the proposed expansion of api bulk drugs...

PREFEASIBILITY REPORT M/S AMOLI ORGANICS PVT. LIMITED

FOR

THE PROPOSED EXPANSION OF API

BULK DRUGS MANUFACTURING UNIT

Category: 5(f)

OF

AMOLI ORGANICS PVT. LIMITED.

Located at:

Plot No. 322/4, 40 shed Area,

GIDC Notified Industrial Area, Vapi, Ta: Pardi, Dist- Valsad

396195. (Gujarat).


EXPANSION PROJECT: I MANUFACTURING :API BULK DRUGS

CONTENTS

1 EXECUTIVE SUMMARY .............................................................................................. 1

1.1 NAME & LOCATION: ............................................................................................... 1

1.2 PROJECT PROPONENT ............................................................................................ 1

1.3 PROJECT DESCRIPTION .......................................................................................... 2

1.4 ENVIRONMENT ........................................................................................................ 5

2 INTRODUCTION OF THE PROJECT ......................................................................... 8

2.1 IDENTIFICATION OF PROJECT AND PROJECT PROPONENT ............................. 8

2.2 BRIEF DESCRIPTION OF NATURE OF THE PROJECT ........................................... 10

2.3 NEED FOR THE PROJECT AND ITS IMPORTANCE TO THE COUNTRY AND OR

REGION ............................................................................................................................. 10

2.4 DEMAND SUPPLY GAP ........................................................................................... 10

2.5 IMPORT VS INDEGINEOUS PRODUCTION ........................................................... 10

2.6 EXPORT POSSIBILITY ............................................................................................... 11

2.7 DOMESTIC/EXPORT MARKETS .............................................................................. 11

2.8 EMPLOYMENT GENERATION (DIRECT AND INDIRECT) DUE TO THE PROJECT 11

3 PROJECT DESCRIPTION............................................................................................. 12

3.1 TYPE OF PROJECT INCLUDING INTERLINKED AND INTERDEPENDENT

PROJECT, IF ANY .............................................................................................................. 12

3.2 LOCATION WITH CO-ORDINATES ........................................................................ 12

3.3 DETAILS OF ALTERNATE SITES CONSIDERED ...................................................... 12

3.4 SIZE OR MAGNITUDE OF THE OPERATIONS ....................................................... 12

3.5 PROJECT DESCRIPTION WITH PROCESS DETAILS .............................................. 12

3.6 RAW MATERIALS & FINAL PRODUCTS ................................................................ 12

3.7 RESOURCE OPTIMIZATION/RECYCLING AND REUSE ENVISAGED IN THE

PROJECT ............................................................................................................................ 18

3.8 AVAILABILITY OF WATER ITS SOURCE, ENERGY/POWER REQUIREMENT AND

SOURCE SHOULD BE GIVEN .......................................................................................... 19

3.8.1 Water ................................................................................................................. 19

3.8.2 Power ................................................................................................................. 21

3.9 QUANTITY OF WASTES TO BE GENERATED AND SCHEME FOR THEIR

MANAGEMENT/DISPOSAL ............................................................................................. 21

3.10 SCHEMATIC REPRESENTATIONS OF THE FEASIBILITY DRAWING WHICH GIVE

INFORMATION OF EIA PURPOSE .................................................................................. 21

4 SITE ANALYSIS ............................................................................................................ 22

4.1 CONNECTIVITY ........................................................................................................ 22

4.2 LAND FORM, LAND USE AND LAND OWNERSHIP............................................. 22

4.3 TOPOGRAPHY (ALONG WITH MAP) ..................................................................... 22

4.4 EXISTING LAND USE PATTERN .............................................................................. 22

4.5 EXISTING INFRASTRUCTURE .................................................................................. 22


EXPANSION PROJECT: II MANUFACTURING :API BULK DRUGS

4.6 SOIL CLASSIFICATION ............................................................................................. 22

4.7 CLIMATIC DATA FROM SECONDARY SOURCES ................................................. 22

4.8 SOCIAL INFRASTRUCTURE ..................................................................................... 23

5 PLANNING BRIEF ........................................................................................................ 25

5.1 PLANNING CONCEPT.............................................................................................. 25

5.2 POPULATION PROJECTION .................................................................................... 25

5.3 LANDUSE PLANNING .............................................................................................. 25

5.4 ASSESSMENT OF INFRASTRUCTURE DEMAND................................................... 26

5.5 AMENITIES/ FACILITIES ........................................................................................... 26

6 PROPOSED INFRASTRUCTURE ................................................................................ 27

6.1 INDUSTRIAL AREA (PROCESSING AREA). ............................................................. 27

6.2 RESIDENTIAL AREA .................................................................................................. 27

6.3 GREEN BELT .............................................................................................................. 27

6.4 SOCIAL INFRASTRUCTURE ..................................................................................... 27

6.5 CONNECTIVITY ........................................................................................................ 27

6.6 DRINKING WATER MANAGEMENT ....................................................................... 27

6.7 SEWAGE SYSTEM ..................................................................................................... 27

6.8 INDUSTRIAL WASTE MANAGEMENT .................................................................... 27

6.9 POWER REQUIREMENT & SUPPLY/ SOURCE ...................................................... 29

7 REHABLITATION & RESETTLEMENT (R & R) PLAN ........................................... 30

7.1 POLICY TO BE ADAPTED (CENTRAL /STATE) IN RESPECT OF THE PROJECT

AFFECTED PERSONS INCLUDING HOME OUTSEE, LAND OUTSEE AND LANDLESS

LABOURERS ...................................................................................................................... 30

8 PROJECT SCHEDULE AND COST ESTIMATE ......................................................... 31

8.1 LIKELY DATE OF START OF CONSTRUCTION AND LIKELY DATA OF

COMPLETION ................................................................................................................... 31

8.2 ESTIMATES PROJECT COST ALONG WITH ANALYSIS IN TERMS OF

ECONOMIC VIABILITY OF THE PROJECT ...................................................................... 31

9 ANALYSIS OF THE PROPOSAL (FINAL RECOMMENDATIONS) ....................... 33

9.1 FINANCIAL AND SOCIAL BENEFITS WITH SPECIAL EMPHASIS ON THE BEFIT

TO THE LOCAL PEOPLE INCLUDING TRIBAL POPULATION, IF ANY, IN THE AREA 33


EXPANSION PROJECT: III MANUFACTURING :API BULK DRUGS

LIST OF TABLES

Table 1-1: Details of Finished Products ............................................................................. 2

Table 1-2: Details of Finished Products ............................................................................. 2

Table 1-3: Details of Resource Requirement ..................................................................... 3

Table 1-4: Details of Raw Material Consumption after proposed Expasnion ............... 4

Table 1-5: Details of Hazardous waste and its Management ......................................... 6

Table 3-1: Details of Product Transportation .................................................................. 12

Table 3-2: Details of Raw Material Transportation ......................................................... 13

Table 3-3: Safe Storage and Handling of Hazardous Chemicals .................................. 15

Table 3-4: Details of Product Wise Solvent Consumption ............................................ 18

Table 3-5: Details of Water Consumption ....................................................................... 19

Table 3-6: Energy Requirements and Its Source ............................................................. 21

Table 3-7: Power Requirements and Its Source .............................................................. 21

Table 4-1: Rainfall projection for Project site and Gujarat for 2011 (June-Oct.) ........ 23

Table 5-1: Area Statemnet of ecisting and Proposed Expansion ................................. 25

Table 6-1: Solid/Hazardous Waste Management .......................................................... 28

Table 8-1: Capital Cost Projection .................................................................................... 31

Table 8-2: Project Viability ................................................................................................. 32

Table 8-3: Recurring/operating Cost Per Annum ........................................................... 32


EXPANSION PROJECT: IV MANUFACTURING :API BULK DRUGS

LIST OF FIGURES

Figure 3-1: Water Balance Diagram of Existing Scenario .............................................. 20

Figure 3-2: Water Balance Diagram after Proposed Expansion ................................... 20


EXPANSION PROJECT: V MANUFACTURING :API BULK DRUGS

LIST OF MAPS

Map 5-1: Site Layout Map with Green Belt Development Planning ............................ 26


EXPANSION PROJECT: VI MANUFACTURING :API BULK DRUGS

LIST OF ANNEXURES

Annexure 1: Location map showing the Project site and inter-state boundary within

5 kms radius ......................................................................................................................... 35

Annexure 2: Site Layout Plan ............................................................................................. 36

Annexure 3: Manufacturing Process with Chemical Reactions and Mass Balance .... 37

Annexure 4: Water Requirement Letter from GIDC ....................................................... 49

Annexure 5: Quantity of Waste Water (liquid waste) Generated and its Management ............................................................................................................................................... 50

Annexure 6: Membership Certificate of CETP, Vapi for Existing and Additional

Effluent Load ........................................................................................................................ 55

Annexure 7: Toposheet Map of Vapi Region .................................................................. 60

Annexure 8: Copy of Plot Allotment Letter issued by GIDC ......................................... 61

Annexure 9: Letter Regarding the Unit is Located In Notified Industrial Area ........... 62

Annexure 10: A Schematic Representation of the Feasibility Drawing ....................... 64

Annexure 11: Details of Air Pollution & Its Control Measures at Existing & After

Proposed Expansion ........................................................................................................... 65

Annexure 12: Copy of CCA of Existing Plant ................................................................... 70

Annexure 13: Copy of Environmental Clearance dated 23/10/2003 ........................... 73


EXPANSION PROJECT: 1 MANUFACTURING :API BULK DRUGS

1 EXECUTIVE SUMMARY

1.1 NAME & LOCATION:

Name of the Project : M/s Amoli Organics Pvt. Limited

Location : Plot No: 322/4, 40 Shed Area,

G.I.D.C, VAPI. Ta: Pardi, Pin Code: 396195

Dist. - Valsad (Gujarat)

Project

Amoli Organics Pvt Limited is located in GIDC notified industrial area, falling under

medium Scale category manufacturing products as mentioned under which the company

had obtained Consent To Establish and Consent to Operate from Gujarat pollution Control

Board.

The company proposes to enhance the capacity of products under the category “API Bulk

Drugs”.

Existing project cost is Rs. 3022.21 Lakh. Proposed expansion Project Cost: Rs.1005 lakh.

Total project cost after proposed expansion will be Rs. 4027.21 Lakh.

Applicability of EIA notification – 2006

Category as per the amended EIA notification-2006: as existing and proposed

expansion products (i.e. API Bulk Drugs) are covered under the Category-5(f).

Hence, Environmental clearance is required.

As per the EIA Notification the proposed expansion project is covered under

category A due to applicability of General Condition (GC), the same is applied to

MoEF for permission.

Submission for obtaining EC under provision of EIA notification 14 September

2006 as amended till date.

1.2 PROJECT PROPONENT

M/S Amoli Organics Pvt. Limited has started manufacturing plant at Vapi in year

1992 for the manufacture of Bulk Drugs & Intermediates. Amoli Group of

Companies founded by Mr. Umed Doshi.

The unit is operated by technocrats having more than 32 years of experience in

manufacturing and marketing of various API Bulk drugs worldwide. The Company

is WHO GMP, EDQM, EU-GMP standards, ISO certified & USFDA.

The Company is professionally managed with its whole time directors



1.3 PROJECT DESCRIPTION

List of Existing and Proposed Products

Table 1-1: Details of Existing and Proposed Products

S. No. Product Capacity, TPM

Existing Proposed Total after expansion

1 Diclofenac Sodium & its Salts

(Diclofenac potassium,

Diclofenac diethyl amine,

Diclofenc free acid, Diclofenac

Resinate, Diclofenac Deonal,

Diclofenac Appolomine)

20.0 245 265

2 Aceclofenac 0.5 49.5 50

3 Norethisterone Acetate 0.25 -0.25 0

4 Clotrimazole 1.0 9 10

5 Oxcarbazepine 5.0 -5.0 0

6 Carbamazepine 1.0 -1.0 0

7 Di Hydralazene Sulphate 1.0 1.5 2.5

8 Sildenafil Citrate 0.5 -0.5 0

9 Pioglitazole 0.5 -0.5 0

10 Momiflumate 1.0 -1.0 0

11 Celecoxib 0.5 -0.5 0

12 Cetrizene Dihydrocloride 0.1 -0.1 0

13 Sertaline Huydrochloride 0.5 -0.5 0

14 Noscapine Resine Complex 0.05 -0.05 0

15 Bifonazole 0.5 4.5 5

16 Nitroxaline 0.05 -0.05 0

17 Formasulphathiazole 1.0 -1.0 0

18 Mentronidazole Bebzoate 1.0 -1.0 0

19 Ascorbic Acid 10.0 -10.0 0

20 Rofecoxib 0.20 -0.2 0

21 2 Chloro Ethyl Phenyl Ether 0.1 -0.1 0

22 Venlafaxine Hydrochloride 0.5 -0.5 0

23 Fexofenadine Hydrochloride 0.5 -0.5 0

24 Catalpidogrel Hydrogensulphate 0.5 -0.5 0

25 Citaiopram Hydrobromide 0.5 -0.5 0

26 Pyridoxine Acetonide Hysro

Chloride 0 2.5 2.5

Total 46.75 288.25 335.0

List of Products after Proposed Expansion

Table 1-2: Details of Production after Expansion


1 Diclofenac Sodium & its Salts (Diclofenac potassium,

Diclofenac diethyl amine, Diclofenc free acid, Diclofenac

265.0




Resinate, Diclofenac Deonal, Diclofenac Appolomine)

2 Aceclofenac 50.0

3 Clotrimazole 10.0

4 Di Hydralazene Sulphate 2.5

5 Bifonazole 5.0

6 Pyridoxine Acetonide Hydro Chloride 2.5

Total 335

Manufacturing process is attached as Annexure 3

Resource Requirement:

Table 1-3: Details of Resource Requirement

Components Existing Proposed

Total After

Proposed

expansion

Resources availability

Power, KVA 650 950 1600

Will be sourced from

Dakshin Gujarat Vij Co.

Ltd

Fresh Water, kl/day 150 220 370 Will be sourced from

GIDC water supply dept.

Coal for Boiler : I

(3000 kgs/hr), kgs/hr 583 0 583


local dealer

Furnace oil for Boiler: II

(3000 kgs/hr), kgs/hr 29 0 29

Is sourced from local

dealer

Furnace for Thermopak

(6 lakh k cal), kgs/hr 35 0 35

Is be sourced from local

dealer

Coal for Boiler : III

(8000 kgs/hr), kgs/hr 0 972 972


local dealer

HSD for D G set : I

(500 KVA), kgs/hr 110 0 110


local dealer

HSD for D G set :II

(500 KVA), kgs/hr 110 0 110


local dealer

HSD for D G set: III

(1250 KVA), kgs/hr 0 220 220


local dealer

Cooling Tower, TR 500 700 1200 In-house

Chilling plant, TR 250 200 450 In-house



Raw material Consumption after Proposed Expansion

Table 1-4: Details of Raw Material Consumption after proposed Expasnion

S. No. Raw Materials

Quantity, MT

Per Tone Per Month

1.0 For Diclofenac Sodium & its Salts

1.1 2,6 Di Chloro Phenol 0.51 135.15

1.2 Potassium Carbonate 0.22 58.3

1.3 Toluene (Recovered) 0.85 236.25

1.4 Toluene (Fresh) 0.075 10.875

1.5 Aniline 0.29 76.85

1.6 Sodium Methoxide 0.68 180.2

1.7 Chloro Acetyl Chloride 0.36 95.4

1.8 Soda Ash 0.004 1.06

1.9 Sulphuric acid 0.004 1.06

1.10 Aluminum Chloride 0.42 111.3

1.11 Hydro Chloric acid 0.099 26.235

1.12 Caustic soda 0.12 31.8

1.13 Sodium Hydro Sulphide 0.03 7.95

1.14 Charcoal 0.056 14.84

1.15 Iso Propyl Alcohol 0.14 37.1

1.16 EDTA 0.001 0.265

Total 3.859 1022.635

2.0 For Aceclofenac

2.1 Chloro Acetyl chloride 0.72 36

2.2 Tertiary Butanol 0.48 24

2.3 N-N Di methyl aniline (Recovered) 0.70 37.15

2.4 N-N Di Methyl Aniline (fresh) 0.07 1.35

2.5 Sodium bi carbonate 0.01 0.5

2.6 Hydro Chloric acid 0.014 0.7

2.7 Diclofenac sodium 0.89 44.5

2.8 T- Butyl Chloro Acetate 0.539 26.95

2.9 T- Butyl Ammonium Bromide 0.01 0.5

2.10 Formic acid (Fresh) 0.12 6

2.11 Formic acid (recovered) 1.22 61

2.12 Acetone (Recovered) 0.938 46.9

2.13 Acetone (fresh) 0.10 5

2.14 Charcoal 0.009 0.45

2.15 Caustic flakes 0.359 17.95


2.17 Toluene (Fresh) 0.096 2.8

Total 8.105 405.25

3.0 For Clotrimazole

3.1 Ortho Chloro Phenyl Di phenyl Chloro methane 0.90 9

3.2 Toluene (recovered) 3.46 34.6

3.3 Toluene (fresh) 0.18 1.8



S. No. Raw Materials

Quantity, MT

Per Tone Per Month

3.4 Imidazole 0.27 2.7

3.5 Tri ethyl Amine 0.363 3.63


3.7 Acetone (Fresh) 0.807 8.07

3.8 Charcoal 0.03 0.3

Total 13.66 136.6

4.0 For Di Hydralazene Sulphate

4.1 Phthalodinitrile 0.44 1.1

4.2 Hydrazine hydrate 0.911 2.2775

4.3 Acetic acid 0.38 0.95

4.4 Methanol (Recovered) 1.28 3.5

4.5 Methanol (fresh) 0.18 0.146

4.6 Sulphuric acid 0.4 1

4.7 Charcoal 0.05 0.125

Total 3.641 9.0985

5.0 For Bifonazole

5.1 Bifonazole Hydro Chloride 1.11 5.55

5.2 Acetic acid 1.06 5.3



Total 8.459 42.3

5.5 For Pyridoxine Acetonide Hydro Chloride

6.0 Pyridoxine Hydro Chloride 0.836 2.09


6.2 Acetone (fresh) 0.336 0.84

6.3 Diglyme 0.16 0.4

6.4 Phosphorous oxy chloride 0.628 1.57

1.4 ENVIRONMENT

Water and Waste Water Management

Total Raw Water requirement will be 370 KL/day. Supply will be met from GIDC

water supply dept. Copy of GIDC water supply is as attached as Annexure 4.

Total industrial Waste Water Generation will be 264 KL/Day, out of which 18

kl/day of concentrated effluent will be segregated and evaporated in

Mechanical Vapour Re-compressor Evaporator (MVR) and balance 246 Kl/day

of normal effluent and 14.94 kl/day of condensate from MVR will be treated in

proposed modified effluent treatment plant consisting of primary, secondary

and tertiary effluent treatment unit and discharge into underground effluent

drainage line to CETP for further treatment and disposal into tide zone of

River Damanganga to Arabian Sea.

Domestic waste water (17 KL/day) will be passed through Septic Tank and overflow

will be taken to final outlet of ETP.



Air Emission and its Control Measures

1. Flue gas emission:

At present, the unit is having one number of 3 TPH of coal fired steam boiler, one

number of 3 TPH oil fired steam boiler and one number of 6 lakh k cal/hr capacity

of oil fired thermopak. Adequate capacity of multi cyclone separator followed by

bag filter and separate 30 meters height of chimney provided. The unit is proposes to

install additional one number of 8 TPH coal fired boiler having ESP and 30 meters

height of chimney will be provided. After proposed expansion, existing oil fired 3

TPH of steam boiler and existing 6 lakh k cal/hr of thermopack will be discontinued.

At present, the unit is having two numbers of 500 KVA of D G set (standby). It will

be used only during power failure. The unit is proposed to install one number of

1250 KVA capacity of D G set (standby). After proposed expansion, existing 500

KVA x 2 numbers of S G sets will be discontinued.

2. Process Gas Emission:

Presently the unit has installed one number of two stage graphite followed by alkali

scrubber and 11 meters height of vent to scrub and recover HCl gas generated from

the process. After proposed expansion, the unit shall install additional one number

of two stage graphite followed by alkali scrubber and 11 meters height of vent to

scrub and recover HCl gas and SO2 generated from the process. (Details of Air

pollution control measures is attached as Annexure 11)

Solid and Hazardous Wastes and its Management

Table 1-5: Details of Soild & Hazardous Waste and its Management

S. No.

Type of Solid &

Hazardous waste

(Hazardous waste

category)

Quantity, TPA

Place of

Storage Disposal

Existing

After

proposed

expansion

Hazardous Waste

1.0 Used oil (5.1) 0.24 0.3 HDPE Drum Sell to registered re-

refiner

2.0 Discarded

containers (33.1) 30.0 50.0 Pallets/drums

Sell to authorized

recycler

3.0 Process Residue &

waste (28.1) 12.0 1200.9 HDPE drums

Sell to actual &

authorized users

4.0 ETP waste, (35.3) 180 4900 HDPE bags Dispose off into

TSDF, Vapi

5.0 Spent Carbon (28.3) 48 192.0 HDPE bags

Sent for co-

processing to RSPL,

Panoli

6.0 Spent solvent (28.6) 20.0 622.764 Storage tank

Recovered in house

and recycled in the

process

7.0

Chemical Sludge

from high COD

stream (35.3)

6.6 0 HDPE drum

Sent to SEPPL,

Kutch for

incineration

8.0 Aluminum Chloride

Soln. (SCH: II, B10) 1500 6264 Storage tank

Sell to actual &

authorized users



S. No.

Type of Solid &

Hazardous waste

(Hazardous waste

category)

Quantity, TPA

Place of

Storage Disposal

Existing

After

proposed

expansion

9.0 Used Glass wool (Z-

22) 0.06 0.12 HDPE bags

Dispose off into

TSDF

10. Salt from MEE

(35.3) 0 842 HDPE bags

Dispose off into

TSDF

11.0

Inorganic Acid

(30% HCl) (Sch: II

B 15 0 2922 Storage tank

Sell to actual &

authorized users

12.0 KCl Powder process

(28.1) 0 744 HDPE bags

Sell to actual &

authorized users

13.0 NaCl from process

(28.1) 0 272 HDPE bags

Sell to actual &

authorized users

Solid Non –Hazardous Waste

14.0 Fly Ash 145 (7%) 243 (7%) Silos Send to brick making

industries



2 INTRODUCTION OF THE PROJECT

2.1 IDENTIFICATION OF PROJECT AND PROJECT PROPONENT

Project

Name of the project Proponent: Amoli Organics Pvt. Limited

M/S Amoli Organics Pvt. Limited is a medium scale unit & is located in notified

industrial estate, GIDC, Vapi Dist: Valsad, Gujarat having total plot area of 7801m2 & total

investment after proposed expansion will be Rs. 4027.21 Lakhs. The proponent wishes to

enhance the existing production capacity of API Bulk Drugs. The API bulk drugs products

are especially used to relieve pain, swelling (inflammation), and joint stiffness caused

by arthritis.

M/S Amoli Organics Pvt. Limited has started manufacturing plant at Vapi in year 1992

for the manufacture of Bulk Drugs & Intermediates. Amoli Group of Companies founded

by Mr. Umed Doshi.

The group is engaged in the manufacturing and marketing of Active Pharmaceutical

Ingredients & Intermediates. Our products are used to relieve pain, swelling (inflammation),

and joint stiffness caused by arthritis.

The unit is operated by technocrats having more than 32 years of experience in

manufacturing and marketing of various API Bulk drugs worldwide.

The company has established well equipped production plant which is being managed by

dedicated, qualified and skilled persons.

The AOPL is a Leading in manufacturing of Diclofenac Salts. The Company is WHO

GMP, EDQM, EU-GMP standards, ISO certified & USFDA.

Quality Management System ensures strict quality control and Full fledged R&D center.

Pilot plant translates laboratory results into production scale.

Undertake Contract Research and Custom Synthesis and Products with Drug Master Files.

Large clients include many multinational companies.

Dedicated and strong work force with specialized technical experts to meet customer's

specific needs.

A Government of India recognized Export House with exports to more than 88 countries.

Manufacturing plants at this site are well supported by Effluent Treatment Facilities and Air

pollution control system. The management is concerned about Environment and Safety

issues and gives utmost importance to these aspects

The Company was promoted by Mr. Manish Doshi a B Pharm Degree holder. Since

beginning the company has been exporting API bulk drugs in developed marker like USA,

Europe, Pakistan, Italy, Mexico, Korea etc.

Technical knowhow was given to the company by Mr. K L khurana . Company has trained

Plant Managers and Trained ETP operators. Company has also got FDA certification, US

FDA, EDQM, WHO, KFDA certification, to supply product to the European Market.

In view of demand from European and export markets from companies quality product need

for expansion has arisen.



The company proposes to expand the capacity of existing product with total capacity of 335

MT per month and process capabilities to manufacture such types of API Bulk Drugs.

The proposed expansion project site lies on 20021’35.42” N Latitude & 72056’06.43” E

Longitude. M/s Amoli Organics Pvt. Limited is located at Plot No: 322/4, 40 shed area,

GIDC Vapi, Dist: Valsad Gujarat. GIDC Vapi is centrally located in both sides of National

Highway No. 8 connecting Mumbai and Ahmedabad and is surrounded by Union territories

of Daman on the western side and Dadra & Nagar Haveli on the eastern side. The western

Railway Main Line passes through the area (Double & Electrified). Vapi is the biggest

railway station in the study area; where, almost all the important mail & express trains stop.

Entire study area is well connected with other major cities of the state and the country.

Beside the rail connectivity, the site is also well connected by road transport. There is a

good network of roads in the area and contributes for the development and economic

growth of the area. The National Highway No. 8 (Surat – Mumbai) is now a six laned,

double tracked, more elevated and Jam free highway, developed by L&T Company. This

highway has given a further boost to the economic growth of this area.

The other major road is state highway No. 185 (Daman – Vapi – Silvasa Road) which is

crosses the NH – 8 in Vapi town. Almost every village in the district is now well connected

to each other by a Pucca road.

About Vapi town: Vapi township has emerged as an Industrial hub on the Gujarat –

Maharashtra border. Administratively, it is a part of Valsad district. After the establishment

of GIDC estate, Vapi has gained a special status on the industrial map of the country mainly

for chemical industrial units. Over the years, it has emerged as a major cosmopolitan

industrial township equipped with hospitals. school, colleges, community centers, temples,

churches, mosques, cinema house, fire stations, blood banks, water filtration plants, police

stations, post offices, banks, telephone exchanges hotels, guesthouses etc. The town has got

a major face-lift after the completion of national highway and other links roads are of good

standard. Mumbai, the economic capital of the country is 180 km from Vapi; whereas, the

state capital “Gandhinagar” is 370 kms. The district Head Quarter – Valsad is 30 km from

Vapi town.

VAPI INDUSTRIAL ESTATE: Vapi Industrial estate came into existence during 1967-

1968. The entire estate, which was developed in phases, is now spread over 1140 hectares

and houses more than 1400 industries, most of which are small-scale industrial units

although some have grown bigger units at later stages. The industrial township is basically a

declared “Chemical Estate” where about 705 of the industrial units are either Chemical or

Chemical related, such as, Dyes and Dyes intermediates, pigments pesticides, fine

chemicals, pharmaceuticals, etc. The remaining 30% comprises of paper mills, packing,

plastics, engineering, textiles, paints, food processing, printing, etc. One of the country’s

largest common effluent treatment plants has been setup in Vapi industrial estate. Being a

major industrial & commercial centre, it caters to other peripheral industrial estates like

Daman, Silvassa, Sarigam, Umbergaon & Dadra and Nagar Haveli, etc.

M/S AMOLI ORGANICS PVT. LIMITED was incorporated in 1992 and is engaged in

the business of manufacturing and marketing API Bulk Drugs. The company has its

corporate office at 407, Dalamal house, Jamnalal bajaj road, Nariman point, Mumbai

400021 and manufacturing unit at Plot No. 322/4, 40 shed area, GIDC, Vapi , Dist: Valsad,

Gujarat.Brief description of nature of the project



Project Proponent

The Company was promoted by Mr. Manish Doshi a B.Pharm Degree holder. Since

beginning the company has been exporting Api Bulk drugs in developed countries.

Technical know how was given to the company by Mr. K L Khurana for API Bulk drugs.

Company has trained Plant Managers and Trained ETP engineers and operators.

The Company is professionally managed with its whole time directors as mentioned below.

1. Mr. Manish Doshi

2. Mrs. Vandana Doshi

3. Mr. K L Khurana

4. Mr. Rupesh Kamdar

2.2 BRIEF DESCRIPTION OF NATURE OF THE PROJECT

M/s Amoli Organics Pvt. Limited proposes the expansion of their production capacity at

Plot No. 322/4, 40 shed Area, GIDC, Vapi, Ta: Pardi, Dist: Valsad, Gujarat.

The proposed expansion project involves in the production of “API Bulk Drugs”. As per the

amended EIA notification- 2006, the proposed product is covered under category 5(f)- b

and hence require Prior Environmental Clearance. As proposed expansion project is located

in notified area and project falls under Category B. Due interstate boundary of union

territory of (D N H) within the 5 kms radius (General condition), the project falls under 5(f)

A category as per EIA notification 2006 & amended till date.

For the proposed project, the company intends to procure the latest technology for

manufacturing the products.

2.3 NEED FOR THE PROJECT AND ITS IMPORTANCE TO THE COUNTRY

AND OR REGION

The proposed project provides a potential growth opportunity for the already running

business of the company. The company is engaged in the business of manufacturing of API

Bulk Drugs. The project would increase the overall export and also increase the foreign

revenue. Product is now well established and acceptable in the international markets.

Additional capacities of product range required over and above our existing capacities, as

the company expects growth of exports to the extent of 60-70%. Local market is also

showing strong growth potential.

2.4 DEMAND SUPPLY GAP

The product has very high specific demand as API bulk drugs products are especially used

to relieve pain, swelling (inflammation) and joint stiffness caused by arthritis.

2.5 IMPORT VS INDEGINEOUS PRODUCTION

Existing product manufactured in the country will be very much economical compared to

imports of the same and also the export of the same will earn extra revenue generation for

our county

http://www.webmd.com/arthritis/about-inflammation

http://www.webmd.com/rheumatoid-arthritis/guide/joint-stiffness-and-rheumatoid-arthritis

http://www.webmd.com/arthritis/default.htm



2.6 EXPORT POSSIBILITY

Existing product has high export potential. Also this product has very good potential in the

local market.

Additional capacities of product range required over & above the unit’s existing capacities,

as the company expects strong growth of exports to the extent of 60-70%. Local market also

shows strong growth potential.

2.7 DOMESTIC/EXPORT MARKETS

The company’s product is used to relieve pain, swelling (inflammation) and joint

stiffness caused by arthritis. These are having very good demand in domestic as well as

international markets.

2.8 EMPLOYMENT GENERATION (DIRECT AND INDIRECT) DUE TO THE

PROJECT

There will be very good opportunity of employment generation directly and indirectly due

to proposed expansion project. Due to proposed project there will be requirement of

manager, supervisor, operator and semi-skilled workers. For this, the company will employ

about additional 200 people to fulfill its need to handle the plant. (Existing manpower: 100+

additional: 200=total 300).

http://www.webmd.com/arthritis/about-inflammation



http://www.webmd.com/arthritis/default.htm



3 PROJECT DESCRIPTION

3.1 TYPE OF PROJECT INCLUDING INTERLINKED AND

INTERDEPENDENT PROJECT, IF ANY

The proposed expansion project is an interdependent project of the company. There is no

interlinked project.

3.2 LOCATION WITH CO-ORDINATES

The map showing general location, specific location and project boundary and project site

lay out is enclosed as Annexure 1. Plant layout is attached as Annexure 2.

3.3 DETAILS OF ALTERNATE SITES CONSIDERED

The proposed activity will be accommodated within the existing factory premises javing

sufficient land located in the notified industrial area having proper industrial

infrastructure so; there is no alternate site consideration. (Plot allotment letter is attached

as Annexure 8)

3.4 SIZE OR MAGNITUDE OF THE OPERATIONS

As per the proposed project cost, the project is covered under medium scale category of

manufacturing industries.

3.5 PROJECT DESCRIPTION WITH PROCESS DETAILS

Detailed project description with process details is enclosed as Annexure 3.

3.6 RAW MATERIALS & FINAL PRODUCTS

Detailed raw material requirement along with estimated quantity, likely source, marketing

of final products, mode of transport of raw materials and finished products &

characteristics of hazardous chemicals are given in following tables:

Table 3-1: Details of Product Transportation

S.

No. Product

Physical

State Dispatch

Means of

Transportation

1.0

Diclofenac Sodium & its

Salts (Diclofenac

potassium, Diclofenac

diethyl amine, Diclofenc

free acid, Diclofenac

Resinate, Diclofenac

Deonal, Diclofenac

Appolomine)

Solid Local/Export Fibre Drum/

Container

2.0 Aceclofenac Solid Local/Export Fibre Drum/

Container



S.

No. Product

Physical

State Dispatch

Means of

Transportation

3.0 Clotrimazole Solid Local/Export Fibre Drum/

Container

4.0 Di Hydralazene Sulphate Solid Local/Export Fibre Drum/

Container

5.0 Bifonazole Solid Local/Export Fibre Drum/

Container

6.0 Pyridoxine Acetonide

Hydro Chloride Solid Local/Export

Fibre Drum/

Container

Table 3-2: Details of Raw Material Transportation

S.

No. Substance

Physical

State

Source of

Supply

Means of

Transportation

Distance of

supplier from

project site

(km)

1 2,6 Di Chloro

Phenol Solid Local/Import Drums 3492 km

2 Potassium

Carbonate Solid Local/Import Bags

260 km/8000

km

3 Toluene Liquid Local/Import Tanker 660 km

4 Aniline Liquid Local Tanker 170 km

5 Sodium

Methoxide Liquid Local Tanker 260 km

6 Chloro Acetyl

Chloride Liquid Local Drums 260 km

7 Sulphuric acid Liquid Local Carboys 2 km

8 Aluminum

Chloride Solid Local Drums 260 km

9 Hydro Chloric

acid Liquid Local Carboys 2 km

10 Caustic soda Solid Local Bags 260 km

11 Sodium Hydro

Sulphide Solid Local Drums 220 km

12 Charcoal Solid Local Bags 700 km

13 Iso Propyl

Alcohol Liquid Local Tanker 180 km

14 EDTA Solid Local Bags 190 km

15 Tertiary

Butanol Liquid Import Drums 3492 km

16 N-N Di methyl

aniline Liquid Local Drums 170 km

17 Sodium bi

carbonate Solid Local Bags 220 km

18 T- Butyl

Chloro Acetate Liquid Local Drums 2 km

19

T- Butyl

Ammonium

Bromide

Solid Local Drums 170 km



S.

No. Substance

Physical

State

Source of

Supply

Means of

Transportation

Distance of

supplier from

project site

(km)

20 Formic acid Liquid Local/Import Tanker 260 km

21 Acetone Liquid Local/Import Tanker 660 km

22 Caustic flakes Solid Local Bags 260 km

23

Ortho Chloro

Phenyl Di

phenyl Chloro

methane

Solid Import Drums 3492 km

24 Imidazole Solid Local/Import Drums 220/3492 km

25 Tri ethyl

Amine Liquid Local Drums 220 km

26 Phthalodinitrile Solid Import Drums 3492 km

27 Hydrazine

hydrate Liquid Import Drums 220 km

28 Acetic acid Liquid Local/Import Carboys 660 km

29 Methanol Liquid Local/Import Tanker 220 km

30 Bifonazole Solid Import Drums 3492 km

31

Pyridoxine

Hydro

Chloride

Solid Import Drums 3492 km

32 Diglyme Liquid Import Drums 220 km

33 Phosphorous

oxy chloride Liquid Local Carboys 35 km



Table 3-3: Safe Storage and Handling of Hazardous Chemicals

S. No. Raw materials

Qty. Stored at a

time ,MT

Storage BP 0C MP

0C

Standard operating

Pressure & temperature Possible Type of

Hazards

Control

Measures

Provided Max Actual

Temp. Pressure

1 2,6 Di Chloro

Phenol 150 80 Drums 218-220 64-66 80-125 Atmospheric Corrosive Use PPES

2 Potassium

Carbonate 60 30 Bags Decomposes 891 80-125 Atmospheric Corrosive Use PPES

3 Toluene 21 15 Tank 110.6 -95 95-120 Atmospheric Flammable liquid Use PPES

4 Aniline 24 18 Tank 184.1 -6.3 70-80 Atmospheric Toxic Use PPES

5 Sodium

Methoxide 23 15 Tank >300 127 70-80 Atmospheric irritant, corrosive Use PPES

6 Chloro Acetyl

Chloride 20 15 Drums 106 -22 55-125 Atmospheric irritant, Toxic Use PPES

7 Sulphuric acid 0.6 0.3 Carboys 337 10 15-20 Atmospheric Corrosive Use PPES

8 Aluminum

Chloride 25 10 Drums 180 192.4 35-180 Atmospheric irritant, corrosive Use PPES

9 Hydro Chloric

acid 2 1 Carboys 110 -26 30-40 Atmospheric irritant, corrosive Use PPES

10 Caustic soda 20 10 Bags 1388 318 30-100 Atmospheric Corrosive Use PPES

11 Sodium Hydro

Sulphide 3 1.5 Drums 160 52 100 Atmospheric Flammable Solid Use PPES

12 Charcoal 4 2 Bags 4827 3500 70-85 Atmospheric Combustible Use PPES

13 Iso Propyl

Alcohol 20 12 Tank 82.6 -89 55-60 Atmospheric Flammable Liquid Use PPES

14 EDTA 0.6 0.3 Bags 382.4 220 55-60 Atmospheric irritant, Slight

Hazardous Use PPES




Qty. Stored at a

time ,MT

Storage BP 0C MP

0C

Standard operating


Hazards

Control

Measures

Provided Max Actual

Temp. Pressure

15 Tertiary Butanol 15 10 Drums 82.2 25.7 30-50 Atmospheric Flammable Liquid Use PPES

16 N-N Di methyl

aniline 3 2 Drums 194 52 30-50 Atmospheric Corrosive ,Toxic Use PPES

17 Sodium bi

carbonate 1 0.5 Bags 851 50 30-50 Atmospheric Combustible Use PPES

18 T- Butyl Chloro

Acetate 3 1.5 Drums 157 NA 70-85 Atmospheric Irritant ,Corrosive Use PPES

19

T- Butyl

Ammonium

Bromide 1 0.5 Drums 101 103 70-85 Atmospheric Irritant Use PPES

20 Formic acid 15 10 Tank 100.8 8.4 50-60 Atmospheric Corrosive Use PPES

21 Acetone 10 5 Tank 56 -95 50-60 Atmospheric Flammable Liquid Use PPES

22 Caustic flakes 20 10 Bags 145 323 30-100 Atmospheric Corrosive Use PPES

23

Ortho Chloro

Phenyl Di

phenyl Chloro

methane

7 5 Drums -- 135 30-60 Atmospheric Oxidizing Agent Use PPES

24 Imidazole 2 1 Drums 256 91 30-60 Atmospheric Toxic Use PPES

25 Tri ethyl Amine 1 0.8 Drums 89.5 -114.70 30-60 Atmospheric Flammable

liquid/Corrosive Use PPES

26 Phthalodinitrile 0.5 0.3 Drums 304 140 80-70 Atmospheric Toxic Use PPES

27 Hydrazine

hydrate 0.8 0.4 Drums 120 -52 70-80 Atmospheric Corrosive Use PPES

28 Acetic acid 0.6 0.4 Drums 118.1 16.6 40-50 Atmospheric Corrosive Use PPES




Qty. Stored at a

time ,MT

Storage BP 0C MP

0C

Standard operating


Hazards

Control

Measures

Provided Max Actual

Temp. Pressure

29 Methanol 12 10 Tank 64.7 -97.6 60-65 Atmospheric Flammable liquid Use PPES

30 Bifonazole 0.5 0.3 Drums 405 142 30-50 Atmospheric Toxic Use PPES

31 Pyridoxine

Hydro Chloride 0.6 0.3 Drums 491.90 214 25-30 Atmospheric Toxic Use PPES

32 Diglyme 0.2 0.1 Drums 162 -64 25-30 Atmospheric Flammable

liquid,Toxic Use PPES

33 Phosphorous

oxy chloride 0.5 0.2 Carboys 105.8 1.25 25-30 Atmospheric

Corrosive

liquid/Toxic Use PPES



3.7 RESOURCE OPTIMIZATION/RECYCLING AND REUSE ENVISAGED

IN THE PROJECT

Resource optimization/recycling and reuse envisaged in the project are mentioned below;

Efficient cooling towers are being planned to reduce evaporation losses.

Adequate solvent recovery system shall be provided to recover more than 96%

and reuse the solvent and minimize the solvent loss.

Recovery of aluminum chloride solution, potassium chloride powder as a valuable

by-product.Availability of water resources, Energy/Power requirement and

source.

Product wise Solvent consumption (fresh and recovered) per tone and per month of

product after proposed expansion

Table 3-4: Details of Product Wise Solvent Consumption


Consumption in MT

Per tone Per Month

1.0 For Diclofenac Sodium & its Salts


1.4 Toluene (Fresh) 0.075 10.875

2.0 For Aceclofenac

2.3 N-N Di methyl aniline (Recovered) 0.70 37.15

2.4 N-N Di Methyl Aniline (fresh) 0.07 1.35

2.10 Formic acid (Fresh) 0.12 6

2.11 Formic acid (recovered) 1.22 61


2.13 Acetone (fresh) 0.10 5


2.17 Toluene (Fresh) 0.096 2.8

3.0 For Clotrimazole

3.2 Toluene (recovered) 3.46 34.6

3.3 Toluene (fresh) 0.18 1.8



4.0 For Di Hydralazene Sulphate

4.4 Methanol (Recovered) 1.28 3.5

4.5 Methanol (fresh) 0.18 0.146

5.0 For Bifonazole



6.0 For Pyridoxine Acetonide Hydro Chloride


6.3 Acetone (fresh) 0.336 0.84



3.8 AVAILABILITY OF WATER ITS SOURCE, ENERGY/POWER

REQUIREMENT AND SOURCE SHOULD BE GIVEN

Availability of water its source, Energy/power required and its source is described below:

3.8.1 Water

Water withdrawal Permission is attached as Annexure 4.

Table 3-5: Details of Water Consumption

S. No. Particulars Existing

(KLD)

Proposed

(KLD)

After Proposed

expansion

(KLD)

1 Domestic 15.0 5.0 20.0

2 Processing & washing 55.0 88.0 143.0

3 Boiler 20.0 40.0 60.0

4 Cooling 20.0 55.0 75.0

5 Scrubber 5.0 2.0 7.0

6 Floor/container/equipment

washing 25.0 25.0 50.0

7 Gardening 10.0 5.0 15.0

Total 150.0 220.0 370.0

Total Industrial 125.0 210.0 335.0



Figure 3-1: Water Balance Diagram of Existing Scenario

Figure 3-2: Water Balance Diagram after Proposed Expansion

Water Balance at Existing Scenario

Total Fresh water Consumption, 150 m3/day sourced from Water supply Department GIDC Vapi

Domestic: 15 Processing &

Washing: 55

Cooling: 20 Boiler: 20 Scrubber: 5 Floor/equip.Washing: 25 Gardening: 10

Septic tank: 12

Final Outlet ofETP

Concentrated: 5 Normal: 47

Salt: 0.75 Loss: 0.1 Condensate: 4.15

10 18 3 25

107.15 M3/day

Primary, secondary, tertiary ETP

CETP

Tidal Zone of river Damanganga to Arabian Sea

Water Balance After proposed expansion

Total Fresh water Consumption, 370 m3/day sourced from Water supply Department GIDC Vapi

Domestic: 20 Processing &

Washing: 143

Cooling: 75 Boiler: 60 Scrubber: 7 Floor/equip.Washing: 50 Gardening: 15

Septic tank: 17

Final Outlet ofETP

Concentrated: 18 Normal: 151

Salt: 2.7 Loss: 0.36 Condensate: 14.94

15 25 5 50

260.94 M3/day

Primary, secondary, tertiary ETP

CETP

Tidal Zone of river Damanganga to Arabian Sea



3.8.2 Power

Table 3-6: Energy Requirements and Its Source

S.

No. Particulars Existing

After Proposed

expansion

Source

1.0 Steam

requirement

5500

kg/Hr 10500 Kg/Hr.

Will be obtained from existing as well

as new steam boiler

Table 3-7: Power Requirements and Its Source

S.

No. Particulars Existing

After

proposed

expansion

Source

1.0 Power – Electricity requirement 650 KVA 1600 KVA

Will be

sourced from

Dakshin

Gujarat Vij

Co. Ltd

3.9 QUANTITY OF WASTES TO BE GENERATED AND SCHEME FOR

THEIR MANAGEMENT/DISPOSAL

Quantity of waste to be generated (liquid and solid) and scheme for their Management/

disposal is enclosed as Annexure 5.

3.10 SCHEMATIC REPRESENTATIONS OF THE FEASIBILITY DRAWING

WHICH GIVE INFORMATION OF EIA PURPOSE

Schematic representation of the feasibility drawing which give information of EIA

purpose: A Schematic representation of the feasibility drawing is enclosed as Annexure

10



4 SITE ANALYSIS

4.1 CONNECTIVITY

The project is located in notified Industrial Estate of Vapi which is very well connected to

National Highway 8 and Western Railways. The nearest airport is Mumbai which is 150 km

away from the project site by road.

4.2 LAND FORM, LAND USE AND LAND OWNERSHIP

The land is in the form of industrial shed owned by Gujarat Industrial Development

Corporation.

4.3 TOPOGRAPHY (ALONG WITH MAP)

Topography map showing the elevation of the study area is enclosed as Annexure 7

4.4 EXISTING LAND USE PATTERN

The existing land is located in the notified industrial area developed for chemical industrial

zone and a copy of gazette notification is enclosed as Annexure 9.

4.5 EXISTING INFRASTRUCTURE

GIDC notified industrial area of Vapi has available infrastructure like water, electricity,

roads, rail, transportation, availability of raw material and drainage system.

4.6 SOIL CLASSIFICATION

General soil classification of the area is as under:

Soil Characteristics & Land use classification: The study area is located at outer

part of Dadra. Northern part of the site is fully developed for settlement with

cropping pattern. Eastern part of the site location has Loamy, clay, Red soil.

The project site around 10 km radius has mixed soil type of Basalt soil and Clay

soil. This type of soil is not suitable for cultivation purpose.

The land is suitable for industrial development as it is notified by GIDC.

Damanganga River is located at 4 km distance from the site location; both side of the river

has mixed soil type (Sand, clay and Basaltic soil).

4.7 CLIMATIC DATA FROM SECONDARY SOURCES

Rainfall Data:

The project site location receives annual rainfall of 1200 to 1300 mm in 35 rainy days

having coefficient of variation of 65 %. There is large spatial and temporal variation in

rainfall of the study area. The low rainfall areas receiving less than 500 mm rainfall are

comprised of Kutch district and western parts of Banaskantha and Patan districts and parts

of Jamnagar, Rajkot and Surendranagar districts. These are also characterized by arid

climate. The high rainfall (> 1400 mm) receiving areas (Project site, Dang, Valsad, Navsari



and Surat, Dadra & Nagar Haveli and Daman & Diu) are characterized as sub humid

climate. The remaining part of the state receives rainfall between 500-1000 mm and

generally falls under semi-arid climate. Considering the abnormality of weather particularly

rainfall during the monsoon period, the observed and predicted rainfall was then analyzed

for its validity.

Table 4-1: Rainfall projection for Project site and Gujarat for 2011 (June-Oct.)

S.

No Region

Rainfall Projection

(in mm) June – Oct

Normal Rainfall

(In mm)

Rainfall Projection

(% Departure from

normal)

1.0 Middle Gujarat 905.3 796 13.7

2.0 South Gujarat 696.3 575 21.0

3.0 Project site 2071.7 1433.7 44.5

4.0 Saurashtra 767.1 580.4 32.2

5.0 Gujarat State 1110.1 846.5 31.1

Source: AAU, Anand, Gujarat

Temperature Data:

The site is located in the southern part of Gujarat. The secondary data was collected from

free data of Worldclim.org for the year 2010. The project site temperature regime for

medium to high level temperature (30-32 °C) during the seasonal months (June to Sep).

4.8 SOCIAL INFRASTRUCTURE

Social Infrastructure in Valsad district is as under:

Education: There are 990 primary, 161 secondary and higher secondary schools.

There are 6 ITIs offering several industrial training Institutes programs which includes,

fitting, armature and motor rewinding, electrician, information technology and electronic

system maintenance etc., 166 Higher Secondary School, One Government polytechnic

College is present in the district offering courses in civil, chemical, electrical, mechanical

and plastic engineering, 6 nos. of ITI’s with an intake capacity of 360, 1 nos of Polytechnic

College With 120 seats, there is one Engineering College, Pharmacy College, Arts,

Commerce, Science, B. Ed and Law College. Valsad district also has instituteswhich offers

management studies with fulltime MBA.

Source: Department of Education, 2007

Health: There are 43 primary healthcare centres, 10 community healthcare centres, 10

Government and 1 Municipal hospital present in the district. Valsad has several private

specialized hospitals to provide a comprehensive range of tertiary and secondary care

services backed by state-of-the-art technology and trained medicos. A multi-specialty

Hospital, (branch of Nadkarni Group of Hospitals) is present in Vapi, providing services in

general and laparoscopic surgery, trauma, orthopedic and urology etc. The hospital is one of

the few centers in India offering Uterine Thermochoice Thermal Balloon Therapy for

Dysfunctioning Uterine Bleeding (DUB) patients. Beside this, several private hospitals such

as, Kasturba Hospital, Bhatia General Hospital and Adarsh Hospital are also present in

Valsad.

Tourism: The Tourism department built the Fire Temple at Udawada in 1742, which is also

known Fire Temple for the Parsi community in India, makes the city a famous pilgrimage

center throughout the world. Dharampur is surrounded on three sides by the Sahyadri

Mountains which grace the town with pleasant climate throughout the year. The collection

at the Lady Wilson Museum in Dharampur includes tribal art and art crafts that highlights



the local culture. Besides this, District Science Centre is also present in Valsad Proximity of

Valsad with Daman & Diu, which has increased the graph of tourist flow in the district.



5 PLANNING BRIEF

5.1 PLANNING CONCEPT

There is a cluster of numerous large-scale, medium-scale and small-scale industries,

engaged in the manufacture of variety of products like pharmaceuticals, dyes and

chemicals, paper mills, paints, plastics, packaging, textiles, specialilty chemicals, pesticides

and others in the Gujarat Industrial Development Corporation (GIDC) notified area of Vapi.

5.2 POPULATION PROJECTION

Not applicable

5.3 LANDUSE PLANNING

The existing as well as proposed expansion project is located within the Notified Industrial

Area by Government of Gujarat and due to the proposed project there will not be any

change in the land use pattern of the region. Proposed Green belt planning in the project

area is as below.

For Green Belt Development as per the revised layout plan, the company proposes 30%

green belt of the total land, i.e. 7801 sq. meter. The company shall develop green belt along

the periphery of the site and in common premises available outside the company premises.

While selecting the plants species to be grown in the green belt zone, following points will

be taken into account:

1. Climatic condition and soil characteristics of the region.

2. The air pollution emitted by the industry – gaseous and particulate matter. Plant

interaction with both gaseous and particulate pollutants and to a great extent absorbs

them and thus, removes them from the atmosphere.

3. Characteristics of plants including shapes of crowns considered necessary for

effective absorption of pollutant gases and removal of dust particles.

4. Height of the plants should not be too high to be lethal.

5. For absorbance of gases, the duration of the foliage should be longer.

6. Vegetation controls soil erosion rates significantly. The decrease of water erosion

rates with increasing vegetation cover is exponential. This review reveals that the

decrease in water erosion rates with increasing root mass is also exponential. Plant

species having good root system are selected, so that soil erosion can be checked.

Table 5-1: Area Statement of Existing and Proposed Expansion

S. No Particulars

Area in m2

Existing Proposed Total

1.0 Total Plot Area 7801 0 7801

1.1 Production Plant 1083.1 0 1083.1

1.2 Green Belt 1200 1200 2400

1.3 Solid Raw Materials Storage 500 200 700

1.4 OHC/EHS/security 21.13 0 21.13



S. No Particulars

Area in m2


1.5 Solvent storage 200 200 400

1.6 Finished product storage area 500 0 500

1.7 ETP 250 250 500

1.8 Utility 278.07 0 278.07

1.9 Roads 100 0 100

1.10 Solid Waste Storage 170.08 0 170.08

1.11 Admin Building/ R&D/Toilets 242.75 0 242.75

1.12 Open Space 3255.87 -1850 1405.87

Map 5-1: Site Layout Map with Green Belt Development Planning

5.4 ASSESSMENT OF INFRASTRUCTURE DEMAND

There is no need for any infrastructure demand in terms of physical or social needs for the

proposed expansion Amenities/Facilities.

5.5 AMENITIES/ FACILITIES

GIDC notified industrial area of Vapi has the available infrastructure like water, electricity,

roads, rail, transportation, availability of raw material and drainage system.



6 PROPOSED INFRASTRUCTURE

6.1 INDUSTRIAL AREA (PROCESSING AREA).

The proposed infrastructure to manufacture products will be built with standard engineering

design considering all the relevant parameters related to environment, health and safety.

6.2 RESIDENTIAL AREA

No residential area is involved in the proposed expansion project.

6.3 GREEN BELT

Green belt will be provided and maintained at the tune of 30% of the total land area.

6.4 SOCIAL INFRASTRUCTURE

Not applicable

6.5 CONNECTIVITY

The project site is very well connected by road through National Highway no. 8, western

railways.

6.6 DRINKING WATER MANAGEMENT

Drinking water is purchased from local suppliers.

6.7 SEWAGE SYSTEM

Source of water is from GIDC water supply services.

6.8 INDUSTRIAL WASTE MANAGEMENT

Industrial liquid effluent generated during the manufacturing of proposed expansion

product will be treated in the primary and secondary effluent treatment plant and

discharge into under ground effluent drainage line to CETP for further treatment and

disposal into tidal zone of River Damanganga.(Membership certificate is attached

as Annexure 6)

Generated domestic liquid waste is being disposed off through septic tank /soak pit.

Details of Solid/ Hazardous Waste management is given in following table:



Table 6-1: Solid & Hazardous Waste Management

S. No.

Type of Solid &

Hazardous waste

(Hazardous waste

category)

Quantity, TPA

Place of

Storage Disposal

Existing

After

proposed

expansion

Hazardous Waste

1.0 Used oil (5.1) 0.24 0.3 HDPE Drum Sell to registered re-

refiner

2.0 Discarded

containers (33.1) 30.0 50.0 Pallets/drums

Sell to authorized

recycler

3.0 Process Residue &

waste (28.1) 12.0 1200.9 HDPE drums

Sell to actual &

authorized users

4.0 ETP waste, (35.3) 180 4900 HDPE bags Dispose off into

TSDF, Vapi

5.0 Spent Carbon (28.3) 48 192.0 HDPE bags

Sent for co-

processing to RSPL,

Panoli

6.0 Spent solvent (28.6) 20.0 622.764 Storage tank

Recovered in house

and recycled in the

process

7.0

Chemical Sludge

from high COD

stream (35.3) 6.6 0 HDPE drum

Sent to SEPPL,

Kutch for

incineration

8.0 Aluminum Chloride

Soln. (SCH: II, B10) 1500 6264 Storage tank

Sell to actual &

authorized users

9.0 Used Glass wool (Z-

22) 0.06 0.12 HDPE bags

Dispose off into

TSDF

10. Salt from MEE

(35.3) 0 842 HDPE bags

Dispose off into

TSDF

11.0

Inorganic Acid

(30% HCl) (Sch: II

B 15

0 2922 Storage tank Sell to actual &

authorized users

12.0 KCl Powder process

(28.1) 0 744 HDPE bags

Sell to actual &

authorized users

13.0 NaCl from process

(28.1) 0 272 HDPE bags

Sell to actual &

authorized users

Solid Non –Hazardous Waste

14.0 Fly Ash 145 (7%) 243 (7%) Silos Send to brick making

industries

(Membership certificates is attached as Annexure 6)



6.9 POWER REQUIREMENT & SUPPLY/ SOURCE

Power requirement for proposed project will be taken from DGVCL.



7 REHABLITATION & RESETTLEMENT (R & R)

PLAN

7.1 POLICY TO BE ADAPTED (CENTRAL /STATE) IN RESPECT OF THE

PROJECT AFFECTED PERSONS INCLUDING HOME OUTSEE, LAND

OUTSEE AND LANDLESS LABOURERS

There will be no rehabilitation and resettlement undertaken as labours and workers from

local & nearby areas for the proposed construction activity which will be minor as the

proposed expansion activity is to be undertaken at the existing site.



8 PROJECT SCHEDULE AND COST ESTIMATE

8.1 LIKELY DATE OF START OF CONSTRUCTION AND LIKELY DATA OF

COMPLETION

After obtaining Environmental clearance and Consent to Establish from GPCB, the

company shall start the proposed construction and commissioning of the project and

complete the project within one year.

8.2 ESTIMATES PROJECT COST ALONG WITH ANALYSIS IN TERMS OF

ECONOMIC VIABILITY OF THE PROJECT

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

is given in following table:

Table 8-1: Capital Cost Projection

S. No. Particluars Cost in Rs.(Lakh)


1.0 Land 117.25 0 117.25

2.0 Building 237.24 300.0 537.24

3.0 Plant & Machinery

3.1 Equipment & Machineries 1950.35 200.0 2150.35

3.2 Pipes & fittings 75.0 25.0 100.0

3.3 Utilities 125.0 35.0 160.0

3.4 Laboratory equipment 136.88 25.0 161.88

4.0 Environmental Management System

4.1 Effluent Treatment Plant 300.49 250.0 550.49

4.2 Air Pollution Control 55.0 20.0 75.0

4.3 Hazardous waste 25.0 150.0 175.0

5.0 Total Project Cost 3022.21 1005.0 4027.21

6.0 Utilities

6.1 Steam Boiler, TPH 3.0 +3.0 3.0 +8.0 11.0

6.2 Thermopak, lakh k cal 6.0 -6.0 0

6.3 Cooling Tower, TR 500 700 1200

6.4 Chilling plant, TR 250 200 450

6.5 D.G. Set (Standby), KVA 500 x 2 1250 1250

7.0 Power from DGVCL, KVA 650 950 1600

8.0 Fuel for utilities

8.1 Coal for boiler, kgs/hr 583 972 1555

8.2 Furnace oil for boiler & thermopak, kgs/hr 64 -64 -

8.3 HSD for D G set, Kgs/hr 220 0 220

9.0 Water from GIDC, Vapi, M3/day 150.0 220.0 370.0

10.0 Waste water generation,M3/day 108.0 156.0 264.0



Table 8-2: Project Viability

S.No. Particluars Amount (INR Cr.)/Annum

1.0 Proposed Sale 168.0

2.0 Raw Material Cost 60.60

3.0 Power & Fuel 15.0

4.0 Labour Cost 9.33

5.0 Environmental Management System 9.17

6.0 Maintenance Cost 10.29

7.0 Selling, Packing & Office Expenses 11.0

8.0 Proposed Profit 52.61

The company will provide budgetary provision for the recurring expenses for environmental

issues while planning the allocation of funds during the annual budgetary planning.

Table 8-3: Recurring/operating Cost Per Annum

S. No. Component Proposed

(Rs. in Lakh/annum)

1.0 Environment & Safety Management System 217.0

2.0 Greenbelt Maintenance 4.0

3.0 Solid/hazardous waste Disposal 155.0

Total 376.0



9 ANALYSIS OF THE PROPOSAL (FINAL

RECOMMENDATIONS)

9.1 FINANCIAL AND SOCIAL BENEFITS WITH SPECIAL EMPHASIS ON

THE BEFIT TO THE LOCAL PEOPLE INCLUDING TRIBAL

POPULATION, IF ANY, IN THE AREA

Proposed expansion activity will provide benefits to the local people in terms of financial

and social welfare.

Local people will get direct financial benefit by way of employment.

Local people will get some contracts of supply and services to get indirect income.

Company will contribute in improving education and health facilities in nearby area



ANNEXURE

S



Annexure 1: Location map showing the Project site and inter-state boundary within 5

kms radius



Annexure 2: Site Layout Plan

Google Image



Annexure 3: Manufacturing Process with Chemical Reactions and Mass Balance

1. Diclofenac Sodium

2, 6 - Dichlorophenol is reacted with MMCA, Aniline & Chloro Acetyl Chloride and

AlCl3 to yield (2, 6 - Dichlorophenol) Indolinone is hydrolyzed using isopropyl alcohol

and sodium hydroxide to give crude Diclofenac Sodium. This on purification using

deminerlised water and isopropyl alcohol gives the pure Diclofenac Sodium.

Cl Cl

OH

DCP

163

+ Cl CH2COOCH3

MMCA

108.5

K2CO3

138

Cl Cl

CH2 COOCH3

235

Cl Cl

OCH2 COOCH3

235 SMO

54

NH2

+ CH3ONa

Aniline

93

+ NH Cl

Cl

238

2:6 Di Chloro Di phenyl Amine

32

Methanol

112

NH

Cl Cl

+ ClCH2COCl

CAC

113

N

Cl Cl

-CH2COCl + HCl

314

N Chloro Acetyl 2:6 Di chloro di phenyl amine

+ CH3OH + CH3COOCH2ONa

238

2:6 Di Chloro Di phenyl Amine

36.5

+ KCl + KHCO3

74.5 100



N

Cl Cl

-CH2COCl + AlCl3

133.4

N

Cl Cl

+ AlCl3 + HCl

133.4 36.5

278

Indolinone

N

Cl Cl

+ NaOH

40

NH

Cl Cl

318

Diclofenac Sodium

CH2COONa

278

Indolinone

314

N Chloro Acetyl 2:6 Di chloro di phenyl amine



(1.0) Mass Balance of Dichlofenac Sodium

REACTOR

2,6 DCDPA: 4380.35 kgsToluene (F): 132.2 kgsToluene (R): 2189.8 kgsChloro Acetyl Chloride: 2080 kgsSoda ash: 29.25 kgsSulphuric acid: 29.25 kgsWater: 3600 kgs

FILTERATION & WASHINGWater: 7500 kgs Wash Water: 7500 kgs

PADDLE VACCUM DRYER

N Chloro Acetyl (2,6 Di Chloro Di Phenyl Amine): 5787.87 kgs

GLASS LINED REACTORAluminum Chloride: 2454.5 kgs HCl gas: 671.59 kgs Scrubber HCl (30%): 2238 kgs

Water: 1564 kgs

REACTORWater: 8776.6 kgsHCl: 292.50 kgs

Aluminum Chloride Solution (10-12%): 11523.6 kgs

CENTRIFUGEWater: 5851.12 kgsHCl: 292.50 kgs

Waste Water: 6143.62 kgs

Indolinone: 5115.10 kgs

SS REACTORCaustic: 736kgsSodium Hydro Sulphide: 175.53 kgsWater: 8776.66 kgs

CENTRIFUGEWater: 2925.55 kgs Waste Water: 11877.74 kgs

DICHLOFENAC SODIUM CRUDE:

SS REACTORCharcoal: 331 kgsWater: 24496.5 kgsIPA: 331 kgsEDTA: 9.93 kgs

SPARKLEER Waste Charcoal: 331 kgs

CENTRIFUGEWater: 24496.5 kgsIPA: 496.55 kgs

Waste Water: 49830.48 kgs

VACUM DRYER

DICLOFENAC SODIUM SALT: 5851.10 KGS

REACTOR(9362.86 KGS)

2,6 DCP: 3000 kgsK2CO3: 1269.93 kgsToluene (F): 309.6 kgsToluene (R): 2786.4 kgs

REACTOR

Waste Water: 165.64 kgsCarbon dioxide: 404.90 kgs

DistillationToluene Recovered: 2786.4 kgsDistillation residue: 77.4 kgsLoss: 232.2 kgs

Water: 4200 kgsKCl Solution: 5571.16 kgs (24.61%) Distillation KCl Powder (by-product): 1371 kgs

Waste water: 4200 kgs

REACTORAniline: 1711.65 kgsSodium methoxide: 3975.44 kgs (25%) Distillation

Methanol Recovered: 3213 kgsDistillation residue: 89.23 kgsLoss: 267.75 kgs

REACTORWater: 1600 kgsMethanol Recovered: 588.95 kgsSodium Glycolate: 1803.67 kgsWaste water: 1268.72 kgs2,6 Di Chloro Di ethyl Amine: 4380.35 kgs

HCl Gas: 671.61 kgs Scrubber 30% HCl: 2238 kgs

Water: 1564 kgs

Distillation Toluene recovered: 2189.8 kgsDistillation residue: 58.05 kgs kgsLoss: 133.17 kgsWaste Water: 3600 kgs



2. Aceclofenac

Stage-1: T Butanol and Chloro Acetyl Chloride react in presence of NN Dimethyl

Aniline at low temperature. After reaction organics mass wash with water and

sodium bicarbonate solution to get stage-1

Stage-2: Stage-I react with Diclofenac Sodium in presence of TBAB in Toluene

media, further react with formic acid and reaction mass quenching in water and

product is isolated by filtration. Finally Crude Aceclofenac purified in ethyl acetate

and charcoal. Pure product isolated by filtration.

CH2COONa

NH

Cl Cl

CH2COOCH2COOC (CH3)3

NH

Cl Cl

410

CH3

CH3

+ CH3 COOCH2Cl C

+ NaCl

58.5

150.5

t-Butyl Chloro Acetate

318

CH2COOCH2COOC (CH3)3

NH

Cl Cl

410

+ HCOOH

46

Formic Acid

CH2COOCH2COOH

NH

Cl Cl

354

+ HCOOC(CH3)3

Salt

102

Aceclofenac



3. Clotrimazole

Clt CL (Ortho Chloro Tritryl Chloride) and Imidazole is heated in Toluene in presence of

Triethyl Amine, wash organics layer by water finally distill out Toluene to get Crude Clt

CL.

Crude Clt CL purified in Acetone and Activated charcoal and pure product is isolated by

filtration.

Mass Balance of AceclofenacChloro Acetyl Chloride : 1000 KgsT- butanol : 670 KgsNN Dimethyl Aniline (R) : 981.0 KgsNN Di methyl aniline (F): 109 kgsSodium Bicarbonate : 15 KgsWater : 3000 KgsHCl : 20 Kgs

Sodium chloride : 229.95 KgsWaste Water : 1875 Kgs

ANF

Water: 1000 kgsCaustic Flakes : 500 Kgs

GLASS LINED REACTOR

NN Dimethyl Aniline DistillationRecovery : 981.003 Kgs

Residue : 26.78 KgsLoss : 80.32 KgsWater : 4552.031 KgsT-butyl Chloro Acetone : 1331.85 Kgs

GLASS LINED REACTOR

GLASS LINED REACTOR

GLASS LINED REACTOR

Diclofenac Sodium : 1250 KgsT-butyl Chloro Acetate : 750 KgsTBAB : 15 KgsWater : 1875 Kgs

GLASS LINED REACTOR

Water : 3750 KgsToluene (R) : 2553.12 KgsToluene (F): 134.38 kgs

Formic Acid (F) : 180.81 KgsFormic acid (R): 1699.19 kgs

Waste Water : 3750 KgsSalt : 400.95 Kgs

Formic ML Toluene ML Distillation

Toluene Recovered : 2553.12 KgsResidue : 80.01 KgsLoss : 77.025 KgsDRYER

HCl gas : 323.016 Kgs Scrubber HCl (30%): 1076 kgs

Water: 753 kgs

Distillation Formic Recovered : 1699.19 KgsResidue : 50 KgsLoss : 100.75 Kgs

SS REACTOR

ANF

Acetone (R): 1306.82 KgsAcetone (F): 145.2 kgsCharcoal : 13 KgsWater: 960 kgs

Charcoal Sludge : 13 Kgs

DRYER

Aceclofenac : 1391.50 Kgs

Acetone Recovered: 1306.82 kgsResidue: 59.96 kgsLoss: 85.24 kgsWaste water: 960 kgs

Cl H

313

N

+ C

Cl

N

344.5

C N N

+ HCl

68 36.5

Ortho Chloro trityl chloride Imidazole Clotrimazole



4. Bifonazole :

Stage-I: Bifinyl and Benzoyl Chloride react in presence of AlCl3 in EDC at low

temperature. Reaction mass quenching in water and HCl. Materials isolated by

filtration.

Stage -II: Stage -I react with sodium borohydrate in presence of NaOH in IPA.

Reaction mass acidify with HCl. Distilled out IPA and add water in reaction mass.

Product isolated by filtration.

Stage-III: Stage-II reacts with Imidazole in presence of Thionyl Chloride in Toluene.

Organic layer wash with water distilled out Toluene to get Crude Bifonazole.

Crude materials purified in Acetone and Charcoal. Pure materials isolated by filtration.

GLASS LINED REACTOR

SS REACTOR

Mass Balance of Clotrimazole

CENTRIFUGE

Ortho -Chloro Phenyl DiphenylCloromethane : 300 Kgs Toluene (R) : 1143.80 KgsToluene (F): 60.2 kgsImidazole : 90 KgsTEA : 120 KgsWater : 600 KgsAcetone (R) : 1244.25 KgsAcetone(F): 138.25 kgs

Charcoal : 10 KgsAcetone (R) : 1283.75 KgsAcetone (F): 128.37 kgs

Toluene Recovered : 1143.80 KgsAcetone Recovered : 1244.25 KgsLoss : 198.45 Kgs

SPARKLER FILTER

GLASS LINED REACTOR

CENTRIFUGE

DRYER

Carbon Waste : 10 Kgs

Acetone Recovered : 869 Kgs

Acetone (Recovered) : 286.375 KgsLoss : 128.375 Kgs

CLOTRIMAZOLE : 330.2 Kgs

Waste water : 744.83 kgs

HCl gas : 34.97 KgsScrubber HCl (30%): 116.56 kgs

Water: 81.59 kgs



+ COCl + AlCl3

Biphenyl

154

Benzyl Chloride

140.5 133

C

O

+ HCl + AlCl3

36.5 133

Ketone

258

Stage: 1

Stage: 2

C

O

+ NaBH4

Ketone

258

C

H

H

Sodium Borohydrate

68

Carbinol

260

+

Salt

(27)



5. Di Hydralazene Sulphate

Dihydrallazine Sulphate is also known as nepresol sulphate or 1-4, dihydrazino-

phthalazine sulphate is manufactured by the condensation of phthalodinitrile (phthalic

acid dinitrile) with hydrazine hydrate in the presence of acetic acid glacial in methyl

alcohol. The base is then converted into the soluble acetate and precipitated as sulphate

containing two molecules of water of crystallization. Phthalodinitrile is reacted with

Hydrazine Hydrate in Methanol with catalytic quantity of Acetic Acid at 65 - 700 C to

get Azinothalazine base. This is converted into acetate by treating with dilute Acetic

Acid. The resulting solution is filtered where the crude Dihydrallazine Sulphate is

precipitated with Sulphuric Acid. The crude Sulphate is dissolved in hot water, treated

with activated Carbon and filtered and the clear filtrate cooled to get pure crystals of

Dihydrallazine Sulphate. The residue after recovery of Methanol from the methanolic

mother liquors is discarded or treatment in effluent treatment plant. Gases generated

from the 2nd

stage will be Scrubbed Off in Scrubber.

GLASS LINED REACTOR

Mass Balance of Bifonazole

CENTRIFUGE

Bifonazole Hydrochloride : 325 KgsGlacial Acetic acid : 310 KgsWater : 1300 Kgs

SPARKLER

GLASS LINED REACTOR

CENTRIFUGE

DRYER

Acetone (R) : 1480 KgsAcetone (F): 100 kgs

Acetone Recovered : 1323.25 Kgs

GLASS LINED REACTOR

Water : 650 Kgs Waste Water : 2294 Kgs

BIFONAZOLE : 291 KGS

Acetone Recovered : 326.27 KgsLoss : 183.28 Kgs

Acetone (F) : 83.28KgsAcetone (R): 169.52 kgs



CN

CN

N

N

NH – NH2

NH – NH2

+ 2NH3

34

+ 3 NH2 NH2

Hydrice

Hydrite

96 Phthalodinitrile

C8 H4 N2

128 190

C8H10N6

N

N

NH – NH2

NH – NH2

190

C8H10N6

+ H2SO4

98

N

N

NH – NH2

NH – NH2

C8H12N6SO4

288

H2SO4



Stage: 3

+

SOCl2

119

C

H

H

+ 2 HCl + SO2

73 64

Carbinol

260

N

N

H

+

C

H

N

Bifonazole

309

N



6. Pyridoxine Acetonide Hydro Chloride

Pyridoxine Hydrochloride reacts with Acetone in presence of phosphorous oxychloride

and Deglyme to obtain Pyridoxine Acetonide Hydrochloride.

Mass Balance of Di Hydralazene Sulphate

GLASS LINED REACTOR

Phthalodinitrile : 100 KgsHydrazine Hydrate : 205 KgsAcetic Acid : 32 KgsMethanol (R) : 383.94 KgsMethanol (F): 42.66 kgsWater : 300 Kgs CENTRIFUGE Water To ETP : 457 Kgs

DHY BASE : 148.44 KGS

DM Water : 3465 KgsAcetic Acid : 55 KgsCharcoal : 5.0 KgsSulphuric Acid : 90 Kgs

SPARKLER FILTER Charcoal : 5.0 Kgs

CENTRIFUGE Waste water: 3610 Kgs

DHY SULPHATE CRUDE : 225 KGS

Water : 300 kgs

DM Water : 2950 KgsCharcoal : 12.0 Kgs

DRYER

SPARKLER FILTER Charcoal : 12.0 Kgs

CENTRIFUGE Waste Water : 3250 Kgs

DI HYDRALAZENE SULPHATE : 225 KGS

GLASS LINED REACTOR

GLASS LINED REACTOR

DistillationMethanol Recovered: 383.94 KgsResidue : 6.75 KgsLoss : 35.91 Kgs



NCH3

OH

O

O

N

CH2OH

CH3

OH

OH.HCl + POCl3 + CH3 C CH3

O

+ Diglyme

CH3

CH3

. HCl

+ POCl3 + H2O + Diglyme

PyridoxineHydro Chloride (205.64)

Acetone ( 58)

Pyridoxine Acetonide Hydro Chloride (245.64)

Pyridoxine Hydro Chloride: 250 kgsAcetone (R) : 333.93 kgsAcetone (F):100.57 kgsDiglyme: 50 kgsPhosphorous Oxychloride : 188 kgs

GLASS LINED REACTOR

FILTERATION

TD

Acetone Recovered : 333.93 kgsLoss : 37.10 kgsML TO ETP : 225.85 kgs

Pyridoxine Acetonide Hydrochloride : 298.62 kgs

Mass Balance of Pyridoxine Acetonide Hydrochloride



Annexure 4: Water Requirement Letter from GIDC



Annexure 5: Quantity of Waste Water (liquid waste) Generated and its Management

Table 1: Quantity of Waste water (liquid waste) generated and its management

Details of Effluent Treatment Plant with proposed modification

Product : API Bulk drugs

Source of effluent : Process, washing & utilities

Actual Flow : 264 kl/day (246 kl/day normal +18 kl/day Concentrated)

Design flow of effluent : 300 kl/day

Design parameter : As under

Table 2: Quantity of Waste water (liquid waste) generated and its management

Parameters

Concentrated

effluent

to MEE

Normal

effluent

MEE

condensate CETP inlet norms

pH 6.5 5.8 7.1 6.5-8.5

Temperature 28°C 28°C 35 40

Color (pt.co. scale), Units 172 145 65 <100

Suspended Solids, mg/l 220 356 20 <300

Oil and Grease, mg/l 2 30 0.2 <10

Phenolic Compound, mg/l 2.5 1.28 0 <1

Cyanides, mg/l ND ND 0 <0.1

Sulphides, mg/l ND 0.6 0 <2

Ammonical Nitrogen, mg/l ND 46 20 <50

BOD (5 days at 200C), mg/l 7200 1500 735 <400

COD, mg/l 23110 4200 2100 <1000

Chlorides, mg/l 25400 1400 160 -

Sulphates, mg/l 95302 120 20 -

S.

No. Particulars

Effluent Generation, m3/day

Normal Effluent Concentrated Effluent

Existing Proposed Total Existing Proposed Total

1 Domestic 12.0 5.0 17.0 0 0 0

2 Processing & washing 47.0 104.0 151.0 5.0 13.0 18.0

3 Boiler 18.0 7.0 25.0 0 0 0

4 Cooling 10.0 5.0 15.0 0 0 0

5 Scrubber 3.0 2.0 5.0 0 0 0

6 Floor/container/equipment

washing 25.0 25.0 50.0 0 0 0

7 Total 115.0 148.0 263.0 5.0 13.0 18.0

8 Total Industrial 103.0 143.0 246.0 5.0 13.0 18.0

9 Mode of Treatment CETP CETP CETP MEE MVR MVR

10 Condensate from MEE to

ETP 4.15 - 14.94 - -

11 Net Discharge to ETP 107.15 - 260.94 - -



Parameters

Concentrated

effluent

to MEE

Normal

effluent

MEE

condensate CETP inlet norms

Total Dissolved Solids, mg/l 150500 6300 200 -

Phosphate, mg/l 3.8 2.5 0 <5

Based on the above criteria effluent treatment plant having under mentioned specification is

required to install:

Details of Effluent Treatment Plant for concentrated stream with proposed

modification:

Concentrated effluent flow: 18 Kl/Day:

Table 3: Details of Modification in Existing ETP for Proposed Expansion

Sr. No. Name of the Equipment

Capacity per day

Total

Existing Proposed

1 Collection tank 10 KL 10 KL 20 KL

2 Neutralization tank 10 KL 10 KL 20 KL

3 Filter nutsch 5 KL 15 KL 20 KL

4 Holding tank 5 KL 10 KL 15 KL

5 Stripper feed tank 10 KL 10 KL 20 KL

6 Solvent stripper 5 KL 15 KL 20 KL

7 MVR Feed tank 5 KL 10 KL 15 KL

8 MVR condensate storage tank 5 KL 10KL 15 KL

9 MVR 20 Kl 0 20 KL

10 Crystallizer 5 KL 25 KL 30 KL

Figure 1: Flow Diagram of MVR



Figure 2: Flow Diagram of Treatemnt Scheme fro Concentrated Effluent

Details of effluent treatment plant for normal effluent

Brief process of waste water treatment:

Collection/Equalization Tank( ET-1) :- The effluent from different production plant &

utility comes thru gravity & pH maintain up to neutral with hydrated lime mixing with

surface aerator .

Equalization /Neutralization Tank ( ET-2) : Effluent from ET-1 is transfer into this tank

thru gravity, these waste water are treated with Fenton treatment system followed by

sulphuric acid, ferrous Sulphate & Hydrogen peroxide .

Flash Mixture :- Effluent is taken from ET-2 after Fenton Treatment into this tank thru

pump. this effluent is treated by dosing of Coagulant / Flocculent for flocculation. Primary

Settling Tank : The flocculates effluent is stay for separation of solid& liquid, the upper

Supernant layer is going into Biological ( secondary ) treatment thru gravity & lower sludge

layer sludge is transfer into sludge holding tank for filtration.

Concentrated effluent collection tank

Neutralization Tank

Solvent stripper

MVR feed Tank

Pre-heat exchanger

Polymer heat exchanger MVR Reactor

Crystalizer

Salt to TSDF

Solvent recovered

Condensate

To ETP

Flow Diagram of Treatment scheme for Concentrated effluent



Filter Press: Filter the material from Sludge holding tank the filtrate taken into ET-02 &

Solid material filled into HDPE woven bag, this bags are stored in separate storage area &

final disposed to TSDF site..

Secondary Effluent Treatment Plant:

Aeration TankNo-1 ( AT-1 ) : Primary treated effluent goes to AT-1 thru gravity , aeration

tank is operated by providing air thru air blower for maintain dissolve oxygen for develop

biomass activity.

Secondary Settling Tank ( SST-1) : AT-1 treated effluent is going into SST-1 thru

gravity, here Supernant upper layer goes to Aeration -2 for further treatment & lower layer

use as RAS or excess sludge transfer into sludge holding tank for filtration.

Aeration Tank No-2 ( AT-2 ) :Effluent from SST-1 is taken into AT-2 & here biomass

maintained by providing air & after treated effluent goes into SST-2.

Secondary Settling Tank ( SST-2): Effluent treated after AT-2 is comes into SS-2 for

settling ,the upper supernet later are goes for further treatment to Tertiary treatment &

Lower layer use as RAS or send to sludge holding tank for filtration.

Tertiary Treatment Plant:

Sand& Carbon Filter: Secondary treated effluent passed thru sand& carbon filter & final

treated effluent send to Common effluent treatment plant (CETP) thru under ground GIDC

drainage system for further treatment & disposal as per GPCB guideline.

Normal effluent quantity: 260.94 m3/day

Table 4: Capacity of ETP along with Sizing

S.

No. Name of equipments Size

Capacity, M3


1 Oil & Grease separator 1 M*2M*1.2M 4.8 0 4.8

2 Lime Dosing Tank -- 1.0 4.0 5.0

2 Equalization cum neutralization

tank ( ET-1) 8M*8M*3.2M 205 0 205

3 Equalization cum neutralization

tank ( ET-2) 8M*8M*3M 192 0 192

4 Flash Mixture 1M*1M*1M 1.0 4.0 5.0

5 Primary settling tank 3M*3M*2.5M 22.50 25.0 47.5

6 Aeration Tank ( AT-1) 10M*10*5M 500 0 500

7 Aeration Tank ( AT-2) 10M*4*5M 200 0 200

8 Secondary Settling tank(SST-1) 4.4M*2.6M*2.5M 30 0 30

9 Secondary Settling tank(SST-2) 4M*2.6M*2.5M 30 0 30

10 Treated effluent holding tank 4M*2.6M*2.5M 30 0 30

11 Sludge Holding tank 2M*2.6M*1.5M 7.8 0 7.8

12 Sand filter 0.8M

(Dia)*1.250M(Length) 10 / 0 10

13 Carbon Filter 0.8M

(Dia)*1.250M(Length) 10 0 10



Table 5: List of ETP Equipments

S. No. Name of equipments Qty. Size

1 Agitator for lime dosing tank Motor/pump

2 Floating aerator

Equalization cum neutralization tank ( ET-1)

1

5 HP

3 Floating aerator

Equalization cum neutralization tank ( ET-2)

1

5 HP

4 Transfer pump at Equalization tank 1+1+1 7.5/5/5 HP

5 Agitator for flax mixture 1 0.5 HP

6 Primary Sludge pump 1+1 2 HP

7 Agitator for poly pre. tank 1+1 0.5 HP

8 Air Blower(twin lob) 1+1 25 HP

9 Air Blower(twin lob) 1+1 15 HP

10 Sludge recycle pump( AT-1) 1+1 2 HP

11 Sludge recycle pump( AT-2) 1+1 2 HP

12 Agitator for Sludge Holding tank 1 2 HP

13 Filter press feed tank 1+1 2 HP

14 Filter press Hydraulic auto 1 33 plats

15 Sand/Carbon filter pump 1+1 2 HP

Figure 3: Flow Diagram of ETP

Collection

Tank

Dosing

Tank

Eff luent Transfer

Pumps

Equalization Cum

Neutralization tank

Flash Mixer

Polyelectrolyte

dosing Tank

Primary

Settling

Tank

Alum dosing

Tank

Aeration

Tank - 1

Aeration

Tank - 2 Treated

Eff luent

To

Vapi CETPdosing

Tank

Sludge Recycle

Pump

Sludge Recycle

PumpSludge Holding

Tank

Sludge Transfer

Pumps

Filter Feed

Pumps

Filter Press

Filtrate

To

Equalization

Tank

Poly. dosing

Tank

Flow Diagram of Effluent treatment plant



Annexure 6: Membership Certificate of CETP, Vapi for Existing and Additional Effluent

Load



Membership Certificate of TSDF Vapi and RSPL, Panoli and SEPPL, Kutch for Co-

Processing and incineration



Annexure 7: Toposheet Map of Vapi Region



Annexure 8: Copy of Plot Allotment Letter issued by GIDC



Annexure 9: Letter Regarding the Unit is Located In Notified Industrial Area



Annexure 10: A Schematic Representation of the Feasibility Drawing

Type of Industry

Existing unit mfg. of "API Bulk drugs

Type of cataegory as per EIA notification

(Catagery -5(f)-b

Proposed Activity:

The proposed expansion project involves the production of "API bulk drugs"

Submission of Form-1 and Pre-Feasibility

Report & Draft TOR

Resource requirments

Raw Material : Sourced from Manufacturer / Traders of the same.

Land: proposed expansion project in Existing plot ,At GIDC Vapi

Water: will be sourced through GIDC water supply.

Power: power will be sourced through Dakshin Gujarat Vij Co. Limited

Env. Mgt. Plan (EMP)

Air Pollution Control Measures: Adequate air pollution control system will be installed.

Water Pollution : normal Effluent will be treated in primary followed by tertiary ETP and discharge into CETP, Vapi and concentrated effluent will be sent to MEE.

Greenbelt Area: 30% of the Total Area will be developed.

Health & Safety measures will be followed properly.

Domestic: Will be disposed off through Soak pit, overflow sent to CETP

Industrial:: normal Effluent will be treated in primary followed by tertiary ETP and discharge into CETP, Vapi and concentrated effluent will be sent to MEE.

Gas emissions: Adequate capacity of MDC followed by bag filter and 30 meters height of chimney provided to coal fired steam boiler. Adequate capacity of two stage scrubbing system will be provided.

Hazardous waste: will be disposed off as per hazardous waste 2016

Fugitive emission: efficient control system

Public consultancy: Not required as the project is

located in GIDC Estate

Presentation before the EAC for TOR/EC

Site location :

The company located at Plot No.322/4, 40 shed, GIDC Vapi, Di:

Valsad



Annexure 11: Details of Air Pollution & Its Control Measures at Existing & After

Proposed Expansion

Flue Gas Emission:

At present, the unit is having one number of 3 TPH of coal fired steam boiler, one

number of 3 TPH oil fired steam boiler and one number of 6 lakh k cal/hr capacity of oil

fired thermopak. Adequate capacity of multi cyclone separator followed by bag filter

and separate 30 meters height of chimney provided. The unit is proposes to install

additional one number of 8 TPH coal fired boiler having ESP and 30 meters height of

chimney will be provided. After proposed expansion, existing oil fired 3 TPH of steam

boiler and existing 6 lakh k cal/hr of thermopack will be discontinued.

At present, the unit is having two numbers of 500 KVA of D G set (standby). It will be

used only during power failure. The unit is proposed to install one number of 1250

KVA capacity of D G set (standby). After proposed expansion, existing 500 KVA x 2

numbers of S G sets will be discontinued.

Process Gas Emission:

Presently the unit has installed one number of two stage graphite followed by alkali

scrubber and 11 meters height of vent to scrub and recover HCl gas generated from the

process. After proposed expansion, the unit shall install additional one number of two

stage graphite followed by alkali scrubber and 11 meters height of vent to scrub and

recover HCl gas and SO2 generated from the process.

Details of Air pollution control measures are given in following table:

Table 1: Flue Gas Emissions

Sr.

No. Particulars

Details

Remarks

Existing Proposed

After proposed

Expansion

1.0 Capacity of

steam boiler: I 3 TPH 0 3 TPH

Existing 1.1 Fuel used Imported coal 0 Imported coal

1.2

Fuel

consumption,

kgs/hr

583 0 583

1.3 APC MDC & bag

filter 0 MDC & bag filter

1.4 Chimney 31 meters 0 31 meters

2.0 Capacity of

steam boiler: II 3 TPH 0 3 TPH

Will be

discontinued

after proposed

expansion

2.1 Fuel used FO/LDO 0 FO/LDO

2.2

Fuel

consumption,

kgs/hr

29 0 29

2.3 APC - 0 -

2.4 Chimney 31 meters 0

3.0 Capacity of 6 lakh k cal 0 6lakh k cal Will be



Sr.

No. Particulars

Details

Remarks

Existing Proposed

After proposed

Expansion

Thermopack: I discontinued

after proposed

expansion 3.1 Fuel used Furnace oil 0 Furnace oil

3.2

Fuel

consumption,

kgs/hr

35 0 35

3.3 APC - - -


4.0 Capacity of

Boiler: III 0 8 TPH 8 TPH

Proposed new

4.1 Fuel used 0 Imported coal Imported coal

4.2

Fuel

consumption,

kgs/hr

0 972 972

4.3 APC 0 ESP ESP

4.4 Chimney 0 30 meters 30 meters

5.0 Capacity of D G

set: I & II 500 KVA x 2 0 500 KVA x 2

Will be

discontinued

after proposed

expansion

5.1 Fuel used HSD 0 HSD

5.2

Fuel

consumption,

kgs/hr 220 0 220

5.3 APC 0 0 0


6.0 Capacity of D G

set: III 0 1250 KVA Proposed New

6.1 Fuel used 0 HSD

6.2

Fuel

consumption,

kgs/hr

0 220

6.3 APC 0 0

6.4 Chimney 0 11 meters

Expected

emissision

PM: <150 mg/Nm3

SOX: < 100 ppm

NOX: < 50 ppm



Table 2: Process Gas Emissions

Sr.

No. Particulars

Details

Remarks

Existing Proposed After proposed

Expansion

7.0 Stack attached to Reactor Reactor Reactor

Total two

numbers of

scrubbing

system

7.1 APC provided

Two stage

graphite

followed by

alkali

scrubber

Two stage

graphite

followed by

alkali

scrubber

Two stage graphite

followed by alkali

scrubber

7.2 Height of vent 11 meters 11 meters 11 meters

Expected

Emission

HCl: <20 mg/Nm3

Cl2 : < 9 mg/Nm3

SO2: < 40 mg/Nm3

DETAILS OF AIR POLLUTION CONTROL SYSTEM:

1. Details of Multi Cyclone Separator followed by Bag Filter attached to Existing Coal

fired 3 TPH Boiler:

Table 3: Specifications of Multi Cyclone Separator & Bag Filter

Particular Details

Capacity 3 tones/hr

Type of fuel used Lignite/steam coal

Quantity used 583 kgs/hr

ID fan cfm 6000

Size of MDC 1250 mm x 1250 mm x 2500 mm

MOC MS

Number of clones 20

Size of clones 150 x 80 NB

Gas volume 9350 m3/hr

Gas temperature 150 0C

Dust load 15 gms/m3

Particle size Above 5 microns

Filtration area 132 m2

Actual filter rate 1.18 m3/m

2/min

Pressure drop 150 mm Wg

Nos. of Bag filter 100 (Glass fibre)

Height of Chimney 31 meters

Dia of chimney 600 mm



2. Details of Electro Static Precipitator to be attached to proposed coal fired 8 TPH Boiler:

Table 4: Specifications of Electro Static Precipitator

Particulars Details

ESP model SC-11-16-24(G) (3x9.125) 1.2 P

Design volume 18588 Am3/hr

Design Temperature 1500C

Maximum Inlet Dust Load 13.01 Gm/ Nm3

Outlet Emission 50 Mgm/ Nm3

Moisture in Gas 15.83% V/V

Collection area 1399 m2

Specific collection area 83.1 m2/m

3/s

No of gas passages 11

Velocity through ESP 0.49 M/s

No of fields 3

Migration velocity 5.37 Cm/s

Residence time 16.9 Sec

Dust collection efficiency 98.8%

(A) Primary Scrubber:

Table 5: Primary Scrubber

Scrubber Dia 450 mm

MOC MS/Graphite

Scrubber height 1930 mm

Overall height 2710 mm

Distributor 1

Type of packing Graphite

Blower 1000 cfm, 1.5 HP

Scrubbing liquid Water

Gas inlet 150 mm

Gas outlet 150 mm

Circulation pump capacity 5 m3/hr 5 HP

Circulation Tank capacity 5 m3

(B) Secondary Scrubber:

Table 6: Secondary Scrubber

Scrubber Dia 450 mm

MOC PP/FRP

Scrubber height 4350 mm


Distributor 1

Type of packing 40 mm pp


Scrubbing liquid 14% HCl

Gas inlet 100 mm



Gas outlet 100 mm

Circulation pump capacity 3 m3/hr 3 HP

Circulation Tank capacity 3.5 m3

(C) Alkali Scrubber:

Table 7: Alkali Scrubber

Scrubber Dia 600 mm

MOC PP/FRP

Scrubber height 2300mm


Distributor 1

Type of packing 40 mm pp


Scrubbing liquid 5-7 % NaOH

Gas inlet 150 mm

Gas outlet 150 mm

Height of vent 11 meter

Circulation pump capacity 2m3/hr 2 HP

Circulation Tank capacity 1.5 m3

Figure 1: Flow Diagram of Scrubbing System for HCl, Cl2 & SO2 gas

Graphite

Falling Fluid

Absorbent

10 m2

PP FRP

Tank, 5000 lits

450 mm dia x

4000 mm ht.,

PP rashing

ring

PP FRP

Tank, 2000 lits

PP FRP

Tank, 2000 lits

300 mm dia x

4000 mm ht.,

PP rashing

ring

FLOW DIAGRAM OF SCRUBBING SYSTEM FOR HCL,CL2& SO2 GAS



Annexure 12: Copy of CCA of Existing Plant



Annexure 13: Copy of Environmental Clearance dated 23/10/2003



Copy of Environmental Clearance dated 30/01/2009 (validity expired)

the proposed expansion of api bulk drugs...

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