor vents are connected to the scrubber to neutralize the toxic vapors. 6 Nos. of scrubbers have been provided with FRP/ water circulation type having neutralizing agents. The same will be followed for additional reactors. Existing Proposed Total 06 Nos 01Nos 07 Nos

5.3 Emissions from materials Yes Construction-Modification Phase: handling including storage This will be restricted to the construction phase and or transport construction site only. However, the generation of such emission will be very minimum. Operation Phase: Transportation of materials will be through closed system, drums and through pipelines. S. Information / Checklist Yes/ Details thereof (with approximate quantities/rates, No. confirmation No wherever possible) with source of information data 5.4 Emissions from construction Yes During construction, the dust is minimized by sprinkling of water and also proper storage. activities including plant and equipment

5.5 Dust or odours from handling Yes The dust is minimized by water sprinkling. of materials including Odours will be controlled by closed environment. construction materials, sewage and waste

5.6 Emissions from incineration No No incineration activity is involved of waste

5.7 Emissions from burning of No No burning activity is involved waste in open air (e.g. slash materials, construction debris)

5.8 Emissions from any other Yes Emission from Chimney. sources  Boiler 1 No. Attached to Boiler chimney, height 30mtr.  DG 2 Nos. Attached to DG chimney, height 20mtr. (Proposed 1*750KVA DG) 6. Generation of Noise and Vibration, and Emissions of Light and Heat: Details thereof (with approximate S. Information / Checklist Yes/ quantities/rates, wherever possible) with source of No. confirmation No information data 6.1 From operation of equipment e.g. Yes The machineries which will be used for the engines, ventilation plant, crushers construction phase will be of highest standard. Hence insignificance impact due to construction machineries is envisaged.

The DG sets will be in operation only during power failure/Preventive maintenance of Existing DG. Moreover, the DG rooms will be acoustically enclosed.

For ventilation plant, thermopack (duck insulation) will be provided for reducing the noise levels.

Noise levels of existing site is monitored on regular basis and is less than 75 dB. 6.2 From industrial or similar processes Yes Noise generation at source will be complied by keeping the noise within the prescribed limits.

6.3 From construction or demolition Yes Will be controlled with proper maintenance of equipments. 6.4 From blasting or piling No NA

6.5 From construction or operational Yes Will be controlled through proper maintenance of traffic equipments / vehicles.

6.6 From lighting or cooling systems No Negligible. Lead LIGHTs have been provided/ proposed 6.7 From any other sources No NA 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:

Details thereof (with approximate S. Information/ Checklist Yes/ quantities/rates, wherever possible) with source No. confirmation No of information data 7.1 From handling, storage, use or No Storage, handling and spillages of hazardous spillage of hazardous materials material is taken care by following the written procedures (SOPs) and waste disposal is made according to local standards.

Proper storage facilities will be provided to prevent the risk of contamination.

7.2 From discharge of sewage or other No Sewage is mixed with effluent with and the same is effluents to water or the land treated in Common Effluent treatment Plant. (expected mode and place of The treated water from CETP is used for utilities, discharge) Boiler and gardening 7.3 By deposition of pollutants No Gaseous emission is scrubbed and stack emissions emitted to air into the land or into are test performed accordingly / planned. water

7.4 From any other sources No Not applicable.

7.5 Is there a risk of long term build up of pollutants in the No Not applicable. environment from these sources? 8. Risk of accidents during construction or operation of the Project, which could affect human health or the environment S. Information / Checklist Details thereof (with approximate quantities/rates, No Yes/ No confirmation wherever possible) with source of information data . 8.1 From explosions, spillages, fires No Hazardous substances like solvents will be used in etc from storage, handling, use operational phase. or production of hazardous Proper handling procedures will be followed as substances. recommended in the MSDS for the solvents and any hazardous materials.

8.2 From any other causes No Not applicable.

8.3 Could the project be affected by No The project site falls under seismic zone-II according natural disasters causing to the Indian Standard Seismic Zoning Map. Further it environmental damage (e.g. is not flood prone or landslide prone area. Hence, no floods, earthquakes, landslides, risk due to natural hazards is envisaged. However cloudburst etc)? suitable seismic coefficients in horizontal and vertical directions will be adopted while designing the structures. 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.

Sr. Information/Checklist Yes/No Details thereof (with approximate No. Confirmation quantities/ rates, wherever possible) with source of information data 9.1 Lead to development of supporting. No The facility is located in KIADB approved industrial area. Facilities, ancillary development or development stimulated by the Since the unit is an Active Pharmaceutical project which could have impact on Ingredients manufacturing unit inside the environment e.g.: KIADB area, no housing development is • Supporting infrastructure (roads, proposed. power supply, waste or waste water treatment, etc.) Not applicable (for Extractive industries, • Housing development Supply industries& others) • Extractive industries • Supply industries • Other 9.2 Lead to after use of the site, which Not applicable could have an impact on the No environment 9.3 Set a precedent for later No Not applicable developments 9.4 Have cumulative effects due to No Not applicable proximity to other existing or planned projects with similar effects III. Environmental Sensitivity

Sr. Areas Name / Aerial distance (with 15-km) Proposed project No. Identity location boundary 1 Areas protected under Bannarghatta 8.57 Km international National Park conventions, national or local legislation for their ecological, landscape, cultural or other related value 2 Areas which are (a) 8.57 Km important or sensitive Bannarghatta of ecological reasons – National Park wetlands, water (b)Haragade 3.24 Km courses or other water Lake bodies, coastal zone, (c) 5.82 Km biospheres, mountains, Kammasandra forests lake 3 Areas used by Bannarghatta 8.57 Km protected, important or National Park sensitive species of flora or fauna for breeding, nesting, foraging, resting, over wintering, migration 4 Inland, coastal, marine No Nil or underground waters 5 State, national Tamil Nadu 11.5 Km boundaries State Boundary Routes or facilities No NA used by the public for 6 access to recreation or other tourist, pilgrim Sr. Areas Name / Aerial distance (with 15-km) Proposed project No. Identity location boundary areas

7 Defense installations No NA 8 Densely populated or (a) 5.66 Km built-up area Bommasandra village (b) 6.55 Km Doddathoguru (c) Electronic 5.95 Km City Sr. Areas Name / Aerial distance (with 15-km) Proposed project No. Identity location boundary 9 Areas occupied by Yes 10 km radius infrastructures: sensitive man made S.No Name Distance Dirn (Km) land uses (hospitals, Schools & Colleges 1. BTL High School 4.63 NE schools, places of 2. Treamis World School 3.06 N 3. worship, community Royal Public School 5.83 NE 4. BTL Institute of Tech and 4.91 NE facilities) Management 5. Condor International school 4.32 NW 6. Christ Academy ICSE school 5.38 NW 7. Nidyananda High school and college 2.37 W 8. Tapovan High School 4.11 W 9. Virindha Educational Academy 5.89 W 10. Film Academy 5.90 W 11. T. Johan College 9.34 NW 12. Sherwood High School 9.56 NW Religious Places 1. Jigani Masjid 2.25 W 2. Sri Channa Keshava Temple 7.64 SE Hospital 1. Narayana Hrudyala 5.07 NE 2. Sparsh Hospital 5.33 NE 5. Srinidhi Hopital 5.65 E Sensitive area

1. Bhannergatta National Park 8.57 W 2. Haragade Lake 3.24 S 3. Kammasandra lake 5.82 NE

S.No Name Distance Dirn (Km) Lakes 1. Yelenahalli kere 9.63 NW 2. Doddkammanahalli Lake 9.14 NW 3. Chikka Togur lake 7.52 N 4. Veerasandra lake 5.89 NE 5. Hebbagodi lake 5.20 NE 6. Kammasandra lake 5.82 NE 7. Rayasandra lake 9.30 N 8. Muthanallur lake 8.83 NE 9. Haragade Lake 3.24 S

10 Areas containing Tourism- important, high quality Bannerghatta 8.57 Km or scarce resources National Park Sr. Areas Name / Aerial distance (with 15-km) Proposed project No. Identity location boundary (ground water resource, surface resources, forestry, agriculture, fisheries, tourism, minerals) 11 Areas already Nil No Notified/Recognized polluted area within 15km subjected to pollution distance. or environmental damage. (those where existing legal environmental standards are exceeded) 12 Areas susceptible to No This area is generally plain not prone to any natural natural hazard which disasters. The project site falls under seismic zone- could cause the project II according to the Indian Standard Seismic Zoning to present Map. Further it is not flood prone or landslide environmental prone area. Hence, no risk due to natural hazards is problems envisaged. However suitable seismic coefficients in (earthquakes, horizontal and vertical directions will be adopted subsidence, landslides, while designing the structures. erosion, flooding or extreme or adverse climatic conditions) Proposed Terms of Reference

Sr. Proposed Terms of Reference No. 1. A recent satellite imagery of the project area and its surroundings 2. Topoplan and layout drawing of the project site. 3. Location of National Park/Wild life sanctuary/ Reserve Forest within 10 km radius of the project. 4. Present land use and cropping pattern based on satellite imagery for the study area of 10 km radius. Location of National Park/Wild life sanctuary /Reserve Forests within 10 km radius of the project. 5. Rain water Harvesting details 6. Process Description along with Process Flow Diagram and material balance. 7. Details of water consumption and source of water supply, waste water generation, treatment and effluent disposal with water Balance. 8. Water Conservation measures proposed 9. Power requirement & power back up 10. Detailed solid & Hazardous waste generation, collection, segregation, its recycling and reuse, treatment and disposal. 11. Fire fighting facilities 12. Total cost of the project along with total capital cost and recurring cost/annum for environmental pollution control measures. 13. Site-specific micro-meteorological data for temperature, relative humidity, hourly wind speed and direction and rainfall for one season at one location. 14. Ambient air quality monitoring at 6 locations within 10 Km radius of study area for PM10, SO2, NOx, CO, HC, VOC for one season (Non Monsoon) taking into account the pre-dominant wind direction, population zone and sensitive receptors. 15. Assessment of ground level concentration of pollutants. Air quality modelling for proposed project. 16. Water quality monitoring including surface & ground water at 8 locationswithin 10 Km radius of study area for one season (Non Monsoon). 17. Soil sample analysis at 8 locations within the study area for one season (Non Monsoon). 18. Noise Monitoring within 8 locations the study area for one season (Non Monsoon) 19. Demography & socio-economics of the study area. 20. Ecological features (terristrial & Aquatic) of the study area for one season (Non Monsson) 21. Assessment of impact on air, water, soil, solid /hazardous waste and noise levels. Sr. Proposed Terms of Reference No. Air pollution control measures proposed for the effective control of gaseous emissions 23. within permissible limits. Risk assessment including Hazard identification, Consequence Analysis, Risk 24. Assessment and preparation of Disaster Management Plan for storage of solvents. Details of proposed Occupational Health Surveillance program for the employees and 25. other labour Detailed Environment management Plan (EMP) with specific reference to Energy conservation and natural resource conservation, details of air pollution control system, 26. water & wastewater management, monitoring frequency, responsibility and time bound implementation plan for mitigation measure and cost towards environmental protection measures.

Page 28 of 29 DECLARATION

I hereby given undertaking that the data and the information given in the application and enclosures are true to the best of my knowledge and belief and I am aware that if any part of the data and information submitted is found to be false or misleading at any stage, the project will be rejected and clearance give, if any to the project will be revoked at our risk and cost.

Date: Place:

Signature of the applicant With Name and full address (Project proponent / Authorized signatory)

Page 29 of 29 PREFEASIBILITY REPORT

FOR CHANGE IN PRODUCT MIX AND ENHANCEMENT OF PLANT FACILITIES

BY

Micro Labs Ltd (API Division)

ML-15

AT

VILLAGE: BOMMASANDRA

TEHSIL: ANEKAL

DISTRICT: BANGALORE

STATE: KARNATAKA

Prepared by

HUBERT ENVIRO CARE SYSTEMS PRIVATE LIMITED

September 2017 Prefeasibility Report

Table of Contents 1. EXECUTIVE SUMMARY ...... 1 2. INTRODUCTION OF THE PROJECT ...... 3 2.1 Identification of the Project and Project Proponent...... 3 2.2 Brief Description of nature of the Project...... 3 2.3 Need for the Project and its importance...... 3 2.4 Demand – Supply Gap...... 4 2.5 Import vs. indigenous Production...... 4 2.6 Export possibility...... 4 2.7 Domestic/ Export Markets...... 4 2.8 Employment Generation due to the Project...... 4 3. PROJECT DESCRIPTION ...... 5 3.1 Type of the Project...... 5 3.2 Project Location...... 5 3.3 Details of Alternate sites considered ...... 11 3.4 Magnitude of Operation...... 12 3.5 Project Description ...... 16 Process description: Annexure 3 ...... 17 3.6 Raw Material Requirement...... 17 3.7 Resource optimization and /recycling and reuse ...... 18 3.8 Water Requirement...... 18 3.8.1 Power Requirement ...... 18 4 SITE ANALYSIS ...... 21 5 PLANNING BRIEF...... 29 6 PROPOSED INFRASTRUCTURE...... 30 7 REHABILITATION AND RESETTLEMENT (R &R) PLAN...... 35 8 PROJECT SCHEDULE AND COST ESTIMATE...... 35 9 ANALYSIS OF PROPOSAL...... 36 10 CONCLUSION...... 37

i Prefeasibility Report

LIST OF TABLES

Table 2-1Manpower for the project...... 4 Table 3-1 Environmental setting of the existing site...... 11 Table 3-2 List of existing and proposed APIs with quantity...... 12 Table 3-3 Water requirement...... 18 Table 3-4 Power and fuel Requirement...... 18 Table 3-5 Solid waste Generation and Management...... 20 Table 3-7Hazardous waste generation and Management ...... 21 Table 4-1 Salient Features of the Project Site ...... 21 Table 4-2 Area Break up for existing facility...... 22 Table 4-3 Sensitive areas from the site boundary, 10 km radius...... 24 Table 4-4 Existing industries within 10 Km radius from the site ...... 27 Table 4-5 Project surrounding feature ...... 28 Table 5-1 Salient Features of the Project Site ...... 29 Table 5-2 Area break-up of the Existing facility...... 30 Table 6-1 Area break-up detail of the Proposed facility...... 30 Table 6-2 Connectivity to site ...... 32 Table 6-3 Hazardous waste generation and management...... 33 Table 6-4 Solid waste generation and management...... 34 Table 6-5 Power Requirement...... 34

LIST OF FIGURES

Figure 3-1 Location of Proposed Project Site ...... 6 Figure 3-2 Project Site Satellite Image...... 7 Figure 3-3Photograph of Existing API Unit ...... 7 Figure 3-4, 10 Km radius Satellite Image showing Project site and Surrounding Features...... 8 Figure 3-5, 5 Km radius Satellite Image showing Project site and Surrounding Features...... 9 Figure 3-6, 1 Km radius Satellite Image showing Project site and Surrounding Features...... 10 Figure 3-7 Plant Layout Sketch ...... 11 Figure 3-8 Process flow for production ...... 17 Figure 3-9 Schematic of ETP cum Reverse Osmosis Plant ...... 19 Figure 4-1 Plant Layout Sketch ...... 23

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LIST OF ABBREVIATIONS

ETP Effluent Treatment Plant STP Sewage Treatment Plant kWh Kilowatt per hour WHO World Health Organization ISO International Standard for Organization API Active Pharmaceutical Ingredients R&D Research & Development USFDA Food & Drug Administration (USA) PO Pure Oil

List if Annexure 1. Existing and Proposed products mix and capacity, Annexure 1. 2. Land possession certificate, Annexure 2. 3. Production and manufacturing processes, Annexure 3. 4. Hazardous waste disp. agreement with Ramky Enviro Engineer Limited, Annexure 4. 5. Hazardous waste disp. agreement with Gomti Incinco, Annexure 5. 6. KSPCB authorization for Existing facility-TSDF, Annexure 6. 7. Schematic of ETP cum Reverse Osmosis Plant, Annexure 7. 8. Water Supply agreement, Annexure 8. 9. Raw material MSDS, Annexure 9. 10. APIs MSDS, Annexure 10. 11. Existing EC, Annexure 11. 12. Existing CFE, Annexure 12. 13. List of Raw Materials for proposed new APIs, Annexure 13. 14. Water balance chart for existing facility, Annexure 14. 15. Water balance chart after proposed expansion, Annexure 15. 16. Green belt Sketch after proposed expansion, Annexure 16.

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1. EXECUTIVE SUMMARY S.No. Particulars Details 1. Name of Company Micro Labs Ltd (ML-15) 2. Location Plot No. 43-45,KIADB Industrial Area,Bommasandra,Link Road.IV Phase Jigani. Anekal Taluk, Bangalore-560105

3. Project Activity Active Pharmacautical Ingredients Schedule, Though the project site is located in KIADB industrial area, Category as per EIA as per the MoEF&CC Notification No. S.O.804 (E) 14th notification 2006 & March, 2017 it has been Categorized as ‘A’ and Schedule amendments 5(f). 4. Name of the project “Change in Product Mix and Enhancement of Plant Facilities” 5. Total Land area 24281.4 Sq. m , 6 Acre 6. Existing building area 15434 Sq. m

7. Proposed additional 270 Sq. m building area (Block D) 8. Total building up area 15704 Sq. m after expansion 9. Proposed product mix No of APIs: 93. with capacity Total capacity: 36445 Kg/A. Annexure 1. 10. Raw material List of Raw Materials for proposed new APIs, Annexure 13. 11. Water Water Consumption: 98 KLD. requirement Source: Private water tankers. (Existing 78 KLD + Proposed 20 KLD, Total 98 KLD). Break up as follows: Requirement Existing Proposed Total(KLD) (KLD (KLD) Process 18 00 18 Washing 08 00 08 Boiler Feed 24 00 24 Cooling Tower 20 05 25 Domestic 05 10 15 Others 03 05 08 Total 78 20 98 Total : 98 KLD 12. Waste water and  LTDS Effluent shall be treated in existing ETP and

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mode of disposal RO system.  HTDS Effluent shall be treated in existing Multi Effective Evaporation Plant.  The treated effluent shall be recycled/reused to the Utility and gardening.  There will be no discharge of effluent outside factory premises; The unit shall be zero liquid discharge. 13. Power Details Capacity (KVA) Source Existing Proposed Total Power 1300 400 1700 BESCOM Requirement Power Back 750x2 750x1 750x3= DG Sets Up 2250 Fuel Oil 2 2 HPCL & Nil KLD. KLD IOL. 14. Manpower

Operation phase: Permanent Contractual Total Existing 300 Nos 120 Nos 420 Nos Proposed 50 Nos 10 Nos 60 Nos Total 350 130 480 Nos

Construction Phase: 50 Nos temporarily

15. Project cost (estimate) 6 Crores

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2. INTRODUCTION OF THE PROJECT

2.1 Identification of the Project and Project Proponent Micro Labs Limited was established in the year 1973 by late Mr.G.C.Surana, now developing under leadership of Shri.Dilip Surana & Shri.Anand Surana with strong focus in & Abroad. It is ranked amongst top 20 in India out of 300 Indian pharma companies-ORG-IMS 2012. The Micro group has approximately 7000 employees comprising management, marketing and technical professionals.

In the early ninetees company decided to enter the export markets and started with export of their products to the neighbouring countries. As a part of the business expansion plan set-up several cGMP-compliant manufacturing facilities and are built to satisfy the Norms of USFDA and manufacturing is done as per stringent norms of WHO, EDQM.

2.2 Brief Description of nature of the Project Micro Labs Limited proposes the change in product mix of Active Pharmaceutical Ingredients within the production capacity of 36445 Kg/ Annum within its 6 Acres of land located at API Division ML-15. Plot.No.43-45, KIADB Industrial area, Bommasandra- Link Road, IV Phase Jigani, Anekal Taluk, Bangalore District, Karnataka State-560105.

The existing and proposed products mix with capacity is given in Annexure 1. Existing quantity is 36445 Kg/A with 65 nos of APIs. Proposed change in product mix will have same 36445 Kg/A with 93 nos of APIs.

There is an existing environmental clearance and CFE for the products given in Annexure 1 which are attached in Annexure 11 and Annexure 12 respectively.

The total site area is 24281.4 sq. m. The green belt is 1717 Sq.m (7.07%) of the total area. The total water requirement for the existing facility is 78 KLD and It is increased due the product mix and man power is 98 KLD. The required water will be met from the local suppliers through tankers. Existing Effluent Treatment Plant capacity is 50 KLD. The solid waste generated from existing facility is 164.38 kg/d and increase due the product mix is nil. Power requirement for the project will be sourced from BESCOM.

2.3 Need for the Project and its importance In order to become an active player in the Active Pharmaceutical Ingredients (API) segment catering to both domestic and international markets, Micro Labs now proposes to expand the

3 Prefeasibility Report facility and change in product mix of API manufacturing facility near Bommasandra- Bangalore, which will also house a state of the art QC/QA/EHS and R&D facility.

2.4 Demand – Supply Gap Based on the market survey the selected molecules for manufacture have potential for export as well domestic market.

2.5 Import vs. indigenous Production To ensure the quality of product and control of manufacturing under current Good Manufacturing Conditions, it is preferred to have the manufacturing done in-house by procuring the basic raw materials.

2.6 Export possibility All the listed products have great potential for exports and hence targeted for export market as an API directly or as an Formulated product.

2.7 Domestic/ Export Markets Micro Labs and its associate companies is a multi-facet organization with a turnover of Rs.2500 crore including exports . The bulk drug facility offices located overseas and a strong distribution network 14 Nos state of the-art manufacturing facilities are 4 sites approved by UK MHRA, 2 sites approved by MCC-South Africa, 2 sites approved by USFDA, 3 sites approved by WHO Geneva, 3 sites approved by TGA Australia, 2 sites approved by Med safe New Zealand.

The group is exporting to over 40 countries including Europe, USA, Asia, Africa and Latin America.

2.8 Employment Generation due to the Project The total no of people to be employed after expansion will be 480 Nos. Construction Phase: 50 Nos temporarily. The break up is given in Table 2-1

Table 2-1Manpower for the project

Permanent Contractual Total Existing 300 Nos 120 Nos 420 Nos Proposed 50 Nos 10 Nos 60 Nos Total 350 130 480 Nos

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3. PROJECT DESCRIPTION

3.1 Type of the Project The proposed project is a product mix of Active Pharmaceutical Ingredients, only number of APIs will be changed without change of Approved production Capacity - 36445kg/Annum. The proposed project falls under Category ‘B’ project and schedule 5 (f) as per the EIA notification dated September 14, 2006 and its amendments. There is no interlinked project.

3.2 Project Location The land was acquired from the Karnataka State Industrial Area Development Board (KIADB) lies in a notified industrial area along the recently developed Bommasandra-Jigani link road, branching away south-westerly from Bangalore-Hosur Road, NH-7.

The project site is located in Bommasandra Village, Anekal taluk of Bangalore District. Survey numbers are 43, 44 and 45 at Latitude 12°47'21.10" North, Longitude 77° 39'19.13" East, approximately 6 km away from the National Highway. The land is marked as Industrial zone. The land possession certificate from KIADB is enclosed in Annexure-2.

A number of other industrial undertakings are being planned and under execution in this notified industrial area, notable among them being the Biocon Park and Infosys software development center.

The project location is given in Figure 3-1 and the Project site is given in Figure 3-2. Photograph of the API Unit Figure 3-3. The 10, 5 & 1 Km radius map from the project is given in Figure 3-4, 3-5 & 3-6 respectively.

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Figure 3-1 Location of Proposed Project Site

Existing Micro Labs Limited- API Unit

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Figure 3-2 Project Site Satellite Image

Existing Facility

Figure 3-3Photograph of Existing API Unit

7 Figure 3-4, 10 Km radius Satellite Image showing Project site and Surrounding Features

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Figure 3-5, 5 Km radius Satellite Image showing Project site and Surrounding Features

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Figure 3-6, 1 Km radius Satellite Image showing Project site and Surrounding Features

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Figure 3-7 Plant Layout Sketch

3.3 Details of Alternate sites considered Since the proposed project is only a product mix at already existing facility, alternate site was not considered. The environmental setting of the existing site is given in Table 3.1:

Table 3-1 Environmental setting of the existing site S. No. Particulars Details

1 Plant site latitude 12°47'21.10"

2 Plant site longitude 77° 39'19.13"

3 Temperature Max. 34 oC, Min. 21.4 oC

4 Present land use Industrial area

5 Nearest Highway Bangalore Chennai road: 10 Km N. NH-44 (Old NH-7)

6 Nearest railway Station Anekal railway: 12 Kms S

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S. No. Particulars Details

Heelalige: 4.5 Kms

7 Nearest Airport Bangalore Airport: 45.5 Kms

8 Nearest village Bande Nallasandra Village 1.22 Km

9 Nearest major city Bangalore: 25 Kms N

10 River Nil

11 Type of soil Reddish brown clay silt soil

3.4 Magnitude of Operation In the view of fulfilling market requirement, we are proposing to change the product mix of Active Pharmaceutical Ingredients within the production capacity of 36445 Kg/ Annum within its 6 Acres of land located at Bommasandra village, Anakel Taluk, Bangalore District, Karnataka State.

The details of existing and proposed products mix with capacity is given in Annexure 1. Existing quantity is 36445 Kg/A with 65 nos of APIs. Proposed change in product mix will have same 36445 Kg/A with 93 nos of APIs. The list of existing and proposed APIs with quantities is given in Table 3-2.

Table 3-2 List of existing and proposed APIs with quantity

S. No Product Name Existing Capacity After Proposed (Kg/A) Expansion, Capacity (Kg/A)

1. Clopidogralbisulfate 500 0 2. Telmisartan 1200 1200 3. Losartan potassium 4000 3000 4. Torsemide 600 300 5. Ebastine 1800 1800 6. Pantoprazole sodium 600 300 7. Rabeprazole sodium 600 0 8. Amolodipine besylate 50 0

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9. Atorvastatin calcium 50 0 10. Olanzapine 600 300 11. Sertraline hydrochloride 50 0 12. Levocertiizine dihydrochoride 50 0 13. Ezetimibe 50 50 14. Ramipril 50 0 15. Ropinirole 50 0 16. Valsartan 300 50 17. Escitalopram oxalate 600 1860 18. Pregabalin 300 0 19. Dorzolamide Hydrochloride 100 500 20. Meloxicam 100 100 21. Glimepiride 600 200 22. Gemifloxacin 100 0 23. Nebivolol Hydrochloride 60 60 24. Memantine Hydrochloride 60 0

25. Olmisartan medoxomil 600 300 26. Citicoline sodium 50 0 27. Diacerin 50 0 28. Acyclofenac 50 0 29. Fluorometholone 50 0 30. Brimoidine Tartrate 240 50 31. Zolpidem Tartarate 300 0 32. Prulifloxacin 300 0 33. Levodropropizine 50 0 34. Gliclazide 3000 3000 35. Melitracen 50 0 36. Flupentixol 50 0 37. Olapatdine Hydrochloride 240 0 38. Citalopram Hyrobromde 100 0 39. Brinzolamide 120 50 40. Artemether 2000 1500 41. Lumefantrine 12000 4000 42. Bosentan 200 0 43. Prasugrel Hydrochloride 150 0 44. Donepezil Hydrochloride 100 0 45. Amisulpride 500 0 46. Ranolazine 500 0

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47. Celecoxib 300 8000 48. Duloxetine Hydrochloride 200 0

49. Ziprasidone Hydrochloride 100 0 50. Artesunate 100 0 51. Montelukast 100 25 52. Omperazole magnesium trithydrate 100 0 53. Aliskiren 50 0 54. Ozagrel 50 0 55. Ramlton 50 0 56. Bromfenac 25 25 57. Cyclizine Hydrochloride 300 2000 58. Irbesartan 800 2000 59. Fexofenadine Hydrochloride 300 0 60. Triflusal 100 0 61. Etoricoxib 100 0 62. Nepafenac 100 50 63. Paliperidone 100 0 64. Zolmitriptan 100 0 65. Candesartan 300 30 66. Abacavir Sulfate 0 300 67. Acrivastne 0 50 68. Alcaftadine 0 50 69. Anagliptin 0 50 70. Apixaban 0 10 71. Atazanvir 0 50 72. Azilsartan Medoxmil Pottasium 0 250 73. Bepotastine Besylate 0 10 74. Besifloxacin Hydrochloride 0 10

75. Bilastine 0 10 76. Bisegliptin 0 50 77. Canagliflozine 0 50 78. Cilnidipine 0 100 79. Cyamemazine Tartarate 0 300

80. Dabigatran Etexylate Mesylate 0 250 81. Darunavir Ethanolate 0 300

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82. Dolutegravir 0 15 83. Empagliflozine 0 50 84. Emtricitabine 0 50 85. Ethambutol Hydrochloride 0 500 86. Flurbiprofen 0 50 87. Iioperidone 0 50 88. Isopropterenol Hydrochloride 0 5

89. Ivabrdine 0 50 90. Lacosamide 0 50 91. Lafutadine 0 50 92. Levomilnaciprn Hydrochloride 0 100 93. Lurasidone Hydrochloride 0 100 94. Meptazinol 0 50 95. Milnacipran Hydrochloride 0 300

96. Mirabegron 0 50 97. Moxifloxacin 0 50 98. Moxonidine 0 50 99. Nefopam 0 50 100. Nephazoline Hydrochloride 0 100

101. Perampanel 0 50 102. Rasagiline Mesylate 0 10 103. Rasigiline Tartarate 0 10 104. Rilpivirine 0 50 105. Rivaroxaban 0 50 106. Rosuvastatin 0 20 107. Sitagliptin 0 20 108. Sodium Nitroprusside 0 20 109. Sofosbuvir 0 50 110. Sollfenacin 0 20 111. Teneligliptin 0 100 112. Ticagrelor 0 20 113. Vilazidone 0 100 114. Vildagliptin 0 100 115. Anagrelide 0 50 116. Dapagliflozine 0 50 117. Tenofovir Alafenamide Fumerete 0 50 118. Pilferridone 0 50 119. Refaxmine 0 50

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120. Hexamine Hippurate 0 500 121. Tofactinib Citrate 0 15 122. Dimethyl Fumarate 0 250 123. Cyclserine 0 50 124. Sacrubitil Valsartan 0 50 125. Gatifloxacin 0 50 126. Daclatasavir 0 50 127. Dalfampyridine 0 50 128. Brexpiprazole 0 50 129. Flupiritine Maleate 0 50 130. Omagrigliptin 0 50 131. Clobazam EC 0 50 132. Febuxostat 0 50 Total 36445 36445

3.5 Project Description The raw materials are charged in the reactor and after reaction it is centrifuged. The centrifuged materials are dried. After milling, sifting and blending, the finished products are packed for dispatch.

The process flow is given below.

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Figure 3-8 Process flow for production

Dispensing Raw Material

Raw Materials Charging in Reactor and Reaction monitoring

Centrifuge operation

Material Drying Operation in Dryer

Milling Operation

Sifting Operatio n Blending Operation

Finished Goods/ Product packing

Finished Goods/ Product Dispatching Process description: Annexure 3 3.6 Raw Material Requirement The raw materials requirement for proposed new APIs and their qty are given in Annexure 13.

Few of the raw materials would be imported by way of sea or air to Chennai port. Further they would be transported by road. The finished goods for the domestic sales would be by road and for exports would be by air.

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3.7 Resource optimization and /recycling and reuse After the reaction is complete the solvents are recovered, tested as per pre-defined specification. The residue is collected in a container and sent to KSPCB authorized incinerators. The recovered solvents are collected in drums, labeled and analyzed. Then they are reused (recycled) for the process, mostly for the same product.

3.8 Water Requirement The total requirement of raw water for the existing unit is 78 KLD. Water requirement after the proposed expansion is 98 KLD. The detailed break up is given Table 3-3. The required water will be met from the local suppliers through tankers. The agreement for water supply is enclosed in Annexure-8. Table 3-3 Water requirement Requirement Existing Proposed Total(KLD) (KLD (KLD) Process 18 00 18 Washing 08 00 08 Boiler Feed 24 00 24 Cooling Tower 20 05 25 Domestic 05 10 15 Others 03 05 08 Total 78 20 98

Water balance chart for existing (78 KLD) facility is enclosed as Annexure 14 and Water balance chart for the proposed product mix (after expansion, total 98 KLD) is enclosed as Annexure 15.

3.8.1 Power Requirement

The power requirement for the project will be sourced from BESCOM. The detail of power and back-up power is given in Table 3-4 Table 3-4 Power and fuel Requirement Details Capacity Source Existing Proposed Total Power 1300 400 1700 Requirement BESCOM (kVA) Power Back Up 750x2 750x1 (kVA) 750x3= 2250 DG Sets Fuel Oil 2 KLD. Nil 2 KLD HPCL & IOL.

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3.9 Waste Management and Disposal Method

3.9.1 Liquid Waste Management

Sewage and effluent generated from process and washings are taken to combined Effluent and sewage Treatment Plant and two stages RO and Multiple Effect Evaporator of 36 KLD capacity. The treated waste water of 25 KLD will be reused for Boiler and Chiller. Zero liquid discharge system will be maintained.

The schematic diagram of combined ETP with RO system is enclosed in Figure 3-9.

Figure 3-9 Schematic of ETP cum Reverse Osmosis Plant

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3.9.2 Hazardous and Solid Waste Management. Solid Waste During operation phase, 260 Kg of solid waste will be generated. The details are given in table 3-5. Table 3-5 Solid waste Generation and Management

Operation phase Type Kg/day Disposal method

Organic (including food Municipal bin (Food waste to 115.2 waste) cattle feed)

Inorganic 124.8 KSPCB authorized recyclers

Total 240

for total 480 Employees

Hazardous waste Hazardous waste materials are properly disposed as per the Hazardous waste management rule2008 and amendment in 2016.

Hazardous waste authorization obtained from KSPCB is given in Annexure 6. Agreement between Ramky Enviro Engineer Limited and Micro Labs for collection, transport, storage, treatment and disposal is enclosed as Annexure 4. Agreement with Gomti Incinco for Incineration is given in Annexure 5. The hazardous waste detail is given in table 3.6.

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Table 3-6Hazardous waste generation and Management

Waste Hazardous waste Quantity Method of handling Category Generated Existing Proposed Total Collected in leak proof containers and disposed 1.5 1 2.5 KL/A only to KSPCB 5.1 Used Oil KL/A KL/A registered Authorized re-processor

Oil soaked cotton 0.1 0.9 1 5.2 Stored in secure manner waste MT/A MT/A MT/A and handed over to KSPCB Authorized Pharmaceutical 05 05 10 MT/A incinerator. 28.1 residues (Process MT/A MT/A residues) Stored in secure manner 7.2 2.8 and handed over to 10 MT/A 28.2 Spent Catalyst MT/A MT/A KSPCB Authorized TSDF 06 15 21 Stored in secure manner 28.6 Spent solvent MT/A MT/A MT/A and handed over to KSPCB Authorized Discarded 5000 5000 33.1 recycler containers Nos/A - Nos/A Stored in secure manner Sludge from ETP 100 100 and handed over to 35.3 - & MEE MTA MTA KSPCB Authorized TSDF

4 SITE ANALYSIS 4.1 Connectivity

Micro Labs Limited- API Unit is located at Bommasandra village, Anekal Taluk. The proposed site is well connected by Highways and easy access to railway station.

Table 4-1 Salient Features of the Project Site Feature Details Project Site Location Bommas andra Village, KIADB Industrial Area Topography Plain Nearest City Bangalore: 8.8 Km Nearest Highway Bangalore Chennai road: 10 Km, N.

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NH-44 (Old NH-7) Nearest Railway line Heelalige: 4.5 Kms Nearest Air port Bangalore Airport: 45.5 Kms Land Available 6 Acres

4.2 Land form, Land use and Land ownership

The total land available for the proposed project is about 6 Acre (24281.1 sq.m). Available land area is utilized for building, plant, road and pavement, green belt, landscaping and feature expansion uses. The land possession certificate from KIADB is enclosed in Annexure 2.

The area break up detail present in Table 4-2. The existing plant layout sketch is given in Figure 4-1.

Table 4-2 Area Break up for existing facility

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Figure 4-1 Plant Layout Sketch

4.3 Topography

The site is more or less a flat terrain. Bangalore has two unique Topography terrains—North Bangalore Taluk and the South Bangalore taluk. The North Bangalore taluk is a relatively more level plateau and lies between an average of 839 to 962 meters above sea level. The middle of the taluk has a prominent ridge running NNE-SSW. The highest point in the city, Doddabettahalli, (962m) is on this ridge. There are gentle slopes and valleys on either side of this ridge. The low-lying area is marked by a series of water tanks varying in size from a small pond to those of considerable extent, but all fairly shallow.

The topography of Bangalore is flat except for a central ridge running NNE-SSW. The highest point is Doddabettahalli, which is 962 m (3,156 ft) and lies on this ridge. No major rivers run through the city, though the Arkavathi and South Pennar cross paths at the Nandi Hills, 60 km (37 mi.) to the north. River Vrishabhavathi, a minor tributary of the Arkavathi, arises within the city at Basavanagudi and flows through the city. The rivers Arkavathi and Vrishabhavathi together carry much of Bangalore's sewage. A sewerage system, constructed in 1922, covers 215 km² (133 mi²) of the city and connects with five sewage treatment centers located in the periphery of Bangalore.

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The South Bangalore taluk has an uneven landscape with intermingling hills and valleys. The southern and western portions of the city consist of a topology of granite and gneissic masses. The eastern portion is a plane, with rare minor undulations.

There are no major rivers flowing through the city. However, rivers Arkavathi and Kaveri merge within the proximity of Nandi Hills, which lie 60 km north of Bangalore. River Vrishabhavati, a tributary of Arkavathi, flows for a small stretch in the Bangalore North taluk and carries a bulk of the city's sewerage. The city has a handful of freshwater lakes and water tanks such as Madivala tank, Hebbal tank, Ulsoor lake and Sankey Tank. Groundwater occurs in silty to sandy layers of alluvialsediments and jointed quartzite.

The rock types prevalent in the district belong to the Saugar, Charnokite and Peninsular Gneissic Complex (PGC) groups. The PGC is the dominant group of rocks and covers two-thirds of the area and includes granites, gneissis and migmatites. The soils in Bangalore vary from red laterite to clayey soils

4.4 Land use pattern

Micro Labs Ltd has already established a facility in KIADB industrial area and the proposed project is only a product mix. The land possession certificate from KIADB is enclosed in Annexure 2.

So, concern over the use of agriculture land, non-agriculture land, forest land, water bodies and CRZ etc., does not arise.

The details of sensitive areas from the site boundary are given in Table 4.3. The site does not fall within the CRZ area

Table 4-3 Sensitive areas from the site boundary, 10 km radius.

S.No Name Distance (km) Direction

1. Bhannergatta National Park 8.57 W

2. Haragade Lake 3.24 S

3. Kammasandra lake 5.82 NE

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4.5 Existing infrastructure

a. Land

The Plant facilities are spread over 24281.4 Sq.m in KIADB Land which is completely fortified and protected on all four sides by boundary walls.

b. Buildings

Total built up area is divided into various sections like Production Blocks, Engineering, Warehouses, Administration, Canteen, Toilets etc. There is adequate space & provision for operations.

c. Plant Machinery & Utilities

The Plant Facilities have been designed and set up with the objective to carry out almost all chemical reactions and processes. Details of plant and machinery and utility equipments used for the production are as below;

i. Process Equipments:

 Reactors  Centrifuges  RCVDs  VTDs  Jet Mill  Multi Mill  Sifter  Blender  Spray dryer

ii. Machinery / Utility Equipments;

 Boilers  Cooling towers  DG sets  Brine chilling plant  Nitrogen Plant  Air compressors  HVAC system  Vacuum pumps  Hot water systems  Chilled water plant

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 Dust collectors  Scrubbers

iii. Safety Equipments:

 Fire Hydrant System  Fire Extinguishers  Fire Alarm System  Eye wash fountain / Safety Showers  Emergency PPE cupboards  Wind Sack  Smoke Detector system  Self Containing Breathing Apparatus  Fire suit

The site is well connected by road to NH 7 (Bangalore- Chennai). The list of the few existing industries within 10 km from the site is given in Table 4.4.

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Table 4-4 Existing industries within 10 Km radius from the site S.No. Name Product Distance Direction from site (km) 1. M/s P.D Biopchem Pvt Ltd Pharmaceutical 0.41 N 2. M/s Mehandira Reva Electric Automobile 3.66 NE Vehicle Pvt Ltd 3. M/s Micro Labs Ltd Pharmaceutical 0.51 SW ML- 22, API divn 4. M/s Shoba Ltd Fabric 2.65 North 5. CIPLA Pharmaceutical 0.86 SW 6. Mylan Limited Pharmaceutical 0.97 SW 7. Syngene Int Ltd (Biocon park) Chemicals 2.01 NE 8. Apotex Pharma Chem Pharmaceutical 2.46 NE 9. Acebright Pharmaceutical 2.76 SW 10. Kumar Organic Products Ltd Pharmaceutical 2.99 SW

4.6 Soil classification

The top soil is reddish brown clay silt soil. The soil classification is Laterite soils and is mainly found in Anekal Taluk.

4.7 Climate data from secondary sources

Normal annual rainfall of is 831mm. During the year 2005, Bangalore urban district received actual rainfall of 1342.7 mm in 69 rainy days. Of the total rainfall, contribution from southwestern monsoon is 54.18% and 26.53% is from northeastern monsoon. In addition to this, Premonsoon showers contribute significant rainfall of 18.53%. The annual average maximum temperature ranges from 23.9 to 30.4°C and minimum temperature ranges from 19.6 to 23.9°C. The annual average humidity is 65.5°C. The annual average wind speed is 4.5 km/h.

4.8 Social Infrastructure available

The social infrastructure facilities available in 10 km radius are given in Table 4.5.

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Table 4-5 Project surrounding feature

S.No Name Distance (Km) Direction Schools & Colleges 1. BTL High School 4.63 NE 2. Treamis World School 3.06 N 3. Royal Public School 5.83 NE 4. BTL Institute of Tech and 4.91 NE Management 5. Condor International school 4.32 NW 6. Christ Academy ICSE school 5.38 NW 7. Nidyananda High school and college 2.37 W 8. Tapovan High School 4.11 W 9. Virindha Educational Academy 5.89 W 10. Film Academy 5.90 W 11. T. Johan College 9.34 NW 12. Sherwood High School 9.56 NW Religious Places 1. Jigani Masjid 2.25 W 2. Sri Channa Keshava Temple 7.64 SE Hospital 1. Narayana Hrudyala 5.07 NE 2. Sparsh Hospital 5.33 NE 5. Srinidhi Hopital 5.65 E Sensitive area 1. Bhannergatta National Park 8.57 W 2. Haragade Lake 3.24 S 3. Kammasandra lake 5.82 NE

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5 PLANNING BRIEF

5.1 Planning concept

Micro Labs Limited proposes products mix of Active Pharmaceutical Ingredients without change of approved production Capacity – 36445 kg/Annum within its 6 Acres land located at Bommasandra village, Anakel Taluk, Bangalore District, Karnataka State. The site is in KIABD industrial area.

The proposed site is well connected by Highways and easy access to railway station.

Table 5-1 Salient Features of the Project Site

Feature Details Project Site Location Bommasandra Village, KIADB Industrial Area Topography Plain Nearest City Bangalore-8.8 Km Nearest Highway NH-44 (Old NH-7) Nearest Railway line Heelalige: 4.5 Kms Nearest Air port Bangalore Airport: 45.5 Kms Land Available 6 Acres

5.2 Population Projection

Operation phase: Permanent Contractual Total Existing 300 Nos 120 Nos 420 Nos Proposed 50 Nos 10 Nos 60 Nos Total 350 130 480 Nos

Construction Phase: 50 Nos temporarily

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5.3 Land use planning

The Total site area is 24281.4 Sq. m. The area details of the facility are given below in Tables 5.2

Table 5-2 Area break-up of the Existing facility

5.4 Assessment of Infrastructure Demand

The facility is within the KIADB industrial area and the proposed project is only a expansion of existing facility. 5.5 Amenities/Facilities

The existing site is having Canteen facility for employees, Occupational Health Center (OHC) and Assembly points on emergency etc.

6 PROPOSED INFRASTRUCTURE 6.1 Industrial Area

The proposed project established in KIADB Industrial area. Table 6-1 Area break-up detail of the Proposed facility

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6.2 Residential Area

Not Applicable. Since the unit is an Active Pharmaceutical Ingredients manufacturing unit inside KIADB area, no housing development is proposed.

6.3 Green belt

The total area of the site is 24281.4 sq. m (6 Acres). Green belt area of the existing facility is 1717 Sq.m (7.07%). Green belt area after the proposed expansion (introduction of production Block D) is 1598 Sq.m (6.58%). The site exists in KIABD industrial area. Green belt Sketch after proposed expansion is enclosed as Annexure 16.

6.4 Social Infrastructure

KIADB Industrial Area.

6.5 Connectivity

The proposed site is well connected by Highways and easy access to railway station Table 6.2.

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Table 6-2 Connectivity to site Feature Details Project Site Location Bommasandra Village, KIADB Industrial Area Topography Plain Nearest City Bangalore-8.8 Km Nearest Highway Bangalore Chennai road: 10 Km, N. NH-44 (Old NH-7) Nearest Railway line Heelalige : 4.5 Kms Nearest Air port Bangalore Airport: 45.5 Kms Land Available 6 Acres

6.6 Drinking Water Management

Drinking water facility is available. Micro Labs has RO plant to generate drinking and process water which we store in a storage tank. Water quality analysis is done on regular basis at in- house Quality Control dept and periodically analysis is done at external approved laboratory.

6.7 Sewerage system

The quantity and quality of wastewater in the plant is controlled by following measures:  Recycle of process water including steam condensate and reuse of treated waste water in Utility, Boiler, Cooling Tower, and Garden etc.  Control of water taps, washings, leakages from pump glands and flanged joints.  Overflow of vessels is strictly avoided  Floor cleaning with water will be replaced with dry cleaning.  Effluents from the plant is been stored and neutralized in a collection tank and then it is treated in the Multi Effective Evaporation Plant  Proper provisions have been made by installation of septic tank and soak pit.

6.8 Industrial waste management

Hazardous waste materials are properly disposed as per the Hazardous waste management rule 1989. Hazardous waste authorization obtained from KSPCB is given in Annexure 6. Agreement between Ramky Enviro Engineer Limited and Micro Labs for collection, transport, storage, treatment and disposal is enclosed as Annexure 4. Agreement with Gomti Incinco for Incinneration is given in Annexure 5.

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Table 6-3 Hazardous waste generation and management

Hazardous Quantity Waste waste Total Method of handling Category Existing Additional Generated Proposed Collected in leak proof 1.5 1 containers and disposed only 2.5 KL/A 5.1 Used Oil KL/A KL/A to KSPCB registered Authorized re-processor

Oil soaked 0.1 0.9 1 5.2 cotton waste MT/A MT/A MT/A Stored in secure manner and Pharmaceutical handed over to KSPCB residues 05 05 Authorized incinerator. 28.1 10 MT/A (Process MT/A MT/A residues) Stored in secure manner and 7.2 2.8 10 MT/A handed over to KSPCB 28.2 Spent Catalyst MT/A MT/A Authorized TSDF 06 15 21 28.6 Spent solvent MT/A MT/A MT/A Stored in secure manner and handed over to KSPCB 5000 5000 Discarded Authorized recycler 33.1 containers Nos/A - Nos/A Stored in secure manner and 100 100 Sludge from - handed over to KSPCB 35.3 MTA MTA ETP & MEE Authorized TSDF

6.9 Solid waste management

The solid waste details are given in table Table 6.4.

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Table 6-4 Solid waste generation and management Operation phase

Type Kg/day Disposal method

Organic (including food Municipal bin (Food waste to 115.2 waste) cattle feed)

Inorganic 124.8 KSPCB authorized recyclers

Total 240

for total 480 Employees

6.10 Power Requirements and Supply/ Source

The power requirement for the project will be sourced from BESCOM. The detail of power and back-up power is given in Table 6-5 Table 6-5 Power Requirement Details Capacity (KVA) Source Existing Proposed Total Power 1300 400 1700 BESCOM Requirement Power Back 750x2 750x1 750x3= DG Sets Up 2250 Fuel Oil 2 2 Nil HPCL & IOL. KLD. KLD

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7 REHABILITATION AND RESETTLEMENT (R &R) PLAN 7.1 Policy to be adopted (Central/ State)

Not applicable as the proposed project is only a product mix within the existing unit of KIADB industrial area.

8 PROJECT SCHEDULE AND COST ESTIMATE 8.1 Likely date of start of construction and likely date of completion

Propose site civil construction shall be started in 2016 and shall be completed by 10 months

8.2 Estimated project cost

6 Crores.

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9 ANALYSIS OF PROPOSAL 9.1 Financial and social benefits

Financial (Last year): Annual Turnover: 2250 Cror of Micro Labs Ltd Annual Profit: 315 Crore.

Social Benefits: Employment to local community: Microlabs always prefer local community for employment and has given employment.

CSR benefit to local community: 1. Microlabs is running education institutes (SURANA degree college, SURANA Management college, SURANA Primary and PU college in Bangalore) for good and quality education to the public. 2. Microlabs is maintaining temple (SUSHIL tham, Hosur road Bangalore) for social benefit to the community. 3. Microlabs helps meritorious students to continue their higher education. 4. Microlabs donates money for various medical camps i.e., Eye Camp, Diabetics, Parkinson disease etc,. for the benefit of society. 5. Microlabs donates money to Hospitals for improving hospital infrastructure and also providing food on free of cost. 6. Microlabs also supports and promotes Swachh Bharat Abhyan activities.

Green belt benefit to environment: 1. Microlabs is maintaining green belt inside the factory premises and also planted tree near the boundary of plant for environmental protection. 2. Microlabs has also planted more than 1200 trees near Micro Labs Veterinary unit nearby its API plant to the benefit of environment.

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10 CONCLUSION  Since the proposed project is only a product mix within the existing facility, there will not be any change in land use.  Zero liquid discharge concept is followed and the treated waste water will be reused for gardening, chiller, boiler feed and process.  Rain water harvesting system is adapted.  Organic waste converter for solid waste management is in force.  There will be positive impact on social conditions in and around the site due to the proposed assignment.  The marginal impact due to the proposed assignment will be fully mitigated by the Environmental Management Plan (EMP).

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