APPLICATION FOR ENVIRONMENTAL CLEARANCEenvironmentclearance.nic.in/writereaddata/FormB/TOR/PFR/15_Jul... · APPLICATION FOR ENVIRONMENTAL CLEARANCE FOR CHANGE IN PRODUCT MIX BY M/s

APPLICATION FOR ENVIRONMENTAL

CLEARANCE

FOR

CHANGE IN PRODUCT MIXBY

M/s. CIPLA Limited

AT

Plot No. 285, 286 & 287, KIADB Industrial Area,Bommasandra-Jigani Link Road, Phase-IV,

VILLAGE: BOMMASANDRA

TEHSIL: ANEKAL

DISTRICT: BANGALORE

STATE: KARNATAKA

[Project termed under schedule 5(f): Category ‘B’ Synthetic organic chemicals as per

EIA Notification 2006 and its Amendments]

Prepared by

EIA Consultant

HUBERT ENVIRO CARE SYSTEMS (P) LTD

CHENNAI

July 2016

2

Latitude: 12°47'8.31"N

Longitude: 77°38'54.28"E

Plot/survey/khasra No. Plot.No.285, 286 & 287

Village Bommasandra

Tehsil Anekal

District Bangalore

State Karnataka

10. Nearest Railway station/Airportalong with the distance in Kms.

Nearest Railway: Heelalige 7.2 Kms towards NEAnekal 9.4 Kms towards SE

Nearest Airport: Kempegowda International Airport 46Kms towards North, Bangalore

11. Nearest town, city, District Headquarters along with distance in kms.

Nearest Town: Anekal -8.9 KmsNearest City: Bangalore- 21.5 KmsDistrict Headquarters: Bangalore 25 kms

12. Village Panchayats, Zilla Parishad,Municipal Corporation, Local Body(complete postal addresses withphone nos. to be given)

M/s. CIPLA LimitedPlot.No.285, 286 & 287KIADB Industrial Area,Bommasandra Industrial Area,Jigani Link Road, Phase-IV,Bommasandra Gram Panchayat,Anekal Taluk,Bangalore 560105, Karnataka.Mobile Nos: 9972309596, 9535998805

13. Name of the applicant M/s. CIPLA Limited

14. Registered Address M/s. CIPLA Limited

15. Address for Correspondence M/s. CIPLA LimitedPlot.No.285, 286 & 287KIADB Industrial Area,Bommasandra-Jigani Link Road, Phase-IV,Anekal Taluk,Bangalore 560105, Karnataka.

Name Mr. Ravinath Shetty

Designation (Owner/Partner/CEO) Site Head

Address M/s. CIPLA LimitedPlot.No.285, 286 & 287KIADB Industrial Area,

3

Bommasandra-Jigani Link Road, Phase-IV,Anekal Taluk,Bangalore 560105, Karnataka.

Pin Code Bangalore - 560 105

E mail [email protected]@cipla.com

Telephone No. Mobile Nos: 9972309596, 9535998805

16. Details of Alternative sitesexamined, if any. Location of thesesites should be shown on atoposheet.

Proposal is for change in product mix in existing factory

Site is situated in a designated KIADB Industrial Area,Jigani.

17. Interlinked Projects No

18. Whether separate application ofinterlinked project has beensubmitted.

Not Applicable

19. If yes, date of submission Not Applicable

20. If no, reason Not Applicable

21. Whether the proposal involvesapproval/clearance under: if yes,details of the same and their statusto be given.

(a) The Forest ConservationAct, 1980?

(b) The Wildlife Protection Act,1972?

(c) The C.R.Z notification,1991?

Not Applicable

22 Whether there is any GovernmentOrder/Policy relevant/relating to thesite?

No

23. Forest Land involved (hectares) No forest land is involved.

24. Whether there is any litigationpending against the project and/orland in which the project is proposeto be set up?

(a) Name of the Court(b) Case No.

No

4

(c) Orders/directions of thecourt, if any and itsrelevance with the proposedproject.

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 landuse (with

respect to local landuse plan)

No Existing.

The present land use in KIABD industrial area, Jigani

Land possession certificate is attached as Annexure 1

1.2 Clearance of existing land,

vegetation and buildings?

No Not Applicable

Site is in KIADB industrial area

1.3 Creation of new land uses? No Not Applicable

Site is in KIADB industrial area

1.4 Pre-construction

investigations e.g. bore

houses, soil testing?

No Not Applicable

1.5 Construction works? No Not Applicable as all the facilities are already existing

1.6 Demolition works? No No demolition works are involved

1.7 Temporary sites used for

construction works or

housing of construction

workers?

No Not Applicable

5

S.

No


confirmation

Yes/

No



1.8 Above ground buildings,

structures or earthworks

including linear structures,

cut and fill or excavations

No Not Applicable

1.9 Underground works

including mining or

tunneling?

No Not Applicable

1.10 Reclamation works? No Not Applicable

1.11 Dredging? No Not Applicable

1.12 Offshore structures? No Not Applicable

1.13 Production and

manufacturing processes?

Yes There will be production of APIs. The process description is

enclosed in Annexure 8.

1.14 Facilities for storage of goods

or materials?

Yes Storage facilities:S.No Description Capacity

Existing Proposed Total1. Solvent Yard Capacity 270 KL No change 270 KL

2. Powder storage(Solid Storage WA)

50 MT No change 50 MT

3. Haz Storage Room 50 MT No change 50 MT

4. Primary Packing Storage 1000 kg No change 1000kg

5. Secondary Packing Storage 2000 kg No change 2000kg

6. Drum Yard StorgaeCapacity

50 MT No change 50 MT

7. API Storage capacity 10 MT No change 10 MT

6

S.

No


confirmation

Yes/

No



1.15 Facilities for treatment or

disposal of solid waste or

liquid effluents?

Yes a. Solid Waste:

WasteQuantity (kg/day) Collection

methodDisposalmethodExisting Proposed Total

Hazardouswaste 580

Nochange 580

Leakproof bagsandbarrels

Authorizedvendors

Effl.&SewagetreatmentSludge

164.38No

change 164.38 Trolleys TSDF

Hazardous waste

Hazardous waste materials are properly disposed as per the

Hazardous waste rules 2016.

Agreement between TSDF and CIPLA for collection,

transport, storage, treatment and disposal and also we have a

valid Agreement with M/s Enano incintech for Incineration of

incinerable wastes.

WasteCategory

Hazardouswaste

Generated

Quantity Method of handling

Existing Proposed Total

5.1

Used Oil 15 KL/A

Nochanges

15KL/A

Shall be collected in Leak proofcontainers and disposed only toKSPCB registered authorizedreprocessors provided the oil meetsthe standards as per schedule-5 part-A of the rules

5.2 Oil soakedcottonwaste

0.5MT/A 0.5MT/A

Shall be stored in a secured manner andhand over to KSPCB authorizedincinerator/Co processing in cement kiln

28.1 Processresidues &Waste

202MT/A

202MT/AShall be stored in a secured manner andhand over to KSPCB authorizedincinerator/Co processing in cement kiln

28.2 DistillationResidue

10 MT/A10MT/A

Shall be stored in a secured manner andhand over to KSPCB authorizedincinerator/Co processing in cement kiln

28.5 Spentsolvent

1200KL/A

1200KL/AShall be stored in a secured manner andhand over to KSPCB authorized recycler

33.3 Discardedcontainers

2500Nos/A

2500Nos/A

Shall be stored in a secured manner andhand over to KSPCB authorized recyclerafter wash only

34.3 Sludgefrom ETP& MEE

60MTA

60MTA

Shall be stored in a secured manner andhand over to KSPCB authorized TSDF

7

S.

No


confirmation

Yes/

No



b. Liquid waste managementSI.No Description Existing Break up (KLD) Proposed

(KLD)Total waterrequirement

Effluentgenerated

Total Recycledwater

1 Process 60 58Permeate 122

KLD

Condensate 38KLD

NoChange

2 Washing 25 253 Boiler Feed 60

354 Chiller 505 Domestic 25 226 Other utilities 20 207 Green belt 60 -

Total 300 160 160Fresh waterrequirement

(300 - 160) = 140

Sewage and effluent generated from process and washings

are taken to combined Effluent and sewage Treatment Plant

of capacity 160 KLD further processed in RO plant. Rejects

from RO Plant along with High TDS effluent is treated in

Multiple Effect Evaporator of 40 KLD capacity. The treated

waste water of 160 KLD is reused for Boiler, cooling towers

and Toilet flushes. Zero liquid discharge system is

maintained in the facility.

Water Balance chart is enclosed as Annexure 9.

Schematic of ETP cum Reverse Osmosis Plant is attached as

Annexure 10.

1.16 Facilities for long term

housing of operational

worker

No Not Applicable

1.17 New road, rail or sea traffic

during construction or

operation?

No The existing Bommasandra-Jigani link road will be utilized.

8

S.

No


confirmation

Yes/

No



1.18 New road, rail, air waterborne

or other transport

infrastructure including new

or altered routes and stations,

ports, airports etc?

No The existing Bommasandra-Jigani link road will be utilized.

1.19 Closure or diversion of

existing transport routes or

infrastructure leading to

changes in traffic

movements?

No Not Applicable

1.20 New or diverted transmission

lines or pipelines? No Not Applicable

1.21 Impoundment, damming,

culverting, realignment or

other changes to the hydrology

of watercourses or aquifers

No Not Applicable

1.22 Stream crossings? No Not Applicable

1.23 Abstraction or transfers of

water form ground or surface

waters?

No In house Bore well

1.24 Changes in water bodies or

the land surface affecting

drainage or runoff?

No Not Applicable

1.25 Transport of personnel or

materials for construction,

operation or

decommissioning?

No Not Applicable

9

S.

No


confirmation

Yes/

No



1.26 Long-term dismantling or

decommissioning or

restoration works?

No Not Applicable

1.27 Ongoing activity during

decommissioning which

could have an impact on the

environment?

No Not Applicable

1.28 Influx of people to an area in

either temporarily or

permanently?

Yes

Existing man power in Operational Phase:

Permanent Contractual Total

Existing 300 300

ProposedThere is no increase of additional man power due to

proposed change in product mix

1.29 Introduction of alien species? No Not envisaged

1.30 Loss of native species or

genetic diversity?

No Not envisaged

1.31 Any other actions? No -

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.


confirmation

Yes/

No



2.1 Land especially undeveloped

or agricultural land (ha)

No The land is earmarked for Industrial use.

10

S.

No.


confirmation

Yes/

No



2.2 Water (expected source &

competing users) unit: KLD

Yes

Sourced: In-house bore well.

Total water Requirement: 300 KLD

Effluent Generated: 160 KLD

Recycled water: 160 KLD

Fresh water Requirement (300 160 KLD) = 140 KLD

SI.No Description Existing Break up (KLD) Proposed(KLD)

Total waterrequirement

Effluentgenerated

Total Recycledwater

1 Process 60 58Permeate 122

KLD

Condensate 38KLD

NoChange

2 Washing 25 253 Boiler Feed 60

354 Chiller 505 Domestic 25 226 Other utilities 20 207 Green belt 60 -

Total 300 160 160Fresh waterrequirement

(300 - 160) = 140

Minerals (MT) No Not applicable

2.4 Construction material-stone,

aggregates, sand/ soil

(expected source-MT)

No Not applicable

2.5 Forests and timber (source

MT)

No Not applicable

2.6 Energy including electricity

and fuels (source, competing

users) Unit: fuel (MT),

energy (MW)

Yes Power requirement.Details Capacity (KVA) Source

Existing Proposed TotalPower

Requirement1000

Nochange

1000 BESCOM

Power BackUp

1500x11500 DG Sets

DieselRequirements

Approx.20000

lit/Month

20000Lit/month

DieselRequirements

Fuel oil 25000lit/Month(Furnace

oil)

25000Lit/month

Furnace Oil /Briquettes

11

S.

No.


confirmation

Yes/

No



2.7 Any other natural resources

(use appropriate standard

units)

No Not applicable

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.


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 This is a Pharmaceutical Ingredients (API)

manufacturing process and solvents will be used in

the process. A separate storage facility is provided

for the storage of solvents and Raw materials.

Materials are handled as per MSDS guidelines.

Details are given in Chapter 2, Page No. 23 & 38

for Hazardous substances & Raw materials

3.2 Changes in occurrence of disease or

affect disease vectors (e.g. insect or

water borne diseases)

No Not such impacts are envisaged.

3.3 Affect the welfare of people e.g. by

changing living conditions?

No Systems are already in place.

Employment generation for local people.

3.4 Vulnerable groups of people who

could be affected by the project

e.g. hospital patients, children, the

elderly etc.,

No

Not Applicable

3.5 Any other cause No Not applicable.

12

4. Production of solid wastes during construction or operation or decommissioning (MT/month)

S.

No.


confirmation

Yes/

No

Details thereof (with approximate quantities/rates,


4.1 Spoil, overburden or mine

wastes

No Not applicable.

4.2 Municipal waste (domestic

and or commercial wastes)

Yes S.No

Nature ofSolid

Waste

QuantityT/Year

Method of Handling

Collection&

Storage

Treatment Disposal

1 Paper /CardBoard

6 Separatestoragearea

Nil Sold asscrap tovendorsunderagreement2 Dust Bin

collections12 Separate

storagearea

Nil

3 Dry leavesGrass

10 Formanure

Nil Manure

4 Metalscrap

12 Separatestoragearea

Nil Sold asscrap tovendorsunderagreement5 Wooden

scrap12 Separate

storagearea

Nil

13

S.

No.


confirmation

Yes/

No



4.3 Hazardous wastes (as per

Hazardous Waste

Management Rules)

Yes Hazardous Waste

Hazardous waste will be properly disposed as per the Hazardous

waste Management rule 1989.

WasteCategory

Hazardouswaste

Generated



5.1

Used Oil 15 KL/A

Nochanges

15KL/A

Shall be collected inLeak proof containersand disposed only toKSPCB registeredauthorizedreprocessors providedthe oil meets thestandards as perschedule-5 part-A ofthe rules

5.2

Oil soakedcottonwaste

0.5MT/A 0.5MT/A

Shall be stored in asecured manner andhand over to KSPCBauthorizedincinerator/Coprocessing in cementkiln

28.1

Processresidues &Waste

202MT/A

202MT/A


28.2

DistillationResidue

10 MT/A10MT/A


28.5 Spentsolvent

1200KL/A

1200KL/A

Shall be stored in asecured manner andhand over to KSPCBauthorized recycler

33.3Discardedcontainers

2500Nos/A

2500Nos/A

Shall be stored in asecured manner andhand over to KSPCBauthorized recyclerafter wash only

34.3 Sludgefrom ETP& MEE

60MTA

60MTA

Shall be stored in asecured manner andhand over to KSPCBauthorized TSDF

4.4 Other industrial process

wastes

No Not Applicable

4.5 Surplus product No Not Applicable

14

S.

No.


confirmation

Yes/

No



4.6 Sewage sludge or other

sludge from effluent

treatment

Yes ETP Sludge Generation from CETP.

Sludge generation from MEE.

Existing 60MTA

Proposed No change

Total 60 MTA

Valid Agreement available with TSDF and Authorised

Incineration Facility

Details are given in Chapter 3, Page No. 39

4.7 Construction or demolition

wastes

No Not Applicable

4.8 Redundant machinery or

equipment No

Not Applicable.

4.9 Contaminated soils or other

materials

No Not Applicable

4.10 Agricultural wastes No Not Applicable

4.11 Other solid waste No Not Applicable

5. Release of pollutants or any hazardous, toxic or noxious substances to air (Kg/hr)

S.

No.


confirmation

Yes/

No



5.1 Emissions from combustion of

fossil fuels from stationary or

mobile sources

No Construction Phase:

Not applicable.

Operation Phase:

Not applicable

There is no increase in emission source due to

Proposed change in product mix

15

S.

No.


confirmation

Yes/

No



5.2 Emissions from production

processes

Yes All the reactors have condensers to condense the

solvent vapors.

The reactor vents are connected to the scrubber to

neutralize the toxic vapors.

Scrubbers have been provided with FRP/ water

circulation type having neutralizing agents.

Details given in PFR Chapter 3. Page no. 33.

5.3 Emissions from materials handling

including storage or transport

No There is no increase in emission source due to


5.4 Emissions from construction

activities including plant and

equipment



5.5 Dust or odours from handling of

materials including construction

materials, sewage and waste



5.6 Emissions from incineration of

waste

No No incineration activity is involved

5.7 Emissions from burning of waste in

open air (e.g. slash materials,

construction debris)

No No burning activity is involved

5.8 Emissions from any other sources Yes Emission from Chimney.

Boiler 2 No. Attached to Boiler

Chimney, height 30mtr.

DG 1Nos. Attached to DG

Chimney, height 30mtr.


16

6. Generation of Noise and Vibration, and Emissions of Light and Heat:

S.

No.


confirmation

Yes/

No


quantities/rates, wherever possible) with source of

information data

6.1 From operation of equipment e.g.

engines, ventilation plant, crushers

Yes The DG sets will be in operation only during power

failure/Preventive maintenance of Existing DG.

Moreover, the DG room is acoustically enclosed.

For ventilation plant, duct insulation is provided for

reducing the noise levels.

Noise levels of existing site are monitored on

regular basis and are less than 75 dB.

6.2 From industrial or similar processes Yes Noise generation at source is compiled by keeping

the noise within the prescribed limits.

6.3 From construction or demolition No Not Applicable

6.4 From blasting or piling No Not Applicable

6.5 From construction or operational

traffic

No Not Applicable

6.6 From lighting or cooling systems No Negligible.

Lead LIGHTs is provided on a phased manner

6.7 From any other sources No Not Applicable

17

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


quantities/rates, wherever possible) with source

of information data

7.1 From handling, storage, use or

spillage of hazardous materials

No Storage, handling and spillages of hazardous

material is taken care by following the written

procedures (SOPs) and waste disposal is made

according to local regulatory standards.

Proper storage facilities provided to prevent the risk

of contamination.

7.2 From discharge of sewage or other

effluents to water or the land

(expected mode and place of

discharge)

No Sewage is mixed with effluent with and the same is

treated in Common Effluent treatment Plant.

The treated water from CETP is used for utilities,

Boiler and Cooling towers and ETP tanks are

completely impervious and effluent storage and

Pls Refer Chapter 3, Page no. 30 & 37.

7.3 By deposition of pollutants

emitted to air into the land or into

water

No Gaseous emission is scrubbed and stack emissions

are monitored on a monthly basis and results are

well within the acceptable limits.


7.4 From any other sources No Not applicable.

7.5 Is there a risk of long term build

up of pollutants in the

environment from these sources?

No Not applicable.

18

8. Risk of accidents during construction or operation of the Project, which could affect human

health or the environment

S.

No

.


confirmationYes/ No



8.1 From explosions, spillages, fires

etc from storage, handling, use

or production of hazardous

substances.

No Hazardous substances like solvents is used in

processes and proper handling procedures are

followed as recommended in the MSDS for the

solvent and other chemical handling.

8.2 From any other causes No Not Applicable.

8.3 Could the project be affected by

natural disasters causing

environmental damage (e.g.

floods, earthquakes, landslides,

cloudburst etc)?

No The site falls under seismic zone-II according to the

Indian Standard Seismic Zoning Map. Further it is not

flood prone or landslide prone area. Hence, no risk due

to natural hazards is envisaged. Suitable seismic

coefficients in horizontal and vertical directions are

adopted while construction of the facility.

19

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.

Sr.

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.:

infrastructure (roads,

power supply, waste or waste water

treatment, etc.)

No The facility is located in KIADB approved

industrial area.

Since the unit is an Active Pharmaceutical

Ingredients manufacturing unit inside

KIADB area, no housing development is

proposed.

Not applicable (for Extractive industries,

Supply industries& others)

9.2 Lead to after use of the site, which

could have an impact on the

environment

No

Not Applicable

9.3 Set a precedent for later

developments

No Not Applicable

9.4 Have cumulative effects due to

proximity to other existing or

planned projects with similar effects

No Not Applicable

20

III. Environmental Sensitivity

Sr.

No.

Areas Name /

Identity

Aerial distance (with 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

Bannarghatta

National Park

Bannerghatta National Park is located at a distance

of 8.57 km (aerial distance) towards WSW from

Project Site.

2 Areas which are

important or sensitive

of ecological reasons

wetlands, water

courses or other water

bodies, coastal zone,

biospheres, mountains,

forests

(a)

Bannarghatta

National Park

Bannerghatta National Park is located at a distance

of 8.57 km (aerial distance) towards WSW from

Project Site.

(b)Haragade

Lake

1.5 Km (aerial distance) towards SE

(c)

Kammasandra

lake

6.22 Km (aerial distance) towards NE

3 Areas used by

protected, important or

sensitive species of

flora or fauna for

breeding, nesting,

foraging, resting, over

wintering, migration

Bannarghatta

National Park

8.57 Km

4 Inland, coastal, marine

or underground waters

No Nil

5 State, national

boundaries

Tamil Nadu

State Boundary

11.5 Km

Routes or facilities

used by the public for

No NA

21

Sr.

No.

Areas Name /

Identity


location boundary

6 access to recreation or

other tourist, pilgrim

areas

7 Defense installations No NA

8 Densely populated or

built-up area

(a)

Bommasandra

village

5.66 Km (aerial distance) towards ENE

(b)

Doddathoguru

6.55 Km (aerial distance) towards NE

(c) Electronic

City

5.95 Km (aerial distance) towards N

22

Sr.

No.

Areas Name /

Identity


location boundary

9 Areas occupied by

sensitive man made

land uses (hospitals,

schools, places of

worship, community

facilities)

Yes 10 km radius infrastructures:

S.No Name Distance

(Km)

Dirn

Lakes

1. Yelenahalli kere 9.63 NW

2. Doddkammanahalli Lake 9.14 NW

3. Chikka Togur lake 7.52 N

4. Veerasandra lake 5.89 NE

5. Hebbagodi lake 5.20 NE

6. Kammasandra lake 5.82 NE

7. Rayasandra lake 9.30 N

8. Muthanallur lake 8.83 NE

9. Haragade Lake 3.24 S

S.No Name Distance

(Km)

Dirn

Schools & Colleges

1. BTL High School 4.63 NE

2. Treamis World School 3.06 N

3. Royal Public School 5.83 NE

4. BTL Institute of Tech and

Management4.91 NE

5. Condor International school 4.32 NW

6. Christ Academy ICSE school 5.38 NW

7. Nidyananda High school and college 2.37 W

8. Tapovan High School 4.11 W

9. Virindha Educational Academy 5.89 W

10. Film Academy 5.90 W

11. T. Johan College 9.34 NW

12. Sherwood High School 9.56 NW

Religious Places

1. Jigani Masjid 2.25 W

2. Sri Channa Keshava Temple 7.64 SE

Hospital

1. Narayana Hrudyalaya 5.07 NE

2. Sparsh Hospital 5.33 NE

5. Srinidhi Hopital 5.65 E

Sensitive area

1. Bhannergatta National Park 8.57 W



23

Sr.

No.

Areas Name /

Identity


location boundary

10 Areas containing

important, high quality

or scarce resources

(ground water

resource, surface

resources, forestry,

agriculture, fisheries,

tourism, minerals)

Tourism-

Bannerghatta

National Park

8.57 Km

11 Areas already

subjected to pollution

or environmental

damage. (those where

existing legal

environmental

standards are

exceeded)

Nil No Notified/Recognized polluted area within 15km

distance.

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 This area is generally plain not prone to any natural

disasters. The project site falls under seismic zone-

II according to the Indian Standard Seismic Zoning

Map. Further it is not flood prone or landslide

prone area. Hence, no risk due to natural hazards is

envisaged. However suitable seismic coefficients in

horizontal and vertical directions will be adopted

while designing the structures.

24

Proposed Terms of Reference

Sr.No. Proposed Terms of Reference1. A recent satellite imagery of the project area and its surroundings2. Topoplan and layout drawing of the project site.3. Location of National Park/Wild life sanctuary/ Reserve Forest within 10 km radius of the

project.4. Present land use and cropping pattern based on satellite imagery for the study area of 10

km radius. Location of National Park/Wild life sanctuary /Reserve Forests within 10 kmradius of the project.

5. Rain water Harvesting details6. Process Description along with Process Flow Diagram and material balance.7. Details of water consumption and source of water supply, waste water generation,

treatment and effluent disposal with water Balance.8. Water Conservation measures proposed9. Power requirement & power back up10. Detailed solid & Hazardous waste generation, collection, segregation, its recycling and

reuse, treatment and disposal.

11. Fire fighting facilities12. Total cost of the project along with total capital cost and recurring cost/annum for

environmental pollution control measures.13. Site-specific micro-meteorological data for temperature, relative humidity, hourly wind

speed and direction and rainfall for one season at one location.14. Ambient air quality monitoring at 6 locations within 10 Km radius of study area for

PM10, SO2, NOx, CO, HC, VOC for one season (Non Monsoon) taking into accountthe pre-dominant wind direction, population zone and sensitive receptors.

15. Assessment of ground level concentration of pollutants. Air quality modelling forproposed project.

16. Water quality monitoring including surface & ground water at 8 locationswithin 10 Kmradius of study area for one season (Non Monsoon).

17. Soil sample analysis at 8 locations within the study area for one season (Non Monsoon).18. Noise Monitoring within 8 locations the study area for one season (Non Monsoon)19. Demography & socio-economics of the study area.20. Ecological features (terristrial & Aquatic) of the study area for one season (Non

Monsson)21. Assessment of impact on air, water, soil, solid /hazardous waste and noise levels.

Page 25 of 26

Sr.No. Proposed Terms of Reference

23.Air pollution control measures proposed for the effective control of gaseous emissionswithin permissible limits.

24.Risk assessment including Hazard identification, Consequence Analysis, RiskAssessment and preparation of Disaster Management Plan for storage of solvents.

25.Details of proposed Occupational Health Surveillance program for the employees andother labour

26.

Detailed Environment management Plan (EMP) with specific reference to Energyconservation and natural resource conservation, details of air pollution control system,water & wastewater management, monitoring frequency, responsibility and time boundimplementation plan for mitigation measure and cost towards environmental protectionmeasures.

Table of Contents 1. EXECUTIVE SUMMARY

2. INTRODUCTION OF THE PROJECT

2.1 Identification of the Project and Project Proponent ................................................................. 9

2.2 Brief Description of nature of the Project ................................................................................ 9

2.3 Need for the Project and its importance ................................................................................... 9

2.4 Demand Supply Gap ........................................................................................................... 10

2.5 Import vs. indigenous Production .......................................................................................... 10

2.6 Export possibility ................................................................................................................... 10

2.7 Employment Generation due to the Project ........................................................................... 10

3. PROJECT DESCRIPTION

3.1 Type of the Project ................................................................................................................. 11

3.2 Project Location ..................................................................................................................... 11

3.3 Details of Alternate sites considered ..................................................................................... 16

3.4 Magnitude of Operation ......................................................................................................... 16

3.5 Project Description ................................................................................................................ 22

3.6 Raw Material Requirement .................................................................................................... 22

3.7 Resource optimization ........................................................................................................... 29

3.7.1 Water Requirement ............................................................................................................ 30

3.7.2 Power Requirement ........................................................................................................... 32

3.7.3 Air Pollution Control System and Management ................................................................ 33

3.8 Waste Management and Disposal Method ............................................................................ 36

4. SITE ANALYSIS

4.1 Connectivity ........................................................................................................................... 40

4.2 Land form, Land use and Land ownership ............................................................................ 41

4.3 Topography ............................................................................................................................ 42

4.4 Land use pattern ..................................................................................................................... 43

4.5 Existing infrastructure ........................................................................................................... 43

4.6 Soil classification ................................................................................................................... 46

4.7 Climate data from secondary sources .................................................................................... 46

4.8 Social Infrastructure available ............................................................................................... 46

5. PLANNING BRIEF

5.1 Planning concept .................................................................................................................... 48

5.2 Population Projection ............................................................................................................. 48

5.3 Land use planning .................................................................................................................. 48

5.4 Assessment of Infrastructure Demand ................................................................................... 48

5.5 Amenities/Facilities ............................................................................................................... 48

6. PROPOSED INFRASTRUCTURE

6.1 Industrial Area ....................................................................................................................... 49

6.2 Residential Area ..................................................................................................................... 49

6.3 Green belt............................................................................................................................... 49

6.4 Social Infrastructure ............................................................................................................... 49

6.5 Connectivity ........................................................................................................................... 49

6.6 Drinking Water Management ................................................................................................ 49

6.7 Sewerage system .................................................................................................................... 49

6.8 Industrial waste management................................................................................................. 50

6.9 Solid waste management ....................................................................................................... 53

6.10 Power Requirements and Supply/ Source .............................................................................. 53

7. REHABILITATION AND RESETTLEMENT (R &R) PLAN

7.1 Policy to be adopted (Central/ State) ..................................................................................... 54

8. PROJECT SCHEDULE AND COST ESTIMATE

8.1 Likely date of start of construction and likely date of completion ........................................ 55

8.2 Estimated project cost ............................................................................................................ 55

9. ANALYSIS OF PROPOSAL

9.1 Financial and social benefits .................................................................................................. 56

10. CONCLUSION

LIST OF TABLES

Table 2-1: Manpower for the project

Table 3-1: Environmental setting of the existing site

Table 3-2: List of Products - existing and proposed APIs with quantity

Table 3-3: List of Raw Materials & Quantity for Proposed New Products

Table 3-4: Water requirement

Table 3-5: Power and fuel Requirement

Table 3-6 Storage Facilities of Existing & Proposed

Table 3-7: Air pollution Sources

Table 3-8: Existing Emission Sources

Table 3-9: Existing Emission Rate

Table 3-10: Liquid waste Generation and treatment

Table 3-11: Existing Effluent Quality

Table 3-12: Solid waste Generation and Management

Table 3-13 Hazardous waste generation and Management

Table 4-1 Salient Features of the Project Site

Table 4-2 Geographical Locations of the Site

Table 4-3 Sensitive areas from the site boundary, 10 km radius.

Table 4-4 Existing Land Area Break up Area

Table 4-5 List of Existing Utilities

Table 4-6 Existing industries within 10 Km radius from the site

Table 4-7 Project surrounding feature

LIST OF FIGURES

Figure 3-1: Location of Proposed Project Site ....................................................................................... 12

Figure 3-2: 10 Km radius Satellite Image showing Project site and Surrounding Features .................. 12

Figure 3-3: 5 Km radius Satellite Image showing Project site and Surrounding Features .................... 13

Figure 3-4: 1 Km radius Satellite Image showing Project site and Surrounding Features .................... 13

Figure 3-5: Project Site Satellite Image ................................................................................................. 14

Figure 3-6: Existing Plant Layout .......................................................................................................... 14

Figure 3-7: Photographs of Existing Unit .............................................................................................. 15

Figure 3-8: Process flow for production ................................................................................................ 22

Figure 3-9: Water Balance Chart ........................................................................................................... 31

Figure 3-10: Schematic of ETP cum Reverse Osmosis Plant and Multiple effect Evaporator plant..... 37

List of Annexures

SI.No Description Annexure

No

1 Land possession certificate 1

2 Existing Environmental Clearance 2

3 Existing Consent for Establishment 3

4 Existing Consent for Operation 4

5 Existing Site Layout 5

6 Existing and Proposed products mix and capacity 6

7 List of Raw Materials & Quantity for proposed new APIs 7

8 Production and manufacturing processes 8

9 Water Balance chart 9

10 Schematic of ETP cum Reverse Osmosis Plant and Multiple effect

Evaporator plant

10

11 EC Compliance Report 11

12 Analysis Report (Air, Stack & Effluent) of Existing Unit 12

LIST OF ABBREVIATIONS

ETP Effluent Treatment Plant

STP Sewage Treatment Plant

kWh Kilowatt per hour

WHO World Health Organization

ISO International Standard for Organization

API Active Pharmaceutical Ingredients

R&D Research & Development

USFDA Food & Drug Administration (USA)

PO Pure Oil

1. EXECUTIVE SUMMARY

CIPLA Limited proposes the change in product mix of Active Pharmaceutical Ingredients

within the production capacity of 114.22 MTA within its 28.23 Acres of land located at API

Division. Plot.No.285, 286 & 287, Bommasandra Jigani Link road, KIADB IVth Phase

Jigani, Bangalore 560105.

The Existing quantity is 114.22 MTA with 63 nos of APIs. Proposed change in product mix

will have 113.46 MTA with 81 nos of APIs. The total site area is 114254.439 sq. m. The

green belt is 38354.5 Sq.m (33.57%) of the total area. There is an existing environmental

clearance and CFE for the products.

S.No. Particulars Details

1. Name of Company M/s. CIPLA LIMITED

2. Project Location Plot.No.285, 286 & 287

KIADB Industrial Area,

Bommasandra-Jigani Link Road, Phase-IV,

Anekal Taluk, Bangalore 560105, Karnataka.

3. Project Activity

Schedule,

Category as per

EIA notification

2006 &

amendments

Active Pharmacautical Ingredients

Schedule 5 (f), Synthetic Organic Chemicals

4. Name of the project Change in Product Mix

5. Total Land area 28.23 acres

6. Existing built-up

area

21.56 acres

7. Proposed additional

built-up area

Not Applicable

8. Total built-up area

after expansion

Not Applicable

9. Proposed product

mix with capacity

Total No of APIs: 81nos

Proposed capacity after product mix: 113.46 MTA.

10. Raw material List of Raw Materials for proposed new APIs

11. Water

requirement

Source: In house Bore well

(Existing 300 KLD + Proposed. No changes, Total 300 KLD).

Break up as follows:

SI.No

Description Existing Break up (KLD) Proposed

(KLD) Total water

requirement

Effluent generat

ed

Total Recycled

water

1 Process 60 58 Permeate 122 KLD

Condensa

te 38 KLD

No Change

2 Washing 25 25 3 Boiler Feed 60 35 4 Chiller 50 5 Domestic 25 22 6 Other

utilities 20 20

7 Green belt 60 - Total 300 160 160 Fresh

water requirement

(300 - 160) = 140





12. Waste water and

mode of disposal

LTDS Effluent is treated in existing ETP and RO system.

HTDS Effluent is treated in existing Multiple Effect

Evaporator

The treated effluent is recycled/reused to the boiler and

cooling towers

There will be no discharge of effluent outside factory

premises; The unit is zero liquid discharge facility

13. Power

Details Capacity (KVA) Source Existing Proposed Total

Power Requirement

No change

1000 BESCOM

Power Back Up

1500x1 1500 DG Sets

Diesel Requirements

Approx.

20000 lit/Month

20000

Lit/month

Diesel Requirements

Fuel oil 25000

lit/Month (Furnace

oil)

25000

Lit/month

Furnace Oil / Briquettes

14. Air Emission

SI.No Emission Source

No of

Stacks

Type Of

fuel

Consumption Chimney Height (in mts) & air pollution

control system provided /

proposed as per previous

consent

Kgs/hr in Case of Liquid

fuel

T/hr in case agro

based fuel.

1 1500 KVA DG set

1 HSD 280

Lts/Hr NA 30 M AGL

2 Steam Boiler 1.5 & 2 TPH

1 FO 90 Kg/Hr NA 30 M AGL

3

Process emission from Production area- attached to Scrubber

5 NA NA NA

Individual chimney - 3 M

ARL & Scrubber.

4

Process emission from finishing area- attached to Scrubber

3

NA NA NA


ARL & Scrubber.

15. Solid Waste The solid waste generated from existing facility is Hazardous waste

580 kg/d and Effluent & sewage treatment sludge 164.38 kg/d and

increase due the product mix is nil.

Hazardous waste materials are properly disposed as per the

Hazardous waste rules 2016.

Agreement between TSDF and CIPLA for collection, transport,

storage, treatment and disposal and also we have a valid Agreement

with M/s Enano incintech for Incineration of incinerable wastes.

16. Manpower

Permanent Contractual Total Existing 300 300 Proposed There is no increase of additional man

power due to proposed change in product mix

17. Project cost

(estimate)

There is no additional project cost as it is an existing unit. The

Gross value of existing infrastructure is Rs. 166 Crores

2. INTRODUCTION OF THE PROJECT

2.1 Identification of the Project and Project Proponent

CIPLA Limited was established in the year 1973 by late Dr. K. A. Hamied now developing

under leadership of Mr. Y. K. Hamied with strong focus in India & Abroad. It is ranked

amongst top 20 in India out of 300 Indian pharma companies-ORG-IMS 2012. The CIPLA

group has approximately more than 25000 employees comprising management, marketing and

technical professionals.

In the early ninetees company decided to enter the export markets and started with export of

their products to the neighboring countries. As a part of the business expansion plan set-up

several cGMP-compliant manufacturing facilities and are built to satisfy the Norms of

USFDA and manufacturing is done as per stringent norms of WHO, EDQM.

2.2 Brief Description of nature of the Project

CIPLA Limited proposes the change in product mix of Active Pharmaceutical Ingredients

within the production capacity of 114.22 MTA within its 28.23 Acres of land located at API

Division. Plot.No.285, 286 & 287, Bommasandra Jigani Link road, KIADB IVth Phase

Jigani, Bangalore 560105, Land possession certificate enclosed as Annexure 1.

The existing and proposed products mix with capacity is given in Annexure 6. Existing

quantity is 114.22 MTA with 63 nos of APIs. Proposed change in product mix will have

113.46 MTA with 81 nos of APIs.

There is an existing environmental clearance and CFE for the products given in Annexure 1

which are attached in Annexure 2 and Annexure 3 respectively.

The total site area is 114254.439 sq. m. The green belt is 38354.5 Sq.m (33.57%) of the total

area. The total water requirement for the existing facility is 300 KLD .The required water is

met from the In house borewells. Existing Effluent Treatment Plant capacity is 160 KLD

(CETP). The solid waste generated from existing facility is Hazardous waste 580 kg/d and

Effluent & ETP sludge 164.38 kg/d and increase due the product mix is nil. Power

requirement for the project will be sourced from BESCOM.

2.3 Need for the Project and its importance

In order to become an active player in the Active Pharmaceutical Ingredients (API) segment

catering to both domestic and international markets, CIPLA now proposes to change in

product mix of API manufacturing facility near Bommasandra-Bangalore, which will also

house a state of the art QC/QA/R&D & EHS to cater the advanced technological and market

requirement.

2.4 Demand Supply Gap

Based on the market survey the selected molecules for manufacture have potential for export

as well domestic market.

2.5 Import vs. indigenous Production

To ensure the quality of product and control of manufacturing under current Good

Manufacturing Conditions, it is preferred to have the manufacturing done in-house by

procuring the basic raw materials.

2.6 Export possibility

All the listed products have great potential for exports and hence targeted for export market as

an API directly or as a Formulated product.

2.7 Employment Generation due to the Project There is no increase of additional man power due to proposed change in product mix

Table 2-1: Manpower for the project

Permanent Contractual Total Existing 300 300 Proposed There is no increase of additional man power due to


3. PROJECT DESCRIPTION

3.1 Type of the Project The proposed project is a product mix of Active Pharmaceutical Ingredients, product mix will

be changed with change of Approved production Capacity 114.22 MTA to 113.46 MTA.

The proposed project falls under and schedule 5 (f), Synthetic Organic

Chemicals as per the EIA notification dated September 14, 2006 and its amendments. There

is no interlinked project.

3.2 Project Location

The land was acquired from the Karnataka State Industrial Area Development Board

(KIADB) lies in a notified industrial area along the recently developed Bommasandra-Jigani

link road, branching away south-westerly from Bangalore-Hosur Road, NH-44.

The project site is located in Bommasandra Village, Anekal taluk of Bangalore District.

Survey numbers are 285, 286 and 287 at Latitude 12°47'8.31"N, Longitude 77°38'54.28"E, at

a distance of 5.4 km (aerial distance) away from the NH 44 (Bangalore to Hosur). The land is

marked as Industrial zone. The land possession certificate from KIADB is enclosed in

Annexure-1

A number of other industrial undertakings are being planned and under execution in this

notified industrial area, notable among them being the Biocon Park and HCL software

development center.

The project location is given in Figure 3.1, Project site is given in Figure 3.5, Site Layout is

given Figure 3.6, Photograph of the Existing Unit Figure 3.7 and the 10, 5 & 1 Km radius map

from the project is given in Figure 3.2, 3.3 & 3.4 respectively.

Figure 3-1: Location of Proposed Project Site

Figure 3-2: 10 Km radius Satellite Image showing Project site and Surrounding Features



Figure 3-5: Project Site Satellite Image

Figure 3-6: Existing Plant Layout

NW Side NE Side

SW Side SE Side

API Unit API Unit

Existing Green Belt Existing Green Belt

Figure 3-7: Photographs of Existing Unit

3.3 Details of Alternate sites considered

Since the proposed project is only a product mix at already existing facility, alternate site was not

considered. The environmental setting of the existing site is given in Table 3.1:

Table 3-1: Environmental setting of the existing site

S. No. Particulars Details

1 Site Co-ordinates of the project site Latitude: 12°47'8.31"N


3 Elevation 890 mts

4 Temperature Max. 38 oC, Min. 21.4 oC

5 Present land use Industrial area

6 Nearest Highway Bangalore to Chennai NH-44 (Old NH-7) at a distance of 5.4 kms towards NE

7 Nearest railway Station Heelalige 7.2 kms towards NE

Anekal 9.4 kms towards SE

8 Nearest Airport Kempegowda International Airport 46 kms towards North, Bangalore

9 Nearest village Bande Nallasandra Village 1.22 kms towards North

Jigani 0.9 km towards WSW

10 Nearest major city Bangalore 25 Kms towards North

11 River Nil

12 Type of soil Reddish brown clay silt soil

3.4 Magnitude of Operation

In the view of fulfilling market requirement, we are proposing to change the product mix of

Active Pharmaceutical Ingredients within the production capacity of 114.22 MTA within its

28.23 Acres of land located at Bommasandra village, Anekal Taluk, Bangalore District,

Karnataka State.

The details of existing and proposed products mix with capacity is given in Annexure 6. Existing quantity is 114.22

of APIs. Proposed change in product mix will have 113.46 MTA with 81 nos of APIs. The list of existing and proposed

quantities is given in Table 3-2.

Table 3-2: List of Products - existing and proposed APIs with quantity

Sl No

Category Products

Existing Quantity (Kgs/A)

Proposed Qty

(Kgs/A)

Category Wise Qty

Variation

quantity

1 CARDIOVASCULAR DRUGS

AMLODIPINE BESYLATE 1000 1000

2600 AMLODIPINE MESYLATE 2000 1000 -

CIOLASTRAZOLE 1000 100 -

FELODIPINE 1000 500 -

2 ANTICANCER DRUGS

ANAGRELIDE 25 25

74430

BICALUTAMIDE 1000 2500 1500

CARBOPLATIN 50 50

CISPLATIN 50 50

ETOPOSIDE 250 500

FLUTAMIDE 2500 2000 -

MITIXANTRONE HCL 20 10

ANASTRAZOLE 100 100

OXALIPLATIN 100 100

CAPACITABINE 20000 38000 18000

IMATINIB MESYLATE (Alpha and Beta Forms)

7500 10000 2500

VINORELBINE TARTRATE 100 50

TEMOZOLOMIDE 500 500

ERLOTINIB HCL 1000 1500

GEFTINIB 1000 1500

SORAFENIB TOSYLATE 1500 1500

DOCETAXEL TRIHYDRATE 100 100

IRINOTECAN TRIHYDRATE 100 100

PACLITAXEL 100 100

LAPATINIB DITOSYLATE 1000 500 -

LENALIDOMIDE 1000 1000

TOPOTECAN HCL 10 10

GEMCITABINE HCL 500 800

PEMETREXED DISODIUM 150 200

BORTEZOMIB 10 10

LETROZOLE 500 500

SUNITINIB MALATE 255 255

VINCRISTINE SULPHATE 50

VINBLASTINE SULPHATE 50

TEGAFUR 1000 1000

PAZOPANIB HCL 2500 2500

ABIRATERONE ACETATE 1000 1000

CARFILZOMIB 20

RUXOLITINIB PHOSPHATE 100

EVEROLIMUS 50

EXEMESTINE 500

ESTRAMUSTINE 500

NILOTINIB 4000 4000

DASATINIB 500

REGORAFENIB 200

IBRUTINIB 500

NINTEDANIB ESYLATE 500

POMALIDOMIDE 500

AXITINIB 500

3 CNS DRUG

DULOXETINE 1500 500

7130

-

OXCARBAZEPINE 200 50 -

RILUZOLE 1000 580 -

RISPERIDONE 1000 500 -

TOPIRAMATE 2500 2500

LAMOTRIGINE POWDER 5000 2500 -

VENLAFAXINE 1000 500 -

4 GASTROINTESTINAL DRUGS

ESOMEPRAZOLE 2000 2000

7000

LANSOPRAZOLE 4500 1000 -

OMEPRAZOLE 8000 2000 -

PANTOPRAZOLE 1000 500 -

RABEPRAZOLE SODIUM 1500 500 -

RABEPRAZOLE POWDER 2000 500 -

ESOMEPRAZOLE POWDER 2500 500 -

5 OSTEOPOROSIS RALOXIFENE 5000 1500 1500 -

6 ANTIBIOTICS / ANTIBACTERIALS

LEVOFLOXACIN 8300 3000

4700

-

OFLOXACIN USP 1000 500 -

CIPROFLOXACIN POWDER 190 190

GATIFLOXACIN POWDER 10 10

ENROFLOXACIN POWDER 1500 1000 -

7 OTHERS - ANTOGONADOTROPHIN

DANAZOL 500 500 500

8 ARTHRITIC / RHEUMATIC AGENTS

LEFLUNOMIDE 500 1000 1000

9 ANTIVIRALS

RIBAVIRIN 1500 1000

3100

-

STAVUDINE 100 100

ZIDOVUDINE 1500 1000 -

VALACICLOVIR HCL 500 500

DIDANOSINE 500 500

10 OPTHALMIC DRUGS REPROTEROLE 5000 1000 1000 -

11 ANTI HELMINTICS

FEBANTEL POWDER 2000 2000

10000 MEBENDAZOLE POWDER 2000 2000

ALBENDAZOLE POWDER 4500 4500

FENBENDAZOLE POWDER 1500 1500

12 R&D products 500 500

114220 113460 113460

13 FORMULATIONS TABLETS : 1500 L / A

CAPSULES :1560 L/ A

3.5 Project Description

The raw materials are charged in the reactor and after reaction it is centrifuged. The centrifuged

materials are dried. After milling, sifting and blending, the finished products are packed for

dispatch. Annexure 8

Figure 3-8: Process flow for production

3.6 Raw Material Requirement

The raw materials requirement for proposed new APIs and their quantity are given in Annexure

7.

Few of the raw materials would be imported by way of sea or air to Chennai port. Further they

would be transported by road. The finished goods for the domestic sales would be by road and

for exports would be by air.

Table 3-3: List of Raw Materials & Quantity for Proposed New Products

SI.No Raw Materials Consumption

quantity Unit Products kg/A

1 Vinblastine Sulphate stage-I 139 Kg/A

Vincristine Sulphate - 50

2 Methanol 1392.5 lit/A

3 Ethanol 1231.5 lit/A

4 Sulfuric acid conc 1 lit/A

5 N2 Gas 94 Kg/A

6 Acetic acid 458.5 lit/A

7 Tetrahydrofuran 3542.5 Kg/A

8 Sodium dichromate 111 Kg/A

9 Sodium bisulfite 278 Kg/A

10 Liq Ammonia 1431 lit/A

11 Hyflo Super Cel 555.5 Kg/A

12 Sodium bicarbonate 833.5 Kg/A

13 Sodium sulphae anhyd 278 Kg/A

14 Dichloromethane 12140.5 lit/A

15 Vinblastine tech 285.5 Kg/A

Vinblastine sulphate - 50

16 Methanol 745 lit/A

17 Sulfuric acid conc 50 lit/A

18 Ethanol 2112.5 lit/A

19 Liq Ammonia 771 lit/A

20 Dichloromethane/Chloroform 1841.5 lit/A

21 Tartaric acid 154 lit/A

22 Sodium sulfate anhyd 137 Kg/A

23 Nitrogen Gas 162.5 Kg/A

24 5-Fluorouracil 890 Kg/A

Tegafur - 1000

25 2,3-Dihydrofuran 1420 Kg/A

26 Dichlorodimethyl silane 1330 lit/A

27 Acetonitrile 3490 lit/A

28 Triethylamine 70 lit/A

29 Diisopropyl ether 3870 lit/A


31 Isopropyl alcohol 13290 lit/A

32 Activated charcoal (acid grade) 20 Kg/A

33 Hyflo 90 Kg/A

34

2,3-Dimethyl-2H-indazole-6-amine hydrochloride (DMIA.HCl) 2725 Kg/A

Pazopanib HCL - 2500

35 2,4-Dichloro pyrimidine 5150 Kg/A

36 Sodium bicarbonate 7825 Kg/A

37 Rectified spirit 43450 lit/A

38 Dimethyl carbonate 5850 Kg/A

39 Potassium carbonate 4500 Kg/A

40 5-Amino-2-methylbenzenesulfonamide 2825 Kg/A

41 IPA HCl 15000 lit/A

42 Liquor Ammonia 10450 lit/A

43 Dimethyl formamide 11250 Kg/A


45 Acetone 21575 lit/A


47 DHEA Compound 1790 Kg/A

Abiraterone Acetate - 1000

48 Hydrazine Hydrate 1250 Kg/A

49 1,1,3,3 Tetramethylguanidine 3390 Kg/A

50 Iodine 3040 Kg/A

51 Diethyl-(3- Pyridyl) borane 610 Kg/A

52

Bis (triphenylphosphine) Palladium dichloride 1 Kg/A

53 HBr 1430 Kg/A

54 Triethylamine 260 Kg/A

55 4 dimethylamino pyridine 20 Kg/A

56 Acetic anhydride 410 lit/A

57 Liq ammonia 5540 lit/A

58 Sodium hydrosuphite 2320 Kg/A

59 Aq. HBr 890 Kg/A

60 Liq ammonia 1880 lit/A



63 MDC 54090 lit/A


65 IPA 14530 Kg/A

66 DMF 3710 Kg/A

67 THF 7940 Kg/A

68 Ac carbon 140 Kg/A

69 Alumina 90 Kg/A

70 Int 1 0.016 Kg/A Carfilzomib - 20

71 Epoxyleucine TFA 0.008 Kg/A

72 N,N DIPEA 0.02 Kg/A

73 EDCI HCL 0.004 lit/A

74 HOBT 0.006 Kg/A

75 Acetonitrile 0.15 lit/A

76 Sat NaHCO3 sol 0.086 lit/A

77 Sat Brine Solution 0.174 lit/A

78 4-chloropyrroo[2,3-d]pyrimidine 224 Kg/A

Ruxolitinib Phosphate - 100

79 4-(pinacolato borane)-1H-Pyrazole 312 Kg/A

80 3-Cyclopentylacrylonitrile 118 Kg/A

81 Tetrakis(triphenylphosphine)palladium(0) 72 Kg/A

82 Trimethylsilylethoxymethyl chloride 279 Kg/A

83 1,8-Diazabicyclo[5.4.0]undec-7-ene 12 Kg/A

84 Phosphoric acid 35 lit/A

85 sodium hydride 90 Kg/A

86 Lithium Tetrafluoroborate 339 Kg/A

87 Ammonium Hydroxide 39 Kg/A

88 Sodium bicarbonate 9 Kg/A

89 Potassium Carbonate 513 Kg/A

90 1,2-dimethoxyethane 444 Kg/A

91 ethyl acetate 20318 lit/A

92 sodium chloride 615 Kg/A

93 Dioxane 3433 Kg/A

94 Toluene 1717 lit/A

95 MTBE 1717 lit/A


97 Dichloromethane 1986 lit/A

98 Heptane 3674 lit/A


100 Isopropanol 429 lit/A

101 Hexane 1717 lit/A

102 Sirolimus 100 Kg/A

Everolimus - 50

103 Ethylene glycol anhydrous 218 Kg/A

104 tert-Butyldimethylsilyl chloride 635 Kg/A

105 Triethyl amine 531.5 Kg/A

106 DMAP 4 Kg/A

107 Sodium sulphate 50 Kg/A

108 Sodium chloride 50 Kg/A

109 Trifluoromethanesulfonic anhydride 1385 Kg/A

110 2, 6 Lutidine 768 Kg/A

111 1 N Hydrochoric Acid 550 lit/A

112 MDC 16600 lit/A

113 Ethyl Acetate 49300.5 lit/A


115 n Heptane 34200 lit/A


117 Exemestane Stage-I 2740 Kg/A

Exemestine - 500

118

2,3 Dichloro-5,6-Dicyano-P-Benzoquinone (DDQ) 3745 Kg/A

119 Sodium Hydroxide Flakes 2190 Kg/A

120 Sodium Sulphate Anhydrous 1825 Kg/A

121 Benzoic Acid 3835 lit/A

122 Hyflo Supercel 270 Kg/A




126 Estramustine Phosphate 525 Kg/A

Estramustine - 500

127 Sodium Methoxide Powder 105 Kg/A

128 Activated Charcoal AR Grade 15 Kg/A

129 Potassium Hydroxide Flakes 450 Kg/A

130 Special Denatured Spirit With Toluene 15000 lit/A lit/A

131 Methanol 6000 lit/A lit/A

132 NTB Guanidinobenzoate 2840 Kg/A

Nilotinib - 4000

133 NTB Enamino Ketone 1920 Kg/A

134 Potassium carbonate 4840 Kg/A

135 Sodium Hydroxide 680 Kg/A


137 N,N Dimethyl acetamide 13400 Kg/A

138 NTB amine 2440 Kg/A

139 Thionyl chloride 1000 Kg/A

140 N methyl pyrrolidone 20560 Kg/A




144 Activated carbon 40 Kg/A

145 Hydrochloric acid 80 lit/A

146 DST-Thiazole carboxamide 555 Kg/A

Dasatinib - 500

147 DST-Dichloro compound 435 Kg/A

148 2-(hydroxy ethy )piperizine 1200 Kg/A

149 Sodium tertary butoxide 665 Kg/A

150 THF 4940 Kg/A

151 methanol 21550 lit/A

152 Acetic acid 555 lit/A

153 N-butanol 10000 lit/A


155 RGB CMP 222 Kg/A

Regorafenib - 200

156 RGB AFP 172 Kg/A

157 Potassium tert butoxide 214 Kg/A

158 DMF 1626 Kg/A

159 Ethyl acetate 13510 lit/A

160 RGB Phenyl carbamate 310 Kg/A

161 RGB CTA 222 Kg/A

162 Phenyl chloroformate 186 Kg/A

163 Pyridine 100 Kg/A



166 PTSA.H2O 88 Kg/A


168 Charcoal 40 Kg/A

169

3-Iodo-lH-pyrazolo[3,4-^pyrimidin-4-amine (31). lH-Pyrazolo[3,4- d]pyrimidin-4-amine, 30 500 Kg/A

Ibrutinib - 500

170 N-iodosuccinimide ( IS) 1070 Kg/A

171 Compound 31 400 Kg/A

172 boronic acid 32 656 lit/A

173 potassium phosphate tribasic monohydrate 1056 Kg/A

174 dioxane 5800 Kg/A

175 tetrakis(triphenylphosphine)palladium 270 Kg/A


177 protected piperidine 143 Kg/A

178 triphenylphosphine 233 Kg/A

179 diisopropyl azodicarboxylate 180 Kg/A

180 DMF 9440 Kg/A

181 nitrogen 110 Kg/A

182 methanol 11800 lit/A

183 ethyl acetate 8960 Kg/A

184 THF 17780 Kg/A


186 solution of hydrogen chloride in dioxane 590 lit/A

187 diethyl ether 1420 lit/A

188 acrylic acid-d4 12 lit/A

189 oxalyl chloride 23600 Kg/A

190 triethylamine 3000 Kg/A

191 MDC 7900 lit/A

192 5% citric acid 8300 lit/A

193 benzene 438 Kg/A

194 DMF 280 Kg/A

195 suspension of 36 45 Kg/A

196 Acryloyl-d3 chloride 11990 Kg/A


198 Nintedanib Base 450 Kg/A Nintedanib Esylate - 500 199 Ethane Sulfonic Acid 95 lit/A


Axitinib - 500

201 6-nitro-indazole 81.55 Kg/A

202 3, 4- dihydro -2H- pyran 84.1 Kg/A

203 2,3- dichloro-5,6-dicyano-p-benzoquinone 11 Kg/A

204 dichloromethane 2915 lit/A

205 DMF 1298 Kg/A

206 tetrahydro -2H- pyran-2-yl) -1H- indazole 112.5 Kg/A

207 potassium carbonate 125.5 Kg/A

208 iodine 207.5 Kg/A

209 sodium thiosulfate 111.5 Kg/A

210 potassium carbonate aqueous solution 0.75 lit/A

211 DMF 944 Kg/A

212 addition of the intermediate (1) 156 Kg/A

213 2- vinylpyridine 63.75 Kg/A

214 N, N- diisopropylethylamine 102.65 Kg/A

215 tri-o-tolylphosphine 11.15 Kg/A

216 palladium chloride 2.45 Kg/A

217 isopropanol 864.6 lit/A

218 ethanol 410 lit/A

219 ammonium chloride 150 Kg/A

220

(E) -6- nitro-3- [2- (pyridin-2-yl) ethenyl] -1- (tetrahydro -2H- pyran-2-yl) -1H- indazole 112.5 Kg/A

221 iron powder 81.3 Kg/A

222 THF 896 Kg/A

223 sodium nitrite 35.1 Kg/A

224

(TC, (E) -6- amino-3- [2- (pyridin-2-yl) ethenyl ] -1- (tetrahydro -2H- pyran-2-yl) -1H- indazole 100 Kg/A

225 glacial acetic acid 682.5 lit/A

226 concentrated hydrochloric acid 66.08 lit/A

227 MDC 1936.836 lit/A

228 potassium iodide 103.65 Kg/A

229 iodine 39.6 Kg/A

230 20% sodium thiosulfate solution 1660 lit/A

231 ammonia 200 lit/A

232

(E) -6- iodo-3- [2- (pyridin-2-yl) ethenyl] -1- (tetrahydro-pyran-2-yl -2H-) -1H- indazole 87.5 Kg/A

233

[1, I, - bis (diphenylphosphino) ferrocene] dichloropalladium dichloromethane complex 7.45 Kg/A

234 cesium carbonate 99.15 Kg/A

235 2-mercapto -N- methylbenzamide 42.45 Kg/A

236 ethyl acetate 1344 lit/A

237

(E) -N- methyl-2 - {[3- (2- (pyridin-2-yl) ethenyl) _1_ (tetrahydro -2H- pyran-2-yl) -1H - indazol-6-yl] thio} benzamide 75 lit/A

238 p-toluenesulfonic acid monohydrate 151.6 lit/A

239 methanol 316.72 lit/A

240 ethanol 328 lit/A

241 ethyl acetate 201.6 lit/A

3.7 Resource optimization

After the reaction is complete the solvents are recovered, tested as per pre-defined specification.

The residue is collected in a container and sent to KSPCB authorized incinerators.

3.7.1 Water Requirement

The total requirement of raw water for the existing unit is 300 KLD. The detailed break up is

given Table 3-4. The required water will be met from the In house borewells

Table 3-4: Water requirement

SI.No Description Existing Break up (KLD) Proposed (KLD) Total water

requirement Effluent

generated Total Recycled

water 1 Process 60 58 Permeate 122

KLD

Condensate 38 KLD

No Change

2 Washing 25 25 3 Boiler Feed 60 35 4 Chiller 50 5 Domestic 25 22 6 Other utilities 20 20 7 Green belt 60 -

Total 300 160 160 Fresh water

requirement (300 - 160) = 140





Water balance chart for existing (300 KLD) facility is enclosed as Annexure 9 and no changes

has been proposed for Water balance chart in the product mix proposal

WATER BALANCE CHART

Figure 3-9: Water Balance Chart

Total Water-300 KLD Fresh Water-140 KL (Borewell) + Recycled

Water 160 KLD

3.7.2 Power Requirement

The power requirement for the project will be sourced from BESCOM. The detail of power and

back-up power is given in Table 3.5

Table 3-5: Power and fuel Requirement

Details Capacity (KVA) Source Existing Proposed Total

Power Requirement

1000 BESCOM

Power Back Up

1500x1

1500 DG Sets

Diesel Requirements

Approx. 20000 lit/Month

20000 Lit/month

Diesel Requirements

Fuel oil 25000 lit/Month (Furnace

oil)

25000 Lit/month


Table 3-6 Storage Facilities of Existing & Proposed

S.No Description Capacity


1. Solvent Yard Capacity 270 KL No

change

270 KL

2. Powder storage

(Solid Storage WA)

50 MT No

change

50 MT

3. Haz Storage Room

50 MT No

change

50 MT

4. Primary Packing Storage

1000 kg No

change

1000 kg

5. Secondary Packing Storage

2000 kg No

change

2000 kg

6. Drum Yard Storgae Capacity

50 MT No

change

50 MT

7. API Storage capacity 10 MT No

change

10 MT

3.7.3 Air Pollution Control System and Management

There is no increase in emission source due to proposed change in product mix. All the reactors

have condensers to condense the solvent vapors. The reactor vents are connected to the scrubber

to neutralize the toxic vapors. Scrubbers have been provided with FRP/ water circulation type

having neutralizing agents.

There shall not be any additional air pollution soruces. Details of existing air pollution sources &

Emission details are listed below Table 3.6 & 3.8 as well as CFE & CFO as attached as

Annexure 3 & 4 respectively.

Table 3-7: Air pollution Sources

SI.

No

Emission Source Total No of

Stacks (EC

Obtained)

Type

Of fuel

Consumption Chimney Height (in

mts) & air pollution

control system

provided / proposed

as per previous

consent

Kgs/hr in

Case of

Liquid fuel

T/hr in

case

agro

based

fuel.

1 750 KVA DG set 1 HSD 150 Lts/Hr NA 20 M AGL


3 Steam Boiler

1.5 & 2.5 TPH 1 FO 90 Kg/Hr NA 30 M AGL

4 Steam Boiler 3 FO 90 Kg/Hr NA 30 M AGL

5

Process emission from

Production area-

attached to Scrubber

5 NA NA NA

Individual chimney -

3 M ARL &

Scrubber.

6


finishing area- attached

to Scrubber

2 NA NA NA


3 M ARL &

Scrubber.

7 Emission from

Formulation unit

2 NA NA NA


3 M ARL &

Scrubber.

8 Quality control Unit -

1No

1 NA NA NA


3 M ARL &

Scrubber.

Table 3-8: Existing Emission Sources

SI.

No

Emission Source No of

Stacks

Type

Of fuel

Consumption Chimney Height (in mts)

& air pollution control

system provided /

proposed as per previous

consent

Kgs/hr in Case

of Liquid fuel

T/hr in case

agro based fuel.


2 Steam Boiler

1.5 & 2 TPH 1 FO 90 Kg/Hr NA 30 M AGL

3


Production area-


5 NA NA NA Individual chimney - 3 M

ARL & Scrubber.

4


finishing area-


3 NA NA NA


ARL & Scrubber.

Table 3-9: Existing Emission Rate

Sl. No

General Details/Parameters in

Units

Existing

No of Stacks

Type Of

fuel

Sulphur

Content

Consumption Chimney Height (in mts) & air pollution control system

provided / proposed as per previous

consent

Stack Dia (m)

Stack Temper

ature (oC)

Emission Rate of PM, (kg/hr)

Sulphur

dioxide (SO

mg/Nm3

Emission Source

Kgs/hr in Case

of Liquid

fuel

T/hr

in case agro based fuel.

1 1500 KVA DG set 1

HSD 0.25% 280

Lts/Hr NA 30 M AGL

0.31 232 0.09 22.8

2 Steam Boiler 1.5 & 2 TPH

1 FO 4.0 %

90 Kg/Hr

NA 30 M AGL 0.59 100 0.33 14.2

3

Process emission

from Production

area- attached to Scrubber

Scrubber - 1

5 NA NA NA NA

Individual chimney - 3

M ARL & Scrubber.

0.16 42 0.008 --

Scrubber - 2

0.16 46 0.007 --

Scrubber - 3

0.22 47 0.01 --

Scrubber - 4

0.62 48 0.10 --

Scrubber - 5

0.48 48 0.07 --

4

Process emission from finishing area- attached to Scrubber

Scrubber 6

3

NA NA NA NA

Individual chimney - 3

M ARL & Scrubber.

0.32 46 0.007 --

Scrubber 7

0.32 46 0.007 --

Scrubber - 8

0.32 46 0.007 --

KSPCB Consent Standards NS NS

3.8 Waste Management and Disposal Method

3.8.1 Liquid Waste Management

Sewage and effluent generated from process and washings are taken to combined Effluent and

sewage Treatment Plant of capacity 160 KLD further processed in RO plant. Rejects from RO

Plant along with High TDS effluent is treated in Multiple Effect Evaporator of 40 KLD capacity.

The treated waste water of 160 KLD is reused for Boiler, cooling towers and Toilet flushes. Zero

liquid discharge system is maintained in the facilities.

Table 3-10: Liquid waste Generation and treatment

Phase Population (Nos)

Qty of water required (KLD)

Sewage/Effluent Generated

(KLD)

Treatment Method

Existing Operation 300 300 160 Treated in combined ETP and STP

Proposed construction Not applicable

After expansion Operation No change after proposed change in product

mix Process 300 300 160

Table 3-11: Existing Effluent Quality

SI.No Existing Standards Protocol Proposed Parameters Results

1 pH 6.9 6.0 8.5 APHA 22nd 4500 H+ B

No Change

2 BOD, mg/L (3days at 27oC)

7.0 100 IS: 3025 (P44) Realfirmed 2014

3 Total Suspended Solids, mg/L

4.0 100 APHA 22nd 2540 D

4 Oil & Grease, mg/L BDL 10 APHA 22nd 5520 B 5 Total dissolved Solids,

mg/L 106.0 2100 APHA 22nd 2540 C

BDL: Below Detectable limit

Analysis Report of Existing Effluent quality enclosed as Annexure 12.

Figure 3-10: Schematic of ETP cum Reverse Osmosis Plant and Multiple effect Evaporator plant

Sludge from Clariflocculator and Clarifier

3.8.2 Hazardous and Solid Waste Management

Solid Waste

During operation phase, 580Kg of solid waste will be generated.

The details are given in Table 3.10.

Table 3-12: Solid waste Generation and Management

Waste Quantity (kg/day) Collection

method Disposal method


Hazardous waste

580 No change 580 Leak proof bags and barrels

Authorized vendors

Effl.& Sewage treatment Sludge

164.38 No change 164.38 Trolleys TSDF

Hazardous waste

Hazardous waste materials are properly disposed as per the Hazardous waste management rule

1989.

Agreement between TSDF and CIPLA for collection, transport, storage, treatment and disposal

and also we have a valid Agreement with M/s Enano incintech for Incineration of incinerable

wastes.

Table 3-13 Hazardous waste generation and Management

Waste Category

Hazardous waste

Generated



5.1 Used Oil 15 KL/A No

changes

15KL/A

Shall be collected in Leak proof containers and disposed only to KSPCB registered authorized reprocessors provided the oil meets the standards as per schedule-5 part-A of the rules

5.2 Oil soaked cotton waste

0.5MT/A

0.5MT/A

Shall be stored in a secured manner and hand over to KSPCB authorized incinerator/Co processing in cement kiln

28.1 Process residues & Waste

202 MT/A 202MT/A


28.2 Distillation Residue

10 MT/A 10MT/A


28.5 Spent solvent 1200 KL/A

1200KL/A

Shall be stored in a secured manner and hand over to KSPCB authorized recycler

33.3 Discarded containers

2500 Nos/A

2500 Nos/A

Shall be stored in a secured manner and hand over to KSPCB authorized recycler after wash only

34.3 Sludge from ETP & MEE

60 MTA

60 MTA

Shall be stored in a secured manner and hand over to KSPCB authorized TSDF

4. SITE ANALYSIS

4.1 Connectivity

CIPLA Limited - API Unit is located at Bommasandra village, Anekal Taluk. The proposed site

is well connected by Highways and easy access to railway station.

Table 4-1 Salient Features of the Project Site

Feature Details

Project Site Location M/s. CIPLA Limited

Plot.No.285, 2 86 & 287, KIADB Industrial Area,

Bommasandra-Jigani Link Road, Phase-IV,

Anekal Taluk, Bangalore 560105, Karnataka.

Site Co-ordinates of the project site Latitude: 12°47'8.31"N


Elevation 890 mts

Topography Plain

Nearest City Bangalore 25 Kms

Nearest Highway Bangalore to Chennai NH-44 (Old NH-7) at a distance of

5.4 kms towards NE

Nearest Railway line Heelalige 7.2 Kms towards NE

Anekal 9.4 Kms towards SE

Nearest Air port Kempegowda International Airport 46 Kms towards

North, Bangalore

Historical/Archaeological phase Nil within 10 km radius

Total Land Area 28.2 Acres

Existing built up area 20 Acres

Table 4-2 Geographical Locations of the Site

Site Point Latitude & Longitude/Directions

A 12°47'16.66"N, 77°38'58.17"E, North

B 12°47'7.78"N, 77°39'3.61"E, East

C 77°38'52.53"E, 77°38'52.53"E, SSW

D 77°38'48.95"E, 77°38'48.95"E, WSW

E 77°38'51.56"E, 77°38'51.56"E, West

F 12°47'10.92"N, 77°38'50.24"E, WNW

The details of sensitive areas from the site boundary are below. The site does not fall within the

CRZ area

Table 4-3 Sensitive areas from the site boundary, 10 km radius.

S.No Name Distance (km) Direction




4.2

The total land available for the proposed project is about 28.23 Acre (114254.439 sq.m).

Available land area is utilized for building, plant, road and pavement, green belt, landscaping and

feature expansion uses. The land possession certificate from KIADB is enclosed in Annexure-1.

The area break up detail present in Table 4.4. The existing plant layout sketch is given in

Annexure 5.

Table 4-4 Existing Land Area Break up Area

Description AREA IN

SQMTS

AREA IN

ACRES

% OF

AREA

Land Utilized for Buildings & Utilities

Purpose 13286.739 3.28 11.63

Land Utilized for other allied purpose

like U/G & Above Ground Tanks,

Machinery Foundations, Loading

Bays, Ramps etc.

5794.225 1.43 5.07

Land Utilized for other allied purpose

like construction of Rcc roads 29459.918 7.28 25.78

Land Utilized for Green Belt

Development 38354.5 9.48 33.57

Area for future expansion 27359.05 6.76 23.95

Total Area 114254.439 28.23 100.00

4.3

The site is more or less a flat terrain. Bangalore has two unique Topography terrains North

Bangalore Taluk and the South Bangalore taluk. The North Bangalore taluk is a relatively more

level plateau and lies between an average of 839 to 962 meters above sea level. The middle of

the taluk has a prominent ridge running NNE-SSW. The highest point in the city,

Doddabettahalli, (962m) is on this ridge. There are gentle slopes and valleys on either side of this

ridge. The low-lying area is marked by a series of water tanks varying in size from a small pond

to those of considerable extent, but all fairly shallow.

The topography of Bangalore is flat except for a central ridge running NNE-SSW. The highest

point is Doddabettahalli, which is 962 m (3,156 ft) and lies on this ridge. No major rivers run

through the city, though the Arkavathi and South Pennar cross paths at the Nandi Hills, 60 km

(37 mi.) to the north. River Vrishabhavathi, a minor tributary of the Arkavathi, arises within the

city at Basavanagudi and flows through the city. The rivers Arkavathi and Vrishabhavathi

together carry much of Bangalore's sewage. A sewerage system, constructed in 1922, covers

215 km² (133 mi²) of the city and connects with five sewage treatment centers located in the

periphery of Bangalore.

The South Bangalore taluk has an uneven landscape with intermingling hills and valleys. The

southern and western portions of the city consist of a topology of granite and gneissic masses.

The eastern portion is a plane, with rare minor undulations.

There are no major rivers flowing through the city. However, rivers Arkavathi and Kaveri merge

within the proximity of Nandi Hills, which lie 60 km north of Bangalore. River Vrishabhavati, a

tributary of Arkavathi, flows for a small stretch in the Bangalore North taluk and carries a bulk

of the city's sewerage. The city has a handful of freshwater lakes and water tanks such as

Madivala tank, Hebbal tank, Ulsoor lake and Sankey Tank. Groundwater occurs in silty to sandy

layers of alluvialsediments and jointed quartzite.

The rock types prevalent in the district belong to the Saugar, Charnokite and Peninsular Gneissic

Complex (PGC) groups. The PGC is the dominant group of rocks and covers two-thirds of the

area and includes granites, gneissis and migmatites. The soils in Bangalore vary from red laterite

to clayey soils

CIPLA Ltd has already established a facility in KIADB industrial area and the proposed project

is only a product mix. The land possession certificate from KIADB is enclosed in Annexure-1.

So, concern over the use of agriculture land, non-agriculture land, forest land, water bodies and

CRZ etc., does not arise.

a. Land

The Plant facilities are spread over 114254.439 Sq. m in KIADB Land which is completely

fortified and protected on all four sides by boundary walls.

b. Buildings

Total built up area is divided into various sections like Production Blocks, Engineering,

Warehouses, Administration, Canteen, Toilets etc. There is adequate space & provision for

operations.

c. Plant Machinery & Utilities

The Plant Facilities have been designed and set up with the objective to carry out almost all

chemical reactions and processes. Details of plant and machinery and utility used

for the production are as below;

i. Process :

Isolators

Reactors

Centrifuges

RCVD

VTDs

Jet Mill

Multi Mill

Sifter

ii. Machinery / Utility Equipments;

Boilers

Cooling towers

DG sets

Brine chilling plant

Nitrogen Plant

Air compressors

HVAC system

Vacuum pumps

Hot water systems

Chilled water plant

Dust collectors

Scrubber

Table 4-5 List of Existing Utilities

S. No. Utility Existing Flow rate Flow rate after

proposed project

1 MP Steam 750Kg/hr

No changes 2 LP Steam 300Kg/hr

3 Nitrogen 20Nm3/hr

4 Cooling Water 200m3/hr

5 Boiler Feed Water 0.5 m3/hr

6 Plant Air 175cfm

7 Electrical Power 700kWh

iii. Safety Equipments:

Fire Hydrant System

Fire Extinguishers

Fire Alarm System

Eye wash fountain / Safety Showers

Emergency PPE cupboards

Wind Sack

Smoke Detector system

Self-Contained Breathing Apparatus

Fire suit

The site is well connected by road to NH 44 (Bangalore- Chennai). The list of the few existing

industries within 10 km from the site is given in Table 4.6.

Table 4-6 Existing industries within 10 Km radius from the site

S.No. Name Product Distance

from site

(km)

Direction

1. M/s P.D Biopchem Pvt Ltd Pharmaceutical 0.41 N

2. M/s Mahindra Reva Electric

Vehicle Pvt Ltd

Automobile 3.66 NE

3. M/s Micro Labs Ltd

ML- 22, API divn

Pharmaceutical 0.51 SW

4. M/s Shoba Ltd Fabric 2.65 North

5. CIPLA Pharmaceutical 0.86 SW

6. Mylan Limited Pharmaceutical 0.97 SW

7. Syngene Int Ltd (Biocon park) Chemicals 2.01 NE

8. Apotex Pharma Chem Pharmaceutical 2.46 NE

9. Acebright Pharmaceutical 2.76 SW

10. Kumar Organic Products Ltd Pharmaceutical 2.99 SW

The top soil is reddish brown clay silt soil. The soil classification is Laterite soils and is mainly

found in Anekal Taluk.

Normal annual rainfall of Bangalore urban district is 831mm. During the year 2005, Bangalore

urban district received actual rainfall of 1342.7 mm in 69 rainy days. Of the total rainfall,

contribution from southwestern monsoon is 54.18% and 26.53% is from northeastern monsoon.

In addition to this, Premonsoon showers contribute significant rainfall of 18.53%. The annual

average maximum temperature ranges from 23.9 to 30.4°C and minimum temperature ranges

from 19.6 to 23.9°C. The annual average humidity is 65.5°C. The annual average wind speed is

4.5 km/h.

The social infrastructure facilities available in 10 km radius are given in Table 4.7

Table 4-7 Project surrounding feature

S.No Name Distance (Km) Direction

Schools & Colleges 1. BTL High School 4.63 NE

2. Treamis World School 3.06 N

3. Royal Public School 5.83 NE

4. BTL Institute of Tech and Management 4.91 NE

5. Condor International school 4.32 NW

6. Christ Academy ICSE school 5.38 NW

7. Nidyananda High school and college 2.37 W

8. Tapovan High School 4.11 W

9. Virindha Educational Academy 5.89 W

10. Film Academy 5.90 W

11. T. Johan College 9.34 NW

12. Sherwood High School 9.56 NW

Religious Places

13. Jigani Masjid 2.25 W

14. Sri Channa Keshava Temple 7.64 SE

Hospital

15. Narayana Hrudyala 5.07 NE

16. Sparsh Hospital 5.33 NE

17. Srinidhi Hopital 5.65 E

Sensitive area




5. PLANNING BRIEF

5.1 Planning concept

CIPLA Limited proposes products mix of Active Pharmaceutical Ingredients, product mix will

be changed with change of Approved production Capacity 114.22 MTA to 113.46MTA within

its 28.23 Acres land located at Bommasandra village, Anekal Taluk, Bangalore District,

Karnataka State. The site is in KIABD industrial area.

The proposed site is well connected by Highways and easy access to railway station.

5.2 Population Projection Permanent Contractual Total Existing 300 300 Proposed There is no increase of additional man power due to


5.3 Land use planning The total land available for the proposed project is about 28.23 Acre (114254.439 sq.m), Green

belt utilized 9.48 Acres of (33.57%) and the for future expansion is 6.76 Acres of (23.9 %).

Available land area is utilized for building, plant, road and pavement, green belt, landscaping and

feature expansion uses. The area details of the facility are given in Chapter 4, Tables 4.2.

5.4 Assessment of Infrastructure Demand The facility is within the KIADB industrial area and the proposed project is only a Change in

product mix

5.5 Amenities/Facilities

The existing site is having Canteen facility for employees, Occupational Health Center (OHC)

and safe Assembly points on emergency etc.

6. PROPOSED INFRASTRUCTURE

6.1 Industrial Area The proposed project established in KIADB Industrial area.

6.2 Residential Area Not Applicable. Since the unit is an Active Pharmaceutical Ingredients manufacturing unit inside

KIADB area, no housing development is proposed.

6.3 Green belt

The total site area is 114254.439 sq. m. The green belt is 38354.5 Sq.m (33.57%) of the total area.

6.4 Social Infrastructure KIADB Industrial Area.

6.5 Connectivity The proposed site is well connected by Highways Bangalore to Chennai NH-44 (Old NH-7) at a

distance of 5.4 kms towards NE and easy access to railway station Heelalige 7.2 Kms towards

NE & Anekal 9.4 Kms towards SE

6.6 Drinking Water Management Drinking water facility is available. CIPLA has RO plant to generate drinking and process water

which we store in a storage tank. Water quality analysis is done on regular basis at in-house

Quality Control dept and periodically analysis is done at external approved laboratory.

6.7 Sewerage system The quantity and quality of wastewater in the plant is controlled by following measures:

Recycle of process water including steam condensate and reuse of treated waste

water in Utility, Boiler, Cooling Tower, and Garden etc.

Control of water taps, washings, leakages from pump glands and flanged joints.

Overflow of vessels is strictly avoided

Floor cleaning with water will be replaced with dry cleaning.

Effluents from the plant is been stored and neutralized in a collection tank and then

it is treated in the Multi Effective Evaporation Plant

Proper provisions have been made by installation of septic tank and soak pit.

6.8 Industrial waste management Hazardous waste materials are properly disposed as per the Hazardous waste management rule

1989.

Agreement between TSDF and CIPLA for collection, transport, storage, treatment and disposal

and also we have a valid Agreement with M/s Enano incintech for Incineration of incinerable

wastes.

a. Air Environment:

i. Sources:

Reactors, Distillation process

Boilers

Fugitive vapours from reactors, centrifuges and at discharges of vessel

contents, etc.

D.G. sets

ii. Mitigative measures:

1. All reactors are connected to scrubber with a stack attached.

2. The vapours are been collected through exhaust system consisting of hood,

duct and then vented out.

3. Stack of 6 m ARL are provided to D.G. sets.

4. Boilers are connected with chimney

5. Plantation of green trees around the factory building and premises to control

the intensity of noise to the surrounding area.

6.

b. Noise Environment:

i. Sources:

Generators

ETP Blowers

Compressors


1. Acoustic barriers or shields to the machineries.

2. Vibration free foundations for machineries

3. Acoustical walls and roofs to the building where such machineries are

installed.

4. Segregation of machineries having high noise level in isolated buildings.

5. Proper maintenance of machineries especially oiling and greasing of bearing

and gears etc.

6. Avoiding vibration of machineries with proper design of machineries such as

speed, balancing etc.

7. Use of personnel protective such as earmuff and ear fug for persons working

in such locations.

8. Plantation of green trees around the factory building and premises to control

the intensity of noise to the surrounding area.

9.

c. Water Environment:

i. Sources: In house bore well

Process water

Cooling tower blow down

Washing

Softner Regeneration

Domestic waste water


Sewage and effluent generated from process and washings are taken to combined

Effluent and sewage Treatment Plant of capacity 160 KLD further processed in RO plant.

Rejects from RO Plant along with High TDS effluent is treated in Multiple Effect

Evaporator of 40 KLD capacity. The treated waste water of 160 KLD is reused for

Boiler, cooling towers and Toilet flushes. Zero liquid discharge system is maintained in

the facilities.

Rain water harvesting plan has been executed effectively & a storage reservoir of

adequate capacity is provided to hold rainwater.

Control of water taps, washings, leakages from pump glands and flanged joints.

Overflow of vessels is strictly avoided

Floor cleaning with water will be replaced with dry cleaning.

Drinking water facility is available. CIPLA has RO plant to generate drinking and

process water which we store in a storage tank. Water quality analysis is done on regular

basis at in-house Quality Control dept and periodically analysis is done at external

approved laboratory.

d. Solid & Hazardous waste:

i. Sources:

Used oil

Oil soaked cotton waste

Process residues & Waste

Distillation residue

Spent Solvent

Sludge from ETP & MEE

Discarded containers

Mitigative measures:

1. Used oil shall be collected in leak proof containers & disposed to Central Pollution

Control Board / Karnataka State Pollution Control Board registered authorized recyclers.

2. Spent solvents will be stored in a secured manner and handed over to Karnataka State

Pollution Control Board authorized recyclers.

3. Distillation residue will be stored in a secured manner and handed over to Karnataka

State Pollution Control Board authorized incinerators/Co-processing in cement kiln.

4. Process residues will be stored in a secured manner and handed over to Karnataka State

Pollution Control Board authorized incinerators/Co-processing in cement kiln

5. Off specification products will be stored in a secured manner and handed over to KSPCB

authorized incinerator.

6. Discarded containers will be stored in a secured manner and handed over to Karnataka

State Pollution Control Board authorized recycler after washing.

7. Sludge from ETP & MEE stored in a secured manner and hand over to KSPCB

authorized recycler and authorized TSDF

6.9 Solid waste management Solid wastes generated will be stored and disposed in scientific manner.

During operation phase Hazardous waste generate 580 Kg/d and Effluent & Sewage

treatment sludge 164.38 kg/d of solid waste is being generated.

Collection method is through Leak proof bags, barrels & Trolleys is being Disposed to

Authorized vendors & TSDF.

6.10 Power Requirements and Supply/ Source The power requirement for the project will be sourced from BESCOM.

Power Requirement Details Capacity (KVA) Source

Existing Proposed Total Power Requirement

1000 BESCOM

Power Back Up

1500x1

1500 DG Sets

Diesel Requirements

Approx. 20000 lit/Month

20000 Lit/month

Diesel Requirements

Fuel oil 25000 lit/Month (Furnace

oil)

25000 Lit/month


7. REHABILITATION AND RESETTLEMENT (R &R) PLAN

7.1 Policy to be adopted (Central/ State)

Not applicable as the proposed project is only a Change in product mix within the existing unit

of KIADB industrial area.

8. PROJECT SCHEDULE AND COST ESTIMATE

8.1 Likely date of start of construction and likely date of completion

Not applicable as the proposed project is only a product mix within the existing unit of

KIADB industrial area.

8.2 Estimated project cost

There is no additional project cost as it is an existing unit. The Gross value of existing

infrastructure is Rs. 166 Crores

9. ANALYSIS OF PROPOSAL

9.1 Financial and social benefits

Financial (Last year):

Annual Turnover: Rs. 75 crores

Social Benefits:

Employment to local community:

CIPLA always prefer local community for employment and has given employment.

CSR benefit to local community:

1. CIPLA helps meritorious students to continue their higher education.

2. CIPLA donates money for various medical camps i.e., Eye Camp, Diabetics, Parkinson

disease etc., For the benefit of society.

3. CIPLA donates money to Hospitals for improving hospital infrastructure and also providing

food on free of cost.

4. CIPLA also supports and promotes Swachh Bharat Abhiyan activities.

Green belt benefit to environment: 1. CIPLA is maintaining green belt inside the factory premises and also planted trees near the

boundary of plant for environmental protection.

2. CIPLA has also planted more than 3000 trees near nearby its API plant to the benefit of

environment.

Documents

APPLICATION FOR ENVIRONMENTAL CLEARANCEenvironmentclearance.nic.in/writereaddata/FormB/TOR/PFR/15_Jul... · APPLICATION FOR ENVIRONMENTAL CLEARANCE FOR CHANGE IN PRODUCT MIX BY M/s