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PRE-FEASIBILITY REPORT

OF

Sai-Tech pharmaceuticals Pvt. Ltd.

A-145/8,TTC Industrial Area, Khairne,Navi- Mumbai 400-705

1

CHAPTER 1

Executive Summery

Proposed project is an expansion project for downstream products the API at their

existing plant atplot no. A-145/8, Khairane MIDC, TTC Industrial Area, Navi Mumbai. It

has been decided to set up a API the capacity of 72 tons per annum for manufacturing

API of different types and grades.

Sr.

No.

Details Information

1 Site A-145/8,TTC Industrial area, Khairne, Navi- Mumbai

400-705

2 Capacity API: 72 MT / Year

3 Water Requirements 45 m3/Day

4 Power Requirements 500 KVA

5 Fuel Requirements HSD or LDO or FO will be used for boiler & HSD

for D.G. Set

HSD = 0.55 MT/ Day

HSD = 25 Lit/ Hr

6 DG Set Proposed: 250 KVA

7 Manpower 45

8 Project Cost Proposed: 6.58 CRORES

2

CHAPTER 2

Introduction of Project/ Background Information

2.1 Identification of project and project proponent

Saitech pharmaceuticals Pvt.Ltd is research driven leading supplier in the chemicals

and intermediates. We are diversifying in the field of manufacturing Active

Pharmaceutical Ingredients and its formulations which will cater the requirements of

pharmaceutical industry. The factory is located at plot no. A-145/8, Khairane MIDC,

TTC Industrial Area, Navi Mumbai. The project will be a Category 5(f)-B as per the New

EIA Notification dated. 14.09.2006.

2.2 Brief Description of nature of the Project

Proposed project is an expansion project for downstream products the API at their

existing plant at plot no. A-145/8, Khairane MIDC, TTC Industrial Area, Navi Mumbai.

It has been decided to set up a API the capacity of 72 tons per annum for manufacturing

API of different types and grades.

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

Saitech pharmaceuticals Pvt. Ltd is leading supplier in the chemicals and

intermediates. It is diversifying in the field of manufacturing Active Pharmaceutical

Ingredients and its formulations which will cater the requirements of pharmaceutical

industry. Saitech pharmaceuticals, is a leader in the Pharmaceutical industry by

manufacturing quality APIs and its formulations. To provide better services in terms of

quality and timely delivery that exceeds the expectations of our esteemed customers. To

build long term relationship with our customers and provide exceptional services by

pursuing business through innovation and advanced technology.

API industry has been identified as a major foreign exchange earner as the API industry

continues to grow, so does the API industry.

The global API market is driven by factors such as emerging global economy and

changing lifestyles.

Uses of Proposed API:

Sr.

no.

Product Name Therapeutic category

1 Raloxifine Hydrochloride Anti osteoporotic

2 Etoricoxib Anti-inflammatory, analgesic

3 Celecoxib Non steroidal anti-inflammatory

4 Homotaurine Advance intermediate for Acamprosate

5 Zolpidem tartrate Sedative, Hypnotic

6 Butamirate citrate Antitussive

7 Butethamate citrate Antitussive

8 Bupropion hydrochloride Anti-depressive disorder

9 Phenylephrine hydrochloride Mydriatic, Decongestant

10 Bazedoxifene acetate selective estrogen receptor modulator (SERM)

In 2015 estimated consumption of API was as below-

1. Bupropion Hydrochloride

Total Exported quantity from India : USD 2,687,285

3

Total Quantity of Export from India : 31,091

Largest Buyers:

Brazil, import value: USD 2,000,976

Canada, import value: USD 564,162

Taiwan, import value: USD 87,524

Exports By Country Total Value (USD) Total Qty. (Kg)

Brazil 20,00,976 26,335

Canada 5,64,162 3,600

Taiwan 87,524 745

2. Raloxifene Hydrochloride

Total Exported quantity from India: USD 604,240

Total Quantity of Export from India: 720 Kg

Largest Buyers:

Canada’s import value: USD 192,562

Oman’s import value: USD 182,756

Algeria’s import value: USD 62,633

Compiled Export data of Raloxifene Hydrochloride

Exports by country Total Value USD Total Qty. (KG)

Canada 1,92,562 200

Oman 182756 219

Algeria 62633 80

3. Celecoxib

Total Exported quantity from India: USD 60,632,075

Total Quantity of Export from India: 122,371,610 Kg

Largest Buyers:

United State Import value: USD 8,974,999

Israel’s Import value: USD 8,193,250

Vietnam’s Import value: USD 4,590,288

4. Etoricoxib

Total Exported Value from India: USD 5,582,124

Total Quantity of Export from India: 16,638 kg

Largest Buyers:

Bangladesh’s Import value: USD 1,384,646

Spain’s Import value: USD 871,066

Lebanon’s Import Value: USD 509,307

5. Butamirate Citrate

Total Exported Value from India: USD 9,796

Total Quantity of Export from India: 45 kg

Largest Buyers:

Argentina’s Import value: USD 5,603

Bangladesh’s Import value: USD 4,193

6. Phenylephrine Hydrochloride


4


Largest Buyers: Turkey’s Import value: USD 13,371

Serbia’s Import Value: USD 9,838

Peru’s Import value: USD 8,626

7. Zolpidem Tartrate



Largest Buyers: Poland’s Import value : USD 92,225

Canada’s Import Value: USD 9,768

Japan’s Import value: USD 1,976

8. Homotaurine



Largest Buyers:

Singapore’s Import value: USD 41,151

2.4 Employment Generation (Direct and Indirect due to project) Project will create direct and indirect opportunities within surrounding region. Unit will

use good faith to employ local people from nearby villages depending upon the

availability of skilled and unskilled manpower surrounding the site.

In operation phase, the proposed project will require significant workforce of non-

technical and technical persons. Migration of highly education and skilled experience will

result in increase of literacy in the surrounding villages.

In addition the proposed expansion of project shall enhance the prospects of employment.

Labour costs are estimated to be 50 lacs per annum.

5

CHAPTER 3

Project Description

3.1 Type of Project Currently M/s Sai-Tech pharmaceutical Pvt Ltd is manufacturing API. Proposed project

API of is for downstream products of below mentioned API.

3.2 Location Sai-Tech pharmaceutical Pvt Ltd proposes to set up this API Plant at company’s existing

plot at plot no. A-145/8, Khairane MIDC, TTC Industrial Area, Navi Mumbai.

3.3 Selection of Site The proposed API plant is an expansion for downstream products. This location is well

connected with internal roads of and the main highway.

3.4 Size/Magnitude of Operation Proposed API plant capacity is 72 Metric Ton Per Annum.

3.5 Project Description

3.5.1 Proposed Products

Sr.

No. Name of Product

Capacity per

annum (MT)

1 Raloxifene Hydrochloride 36 MT

2 Butamirate Citrate 36 MT

3 Celecoxib 36 MT

4 Etoricoxib 36 MT

5 Phenylephrine Hydrochloride 36 MT

6 Bupropion hydrochloride 36 MT

7 Butethamate citrate 36 MT

8 Homotaurine 36 MT

9 Zolpidem Tartrate 36 MT

Maximum two products simultaneously correspond to annul installed capacity:

72 MT/A

6

3.5.2 Production Processes Company intends to manufacture 6 MT /Month of following active pharmaceutical

ingredients in the proposed plant at Khairane MIDC.

I. Raloxifene Hydrochloride: General Information:Raloxifene is an oral modul selective estrogen receptor (SERM)

that has estrogenic actions on bone and anti-estrogenic actions on the uterus and breast. It

is used in the prevention of osteoporosis in postmenopausal women. It is also used for

reduction of risk and treatment of invasive breast cancer.

Manufacturing process: Hydrolysis of 6-acetoXy-2(4-acetoXyphenyl)-3-[4-(2-

ridinoethoxy) benzoyllbenzo[b]thiophene according to the following operating

conditions:

d1)Treatment of 6-acetoxy-2-(4-acetoxyphonyl)-3-[4-(2-

PiperidinoethoXy) benZoyl]benZo[b]thiophene with alkaline hydroxide in alcohol

solvent,

d2) Acidification of the product obtained in the preceding stage (d1) with a strong acid,

to obtain the corresponding Raloxifene salt.

List of Raw Materials:

• 6-methylsulpholoxy benzothiophene HCl

• Sodium hydroxide

• Acetone, HCl

Process flow chart:

II. Butamirate Citrate:

General Information: Butamirate is a cough suppressant.

Brief manufacturing process: Phenylbutyric acid chloride is treated with

diethylaminoethoy ethanol in toluene ml at reflux Toluene is distilled off to get base.

Citrate salt is prepared in acetone.


• 2(2-Diethylamino)ethoxy ethanol

• 2-Phenylbutyrylchloride

• Citric acid

Process flow chart:

7

III. Celecoxib: General Information:Celecoxib is a nonsteroidal anti-inflammatory drug. It works by

reducing hormones that cause inflammation and pain in the body. Celecoxib is used to

treat pin or inflammation caused by many conditions such as arthritis, spondylysis and

menstrual pain.

Brief manufacturing process: Solution of 4,4,4-trifluoro-1-[4-(methyl)phenyl]butane-

1,3-dione & 4-sulfonamidophenylhydrazine hydrochloride in Isopropyl alcohol is

refluxed for 24 hrs to obtain Crude Celecoxib which is purified to obtain pure Celecoxib.


• 1,3 dione

• Sulphonamide

• Isopropyl Alcohol

Process flow chart:

IV. Etoricoxib:

General Information: Etoricoxib is indicated for the treatment of rheumatoid

arthritis, psoriatic arthritis, osteoarthritis, ankylosing spondylitis, chronic low back pain,

acute pain, and gout.

Brief manufacturing process: Solutionof KetoSulphone&Fluorophosphates in Acetic

acid is refluxed for 24 hrs to obtain Crude Etoricoxib which is purified in Isopropyl

Alcohol to obtain pure Etoricoxib


• 2-chlro-1,3-bis(dimethylamino) Trimethiniumhexafluorophosphate

• 1-(6-methyl pyridine-3yl)-2{(4-methyl) Sulfonyl)phenyl}ethanone

• Pot. Tert. Butoxide

• Acetic acid

Process flow chart:

Reactor

2(2-Diethylamino)ethoxy ethanol

2-Phenylbutyrylchloride

Toluene

Reactor Citric Acid

Butamirate Citrate

Crude Celecoxib

1,3 Dione

Sulphonamide

IPA

Celecoxib

8

V. Phenylephrine Hydrochloride:

Phenylephrine and its salts are most commonly used, either topically or by mouth, for the

symptomatic relief of nasal congestion. They are frequently included in preparations

intended for the relief of cough and cold symptoms

Brief manufacturing process;

MAP Sulphate is taken in water and IPA and maintained and added TEA buffer to adjest

PH 7.Added NADP and Ketoreductage in traces for reduction to get R- Phenylephrine

base in IPA. R- Phenylephrine base IPA solution is acidified with HCl in IPA to filter

PhenylephrineHydocloride Salt.

List of Raw materials:

• MAP Sulphate

• Ketoreductage

• IPA

• HCl

Process flowchart:

VI. Bupropion hydrochloride

General Information:Bupropion hydrochloride is a Antidepresent and used in smoking

cessation.

Brief manufacturing process: α-bromo-3’-chloropropiophenone is treated with tert-

butylamine in acetonitrile under reflux to give Bupropion free base followed by

hydrochloride salt preparation by IPA-HCl.


alpha-bromo-3’-chloropropiophenone

Dichloromethane

tert-Butylamine

• Acetonitrile

• Isopropyl alcohol

Crude Etoricoxib

2-chlro-1,3-bis(dimethylamino)

Trimethiniumhexafluorophosphate

Etoricoxib

1-(6-methyl pyridine-3yl)-2{(4-

methyl) Sulfonyl)phenyl}ethanone

Pot. Tert. Butoxide ,

Acetic Acid

Reactor

Phenylephrine Base

MAP Sulphae

Ketoreductage +NADP

IPA

HCl

Phenylephrine Hydrochloride

9

• IPA-HCl

Process flow chart:

VII. Butethamate citrate: General Information:Butamirate is a cough suppressant.

Brief manufacturing process: Phenylbutyric acid chloride is treated with

diethylaminoethanol in toluene ml at reflux Toluene is distilled off to get base. Citrate

salt is prepared in acetone.


• diethylaminoethanol

• 2-Phenylbutyrylchloride

• Citric acid0

• Toluene

• Acetone

• Hexane

Process flow chart:

VIII. Homotaurine: General Information: Homotaurine is a Sedative,Hypnotic.

Brief manufacturing process: 3-Aminochloropropane aqueous solution is sulfonated

with the aqueous solution of Sodium sulphite by reflux followed by acidifying by

hydrochloric acid, filtering, and cooling to get crude followed by purification in Methanol

to get pure 3-aminopropanesulfonic acid Homotaurine.

List of Raw Material:

• 3-Aminochloropropane

• Sodium sulphite

Acetonitrile

α-bromo-3’-chloropropiophenone

IPA

Bupropion Base

Bupropion HCl

Tertbytylamine

IPA/HCl

Toluene

(2-Diethylamino) ethanol

2-Phenylbutyrylchloride

Citric Acid

Reactor

Reactor

Butethamate

10

• Methanol

• Conc. HCl

Process Flow Chart:

IX. Zolpidem Tartrate:

General Information:Zolpidem Tartrate is a Sedative,Hypnotic used as deprssent.

Brief manufacturing process: Zolpedemic acidchloride to condensation with

dimethylamine then leads to zolpidem free base, which is converted to its L-(+)- tartrate

(2:1) by treatment with L-(+)-tartaric acid


• 6-methyl-2-p-toyl-imidazo [1, 2,-a]pyridine-2-yl) acetic chloride (Zolpidemic acid

chloride)

• Dimethyl amine solution. (40%)

• Ethyl Acetate

• IPA

Process Flow Chart:

3.6 Raw Materials

Sr no Raw material Quantity Unit

Bupropion

1 Metachloropropiophenone 1.406 T

2 Bromine 1.322 T

3-Aminochloropropane

Sodium sulphite

Water

Methanol

Reactor

Reactor

Homotaurine

HCl

Zolpedemic acidchloride

Dimethylamine solution

Ethyl Acetate

Zolpidem Base

Crude

Zolpidem

Base

Zolpidem

Tartrate

Methanol

L(+)Tartaric acid

11

3 MDC 2.109 KL

4 tert-Butylamine 2.100 T

5 Acetonitrile 0.183 KL

6 IPA 1.1248 KL

Butamirate

1 2-Phenylbutyryl chloride 0.7040 T

2 2(2-Diethylamino) ethoxy ethanol 0.6195 T

3 Toluene 0.3960 kL

4 Aq. Ammonia 0.5132 kL

6 citric acid 0.648 T

7 Acetone 0.5133 kL

8 Hexane 2.933286 kL

Butethamate

1 2-Phenylbutyryl chloride 0.9 T

2 2-Diethylaminoethanol 0.576 T

3 Toluene 0.48 KL

4 Aq. Ammonia 0.4 KL

5 citric acid 0.656 T

6 Acetone 0.48 KL

7 Hexane 0.48 KL

Etoricoxib

1 Ketosulphone 1.365 T

2 2-chloro compound 1.7472 T

3 Potassium tertiary butoxide 0.735 T

4 Toluene 1.26 KL

5 DMF 2.247 KL

6 Acetic acid 2.1 KL

7 Ammonium acetate 0.735 T

8 Formaldehyde solution 0.315 KL

9 Sodium bi carbonate 1.155 T

10 Isopropyl alcohol 2.247 KL

11 Ammonia solution 3.885 KL

12 Isopropyl alcohol 0.336 KL

13 Norrit Charcoal 0.105 T

Raloxifene Hydrochloride

1

6-hydroxy-2-(4-hydroxyphenyl)-benzo(b) thiphene

mesylate 1.4 T

2 4-(2-piperidino ethoxy) benzoyl Chloride 1.5 T

3 MDC 15.4 KL

4 AlCl3 3.9 T

5 Methanol 7.0 KL

6 NaOH 2.8 T

7 Water 9.5 KL

8 Acetone 18.9 KL

10 HCl 4.2 KL

11 Acetone 5.35 KL

12 Water 2.64 KL

13 HCl 0.32 KL

12

14 Methanol 24.8 KL

Celecoxib

1

4,4,4-Trifluoro-1-[4-(methyl)phenyl]butane-1,3-

dione 0.855 T

2 4-sulfonamidophenylhydrazine hydrochloride 0.88065 T

3 Isopropanol 1.71 KL

4 Methylene dichloride 11.4 KL

5 n-Hexane 5.7 KL

Homotaurine

1 3-Chloropropyl Amine 1.275 kg

2 DM water 5.763 KL

3 Sodium sulphite 12.852 T

4 Concentrate HCl 5.304 T

5 Methanol 0.612 T

6 CTH –N-1 1.1645 T

7 D M water 4.658 KL

8 Ammonia solution 0.425 KL

9 Ethanol 1.8632 KL

Zolpidem Tartrate

1 Zolpidic acid 1.1 T

2 Phosphorous oxy chloride 0.902 T

3 Dimethyl amine sol (40%) 3.96 T

4 MDC 14.19 T

5 Ethyl acetate 1.485 T

6 Tartaric acid 0.176 T

7 Methanol 1.353 T

3.6.1 Power & Fuel Requirement Total power requirement for the proposed Project is 500 KVA. The required power will

be sourced from MSEB in construction and operating phase.

DG set of capacity 250 KVA will be used as backup for emergency purpose.

The details of Fuel requirement is as given bellow.

Sr. No. Type of Fuel Quantity T/Day

1 Fuel Oil 30 Kg/Hr

2 HSD 25 Lit / hr.

Consumption of Utilities Electricity: 1500 KW/Hr

Cooling Water: 8 M3

3.6.2 Selection of Technology Manufacturing process with proven technology has been developed in consultation with

specialists from R & D team of Sai-Tech pharmaceuticals Pvt Ltd. No patented process

will be used. Technology tie-up with any process collaborator is not envisaged.

3.7 Resource Optimization

The main raw materials used in proposed API project are from the local market. Existing

plant manufactures the above mentioned range of products.

3.8 Water Requirement & Distribution The water requirement for the proposed project will be met from the MIDC supply. The

daily water requirement is m3/day as detailed in below table.

13

Sr.

No. Purpose Requirement (cmd)

1 Domestic 5

2 Industrial Processing

For Steam Generation 10

For Cooling Tower 5

For Scrubber& ejector make up 2

For Neutrallization 3

Water of Reaction generated in the process. 12

Boiler water make up

Water for DM unit back wash 1

Water for floor washing 1

Water for green belt 6

TOTAL

Less Water of reaction generated in the process 0

Actual water required from MIDC Supply 45

3.9 Waste Water Generation

The waste water generated from proposed project as estimated is given in below table:

Sr.

No. Source Used

Losses

M3/Day

Effluent

Generation

M3/Day

Remarks

1 Domestic 5 1 4 -

2 Industrial Processing & water

generated from process 14 5 9

-

3 Boiler 10 9 1 -

4 Water for DM unit back wash 1 0 1 -

5 Water for floor washing 1 0.5 0.5 -

6 Water for green belt 6 6 0 -

7 Cooling Tower make up 8 7 1 -

TOTAL 45 28.5 16.5

3.8.1 Efluent Charecteristic & Treatment Scheme:

The total effluent generated is divided in three categories as Industrial Effluent, Utility

Plant Effluent and Domestic Effluent

3.8.1.1 Industrial Effluent

Total effluent generated industrial processing and floor washings will be treated at

Effluent Treatment Plant (ETP). Thus actual load on effluent treatment plant will be 12

m3/ day.

Liquid effluent thus generated is collected separately in a underground tank having

capacity of 10 m3. It is then pumped to Waste Water Treatment Plant.

Treated effluent will be discharged to CETP.

Characteristics of Effluent from Proposed activity:

Sr. No. Parameters Results

1 pH 5.50-6.00

2 TSS 250-300 mg/ml

3 BOD 1400-1600 mg/ml

4 COD 3500-4000 mg/ml

5 TDS 6000-7000 mg/ml

6 Chlorides 700-750 mg/ml

14

Effluent Treatment Scheme:

Solid Waste: 4000 Kg/Month solid waste will be generated and will be sent to Authorized reprocess

or/ TTWM, Navi Mumbai. The solid filter cake generated in process, will be disposed

off to compound of manufacturers.

All uncondensed vapors are directed to Vacuum Ejector System. No harmful, toxic or

uncontrollable gaseous emit out from production process.

3.8.1.2 Utility Plants’ Effluent

• DM plant regeneration water is 1 m3/ day.

Sr No. Parameters Results

1 pH 4-9

2 TDS 5000-6000 mg/l

• Steam Boiler Blow down is 1m3/ day .

• Cooling Tower Blow down is 1 m3/ day.

3.8.1.3 Domestic Waste water:

Domestic waste water will be treated in Septic tank & soak pit. The overflow from the

Septic tank will be used for gardening. This water generated is 4 m3/ day.

Sr No. Parameters Results

1 pH 7-8.5

2 BOD 200-250 mg/l

3 COD 300-400 mg/l

4 TDS 800-900 mg/l

3.8.1.4 Greenbelt Development

Greenbelt will be developed at site to enhance environment quality through limitations

of air emissions, attenuation of noise levels, balancing eco-environment, prevention of

soil erosion. 495 Sq. m. of area is covered with green cover/lawn development in

existing facility.

15

CAPTER – 4

SITE ANALYSIS

4.1 Connectivity:

Sr. No. Particulars Details

1 Nearest Road TTC Industrial, MIDC Road

2 Nearest High Way Thane Belapur Road

3 Nearest Railway Station KoparKhairne 1.5 Km.

4 Nearest Bus Station Turbhe BEST DEPOT

5 Nearest Air Port Chhatrapati Shivaji Air Port, Mumbai.

4.2 Land Form Land Use & Land Ownership

Project pertains to expansion of existing plant within MIDC Chemical zone – hence no

change in land use anticipated

4.3 Existing Land Use & Pattern:

TTC is an industrial suburb in which MIDC has developed all infrastructures and this

MIDC is spread over about 10000 hectors. TTC MIDC is a rapidly growing and

progressing industrial zone only 50 kms from CST and 10kms from Panvel.

4.4 EXISTING INFRASTRUCTURE:

The proposed project is planned in the company’s existing premises i.e. plot area of 3000

sq. met.

4.5 Climatic Conditions

The weather of the area is typical coastal sultry and humid. The average rainfall records

from 1,500mm to 2,000mm. The place experiences the onset of the monsoon in the

month of June and experiences monsoon till the end of September. The average

temperature recorded varies from 25 to 42 degrees.

16

CHAPTER 5

PLANNING BRIEF

5. Planning Brief

5.1 Planning Concept In existing unit atplot no. A-145/8, Khairane MIDC, TTC Industrial Area, Navi Mumbai.

Sai-Tech pharmaceuticals manufactures API with the production capacity of 72 MT/

Annum This unit is situated in notified industrial area i.e. MIDC Khairne

5.2 Man Power Requirement During the operating phase manpower requirement for proposed plant operation is

estimated as 72. The details of man power requirement are as given in table below.

Most of the employees will be recruited from local areas.

Category SI Title Requirement for

Operations

Company 1 Vice President 1

2 General managers 2

3 Engineering Manager 1

4 Administration 1

5 Production Plant Executive 4

6 Asst. Managers 2

7 QC Chemist 3

8 EHS 1

9 Utility Operators 3

10 Plant Operator 12

Contractual 11 Labours 10

12 Security In Charge 5

Total Per annum for Operations 45

5.2.1 Land Use Planning

Sr.

No.

Description Proposed Area

(Sq. Met)

1 Plant and Machinery Area 632

2 Canteen

Security Area

Workers Change Room 79

3 Utility Area: Boiler, Chilled water, DG Unit 44

4 MCC Room 66

Transformer 15

Control Room 18

5 ETP/ By Product recovery & Storage, Residue

Storage

22

6 Road

Storm Water Drain 670

7 Godown (Finished products Drums storage)

Finished product Storage Tanks 93

8 Bulk Storage tank yard 46

17

9 Administrative Office, QC Lab 204

10 Ware House 78

11 Raw Water Storage 28

TOTAL USED AREA

12 Open Space 1504

13 Total Green Belt Area 495

5.3 FACILITIES PROVIDED

5.3.1 Landscaping and Green belt Development Adequate land is embarked as open spaces and other non building purposes. 495 Sq. m.

of area is covered with green cover/lawn development in existing facility. No additional

green belt area is envisaged. Varieties are planted with adequate spacing and density for

their fast growth and survival.

5.3.2 Fire Fighting System The existing facility already has the adequate fire Hydrant system with fire water storage

tank. The proposed Project design and development has been planned with utmost care

and all provisions have been made for the safety and security of the plant and personnel.

Flammable and hazardous chemicals like Methanol and IPA are being used in the

manufacturing of process which poses explosion/ Fire Hazard. HSD as fuel for DG set as

a fire hazard.

For protection of the facility against fire, all the blocks and yards are equipped with any

one or a combination of the following fire fighting systems:

• Hydrant System:

• Fire Detection and Alarm System; and

• Different types of Fire Extinguishers.

Fire water storage facilities are as provided given below:

Main water storage tank: 10 KL

Sources of water supply: MIDC

In order to provide easy access to the fire tenders to extinguish fire in case of fire

accidents, the fire tender tracks have been provided at the building blocks. The warning

signs for prevention of fire and plans showing the exit paths for escape from fire shall be

displayed in the working places and corridors of the buildings.

5.3.3 Storm Water Collection and Disposal

Storm water drains will be provided and Storm water from the entire plot will be collected

through network of storm drains (RCC).

18

CHAPTER 6

PROPOSED INFRASTRUCTURE

Particulars Details

1 Existing Industrial Area 3000 Sq. m

Proposed for this project 3000 Sq. m

2 Connectivity Nearest Highway: NH4

Nearest Road: MIDC Road

Nearest Railway Station: Kopar-Khairne

3 Green Belt No additional green belt is envisaged for the

expansion

4 Power Management Source: MSEB, 500 KVA

5 Waste Water Effluent will be treated in the primary treatment

plant and transferred to CETP drainage system.

6 Solid Waste Management

solid waste

Solid waste will be sent to TTCWMA Thane.

7 Hazardous Waste Hazardous waste will be sent to TTCWMA,Thane

CHAPTER 7

REHABILATION AND RESETTLEMENT PLAN Since project is located in notified industrial area i.e. MIDC Khairne, R & R is not

applicable to this project.

CHAPTER 8

PROJECT SCHEDULE

PROJECT SCHEDULE

8.1 PROPOSED SHEDULE AND APPROVAL FOR IMPLEMENTAION The proposed project shall be established in 6 months period after getting the

environmental clearance from the SEIAA and consent from MPCB

8.2 PROJECT COST ESTIMATION Estimated cost estimation for the proposed project will be as below:

Sr. No. Item Amount (In Crores)

1 Infrastructure cost 4.78

2 Working Capital 1.80

Total 6.58

19

CHAPTER 9

ANALYSIS OF PROPOSAL

Project will create direct and indirect employment opportunities in surrounding region.

Unit will use good faith efforts to employ local people from nearby villages depending

upon skilled and unskilled man power from surrounding the project site.

In operation phase the proposed project would require significant force of technical as

well as non-technical persons.

Migration of highly education and skilled experience will result in increase of literacy in

the surrounding villages.

In addition, the proposed expansion project shall enhance the prospects of employment.

Additional government revenue expected from royalty, taxes, duties and other fees. The

added benefit to the proposed project will result in considerable growth of stimulating the

industrial and commercial activities in the state.

20

CHAPTER 10

ENVIRONMENTAL MANAGEMENT SYSTEM (EMS)

1. Safety: Operational controls related to safety, such as issuing of work permits, handling

and storage of hazardous chemicals, use of tools and protective equipment,

transportation, working in laboratories, working in special conditions etc. are included

under Safety Manual.

The MSDS for all hazardous chemicals are maintained. Adequate first aid facilities are

maintained to deal with the situations of accidental chemical exposure.

Due precautions are taken by chemists while handling the chemicals. The personal

protective equipments are provided to avoid accidental exposures.

The residue samples/ chemicals, expired chemicals are disposed off in the most

environment friendly way. The residue samples of approved finished products, are

collected and fixed in final product.

2. Waste Management: Sai-Tech Pharmaceuticals Pvt. Ltd. uses an ETP manual to control

the storage and disposal of wastes. This manual indicates the source, quantification,

storage and disposal of all categories of hazardous and solid wastes. Possibility of waste

recycling is explored. The HSE & TS function identifies possibilities for external reuse of

wastes generated.

3. Wastewater Quality Management: Wastewater generation and treatment is regulated

through ETP Manual. The operation of the Effluent Treatment Plant and accessories is

controlled to avoid incidents of non-compliance.

4. Air Quality Management: The departmental procedure for the operation of boilers and

diesel generator sets include the control over EMS impacts in the form of emissions from

stacks. Emission of solvent vapors is minimized through various control measures during

storage, handling and operation.

5. Soil Management: Pollution of the soil is avoided through liquid tight provisions,

measures to prevent leakage and overfilling and inspection of process installations above

ground.

6. Energy Management: Wherever possible, energy saving measures would be put in place

and process equipment modified.

EMERGENCY PREPAREDNESS AND RESPONSES

The organization has established emergency plan to ensure appropriate responses to

unexpected and accidental incidents. A procedure has been established for preventing and

mitigating the impacts of such emergency situation. The organization shall review and

revise its emergency preparedness and response procedures after the occurrence of

accidents or emergency situations where necessary. The requirement of mock drills for

testing and verification of implementation of these procedures have been documented in

the procedure.

In an emergency, in line with Sai-Tech Pharmaceuticals Pvt. Ltd. on-site emergency

plans, the various responsible personnel carry out their assigned functions. Emergency

services are made available and can be alerted through alarms and communications in the

event of an emergency.

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