proposed bulk drug intermediates manufacturing unit

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1 PRE - FEASIBILITY REPORT For PROPOSED BULK DRUG INTERMEDIATES MANUFACTURING UNIT Of M/S. SARGAM ENTERPRISE PLOT NO. 5731, NR. SEVEN WATER TANK, GIDC, ANKLESHWAR-393002, DISTRICT, BHRUCH, GUJARAT

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1

PRE - FEASIBILITY REPORT

For

PROPOSED BULK DRUG INTERMEDIATES

MANUFACTURING UNIT

Of

M/S. SARGAM ENTERPRISE

PLOT NO. 5731, NR. SEVEN WATER TANK, GIDC, ANKLESHWAR-393002, DISTRICT, BHRUCH,

GUJARAT

2

1.0 EXECUTIVE SUMMARY

1.1 Project Details

M/s. Sargam Enterprise proposed bulk drug intermediates manufacturing unit at Plot No.5731, Near seven water tank, GIDC-Ankleshwar, Pin-393002, Tal: Ankleshwar, Dist: Bharuch, Gujarat.

1.1.1 Products along with Production Capacity

SR. NO.

NAME OF PRODUCT CAS NO. QUANTITY MT/MONTH

1. 2, 2’, 4’-Trichloro Acetophenone 4252-78-2

30

2. Tetra Butyl Ammonium Bromide (TBAB) 1643-19-2

3. Tri ethyl Benzyl Ammonium Chloride (TEBA) 56-37-1

4. 1-(2, 4-difluorophenyl)-2-(1h-1,2,4-triazol-1-yl) ethanone (DFTA)

86404-63-9

5. 1-[2-(2,4-difluorophenyl)-2,3-epoxypropyl]-1H-1,2,4-Trizole 86386-76-7

6. Bromo Benzene 108-86-1

7. Methyl-3-aminocrotonate 14205-39-1

8. 2-Choloro-1-(2,4-difluorophenyl)ethanone 51336-94-8

9. 4-Amino-1[2-(2,4-difluorophenyl)-2-oxoethyl -

10. 4-Bromo Anisol 104-92-7

11. 4-Hydroxy Anisol 150-76-5

12. N-[5-(bromo methyl)-4-(4-fluoro phenyl)-6-isopropyl pyrimidin-2-yI]-N-methyl methane sulfonamide.TPP salt

799842-07-2

13. Tert-butyl2-((4R,6S)-6-((E)-2-(4-(4-flurophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-2,2-dimethyl-1,3-dioxan-4-yl)acetate

289042-12-2

14. monomethylamine salt of rosuvastatin -

15. Mefenamic Acid 61-68-7

16. 4-Bromo Fluorobenzene 460-00-4

17. 1,4-Dibromobutane 110-52-1

18. Amoxicillin Trihydrate 61336-70-7

19. 3-(dimethylamino)-1-(3-methoxyphenyl)-2-methylpropan-1-one

197145-37-2

20. 1-(hydroxycyclohexyl)-(4-methoxyphenyl)acetonitrile 131801-69-9

21. 2-[(dimethylamino)methyl]cyclohexanone hydrochloride 42036-65-7

22. 2-Phenylpropanoic acid 492-37-5

23. 2-methylprop-2-en-1-yl-acetate 820-71-3

24. Acetic acid 2-methyl-2-phenyl-propyl ester 18755-52-7

25. Acetic acid 2-[4-(4-chloro-butyryl)-phenyl]-2- methyl-propyl ester

-

26. 4-Chloro-1-[4-(2-hydroxy-1,1-dimethyl-ethyl) -

3

-phenyl]-butan-1-one

27. 2-[4-(4-Chloro-butyryl)-phenyl]-2-methyl-propionic acid 169280-21-1

28. Methyl-2-[4-(4-chlorobutanoyl) phenyl]-2-methylpropanoate 154477-54-0

29. 2-(4-{4-[4-(Hydroxy-diphenyl-methyl)- piperidin-1-yl]-butyryl}-phenyl)-2- methyl-propionic acid methyl ester

154477-55-1

30. 2-(4-{1-Hydroxy-4-[4-(hydroxy- diphenyl-methyl)-piperidin-1-yl]- butyl}-phenyl)-2-methyl-propionic acid)

153439-40-8

31. (2-(chloromethyl)-3,4- dimethoxypyridine hydrochloride 72830-09-2

32. Panto-I (Sulphide) 102625-64-9

33. Panto-2 (Sulphoxide) (5- (difluoromethoxy)-2- {[3,4-dimethoxypyridin- 2-yl)methyl] thio}-1H2 benzimidazole

-

34. 4-((2-isopropoxyethoxy) methyl) phenol 177034-57-0

35. 2, 3,4, 5-Bis-O-(1-MethylEthylidene)-B-D-fructo pyranose 20880-92-6

36. 2-choloro-1-(2,7-dichloro-9H-fluoren-4-yl)ethan-1-one 131023-37-5

37. 2-chloro-1-(2,7-dichloro-9H-fluoren-4-yl) ethane-1-ol -

38. 2-(dibutylamino)-1-(2,7-dichloro-9H-fluoren-4-yl)ethane-1-ol 69759-61-1

39. 4-Amino-piperidine-1-carboxylic acid ethylester 58859-46-4

40. 4-(4-Chloro-2-nitro-phenylamino -piperidine-1-carboxylic acid ethyl ester

53786-44-0

41. 4-(2-Amino-4-chloro-phenylamino)-piperidine-1-carboxylic acid ethyl ester

-

42. 4-(5-Chloro-2-oxo-2,3-dihydro- enzoimidazol-1-yl)-piperidine-1- carboxylic acid ethyl ester

-

43. 5-Chloro-1-piperidin-4-yl-1,3-dihydro-benzoimidazol-2-one 53786-28-0

44. 3-chloro-1-phenyl propan-1-ol 18776-12-0

45. Hydroxyl Naphthyl Ether -

46. Dapoxetine base 119356-77-3

47. 2-methoxybenzoic acid 579-75-9

*R&D 10 KG/Month

Total 30 MT/Month

*Remark: Unit operation of R & D will remain same as per products mention in Table.

1.2 Raw Material Requirement

For raw material requirement please refer Annexure-1.

Details of Solvents

For Details of solvents please refer Annexure-13.

1.3 Water Requirement, Waste Water Generation and Treatment

For Brief detail of Water Requirement and Wastewater Generation & treatment, please

refer Annexure-4.

4

Total water requirement will be 26.2 KLD, which will be met through GIDC water supply

Authority.

Total wastewater generation will be 21.5 KL/day.

Total Ind. Waste Water = 20 KL/Day

Domestic wastewater@ 1.5 KLD will be discharged through Septic Tank/ Soak Pit System.

Total industrial wastewater@ 17.3 KLD (14.8 KLD wastewater from process after solvent

stripper and 0.3 KLD for boiler blowdown & 0.2 KLD from cooling tower & 1 KLD from wash

water & 1 KLD NaCl Scrubbing solution) will be sent to Common MEE Facility after Primary

treatment (M/s. BEIL, Ankleshwar).

Dilute NaBr Solution @ 0.5 KLD from scrubber will be sell to end users having permission

under Rule 9.

Dilute Liquor Ammonia Solution Solution @ 2.0 KLD from scrubber will be reused in the

manufacturing process.

Dilute NaCl Solution @ 1.0 KLD will be sent to Common MEE (M/s. BEIL-Ankleshwar) after

primary treatment.

1.4 Air Pollution Source and Control Management

For Air Pollution and Control Management please refer Annexure-7.

1.5 Hazardous Waste

For Hazardous Waste details please refer Annexure-6.

1.6 Green Belt

Total 1996.44 m2 land area is available at site; out of this (33%) 660 m2 will be developed

as greenbelt.

1.7 Power & Fuel Requirements

Power requirement will be 56 KVA, which will be taken from DGVCL.

1 No. of 125 KVA DG Set will be kept for emergency power back up.

Fuel: Bio Coal/Briquette: 10.6 MT/Day

or

Coal: 7.5 MT/Day

or

Natural Gas: 5632 SCM/Day

Diesel: 20 Lit/Hr.

5

2.0 INTRODUCTION OF THE PROJECT/BACKGROUND INFORMATION

2.1 Identification of the project and project proponent. In case of mining project, a copy of

mining lease/letter of intent should be given.

Identification of the project

M/s. Sargam Enterprise proposed bulk drug & bulk drug intermediates manufacturing

unit at Plot No.5731, Near Seven Water Tank, GIDC, PIN-393002, Tal: Ankleshwar, Dist:

Bharuch, Gujarat.

Identification of the project proponent

M/s. Sargam Enterprise proposed bulk drug & bulk drug intermediates manufacturing

unit at Plot No.5731, Near Seven Water Tank, GIDC, Pin-393002, Tal: Ankleshwar, Dist:

Bharuch, Gujarat.

LIST OF PARTNERS

SR. NO.

NAME DESIGNATION

CORRESPONDENCE ADDRESS WITH CONTACTS

1 Mr. Hardik G Malaviya Partner Resi. Plot No. H-4030, Nr. Sajjan india GIDC Estate, Ankleshwar-393 002, Dist: Bharuch, Gujarat.

2 Mrs. Heenaben V Malaviya Partner Resi. Plot No. H-4030, Nr. Sajjan india GIDC Estate, Ankleshwar-393 002, Dist: Bharuch, Gujarat

3 Mrs. Kajalben H Malaviya Partner Resi. Plot No. H-4030, Nr. Sajjan india GIDC Estate, Ankleshwar-393 002, Dist: Bharuch, Gujarat

2.2 Brief description of nature of the Project

• Sargam Enterprise proposed bulk drug & bulk drug intermediates manufacturing unit

at Plot No.5731, Nr. Seven Water Tank, GIDC-Ankleshwar, Pin-393002, Tal: Ankleshwar,

Dist: Bharuch, Gujarat.

2.3 Need for the project and its importance to the country and or region

6

The demand for products intended to be manufacture is increasing in the country. By

this proposed manufacturing unit, Sargam Enterprise Industries will be able to meet the

demand of various products internationally and locally. This will also generate direct and

indirect employment opportunity for various levels of people.

2.4 Demands-Supply Gap

Based on our informal survey of the market with our current customers and various

traders, we have found that there is a big potential for the range of the products we are

planning. These products will be an addition to the current range of our group's

products.

2.5 Imports vs. Indigenous production

Based on the current cost of indigenous raw materials, it will make us very competitive

against imported finished products and we will be able to increase the export of our

finished products.

2.6 Export possibility

We shall export our products.

2.7 Domestic/Export Markets

Majority of the products will be sold in local market and some products will be

exported.

2.8 Employment Generation (Direct and Indirect) due to project.

M/s. Sargam Enterprise will give direct employment to local people based on

qualification and requirement. In addition to direct employment, indirect employment

shall generate ancillary business to some extent for the local population.

3.0 PROJECT DESCRIPTION

3.1 Type of Project including interlinked and interdependent projects, if any.

7

No interlinked project has been submitted.

Location (map showing general location, specific location and project boundary & project site

layout) with coordinates.

Map showing general location

PROJECT

SITE

8

Specific location and project boundary

9

10 KM Radius

10

3.2 Details of alternate sites considered and the basis of selecting the proposed site,

particularly the environmental considerations gone into should be highlighted.

Looking to the market demand of the products in International market, it was decided by

M/s. Sargam Enterprise Industries to proposed bulk drug & bulk drug intermediates

manufacturing Over and above major raw material suppliers are available in this region

and considering proximity to other group's unit in Ankleshwar GIDC, it was finally decided

to propose the project.

Major factors involved in the selection of site are listed below:

Site situated in Notified Industrial Estate.

Site is well connected by road & Rail

Proximity to raw material suppliers

Availability of power and cleaner fuel, natural gas.

Availability of water from GIDC water supply

Availability of MEE (M/s. BEIL)

Availability of common TSDF and common incineration sites near the estate.

Availability of skilled workmen

Proximity to cities like Bharuch and Ankleshwar, ensure access to already existing social

and commercial infrastructure.

Modern infrastructure support and amenities at par in other global markets, including:

Efficient transport facilities.

Environment-friendly zone.

Uninterrupted power supply.

Size or Magnitude of Operation

Please refer Section-1.1.1

3.3 Project Description with process details (a schematic diagram/flow chart showing the

project layout, components of the project, etc. should be given)

Please refer Form-I, Annexure-3.

11

3.4 Raw Material required along with estimated quantity, likely source, marketing area of

final product/s, mode of transport of raw material and Finished product.

For raw material required along with quantity; Please refer Form-I, Annexure-I. Majority of

the products will be used for domestic market and some products will be sold in

international market.

3.5 Resource optimization/recycling and reuse envisaged in the project, if any, should be

briefly outlined.

Unit shall implement the concept of waste minimization. Good Housekeeping practice

makes the system easier and less costly. Some of these are as follows:

Cleaner production technology shall be adopted for the resource conservation and

pollution control.

Utilization of water & fuel as per standard operating procedure and avoid its excess use

can indirectly conserve our natural resources.

All electric motors shall be connected with inverter drive.

3.6 Availability of water its source, energy/power requirement and source should be given.

Water Source

Total water requirement shall meet through GIDC water supply.

Power & Fuel Requirement

Power requirement will be 56 KVA, which will be taken from DGVCL.

1 No. of 125 KVA DG Set will be kept for emergency power back up.

Fuel: Bio Coal/Briquette: 10.6 MT/Day or

Coal: 7.5 MT/Day or

Natural Gas: 5632 SCM/Day

Diesel: 20 Lit/Hr.

3.7 Quantity of wastes to be generated (liquid and solid) and scheme for their

management/disposal.

Please refer Form-I, Annexure-6.

12

3.8 Schematic representations of the feasibility drawing which give information of EIA

purpose.

RECONNAISSANCE SURVEY OF EXISTING PLANT ANNUAL REPORT MARKET ASSESSMENT FINANCIAL REPORT PROJECT REPORT

INTRODUCTION

MONITORING OF AIR, WATER & SOIL QUALITY & NOISE LEVELS. DATA ON METEOROLOGY SOCIO-ECONOMIC STATUS & BASIC AMENITIES. SITE VISITS BY AND INTERVIEWS WITH LOCALS

BASELINE ENVIRONMENTAL

STATUS

ENVIRONMENTAL INFORMATION CENTRE CENTRAL GROUND WATER BOARD GUJARAT POLLUTION CONTROL BOARD (GPCB) PUBLIC HEALTH ENGINEERING DEPT. AGRICULTURE DEPARTMENT FOREST DEPARTMENT IRRIGATION DEPARTMENT EMPLOYMENT EXCHANGE HEALTH CENTER CENSUS DEPT. INDIAN METEOROLOGICAL DEPT.

SOCIOECONOMIC STATUS &

INFRASTRUCTURE

PROPOSED PLANT

FACILITY DESCRIPTION

IMPACTS METHODOLOGY OF

IMPACT ASSESSMENT

IDENTIFICATION & ASSESSMENT OF IMPACTS EVALUATION OF IMPACTS BY MATRIX METHOD

SOURCE OF INFORMATION OVERVIEW OF E. I. A. STUDIES

ACTIVITIES

ENVIRONMENTAL MANAGEMENT PLAN

DESCRIPTION OF EFFLUENT TREATMENT PLAN, AIR POLLUTION CONTROL, HAZARDOUS WASTE MANAGEMENT, GREEN BELT DEVELOPMENT MONITORING PROGRAM

RISK ANALYSIS STUDIES & DISASTER

MANAGEMENT PLAN

SAFETY, HEALTH & ENVIRONMENTAL POLICY, GUIDELINES BY DIRECTOR GENERAL OF FACTORY SAFETY, MINISTRY OF LABOR. CONSEQUENCE ANALYSIS

PREPARATION OF DISASTER MANAGEMENT PLAN

13

4.0 SITE ANALYSIS

4.1 Connectivity

Site situated in Notified Area.

Site is well connected by road & Rail

Proximity to raw material suppliers

Availability of power and cleaner fuel.

Availability of water from GIDC water supply

Availability of effluent discharge facility in MEE (M/s. BEIL).

Availability of common TSDF and common incineration sites near the estate.

Availability of skilled workmen

Proximity to cities like Bharuch and Ankleshwar, ensure access to already existing social and commercial infrastructure.

4.2 Land Form, Land Use and Land Ownership

It shall be incorporated in the EIA Study. Detail of Land Ownership in Annexure-9.

4.3 Land use pattern (agriculture, non-agriculture, forest, water bodies (including area under CRZ)), shortest distances from the periphery of the project to periphery of the forests, national park, wild life sanctuary, eco sensitive areas, water bodies (distance from hfl of the river), CRZ. In case of the notified industrial area, a copy of the gazette notification should be given.

Shall be incorporated in EIA. 4.4 Areas under different Landuse Shall be incorporated in EIA.

4.5 Soil Classification

It shall be incorporated in the EIA Study.

4.6 Climatic data from secondary sources.

It shall be incorporated in the EIA Study.

4.7 Social infrastructure available.

Depending on the growth of the company the required social infrastructure will be

provided.

14

5.0 PLANNING BRIEF

5.1 Planning Concept (type of industries, facilities, transportation etc) Town and Country

planning/Development authority classification.

Type of Industry:

M/s. Sargam Enterprise proposed bulk drug & bulk drug intermediates manufacturing unit

at Plot No.5731, Nr. Seven Water Tank, GIDC-Ankleshwar, Pin-393002, Tal: Ankleshwar,

Dist: Bharuch, Gujarat.

5.2 Population Projection It shall be incorporated in the EIA Study.

5.3 Land use planning (breakup along with green belt etc.)

Total Plot Area: 1996.44 m2

Total 1996 m2 land area is available at site; out of this (33%) 660 m2 will be developed as

greenbelt.

Sr. No. Detail Area (m2)

1 SECURITY CABIN-1 6.60

2 SECURITY CABIN-2 6.60

3 ADMIN BUILDING 63.21

4 MECHANICAL WORKSHOP 22.53

5 RAW MATERIAL STORAGE 50.00

6 PRODUCT STORAGE AREA 50.00

7 HAZ. WASTE STORAGE AREA 41.92

8 TANK FARM AREA 66.96

9 PROCESS BUILDING 170.19

10 ETP 83.60

11 TOILET BLOCK 16.53

12 BOILER & UTILITY 39.69

13 DG SET 2.32

14 ROAD AREA 716.29

15 GREEN BELT 660

Total 1996.44

15

5.4 Assessment of Infrastructure Demand (Physical & Social)

Employment would be as per prevailing norms of state government for skilled and

unskilled people for the proposed project activity.

Social Welfare

Cordial relation with the industry shall be established and representation shall be made

to villagers for help for creation of facilities related to health, education, etc.

5.5 Amenities/Facilities

All the basic facilities like tap water, sanitation & drinking water, lunch space will be provided

within premises.

First aid box, free medicines & doctor service (on call basis) will be provided.

Adequate PPE’s will be provided to all workers.

16

6.0 PROPOSED INFRASTRUCTURE

Proposed unit is within the Ankleshwar-GIDC.

6.1 Green Belt

M/s. Sargam Enterprise shall develop an effective green belt within the factory and on

periphery of the factory. In addition to this, majority of the vacant land shall be planted

with trees.

6.2 Social Infrastructure

Depending on the growth of the company the required social infrastructure will be

provided.

6.3 Connectivity (Traffic and Transportation Road/ Rail/Metro/ Water ways etc)

Major factors involved in the selection of site are listed below:

Site situated in Notified Industrial Estate.

Site is well connected by road & Rail

Proximity to raw material suppliers

Availability of power and cleaner fuel, natural gas.

Availability of water from GIDC water supply

Availability of MEE (M/s. BEIL)

Availability of common TSDF and common incineration sites near/within the estate.

Availability of skilled workmen

Proximity to cities like Bharuch and Ankleshwar, ensure access to already existing social

and commercial infrastructure.

6.4 Drinking water Management (Source & Supply of water)

Total water requirement shall be met through GIDC water supply.

6.5 Sewerage System

Sewage pipes would be laid in entire company for the removal and disposal of mainly

non-harmful liquid wastes from the offices, canteen and domestic waste coming from

different sections of the industry. These liquid wastes would be sent to septic tank & soak

pit.

17

6.6 Solid Waste Management

Please refer Form-I, Annexure-6.

6.7 Power Requirement & Supply/Source

Please refer Section 3.8 of this report.

18

7.0 REHABILITATION AND RESETTLEMENT (R & R) PLAN

7.1 Policy to be adopted (central/state) in respect of the project affected including home

oustees, land oustees and landless laborers (a brief outline to be given)

There is no habitation on the proposed project area and it is open industrial land which is

purchased from GIDC for development of factory, so R & R policy is not applicable to this

project.

There shall not be displacement of any population in project area. Any major activity that

may lead to resettlement of the people is considered as permanent impact. Hence, there

is no permanent impact on this account. The increasing industrial activity will boost the

commercial and economical status of the locality up to some extent.

19

8. PROJECT SCHEDULE & COST ESTIMATES

8.1 Likely date of start of construction and likely date of completion (Time schedule for the

project to be given).

All project activities shall be started soon after getting Environmental Clearance.

8.2 Estimated Project cost along with analysis in terms of economic viability of the project.

TOTAL PROJECT COST

Total Project Cost for project activity is Rs. 377 Lakhs.

Details Approximate Capital Cost

(Rs. In Lakhs)

Building 075.0

Plant & Machinery 175.0

ETP, APCS & HWM 027.0

Land 100.0

Total 377.0

20

8.3 EMS Budget

Sr. No.

Item Capital Cost

in Lakhs Recurring Cost in

lakhs/Annum

1 Air Act

Air Pollution Control Equipment/Chimney 20.5 2.0

Operation & Maintenance 1.0

Total 20.5 3.0

2 Water

Act

Primary Treatment Facility 8.5 2.0

Treatment Charges of CMEE 0.5 306

Total 9 308

3 Haz

Waste Rule

Membership Fees for TSDF facility 0.5 NIL

Haz Waste Transportation NIL 2.0

Disposal Charges NIL 7.8

Membership Fees for Incineration Facility 0.5 NIL

Incineration Charges NIL 57.0

Total 1.0 66.8

4 AWH Environmental Monitoring expenses 1.5 0.10

5 OH & Safety

Environment & Safety training Fire Fighting, PPEs, Other Risk Minimise Action

2.0 1.00

6 Green

Belt Greenbelt development 0.2 1.15

Total 34.2 377.05

21

9. Analysis of Proposal (Final Recommendations)

9.1 Financial and social benefits with special emphasis on the benefit to be local people

including tribal population, if any, in the area.

Employment would be as per prevailing norms of state government for skilled and

unskilled people for the proposed project.

Social Welfare shall be done.

Cordial relation with the industry shall be established and representation shall be made to

villagers for help for creation of facilities related to health, education, etc.