sy. no. ida, village, jinnaram mandal, medak district,...

MYLAN LABORATORIES LIMITED, UNIT ‐ I SY. NO. 10, IDA, GADDAPOTHARAM VILLAGE, JINNARAM MANDAL,

MEDAK DISTRICT, ANDHRA PRADESH

FORM I

Project No. 0314‐21‐01March 2014

Mylan Laboratories Limited, Unit ‐ I Sy. No. 10, IDA, Gaddapotharam (V), Jinnaram (M), Medak (Dist.)‐ 502 319 Phone: +91 040‐3049 3876, 8008001511 E‐mail ID: [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 PARYAVARAN BHAVAN, LODHI ROAD, NEW DELHI

Mylan Laboratories Limited, Unit ‐ 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 M/s Mylan Laboratories Limited, Unit ‐ 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 22.65 TPM to 60.5 TPM Cost of the project (Expansion): 25 Crores

4 New/Expansion/Modernization Expansion 5 Existing Capacity/Area etc. Existing Capacity: 22.65 TPM

Area Existing: 15 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.

Yes. The Unit is Located in Notified Industrial Estate / Area.

Critically Polluted Area of Pattancheru and Bollaram are located at a distance of 5 KM’s from the Site.

9 Location Location Plan is attached in prefeasibility report Plot/Survey/Khasra No. Sy. No. 10, IDA Village Gaddapotharam (V) Tehsil Jinnaram (M) District Medak District State Andhra Pradesh

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

Nearest Railway Station is Secunderabad at a distance of 30 KM from the site.

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

Town & District HQ – Jeedimetla ‐ 20 KM distance from site City ‐ Hyderabad ‐ 35 KM distance from site

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

Sy.No. 10, IDA, Gaddapotharam, Jinnaram Mandal, Medak District – 502319 Direct : 040 3049 1328 Mobile : 8008001511


Form I Page 2

13 Name of the Applicant G. Srinivas Rao 14 Registered Address Mylan Laboratories Limited, Plot No 564/A/22,

Road No 92, Jubile Hills, Hyderabad‐500034 15 Address for Correspondence: Name G. Srinivas Rao Designation(Owner/Partner/CEO) General Manger – EHS Address Sy. No. 10, IDA, Gaddapotharam, Jinnaram Mandal,

Medak District – 502319 Pin Code 502319 E‐mail [email protected] Telephone Number Direct: 040 3049 1328 Mobile: 8008001511

Fax No. 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 we are not discharging any effluents to CETP, 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 in the existing unit. No additional land. Total Land area after proposed expansion 15 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 manufacturing facility and additional utilities like Chilling Plant etc.

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?

YES 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 land fill or 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.


Form I Page 4

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 124

KLD to 713.6 KLD out of which 452 KLD shall be met from HMWS (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 124 KLD to 713.6 KLD out of which 452 KLD shall be met from HMWS (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. Backup DG sets of 3 x 1500 KVA and 2 x 500 KVA, 3 x 750 KVA and 1 x 1010 KVA existing shall be provided to cater to energy requirement during load shut downs. The other energy source is existing Coal fired boilers of 8 TPH, 1TPH and 2x2TPH capacity to meet the steam requirement both for process and ZLD system.

The surplus steam and power generated from the 5 MW Captive power generation plant of M/s Astrix Laboratories Limited (Group of Mylan Laboratories Limited) will be utilized in Mylan Laboratories Limited, Unit – 1, which is adjacent to our plant and also part of Mylan Group of industries.

2.7 Any other natural resources (use appropriate standard units)

NO


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) YES Wastes from canteen is generated. The

canteen wastes shall be in the range of 50 kgs/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 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.


Form I Page 7

4.7 Construction or demolition wastes YES Construction activity involves creation of manufacturing facility and additional utilities like Chilling Plant etc.

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 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


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

YES Coal is 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 From 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 treatment in “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, Dust Collectors and emissions from boiler shall be controlled by providing Multi‐cone cyclone separators/bag filter.

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 Danara Cheru– Southeast– 7.7 Km, Lingam Cheru‐ Northwest‐ 5.1 Km, Pirshab Cheru‐ Northwest‐ 5.2 Km, Akkam Cheru – Northwest – 7.8 Km Tunkini Cheru – West – 8.2 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 Sambhupur village at 0.95 km from

site. 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)

YES Patancheru and Bollaram Industrial areas at a distance of 5Km.

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.



ANNEXURES



Mylan Laboratories Limited, Unit ‐ I Form I Annexures

Page 1

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ANNEXURE - I M/s. Mylan Laboratories Limited, Unit – I obtained consent for establishment and

operation for Bulk Drugs & intermediates at Sy. No. 10, IDA, Gaddapotharam village,

Jinnaram mandal, Medak district, Andhra Pradesh. It is proposed to expand the

manufacturing capacity of API’s from 22.65 TPM to 60.5 TPM. The expansion entails a

capital cost of Rs. 25 crores towards Manufacturing capacity enhancement, 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 Product Name Capacity Kg/Day TPM

Group - 1 Regular Products ( Five products at any given time) 1 Lopinavir 166.67 5.00

OR 2 Pregabiline 178.33 5.35

3 Zidovudine 166.67 5.00

OR 4 Lamivudine 166.67 5.00

5 Tenofavir 166.67 5.00

OR 6 Oxcarbazepine 133.33 4.00

ANY ONE PRODUCT 7 Paroxetine HCl 81.67 2.45

8 Zolpidem 133.33 4.00 9 Quetipine Fumarate 66.67 2.00

ANY ONE PRODUCT 10 Montelukast 33.33 1.00

11 Enrofloxacin 33.33 1.00 12 Febantel 33.33 1.00 13 Tolmetan 33.33 1.00 14 Nadolol 8.33 0.25

Total Group 1 678.33 20.35


Page 4


Group - 2 Compaign Products ( Six products at any given time ) 15 Atavaquone 6.67 0.20

OR 16 Sumatriptan 8.33 0.25

17 Clindamycin Palmitate HCl 16.67 0.50

OR 18 Mirtazapine 8.33 0.25

19 Lisinopril 6.67 0.20

OR 20 Moxifloxacin 6.67 0.20

ANY ONE PRODUCT 21 Irbesartan 15.00 0.45

22 Oseltamivir 8.33 0.25 23 Valgancyclovir 3.33 0.10 24 Duloxetine HCl 8.33 0.25 25 Atenolol 8.33 0.25

ANY ONE PRODUCT 26 Quinapril 3.33 0.10

27 Stavudine 16.67 0.50 28 Citalopram 8.33 0.25 29 Darunavir 8.33 0.25 30 Effavirenz 3.33 0.10 31 Voriconzole 8.33 0.25 32 Levetiracetam 16.67 0.50 33 Olmesartan Medoxomil 3.33 0.10

ANY ONE PRODUCT 34 Nevirapine(RAP) 8.33 0.25

35 Atomoxctine HCl 2.67 0.08 36 Triclabendazole 8.33 0.25 37 Eletripton Hydrobromide 2.67 0.08 38 Sitaglipton phosphate 5.00 0.15 39 Pironaridine Tetraphosphate 8.33 0.25 40 Gatifloxacine 8.33 0.25

Total Group 2 71.67 2.15


Page 5


Group - 3 Validations / Test samples / Lab scale products ( One product at any given time)

41 Clarithromycin 0.67 0.02 42 Bosentan 0.67 0.02 43 Artmether 0.67 0.02 44 Artesumate 0.67 0.02 45 Ezetamibe 0.67 0.02 46 Milnacipran 0.67 0.02 47 Barnidipine 0.67 0.02 48 Febuxostat 0.67 0.02 49 Candesartan 0.67 0.02 50 Fosamprenavir 0.67 0.02 51 Atazanavir sulfate 0.67 0.02 52 Piperaquine Phospahate 0.67 0.02 53 Raltegravir 0.67 0.02 54 Levofloxacine 0.67 0.02 55 Prasugrel 0.67 0.02 56 Aripiprazole 0.67 0.02 57 Dihydro Arstemisinin 0.67 0.02 58 Deasmopression Acetate 0.17 0.01 59 Blonanserin 0.67 0.02 60 Etroicoxib 0.67 0.02 61 Mitiglinide Calcium Dihydrate 0.67 0.02 62 Octreotide Acetate 0.50 0.02 63 Tetrabenazine 0.67 0.02 64 Vardenafil Hydrochloride Trihydrate 0.67 0.02 65 Aliskiren Hemifumarate 0.67 0.02 66 Atrovastatin 0.67 0.02 67 Amolodiphine 0.67 0.02 68 Azilsartan medoxomil potassium 0.67 0.02 69 Cabazitaxel 0.67 0.02 70 Fingolimod 5.00 0.15 71 Vilazadone 0.67 0.02 72 Linagliptin 0.67 0.02 73 Bocepravir 0.67 0.02 74 Telepravir 0.67 0.02 75 Miglitol 0.67 0.02 76 Finasartan 0.67 0.02 77 Other Validation Products 5.00 0.15

Total Group 3 5.0 0.15 Total Worst Case Load (Group: 1+2+3) 755.0 22.65


Page 6

Table A-2 Manufacturing Capacity – After Expansion

S.No Name of the Product Quantity Kg/day TPM

1 Lopinavir 166.67 5.00 2 Pregabiline 233.33 7.00 3 Zidovudine 200.00 6.00 4 Quetipine Fumarate 166.67 5.00 5 Tenofavir 233.33 7.00 6 Oxcarbazepine 100.00 3.00 7 Febantel 66.67 2.00 8 Zolpidem 100.00 3.00 9 Lamivudine 133.33 4.00 10 Montelukast 33.33 1.00 11 Enrofloxacin 66.67 2.00 12 Paroxetine HCl 66.67 2.00 13 Nadolol 16.67 0.50 14 Atavaquone 16.67 0.50 15 Valgancyclovir 33.33 1.00 16 Duloxetine HCl 33.33 1.00 17 Effavirenz 16.67 0.50 18 Levetiracetam 33.33 1.00 19 Olmesartan Medoxomil 33.33 1.00 20 Nevirapine(RAP) 16.67 0.50 21 Atomoxctine HCl 16.67 0.50 22 Tolmetan 33.33 1.00 23 Sumatriptan 8.33 0.25 24 Clindamycin Palmitate HCl 11.33 0.34 25 Mirtazapine 8.33 0.25 26 Lisinopril 6.67 0.20 27 Moxifloxacin 6.67 0.20 28 Irbesartan 15.00 0.45 29 Oseltamivir 8.33 0.25 30 Atenolol 8.33 0.25 31 Quinapril 3.33 0.10 32 Stavudine 10.00 0.30 33 Citalopram 8.33 0.25 34 Darunavir 8.33 0.25 35 Voriconzole 8.33 0.25 36 Triclabendazole 8.33 0.25 37 Eletripton Hydrobromide 2.67 0.08 38 Sitaglipton phosphate 5.00 0.15 39 Pironaridine Tetraphosphate 8.33 0.25 40 Gatifloxacine 8.33 0.25 41 Clarithromycin 0.67 0.02 42 Bosentan 0.67 0.02


Page 7

43 Artmether 0.67 0.02 44 Artesumate 0.67 0.02 45 Ezetamibe 0.67 0.02 46 Milnacipran 0.67 0.02 47 Barnidipine 0.67 0.02 48 Febuxostat 0.67 0.02 49 Candesartan 0.67 0.02 50 Fosamprenavir 0.67 0.02 51 Atazanavir sulfate 0.67 0.02 52 Piperaquine Phospahate 0.67 0.02 53 Raltegravir 0.67 0.02 54 Levofloxacine 0.67 0.02 55 Prasugrel 0.67 0.02 56 Aripiprazole 0.67 0.02 57 Dihydro Arstemisinin 0.67 0.02 58 Deasmopression Acetate 0.33 0.01 59 Blonanserin 0.67 0.02 60 Etroicoxib 0.67 0.02 61 Mitiglinide Calcium Dihydrate 0.67 0.02 62 Octreotide Acetate 0.67 0.02 63 Tetrabenazine 0.67 0.02 64 Vardenafil Hydrochloride Trihydrate 0.67 0.02 65 Aliskiren Hemifumarate 0.67 0.02 66 Atrovastatin 0.67 0.02 67 Amolodiphine 0.67 0.02 68 Azilsartan medoxomil potassium 0.67 0.02 69 Cabazitaxel 0.67 0.02 70 Fingolimod 5.00 0.15 71 Vilazadone 0.67 0.02 72 Linagliptin 0.67 0.02 73 Bocepravir 0.67 0.02 74 Telepravir 0.67 0.02 75 Miglitol 0.67 0.02 76 Finasartan 0.67 0.02 77 Other Validation Products 28.33 0.85 Total 2017.08 60.51


Page 8

Process Description of Citalopram Hydrobromide

Chemical Reaction of Citalopram Hydrobromide

Stage I

O H

O HN

C H 3

C H 3

F

O H

O H NC H 3

C H 3

F

C C

H 3 P O 4 , D M W

T o lu e n e ,N a o HH C l H 3 P O 4

D io l H y d r o c h lo r id e D io l P h o s p h a te

N N

Stage II O H

O H NC H 3

C H 3

F

C

NC H 3

C H 3

F

O

C

H 3 P O 4

D io l P h o s p h a t e

N

H B r

C i t a lo p r a m H y d r o b r o m id e

N

H 3 P O 4

N a o H , T o lu e n e I P A / H B r

Process Description for Citalopram Hydrobromide

Stage I: Diol Hydrochloride is converted to Diol Phosphate using with Sodium hydroxide

solution in water and Toluene and by the treatment with phosphoric acid affords the Diol

phosphate.

Stage II: Diol Hydrochloride is converted to Diol Phosphate using with Sodium hydroxide

solution in water and Toluene and by the treatment with phosphoric acid affords the Diol

phosphate. The process flow diagram is presented in Fig A-1 and material balance is

presented in Table A-3.


Page 9

Diol Hydrochloride Stage-I productWater

Toluene WastewaterSodium Hydroxide

Ortho Phosphoric acid Stage I Solid WasteOrganic Recovery Residue

Recoveries(-):Toluene

Stage -I WastewaterO-Phosphoric acid Sodium Hydroxide Solid Waste

Toluene Organic Isopropyl alcohol Recovery Residue

Water Carbon Stage II Spent carbon

HyfloAq.HBr Recoveries(-):

TolueneIsopropyl alcohol

Proposed Product - CITALOPRAM HYDROBROMIDE

CITALOPRAM HYDROBROMIDE

Fig A-1 Process Flow Diagram of Citalopram Hydrobromide


Page 10

Table A-3 Material Balance for Citalopram Hydrobromide C apacity (TPM ) = 0.25 Batches per day = 0.19B atches per month = 5.68 Yield per batch = 44.00

S.No In put Qty Kg/batch Output Kg/ batch1 Dio l Hydrochloride 55.50 Stage- I product 602 W ater 460.653 Toluene 312.73 Wastewater4 Sodium H ydroxide 8.71 Water 4665 Ortho Phosphoric acid 19.43 Toluene 3

Sodium chlor ide 8Sodium Phosphate 10

Solid WasteOrganic Recovery Residue 3

Recoveries(-) : Emissio nsToluene 297.10 Toluene 9

Total 559.92 Total 55 9.92

Process Organic (kgs) 0 Wastewater (k g) 466Organic R esidue (kgs) 3 COD (kgs) 5Inorganic(kgs) 0 COD (mg/l) 9972Spent carbon (kgs) 0.0 TDS(kgs ) 18Gas(kgs) 0 TDS(mg/l) 38815Em issions(kgs) 9.40

Proposed Product - CITALOPRAM HYDROBRO MIDE

Stage - I

Wa ste Genera tion

S.No Input kg/ batch Output kg/ batch1 Stage -I 60 Stage-II product 44.02 O-Phosphoric acid 200.003 Sodium Hydroxide 258.504 Toluene 541.81 Wastewater5 Isopropyl alcohol 145.41 Water 15336 Water 1410.00 Toluene 57 Carbon 5.00 Isopropyl alcohol 18 Hyflo 4.00 Sodium Phosphate 3679 Aq.HBr 15.50

Solid WasteOrganic Recovery Residue 7

Spent carbonCarbon 5Hyflow 4

Recoveries(-): EmissionsToluene 514.72 Toluene 16.3Isopropyl alcohol 138.14 Isopropyl alcohol 4.4

Total 1987.36 Total 1987.36

Process Organic (kgs) 0 Wastewater (kg) 1533Organic Residue (kgs) 6.87 COD(kgs) 10Inorganic(kgs) 0 COD(mg/l) 6726Spent carbon (kgs) 5.0 TDS(kgs ) 367Gas(kgs) 0 TDS(mg/l) 239699Emissions(kgs) 20.6

Stage II -- Proposed Product - CITALOPRAM HYDROBROMIDE

Waste Generation


Page 11

ANNEXURE – II: Wastewater Treatment Facilities

The effluent generated from the proposed expansion of M/s. Mylan Laboratories Limited,

Unit – I is mainly from process, washings, scrubbers, cooling towers & boiler blow downs

and domestic effluent. HTDS effluent sent to Stripper, Multiple Effect Evaporator

followed by ATFD, Biological treatment and RO. LTDS effluent from process, washings,

scrubbers, Solvent recovery system, DM rejects, Cooling towers, boiler bow downs,

detoxification effluent, ZLD washings and domestic effluents shall be sent to Biological

treatment system followed by RO. The treated effluent reused for cooling towers. 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


Table A-4 Quantity of Effluent Generated – After Expansion (Tentative)

Description of Effluent Quantity (KLD) Mode of Final Disposal Permitted After

Expansion HTDS Effluents

Process 44.3 147.3 Treated in effluent treatment plant consist of Stripper, MEE, ATFD and Biological treatment followed by RO.

RO Permeate reused for cooling tower makeup and RO rejects sent to MEE.

Total HTDS 44.3 147.3 LTDS Effluents

Process Effluent 12.7 12.3 Biological treatment followed by RO. RO Permeate reused for cooling tower makeup and RO rejects sent to MEE.

Washings Effluent 5 Scrubber Effluent 5 Solvent recovery plant 2 Boiler 10 Cooling Tower 15 DM Plant, Softener & Purified water system

20

Detoxification 5 ZLD Washings 10 Domestic 8 30 Total LTDS 20.7 114.3 Grand Total (HTDS+LTDS) 65 261.6


Page 12

Table A-5 Quantity and Quality of Effluent Generated from Process (Tentative)

S.No Descrition Water Input (kg/day)

EFFLUENT DETAILS TDS

(kg/day) COD

(kg/day) Total

Effluent (Kg/day)

TDS (mg/l)

COD (mg/l)

A) Process 1 Lopinavir 8857 95 102 8932 10663 11425 2 Pregabiline 5415 81 122 5674 14336 21512 3 Zidovudine 18628 992 634 19267 51491 32891 4 Quetipine Fumarate 21297 265 288 21493 12319 13383 5 Tenofavir 10008 637 230 11380 55981 20251 6 Oxcarbazepine 7614 533 335 7870 67714 42542 7 Febantel 678 86 57 852 100983 67113 8 Zolpidem 8089 400 41 8076 49587 5134 9 Lamivudine 3129 127 88 3516 36105 25097

10 Montelukast 11 Enrofloxacin 2084 17 14 2139 7966 6694 12 Paroxetine HCl 8687 268 149 8846 30253 16868 13 Nadolol 253 9 17 290 29298 57006 14 Atavaquone 3208 294 162 3373 87236 48057 15 Valgancyclovir 20350 702 530 22761 30838 23292 16 Duloxetine HCl 11285 650 681 12288 52923 55392 17 Effavirenz 2943 70 78 3269 21544 23952 18 Levetiracetam 0 8 39 225 34997 174983 19 Olmesartan Medoxomil 3839 305 217 4267 71403 50826 20 Nevirapine(RAP) 310 36 11 325 109945 34028 21 Atomoxctine HCl 3374 123 220 3671 33418 59877 22 Tolmetan 956 131 69 997 131093 69640 23 Sumatriptan 1378 36 43 1517 23613 28407 24 Clindamycin Palmitate HCl 188 0 21 211 0 99412 25 Mirtazapine 381 40 14 409 97651 33111


Page 13

26 Lisinopril 605 24 16 652 36946 25233 27 Moxifloxacin 100 0 15 123 0 125440 28 Irbesartan 991 60 42 1052 57087 39771 29 Oseltamivir 171 16 82 256 60917 318360 30 Atenolol 681 5 15 698 7855 21742 31 Quinapril 275 22 24 292 76888 81685 32 Stavudine 156 0 24 245 0 97831 33 Citalopram 354 73 3 380 191879 7446 34 Darunavir 332 21 26 361 57240 71132 35 Voriconzole 231 13 5 234 53924 22274 36 Triclabendazole 265 3 13 274 11488 46960 37 Eletripton Hydrobromide 537 8.8 30.1 577 15284 52104 38 Sitaglipton phosphate 448 40 16.7 459 87373 36247 39 Pironaridine Tetraphosphate 326 1.1 3.1 333.5 3370 9337 40 Gatifloxacine 69.4 6.1 2.5 72.8 84314 33921 41 Clarithromycin 102 3.8 3.6 104.3 36501 34156 42 Bosentan 62.9 0.2 0.5 63.7 2980 7434 43 Artmether 27.0 0.2 2.6 28.7 5356 89420 44 Artesumate 14.0 0.3 0.9 14.6 22754 61009 45 Ezetamibe 52.7 5.0 6.5 66.3 74849 98773 46 Milnacipran 46.9 1.1 1.6 49.3 22809 33359 47 Barnidipine 13.0 0.6 1.7 14.2 45028 119725 48 Febuxostat 26.8 0.9 1.5 28.0 31084 54057 49 Candesartan 25.0 0.8 3.5 27.5 27362 128974 50 Fosamprenavir 28.2 2.6 0.4 35.8 72577 10290 51 Atazanavir sulfate 10.2 0.1 0.1 10.3 6493 9740 52 Piperaquine Phospahate 25.8 1.1 2.6 27.7 38792 94053 53 Raltegravir 79.7 4.7 3.7 85.5 54757 42981 54 Levofloxacine 16.2 0.4 0.4 17.6 23830 20146 55 Prasugrel 13.5 0.5 0.6 13.9 37353 43813 56 Aripiprazole 14.7 0.2 0.2 14.9 16539 11448 57 Dihydro Arstemisinin 42.0 0.2 0.8 42.5 3636 18860


Page 14

58 Deasmopression Acetate 424.4 0.0 0.2 423.4 51 366 59 Blonanserin 41.2 8.2 1.4 40.3 202264 33724 60 Etroicoxib 4.7 0.4 0.5 4.9 75626 92094 61 Mitiglinide Calcium Dihydrate 16.7 0.1 0.3 17.0 4012 16106 62 Octreotide Acetate 377.5 0.5 3.9 380.4 1219 10341 63 Tetrabenazine 7.8 1.2 1.4 8.9 140206 156150 64 Vardenafil Hydrochloride Trihydrate 20.1 1.3 0.8 21.5 58231 37324 65 Aliskiren Hemifumarate 14.9 0.4 0.7 15.8 25320 43814 66 Atrovastatin 47.6 0.5 1.9 49.3 9599 39407 67 Amolodiphine 13.6 0.0 0.7 16.9 0 43432 68 Azilsartan medoxomil potassium 11.4 0.4 0.3 11.9 30808 22332 69 Cabazitaxel 180.6 2.8 2.5 182.7 15497 13665 70 Fingolimod 15.6 7.2 5.3 22.1 323187 240103 71 Vilazadone 2.9 0.0 0.5 3.5 0 153161 72 Linagliptin 25.9 1.6 1.6 28 58535 58591 73 Bocepravir 3.8 2.6 0.1 4 607430 26165 74 Telepravir 7.0 0.7 1.6 9 79876 189555 75 Miglitol 21.6 3.5 0.1 22 158805 6194 76 Finasartan 7.1 0.7 0.2 7 99644 32574 77 Other Validation Products 15.6 7.2 5.3 22 323187 240103

Total 150352 6260 4541 159597 39221 28452 B) Process Washings & Laboratories

78 Process Washings & Laboratories 5000 20 20 5000 4000 4000 Total - Group-A+B 155352 6280 4561 164597 38151 27710


Page 15

ANNEXURE – III: Water Balance

The total water requirement shall increased from 124 KLD to 713.6 KLD after expansion

out of which 452 KLD shall be drawn from KMWS (Industrial Supply) and balance shall

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

in Table A-6.

Table A-6 Total Water Balance – After Expansion (Tentative)

Purpose INPUT (KLD) OUTPUT (KLD) Fresh Water

Recycled Water

Loss Wastewater

Process & Washings 156 164.6* Scrubber 5 5 Solvent recovery plant 2 2 Boiler 65 55 10 Process & Utility RO rejects to Cooling tower make-up

119** 261.6 385.6 15

Cooling Tower 20 DM Plant, Softener & Purified water system

20 20

Detoxification 5 5 ZLD Washings 10 10 Water for gardening 20 20 Domestic 30 30 Gross Total 452 261.6 460.6 261.6 Total 713.6 722.2

* Process effluents contain soluble raw materials, byproducts, solvents etc. **119 KLD generated from process & Utility RO is being recycled into Cooling Tower for make up.


Page 16

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 (Tentative) S.No Description of waste UOM Permitted After

Expansion Disposal method

1.Hazardous Waste with Disposal Option: 1 Forced Evaporation Salts Kg/day 1001 6603 TSDF 2 ETP Sludge Kg/day 500 1500 TSDF 3 Process Inorganics Salts Kg/day 88 499 TSDF 4 Mixed Spent Solvents KL/day 25 TSDF / Cement

Industry 5 Spent Carbon Kg/day 53 1014 TSDF / Cement

Industry 6 Distillation bottom

residue (including process organics)

Kg/day 649 2608 TSDF / Cement Industry

7 Thermocol Kg/day 50 TSDF 8 Insulation Waste Kg/day 50 TSDF 9 Glass wool Kg/day 50 TSDF 10 Softener / DM Plant

Resins Kg/day 15 TSDF

11 Off specifications, rejected & Discarded Raw materials, lab chemicals & products etc

Kg/day 25 TSDF / Cement Industry

12 Stripper Distillate ( VOC) KL/Day 2 TSDF / Cement Industry

13 Used Filters (HEPA filters Oil Filters etc)

Nos / Month

20 TSDF for Incineration

14 Discarded PPE Kgs / day 30 TSDF for Incineration 15 Lab Vials Kg/month 500 TSDF

2.Hazardous Waste with Recycling Option : 15 Discarded Container & liners Dispose off to outside

agencies after detoxification

a HDPE containers No's/ M 120 2500 b Glass Bottles No's/ M 1500 c Plastic Containers No's/ M 1500 d Liners & bags Kg/day 1000

16 Used Oil LPM 150 1000 Authorized recyclers 17 Distilled Industrial waste

solvent after recovery KL/day 10 Sale to authorized

recyclers


Page 17

(colorless ) 18 Spent Solvents KL/day 13.93 25 Recovered within the

premises / Sale to authorized recyclers

19 Lead acid batteries No's/Year 50 Authorized recyclers 20 E- Waste Kg/day 50 E – waste Disposal

facility 3. Non Hazardous Waste :

21 Paper, cotton waste & Packing materials i.e.wood, carton , ropes

TPM 25 Sale to out side agencies/ recyclers

22 Ply wood containers/ broken glass etc


23 Metal scrap ( MS, SS, GI ,Aluminum)


24 Coal Ash / Fly Ash TPM 400 TSDF to use as a stabilizing agent / Brick manufactures


Page 18

ANNEXURE – V: Stack Emissions Details

The sources of air pollution in the plant are from the existing 8TPH, 1TPH and 2X2 TPH

Coal fired boilers to meet the steam requirement and existing backup DG sets of 2x500,

3x750 and 1x1010 and proposed 3 x 1500 KVA, to cater to energy requirement during load

shut downs. The proposed air pollution control equipment for coal fired boiler is bag

filter. 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


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 Velocity (m/sec)

Pollutant Emission Rate

(g/sec)

SPM SO2 NOx

Permitted 1 8TPH Coal fired

Boiler 30 1.5 130 6.05 0.6 0.7 0.25

2 2x2TPH and 1TPH Coal fired Boilers

30 0.4 180 7.5 0.05 0.08 0.21

3 2x500 KVA DG Sets*

5 0.25 185 7.2 0.004 0.16 0.028

4 3 x 750KVA DG Sets*

8.5 0.2 165 6.2 0.01 0.02 0.03

5 1 x 1010KVA DG Set*

10 0.2 180 8 0.01 0.02 0.03

Proposed 1 3 x 1500KVA

DG Sets* 12 0.2 151 10 0.02 0.03 0.04

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


Page 19

ANNEXURE – VI: Process Emissions Details

Table A-9 Quantity of Process Emission Generated and Mode of Treatment/Disposal (Tentative)

S.No. Name of product Stage Name of the gas Quantity (Kg/day)

Treatment/Disposal

1 Lopinavir I Carbon dioxide 46.01 Safely let into atmosphere 2 Quetipine Fumarate II Carbon dioxide 22.55 Safely let into atmosphere 3 Tenofavir I Carbon dioxide 16.99 Safely let into atmosphere

4 Lamivudine

I

Hydrogen 1.81

Safely let into atmosphere

5 Montelukast I Sulfur dioxide 4.13 To Scrubber 6 Nadolol I Carbon dioxide 0.14 Safely let into atmosphere 7 Valgancyclovir IV Hydrogen chloride 0.08 To Scrubber

8 Effavirenz

I

Hydrogen 1.13


9 Olmesartan Medoxomil

I Carbon dioxide 165.56 Safely let into atmosphere III Carbon dioxide 13.00 Safely let into atmosphere IV Carbon dioxide 277.78 Safely let into atmosphere

10 Nevirapine(RAP)

II

Hydrogen 0.76


11 Tolmetan I Carbon dioxide 2.64 Safely let into atmosphere 12 Sumatriptan I Carbon dioxide 10.41 Safely let into atmosphere

13

Lisinopril

II

Hydrogen gas 11.25


Carbon dioxide 1.57 Safely let into atmosphere III

Hydrogen gas 0.39


14 Quinapril II Carbon dioxide 2.48 Safely let into atmosphere

Nitrogen gas 0.13 Safely let into atmosphere Darunavir I Nitrogen 0.27 Safely let into atmosphere

15 Eletripton Hydrobromide

III

Hydrogen gas 0.05


Nitrogen gas 0.06 Safely let into atmosphere 16 Gatifloxacine I HF Gas 5.21 To Scrubber 17 Clarithromycin I Carbon dioxide 0.03 Safely let into atmosphere 18 Milnacipran II Sulfur dioxide 0.03 To Scrubber 19 Barnidipine I Carbon dioxide 0.03 To Scrubber 20 Candesartan III Carbon dioxide 0.02 Safely let into atmosphere 21 Fosamprenavir I Carbon dioxide 0.06 Safely let into atmosphere


Page 20

22

Piperaquine Phospahate

I

Hydrogen chloride 0.06

To Scrubber

23 Deasmopression Acetate I

Carbon dioxide0.08


24 Etroicoxib II Carbon dioxide 0.04 Safely let into atmosphere

25 Octreotide Acetate I Sulfur dioxide 0.10 To Scrubber

Hydrogen chloride 0.40 To Scrubber Carbon dioxide 2.50 Safely let into atmosphere

26 Vardenafil Hydrochloride Trihydrate

I

Carbon dioxide 0.11 Safely let into atmosphere

Hydrogen chloride 0.11 To Scrubber

II Hydrogen chloride 0.08 To Scrubber

27 Aliskiren Hemifumarate

III

Nitrogen 0.03


26 Atrovastatin I Carbon dioxide 0.10 Safely let into atmosphere 28

Azilsartan medoxomil potassium

I

Hydrogen chloride 0.09

To Scrubber

29 Bocepravir I Sulfur dioxide 0.04 To Scrubber 30

Miglitol

II

Hydrogen 0.02


Total 588.33



Status of Compliance of the conditions and Environmental safeguards

stipulated in Environment Clearance

Mylan Laboratories Limited, Unit ‐ I Sy. No. 10, IDA, Gaddapotharam (V), Jinnaram (M), Medak (Dist.)‐ 502 319 Phone: +91 040‐3049 3876, 8008001511 E‐mail ID: [email protected]



MYLAN LABORATORIES LIMITED, UNIT – I SY. NO. 10, IDA, GADDAPOTHARAM VILLAGE, JINNARAM MANDAL,


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]

sy. no. ida, village, jinnaram mandal, medak district,...

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