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HINDYS LAB PVT.LTD. SY.NO. PARTS OF 289, 290, 291 AND 292, VELIMINEDU VILLAGE,

CHITYAL MANDAL, NALGONDA DISTRICT, TELANGANA

FORM I

Project No. 0217‐21‐02 February 2017

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 BY TEAM 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.Hindys 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.Hindys Lab Pvt. Ltd.,

(formerly known as Hychem Laboratories.) 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: 3.47 Acres Area after Expansion: 11 Acres

Permitted Production Capacity: 5.25 TPM Capacity after Expansion: 150 TPM It is proposed to manufacture 27 products at a time on campaign basis out of 32 Products

4 New/Expansion/Modernization Expansion 5 Existing Capacity/Area etc. Existing Capacity: 5.25 TPM

Area Existing: 3.47 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. : Parts of 289, 290, 290 291 and 292 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– 6 Km Rajiv Gandhi International Airport – 55 Km

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

Nalgonda is the Nearest Town to Veliminedu with a distance of 35 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 Hindys Lab Pvt. Ltd.,

( formerly known as Hychem Laboratories., ) Survey No. Parts of 289, 290, 290 291 and 292, Veliminedu Village, Chityal Mandal Nalgonda District, Telangana

15 Address for Correspondence: Name J.Sambi Reddy Designation(Owner/Partner/CEO) Director Address Plot no.7‐2‐A2, Hetero Corp, Industrial


Form I Page 2

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 applicable 18 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 7.53 Acres. The Total Land Area after expansion is 11 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 7.53 Acres. The Total Land Area after expansion is 11 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, enhancement of ZLD system.

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, enhancement of ZLD system

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.


Form I Page 4

1.17 New road, rail or sea traffic during construction or operation?

YES Construction materials shall be transported to the site. 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 11.35 KLD. Total water required after expansion shall be 299.6 KLD out of which 206.6 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? NO1.30 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 10 acres

Located at Survey No. Parts of 289, 290, 290 291 and 292, Veliminedu Village, Chityal Mandal, Nalgonda District, Telangana

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

YES Permitted water consumption is 11.35 KLD. Total water required after expansion shall be 299.6 KLD out of which 206.6 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 1 x 1500 KVA, 2 X 1000 KVA and 3 x 500 KVA is proposed in addition to existing 250 KVA DG set.

It is proposed to establish 2 x 8 TPH coal fired boiler in addition to existing 2 TPH coal fired boiler to meet the steam requirement both for process and ZLD system. Coal consumption after expansion is 75 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. 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. 4.7 Construction or demolition wastes NO Construction activities involve creation of Production

Blocks, Utilities and enhancement of 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 let out into 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 Chityal 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



ANNEXURES

Project No. 0217‐21‐02 February 2017

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 BY TEAM 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. Hindys Lab Pvt. Ltd., Form I Annexures

Page 1

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Fig A.2 Plant Layout after Expansion of M/s. Hindys Lab Pvt. Ltd.,


Page 3

ANNEXURE - I

M/s. Hindys Lab Pvt. Ltd., (formerly known as M/s. Hychem Laboratories) located at

Survey No. Parts of 289, 290, 291 and 292, Veliminedu village, Chityal Mandal, Nalgonda

District, Telangana. The unit obtained consent for operation (CFO) vide Letter No.

TSPCB/RCP/NLG/CFO&HW/HO/2016-05 dated 29.03.2016. It is proposed to increase

the manufacturing capacity from 5.25 TPM to 150 TPM by acquiring additional land of 7.53

acres in addition to existing 3.47 acres of land; total land area after expansion is 11 acres.

Expansion includes addition of production blocks, facility for utility proposed and

enhancement of ZLD system. Capacity before and after 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 Group A*

1 2- Chloro methyl - 1,4 - methoxy -3,5-dimethyl Pyridine

116.66 42

2 N- Butyl Lithium 58.33 21 Total 174.99 63

Group B* 3 5- Cyano Phthalide 61.1 22 4 Cis - Bromo benzoate 91.6 33

Total 152.7 55 Note: The above products are manufactured on campaign basis, i.e. at any point of time only one group will be manufactured.


Page 4

Table A-2 Manufacturing Capacity –After Expansion S.No Product Name Capacity

TPM Kg/day 1 Amlodipine Besylate 1000 33.3 2 Clopidogrel Hydrogen Sulfate 5000 166.7 3 Dex Lansoprazole 1000 33.3 4 Divolproex sodium 3500 116.7 5 Dulaxetine 5000 166.7 6 Glimepiride 600 20.0 7 Mesalamine 1000 33.3 8 Metaprolol 7000 233.3 9 Nebivolol HCL 9000 300.0 10 Pragabalin 1000 33.3 11 Rosuvastatin 3000 100.0 12 Sertraline HCl 4000 133.3 13 Valaciclovir 1000 33.3 14 2- Acetyl Ethoxy acetyl methoxy ether (AEA) (Acyclovir

Intermediate) 12400 413.3

15 Trans-4-(4-chlorophenyl)-cyclohexane carboxylic acid (Atovaquone Intermediate)

500 16.7

16 5-Cyano phthalide (Citalopram Intermediate) 8000 266.7 17 Ethyl 3-{[3-Amino-4-(Methylamino) Benzoyl](Pyridine-2-Yl)

Amino} Propanoate (EMP) (Dabigatran Etixilate Mesylate Intermediate)

1000 33.3

18 (S)-3-(Dimethylamino)-1-(2-thienyl)-1-propanol (DMTP) (Duloxetine Intermediate)

500 16.7

19 (Cis-Exo)-2,3-norbornane dicarboximide [BDX] (Lurosidone HCl Intermediate)

9000 300.0

20 (1R,2R)-cyclohexane-1,2-diyl-bis (methylene) dimethane sulfonate [MOC] (Lurosidone HCl Intermediate)

1500 50.0

21 2-[2-[3(S)-[3-[2-(7-Chloro-2-Quinolinyl)-ethenyl]phenyl]-3-hydroxypropyl]phenyl-2-propanol (CQHP) (Montelucast Sodium Intermediate)

500 16.7

22 2,8-Diazo bicyclo Nonane (Moxifloxacin Intermediate)

500 16.7

23 Carbamyl Methyl-5-Methyl hexanoic Acid (CMM) (Pragabalin Intermediate)

4000 133.3

24 (2S,3S,5S)-2-Amino-3-Hydroxy-5-Tert-Butylcarbonyl Amino 1,6-Diphenyl (BDH pure) (Ritonavir Intermediate)

500 16.7

25 Tert-butyl 2-((4R,6S)-6-((E)-2-(4-(4-flurophenyl)-6-isopropyl-2-(N- methylmethane sulfonamido)Pyrimidin - 5-yl)vinyl)-2,2-dimethyl-1,3-dioxane-4-yl-) acetate (TIN) (Rosuvastatin Intermediate)

3000 100.0

26 Poly allyl amine HCl (Sevelamir Intermediate) 5000 166.7 27 Dibenzimidazole (Telmisartan Intermediate) 6000 200.0 28 Diacetyl acyclovir (Valaciclovir Intermediate) 16000 533.3


Page 5

29 Camphor sulfonyl dichloride (Intermediate of Esmoperazole Magnesium)

7000 233.3

30 D- Mandalic acid (Intermediate of Sertraline HCl) 5000 166.7 31 4-(3,4-Dichlorophenyl)-3,4-dihydro-N-methyl-1-(2H)-

Napthaleneimine (Intermediate of Sertraline Hcl) 26000 866.7

32 N2-(1-(S)-ethoxy carbonyl-3-phenyl propyl-N6-trifluoro acetyl-L-lyline (Intermediate of Lisinopril)

4000 133.3

Total Worst Case: 27 Products on Campaign Basis 150000 5000

Reaction Schemes of Clopidogrel

OS

S

OO

C H3

O OC H3

NH2

C l

NH

S C l

C O O C H3

NH

S C l

C O O C H3

N

S C l

C O O C H 3

OHO H

O

O H

O H

OS O 3H

C H3

(2-T hienyl)e thylpara-tou lenesulphonate

D ipotassium hydrogen phosphate

Ethyl acetate.T artaric acid salt

M ethyl(+)-a lpha-am ino(2-ch lorophenyl)acetate tartaric acid salt

+

Liq.Am m onia

M ethyl (+)-a lpha-(2-th ienylethylam ino)(2-chlorophenyl)acetate

H C l

STAG E-I

STAG E-II

M ethyl (+)-a lpha-(2-th ienyle thylam ino)(2-chlorophenyl)acetate

AcetoneL(-) cam phor su lphonic acid

E thyl acetate

Sodium bicarbonate

.H SO 4

-

C lopidogre l hydrogen sulfate (Pharm a)

Activated carbon

M .W t: 349.5M .W t: 282

M .W t: 309.5

+ +

Tartaric ac id

M .W t: 150 M .W t: 172

M .W t: 309.5

M .W t: 419.5

+ HC H O + H 2SO 4

M .W t: 30 M .W t: 98

+ H 2O

M .W t:18

p-T oluene sulfonic acid

W ater

W ater


Page 6

Process Description of Clopidogrel:

Stage-I

Methyl(+)-alpha-amino(2-chlorophenyl)acetate tartaric acid salt is condensed with (2-

thienyl)ethylpara-toulene sulphonate in the presence of Liq. Ammonia in ethyl acetate and

water to give methyl(+)-alpha-(2-thienylethylamino)(2-chlorophenyl)acetate.

Stage-II

methyl(+)-alpha-(2-thienylethylamino)(2-chlorophenyl)acetate is condensed with

formaldehyde and on treatment with sulfuric acid in the presence of acetone and water to

yield Clopidogrel hydrogen sulfate (Pharma).

M ethyl(+)-alpha-am ino(2-chlorophenyl)acetate tartaric acid

(2-T hienyl)ethylpara-toulenesulphonate

Liq.A m m onia

M ethylene d ichloride

D ipotassim hyd rogen phosphate

Ethyl acetate

H ydrochloric acid

C on denisation

M ethy(+)-alpha-(2-th ienylethylam ino)(2-chlorophenyl)acetate

L iq.A m m onia

M ethylene d ichlorid e

D ipotassim hyd rogen phosphate

E thyl acetateH yd roch loric acidTartaric acid

P-T oulene su lp honic acid

Stage-I

Stage-II

C yclisation

M ethy(+)-alpha-(2-th ienylethylam ino)(2-chlorophenyl)acetate

Form ald ehyde

Sulfuric acid

A cetoneM ethylene d ichlorid e

L(-)-cam phor su lphonic acidE thyl acetate

Sodium bicarbonateM ethyl isobutyl ketone

A ctivated carbon

A cetone

M ethylene d ich loride

L (-)-cam phor su lphonic acid

E thyl acetate

Sodium bicarbonate

M ethyl isobutyl ketone

A ctivated carbon

Saltification

C lop id ogrel h ydrogen sulfate(P harm a)

W ater W aste w ater

W ater

W aste w ater

Fig A.3 Process Flow Diagram of Clopidogrel hydrogen sulfate


Page 7

Table A-3 Material Balance of Clopidogrel hydrogen sulfate Stage I Input Quantity

(Kg/day) Output Quantity

(Kg/day) Remarks

Methyl(+)-alpha-amino(2-chlorophenyl)acetate tartaric acid salt

210.7 Stage I Product 162.7 To Stage II

(2-Thienyl)ethyl para-toulene sulphonate

170.0 Tartaric acid 78.9 To Wastewater

Liq. Ammonia (20%) 30 p-toluene sulfonic acid 90.4 To Wastewater Methylene chloride 400 MDC Recovered 386 Recovered & Reused Dipotassium hydrogen phosphate

27 MDC Loss 2 Fugitive Loss

Ethyl acetate 500 MDC to Residue 12 Solvent in Residue Hydrochloric acid 13 Ethyl acetate Recovered 485 Recovered & Reused Water 900 Ethyl acetate Loss 2 Fugitive Loss Ethyl acetate to

Wastewater 3 To Wastewater

Ethyl acetate to Residue 11 Solvent in Residue Methyl(+)-alpha-

amino(2-chlorophenyl)acetate tartaric acid salt

27.0 Organic Residue

(2-Thienyl)ethyl para-toulene sulphonate

21.8 Organic Residue

Dipotassium hydrogen phosphate

27 Inorganic residue

Waste Water 924.0 To Wastewater Ammonium Chloride 18.9 To Wastewater Total Input 2250.6 Total Output 2250.6 Stage II Input Quantity

(Kg/day) Output Quantity

(Kg/day) Remarks

Stage I Product 162.7 Clopidogrel hydrogen sulfate

166.7 Final Product

Formaldehyde 15.8 Water 7.2 To Wastewater Sulfuric acid 51.5 Ethyl acetate Recovered 723.8 Recovered & Reused Acetone 600 Ethyl acetate Loss 3.8 Fugitive Loss L-(-)-Camphor sulphonic acid

8 Ethyl acetate to Wastewater

7.5 To Wastewater

Methylene chloride (MDC) 1000 Ethyl acetate to Residue 15.0 Solvent in Residue Ethyl acetate 750 MIBK Recovered 582.0 Recovered & Reused Sodium bicarbonate 30 MIBK Loss 2.4 Fugitive Loss Methyl isobutyl ketone (MIBK)

600 MIBK to Wastewater 3.0 To Wastewater

Activated Carbon 20 MIBK to Residue 12.6 Solvent in Residue


Page 8

Water 750 MDC Recovered 965.0 Recovered & Reused Sodium hydroxide 10.3 MDC Loss 5.0 Fugitive Loss MDC to Residue 30.0 Solvent in Residue Acetone Recovered 579.0 Recovered & Reused Acetone Loss 3.0 Fugitive Loss Acetone to Wastewater 9.0 To Wastewater Acetone to Residue 9.0 Solvent in Residue Stage I Product 39.8 Organic Residue L-(-)-Camphor

sulphonic acid 7.5 Organic Residue

Formaldehyde 3.9 Organic Residue Activated Carbon 20.0 To Spent carbon Sodium sulfate 18.2 To Wastewater Sodium bicarbonate 30.0 To Wastewater Water 754.6 To Wastewater Total Input 3997.8 Total Output 3997.8


Page 9

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 5 42 Sent to Stripper followed by MEE and ATFD.

Stripper Condensate sent to Cement Plants for Co-Incineration. MEE and ATFD Condensate sent to Biological treatment plant followed by RO. RO rejects sent to MEE and permeate is reused in cooling towers make-up and scrubbers.

Washings 5

Scrubber Effluent 0.6 3 Sent to MEE followed by AFTD, Biological treatment plant and RO. RO/DM Plant

Rejects 8

Total I 5.6 58 LTDS Effluents

Boiler Blow downs 0.64 8 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

23

Domestic 1 8.5 Total II 1.64 39.5 Grand Total (I+II) 7.24 97.5


Page 10

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 299.6 KLD consisting of 206.6 KLD 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 38.6 42* Washings 5 5 Scrubber 3 3 Boiler Feed 40 20 52 8 Cooling Tower 92 73 142 23 RO/DM Plant 8 8 Domestic 10 1.5 8.5 Gardening 10 10 Gross Total 206.6 93 205.5 97.5 Total 299.6 303 * Process effluents contain soluble raw materials, byproducts, solvents etc.


Page 11

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 Solvent residue TPD 2.67 Sent to TDSF/Cement

Plants for Co-incineration 2 Process Organic residue

TPD 0.27 5.94

3 Stripper Distillate KLD 1.1 4 Spent Carbon Kg/day 126.4 5 Spent Solvents KLD 11.4 Recovered within the plant

premises. 6 Spent Mixed

Solvents (Non-recoverable)

KLD 1.27 Sent to authorized recovery units/Cement plants for co-incineration

7 Inorganic residue TPD 0.2 3.4 Sent to TSDF 8 Evaporation salts TPD 0.26 2.28 9 ETP Sludge TPD 140 10 Ash from Boiler TPD 32 Sold to Brick manufactures 11 Detoxified

containers No.s/ month

300 2500 Sold to authorized vendors

12 Waste oil LPM 15 200 Sent to Authorized Recyclers 13 Used batteries No.s/Yr 20


Page 12

ANNEXURE – V: Stack Emissions Details

The sources of air pollution from the plant are existing 2 TPH Coal fired boiler and proposed

2 x 8 TPH Coal fired boiler. DG sets of 250 KVA of existing and Proposed 1 x 1500 KVA, 2 x

1000 KVA and 3 x 500 KVA capacity. The proposed air pollution control equipment for coal

fired boilers 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 2TPH Coal Fired Boiler

15 1 180 4.5 1.12 0.04 0.13

3 250KVA DG Set 3 0.1 200 10 0.028 0.09 0.18 Proposed

1 2 x 8 TPH Coal Fired Boiler

30 0.9 130 6.05 0.6 0.7 0.25

2 1 x 1500 kVA DG set

12 0.2 180 10 0.02 0.03 0.5

3 2 x 1000 kVA DG sets

7 0.2 170 10 0.09 0.25 0.38

4 3 X 500 kVA DG sets

5 0.2 200 6.8 0.002 0.025 0.04

*DG sets will be used during load shut down by TSPDCL.



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]

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