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Proposed Production Enhancement of Synthetic Drug API (From 2551.5 TPA to 3222 TPA), Formulations & proposed production of Steroid & Hormonal products (41.391 TPA) and R&D Products (5 TPA) in the Existing Plant Premises near Village Sejavata, Tehsil & District Ratlam (M.P.)

INDEX-Executive Summary

M/s. Ipca Laboratories Ltd a

INDEX

S. NO. PARTICULAR PAGE NO.

1.0 PROJECT DESCRIPTION 1

1.1 INTRODUCTION 1

1.2 SCREENING CATEGORY 1

1.3 SCOPE OF THE REPORT 1

1.4 DETAILS OF PROJECT AREA 1

1.5 LOCATION MAP 3

2.0 REQUIREMENTS OF THE PROJECT 4

3.0 PROCESS DESCRIPTION 5

3.1 MANUFACTURING PROCESS OF SYNTHETIC DRUGS API’s 5

3.1 (A) MANUFACTURING PROCESS OF FORMULATIONS 5

4.0 DESCRIPTION OF ENVIRONMENT 7

5.0 ANTICIPATED ENVIRONBMENTAL IMPACTS & MITIGATION MEASURES 7

5.1 AIR ENVIRONMENT 7

5.2 WATER ENVIRONMENT 8

5.3 NOISE ENVIRONMENT 8

5.4 SOCIO-ECONOMIC ENVIRONMENT 8

6.0 ENVIRONMENTAL MONITORING PROGRAMME 8

7.0 PROJECT BENEFITS 9

8.0 ENVIRONMENTAL MANAGEMENT PLAN 9

8.1 AIR ENVIRONMENT 9

8.2 WATER ENVIRONMENT 9

8.3 NOISE /ODOUR ENVIRONBMENT 10

8.3.1 NOISE ENVIRONMENT 10

8.3.2 ODOUR MANAGEMENT 10

8.4 HAZARDOUS WASTE MANAGEMENT 11

8.5 OCCUPATIONAL HEALTH & SAFETY MEASURES 14

8.6 GREEN BELT DEVELOPMENT 14

9.0 CONCLUSION 14

Proposed Production Enhancement of Synthetic Drug API (From 2551.5 TPA to 3222 TPA), Formulations

& proposed production of Steroid & Hormonal products (41.391 TPA) and R&D Products (5 TPA) in the

Existing Plant Premises near Village Sejavata, Tehsil & District Ratlam (M.P.)

Executive Summary

M/s. Ipca Laboratories Ltd 1

EXECUTIVE SUMMARY

1.0 PROJECT DESCRIPTION

1.1 INTRODUCTION

M/s. Ipca Laboratories Ltd. has proposed for Enhancement in production capacity of Synthetic

Drug API (From 2551.5 TPA to 3222 TPA), Formulations & proposed production of Steroid &

Hormonal products (41.391 TPA) and R&D Products (5 TPA) in the existing plant premises near

Village Sejavata, Tehsil & District Ratlam (M.P). The present EIA Report addresses the

environmental impacts of the proposed project and proposes the mitigation measures for the

same.

1.2 SCREENING CATEGORY

As per EIA Notification dated 14th Sep, 2006 as amended on 1st December 2009, the project falls

under Category “A”, Project or Activity 5(f) (3), which requires the preparation of EIAReport to get

Environmental Clearance (EC) from Ministry of Environment & Forests (MoEF), New Delhi.

1.3 SCOPE OF THE REPORT

The scope of the EIA report is based on

� Terms of Reference (TOR) granted by MoEF, Vides F. No. J-11011/169/2011- IA II (I) DATED 26th

JULY, 2011

� Baseline data collected during Post Monsoon Season, 2011.

M/s. J. M. EnviroNet Private Limited, Gurgaon – a NABET accredited EIA consultancy organization

has been retained by IPCA Laboratories Ltd. to carry out and prepare the EIA report as per MoEF

guidelines.

1.4 DETAILS OF THE PROJECT AREA

The details of environmental setting of Project Site are given below:

TABLE-1

SALIENT FEATURES OF THE PROJECT

S. No.

Particulars Details

1 Nature & size of the Project Proposed Production Enhancement of Synthetic Drug API (From 2551.5 TPA to 3222 TPA), Formulations & proposed production of Steroid & Hormonal products (41.391 TPA) and R&D Products (5 TPA) in the existing plant premises.

2 Land Details

Total Area 40.47 ha

Proposed Area for Green Belt 14.76 ha i.e. 36.5% of the project area

Type of Land Private land




Executive Summary


3 Location details

A. Village Sejavata

B. Tehsil & District Ratlam

C. State Madhya Pradesh

D. Latitude & Longitude 230 23’3.12” N – 230 23’39.32” N

750 03’5.81” E – 750 04’05.81” E

4. Cost Details

Project Cost 321.65 Crores

Cost of EMP 16 Crores

Recurring Cost of EMP 5.6 Crore/annun

5. Environmental Settings (Distance & direction from plant site)

Nearest City Ratlam (~5.0 km in SSW direction)

Nearest National Highway / State Highway • NH-79 (adjacent to the existing manufacturing unit)

• SH-10 (~ 4.0 Km in SW direction)

Nearest Railway Station Ratlam Railway station (~5.0 km. in SSW direction)

Nearest Airport Devi Ahillyabai Holkar airport, Indore (~105 Km. in SE direction)

National Park, Biosphere Reserve, Wild Life Sanctuary, Wildlife corridors, Migratory route for birds, Reserved Forests falls within 10 km radius.

No National Park/ Wild Life Sanctuary/ Biosphere Reserve/ Wildlife corridors/ Migratory route for birds/ Reserved Forests lies within 10 km radius of the proposed project site.

Protected Forest within 10 km radius (Boundary to boundary distance)

Sambharkho PF (~9.5 km in WNW direction)

Water Bodies within 10 km radius � Sajjan Mil Talab (~ 6.0 km in SW direction).

� Jammar River (Seasonal River) (~7.5 km in SW direction).

� Amrit Sagar Talab (~ 8.5 km in SSW direction).

� Kurel River (Seasonal River) (~ 9.5 km in E direction)

Source: Site Visit & Pre-feasibility Report




Executive Summary


1.5 LOCATION MAP




Executive Summary


2.0 REQUIREMENTS FOR THE PROJECT

TABLE -2

REQUIREMENT FOR THE PROJECT

S. No.

Particular Requirements Source & Mode of Transportation/ Permission status

1. Water Requirement –

Municipal authorityand Borewells.

Permission Status: Permission for 786 KLD ground water withdrawal has been obtained from CGWA vide letter no. 21-4/ (27)/NCR/CGWA/2008 dated 26th Nov. 2008 and Municipal Authority, Ratlam vide letter no. 323/07 dated 16.05.2007. (Aneexure 11 of Draft EIA/EMP Report.)

Existing

1050 KLD

Proposed

450 KLD

Total 1500 KLD

2. FUEL Requirement –

Coal 50 TPD Local Coal suppliers Road

Pet coke 35 TPD Reliance, Jamnagar

LSHS/FO 800 LPD IOC/HPCL

LDO 1000 LPD IOC/HPCL

HSD 600 LPD IOC/HPCL

Agrowaste (dry leaves)

1200 TPD Nearby areas

3. Power Requirement

Existing Requirement 4450 KVA

M.P.P.K Vidut Vitran Co. Ltd Additional Requirement 4050 KVA

1500 KVA

Total Requirement 10000 KVA

4. Manpower

Existing Requirement 2235 Persons

Additional Requirement 415 Persons

Total Requirement 2650 Persons

Source: Pre feasibility Report




Executive Summary


3.0 PROCESS DESCRIPTION

3.1 MANUFACTURING PROCESS OF SYNTHETIC DRUGS API’s

Process flow chart of Synthetic Drug (API)

3.1.A MANUFACTURING PROCESS OF FORMULATIONS

Process flow chart for Tablet manufacturing process




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Process flow chart for Injectables Manufacturing Process

Process flow chart for Oral Liquid Manufacturing Process




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Process flow chart for Dry Syrup Manufacturing Process

Process flow chart for Gel/Ointment Manufacturing Process

4.0 DESCRIPTION OF ENVIRONMENT

The concentration for all the 6 AAQM stations for PM10 ranges between 44.60 µg/m3 to 80.20

µg/m3 PM2.5 ranges between 16.80 µg/m3 to 36.30 µg/m3, SO2 ranges between 5.90 µg/m3 to 9.70

µg/m3 and NO2 ranges between 10.20 µg/m3 to 24.30 µg/m3.

Noise levels for all the 6 stations varies from 46.09 to 54.18 Leq. dB (A) in day time and in night

time 41.14 to 48.23 Leq. dB (A).

The Surface water analysis for Kurel river shows that pH is 7.42, BOD is 3.90 mg/l, COD is 11.78 mg/l

& Total Dissolved Solid is 306 mg/l.

The ground water analysis for all the 6 sampling stations shows that pH varies from 7.62 to 8.12,

total hardness varies from 200 mg/l to 380 mg/l & total dissolved solids varies from 394 mg/l to

1058 mg/l.

The analysis results for soil shows that soil is slightly alkaline in nature as pH value ranges from 7.10

to 7.84 & is Silty clay in texture. The concentration of Nitrogen & potassium has been found to be

in good amount whereas phosphorous is very less.

5.0 ANTICIPATED ENVIRONMENTAL IMPACTS & MITIGATION MEASURES

5.1 AIR ENVIRONMENT

The sources of fugitive dust emissions are:

1. Burning of fuel at industry

2. Reactor Vessel

3. Exhaust gas from vehicles




Executive Summary


Paved road dust The key emissions generated during construction & operation phase will mainly

include gaseous pollution (SO2, NO2, and CO) and Particulate Matter. These emissions are expected

to have temporary adverse impact on ambient air quality of surroundings of the construction site.

5.2 WATER ENVIRONMENT

There will be no likelihood of impact over the water environment of the study area during

construction phase. Waste water generated during construction will be only domestic waste

which will pass through septic tank and used for dust suppression etc. During operational phase

excess drawl of ground water can cause depletion of ground water resources. But proper water

conservation (Reuse & Recycle and ground water augmentation by rain water harvesting)

measures are being taken to reduce ground water withdrawal. Operational waste water will be

treated in ETP.

5.3 NOISE ENVIRONMENT

During construction phase impact of noise in the area will temporary in nature.

Green belt development will help in reduction of the noise levels in the plant premises as a result

of attenuation of noise generated due to plant operations, and transportation. Hence, dense

plantation will be done along the boundary.

5.4 SOCIO – ECONOMIC ENVIRONMENT

M/s IPCA Laboratories Ltd. will be actively contributing to improve the socio – economic

conditions of the area and also actively participating in Various Socio economic activities like;

educational campaigns, health check-ups, training programme etc will lay stress on the overall

development of the project site. Following points will be stressed upon:

� The plant shall provide direct and indirect employment and improve infrastructure facilities.

Already 2235 workers have been employed by IPCA for existing plant. Enhancement in

production capacity of the plant will generate employment for additional 415 workers.

� Company will provide assistance to the nearby villagers for their development related to

education, hospital, postal, transportation, medical services etc.

� The industry would help in promoting the activities related to environmental awareness in

the nearby villages.

6.0 ENVIRONMENTAL MONITORING PROGRAMME

TABLE 3

Environmental Monitoring

S. No. DESCRIPTION FREQUENCY OF MONITORING

1. Meteorological Data Daily




Executive Summary


2. Ambient Air Quality in Core Zone Twice a week

3. Water Quality Quarterly/ Half Yearly

4. Noise Level Monitoring Quarterly/ Half Yearly

5. Soil Quality Half Yearly/yearly

6. Monitoring of Agricultural crops Yearly

7. Socio – economic status of nearby area Yearly

7.0 PROJECT BENEFITS

� The company’s management will recruit the semi skilled & unskilled workers from the

nearby villages, hence rapidly increasing the social status of the villagers.

� Overall development of rural areas, new shops, upliftment of locals through small business

opportunities.

� Indirect employment creation for several persons involved with raw materials, products

from such projects.

8.0 ENVIRONMENTAL MANAGEMENT PLAN

8.1 AIR ENVIRONMENT

� Gaseous emission from fuel burning, which consists of common pollutants like SO2, NO2

and PM10, would be discharged into atmosphere through stacks with dust collector of

suitable height.

� All reactor vessels are protected by primary and secondary condenser with circulation of

brine and chilling in order to prevent emission of volatile solvent.

� The hazardous chemicals and volatile organic solvents are carefully handled in a closed

system, thereby preventing any discharge of these chemicals into the air.

� Green belt has been developed around the plant boundary as dust preventive barrier.

8.2 WATER ENVIRONMENT

� Zero discharge is maintained

� There is no source of surface water near to the plant site hence any significant adverse

impacts on water sources are not encountered.

� ETP I capacity is 495 KLD & ETP II capacity is 25 KLD; which is sufficient for proposed

production enhancement.

� Treated effluent recycled back with help of RO and Evaporator.

� Treated water is also sent to impervious Lagoons from where it is utilized in Green belt

Development and irrigation within the premises as there is Zero discharge.

� Treated Waste Water is also used from quenching of Hot Ash generated from Boiler and

Incinerator.

� Existing 400 KLD RO & 200 KLD RO plant will be provided.




Executive Summary


� The sludge from Effluent Treatment Plant is dried in Sludge drying beds and the dried sludge is

being sent to M.P. Waste Management Project for secured land fill.

� The same practice will be continued in future after enhancement in production capacity of

plant.

� Rain water harvesting is practiced.

8.3 NOISE/ODOUR ENVIRONMENT

8.3.1 Noise Environment

� Periodical monitoring is being carried out on regular basis.

� D.G. sets are enclosed in acoustic enclosures.

� Noise generating units like formulation plant, canteen etc are well insulated with enclosure

doors. A high standard of maintenance is practiced for plant machinery and equipments which

helps to avert potential noise problems.

� Future enhancement and installation of the plant machinery will be done after- due

consideration to design noise levels and noise mitigation measures.

� The green belt developed helps in reducing noise levels in the campus as a result of

attenuation of noise generated due to plant operations, and transportation.

� There are no major sources of industrial noise; minor noise is being generated from the

industrial operations which are being controlled by proper maintenance and compact

technology.

� Proper mitigation measures are taken for the reduction of noise levels i.e. acoustic enclosures

and the workers are provided with personal protective equipments.

� Proper maintenance, oiling and greasing of machines at regular intervals is done to reduce

generation of noise.

8.3.2 Odour Management

� Exhaust gases are released through stack of appropriate height

� Scrubber installled to adsorb odour emitting gases

� Proper Ventillation system is provided to remediate the odour problem

� Incineration of hazardous odour emitting waste is done to eliminate odour

� Bio-reactors are installed to digest the biodegradable odour emitting waste.

� Activated carbon filter installed to adsorb odour emitting particles froom treated water.

� Fully fledge green belt is developed.

� SOLID WASTE ENVIRONMENT

� The solid waste is generated in the form of sludge from ETP and Evaporator after treatment.

� This sludge is isolated with the help of Filter press and dried in sludge drying beds and sent for

land filling at Madhya Pradesh waste Management Project, Pithampur (M.P.).




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� Ash generated from incinerator sent to Madhya Pradesh waste Management Project,

Pithampur (M.P.) for disposal.

� Similarly salts generated during effluent evaporation process through MEE shall also be sent

to Landfill site as developed by M.P. Waste Management Projects, Pithampur (M.P.)

� There is separate vermin-composting bed for handling of kitchen waste.

� Bottom and Fly ash is generated from boiler sent to bricks manufacturer in local area.

� Scrap is being disposed through authorized recycler by MPPCB.

� The same practice will be continued in enhancement plant.

8.4 HAZARDOUS WASTE ENVIRONMENT

The hazardous waste generated and its management and disposal is summarized in the table

below:




Executive Summary


Sr. No

Hazardous Waste Category of waste

Existing Proposed Total Mode of Disposal Rate of

generation in MT / Year

Rate of generation in MT / Year

Rate of generation in MT /

Year

1. Used /Spent oil 5.1 7.0 01 8.0 RECYCLING IN AUTHORIZED VENDORS

2. Residues and wastes* 28.1 235 125 360 CEMENT MANUFACTURER OR INCINERATOR AT IPCA

RATLAM

3. Spent Catalyst Carbon 28.2 73 112 185 CEMENT MANUFACTURER OR INCINERATOR AT IPCA

RATLAM

Catalyst 28.2 2 3 5 SENT FOR REGENERATION/RECYCLING

4. Date-expired, discarded and off-specification drugs /medicines.

28.4 1.5 3.5 5.0 INCINERATION AT IPCA RATLAM

5. Spent organic solvents 28.5 15 1110 1125.0 CEMENT MANUFACTURER OR INCINERATOR AT IPCA

RATLAM

6. Chemicals-containing residue from decontamination and disposal

33.1 1.6 0.4 2.0 CEMENT MANUFACTURER OR INCINERATOR AT IPCA

RATLAM

7. Discarded containers/barrels/liners contaminated with hazardous waste

33.3 50 NOS (1.2 MT)

1950 ( 1.2 MT)

2000 NOS (2.4 MT)

DECONTAMINATED / REUSE

8. Flue gas cleaning residue 34.1 2.0 1.0 3.0 TREATMENT AT ETP

9. Spent Ion Exchange Resin containing toxic metals

34.2 1.5 0.5 2.0 INCINERATION AT IPCA RATLAM

10. Chemical sludge from ETP 34.3 150 50 200 TSDF* * PITHAMPUR 11. Oil & grease skimming residues

from (CETPs) & (ETPs) 34.4 3.0 1.0 4.0 INCINERATED AT IPCA

RATLAM

12. Ash from incineration of hazardous waste.

36.2 35 15 50 TSDF* * PITHAMPUR

13. Chemical Salt / sludge from 34.3 1080 120 1200 TSDF* * PITHAMPUR




Executive Summary


Evaporator 14. Distillation residues from

contaminated organic solvent 36.4 98 102 200 CEMENT MANUFACTURER

OR INCINERATOR AT IPCA RATLAM

Total 1705.80 1645.6 3351.4

Source: Detailed Project Report




Executive Summary


8.5 OCCUPATIONAL HEALTH & SAFETY MEASURES

Occupational health surveillance programme will be undertaken as a regular exercise for all the

employees and their records will be properly maintained. The health of the workers will be

regularly checked and suitable medical facilities will be provided.

8.6 GREEN BELT DEVELOPMENT

� Green belt has already been developed in an area of 9.3 Ha. (23%) and further will be raised

on an area of 5.46 Ha. (13.5%) thus making a total of 14.76 Ha. (36.5%) of the total plant

area.

� Avenue plantation along the roads and green belt development in the plant is being

developed under afforestation program.

� Local species are being planted as per the guidelines in consultation with the local

horticulturist.

� Few of the species planted are Azadirachta indica (Neem), Dalbergia sissoo (Shisham),

Mangifera indica (Mango), Syzygium cumini (Jamun), Polyalthia longifolia (Ashoka), Cassia

fistula (Amaltash), Emblica officinalis (Amla), Eucalyptus lanceolatus (Safeda), Pongamia

glabra (Karanj) etc.

� The dead plants are being replaced by fresh plants.

� Eco-toxicological Study has been carried out for 2 years which indicates there is no adverse

effect on soil.

9.0 CONCLUSION

As discussed, it is safe to say that the project is not likely to cause any significant impact on the

ecology of the area, as adequate preventive measures will be adopted to contain the various

pollutants within permissible limits. Green belt development around the area will be taken up as

an effective pollution mitigative technique. Community impacts will be beneficial, as the project

will generate significant economic benefits for the region. With the effective implementation of

the Environment Management Plan (EMP) during the Plant activities, the proposed project can

proceed without any significant negative impact on environment.

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