Piramal Updated Form I Titles - Welcome to...

PIRAMAL ENTERPRISES LIMITED SY. NO. 71, 77, 78, 79A to 80A, 81A & 82A,

DIGWAL VILLAGE, KOHIR MANDAL, MEDAK DISTRICT, TELANGANA

UPDATED FORM I

Project No. Piramal Enterprises Limited Digwal (V), Kohir (M), Medak (Dist.)‐ 508 213 Phone: +91 8451 287508/+918978884596 Fax: +91 8451 287553 E‐mail ID: [email protected] [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

Piramal Enterprises Limited

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 Piramal Enterprises Limited 2 S. No in the Schedule 5 (f) – A category – Synthetic Organic Chemicals

(Bulk Drugs and Intermediates) 3 Proposed capacity/area/length/tonnage to

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

Area Existing: 79 acres Existing Capacity: 363.22 TPM Capacity after expansion: 505.47 TPM Proposal: Extension of validity of TOR TOR File No. J‐11011/213/2014‐IA.II (I) dt. 21.10.2014

4 New/Expansion/Modernization Expansion 5 Existing Capacity/Area etc. Existing Capacity: 363.22 TPM

Area Existing: 79 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. Sy. No. 71, 77, 78, 79A to 80A, 81A & 82A Village Digwal Village Tehsil Kohir Mandal District Medak District State Telangana

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

Kohir Railway Station – 5.87 Km – S, Shamshabad Airport – 88Km ‐ NE

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

Kohir – 6.6 Km ‐ S

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

Digwal

13 Name of the Applicant Mr. Sunil Deshmukh 14 Registered Address M/s. Piramal Enterprises Limited

Sy. No. 71, 77, 78, 79A to 80A, 81A & 82A, Digwal (V), Kohir (M), Medak (Dist.), Telangana.

15 Address for Correspondence: Name Mr. Sunil Deshmukh Designation(Owner/Partner/CEO) Vice President ‐ Operations Address M/s. Piramal Enterprises Limited

Sy. No. 71, 77, 78, 79A to 80A, 81A & 82A, Digwal (V), Kohir (M), Medak (Dist.), Telangana.


Form I Page 2

Pin Code 502321 E‐mail [email protected] Telephone Number Mobile: +919849201026

Fax No. Fax: 08451 287553

040‐23748666 16 Details of alternative Sites examined, if any.

Location of these sites should be shown on a topo sheet.

Not Applicable, as the proposed expansion is within the existing industry.

17 Interlinked Projects Not applicable 18 Whether separate application of interlinked

project has been submitted? Not applicable

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 the existing unit. No additional land. Total Land area after proposed expansion 79 Acres.

1.2 Clearance of existing land, vegetation and buildings?

NO The proposal is for expansion of existing bulk drug and intermediate manufacturing unit.

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

1.5 Construction works? YES Construction activity involves creation of additional utilities like Boilers, Chilling Plant etc and Zero Liquid Discharge (ZLD) system.

1.6 Demolition works? NO No structures for demolition 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? NO1.12 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 safety precautions.

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

YES Solid waste shall be disposed to end users/recyclers or sent to incineration. Effluent generated from the plant are treated and reused. Details presented in Annexure II

1.16 Facilities for long term housing of operational workers?

NO Local people shall be employed.

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

NO

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 NO


Form I Page 4

transport routes or infrastructure leading to changes in traffic movements?

1.20 New or diverted transmission lines or pipelines?

NO

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

NO

1.22 Stream crossings? NO 1.23 Abstraction or transfers of water

form ground or surface waters? YES Total water required shall increase from 1161.9

KLD to 2318.5 KLD out of which 1298.5 KLD shall be met from ground water and the balance shall be 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 – 15 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 and hence may lead to migration to surrounding villages.

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

diversity? NO No, as the proposed expansion is within existing unit.

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) No Existing Unit

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

YES Total water required shall increase from 1161.9 KLD to 2318.5 KLD out of which 1298.5 KLD shall be met from ground water and the balance shall be 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 Will 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 (MT), energy (MW)

YES The required energy shall be drawn from TSTRANSCO. Backup DG sets of 2x1000, 3x500, 2x380KVA, 2x250 and 1x225 existing and 4x750KVA, 3x725KVA proposed, shall be provided to cater to energy requirement during load shut downs. The other energy source is boilers of 6TPH oil fired and 16TPH coal fired proposed and existing 16TPH, 4TPH and 3x6TPH coal fired boilers and 6TPH Oil fired boilers to meet the steam requirement both for process and ZLD system. The required quantity of fuel (coal) is 54TPD, (FO) is 10KLD and Diesel for DG sets (standby) is 0.7 KLD.

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 50‐60 kg/day

4.3 Hazardous wastes (as per Hazardous Waste Management Rules)

YES The hazardous wastes generated during construction contain waste oils and batteries from DG sets.

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

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 activity involves creation of new

production blocks, additional utilities like boilers, Chilling Plant etc and ZLD system.

4.8 Redundant machinery or equipment NO 4.9 Contaminated soils or other materials NO Structures of all waste treatment facilities are made of

concrete and also above ground to eliminate the possibility of any contamination due to seepage and


Form I Page 7

for ease of maintenance. 4.10 Agricultural wastes NO 4.11 Other solid wastes YES Enclosed at Annexure IV

5. Release of pollutants or any hazardous, toxic or noxious substances to air (Kg/hr) S.No. Information/Checklist confirmation Yes/No Details thereof (with approximate quantities/rates,

wherever possible) with source of information data 5.1 Emissions from combustion of fossil

fuels from stationary or mobile sourcesYES Coal and FO Shall be used as fuel. Quantity of fuel and

emissions details are enclosed in Annexure V 5.2 Emissions from production processes YES HCl, SO2, NH3 will be sent to scrubbers and CO2

and nitrogen will be let out into atmosphere safely

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 Sewage will be treated in the treatment plant.

5.6 Emissions from incineration of waste NO 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. DG sets will be used in case of power failure from TSTRANSCO.

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 data7.1 From handling, storage, use or

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

drums, in a covered shed with concrete flooring so that there is no contamination of soil during spillage.

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

NO All effluents generated in plant will be treated in the Zero Liquid Discharge (ZLD) system. No contamination is expected.

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, Dust Collectors and emissions from boiler shall be controlled by providing bag filter & multi cyclone separators.

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. There are no major support industries required for this plant.

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 No similar units are present in the surrounding area.


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 Karanja Vagu stream – 2Km in Southwest Kotturu Reservoir – 7.2Km in northeast. Digwal RF – 2.5 Km in North

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 NO6 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 Digwal village with population of

about 4300. 9 Areas occupied by sensitive man‐made land uses

(hospitals, schools, places of worship, community facilities)

NA 1 Km from the site

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

(IV) Proposed Terms of Reference for EIA studies Scope of Work of EIA The standard terms of reference (page 181‐187) issued by the Ministry of Environment Forest and Climate change shall be followed for preparation of EIA report. Any additional study proposed by the SEAC shall also be completed.

Ref: Standard Terms of Reference (TOR) for EIA/EMPO report for projects/activities requiring environmental clearance under EIA notification, 2006, MoEF & CC, GOI, April 2015.


Form I Page 11

I hereby give the undertaking that data and 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 given, 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)

Mr. Sunil DeshmukhVice President ‐ Operations

M/s. Piramal Enterprises LimitedDigwal (V), Kohir (M), Medak (Dist.),

Telangana



ANNEXURES

SUBMITTED TO MINISTRY OF ENVIRONMENT, FOREST AND CLIMATE CHANGE

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

Piramal Enterprises Limited Form I Annexures

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ANNEXURE - I

M/s. Piramal Enterprises Limited (formerly known as Piramal Healthcare Limited,

previously Nicholas Piramal India Ltd.,) - (Unit –I, II & III) obtained consent for operation

for Bulk Drugs & intermediates vide letter no. TSPCB/RCP/MDK1/CFO/HO/2015-92

dated 09.04.2015 at 71, 77, 78, 79A to 80A, 81A & 82A, Digwal Village, Kohir Mandal,

Medak District, Telangana. It is proposed to expand the manufacturing capacity from

363.22 TPM to 505.47 TPM in existing area of 79 acres. It is proposed to merge three

colocated units and expand the capacity. The capital cost for expansion is Rs. 250 crores,

towards production blocks, utilities and enhancement of zero liquid discharge facility.

The manufacturing capacity of permitted and proposed products and by productsis

presented in Table A-1 and Table A-2 and Table A -3.

Table A-1 Manufacturing Capacity – Permitted

S.No Name of the Product Capacity (TPM)

Unit – I 1 Ibuprofen 39.9 2 Levobunolol Hydrochloride (Al1) 0.21 3 Brimonidine Tart rate (AL2) 0.21 4 Ubidecarenone 2.01 5 Trazadone Hydrochloride 2.01 6 Gemfibrozil 1.02 7 Ipratropium Bromide 0.51 8 Abacavir Sulphate 3.99 9 Flecanide Acetate (Stage-I, II & III) Intermediate 5.01

10 Mebeverine Hydrochloride 2.01 11 FC- 4010- [5,6-Dihydro-(S)-6-methyl-4-oxo-thieno(2,3,6) thiopyaram-7,7-

dioxide] 3.99

12 FC-2086-[Carbamic acid,(1S,2R)-2-hydroxy-3[2-methyl propyl]{(4-Nitrophenyl)sulfonyl}amino]-1-(phenylmethyl)propyl]

3.99

Total – I 64.86 Unit – II

13 Diltiazem Hydrochloride 25.00 14 Cis Hydroxylactom 15.00 15 Ketoconozole 10.02 16 Cis-Tosylate 5.01 17 Verapamil Hydrochloride 6.99


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18 Cetrazine Dyhydrochloride 0.21 19 Fluconozole 0.51 20 Ephedrine Resinate 1.02 21 GMPA 1.02 22 Paraoxetine 3.00 23 Oxybutine Hydrochloride 0.51 24 FC-1196 [2-{(2-Formyl-4-hydroxy phenyl) methylidene} succcinic acid] 0.21 25 Iodoaniline Methyltriazole 0.51 26 Immiquimod 0.21 27 FC 2272 [n-Benzofuran-2-carbonyl-Lleucine] 0.12 28 Flecanide Acetate 5.01 Total – II 74.35

Unit – III 29 Halothane 42.00 30 Desflurane 9.00 31 Isoflurane 21.00 32 Bottling Process 72.00 33 2,9-(Acetylamino)-1,7-dihydro-6H-one 15.00 34 1-[2-(2,4-Diflurophenyl)-2,3-epoxypropyl]-1,2,4-Triazole methane 60.00 35 Flecnide Acetate 5.01 Total – III 224.01 Grand Total (I+II+III) 363.22


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Table A-2 Manufacturing Capacity – After Expansion

S.No Name of the Product CAS No. Capacity (TPM)

1 Abacavir Sulfate 188062-50-2 2 2 Diltiazem Hydrochloride 33286-22-5 25 3 Cis Hydroxy Lactam 42399-49-5 10 4 Ketoconazole 65277-42-1 17.5 5 Verapamil Hydrochloride 152-11-4 13.75 6 Halothane 151-67-7 25 7 Desflurane 57041-67-5 25 8 Isoflurane 26675-46-7 150 9 Sevoflurane (Bottling) 28523-86-6 72

10 Levobunolol Hydrochloride 27912-14-7 0.04 11 Brimonidine Tartrate 70359-46-5 0.04 12 Trazodone Hydrochloride 25332-39-2 5.57 13 FA (2,5-Bis (2,2,2-trifluoroethoxy)-2,2,2-trichloro

acetophenone) 54143-56-5 2.9

14 Mebeverine Hydrochloride 2753-45-9 8.75 15 FC-4010 (Hydroxsulphane) 147086-81-5 0.42 16 Paroxetine 61869-08-7 4.5 17 Oxybutynin Hydrochloride 1508-65-2 0.05 18 Iodoaniline Methyltriazole 160194-26-3 0.3 19 Immiquimod 99011-02-6 0.1 20 Flecainide Acetate 54143-56-5 2.2 21 Vitamin A Palmitate 79-81-2 0.1 22 Vitamin E Alcohol 10191-41-0 12.5 23 Vitamin A Alcohol 68-26-8 6.67 24 Dry Vitamin A Acetate 127-47-9 25 25 Chloropurine 87-42-3 9.2 26 Sevoflurane 28523-86-6 25 27 Amiodarone Hydrochloride 19774-82-4 2.6 28 Sertraline Hydrochloride 79559-97-0 1 29 Quetiapine Hemifumarate 111974-72-2 2.3 30 Tolcapone 134308-13-7 0.4 31 Methyl-2-(2-methyl-1H-pyrrolo [2,3-b] Pyridin-3yl)

acetate (FCI-1641 ) 1134327-80-2

0.03

32 Sodium Carboxymethyl Cellulose 9004-32-4 0.19 33 SSPP (4aS, 7aS)-Octahydro-1H-Pyrrolo[3,4-b] Pyridine 151213-40-0 0.9 34 Droxidopa 23651-95-8 0.4 35 Tramadol Hydrochloride 22204-88-2 5.47 36 Acyclovir 59277-89-3 1.3 37 Tafenoquine Succinate 106635-81-8 0.08


Page 6

38 Spirapril Hydrochloride Dihydrate 83647-97-6 0.01 39 Clozapine 5786-21-0 2.08 40 Halofuginone Hydrobromide 64924-67-0 0.25 41 Donepezil Hydrochloride 120011-70-3 0.1 42 Irbesartan 138402-11-6 0.4 43 Telmisartan 144701-48-4 0.4 44 Sulindac 38194-50-2 0.2 45 Ziprasidone Hydrochloride 138982-67-9 0.05 46 Valacyclovir Hydro chloride 124832-27-5 2 47 Metaxalone 1665-48-1 0.8 48 Lisnopril Dihydrate 83915-83-7 0.2 49 Loratadine 79794-75-5 0.2 50 Netaglinide Hydrochloride 105816-04-4 0.1 51 Imipramine Hydro chloride 113-52-0 0.1 52 Opipramol Dihydrochloride 909-39-7 0.1 53 Clomipramie Hydrochloride 17321-77-6 0.1 54 Memantine Hydrochloride 41100-52-1 10 55 Itra 1330 106461-41-0 0.1 56 Itra 1334 67914-86-7 0.5 57 Aprepitant 170729-80-3 0.03 58 Candesartan Cilexetil 145040-37-5 3 59 Perindopril Erbumine 107133-36-8 12.54 60 Bittermelon 90063-94-8 1.4 61 Tinefcon 12.54 62 Allopurinal 315-30-0 0.01 Total 505.47

Table A-3 List of By-Products after Expansion

S.No Name of Byproduct Quantity (Kg/day)

Name of Product

1 Methanol 156 Diltiazem Hydrochloride 2 Sodium Bromide (16%) 2716.2 Halothane 3 P-Toluene Sulfonyl Sodium 213.1 Ketoconazole 4 Spent Sulfuric Acid 5921.3 Memantine Hydrochloride


Page 7

Process Description of Acyclovir

Chemical Reaction of Acyclovir

Stage I

Stage II

Process Description for Acyclovir

Stage – I: Preparation of Stage-I is a typical condensation reaction of guanine diacetate

with dioxalane diacetate in the presence of louis acid at 100°C. P-Toluene sulphonic

acid is used as a louis acid. After completion of reaction charge acetone for the

isolation of product. Finally filter the product & dry it u/v at 50-55°C.

Stage – II : Preparation of Stage-II is a base hydrolysis reaction of acyclovir stage-I

intermediate. Triethyl amine is used as a base in presence of water. After deacetylation

amide is converted to amine & ester is converted to substituted alcohol. Charcoal’s

treatment given to the reaction mass to remove the color impurity & then mass is filtered

through the hyflow bed. Product is filter through the water & dried u/v at 50-60°C. The

material balance is presented in Table A-3.

G u an in e d iac e ta teM .F .:C 9H 9 O 3N 5M .w t:235 .0

+

D io xa lan e d iace ta teM .F .:C 7H 12O 5M .w t:17 6 .0

P T S AN

NN

O

N

N

H

O

O

N

NN

O

N

N

H

O

O

O

O

O O

O

O A C

M .F .:C 12 H 15O 5N 5M .w t:30 9 .0

(C H 3 C O )2O

M .W t:102 .0

+

T E A

A c y c lo v i rM .F . : C 8 H 1 1 O 3 N 5M .w t : 2 2 5 .0

M .F . : C 1 2 H 1 5 O 5 N 5M .w t : 3 0 9

N

NN

O

N

N

H

O

O

O A C

N

NN

O

N

N

O

O H

H

H

H

/ 2 H 2 O+ 2 C H 3 C O O H

M .W t : 6 0 .0


Page 8

Table A-3 Material Balance for Acyclovir Stage I INPUT Kg OUTPUT Kg Guainine diacetate 160 Product Dioxolone diacetate 300 Stage-1 189 Acetone 240 Recovery PTSA 1 Dioxolone diacetate 180 Acetone 192 Acetone(Loss) 24 Acetic Anhydride 65 Organic Residue Unreacted Organic Impurities 51 Total Input 701 Total Output 701

Stage II INPUT Kg OUTPUT Kg Stage1 170 Product TEA 140.3 Stage-2 102 Water 5227 Recovery Carbon 17 TEA 126.3 TEA(Loss) 14 Aq. Effluent Aq. Effluent 5278 Solid waste Spent carbon 34 Total Input 5554.3 Total Output 5554.3


Page 9

ANNEXURE – II: Wastewater Treatment Facilities

The effluents generated in the process, separation techniques and during purification

contain organic residues and inorganic raw materials, solvents, and products. Hence the

effluents contain both organic and inorganic salts in various quantities leading to high

COD and TDS levels respectively. Effluents from process, washings, Scrubbing media, and

utility blow downs will be sent to the effluent treatment system. The treated effluent will

be reused for cooling towers, Boiler makeup, washings and scrubbers. Total Effluent

generated and mode of treatment before and after expansion is presented in Table A-4

and quantity and quality of effluent generated from process after expansion is presented

in Table A-5.

Table A-4 Quantity of Effluent Generated – After Expansion

Description Quantity (KLD)

Mode of Treatment Permitted After Expansion

HTDS Effluents (TDS & COD> 15000 mg/l) Process 207 261.9 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, Boilers make-up, washings and scrubbers.

Washings 70

Scrubber Effluent 5 50 Sent to MEE followed by ATFD, Biological treatment plant and RO.

Total – I 212 381.9 LTDS Effluents (TDS & COD< 15000 mg/l)

Process 97.7 262.3 Sent to Biological Treatment System followed by RO. RO permeate reused for cooling tower Boilers make-up, washings and scrubbers. RO rejects sent to MEE.

Washings 59 Lab Washings 10 Boiler Blow downs 95.78 15 DM/RO Rejects 225 Cooling Tower Blow downs 70 75

Domestic 28 84 Total – II 350.48 671.3 Grand Total (I+II) 562.48 1053.2


Page 10

Table A-5 Quantity and Quality of Effluent Generated from Process S.No Name of the Product Quantity Conc. (mg/l)

Water Input (KLD)

TDS (Kg/day)

COD (Kg/day)

Total Effluent (KLD)

TDS COD

1 Abacavir Sulfate 2.58 223.9 115.1 2.95 75892 39005 2 Diltiazem Hydrochloride 32.79 3169 571.0 39.86 79496 14323 3 Cis Hydroxy Lactam 58.00 847.8 360.3 59.95 14141 6010 4 Ketoconazole 7.64 0 176.5 7.76 0 22733 5 Verapamil Hydrochloride 11.50 1279.4 86.7 13.2 96955 6574 6 Halothane 10.50 1234.6 145.4 12.59 98092 11553 7 Desflurane 18.60 2042.2 284.9 21.63 94409 13171 8 Isoflurane 57.50 7719 412.3 77.74 99291 5304 9 Sevoflurane (Bottling) 0.00 0 0 0 0 0

10 Levobunolol Hydrochloride

0.25 28.3 0.3 0.29 97403 887

11 Brimonidine Tartrate 0.29 32.3 4 0.34 93806 11556 12 Trazodone Hydrochloride 3.6 388.1 26.2 4.11 94362 6364 13 FA (2,5-Bis (2,2,2-

trifluoroethoxy)-2,2,2-trichloro acetophenone)

4.2 411 16.9 4.9 83892 3441

14 Mebeverine Hydrochloride 7.37 389.9 51.6 7.92 49254 6512 15 FC-4010 (Hydroxsulphane) 1.06 75.9 37.6 1.33 57164 28312 16 Paroxetine 8.27 618.7 313.8 9.25 66881 33924 17 Oxybutynin Hydrochloride 0.06 2.4 1.3 0.06 37841 20073 18 Iodoaniline Methyltriazole 0.60 52.8 6.6 0.68 77414 9720 19 Immiquimod 0.73 60.2 16.2 0.83 72262 19463 20 Flecainide Acetate 0 0 0 0 0 0 21 Vitamin A Palmitate 0.25 23.3 0.7 0.28 84095 2389 22 Vitamin E Alcohol 2.79 293.3 6.1 3.13 93662 1954 23 Vitamin A Alcohol 1.02 103 55.8 1.16 88867 48152 24 Dry Vitamin A Acetate 1.17 62 0.0 0.70 88740 0 25 Chloropurine 0 0 0 0.04 0 0 26 Sevoflurane 7 750.3 0 7.86 95476 0 27 Amiodarone

Hydrochloride 2.2 28 0.3 2.23 12542 145

28 Sertraline Hydrochloride 2.1 129.2 31.6 2.27 56971 13919 29 Quetiapine Hemifumarate 14.56 206.9 167.8 14.92 13866 11246 30 Tolcapone 1.01 50.3 53.1 1.12 45010 47536 31 Methyl-2-(2-methyl-1H-

pyrrolo [2,3-b] Pyridin-3yl) acetate (FCI-1641 )

0.19 6.4 3.5 0.22 28945 16063


Page 11

32 Sodium Carboxymethyl Cellulose

0.28 3 3 0.29 10557 10476

33 SSPP (4aS, 7aS)-Octahydro-1H-Pyrrolo[3,4-b] Pyridine

0.45 48.8 3.6 0.54 90406 6591

34 Droxidopa 1.88 132.2 60.6 2.49 53146 24341 35 Tramadol Hydrochloride 6.3 444.1 9.7 7.03 63142 1382 36 Acyclovir 1.01 0 25.8 1.03 0 25138 37 Tafenoquine Succinate 0.23 2.3 0.8 0.23 9722 3294 38 Spirapril Hydrochloride

Dihydrate 0.01 0.1 0.2 0.01 16149 42947

39 Clozapine 2.3 232.8 25.6 2.72 85548 9392 40 Halofuginone

Hydrobromide 1.07 80.0 33.4 1.36 58872 24587

41 Donepezil Hydrochloride 0.17 11.8 1.2 0.19 63162 6349 42 Irbesartan 0.69 28.0 30.4 0.76 36921 40148 43 Telmisartan 1.2 45.1 5.1 1.37 32924 3698 44 Sulindac 0.33 20.7 10.5 0.36 56965 28832 45 Ziprasidone Hydrochloride 0.06 0.5 3 0.06 9120 50826 46 Valacyclovir Hydro

chloride 1.8 0 24.1 1.84 0 13119

47 Metaxalone 0.42 7 5.7 0.47 14894 12124 48 Lisnopril Dihydrate 0.22 15.1 2.4 0.25 59292 9275 49 Loratadine 0.71 48.7 21.1 0.82 59033 25544 50 Netaglinide Hydrochloride 0.02 1.5 2.4 0.03 50279 82450 51 Imipramine Hydro

chloride 0.1 2.1 1.7 0.1 20895 16540

52 Opipramol Dihydrochloride

0.15 8.6 2.9 0.16 52660 17691

53 Clomipramie Hydrochloride

0.03 3.2 0.7 0.04 83028 18624

54 Memantine Hydrochloride 7.65 465.5 89.3 5.70 81691 15672 55 Itraconazole 1330 0.24 25.7 4.5 0.27 94041 16557 56 Itraconazole 1333 0.44 41.9 12.3 0.53 78879 23171 57 Aprepitant 0.14 0.6 0.5 0.14 4387 3882 58 Candesartan Cilexetil 11.72 687.3 246.5 13.01 52838 18949 59 Perindopril Erbumine 0.80 0 57.8 0.86 0 66789 60 Bittermelon 0.15 0 0 0.15 0 0 61 Tinefcon 181.2 895.0 0 182.1 4915 0 62 Allopurinal 0.01 0.2 0.1 0.01 44116 10738 Total – LTDS 259.0 1990.5 562.4 262.3 7587 2144 Total – HTDS 220.6 21489.2 3067.6 261.9 82057 11714 Grand Total (HTD+LTDS) 479.6 23479.7 3630.1 524.2


Page 12

ANNEXURE – III: Water Balance

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

generation and domestic purposes. The total water requirement after the proposed

expansion increase from 1161.9 KLD to 2318.5 KLD out of which 1298.5 KLD will be fresh

water and 1020 KLD is recycled and fresh water is sourced from ground water using bore-

wells within plant premises. The unit permission to abstract ground water in the order of

1300 KLD. The water balance for daily consumption after expansion is presented in Table

A-6.

Table A-6 Total Water Balance – After Expansion

Purpose INPUT KLD OUTPUT KLD Fresh Water

Recycled Water Loss Effluent

Process 479.55 524.22* Washings 50 20 70 Lab Washings 10 10 Scrubber 30 20 50 Boiler 147 20 152 15 Cooling Tower 172 960 1057 75 RO/DM Rejects 225 225 Domestic 95 11 84 Water for gardening 90 90 Gross Total 1298.5 1020 1310 1053.22 Total 2318.5 2363.22

* Process effluents contain soluble raw materials, byproducts, solvents etc.


Page 13

ANNEXURE – IV: Solid Waste

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

shall send to TSDF/ Cement Industries for Co-incineration. Evaporation salts from MEE and ATFD and ETP Sludge shall be

sent to TSDF. The total solid waste generated and mode of disposal is presented in Table A-7.

Table A-7 Solid Waste Details – After Expansion S.No Description Units Quantity Mode of Treatment/Disposal

Permitted After Expansion

1 Process Residue TPD 16.57 11.44 Sent to TSDF/Cement Plants for Co-incineration 2 Solvent distillation Residue TPD 6.9

3 Stripper Distillate KLD --- 6.51 4 Spent Carbon Kg/day 120.7 174.5 Sent to TSDF/Cement Plants for Co-

incineration 5 Hyflow Kg/day --- 31 Sent to TSDF 6 Spent HCl KLD 1.59 0.25 Sent to Authorized reprocessors/recyclers 7 Chromic Acid KLD 4.82 ---- 8 Spent Mixed Solvents KLD 8 20.4 Sent to authorized recovery units/Cement

plants for co-incineration 9 Spent Solvents KLD 183.2 Recovered within the plant premises.

10 Inorganic residue Kg/day --- 212.6 Sent to TSDF 11 Catalyst Kg/day 25 --- Sent to Authorized Recyclers 12 Spent Silica TPD 2.6 --- Sent to TSDF 13 Raney Nickel Kg/day 59.5 30 Sent to TSDF 14 Evaporation salts TPD 20.67 24.4 Sent to TSDF 15 ETP Sludge TPD 2.64 3.26 Sent to TSDF 16 Ash from Boiler TPD 15 27 Sold to Brick manufactures 17 Detoxified containers & liners No.s/month 5250 6500 Sold to authorized vendors 18 Off-Seperation & discarded Kg/day 27 35 Sent to TSDF


Page 14

product 19 Discarded waste mineral from

dust collector, Vacuum system & floor sweeping and resign from DM plants

Kg/day 52 100 Sent to TSDF

20 Iron Powder Kg/day 42 --- Sent to TSDF 21 Waste oil KLD 2.75 3.5 Sent to Authorized Recyclers 22 Used Lead acid batteries No.s/Yr --- 18 Sent to Authorized Recyclers


Page 15

ANNEXURE – V: Stack Emissions Details

The sources of air pollution from the plant are from proposed 6TPH Oil fired and 16 TPH

coal fired boilers and existing 16TPH coal fired boiler, 4TPH and 2x6TPH coal fired boilers

will be in operation while existing 4TPH and 6TPH coal fired boilers will be removed.

Backup DG sets of 2x1000, 3x500, 2x380KVA, 2x250 and 1x225 existing and 4x750KVA,

3x725KVA proposed. The proposed air pollution control equipment for coal fired boiler is

bag filters and multi-cone cyclone separators. DG sets shall be provided with stack heights

based on the CPCB formula for effective stack height. The emission rates of SO2, NOx and

PM from each stack are presented in Table A-8.

Table A-8 Stack Emission Details S. No

Stack Connected to Stack

Ht (m)

Dia of stack at top(m)

Temp. of

exhaust gases (0C)

Exit Velocit

y (m/sec)

Pollutant Emission Rate (g/sec)

SPM SO2 NOx

Permitted 1 16TPH Coal Fired

Boiler 30 1.3 121 6.05 0.63 0.72 0.3

2 2x 4TPH Coal fired Boilers*

30 1.3 121 6.05 0.6 0.7 0.25

3 3x 6TPH Coal fired Boilers*

30 1.5 130 8.2 0.8 0.9 0.34

4 6TPH Oil fired Boiler 40 1.2 185 4.25 0.29 0.80 0.41 5 2x1000KVA DG sets 7 0.2 170 15 0.09 0.25 0.41 6 3 x 500KVA DG Set 5 0.25 185 7.2 0.04 0.16 0.028 7 2 x 380KVA DG Set 4 0.15 145 6.5 0.02 0.07 0.1 8 2x250KVA DG Sets 4 0.1 180 5.0 0.04 0.06 0.01 9 1x225KVA DG Set 4 0.1 180 5.0 0.03 0.05 0.01

Proposed 1 16TPH Coal Fired

Boiler 30 1.3 121 6.05 0.63 0.72 0.3

2 6TPH Oil fired Boiler 40 1.2 185 4.25 0.29 0.80 0.41 3 4x750KVA DG Sets 6 0.2 165 8 0.07 0.18 0.30 4 3x725KVA DG set 6 0.2 165 8 0.05 0.17 0.28

*1 x 4TPH and 1 x 6TPH coal fired boilers will be removed ** DG sets stack heights are above the roof level.



STUDIES AND DOCUMENTATION BY TEAM Labs and Consultants QCI: MoE&F OM, List A-1, S.No. 150. (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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