as per the ‘generic structure of eia’ given...

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10. Action plan to control ground water pollution. 11. Details of solid waste management including management of boiler ash, yeast, etc.

Details of incinerated spent wash ash generation and its disposal. 12. Details of bio-composting yard. 13. Action plan to control odour pollution. 14. Arrangements for installation of continuous online monitoring system (24x7

monitoring device). 15. Complete process flow diagram describing each unit, its processes and operations

in production of sugar, alongwith material and energy inputs and outputs (material and energy balance).

16. Details on water balance including quantity of effluent generated, recycled &reused. Efforts to minimize effluent discharge and to maintain quality of receiving water body.

17. Details of effluent treatment plant, inlet and treated water quality with specific efficiency of each treatment unit in reduction in respect of all concerned/ regulated environmental parameters in respect of Sugar.

18. Number of working days of the sugar production unit. 19. Details of the use of steam from the boiler. 20. Details of proposed source-specific pollution control schemes and equipment s to

meet the national standards. 21. Collection, storage, handling and transportation of molasses, 22. Collection, storage and handling of bagasse and press mud. 23. Flyash management plan for coal based and bagasse and action plan 24. Details on surface/ground water quality parameters such as Temperature, Colour,

pH, BOD, COD, Total Kjeldhal Nitrogen, Phosphates, Oil & Grease, Total suspended Solids, Total Coliform bacteria etc.

25. Details on existing ambient air quality and expected, stack and fugitive emissions for PM10, PM2.5, SO2*, NOx*, etc., and evaluation of the adequacy of the proposed pollution control devices to meet standards for point sources and to meet AAQ standards.(*-As applicable)

B. Additional TOR

i. Public hearing to be conducted and issues raised and commitments made by the project proponent on the same should be included in EIA/EMP Report in the form of tabular chart with financial budget for complying with the commitments made.

ii. No ground water to be drawn for the proposed project.

It was recommended that ‘TORs’ along with Public Hearing prescribed by the Reconstituted Expert Appraisal Committee (Industry) should be considered for preparation of EIA / EMP report for the above mentioned project in addition to all the relevant information as per the ‘Generic Structure of EIA’ given in Appendix III and IIIA in the EIA Notification, 2006. The draft EIA/EMP report shall be submitted to the State Pollution Control Board for public hearing. The issues emerged and response to the issues shall be incorporated in the EIA report.

6.10.4 Expansion of Bulk Drugs and Intermediates Manufacturing ( from 15 TPM to 421 TPM) at Sy. No. 404, 405, 407, 408, 409 & 410 at Village Veliminedu, Chityal Mandal, District Nalgonda, Telangana by M/s Dasami Lab Pvt. Ltd. (formerly known as Medchem Organics Pvt. Ltd.)- reg TOR

The project authorities gave a detailed presentation on the salient features of the project and proposed environmental protection measures to be undertaken along with the draft Term of References for the preparation of EIA-EMP. All Synthetic Organic Chemicals

97

Industry (Bulk drug and intermediate) located outside the notified industrial area/estate are listed at S.N. 5(f) under category ‘A’ and appraised by Expert Appraisal Committee (I).

M/s. Dasami Lab Pvt. Ltd has proposed for expansion of bulk drugs and intermediates manufacturing unit (From 15 TPM to 421 TPM) at Survey No. 404, 405, 407, 408, 409 & 410, Veliminedu Village, Chityal Mandal, Nalgonda District, Telangana. Ministry has issued the Environmental Clearance vide letter no. F. No. J-11011/533/2007-IA.II (I), dated 21.02.2008 in the name of M/s SVAKRM Laboratories (Pvt.) Ltd.and obtained consent and authorization (CFO) vide Letter No. TSPCB/256/RCP/NLG/HO/ CFO/2014-196 dated 22.11.2014. It is reported that no national parks, wildlife sanctuaries, Protected Forests (PF), Biosphere Reserves, Tiger/Elephant Reserves, Wildlife Corridors etc. lies within 10 km distance. There are two Reserve Forests in the study area; Chityala RF at a distance of 6 Km in east direction, Shivanenigudem RF at a distance of 9 Km in NE direction of the site.

Total plot area after expansion is 51 acres out of which 18 acres of land will be developed as green belt. Total project cost is Rs. 45 crore. About 560 persons will be employed in this proposed expansion project Following are the existing and proposed:

A. Existing product as per EC: S.No Name of the Product Capacity (TPA)

1. Tramadol Hydrochloride 60.0

2. Ramipril 60.0

3. Omeprazole 60.0

4. Carvedilol 60.0

5. Setreline Hydrochloride 60.0

6. Duloxetine Hydrochloride 36.0

7. Sparfloxacin 48.0

8. Drotaverine Hydrochloride 30.0

9. Clopidogrel Hydrogen Bisulfate 60.0

b. By- product

10. Spent Sulphuric acid 364.8

B. Proposed products

S.No Name of the Product Capacity

TPM TPD

1 Amlodipine Besylate 20 0.67

2 Aprimilast 3 0.10

3 Bocepravir 6 0.20

4 Bupropion HCl 20 0.67

5 Carvedilol 30 1.00

6 Clopidogrel Hydrogen Bisulfate 10 0.33

7 Colisevelam 6 0.20

8 Dalfampridine 17 0.57

9 Dex lansoprazole 5 0.17

10 Divalproex Sodium 15 0.50

11 Drotaverine HCl 3 0.10

12 Duloxetine HCl 15 0.50

13 Esli Carbazapine 2 0.07

14 Fexofenadine HCl 10 0.33

15 Glimepride 3 0.10

16 Lansoprazole 8 0.27

17 Lomitapide 2 0.07

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18 Mesalamine 7 0.23

19 Nebumitone 10 0.33

20 Omeprazole 5 0.17

21 Piperquine Phosphate 5 0.17

22 posacanazole 7 0.23

23 Ramipril 7 0.23

24 Ranolazine 10 0.33

25 Sevelamir HCl 29 0.97

26 Sparfloxacin 20 0.67

27 Telapravir 5 0.17

28 Ticagrelor 1 0.03

29 Tramadol HCl 12 0.40

30 Valacyclovir 6 0.20

31 Valagancyclovir HCl 2 0.07

32 Abiraterone Acetate 1 0.03

33 Anastrozole 2 0.07

34 Bendamustine Hydochloride 2.5 0.08

35 Bexarotene 3 0.10

36 Bicalutamide 5 0.17

37 Bortezomib 0.5 0.02

38 Carboplatin 5 0.17

39 Capecitabine 2 0.07

40 Cisplatin 2 0.07

41 Cyclophosphamide 2 0.07

42 Dasatinib 2 0.07

43 Emtricitabine 30 1.00

44 Erlotinib HCl 4 0.13

45 Gefitinib 2 0.07

46 Gemcitabine HCl 1 0.03

47 Imatinib Mesylate 16 0.53

48 Irinotecan HCl 14 0.47

49 Lapatinib Ditosylate Monohydrate 2 0.07

50 Letrozole 2.5 0.08

51 Nilotinib HCl 2 0.07

52 Oxaliplatin 4 0.13

53 Pazopanib Hydrchloride 2 0.07

54 Pemetrexed Disodium 0.5 0.02

55 Sorafenib Tosylate 6 0.20

56 Temozolomide 1 0.03

57 Sunitinib Malate 6 0.20

Total (Worst Case-27 Products) 421 11.57

Capacity of the existing Coal fired boiler is 5 TPH and proposed coal fired boilers will be 2 x 10 TPH, provided with bagfilter as APCS. Backup DG sets of 3X1000 KVA has been proposed in addition to existing DG sets of 1x 380 KVA to cater to energy requirement during load shut down. DG sets shall be provided with stack of adequate height.

Gaseous emissions from process are Hydrogen Chloride, Sulfur dioxide, Carbon dioxide, Oxygen and Hydrogen. HCl and SO2 are scrubbed in two stage scrubbers. Water is used as scrubbing media in primary scrubbers and caustic in secondary scrubbers and scrubbed effluents are sent to ETP. Hydrogen, Oxygen and carbon dioxide gases are let out into atmosphere by following a standard operating procedure. Hydrogen gas is let out into atmosphere through water column.

Total water requirement after expansion is in the order of 487.2 m3/day consisting of 292.2 m3/day of freshwater and the remaining is recycled water. Effluent will be segregated

99

into high TDS/ COD and low TDS/ COD streams. The Process, Washing Scrubber effluent and RO reject (HTDS effluents) will be sent to stripper. Stripper condensate shall dispose to cement industries/ TSDF. Stripper bottom sent to MEE followed by AFTD. Condensate from MEE shall be sent to biological treatment plant by RO. RO reject to be sent to MEE and permeate is reused in cooling towers and boiler makeup and scrubbers while LTDS effluents sent to Biological treatment system followed by RO. RO permeate reused for cooling tower makeup and scrubbers. RO reject sent to MEE. ETP Sludge and Evaporation residue will be sent to TSDF. Used Oil used within premises as a lubricant / sold to registered recycler. Ash from boiler will be sent brick manufacturers. Organic residue, solvent residue and stripper distillate will be sent to TSDF/Cement industries.

After detailed deliberations, the Committee prescribed the following Specific and Additional TOR in addition to Generic TOR provided at Annexure-I ( as referred on Ministry’s web site) for preparation of EIA-EMP report. A. Specific TOR

1. Details on solvents to be used, measures for solvent recovery and for emissions control.

2. Details of process emissions from the proposed unit and its arrangement to control. 3. Ambient air quality data should include VOC, other process-specific pollutants* like

NH3*, chlorine*, HCl*, HBr*, H2S*, HF*, etc., (* - as applicable)

4. Work zone monitoring arrangements for hazardous chemicals. 5. Detailed effluent treatment scheme including ssegregation of effluent streams for

units adopting ‘Zero’ liquid discharge. 6. Action plan for odour control to be submitted. 7. A copy of the Memorandum of Understanding signed with cement manufacturers

indicating clearly that they co-process organic solid/hazardous waste generated. 8. Authorization/Membership for the disposal of liquid effluent in CETP and

solid/hazardous waste in TSDF, if any. 9. Action plan for utilization of MEE/dryers salts. 10. Material Safety Data Sheet for all the Chemicals are being used/will be used. 11. Authorization/Membership for the disposal of solid/hazardous waste in TSDF. 12. Details of incinerator if to be installed. 13. Risk assessment for storage and handling of hazardous chemicals/solvents. Action

plan for handling & safety system to be incorporated. 14. Arrangements for ensuring health and safety of workers engaged in handling of

toxic materials.

B. Additional TOR

1. Public hearing to be conducted and issues raised and commitments made by the project proponent on the same should be included in EIA/EMP Report in the form of tabular chart with financial budget for complying with the commitments made.

2. A Copy of certified compliance report to the environmental conditions prescribed in the existing EC. Action taken report/ detailed action plan on the partly/non-compliance conditions reported by the MoEF&CC Regional Office.

3. Existing EC need to be transferred in the name of M/s Dasami Lab Pvt. Ltd. 4. Proposed expansion including chemical storage should to be undertaken within the

existing plot area without affecting nearby agricultural land. Adequate safty measure to be adopted without affecting nearby farmer’s land.

100

It was recommended that ‘TORs’ along with Public Hearing prescribed by the Expert Appraisal Committee (Industry) should be considered for preparation of EIA / EMP report for the above mentioned project in addition to all the relevant information as per the ‘Generic Structure of EIA’ given in Appendix III and IIIA in the EIA Notification, 2006. The draft EIA/EMP report shall be submitted to the State Pollution Control Board for public hearing. The issues emerged and response to the issues shall be incorporated in the EIA report.

6.10.5 Setting up of Synthetic Organic Chemicals (Bulk Drugs and Intermediates) at Sy.No. 97(Part), 98 (Part), 61 (Part), 60 (Part) and 99 (Part) , Abdulla Nagar Village, Tadwai Mandal, Nizamabad District, Telangana by M/s Sapala Organics Pvt. Ltd. – reg TOR.

The project authorities gave a detailed presentation on the salient features of the project and proposed environmental protection measures to be undertaken along with the draft Term of References for the preparation of EIA-EMP. All Synthetic Organic Chemicals (Bulk Drugs and Intermediates) Industry located outside the notified industrial area/estate are listed at S.N. 5(f) under category ‘A’ and appraised by Expert Appraisal Committee (I).

M/s. Sapala Organics Pvt. Ltd., proposed to setting up Synthetic Organic chemical Manufacturing Unit at Sy.No. 97(Part), 98 (Part), 61 (Part), 60 (Part) and 99 (Part) , Abdulla Nagar Village, Tadwai Mandal, Nizamabad District, Telangana. There are three reserve forests in the study area; Lingampet RF at a distance of 7 km in south direction, Nandiwada RF at a distance of 7.6 km in southwest direction, Sarampalle RF at a distance of 8 km in west direction. Kamareddy tank is at distance of 4.5 km in northeast direction and Yellareddypet tank is at a distance of 6.5 km in north direction. As per Form-1, it is reported that no ecologically sensitive areas like national parks, sanctuaries within 10 km radius of the site.

Total plot area is 26.46 Acres of which an area earmarked for greenbelt is 8.8 Acres. Total capital cost of the project is Rs. 30 Crores.

Manufacturing product with capacity is presented as follows:

S.No Name of the Product Capacity

TPM (Kg/day)

1 Alendronate Sodium 3.0 100

2 Aripiprazole 9.0 300

3 Atorvastatin Calcium 1.2 40

4 Azacitidine 3.0 100

5 Bicalutamide 3.0 100

6 Bortezomib 0.5 15

7 Candesartan 2.3 75

8 Capacitabine 12.0 400

9 Carvedilol 6.0 200

10 Celecoxib 12.0 400

11 Cetrizine HCl 6.0 200

12 Citalopram HBr 4.5 150

13 Clopidogrel Bi Sulphate 3.0 100

14 Disodium Pamidronate 1.5 50

15 Divalprox Sodium 15.0 500

16 Docetaxal Trihydrate 0.3 10

17 Domperidone 3.0 100

18 Donepezil HCl 3.0 100

19 Dronedarone HCl 9.0 300

20 Duloxetine HCl 3.0 100

21 Esomeprazole Mg 15.0 500

DASAMI LAB PVT.LTD. (Formerly Known as Medchem Organics Pvt. Ltd.)

SY.NO. 404, 405, 407, 408, 409 & 410, VELIMINEDU VILLAGE, CHITYAL MANDAL, NALGONDA DISTRICT,

TELANGANA

UPDATED FORM I

Project No. 1216‐21‐01 December 2016

M/s. Hetero Drugs Limited Plot No: 7‐2‐A2 Hetero Corp, Industrial Estate, Sanathnagar, Hyderabad‐500018 Phone: 040‐23704923/23704924 E‐mail: [email protected]

STUDIES AND DOCUMENTATION BYTEAM Labs and Consultants B‐115‐117 & 509, Annapurna Block, Aditya Enclave, Ameerpet, Hyderabad‐500 038. Phone: 040‐23748 555/23748616, Telefax: 040‐23748666

SUBMITTED TO MINISTRY OF ENVIRONMENT, FOREST AND CLIMATE CHANGE

GOVERNMENT OF INDIA INDIRA PARYAVARAN BHAWAN, JOR BAGH ROAD, NEW DELHI

M/s. Dasami Lab Pvt. Ltd

Form I Page 1

APPENDIX – I (See Paragraph – 6)

FORM I I) Basic Information S.No. Item Details 1 Name of the Project/s M/s. Dasami Lab Pvt. Ltd.

(formerly known as Medchem Organics Pvt Ltd. ) 2 S. No in the Schedule 5 (f) –A category (Synthetic Organic Chemicals) 3 Proposed capacity/area/length/tonnage to

be handled/command area/lease area/number of wells to be drilled

Area Existing: 7.125 Acres Area after Expansion: 51 Acres

Permitted Production Capacity: 15 TPM Capacity after Expansion: 421 TPM It is proposed to manufacture 27 products at a time on campaign basis out of 35 Products CHANGE in Layout

4 New/Expansion/Modernization Expansion 5 Existing Capacity/Area etc. Existing Capacity: 15 TPM

Area Existing: 7.125 Acres 6 Category of Project i.e 'A' or 'B' “A” 7 Does it attract the general condition? If yes,

please specify No

8 Does it attract the Specific condition? If yes, please specify.

No

9 Location Plot/Survey/Khasra No. Survey No. : 404, 405, 407, 408, 409 & 410 Village Veliminedu Village Tehsil Chityal Mandal District Nalgonda District State Telangana

10 Nearest railway station/airport along with distance in km.

Railway Station: Chityal Railway Station– 9.64 Km Airport : Rajiv Gandhi International Airport – 61.72 Km

11 Nearest Town, City, District Headquarters along with distance in kms.

Chityal– 7.6 Km

12 Village Panchayats, Zilla Parishad, Municipal Corporation, Local body (complete postal address with telephone nos. to be given)

Veliminedu –Village Panchayat

13 Name of the Applicant Mr. J. Sambi Reddy 14 Registered Address M/s Dasami Lab Pvt. Ltd.,

( formerly known as Medchem Organics Pvt.Ltd., ) Survey No. 404, 405, 407, 408, 409 & 410 Veliminedu Village, Chityal Mandal Nalgonda District, Telangana

15 Address for Correspondence: Name J.Sambi Reddy Designation(Owner/Partner/CEO) Director


Form I Page 2

Address Plot no.7‐2‐A2, Hetero Corp, Industrial Estates, Sanathnagar, Hyderabad, Telangana.

Pin Code 500018 E‐mail [email protected]; Telephone Number 040‐23704923/23704924 Fax No. 040‐23704035

16 Details of alternative Sites examined, if any. Location of these sites should be shown on a topo sheet.

Not Applicable

17 Interlinked Projects Not applicable18 Whether separate application of interlinked

project has been submitted? ‐NA‐

19 If yes, date of submission ‐NA‐ 20 If no, reason 21 Whether the proposal involves

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?

‐NA‐

22 Whether there is any Government Order/Policy relevant/relating to the site?

No

23 Forest land involved (hectares) No 24 Whether there is any location 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.

No


Form I Page 3

(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

land use, land cover or topography including increase in intensity of land use (with respect to local land use plan)

NO The proposal is for expansion of existing bulk drug and intermediate manufacturing unit. The additional land acquired for proposed expansion is 43.875 Acres. The Total Land Area after expansion is 51 Acres.

1.2 Clearance of existing land, vegetation and buildings?

NO The proposal is for expansion of existing bulk drug and intermediate manufacturing unit. The additional land acquired for proposed expansion is 43.875 acres.

1.3 Creation of new land uses? NO Existing – industrial

1.4 Pre‐construction investigations e.g. bore houses, soil testing?

YES Soil test done and soil load bearing capacity established

1.5 Construction works? YES Construction activity involves creation of Production Block, Utilities, ZLD system etc.

1.6 Demolition works? NO The proposal is for expansion of existing bulk drug and intermediate manufacturing unit. The proposed expansion activity involves creation of Production Block, Utilities, ZLD system, etc.

1.7 Temporary sites used for construction works or housing of construction workers?

NO Construction labor from local villages shall be employed.

1.8 Above ground buildings, structures or earthworks including linear structures, cut and fill or excavations

YES Storage facilities shall be constructed. No major cut and fill or excavation is anticipated.

1.9 Underground works including mining or tunneling?

NO No underground works like mining and tunneling.

1.10 Reclamation works? NO 1.11 Dredging? NO 1.12 Offshore structures? NO 1.13 Production and manufacturing

processes? YES Enclosed in Annexure – I

1.14 Facilities for storage of goods or materials?

NO Raw materials and solvents shall be stored with in factory premises. Materials in bags and drums will be stored in flame proof ware houses.

1.15 Facilities for treatment or disposal of solid waste or liquid effluents?

YES High TDS and low TDS effluents are treated in ZLD system. Organic waste is sent to cement plants for co‐ processing or to TSDF. Details of waste treatment facilities presented in Annexure II

1.16 Facilities for long term housing of operational workers?

NO Operational workers stay in surrounding villages.

1.17 New road, rail or sea traffic during YES Construction materials shall be transported to the site.


Form I Page 4

construction or operation? The traffic density of the existing connecting road is negligible.

1.18 New road, rail, air waterborne or other transport infrastructure including new or altered routes and stations, ports, airports etc?

NO

1.19 Closure or diversion of existing transport routes or infrastructure leading to changes in traffic movements?

NO

1.20 New or diverted transmission lines opipelines?

NO

1.21 Impoundment, damming, culverting, realignment or other changes to the hydrology of watercourses or aquifers?

NO

1.22 Stream crossings? NO All raw materials, solvents and waste streams are pumped through pipe lines above ground level.

1.23 Abstraction or transfers of water form ground or surface waters?

YES Total water required shall be met from ground water using bore‐wells within the plant premises. Permitted water consumption is 107.06 KLD. Total water required after expansion shall be 487.2 KLD out of which 292.2 KLD is fresh water requirement and balance is recycled water.

1.24 Changes in water bodies or the land surface affecting drainage or run‐off?

NO

1.25 Transport of personnel or materials for construction, operation or decommissioning?

YES The construction material shall be drawn from local sources within 10 km. There is no transport of personnel, as the construction workers shall be drawn from local villages.

1.26 Long‐term dismantling or decommissioning or restoration works?

NO

1.27 Ongoing activity during decommissioning which could have an impact on the environment?

NO

1.28 Influx of people to an area in either temporarily or permanently?

YES The proposed project shall increase the employment potential.

1.29 Introduction of alien species? NO 1.30 Loss of native species or genetic

diversity? NO There are no major losses of tree/shrub species.

1.31 Any other actions? NO


Form I Page 5

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

agricultural land (ha) YES Land area after expansion 51 acres

Located at Survey No. 404, 405, 407, 408, 409 & 410 Veliminedu Village, Chityal Mandal, Nalgonda District, Telangana.

2.2 Water (expected source & competing users) unit: KLD

YES Permitted water consumption is 107.06 KLD. Total water required after expansion shall be 487.2 KLD out of which 292.2 KLD is fresh water requirement and balance is recycled water. (Water Balance Enclosed in Annexure III)

2.3 Minerals (MT) NA 2.4 Construction material – stone,

aggregates, sand / soil (expected source – MT)

YES Shall be sourced from the local villages.

2.5 Forests and timber (source – MT)

NO

2.6 Energy including electricity and fuels (source, competing users) Unit: fuel (T), energy (MW)

YES The required energy shall be drawn from TSPDCL. Standby DG sets of 3 X 1000 KVA is proposed in addition to existing 380 KVA DG set.

It is proposed to establish 2X10 TPH coal fired boiler in addition to existing 5 TPH coal fired boiler to meet the steam requirement both for process and ZLD system. Existing 5TPH coal fired boiler shall be kept as standby after expansion. Coal consumption after expansion is 116 TPD.

2.7 Any other natural resources (use appropriate standard units)

NA


Form I Page 6

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

are hazardous (as per MSIHC rules) to human health or the environment (flora, fauna, and water supplies)

YES Hazardous chemicals shall be used for manufacturing of Synthetic Organic Chemicals and intermediates. MSIHC rules shall be followed during storage, transportation and handling of raw materials. Hazardous chemicals and solvent shall be stored and handled in closed systems.

3.2 Changes in occurrence of disease or affect disease vectors (e.g. insect or water borne diseases).

NO

3.3 Affect the welfare of people e.g. by changing living conditions?

YES Shall increase the employment potential for locals and affect the living conditions for betterment.

3.4 Vulnerable groups of people who could be affected by the project e.g. hospital patients, children, the elderly etc.,

NO No sensitive receptors are present in the immediate vicinity of the site. The project shall not have any significant impact on 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

commercial wastes) NO Wastes from canteen, other commercial wastes like

paper, empty containers etc. The canteen wastes and commercial wastes shall be in the range of 30 kg/day

4.3 Hazardous wastes (as per Hazardous Waste Management Rules)

YES Hazardous waste generation during construction shall be limited to waste oils, batteries and containers of paints etc. The quantity of hazardous wastes generated during operation contain salts from evaporators, process residue, and solvent residues, ETP sludge and filtration media etc.

4.4 Other industrial process wastes YES Enclosed at Annexure IV 4.5 Surplus product NO 4.6 Sewage sludge or other sludge from

effluent treatment YES Sludge from Effluent treatment plant and evaporation

salts shall be sent to TSDF ,Dundigal ,RR district. 4.7 Construction or demolition wastes NO Construction activities involve creation of Production

Blocks, Utilities and ZLD system. 4.8 Redundant machinery or equipment NO 4.9 Contaminated soils or other materials NO All pipe lines including pipe lines of waste streams

are above ground level 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 YES


Form I Page 7

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

fuels from stationary or mobile sourcesYES Coal Shall be used as fuel. Emissions details are

enclosed in Annexure V5.2 Emissions from production processes YES Gaseous emissions from process are ammonia, HCl,

SO2, are scrubbed in two stage scrubbers while carbondioxide, oxygen and nitrogen gases are let out into atmosphere using standard operating procedure. Hydrogen gas send to atmosphere through water column.

5.3 Emissions from materials handling including storage or transport

NO Material transfer takes place in closed pipeline systems using pumps with mechanical seals.

5.4 Emissions from construction activities including plant and equipment

YES Dust may rise during transport of material and 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 materials including construction materials, sewage and waste

NO Domestic wastewater sent to zero liquid discharge system.

5.6 Emissions from incineration of waste NO Organic waste streams are sent to cement plants for co‐incineration.

5.7 Emissions from burning of waste in open air (e.g. slash materials, construction debris)

NO

5.8 Emissions from any other sources NO


Form I Page 8

6. Generation of Noise and Vibration, and Emissions of Light and Heat: S.No. Information/Checklist confirmation Yes/No Details thereof (with approximate quantities/rates,

wherever possible) with source of information data with source of information data

6.1 From operation of equipment e.g. engines, ventilation plant, crushers

YES Material transport and construction equipment shall be source of noise, while transfer pumps, vacuum systems, DG sets are the sources of noise during operation.

6.2 From industrial or similar processes YES DG sets controlled by providing Acoustic 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

traffic NO The increased traffic shall not have any significant

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 confirmation Yes/No Details thereof (with approximate quantities/rates,

wherever possible) with source of information data 7.1 From handling, storage, use or

spillage of hazardous materials NO All the hazardous materials will be stored in MS drums,

in a covered shed and no contamination of soil is expected. Same philosophy will be followed for the after expansion

7.2 From discharge of sewage or other effluents to water or the land (expected mode and place of discharge)

NO All the waste from domestic operations sent to ZLD system.

7.3 By deposition of pollutants emitted to air into the land or into water

NO All the emissions from process are controlled by providing control equipment like scrubbers, Bag filters.

7.4 From any other sources NO 7.5 Is there a risk of long term build up

of pollutants in environment from these sources?

NO


Form I Page 9

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 storage, handling, use or production of hazardous substances

YES All Inbuilt Safety precautions will be adopted and there will not be any damage to environment or human health

8.2 From any other causes NA 8.3 Could the project be affected by natural disasters

causing environmental damage (e.g. Floods, earthquakes, landslides, cloudburst etc)?

NO

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. facilities, ancillary development or development stimulated by the project which could have impact on the environment e.g.: • Supporting infrastructure (roads, power supply, waste or waste water treatment, etc.) • housing development • extractive industries • supply industries • other

YES The project shall enhance the socio economic status of the area by increasing the demand for housing, improving the employment.

9.2 Lead to after‐use of the site, which could haven impact on the environment

NO

9.3 Set a precedent for later developments NO

9.4 Have cumulative effects due to proximity to other existing or planned projects with similar effects

NO The baseline environmental status of the surrounding areas is within the prescribed limits as observed from the Secondary data.


Form I Page 10

(III) Environmental Sensitivity S.No. Areas Name/

Identity Aerial distance (within 15 km.) Proposed project location boundary

1 Areas protected under international conventions, national or local legislation for their ecological, landscape, cultural or other related value

NA

2 Areas which are important or sensitive for ecological reasons ‐ Wetlands, watercourses or other water bodies, coastal zone, biospheres, mountains, forests

YES Chityala RF ‐ E ‐ 6 km Shivanenigudem RF – NE ‐ 9 km Chinna Vagu is in SW direction at a distance of 7.1 Km from the site

3 Areas used by protected, important or sensitive species of flora or fauna for breeding, nesting, foraging, resting, over wintering, migration

NA

4 Inland, coastal, marine or underground waters NO 5 State, National boundaries NO 6 Routes or facilities used by the public for access to

recreation or other tourist, pilgrim areas NO

7 Defense installations NO 8 Densely populated or built‐up area YES Nearest habitation from the site is

Veliminedu village at a distance of 2.9 Km in NW direction

9 Areas occupied by sensitive man‐made land uses (hospitals, schools, places of worship, community facilities)

NA

10 Areas containing important, high quality or scarce resources (ground water resources, surface resources, forestry, agriculture, fisheries, tourism, minerals)

NO

11 Areas already subjected to pollution or environmental damage. (those where existing legal environmental standards are exceeded)

NO

12 Areas susceptible to natural hazard which could cause the project to present environmental problems (earthquakes, subsidence, landslides, erosion, flooding or extreme or adverse climatic conditions)

NO



TELANGANA

ANNEXURES

Project No. 1216‐21‐01 December 2016

M/s. Hetero Drugs Limited. Plot No: 7‐2‐A2 Hetero Corp, Industrial Estate, Sanathnagar, Hyderabad‐500018 Phone: 040‐23704923/23704924 E‐mail: [email protected]

STUDIES AND DOCUMENTATION BYTEAM Labs and Consultants B‐115‐117 & 509, Annapurna Block, Aditya Enclave, Ameerpet, Hyderabad‐500 038. Phone: 040‐23748 555/23748616, Telefax: 040‐23748666

SUBMITTED TO MINISTRY OF ENVIRONMENT, FOREST AND CLIMATE CHANGE

GOVERNMENT OF INDIA INDIRA PARYAVARAN BHAWAN, JOR BAGH ROAD, NEW DELHI

M/s. Dasami Lab Pvt. Ltd., Form I Annexures (formerly known as Medchem Organics Pvt. Ltd.,)

Page 1

Fig

A.1

Loc

atio

n M

ap o

f M /

s. D

asam

i Lab

Pvt

. Ltd

.,


Page 2

Fig A.2 Plant Layout after Expanion of M/s. Dasami Lab Pvt. Ltd.,


Page 3

ANNEXURE - I

M/s. Dasami Lab Pvt. Ltd., (formerly known as Medchem Organics Pvt. Ltd.) located at

Survey No. 404, 405, 407, 408, 409 & 410. Veliminedu (V), Chityal Mandal, Nalgonda

District, Telangana obtained consent and authorization (CFO) for manufacturing of 10.5

TPM of vide Letter No. TSPCB/256/RCP/NLG/HO/CFO/2014-196 dated 22.11.2014. It is

proposed to increase the manufacturing capacity from 15 TPM to 421 TPM by acquiring

additional land of 43.875 acres in addition to existing 7.1254 acres of land; total land area

after expansion is 51 acres. Expansion includes addition of production blocks, facility for

utility proposed and enhancement of ZLD system. Capacity permitted and after proposed

expansion is presented in Table A-1 and A-2.

Table A-1 Manufacturing Capacity - Permitted S.No Name of the Product Capacity

Kg/day TPA 1 Tramadol HCl 166.7 60 2 Ramipril 166.7 60 3 Omeprazole 166.7 60 4 Carvedilol 166.7 60 5 Setraline HCl 166.7 60 6 Duloxetine HCl 100.0 36 7 Sparfloxacin 133.3 48 8 Drotaverine HCl 83.3 30 9 Clopidogrel Hydrogen Bisulfate 166.7 60 Total (Worst case-3 Products) 500.0* 180

Note:* Maximum capacity of any of the above three products


Page 4

Table A-2 Manufacturing Capacity –After Expansion

S.No Name of the Product Capacity TPM

1 Amlodipine Besylate 20 2 Aprimilast 3 3 Bocepravir 6 4 Bupropion Hcl 20 5 Carvedilol 30 6 Clopidogrel Hydrogen Bisulfate 10 7 Colisevelam 6 8 Dalfampridine 17 9 Dex lansoprazole 5 10 Divalproex Sodium 15 11 Drotaverine Hcl 3 12 Duloxetine HCL 15 13 Esli Carbazapine 2 14 Fexofenadine Hcl 10 15 Glimepride 3 16 Lansoprazole 8 17 Lomitapide 2 18 Mesalamine 7 19 Nebumitone 10 20 Omeprazole 5 21 Piperquine Phosphate 5 22 posacanazole 7 23 Ramipril 7 24 Ranolazine 10 25 Sevelamir Hcl 29 26 Sparfloxacin 20 27 Telapravir 5 28 Ticagrelor 1 29 Tramadol Hcl 12 30 Valacyclovir 6 31 Valagancyclovir Hcl 2

Oncology 32 Abiraterone Acetate 1 33 Anastrozole 2 34 Bendamustine Hydochloride 2.5 35 Bexarotene 3 36 Bicalutamide 5 37 Bortezomib 0.5 38 Carboplatin 5 39 Capecitabine 2 40 Cisplatin 2


Page 5

41 Cyclophosphamide 2 42 Dasatinib 2 43 Emtricitabine 30 44 Erlotinib HCl 4 45 Gefitinib 2 46 Gemcitabine HCl 1 47 Imatinib Mesylate 16 48 Irinotecan HCl 14 49 Lapatinib Ditosylate Monohydrate 2 50 Letrozole 2.5 51 Nilotinib HCl 2 52 Oxaliplatin 4 53 Pazopanib Hydrchloride 2 54 Pemetrexed Disodium 0.5 55 Sorafenib Tosylate 6 56 Temozolomide 1 57 Sunitinib Malate 6

Total 421


Page 6

Process Description of Mesalamine:

Reaction Schemes

Stage I

O H

O

N +

O - O

C l

+ K O HO H

O

N +

O - O

O H

+ K C l

2 - c h lo r o - 5 - P o t . H y d r o x i d e 2 - h y d r o x y - 5 - P o t c h l o r i d e n i t r o b e n z o i c a c id n i t r o b e n z o i c a c i d M o l W t . 7 4 . 1 5 M o l .W t : 2 0 1 .5 M o l . W t : 5 6 M o l .W t : 1 8 3 Stage II

Stage III

O H

O

N H 2

O H

O H

O

N H 2

O H

+ N aO HC lH + + Na COH 2 +

5 -a m in o-2 -h yd ro xyb e nz o ic a cid 5 -a m in o-2 - hy d rox yb en z o ic a c id M o l.W t: 1 5 3 M .W t :1 53 Process Description:

Stage I: MES2 (2-chloro-5-nitro-benzoic acid) is dissolved in Potassium hydroxide solution.

Reaction mass is heated. After TLC is complied, pH of reaction mass is adjusted. Reaction

mass is filtered. One water slurry operation has been incorporated to this wet material to

remove the excess salts present. After filtration the product is dried.

Stage II: Hydrogenation of MAN1 (2-hydroxy-5-nitro benzoic acid) in Basic medium (Water +

Sodium carbonate) gives sodium salt of MAN2 in presence of Raney Nickel as catalyst. After

filtering the raney nickel from the reaction mass, pH of the reaction mass is adjusted. MAN2

(crude) is precipitated and the reaction mass is filtered.


Page 7

Stage III: Stage II Product is reacted with Hydrochloric acid and sodium Hydroxide to give

the final product Mesalamine. The process flow diagram for Mesalamine is presented in Fig

A.3 and material balance is presented in Table A.3.


Page 8

Fig A.3 Process Flow Diagram of Mesalamine


Page 9

Table A-3 Material Balance of Mesalamine Stage I Input Quantity

(Kg/day) Output Quantity

(Kg/day) Remarks

2-chloro-5-nitrobenzoic acid

524.9 2-hydroxy-5-nitrobenzoic acid 456.7 To Stage-II

Potassium hydroxide 145.9 Potassium Chloride 185.9 To Wastewater Water 2312 2-chloro-5-nitrobenzoic acid 22.0 To Wastewater HCl for KOH Neutrtalization

4.0 Potassium hydroxide 6.1 To Neutralization

Water 2314 To Wastewater KCl from KOH Neutralization 8.2 To Wastewater Total Input 2986.8 Total Output 2986.8 Stage II Input Quantity


(Kg/day) Remarks

2-hydroxy-5-nitrobenzoic acid

456.7 5-amino-2-hydroxybenzoic acid 253 To Stage-III

Hydrogen 9.9 Water 5874.5 To Wastewater Nickel 105.1 2-hydroxy-5-nitrobenzoic acid 154 To Wastewater Sodium hydrosulphite 70.1 Nickel 105 Inorganic Residue Sodium bi carbonate 210.2 Sodium hydrosulphite 70 To Wastewater Water 5815.0 Sodium bi carbonate 210 To Wastewater Total Input 6667.0 Total Output 6667.0 Stage III Input Quantity


(Kg/day) Remarks

5-amino-2-hydroxybenzoic acid

252.9 Mesalamine 233.3 Final Product

Hydrochloric acid 65.0 Sodium Chloride 104.2 To Wastewater sodium hydroxide 71.2 Water generated during reaction 27.4 To Wastewater water 2347 5-amino-2-hydroxybenzoic acid 19.6 To Wastewater water 2351.6 To Wastewater Total Input 2736.1 Total Output 2736.1


Page 10

ANNEXURE – II: Wastewater Treatment Facilities

The main sources of effluent generation from the plant are from process, floor washings,

blowing downs from boiler and cooling tower, and domestic effluents. The effluents

generated in the process, separation techniques and during purification contain organic

residues of raw materials, solvents, and products. Some of the raw materials used in the

process are also inorganic in nature. Hence the effluents contain both organics and in-

organics in various quantities leading to high COD and TDS levels respectively. The

quantity of effluents generated and mode of treatment is presented in Table A-4.

Table A-4 Quantity of Effluent Generated and Mode of Treatment

Description Quantity (KLD) Mode of Treatment Permitted After

Expansion HTDS Effluents

Process 20.8 118.44 Sent to Stripper. Stripper condensate shall dispose to cement industries for co-processing/TSDF. Stripper bottom sent to MEE followed by AFTD. Condensate from MEE shall be sent to biological treatment plant followed by RO. RO rejects sent to MEE and permeate is reused in cooling towers and boiler make-up and scrubbers.

Washings 3 10 Scrubber Effluent 5 RO/DM Plant Rejects 24

Total I 23.8 157.44 LTDS Effluents

QC and R&D 1 Boiler Blow downs 3 10 Sent to Biological Treatment System

followed by RO. RO permeate reused for cooling tower makeup and scrubbers. RO rejects sent to MEE.

Cooling Tower Blow downs

36

Domestic 3 20 Total II 7 66 Grand Total (I+II) 30.8 223.44


Page 11

ANNEXURE – III: Water Balance

Water is required for process, scrubbers, washing, cooling tower makeup, steam

generation and domestic purposes. The required water shall be drawn from ground water

sources in addition to reuse of treated wastewater. The total water requirement after

expansion is in the order of 487.2 KLD consisting of 292.2KLD fresh water and the

remaining of recycled water. Total water balance after expansion is presented in

Table A-5.

Table A-5 Total Water Balance – After Expansion

Purpose INPUT (KLD) OUTPUT (KLD) Fresh Water Recycled Water Loss Effluent

Process 113.2 118.44 Washings 10 10 Scrubber 5 5 Boiler Feed 95 85 10 Cooling Tower 10 190 164 36 RO/DM Plant 24 24 Domestic 25 5 20 Gardening 15 15 Gross Total 292.2 195 269.0 223.44 Total 487.2 492.4


Page 12

ANNEXURE – IV: Solid Waste

Solid wastes are generated from the process shall be sent to TSDF/ Cement Industries for Co-

incineration. The inorganic residue, evaporation salts from MEE and ATFD and ETP Sludge

shall be sent to TSDF. Total solid waste generated and mode of disposal is presented in Table

A-6.

Table A-6 Total Solid Waste Generated and Mode of Disposal S.No Description Units Quantity Mode of

Treatment/Disposal Permitted After Expansion

1 Ash from Boiler TPD - 2.13 Sold to Brick manufactures and cement plants

2 Organic residue+Solvent Residue

TPD 1.6 11.5 Sent to TDSF, Dundigal, RR District or Co-incineration/Cement Plants for Co-processing

3 Spent Carbon TPD 0.06 0.99 Sent to TSDF/Cement Industries

4 Stripper Distillate KLD 5.6 Sent to TSDF/Cement Industries

5 Inorganic Residue TPD 1.2 6.76 Sent to TDSF, Dundigal, RR District for secured land filling

6 Evaporation salts TPD 9.23

7 ETP Sludge Kg/day 25 923 Sent to TSDF 8 Detoxified

containers & container liners

No.s/Month

-- 500 Sold to authorized vendors

9 Waste oil KLPA 2 5.28 Sent to Authorized Recyclers

10 Used batteries No.s/Yr 3

10 Sent to Authorized Recyclers


Page 13

ANNEXURE – V: Stack Emissions Details

The sources of air pollution from the plant are existing 5 TPH Coal fired boiler and proposed

2X10TPH Coal fired boiler. DG sets of 380 KVA of existing and proposed 3 x 1000 KVA

capacity. The proposed air pollution control equipment for coal fired boiler is Bag filters. DG

sets shall be provided with stack heights based on the CPCB formula for effective stack

height.

Stack Emission Details

S. No

Stack Connected to Stack Ht (m)

Dia of stack at top(m)

Temp. of exhaust

gases (0C)

Exit Velocity (m/sec)

Pollutant Emission Rate (g/sec)

SPM SO2 NOx Existing

1 5TPH Coal Fired Boiler

27 1.45 180 4.5 0.15 0.18 0.33

3 380KVA DG Set 4 0.1 200 10 0.19 0.14 0.27 Proposed

1 2X10 TPH Coal Fired Boiler

30 1.2 200 10 0.3 0.5 0.8

2 3X1000KVA DG set 10 0.15 151 13.86 0.01 0.02 0.03 *DG sets will be used during load shut down by TSPDCL.



TELANGANA

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]

as per the ‘generic structure of eia’ given...

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