PRE - FEASIBILITY REPORT -...

PRE - FEASIBILITY REPORT

FOR OBTAINING ENVIRONMENT CLEARANCE

For Proposed Expansion of Bulk Drugs, Bulk Drug Intermediates

Manufacturing Unit of

M/s. GUJARAT THEMIS BIOSYN LTD.

Located at

Plot No. 69/C, Phase-I, G.I.D.C Estate, Vapi-396 195, District:

Valsad, Gujarat

Prepared by:

en-vision

Enviro Technologies Pvt. Ltd.

2nd

Floor, Shree Ram Complex, Above Bank of India,

Near Kargil Chowk, Surat Dumas Road,

Piplod, Surat-395007, Gujarat, India

Contact No: +91 2612223003, 2224004

E-mail: [email protected]

Website: www.en-vision.in

September 2017

mailto:[email protected]

http://www.en-vision.in/

INDEX

CHAPTER-1 INTDOUCTION OF THE PROJECT ................................................................................. 1

CHAPTER-2 PROJECT DESCRIPTION .................................................................................................. 4

CHAPTER-3 SITE ANALYSIS ................................................................................................................ 8

CHAPTER-4 PLANNING BRIEF ........................................................................................................... 11

CHAPTER-5 PROPOSED INFRASTRUCTURE ................................................................................... 12

CHAPTER-6 REHABILITATION AND RESETTLEMENT (R & R) PLAN ....................................... 14

CHAPTER-7 PROJECT SCHEDULE & COST ESTIMATES ............................................................... 15

CHAPTER-8 ANALYSIS OF PROPOSAL ............................................................................................ 16

PRE-FEASIBILITY REPORT OF M/S GUJARAT THEMIS BIOSYN LTD.

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CHAPTER-1 INTDOUCTION OF THE PROJECT

1.1 IDENTIFICATION OF PROJECT AND PROJECT PROPONENT

M/s. Gujarat Themis Biosyn Ltd. is planning for the expansion of their existing Bulk Drugs & Bulk Drug

Intermediates manufacturing unit at Plot No. 69/C, Phase-I, G.I.D.C Estate, Vapi-396 195, District: Valsad,

Gujarat.

Table 1-1: Details of Products

Sr.

No. Name of Product

Quantity (MT/Month)

Existing Proposed Total after

expansion

1 Fuma DCHA Salt -

40 40

2 LOVA STATINE -

3 LOVASTATINE

BORONATE -

4 RIFA-S 18

5 RIFAMPICIN 6.6

Total 24.6 40 40

The proposed products fall under Category 5(f) as stated in Environment Impact Assessment Notification

Published on 14th September, 2006. Although the unit is located in notified area of GIDC Vapi (exempted from

critically polluted area by MOEF&CC) the boundary of union territory (Daman) is 2.4 km in WNW direction,

hence the project proponent has to obtain the EC from the Ministry of Environment, Forests & Climate Change,

New Delhi.

The pharmaceutical industry is based primarily upon the scientific research and development (R&D) of

medicines that prevent or treat disease and disorder. Modern scientific and technology advances are accelerating

the discovery and development of innovative pharmaceuticals with improved therapeutic activity and reduced

side effects. Industrial chemicals are used in researching and developing active drug substances and

manufacturing bulk substances and finished pharmaceutical products. M/s. En-vision Enviro Technologies

Private Limited has been appointed to carry out EIA/EMP studies for Environmental Clearance.

Total plot area of the project is 53,869 m2 from which currently 2,948 m

2 is developed as greenbelt, during

expansion additional 14,829 m2 will be developed as greenbelt, thus 33% of total land area will be covered with

green belt. The estimated cost of the proposed project is 6465 Lacs. Total budget allocation towards

Environmental Management Facilities will be Rs. 1500 Lacs. Total 395 (existing 195 and additional 200)

personnel will be required, including skilled persons, unskilled persons and office staff.


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1.2 PROMOTERS BACKGROUND

Details of project promoters are as below:

Dr. Dinesh S. Patel holds a Doctorate in Medicinal Chemistry. He is a Fellow of the Royal Society of

Chemistry, London, U.K. He is an Industrialist and having more than 45 years experience. His areas of

expertise are Pharmaceutical research, Biotechnology, Fermentation technology, Banking and Business

Management.

Dr. Sachin Dinesh Patel holds Doctorate in Biological chemistry from Christ's College, University of

Cambridge, UK. He is an Industrialist and expertise in Business development and having more than 15 years

experience

Mr. Vijay Agarwal is a practicing Chartered Accountant with expertise in finance and taxation and having

more than 30 years experience.

Mrs. Preeti Kaushik Trivedi is is a Chartered Accountant with more than 25 years of experience in Corporate

Finance and Management Consulting.

Mr. Hinesh Doshi is a Practicing Chartered Accountant with expertise in finance and taxation and having more

than 25 years experience.

Mr. Siddharth Y. Kusumgar is an Industrialist with expertise in Market Development, Sales, Finance and

Administration having more than 15 years experience

Mr. J.H Choi is expertise in Planning & Co-ordination, Overseas Business and having more than 30 years

experience.

Mr. S.S. Lee is expertise in Product Development & Overseas Business and having more than 25 years

experience.

Dr. Vikram D Sanghvi is a Surgical Oncologist and having more than 40 years experience. He was Professor

and Chef of Surgical Oncrologist at Ttat Memorial Hospital.

1.3 BRIEF DESCRIPTION OF NATURE OF THE PROJECT

The existing small scale unit is a small scale project for production of Bulk Drugs & Bulk Drug Intermediates

manufacturing. The products are used for captive consumption as well as for sell purpose. The practice will be

continued after expansion.

1.3.1 Need for the Project and Its Importance to the Country and/or Region

The proposed expansion project will provide a potential & required growth opportunity for the Company.

Moreover company has strong presence with leading pharma customers locally as-well-as internationally;


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mainly in regulated market. The company & the products are well approved & registered with the leading

regulatory authorities & the pharma customers’ in local & international markets.

The Active Pharmaceutical Ingredient Industry is the organ by which active pharmaceutical ingredients are

manufactured from raw materials through both chemical and physical means. Depending on the complexity of

the molecule required, synthesis of APIs might need multi-step complex chemistry utilizing a range of

processing technologies.

1.3.2 Demand-Supply Gap

The pharma / health industrial sector in the past many years has seen a consistent growth and also keeping in

mind our strong presence in the local & global market. Hence we have identified the demand for the proposed

products which are meant for very new medicines meant for fast growing therapeutic segments with pilot plant

developed our own process patents we can take a lead & produce commercially in bulk for domestic market as

well as with strong presence in export markets.

1.3.3 Employment Generation (Direct and Indirect)

Total 395 (existing 195 and additional 200) personnel will be required.


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CHAPTER-2 PROJECT DESCRIPTION

2.1 TYPE OF PROJECT INCLUDING INTERLINKED AND INTERDEPENDENT

PROJECTS

Industrial development in India has increased economic growth and improved living standards of people. These

growths are achieved through industrialization, infrastructure development. The industrialization has played a

major role in development of the country. This industrialization is also has many other benefits. Although the

industrial development leads to rapid consumption of natural resources, fuel etc. in day to day operational

activity. To control the pollutions from industrial activity, government has framed regulations which are

governed by Ministry of Environment, Forests and Climate Change in India.

2.2 LOCATION

M/s. Gujarat Themis Biosyn Ltd. is planning for the expansion of their existing Bulk Drugs & Bulk Drug

Intermediates manufacturing unit at Plot No. 69/C, Phase-I, G.I.D.C Estate, Vapi-396 195, District: Valsad,

Gujarat. No new land will be acquired for the proposed expansion project. The proposed expansion project will

get established in existing premises by doing small modification and in available open space in existing

premises. Total plot area of the project is 53,869 m2 from which currently 2,948 m

2 is developed as greenbelt,

during expansion additional 14,829 m2 will be developed as greenbelt, thus 33% of total land area will be

covered with green belt. A map showing project site is given in Figure 2-1.

Identification Latitude & Longitude

20°21'32.89"N

72°54'30.90"E

1 20°21'38.75"N

72°54'26.96"E

2 20°21'33.89"N

72°54'36.81"E

3 20°21'28.01"N

72°54'33.79"E

4 20°21'31.83"N

72°54'25.94"E


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Figure 2-1: Location of the Project Site


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Table 2-1: Salient Features In the Surroundings Area of the Site within 10 Km Radius

Sr.

No. Feature Description

1. Address Plot No. 69/C, Phase-I, G.I.D.C Estate, Vapi-396 195,

District: Valsad, Gujarat

2. GPS Co-ordinates 20°21'32.89"N

72°54'30.90"E

3. Mean Sea Level 25 mt

4. Power station Dakshin Gujarat Vij Company Limited

5. Temperature Range 10-40 °C

6. Annual Rainfall 1500-3000 mm

7. Nearest Airport Daman Airport 10.1 km in NW

8. Distance of Union Territory Daman Union Territory 2.4 km in WNW

Dadra and Nagar Haveli Union Territory 6.0 km in ESE

9. Sea Arabian Sea 9.1 km in WNW

10. Nearest Road NH-8 0.44 km in ESE

11. Nearest Railway Station Vapi Railway Station 1.1 km in N

12. Nearest Railway Line Western Railway Line 0.04 km in W

13. Nearest City Vapi Town 0.9 km in NNW

14. Nearest River Damanganga River 1.9 km SSW

Darota River 3.8 km WSW

Kolak River: 6.1 km in NE

Rati Nadi: 6.0 km in ENE

15. Seismic Zone Seismic Zone-III

16. National Park and / Sanctuary None within 10 km Radius study area

2.2 PROCESS DESCRIPTION

For detailed manufacturing process, chemical reactions, material balance and process flow diagram please refer

Annexure-4 of Additional Attachments to Form-1.

2.3 RAW MATERIALS REQUIREMENT WITH THEIR SOURCE AND

TRANSPORATATION

Raw material will be purchased from local market and convenient mode of transportation is either road/

railways. For product wise raw material requirement please refer Annexure-5 of Additional Attachment to

Form-1.


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2.4 RESOURCE OPTIMIZATION / RECYCLING AND REUSE IN THE PROJECT

The materials are packed in drums and stored in a very organized way, segregated as Solid and Liquid area in

ware house. We have good practices in place like good house-keeping, good Manufacturing practices, best

Environment control, safety and health practices. By adoption of continuous improvement in technology and

processes the desired reduction in process waste generation will be achieved. By proper and efficient handling

of raw materials, wastages of raw materials will be reduced.

2.5 AVAILABILITY OF WATER ITS SOURCE, ENERGY / POWER REQUIREMENT

AND SOURCE

2.5.1 Water

The existing fresh water consumption is 430 KL/d, which is sourced from GIDC. Additional 610 KL/d water

will be required during expansion, which would be sourced from GIDC.

2.5.2 Power

Existing power requirement is of 2400 kVA, which is supplied by DGVCL. Additional 3600 kVA power will

be required during expansion which will be supplied by DGVCL.

There are 2 nos. of DG set of 1250 kVA capacity each in existing, which runs on diesel. During expansion

additional 3 nos. of DG set will be installed (1250 kVA x 2 Nos. + 750 kVA x 1 No.). This is standby source of

power, which is used only in case of power failure.

2.6 QUANTITY OF WASTES TO BE GENERATED AND SCHEME FOR THEIR

MANAGEMENT/DISPOSAL

For details of water consumption and wastewater generation Annexure-6 of Additional Attachment to Form-1.

For details of effluent treatment scheme refer Annexure-7 of Additional Attachment to Form-1.

For details of solid and hazardous waste management refer Annexure-8 of Additional Attachment to Form-1.

For details of process and flue gas emission refer Annexure-9 of Additional Attachment to Form-1.


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CHAPTER-3 SITE ANALYSIS

3.1 CONNECTIVITY

The unit is located in GIDC area which well connected to rest of the country through highways, railways and

airports. The details of the facility with distance from the unit is as under:

Sr.

No. Particular Description

Distance

(km) Direction

1. Nearest National Highway NH-8 0.44 ESE

2. Nearest city Vapi 0.9 WNW

3. Nearest Airport Daman 10.1 NW

4. Nearest Railway station Vapi 1.1 N

3.2 COMMUNICATION

Proposed project site is within existing company premises which is already well connected with telephone,

telefax etc. all the communications facilities are well developed in the area.

3.3 TOPOGRAPHY AND GEOGRAPHY OF THE STUDY AREA

The topography of the area is plain with general slopes from East (34 m) to West (3 m). The study area falls in

Damanganga river basin.

Deccan trap rocks are the oldest rock type, exposed in the Valsad district area. The exposed thickness of the

basalt here is more than 600 m. The weathered part of the Deccan trap is locally known as muram. It is soft and

easily crumbles into pieces. The thickness and areal extent of the weathered portion is very erratic; it ranges

from 1 to more than 18 m at places. Laterised and weathered basaltic outcrop in the form of hummocks of about

3 to 8 m height are observed near Pardi, west of Vapi and in many interior parts of Dharampur & Kaparada

taluka areas. In river section of Damanganga, fluvial sediments, sands with cobbles and pebbles are resting

over Deccan trap, represent lower portion of Quaternary continental deposits.

The study area comprises of Black to Medium black and alluvial Soils. This strip is broad in north and narrow

in south and lastly it completely disappears. Crop like cotton, paddy and mango are grown in black land.


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3.4 CLIMATE OF THE STUDY AREA

The unit is located in Pardi Taluka of Valsad District. Valsad district is located in south of tropic of Cancer,

comes under heavy rainfall areas of South Gujarat, having sub-tropical climate with moderately high

humidity.

Humidity of Pardi Taluka ranges between 47.5 to 80%.

The temperature of the study area ranges from 10-40 °C.

Winds are generally light with some strengthening in force during the late summer and early south-west

monsoon season.

May and the south west monsoon season: winds blow mostly from directions between S and W.

October: winds are variable in direction.

November and December: winds are mostly from directions between N and E.

January to March: in the morning are from directions between N and E and in the afternoons between

SW and NW.

April: winds are variable in direction in the mornings. In the afternoons winds are from directions

between SSW and NW.

The main seasons prevailing in the study area are

Monsoon - mid of June to October

Winter - November to February

Summer – March to June

The study area receives the rainfall through south-west monsoon which normally starts from middle of June.

July and August are the months of heavy rainfall. The average rainfall varies from 1500 mm to 3000 mm.

3.5 EXISTING LAND USE PATTERN

There is no Forest, National park; Wild life sanctuary within a radius of 10 km. The study area comprises of

Industrial estates of Vapi and Sarigam

Residential areas of Vapi town, Daman, Dadra and Nagar haveli, and other small villages

Rivers such as Damanganaga river, Kolak river, Darota river and Rati Nadi

Arabian sea

Cropped area

Small reserve forest

The landuse map of Study area is as under:


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3.6 EXISTING SOCIAL STRUCTURE

Project site is located at Vapi, G.I.D.C. All the infrastructures are available within city like Schools, Colleges,

Hospitals & community facilities even nearby area of the project site is also developed.


11

CHAPTER-4 PLANNING BRIEF

4.1 PLANNING CONCEPT

The unit is located in Vapi GIDC which has different types of industries, such as Pharmaceutical, dyes and dyes

intermediates, color, speciality chemicals. The proponent is manufacturing Active Pharmaceutical Ingredients,

the Active Pharmaceutical Ingredient industry is the organ by which active pharmaceutical ingredients are

manufactured from raw materials through both chemical and physical means. Depending on the complexity of

the molecule required, synthesis of APIs might need multi-step complex chemistry utilizing a range of

processing technologies.

4.2 LAND USE PLANNING

The general Plant Layout has been planned considering production facilities, auxiliary and ancillary facilities

and plant utilities & services. Total plot area of the project is 53,869 m2 from which currently 2,948 m

2 is

developed as greenbelt, during expansion additional 14,829 m2 will be developed as greenbelt, thus 33% of total

land area will be covered with green belt. Land use shall be as build up area of buildings, storage facility, roads,

greenbelt, open land etc. Layout plant of existing and total after expansion is given in Annexure-2 of

Additional Attachments to Form-1. The land use break-up is as under:

Sr.

No. Particular

Area (m2)

% of Total

Area Existing Proposed Total after

Expansion

1. Built-up 17553 5107 22660 42.1%

2. Gardening 2948 14829 17777 33.0%

3. Open 30327 -19936 10391 19.3%

4. Paved 3041 0 3041 5.6%

Total 53869 0 53869 100%

4.3 AMENTIES / FACILITIES

Following facilities are provided in the existing unit:

Adequate storage facility for chemicals, machinery spares and consumables

A small mechanical and electrical/ instrument workshop facilities for repairs and maintenance

Time and security offices

Internal fire hydrants system


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CHAPTER-5 PROPOSED INFRASTRUCTURE

5.1 INDUSTRIAL AREA

The company has already acquired land area of 53,869 m2

in which company will expand their production

capacity.

5.2 GREEN BELT

The main objective of the green belt is to provide a barrier between the source of pollution and the surrounding

areas. The green belt helps to capture the fugitive emission and to attenuate the noise generated apart from

improving the aesthetics. Development of green belt and other forms of greenery shall also prevent soil erosion

and washing away of topsoil besides helping in stabilizing the functional ecosystem and further to make the

climate more conducive and to restore water balance. Currently 2,948 m2 area is developed as greenbelt, during

expansion additional 14,829 m2

area will developed as green belt area with Lawn, plants and flowers spread.

The total area after expansion under greenbelt will be 17,777 m2

across about 33% of the total area. Green belt

will be developed at plant boundary, road side, around offices & buildings and Stretch of open land. The

selection of tree species suitable for plantation at the industry are governed by guiding factors as stated below:

The trees should be tolerant to air pollutants present in the area

The trees should be able to grow and thrive on soil of the area, be evergreen, inhabitant, having

minimum of leaf fall.

The trees should be tall in peripheral curtain plantation and with large and spreading canopy in primary

and secondary attenuation zone.

The trees should posses extensive foliar area to provide maximum impinging surface for continued

efficient adsorption and absorption of pollutants.

The trees should be fast growing and indigenous and should maintain ecological, land and hydrological

balance of the region.

It is also recommended to plant few trees, which are sensitive to air pollution, as air pollution indicator.

It is also recommended to carry out extensive plantation within premises.

Keeping in view the climatic conditions, status of soils and vegetation types in and around the project area the

species shall be selected for proposed green belt development.

5.3 SOCIAL INFRASTRUCTURE

Expansion in existing infrastructure such as drinking water facility, canteen, proper sanitation, etc. will be

carried out as per requirement for the workers working in plant.


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The Project proponent will contribute annually 2.5% of total profit towards CSR (Corporate Social

Responsibility) activity like following in nearby villages;

Education Facilities:- Facilities for village schools like game kits, drawing kits, table-chairs; school

construction (classroom/toilet/school boundary), ceiling fans or books for school library

Health Facilities:- to provide assistance to existing health facilities in Nearest Hospital, for improvement in

health facilities or services.


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CHAPTER-6 REHABILITATION AND RESETTLEMENT (R & R) PLAN

The unit is located in GIDC area, which is already acquired for industrial purpose and there is no habitat. So the

project proposal does not involve any Rehabilitation & Resettlement.


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CHAPTER-7 PROJECT SCHEDULE & COST ESTIMATES

7.1 TIME SCHEDULE FOR THE PROJECT

The implementation of the project will involve major activities like preparation of specification / drawings,

issue of tenders, receipt of quotations, scrutiny of tenders, placing of orders, civil & structural construction,

delivery & erection of equipment, test trial runs of various items of equipment and commissioning of the plant

& equipment and completion of the project will take about 6 months after the necessary clearances are

available, and the funding for the project has been tied up.

7.2 ESTIMATED PROJECT COST

The total project cost for the proposed expansion project would be around Rs. 6465 Lacs. Total capital cost of

pollution control measures will be Rs. 1500 Lacs & recurring cost per annum will be 107 Lacs.

7.3 BUDGETORY PROVISIONS FOR EMP

Adequate budgetary provisions have been made by the management for execution of environmental

management plans. The details of capital and recurring (per annum) budget earmarked for pollution control /

monitoring equipment; operation and maintenance of pollution control facilities, for greenbelt development and

maintenance.

Sr.

No. Particulars Rs. In Lacs

1. Capital Expenditure 1500

2. Recurring expenditure on environmental management cell and on

pollution control systems per annum. 107


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CHAPTER-8 ANALYSIS OF PROPOSAL

8.1 FINANCIAL AND SOCIAL BENEFITS

The total cost of the proposed expansion project is estimated at about Rs. 6465 Lacs. For the coming of this

project surrounding area will get developed due to this project and through the Corporate Social Responsibility

(CSR) activities, socio-economic status of the region will also get developed.

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