PLOT NO.137, S.V. CO OP. IND. ESTATE, VILLAGE,environmentclearance.nic.in/writereaddata/Online/TOR/0_0_14_Nov...GOVERNMENT OF INDIA ... emergency usage as the plant has ZLD based

DR. REDDY’S LABORATORIES LTD. CHEMICAL TECHOPS – I

PLOT NO.137, 138, 145 & 146, S.V. CO‐OP. IND. ESTATE, BOLLARAM VILLAGE, JINNARAM MANDAL,

MEDAK DISTRICT, TELANGANA

FORM I

Project No. 1114‐21‐04November 2014

DR. REDDY’S LABORATORIES LTD. Regd. Office : 8‐2‐337, Road No.3, Banjara Hills, Hyderabad – 500 034. Phone: 040 4900 2900 Fax: 040 4900 2999 E‐mail: [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 AND FORESTS,

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

Chemical Tech Ops ‐ I

Form I Page 1

APPENDIX – I (See Paragraph – 6)

FORM I

I) Basic Information S.No. Item Details 1 Name of the Project/s Dr. Reddy’s laboratories Ltd,

Chemical Tech Ops ‐ I 2 S. No in the Schedule 5 f – A category 3 Proposed capacity/area/length/tonnage

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

Proposed to enhance the production capacity of Active Pharma Ingredients (API’s) from 14.7 TPM to 45.5 TPM and inclusion of Solvent Recovery System Cost of the project (Expansion): 30 Crores

4 New/Expansion/Modernization Expansion 5 Existing Capacity/Area etc. Existing Capacity: 14.7 TPM

Area Existing: 16.5 Acres 6 Category of Project i.e 'A' or 'B' “A” 7 Does it attract the general condition? If

yes, please specify Yes. The Unit is Located in Notified Industrial Estate / Area. The project site is located in Bollaram and Patancheru Industrial Estates (IE’s), Office Memorandum (OM) No. J‐11013/5/2010‐IA.II(I) dated 10.06.2014 mandated that projects required EC in these areas will be considered by MoEF.

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

No

9 Location Plot/Survey/Khasra No. Plot. Nos. 137,138,145 & 146

Survey No. 172/A,172A&U,172/C,172/E S.V. Cooperative Industrial Estate, IDA, Bollaram

Village Bollaram (V) Tehsil Jinnaram (M) District Medak District State Telangana

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

Railway Station: Bollaram – 18.1 Km Airport : Rajiv Gandhi International Airport – 34.26 Km

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

Town & District HQ – Sangareddy ‐ 60 KM City ‐ Hyderabad ‐ 23 KM

12 Village Panchayats, Zilla Parishad, Municipal Corporation, Local body (complete postal address with telephone

Bollaram Village


Form I Page 2

nos. to be given) 13 Name of the Applicant Jitender Kumar Sinha 14 Registered Address Dr. Reddy’s Laboratoires Limited

Regd. Office : 8‐2‐337, Road No.3, Banjara Hills, Hyderabad – 500 034

15 Address for Correspondence: Name Jitender Kumar Sinha Designation(Owner/Partner/CEO) Associate Director ‐ Operations Address Plot. Nos. 137,138,145 & 146,

S.V. Cooperative Industrial Estate, Bollaram IDA, Jinnaram (M), Medak (Dist), Telangana

Pin Code 502 325 E‐mail [email protected]

[email protected], Telephone Number Direct : +91‐ 8458 279588

Mobile : +91 91 9177001911 Fax No. +91‐ 8458 279623

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

‐NA‐

17 Interlinked Projects ‐NA‐ 18 Whether separate application of

interlinked project has been submitted? No

19 If yes, date of submission 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 Individual Court case against the Project.

However Green Tribunal Case, W.P. No. 19661 of 2002 on the file of Hon’ble High Court of Andhra Pradesh / Application No. 90 of 2013 before NGT is filed against CETP Members. (Presently our CETP Membership is limited to emergency usage as the plant has ZLD based effluent Treatment System)


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 API’s manufacturing capacity and inclusion of Solvent Recovery System (SRS) in the existing unit. No additional land. Total Land area after proposed expansion 16.5 Acres.

1.2 Clearance of existing land, vegetation and buildings?

NO Industrial

1.3 Creation of new land uses? NO 1.4 Pre‐construction investigations e.g.

bore houses, soil testing? YES Soil Testing completed

1.5 Construction works?

YES Construction activity involves creation of new additional utilities like Boiler, Chilling Plant etc and enhancement of treatment system.

1.6 Demolition works? NO

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 orearthworks 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

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 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


Form I Page 4

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 transport routes or infrastructure leading to changes in traffic movements?

NO

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 180

KLD to 580.6 KLD out of which 360.6 KLD shall be met from APIIC (Industrial supply) 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

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 180 KLD to 580.6 KLD out of which 360.6 KLD shall be met from APIIC (Industrial supply) 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 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 (MT), energy (MW)

YES The required energy shall be drawn from APTRANSCO. The power shall be drawn from existing DG sets during load shut downs. Backup DG sets of 1 x 320kVA, 1 x 725 kVA, 1x1000 KVA existing, and 4 x 1450KVA additional shall be provided to cater to energy requirement during load shut downs. The other energy source is existing Coal Fired Boiler of 1 x 8 TPH and proposed 10 TPH Briquette Biomass / Coal Fired Boiler to meet the steam requirement both for process and ZLD system. Fuel quantity of Coal fired boiler is 33.8TPD. Fuel quantity for Briquette Biomass fired boiler is 35.4 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 Solvents shall be used as reaction media. MSIHC rules shall be followed during storage, transportation and handling of raw materials and hazardous chemicals.

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


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 25kg/day

4.3 Hazardous wastes (as per Hazardous Waste Management Rules)

YES 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


Form I Page 7

4.6 Sewage sludge or other sludge from effluent treatment

YES Sludge from Effluent treatment plant and Salts from MEE & ATFD shall be sent to TSDF.

4.7 Construction or demolition wastes YES Construction activity involves creation of new additional utilities like boiler, Chilling Plant etc and enhancement of treatment system.

4.8 Redundant machinery or equipment NO

4.9 Contaminated soils or other materials NO

4.10 Agricultural wastes NO

4.11 Other solid wastes NO Enclosed at Annexure IV

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


5.1 Emissions from combustion of fossil fuels from stationary or mobile sources

YES Briquette biomass and Coal Shall be used as fuel. Quantity of fuel and emissions details are enclosed in Annexure V

5.2 Emissions from production processes YES Enclosed in Annexure ‐ VI 5.3 Emissions from materials handling

including storage or transport NO Material transfer takes place in closed

pipeline systems. 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

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.

5.6 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.

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


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

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

NO All the wastes from domestic operations are sent to Biological effluent treatment plant.

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 boilers shall be controlled by providing 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


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


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 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/

IdentityAerial 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 Wailal RF – N – 6.3 Km Pottaguda RF – NW ‐ 8.6 Km Kazipalli RF – N – 3.1 Km Kodakanchi RF – NW – 8.8 Km Dundigal RF – NE – 8.7 Km Suraram RF – E – 9.5 Km Gajularamaram RF – E – 9.3 Km Borampet RF – E – 9.1 Km

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 Bollaram – 1.1 Km. 9 Areas occupied by sensitive man‐made land

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

NA 2 Km away 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)

YES Bollaram and Patancheru Industrial areas at a distance of 1.1Km.

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


Form I Page 11

(IV) Proposed Terms of Reference for EIA studies Scope of Work of EIA “...The EIA shall cover the following: Description of the proposed project: The first task:” Description of the proposed project” forms a vital component of the Environmental Impact Assessment (EIA) as it provides the basis for evaluating the likely causes of Environmental Impacts.

Existing Environment and Baseline Conditions: The baseline assessment will be carried out to identify potentially sensitive and critical areas that may be affected by the project in an area of 10 km surrounding the project location. The critical and sensitive targets shall be plotted on land use map of project impact area. The existing environment and baseline conditions should be established from:‐ Analysis of existing information published and secondary data. ‐Consultation with relevant statutory authorities, and Field visits for supplementation of missing gaps.

The key subject areas which the EIA shall address include Ecology and Nature conservation, Air quality, surface and water quality in project impact area, soil quality, cultural heritage, landscape, land use, noise quality, etc. Natural habitats like national parks, wildlife reserves, sanctuaries, sacred grove, protected areas, forests, wetlands, major rivers and waterways if any, shall also be identified and marked.

Assessment of Environmental Impacts: Based upon the results from the review of existing information, field visits, site data collection and consultation, for each component of environment (physical, biological and socio economic) the positive, negative, direct and indirect, temporary and permanent impacts will be evaluated along with an indication of the degree of impact, i.e., whether the impact is significant, moderate, minor or negligible. The degree of impact shall also be quantified by using state of the art air quality impact prediction models based on ISCST3 algorithms.

Environment Management Plan And Mitigation Plan: For each significant negative impact identified, specialist shall work closely with the engineering team/technical consultants to suggest practicable measures to avoid or mitigate the impact. The mitigation of environmental impacts will be by three mechanisms. =>Introduction of mitigation features through the engineering practices. =>Implementation of environmental controls during construction and operation. =>Legislative control involving compliance with Indian environmental laws. The Environmental management plan shall include an estimate of capital and recurring costs of mitigation measures and will identify the institutional framework for implementation.

Monitoring Plan: Having identified the significant environmental impact that is likely to arise as a result of the project, the project team shall specify what monitoring is required during the various phases of the project cycle. The monitoring plan will identify parameters and frequency of monitoring and responsible organization.


Form I Page 12

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)

Jitender Jumar Sinha Associate Director ‐ Operations Plot. Nos. 137,138,145 & 146

Dr. Reddy’s Laboratories Ltd., Chemical TechOps – I S.V. Cooperative Industrial Estate, Bollaram IDA,

Jinnaram (M), Medak (Dist), Telangana – 502 325




ANNEXURES

SUBMITTED TO MINISTRY OF ENVIRONMENT AND FORESTS,

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

Chemical TechOps ‐ I Form I Annexures

Page 1

Loca

tion

Map

of D

r. re

ddy’

s La

bora

tori

es L

td.,

Che

mic

al T

echO

ps I


Page 2

Dr.R

eddy

's

Plan

t Lay

out o

f Dr.

redd

y’s

Labo

rato

ries

Ltd

., C

hem

ical

Tec

hOps

I


Page 3

ANNEXURE - I

M/s. Dr. Reddy’s Laboratories Ltd., CTO Unit I obtained consent for establishment and

operation for Bulk Drugs & intermediates at Plot. Nos. 137,138,145 & 146 & Survey

No.172/A,172A&U,172/C,172/E, S.V. Cooperative Industrial Estate, IDA, Bollaram,

Jinnaram Mandal, Medak District, Telangana. It is proposed to expand the manufacturing

capacity of API’s with inclusion of Solvent Recovery System. The expansion entails a

capital cost of Rs. 30 crores towards modernization of zero liquid discharge facility,

debottlenecking by way of incorporating the advanced technology. and state of the art

equipment. Manufacturing capacity is presented in Table A-1. The proposed

manufacturing capacity is presented in Table A-2.

Table A-1 Manufacturing Capacity – Permitted

S.No Name of the Product Production Capacity (Kg/day) Combination 1 Combination 2 Combination 3

1 Clopidogrel Bisulphate 210.96 251.51 373.97 2 Fexofenadine HCl 83.56 67.12 1.37 3 Ziprasidone HCl 16.44 10.96 24.66 4 Cetirizine Hcl 24.66 24.66 36.99 5 Losartan Postassium 65.75 54.79 2.74 6 Lamotragine 21.92 21.92 28.77 7 Sparfloxacin 16.44 13.7 1.37 8 Norfloxacin 0.92 0.87 0.87 9 Risperidone 2.24 2.24 2.42

10 Rivastigmine 2.19 1.92 2.19 11 Zolmitriptan 0.11 0.1 0 12 Alfuzosin 1.37 1.37 1.23 13 Fluoxetine 29.14 24.48 1.37 14 Gemcetabine 13.33 13.33 10.41 15 Irinotecan 0.05 0.05 0.14 16 Docetaxel 0.14 0.14 0.27 17 Lomoustine 0.05 0.05 0.14 18 Topotecan 0.01 0.01 0.01 19 Pemetrexed 0.14 0.14 0.27 20 Paclitaxel 0.03 0.03 0.05 21 Amsacarine 0.05 0.05 0.14 22 Azacitadine 0.03 0.03 0.14 23 Boertezomib 0.03 0.03 0.03 24 Altratemine 0.05 0.05 0.14 25 Temozolomide 0.01 0.01 0.01


Page 4

26 Valganciclovir 0.02 0.02 0.02 27 Meloxicam 0.93 0.93 0.93 28 Bivalirudin Trifluoro Acetate 0.03 0.03 0.03

Total 490 490 490

Table A-2 Manufacturing Capacity – After Expansion

S.No Name of the Product CAS No. Capacity TPM Kg/day

1 Clopidogrel Bisulphate 144077-07-6 15 500 2 Fexofenadine Hydrochloride 153439-40-8 15 500 3 Ziprasidone Hydrochloride 138982-67-9 3 100 4 Cetirizine Hydrochloride 83881-52-1 2 66.67 5 Losartan Postassium 124750-99-8 4.5 150 6 Lamotragine 84057-84-1 1 33.33 7 Sparfloxacin 110871-86-8 0.1 3.33 8 Norfloxacin 70458-96-7 0.001 0.03 9 Risperidone 106266-06-2 0.4 13.33

10 Rivastigmine 123441-03-2 0.2 6.67 11 Zolmitriptan 139264-17-8 0.025 0.83 12 Alfuzosin 81403-68-1 0.07 2.33 13 Fluoxetine 54910-89-3 3.3 110 14 Gemcitabine 95058-81-4 0.4 13.33 15 Irinotecan 97682-44-5 0.01 0.33 16 Docetaxel 114977-28-5 0.057 1.9 17 Lomustine 13010-47-4 0.04 1.33 18 Topotecan 123948-87-8 0.002 0.07 19 Pemetrexed 137281-23-3 0.02 0.67 20 Paclitaxel 33069-62-4 0.01 0.33 21 Amsacarine 51264-14-3 0.002 0.07 22 Azacitidine 320-67-2 0.02 0.67 23 Bortezomib 179324-69-7 0.001 0.03 24 Altratemine 645-05-6 0.001 0.03 25 Temozolamide 85622-93-1 0.001 0.03 26 Valgaanciclovir 175865-60-8 0.001 0.03 27 Meloxicam 71125-38-7 0.001 0.03 28 Bivalirudin Trifluoro Acetate 128270-60-0 0.001 0.03 29 Imatinib 152459-95-5 0.005 0.17 30 Cabazitaxel 183133-96-2 0.0005 0.02 31 Validation , R&D products 0.3 10

Total 45.5 1515.6


Page 5

Process Description of Lamotrigine

Chemical Reaction of Lamotrigine

Process Description for Lamotrigine

Stage-1: 2,3-Dichlorobenzoyl Cyanide with Acetonitrile in the presence of

Aminoguanidine Bicarbonate and Sulfuric Acid undergoes schiffbase reaction to get

Lamotrigine (Crude).

Stage-2: Lamotrigine (Crude) purify in the presence of Methanol to get Lamotrigine

(Pure). The process flow diagram is presented in Fig A-1 and material balance is

presented in Table A-3.

2,3-Dichlorobenzoyl Cyanide

Aminoguanidine Bicarbonate Sol.Recovery Acetonitrile Evaporation Loss Sulfuric Acid Effluent Methanol Organic Residue Sodium Hydroxide Process Emissions Water

Lamotrigine (Crude) Sol.Recovery Methanol Evaporation Loss

Organic Residue

Lamotrigine

Fig A-1 Process Flow Diagram of Lamotrigine


Page 6

Table A-3 Material Balance for Lamotrigine Stage I Input Quantity

(Kg/day) Output Quantity

(Kg/day) Remarks

2,3-Dichlorobenzoyl Cyanide

56.3 Lamotrigine Crude 37.5 Stage I Product

Aminoguanidine Bicarbonate

38.3 Water formed in reaction

5.3 To wastewater

Water 676.7 Carbondioxide 6.5 Let out into atmosphere safely

Acetonitrile 120 Solvents Methanol 650 Acetonitrile Sulfuric Acid 22 Acetonitrile Recovered 112.2 Recovered & reused Sodium Hydroxide 18 Acetonitrile Loss 1.8 Fugitive Loss Acetonitrile To

Wastewater 0.4 To wastewater

Acetonitrile in Residue 5.6 Solvent in residue Methanol Methanol Recovered 617.5 Recovered & reused Methanol Loss 3.9 Fugitive Loss Methanol To

Wastewater 3.9 To wastewater

Methanol in Residue 24.7 Solvent in residue Organics 2,3-Dichlorobenzoyl

Cyanide 27.0 Organic Residue

Aminoguanidine Bicarbonate

18.3 To Neutralization

Water 684.8 To wastewater Sodium Sulfate 31.9 To wastewater Total Input 1581.2 Total Output 1581.2 Stage II Input Quantity

(Kg/day) Output Quantity

(Kg/day) Remarks

Lamotrigine Crude 37.5 Lamotrigine 33.3 Final Product Methanol 400 Solvents Methanol Methanol Recovered 380 Recovered & reused Methanol Loss 2 Fugitive Loss Methanol in Residue 18 Solvent in residue Organics Lamotrigine Crude 4.2 Organic residue Total Input 437.5 Total Output 437.5


Page 7

ANNEXURE – II: Wastewater Treatment Facilities

The effluent generated from the proposed expansion of M/s. Dr. Reddy’s Laboratories

ltd., CTO Unit I is mainly from process, washings, scrubbers, cooling towers & boiler blow

downs, RO/DM rejects from pre-treatment of water and domestic effluent. Effluent from

process, washings, scrubbers and RO/DM rejects from pre-treatment sent to Stripper,

Multiple Effect Evaporator followed by ATFD, Biological treatment and RO. Effluent from

Cooling towers and boiler bow downs along with condensate from MEE and ATFD and

domestic effluent will be sent to Biological treatment system followed by RO. The treated

effluent shall be reused for cooling towers. Total Effluent generated and mode of

treatment before and after expansion is presented in Table A-4 and A-5 respectively and

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

Table A-6.

Table A-4 Quantity of Effluent Generated – Permitted

S.No Description Quantity KLD

Treatment/Disposal

1 Process & Washings 23.4 Waste water recycling facility (WWRF) at Dr. Reddy’s Laboratories Ltd., CTO Unit – II, IDA Bollaram consisting of Stripper, Multiple Effect Evaporator system followed by Spray drier. Stripper condensate to distillate for recovery of organics.Stripped effluents to forced evaporation in the MEE & spray drier. Condensate of MEE to ETP.

2 Washings 10.3

3 Domestic 25 Waste water recycling facility (WWRF) at Dr. Reddy’s Laboratories Ltd., CTO Unit – II, IDA Bollaram for treatment in the ETP. Treated effluents for filtration in the RO plant.RO permeate to reuse. RO rejects to MEE & spray drier for evaporation.

4 Boiler & Cooling Towers blow down

7

Total 65.7


Page 8

Table A-5 Quantity of Effluent Generated – After Expansion (Tentative)

S.No Description Quantity (KLD)

Treatment/Disposal

1 Process Effluent 79.56 After pre treatment sent to Waste water recycling facility (WWRF at CTO II) having Multiple Effect Evaporator followed by ATFD and condensate to biological treatment. RO is provided for tertiary treatment.

2 Washings Effluent 15 3 Scrubber Effluent 10 4 R & D Effluent 15 5 DM/RO Rejects from pre-

treatment of raw water 31

Total HTDS - I 150.56 6 Boiler Blow Down 10 Pretreated and sent to Biological treatment followed by RO. RO rejects sent to WWRF at CTO II

7 Cooling tower Blowdown 29 8 Domestic Effluent 38 Total HTDS - I 77 Grand Total (I+II) 227.56


Page 9

Table A-6 Quantity and Quality of Effluent Generated from Process (Tentative)

S.No Name of the Product Quantity (Kg/Day) Concentration (mg/l)

Water TDS COD Total Effluent

COD TDS

1 Clopidogrel Bisulphate 26975.0 659.0 244.3 28231.0 8654 23343 2 Fexofenadine HCl 30297.5 856.2 120.0 32198.2 3725 26590 3 Ziprasidone HCl 810.0 23.6 77.6 1192.8 65066 19769 4 Cetirizine Hcl 816.7 20.7 21.1 866.7 24306 23883 5 Losartan Postassium 3600.0 197.8 32.6 3844.4 8483 51457 6 Lamotragine 676.7 31.9 4.5 726.2 6197 43927 7 Sparfloxacin 27.2 0.0 1.6 29.2 55902 0 8 Norfloxacin 0.3 0.0 0.0 0.3 35513 13548 9 Risperidone 1333.3 54.9 21.9 1408.9 15544 38971 10 Rivastigmine 833.3 0.6 48.6 733.7 66246 772 11 Zolmitriptan 261.7 5.7 6.8 273.7 24814 20765 12 Alfuzosin 350.0 10.7 3.3 364.1 9002 29497 13 Fluoxetine 770.0 70.3 133.2 930.4 143210 75560 14 Gemcetabine 4333.3 163.9 278.7 4797.7 58094 34155 15 Irinotecan 190.7 6.5 10.0 204.9 48615 31532 16 Docetaxel 1189.4 33.7 32.6 1248.1 26093 27037 17 Lomoustine 353.3 9.5 12.3 370.5 33105 25657 18 Topotecan 111.7 0.0 3.2 114.1 27847 82 19 Pemetrexed 244.0 0.3 15.8 256.5 61468 1274 20 Paclitaxel 120.0 12.0 4.2 135.6 31316 88221 21 Amsacarine 0.3 0.0 0.0 0.3 0 0 22 Azacitadine 16.7 1.9 4.3 20.6 208151 92350 23 Boertezomib 3.0 0.1 0.1 3.3 33966 42757 24 Altratemine 0.0 0.0 0.0 0.2 0 0 25 Temozolomide 0.1 0.0 0.0 0.1 0 0 26 Valgaanciclovir 1.0 0.1 0.0 1.1 25983 69812 27 Meloxicam 0.7 0.0 0.0 0.8 28775 35109 28 Bivalirudin Trifluoro Acetate 40.0 1.6 1.0 42.2 22637 37820 29 Imatinib 24.3 0.4 1.5 26.0 56491 14123 30 Cabazitaxel 66.7 0.9 1.2 69.3 17347 13344 31 Validation , R&D products 875.0 55.0 46.0 1468.0 31335 37466

Total 74321.8 2217.3 1126.3 79559.0 14157 27869


Page 10

ANNEXURE – III: Water Balance

The total water requirement shall increased from 180 KLD to 580.6 KLD after expansion

out of which 360.6 KLD shall be drawn from APIIC (Industrial water supply) and balance

shall be recycled water. The water balance for daily consumption after expansion is

presented in Table A-7.

Table A-7 Total Water Balance – After Expansion (Tentative)

Purpose INPUT (KLD) OUTPUT (KLD) Fresh Water

Recycled Water

Loss Effluent

Process 74.3 79.6* Washings 15 15 Scrubber 10 10 R& D 15 15 Boiler Feed 125 115 10 Cooling Tower 25 220 216 29 Additional water required for pretreatment of water in RO/DM Plant

31 31

Domestic 40 2 38 Gardening 25 25 Gross Total 360.6 220 358.0 227.8 Total 580.6 585.8

* 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. 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-8

and A-9 respectively.

Table A-8 Solid Waste Details – Permitted S.No Name of the

Hazardous waste Units Quantity Disposal

1 Process Residues (Distillation Bottom residue)

Kg/day 370 TSDF, Dundigal (V), Rangareddy District for Incineration / Authorized cement plants for co - processing. 2 Spent Carbon Kg/day 33.33

3 Forced Evaporation System Salts

Kg/day 800 TSDF, Dundigal (V), Rangareddy District for land filling.

4 ETP Sludge Kg/day 300 5 Process inorganic

waste Kg/day 300

6 Used oil/Waste lubricating oil

KL/Month 1 Authorized Reprocessors / Recyclers.

7 Detoxified Containers and container liners of HW & hazardous chemicals

After complete detoxification, it Should be disposed to the outside agencies.

HDPE Drums no.s/Month 500 Plastic Bags Kg/Month 500 Glass Bottles Kg/Month 300 Carboys no.s/Month 450

8 Spent Catalyst Kg/day 25 Sent to manufacturers for recovery. 9 Spent solvents KL/Month 160 Recovered within the premises and

reused into the process duly sending the residues to TSDF for incineration.


Page 12

Table A-9 Solid Waste Details – After Expansion (Tentative) S.No Name of the

Hazardous waste Units Quantity Disposal

1 Process Residues (Distillation Bottom residue, including SRS)

TPD 6.0 TSDF, Dundigal (V), Rangareddy District for Incineration / Authorized cement plants for co - processing. 2 Spent Carbon TPD 0.6

3 Spent Solvents & Spent Mixed Solvents

KLD 1600 Recovered within the plant premises / Reused / Sold to Authorized third parties.

4 Inorganic residue TPD 0.03 TSDF, Dundigal (V), Rangareddy District for land filling.

5 Evaporation salts TPD 2.2 6 ETP Sludge TPD 1 7 Chemical Sludge TPD 0.75 8 Catalyst Kg/day 50 Sent to manufacturers for recovery. 9 Ash from Boiler TPD 12.57 Sold to Brick manufactures

10 Detoxified Containers and container liners of HW & hazardous chemicals

Shall be disposed after complete detoxification.

HDPE Drums no.s/Month 1500 Plastic Bags Kg/Month 1500 Glass Bottles Kg/Month 3000 Carboys no.s/Month 5000

11 Waste oil LPM 3000 Authorized Reprocessors / Recyclers.

12 Used batteries No.s/Year 30 Authorized Reprocessors / Recyclers.


Page 13

ANNEXURE – V: Stack Emissions Details

The sources of air pollution in the plant are from the existing 8 TPH Coal fired boiler and

proposed 10TPH Briquette Biomass / Coal Fired Boiler. Backup DG sets of 1x 320 KVA, 1

x 725kVA, 1 x 1000 kVA existing and 4 x 1450KVA capacity proposed. 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. The emission

rates of SPM, SO2, NOx and SPM from each stack are presented in Table A-10.

Table A-10 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) PM SO2 NOx

Permitted 1 8 TPH Coal

Fired Boiler 40 1.3 121 6.05 0.63 0.72 0.28

2* 320KVA DG Set 4.0 0.16 160 8.5 0.06 0.14 0.18

3* 725KVA DG Set 6.0 0.25 165 12.04 0.07 0.18 0.30

4* 1000KVA DG Set

7.0 0.3 170 15.72 0.09 0.25 0.41

Proposed 1 10 TPH

Briquette Biomass/Coal Fired Boiler

32 0.6 90 7.8 1.87 2.66 2.84

2* 4 x 1450KVA DG Sets

12 0.36 308 18 0.04 0.14 0.24

*DG sets will be removed


Page 14

Table A-11 Quantity of Process Emission Generated and Mode of Disposal – Proposed (Tentative)

Name of the Product Name of the Gas Quantity (Kg/day)

Mode of Treatment

Clopidogrel Bisulfate Carbon Dioxide 214.6 Dispersed into atmosphere Losartan Potassium Hydrogen 2.71 Diffused with flame arrestor Cetirizine Hydrochloride Hydrogen Chloride 0.36 Scrubber using water Gemcitabine Hydrochloride

Carbon Dioxide 28.92 Dispersed into atmosphere Ammonia 18.9 Scrubber using water Hydrogen Chloride 12.9 Scrubber using water

Bortezomib Carbon Dioxide 0.01 Dispersed into atmosphere Norfloxacin Hydrogen Chloride 0.003 Scrubber using water Risperidone Carbon Dioxide 3.07 Dispersed into atmosphere Ziprasidone Hydrochloride

Oxygen 0.73 Dispersed into atmosphere

Azacitidine Ammonia 0.22 Scrubber using water Docetaxel Trihydrate Carbon Dioxide 1.76 Dispersed into atmosphere Lamotrigine Carbon Dioxide 7.92 Dispersed into atmosphere Pemetrexed Disodium Heptahydrate

Sulphur Dioxide 0.60 Scrubber using caustic sol.

Paclitaxel Carbon Dioxide 0.88 Dispersed into atmosphere Zolmitriptan Hydrogen 0.08 Diffused with flame arrestor Sparfloxacin Hydrogen Fluoride 0.23 Scrubber using caustic sol. Fexofenadine DiHydrochloride

Carbon Dioxide 3.18 Dispersed into atmosphere

Imatinib Hydrogen Chloride 0.34 Scrubber using water Cabazitaxel Carbon Dioxide 0.002 Dispersed into atmosphere




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]

Documents

PLOT NO.137, S.V. CO OP. IND. ESTATE, VILLAGE,environmentclearance.nic.in/writereaddata/Online/TOR/0_0_14_Nov...GOVERNMENT OF INDIA ... emergency usage as the plant has ZLD based