proposed expansion of bulk drugs and bulk drug...

31
1 PRE FEASIBILITY REPORT For PROPOSED EXPANSION OF BULK DRUGS AND BULK DRUG INTERMEDIATES IN EXISTING MANUFACTURING UNIT of M/s. PRUDENCE PHARM CHEM PLOT NO. 7407 & 7408, GIDC ESTATE, Ankleshwar-393 002, TAL: ANKLESHWAR, DIST: BHARUCH, GUJARAT

Upload: lamlien

Post on 09-Mar-2019

237 views

Category:

Documents


1 download

TRANSCRIPT

Page 1: PROPOSED EXPANSION OF BULK DRUGS AND BULK DRUG ...environmentclearance.nic.in/writereaddata/Online/TOR/28_Jun_2017... · DRUG INTERMEDIATES IN EXISTING MANUFACTURING UNIT of M/s

1

PRE FEASIBILITY REPORT

For

PROPOSED EXPANSION OF BULK DRUGS AND BULK

DRUG INTERMEDIATES IN EXISTING

MANUFACTURING UNIT

of

M/s. PRUDENCE PHARM CHEM

PLOT NO. 7407 & 7408, GIDC ESTATE,

Ankleshwar-393 002, TAL: ANKLESHWAR,

DIST: BHARUCH, GUJARAT

Page 2: PROPOSED EXPANSION OF BULK DRUGS AND BULK DRUG ...environmentclearance.nic.in/writereaddata/Online/TOR/28_Jun_2017... · DRUG INTERMEDIATES IN EXISTING MANUFACTURING UNIT of M/s

2

CONTENTS

Sr.

No.

Description Page

No.

1. Executive Summary 3

2. Introduction of the Project/Background information 19

3. Project Description 21

4. Site Analysis 26

5. Planning Brief 28

6. Proposed Infrastructure 29

7. Rehabilitation and resettlement (R & R) Plan 31

8. Project Schedule & Cost Estimates 31

9. Analysis of Proposal (Final Recommendations) 31

Page 3: PROPOSED EXPANSION OF BULK DRUGS AND BULK DRUG ...environmentclearance.nic.in/writereaddata/Online/TOR/28_Jun_2017... · DRUG INTERMEDIATES IN EXISTING MANUFACTURING UNIT of M/s

3

1.0 EXECUTIVE SUMMARY

1.1 Company Profile

M/s. Prudence Pharm Chem proposes expansion of Bulk Drugs and Bulk Drug intermediates in

existing manufacturing unit located at Plot no. 7407 & 7408, GIDC Estate, Ankleshwar-393 002,

Tal: Ankleshwar, Dist: Bharuch, Gujarat.

1.2 Project Details

1.2.1 Products along with Production Capacity

Sr.

No.

NAME OF PRODUCTS CAS No. Existing

Capacity

MT/Month

Additional

Capacity

MT/Month

Total

Capacity

MT/Month

1 G.C. Ester (Methyl 5-Chloro 2

Methoxy

Benzoate)

33924-48-0 2.0 - 2.0

2 Niclosamide (5-Chloro-N-(2-

Chloro-4-Nitrophenyl)-2-

Hydroxybenzamide)

50-65-7 1.0 - 1.0

3 Amlodipine Besylate(3-Ethyl 5-

Methyl (4RS)-2- [(2-

Aminoethoxy)Methyl ]-4-(2-

chlorophenl)-6-Methyl-1,4-

Dihydropyridine-3,5-

Dicarboxylate

Benzenesulphonate)

111470-99-6 3.5 - 3.5

4 Glibenclamide (1-[[4-[2-[(5-

Chloro-2- ethoxybenzoyl)

Amino] Ethyl]Phenyl]Sulphonyl]-

3 Cyclohexylurea)

10238-21-8 3.3 - 3.3

GROUP- A

1 Acebrofylline 96989-76-3

--

12

12

2 Ambroxol Hydrchloride 15942-05-9

3 Bupropion Hydrochloride 31677-93-7

4 Celecoxib 169590-42-5

5 Doxofylline 69975-86-6

6 Drotaverine Hydrochloride 985-12-6

7 Etoricoxib 202409-33-4

8 Flubiprofen 5104-49-4

9 Phenazopyridine Hydrochloride 136-40-3

10 Phenyl Ephrine 61-76-7

11 Quetiapine Hemifumarate 111974-72-2

12 Telmisartan 144701-48-4

Page 4: PROPOSED EXPANSION OF BULK DRUGS AND BULK DRUG ...environmentclearance.nic.in/writereaddata/Online/TOR/28_Jun_2017... · DRUG INTERMEDIATES IN EXISTING MANUFACTURING UNIT of M/s

4

13 Valsartan 137862-53-4

GROUP- B

14 Bisoprolol Fumarate 66722-44-9

--

10

10

15 Brimonidine Tartrate 70359-46-5

16 Capacitabine 154361-50-9

17 Donepezil Hydrochloride 120011-70-3

18 Gemcitabin 122111-03-9

19 Glimepiride 93479-97-1

20 Glipizide 29094-61-9

21 Nevivolol Hydrochloride 152520-56-4

22 Pirfenidone 53179-13-8

23

Sofosbuvir

1190307-88-

0

24 Terbinafine Hydrochloride 78628-80-5

25 Ursodeoxycholic acid 128-13-2

GROUP- C

26 2 Amino Phenyl phenyl Sulfide 1134-94-7

--

15

15

27 Dibenzo Thio 3159-07-7

28 CDT (2-Chloro-1,3-

bis(dimentylamino)trimethinium

hexafluorophosphate )Salt 291756-76-8

29 DBDT (2,3-Dibenzoyl-D-Tartaric

acid) 17026-42-5

30 Phthaloyl Amlodipine 88150-62-3

TOTAL 9.8 37 46.8

1.3 Raw Material Requirement

List of Raw Materials and Their Capacity

SR. NO. Name of Raw Materials CAPACITY

(MT/Month)

Existing

1. G.C. Ester (Methyl 5-Chloro 2 Methoxy Benzoate)

1. 5-Chloro Salicylic Acid 1.744

2. Di-Methyl Sulphate 1.3

3. Caustic Soda Flakes 0.806

4. Catalyst 0.078

5. Soda Ash 0.32

Page 5: PROPOSED EXPANSION OF BULK DRUGS AND BULK DRUG ...environmentclearance.nic.in/writereaddata/Online/TOR/28_Jun_2017... · DRUG INTERMEDIATES IN EXISTING MANUFACTURING UNIT of M/s

5

6. Cyclohexanone 5.00

2. Niclosamide (5-Chloro-N-(2-Chloro-4-Nitrophenyl)-2-Hydroxybenzamide)

1. 1,4-Dioxane 2.00

2. 5-Chloro Salicylic Acid 0.666

3. O-Chloro P Nitro aniline 0.666

4. Thionyl chloride 0.460

5. Methanol 10.30

3.Amlodipine Besylate(3-Ethyl 5-Methyl (4RS)-2- [(2-Aminoethoxy)Methyl ]-4-(2-

chlorophenl)-6-Methyl-1,4-Dihydropyridine-3,5-Dicarboxylate Benzenesulphonate)

1. Phthloyal Amlodipine Hipure 2.8

2. Benzene Sulphonic Acid 0.525

3. Mono Methyl Amine 0.525

4. Methanol 7.00

5. Carbon/ Chacoal 0.07

6. Hyflow 0.035

7. Ethyl acetate 10.50

4. Glibenclamide (1-[[4-[2-[(5-Chloro-2- ethoxybenzoyl) Amino] Ethyl]Phenyl]Sulphonyl]-3

Cyclohexylurea)

1. 5-Chloro Salicylic Acid 1.188

2. Dimethyl Sulphate 1.485

3. Caustic Soda Flakes 1.478

4. Catalyst 0.099

5. Soda Ash 0.403

6. Sodium Metal 0.03

7. Methanol (Fresh) 42.90

8. Beta Phenyl Ethyl Amine 0.858

9. Ethylene Di Chloride (Fresh) 22.176

10. Hydrochloric Acid 0.990

Page 6: PROPOSED EXPANSION OF BULK DRUGS AND BULK DRUG ...environmentclearance.nic.in/writereaddata/Online/TOR/28_Jun_2017... · DRUG INTERMEDIATES IN EXISTING MANUFACTURING UNIT of M/s

6

11. ChloroSulphonic Acid 1.485

12. Liq. Ammonia 24.239

13. Acetone 25.328

14. Cyclo hexyl Isocyanate 0.825

15. Charcoal 0.66

16. Hyflow 0.066

Proposed

GROUP-A

1. Acebrofylline

1. Acefylline 4.80

2. Toluene 28.20

3. Ambroxol base 7.56

4. DMF 12.00

2. Ambroxol Hydrochloride

1. Toluene 28.80

2. 2 Amino 3,5 dibromo benzaldehyde 8.88

3. Trans-4-Amino cyclohexanol 3.60

4. Methanol 28.80

5. Sodium Borohydride 1.44

6. Activated Carbon 0.48

7. Methanolic HCl 5.16

3. Bupropion Hydrochloride

1. Toluene 30.00

2. 3-Chloro-2’-Bromo Propiophenone 12.00

3. tert butyl amine 4.20

4. 20% Methanolic HCl 9.75

5. Iso Propyl Alcohol 24.00

6. Carbon 0.30

Page 7: PROPOSED EXPANSION OF BULK DRUGS AND BULK DRUG ...environmentclearance.nic.in/writereaddata/Online/TOR/28_Jun_2017... · DRUG INTERMEDIATES IN EXISTING MANUFACTURING UNIT of M/s

7

4. Celecoxib

1. 4 SPH 8.40

2. Dione Deri 7.80

3. Toluene 33.60

4. Carbon 0.60

5. Doxofylline

1. Theofylline 10.40

2. 2-Bromomethyl-1,3-dioxolane 9.76

3. Sodium Carbonate 3.36

4. Dimethyl Formamide (DMF) 28.80

5. Carbon 0.16

6. Drotaverine Hydrochloride

1. 3,4-Diethoxy phenylacetic acid 6.60

2. 3,4-Diethoxy phenyl ethyl amine 6.05

3. Toluene 36.00

4. Sodium Hydroxide 0.60

5. Phosphorous oxychloride 5.52

6. IPA 18.00

7. Etoricoxib

1. Ketosulfone 10.20

2. DMF 30.00

3. CDT Salt 11.10

4. Potassium tert Butoxide 5.10

5. Toluene 24.00

6. Acetic Acid 3.60

7. IPA 18.00

8. Carbon 0.30

8. Flurbiprofen

1. 2,4-Difluoronitrobenzene 10.50

Page 8: PROPOSED EXPANSION OF BULK DRUGS AND BULK DRUG ...environmentclearance.nic.in/writereaddata/Online/TOR/28_Jun_2017... · DRUG INTERMEDIATES IN EXISTING MANUFACTURING UNIT of M/s

8

2. Diethyl methyl malonate 11.40

3. Sodium Hydroxide 9.45

4. Dimethylformamide 11.70

5. Toluene 64.50

6. Palladium Catalyst 0.21

7. Hydrogen 0.54

8. Methanol 34.50

9. Benzene 7.95

10. Copper Powder 1.74

11. Sodium Nitrite 5.85

12. Acetic Acid 5.40

13. Conc HCl 32.10

14. Carbon 0.15

9. Phenazopyridine Hydrochloride

1. Aniline 4.95

2. Conc HCl 7.80

3. Sodium Nitrite 3.75

4. 2,6 Diamino Pyridine 5.55

5. Acetone 30.00

6. HCl gas 2.04

10. Phenyl Ephrine Hydrochloride

1. m Hydroxy Acetophenone 13.50

2. Ethyl Acetate 19.80

3. Bromine 16.80

4. Toluene 67.80

5. N Methyl benzyl Amine 18.60

6. IPA.HCl 12.60

7. Palladium carbon 0.48

8. Methanol 40.20

Page 9: PROPOSED EXPANSION OF BULK DRUGS AND BULK DRUG ...environmentclearance.nic.in/writereaddata/Online/TOR/28_Jun_2017... · DRUG INTERMEDIATES IN EXISTING MANUFACTURING UNIT of M/s

9

9. Liq Ammonia 18.00

10. L Tartaric Acid 12.30

11. IPA 27.90

12. Acetic Anhydride 9.00

13. Sulfuric Acid 2.82

14. Methanolic HCl 12.00

15. Carbon 0.30

11. Quetiapine Fumarate

1. Dibenzo-1,4-thiazepine one 6.90

2. Thionyl chloride 6.00

3. Toluene 30.00

4. Piperazin ethoxy ethanol 5.55

5. Ethanol 36.00

6. Fumaric Acid 1.80

7. Acetic Acid 1.20

12. Telmisartan

1. 1,7'-Dimethyl-2'-propyl-2,5'-bibenzimidazole 7.80

2. Methyl 4'-(bromomethyl) biphenyl-2-carboxylate 7.92

3. Sodium carbonate 3.84

4. DMF 48.00

5. Methanol 39.60

6. Sodium hydroxide 1.44

7. Conc HCl 4.56

8. Carbon 0.24

13. Valsartan

1. Bromo OTBN 9.00

2. L Valine 4.20

3. Methanol 24.00

4. Thionyl Chloride 4.98

Page 10: PROPOSED EXPANSION OF BULK DRUGS AND BULK DRUG ...environmentclearance.nic.in/writereaddata/Online/TOR/28_Jun_2017... · DRUG INTERMEDIATES IN EXISTING MANUFACTURING UNIT of M/s

10

5. Ethyl Acetate 30.00

6. Conc HCl 6.90

7. Acetone 36.00

8. Valeryl Chloride 4.35

9. MDC 30.00

10. Sodium Azide 3.90

11. Caustic lye 1.50

12. Carbon 0.60

GROUP-B

14. Bisoprolol Fumarate

1. 4-hydroxy benzyl alcohol 3.75

2. 2- Isopropoxy ethanol 3.50

3. Amberlyst-15 1.25

4. Sodium Carbonate 3.50

5. Sodium Hydroxide 1.50

6. Epichlorohydrin 2.88

7. Toluene 27.50

8. Sodium borohydride 0.38

9. Methanol 31.25

10. Isopropyl amine 2.75

11. MDC 21.25

12. Acetone 40.00

13. Fumaric Acid 3.25

14. Carbon 0.30

15. Brimonidine Tartrate

1. Choro benzene 80.00

2. 5-Bromo-6-thiouredo quinoxaline 8.00

3. Ethylene diamine 5.00

4. Isopropyl alcohol 20.00

Page 11: PROPOSED EXPANSION OF BULK DRUGS AND BULK DRUG ...environmentclearance.nic.in/writereaddata/Online/TOR/28_Jun_2017... · DRUG INTERMEDIATES IN EXISTING MANUFACTURING UNIT of M/s

11

5. Conc HCl 25.00

6. Caustic Lye dilute 40.00

7. Methanol 90.00

8. L Tartaric Acid 5.50

9. Carbon 1.00

16. Capacitabine

1. 5 Fluoro Cytosine 5.00

2. MDC 75.00

3. 5-Methyltetrahydrofuran-2,3,4-triyl triacetate 10.75

4. Methanol 90.00

5. n Pentyl Chloroformate 11.25

6. Conc HCl 8.00

7. Caustic lye 5.00

8. Carbon 0.50

9. Ethyl acetate 62.50

10. n Heptane 2.50

17. Donepezil Hydrochloride

1. 2-[(1-Benzyl-4-piperidyl)methyl]-5,6-dimethoxy

inden-1-one 10.75

2. Methanol 55.00

3. Palladium Carbon 0.55

4. Hydrogen 2500 M3

5. Toluene 37.50

6. IPA 20.00

7. Carbon 0.25

8. IPA HCl 9.15

18. Gemcitabin

1. Dibenzoyl Lactum 32.50

2. Ethyl Acetate 125.00

3. Sodium bis(2-methoxyethoxy)- aluminumhydride 17.50

Page 12: PROPOSED EXPANSION OF BULK DRUGS AND BULK DRUG ...environmentclearance.nic.in/writereaddata/Online/TOR/28_Jun_2017... · DRUG INTERMEDIATES IN EXISTING MANUFACTURING UNIT of M/s

12

4. Tri ethyl amine 5.00

5. Methane Sulfonyl Chloride 32.50

6. Acetyl Cytosine 13.30

7. Trimethylsilyl chloride 2.30

8. Toluene 82.50

9. Liq Ammonia 17.50

10. Conc HCl 33.80

11. Acetone 25.00

12. Carbon 0.50

19. Glimepiride

1. Sulfonamide Derivative 10.00

2. Trans Iso Cyanate 6.00

3. Acetone 100.00

4. Potassium Carbonate 7.50

5. Methanol 40.00

6. Conc HCl 16.30

7. Carbon 2.50

20. Glipizide

1. Sulfonamide Derivative 8.00

2. Cyclo Hexyl Iso Cyanate 3.50

3. Acetone 80.00

4. Potassium Carbonate 5.00

5. Methanol 35.00

6. Conc HCl 16.30

7. Carbon 0.30

21. Nebivolol Hydrochloride

1. 6-Fluoro-2-(oxiran-2-yl)-3,4-dihydro-2H-chromene 10.00

2. Benzyl amine 3.25

3. TBAB 1.00

Page 13: PROPOSED EXPANSION OF BULK DRUGS AND BULK DRUG ...environmentclearance.nic.in/writereaddata/Online/TOR/28_Jun_2017... · DRUG INTERMEDIATES IN EXISTING MANUFACTURING UNIT of M/s

13

4. Toluene 30.00

5. IPA 37.50

6. Palladium on Carbon 0.25

7. Methanol 40.00

8. Carbon 0.50

9. HCl Gas 1.75

10. Hydrogen Gas 4000 M3

22. Pirfenidone

1. Di methyl formamide 22.50

2. Bromo benzene 10.80

3. Potassium Carbonate 5.50

4. 5-Methyl-1H-pyridin-2-one 1.90

5. Copper Oxide 7.00

6. Toluene 16.00

7. Sodium Hydroxide 3.00

8. Conc HCl 9.00

23. Sofosbuvir

1. Phenyl Phosphorodichloridate 5.25

2. (S)-Isopropyl 2-Amino propanoate hydrochloride 4.50

3. Potassium carbonate 4.25

4. DMF 20.00

5. TBAB 0.50

6. Ethyl Acetate 30.00

7. 1-((2R,3R,4R,5R)-3-fluoro-4-hydroxy-5-

(hydroxymethyl)-3-ethyltetrahydro-furan-2-

yl)pyrimidine-2,4(1H,3H)-dione

6.25

8. Methanol 25.00

9. Carbon 0.50

24. Terbinafine Hydrochloride

1. Naphthyl methyl chloride 6.25

Page 14: PROPOSED EXPANSION OF BULK DRUGS AND BULK DRUG ...environmentclearance.nic.in/writereaddata/Online/TOR/28_Jun_2017... · DRUG INTERMEDIATES IN EXISTING MANUFACTURING UNIT of M/s

14

2. Methyl amine 4.00

3. Toluene 30.00

4. 1 Chloro 6,6 Dimethylhept

-2-en-4-yne 5.75

5. Potassium Carbonate 3.50

6. DMF 37.50

7. IPA 20.00

8. HCl gas 2.25

9. Carbon 0.50

25. Ursodeoxycholic acid

1. 3-hydroxy-7-ketocholanic acid 10.80

2. Butanol 22.50

3. Sodium metal 1.50

4. Phosphoric acid 85% 9.30

5. Imidazole 2.30

6. Methanol 47.50

7. Sodium Hydroxide 1.50

8. Conc HCl 10.50

GROUP-C

26. 2 Amino Phenyl Phenyl Sulfide

1. Thio Phenol 9.60

2. 2 Nitro Chloro Benzene 12.90

3. Caustic Flakes 4.20

4. Raney Nickel 0.30

5. Methanol 60.00

6. Hydrogen gas 12000 M3

7. Nitrogen 1200 M3

27. Dibenzo[b,f][1,4]Thiazepin-11(10H)-One

1. 2 Amino phenyl phenyl sulfide 14.25

2. Poly Phosphoric Acid PPA 45.00

Page 15: PROPOSED EXPANSION OF BULK DRUGS AND BULK DRUG ...environmentclearance.nic.in/writereaddata/Online/TOR/28_Jun_2017... · DRUG INTERMEDIATES IN EXISTING MANUFACTURING UNIT of M/s

15

1.4 Water Requirement, Waste Water Generation and Treatment

Total water requirement will be 36.0 m3/day, which is met through GIDC water supply. Total

waste water generations will be 24.7 m3/day. Industrial effluent 20.2 m

3/day will be treated in

ETP consists of Primary treatment then it will be sent to CETP (M/s. ETL) for further treatment

and disposal. Domestic Waste water 4.5 m3/day will be disposed of through the specific tank &

Soak Pit System.

1.5 Air Pollution Source and Control Management

There will be flue gas emission from Boiler & Process Gas emission from Reaction Vessel.

• EXISTING (FLUE GAS EMISSION THROUGH STACK)

3. Ethyl Chloro formate 9.38

28. 2-Chloro-1,3-bis(dimentylamino)trimethinium hexafluorophosphate

1. Dimethylformamide 5.40

2. Chloroacetyl chloride 6.00

3. Phosphorus Oxychloride 8.25

4. Caustic Flakes 9.90

5. Hexafluoro phosphoric acid 13.50

29. 2,3-Dibenzoyl-D-Tartaric acid (DBDT)

1. Benzoyl Chloride 13.38

2. D Tartaric Acid 7.88

30. Phthaloyl Amlodipine

1. Ethyl-4-(2-phthalimido) ethoxy acetoacetate 10.50

2. o Chloro Benzaldehyde 4.95

3. Acetic Acid 1.50

4. Methyl 3 Amino Crotonate 4.20

5. Methanol 45.00

Page 16: PROPOSED EXPANSION OF BULK DRUGS AND BULK DRUG ...environmentclearance.nic.in/writereaddata/Online/TOR/28_Jun_2017... · DRUG INTERMEDIATES IN EXISTING MANUFACTURING UNIT of M/s

16

Sr.

No.

Stack

Attached to

Stack Height in

meter

Air Pollution

Control Measure

Parameter Permissible Limit

1.

Boiler

(0.9 TPH)

(Fuel: Agro Waste

Briquettes)

20 Cyclone + Water

Scrubber

PM

SO2

NOX

150 mg/Nm3

100 ppm

50 ppm

• EXISTING (PROCESS GAS EMISSION THROUGH STACK)

Sr.

No.

Stack

Attached to

Stack Height in

meter

Air Pollution

Control Measure

Parameter Permissible Limit

1.

Reaction Vessel

(Glibenclamide &

Niclosamide)

11 Alkali Scrubber

(Two Stage)

HCl

SO2

NH3

20 mg/Nm3

40 mg/Nm3

3 ppm

• PROPOSED (FLUE GAS EMISSION THROUGH STACK)

Sr.

No.

Stack

Attached to

Stack Height in

meter

Air Pollution

Control Measure

Parameter Permissible Limit

1.

Boiler

[Fuel: Agro waste

3000 kg/day]

20 Cyclone &

Water Scrubber

SPM

SO2

NOx

≤ 150 Mg/NM3

≤ 100 PPM

≤ 50 PPM

2 Boiler

[Natural Gas 10000

scm/day]

20 NA

3 D.G. Set

[HSD: 20 Lit/Hr]

11 --

• PROPOSED (PROCESS GAS EMISSION THROUGH STACK)

Sr.

No.

Stack

Attached to

Stack Height in

meter

Air Pollution

Control Measure

Parameter Permissible Limit

1.

Reaction vessel Two stage

Alkali

scrubber

11 SO2

HCl

NH3

< 40 Mg /NM3

< 20 Mg /NM3

< 3 PPM

Page 17: PROPOSED EXPANSION OF BULK DRUGS AND BULK DRUG ...environmentclearance.nic.in/writereaddata/Online/TOR/28_Jun_2017... · DRUG INTERMEDIATES IN EXISTING MANUFACTURING UNIT of M/s

17

1.6 Hazardous Waste

CAT.

NO.

HAZARDOUS

WASTE

Existing

Quantity Proposed

Quantity

Total

Quantity METHOD OF

DISPOSAL

28.6 Spent Solvent 111.67

MT/Month

138.33

MT/Month 250

MT/Month

Collection, Storage,

Transportation &

Recovered through in

house distillation or

send for distillation job

work to Authorized

Recycler, Reuse in

process or sale to

Authorized end users.

28.3 Spent Carbon 0.23

MT/Month

0.24

MT/Month

0.47

MT/Month

Collection, Storage,

Transportation & co-

processing in cement

industries or

incineration at CHWIF

20.3 Distillation

residue

1.5

MT/Month

-

1.5

MT/Month

31.1 Process Residue -- 3.45

MT/Month 3.45

MT/Month

28.1 Inorganic process

waste

3.16

MT/Month

-- 3.16

MT/Month

Collection, Storage,

Transportation &

disposal at common

TSDF

33.1 Discarded

Bags/Liners

83.33

Kg/Month

166.67

Kg/Month 250

Kg/Month

Collection, Storage,

Transportation,

Decontamination & sale

authorized vendor 33.1 Discarded

Containers/Drum

s/Carboys

416.67

Kg/Month

833.33

Kg/Month 1250

Kg/Month

5.1 Spent Oil 0.416

Lit/Month

4.584

Lit/Month 5 Lit./Month Collection, Storage,

Transportation & reuse

or sale to authorized

Reprocessor

35.3 ETP Waste -- 10

MT/Month 10

MT/Month

Collection, Storage,

Transportation &

disposal at common

TSDF

Page 18: PROPOSED EXPANSION OF BULK DRUGS AND BULK DRUG ...environmentclearance.nic.in/writereaddata/Online/TOR/28_Jun_2017... · DRUG INTERMEDIATES IN EXISTING MANUFACTURING UNIT of M/s

18

1.7 Green Belt

Total 1,500 sq. meter land area is available at site; out of this area around 495 sq. meter (33%)

area will be developed as greenbelt.

1.8 Power & Fuel Requirements

Power required : 125 KW (Existing)

: 400 KW (Proposed)

Source: DGVCL

D.G. Set : 150 KVA

Fuel Requirement:

Agro waste Briquettes: 1500 Kg/Day (Existing)

Agro waste Briquettes: 3000 Kgs/Day (Proposed)

Natural Gas: 10000 SCM/Day (Proposed)

HSD : 20 Lit/Hr (Proposed)

2.0 INTRODUCTION OF THE PROJECT/BACKGROUND INFORMATION

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

mining lease/letter of intent should be given.

Identification of the project and project proponent

M/s. Prudence Pharm Chem proposes expansion of Bulk Drugs and Bulk Drug intermediates in

existing manufacturing unit located at Plot no. 7407 & 7408, GIDC Estate, Ankleshwar-393 002,

Tal: Ankleshwar, Dist: Bharuch-393002, Gujarat.

List of Partners:

Sr.

No.

Name of Partners Residential. Address Phone No. Designation

1. Mr. Rameshkumar

Dhirubhai

Chodvadiya

Plot No. 2208/1, GIDC Colony

Residencies Area, Rameshwar

Park Society, Jaldhara Square

area, Ankleshwar-393002

9825205460

Managing

Partner

2. Mr. Vinubhai

Gopabhai

Chodvadiya

90/91, Yogeshwar Park society,

Nr. Dharmagar, A.K. Road, Surat-

395008

9825294402 Partner

3. Mr. Natubhai

Popatbhai

Chodvadiya

90-91, Yogeshwar Park society,

Nr. Dharmagar, A.K. Road, Surat-

395008

9825918064 Partner

Page 19: PROPOSED EXPANSION OF BULK DRUGS AND BULK DRUG ...environmentclearance.nic.in/writereaddata/Online/TOR/28_Jun_2017... · DRUG INTERMEDIATES IN EXISTING MANUFACTURING UNIT of M/s

19

4. Mr.

Ghanshyambhai

Dhirubhai

Chodvadiya

Plot No 2208/1, GIDC Colony

residencies Area, Near

Rameshwar Park Society,

Jaldhara Square area,

Ankleshwar-393002

9825737696 Partner

5. Mr. Vimal Natvarlal

Chodvadiya

Plot No 2208/1, GIDC Colony

residencies Area, Near

Rameshwar Park Society,

Jaldhara Square area,

Ankleshwar-393002

9727143007 Partner

2.2 Brief description of nature of the Project

Proposed Expansion of Bulk Drugs & Bulk Drug Intermediates in existing manufacturing unit.

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

The demand for products intended to be manufacture is increasing in the country by expanding

this unit, M/s. PPC will be able to meet the demand of various products locally. The project will

save forex as certain products import will be reduced. This will also generate direct and indirect

employment opportunity for various levels of people.

2.4 Demands-Supply Gap

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

have found that there is a big potential for the range of the products we are planning. These

products will be an addition to the current product as well as expansion of Bulk Drugs & Bulk

Drug Intermediates in existing manufacturing unit.

2.5 Imports vs. Indigenous production

Based on the current cost of indigenous raw materials and the non availability of some

materials, we will have to import some of the key raw materials as they are not available

indigenously. This will make us very competitive against imported finished products and we will

export of our finished products in the international market.

Page 20: PROPOSED EXPANSION OF BULK DRUGS AND BULK DRUG ...environmentclearance.nic.in/writereaddata/Online/TOR/28_Jun_2017... · DRUG INTERMEDIATES IN EXISTING MANUFACTURING UNIT of M/s

20

2.6 Export possibility

We shall explore the possibility of export the products.

2.7 Domestic/Export Markets

Our products have good demand in international market. We shall explore the possibility of

export the products.

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

M/s. Prudence Pharm Chem will give direct employment to local people based on qualification

and requirement. In addition to direct employment, indirect employment shall generate

ancillary business to some extent for the local population.

3.0 Project Description

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

No interlinked project has been submitted.

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

site layout) with coordinates.

Page 21: PROPOSED EXPANSION OF BULK DRUGS AND BULK DRUG ...environmentclearance.nic.in/writereaddata/Online/TOR/28_Jun_2017... · DRUG INTERMEDIATES IN EXISTING MANUFACTURING UNIT of M/s

21

• Map showing general

location.

Project

Site

Page 22: PROPOSED EXPANSION OF BULK DRUGS AND BULK DRUG ...environmentclearance.nic.in/writereaddata/Online/TOR/28_Jun_2017... · DRUG INTERMEDIATES IN EXISTING MANUFACTURING UNIT of M/s

22

• Specific location and project boundary

• Project Site (Google Map)

Page 23: PROPOSED EXPANSION OF BULK DRUGS AND BULK DRUG ...environmentclearance.nic.in/writereaddata/Online/TOR/28_Jun_2017... · DRUG INTERMEDIATES IN EXISTING MANUFACTURING UNIT of M/s

23

• Plot Layout

Page 24: PROPOSED EXPANSION OF BULK DRUGS AND BULK DRUG ...environmentclearance.nic.in/writereaddata/Online/TOR/28_Jun_2017... · DRUG INTERMEDIATES IN EXISTING MANUFACTURING UNIT of M/s

24

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

particularly the environmental considerations gone into should be highlighted.

Looking to the international market demand of the products it was decided by M/s.

Prudence Pharm Chem to expand existing facility.

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

• Existing operational unit

• Minor site clearance activities shall be carried out.

• The project site is located on level ground, which does not require any major land filling

for area grading work.

• Proximity to Raw Material suppliers.

• Site is very well connected by road and railway.

• Availability of Fuel, Power, TSDF, etc.

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

� Efficient transport facilities.

� Environment-friendly zone.

� Uninterrupted power supply.

3.4 Size or Magnitude of Operation

Please refer Section-1.2.1, Page No. 3.

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

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

Please refer Form-I, Annexure-III.

Page 25: PROPOSED EXPANSION OF BULK DRUGS AND BULK DRUG ...environmentclearance.nic.in/writereaddata/Online/TOR/28_Jun_2017... · DRUG INTERMEDIATES IN EXISTING MANUFACTURING UNIT of M/s

25

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

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

For raw material required along with quantity; Please refer Section-1.3, Page No. 4. We shall

procure the raw material as much as possible from domestic market and if there is no

availability of any raw material we will import. We shall explore the possibility of export the

finished products.

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

briefly outlined.

After expansion of the unit, possibility for reuse and recycle will be explored.

3.8 Availability of water its source, energy/power requirement and source should be

given.

Water Source

Total water requirement shall be met through GIDC Water Supply.

Power Requirement:

Power required : 125 KW (Existing)

: 400 KW (Proposed)

Source: DGVCL

D.G.Set :150 KVA

Fuel Requirement:

Agro waste Briquettes: 1500 Kg/Day (Existing)

Agro waste Briquettes: 3000 Kgs/Day (Proposed)

Natural Gas : 10000 SCM/Day (Proposed)

HSD : 20 Lit/Hr (Proposed)

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

management/disposal.

Please refer Please refer Form-I, Annexure-IV & VI.

Page 26: PROPOSED EXPANSION OF BULK DRUGS AND BULK DRUG ...environmentclearance.nic.in/writereaddata/Online/TOR/28_Jun_2017... · DRUG INTERMEDIATES IN EXISTING MANUFACTURING UNIT of M/s

26

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

purpose.

4.0 Site Analysis

4.1 Connectivity

• Site is very well connected by road

• Availability of fuel, power, TSDF, etc.

4.2 Land Form, Land Use and Land Ownership

Land Use will be incorporated in the EIA Study.

RECONNAISSANCE SURVEY OF EXISTING PLANT ANNUAL REPORT

MARKET ASSESSMENT

FINANCIAL REPORT

PROJECT REPORT

INTRODUCTION

MONITORING OF AIR, WATER & SOIL QUALITY & NOISE

LEVELS. DATA ON METEOROLOGY SOCIO-ECONOMIC STATUS

& BASIC AMENITIES. SITE VISITS BY AND INTERVIEWS WITH

LOCALS

BASELINE

ENVIRONMENTAL

STATUS

ENVIRONMENTAL INFORMATION CENTRE

CENTRAL GROUND WATER BOARD

GUJARAT POLLUTION CONTROL BOARD (GPCB)

PUBLIC HEALTH ENGINEERING DEPT.

AGRICULTURE DEPARTMENT

FOREST DEPARTMENT

IRRIGATION DEPARTMENT

EMPLOYMENT EXCHANGE

HEALTH CENTER

CENSUS DEPT.

INDIAN METEOROLOGICAL DEPT.

SOCIOECONOMIC

STATUS &

INFRASTRUCTURE

PROPOSED

PLANT

FACILITY DESCRIPTION

IMPACTS

METHODOLOGY OF

IMPACT

ASSESSMENT

IDENTIFICATION & ASSESSMENT OF IMPACTS

EVALUATION OF IMPACTS BY MATRIX METHOD

SOURCE OF INFORMATION OVERVIEW OF

E. I. A. STUDIES

ACTIVITIES

ENVIRONMENTAL

MANAGEMENT PLAN

DESCRIPTION OF EFFLUENT TREATMENT PLAN, AIR

POLLUTION CONTROL, HAZARDOUS WASTE MANAGEMENT,

GREEN BELT DEVELOPMENT MONITORING PROGRAM

RISK ANALYSIS

STUDIES &

DISASTER

MANAGEMENT PLAN

SAFETY, HEALTH & ENVIRONMENTAL POLICY, GUIDELINES BY

DIRECTOR GENERAL OF FACTORY SAFETY, MINISTRY OF LABOR. CONSEQUENCE ANALYSIS

PREPARATION OF DISASTER MANAGEMENT PLAN

Page 27: PROPOSED EXPANSION OF BULK DRUGS AND BULK DRUG ...environmentclearance.nic.in/writereaddata/Online/TOR/28_Jun_2017... · DRUG INTERMEDIATES IN EXISTING MANUFACTURING UNIT of M/s

27

4.4 Existing land use pattern (agriculture, non-agriculture, forest, water bodies (including

area under CRZ)), shortest distances from the periphery of the project to periphery of the

forests, national park, wild life sanctuary, eco sensitive areas, water bodies (distance from

HFL of the river), CRZ. In case of the notified industrial area, a copy of the Gazette

notification should be given.

Existing land use pattern will be incorporated in the EIA Study. CRZ Clearance is not

applicable.

4.5 Existing Infrastructure

Existing operating industry having Manufacturing plant, Adm. Bldg., Parking, Raw Material

Storage, etc.

4.6 Soil Classification

Soil Classification will be incorporated in the EIA Study.

4.7 Climatic data from secondary sources.

Climatic data will be incorporated in the EIA Study.

4.8 Social infrastructure available.

Various Programs/ Projects related to Social & Economic development of surrounded area

has been planned, which are as follows.

A) Natural Resource Management – The main focus of this program will be to maximize the

yield returns of the farmers through efficient management of existing resources &

extension of new agricultural practices.

1) Integrated Agricultural Growth Project – For improvement and use of the modern

techniques and thereby would certainly contribute to prosperity in the agriculture

sector and reduce the rural poverty by programs like Farmers Training, Nursery

Growing Trainings, Modern agriculture equipment distribution programs etc.

Page 28: PROPOSED EXPANSION OF BULK DRUGS AND BULK DRUG ...environmentclearance.nic.in/writereaddata/Online/TOR/28_Jun_2017... · DRUG INTERMEDIATES IN EXISTING MANUFACTURING UNIT of M/s

28

2) Animal Husbandry Projects – Various programs like health checkups & treatment,

vaccination program, Anti sterility camps, breed improvement etc. will be carried

out.

B) Income Generation Program -

1) Establishment of Self help groups.

2) Rural Entrepreneurship Development Program

3) Handcrafts Development Program

4) Vocational Training

5) Business process outsourcing

C) Health, Education & Infrastructure

1) Aids Awareness Program

2) General Health Camps

3) Innovative Teaching Methods

4) Adult Education

5) Sanitation

6) Infrastructure Development Projects

5.0 Planning Brief

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

planning/Development authority classification.

Type of Industry: Proposed expansion of Bulk Drugs & Bulk Drug Intermediates in existing

manufacturing unit.

5.2 Population Projection

Population Projection will be incorporated in the EIA Study

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

SR. NO. PARTICULAR AREA (m2)

Page 29: PROPOSED EXPANSION OF BULK DRUGS AND BULK DRUG ...environmentclearance.nic.in/writereaddata/Online/TOR/28_Jun_2017... · DRUG INTERMEDIATES IN EXISTING MANUFACTURING UNIT of M/s

29

1 Manufacturing Area 300

2 Raw Material Storage Area 150

3 Finished Product Storage Area 200

4 Effluent Treatment Plant 250

5 Green Belt 495

6 Utility 45

7 Office 30

8 Parking Area 15

9 Gate 15

Total 1,500

5.4 Assessment of Infrastructure Demand (Physical & Social)

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

unskilled people for the proposed expansion activity.

• Social Welfare

• Cordial relation with the villages shall be established and representation shall be made

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

5.5 Amenities/Facilities

Details of amenities available in study area

Population Projection will be incorporated in the EIA Study.

6.0 Proposed Infrastructure

6.1 Industrial Area (Processing Area)

Processing Area (Manufacturing Area, Utility , ETP Area, Office): 625 m2

6.2 Residential Area (Non Processing Area)

Non Processing Area (Raw material storage area, Finished Product Storage Area,

Parking Area, green belt, Gate): 875 m2

Green Belt: 495 m2

Page 30: PROPOSED EXPANSION OF BULK DRUGS AND BULK DRUG ...environmentclearance.nic.in/writereaddata/Online/TOR/28_Jun_2017... · DRUG INTERMEDIATES IN EXISTING MANUFACTURING UNIT of M/s

30

6.3 Green Belt

Total 1,500 sq. meter land area is available at site; out of this area around 495 sq. meter

(33%) area will be developed as greenbelt.

6.4 Social Infrastructure

• Water requirement will be met through GIDC Water Supply.

• Power supply by DGVCL.

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

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

• Site is very well connected by road

• Proximity to Raw Material suppliers

• Availability of sufficient land free from cultivation

• Availability of power facilities

• Availability of fuel

6.6 Drinking water Management (Source & Supply of water)

Total water requirement shall be met through GIDC Water Supply.

6.7 Sewerage System

Sewage pipes are laid in entire company for the removal and disposal of mainly non-

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

section of industry. These liquid wastes are sent to septic tank & soak pit.

6.8 Solid Waste Management

Please refer Form-I, Annexure-VI.

6.9 Power Requirement & Supply/Source

Please refer Section 1.8, Page No. 18 of this report.

Page 31: PROPOSED EXPANSION OF BULK DRUGS AND BULK DRUG ...environmentclearance.nic.in/writereaddata/Online/TOR/28_Jun_2017... · DRUG INTERMEDIATES IN EXISTING MANUFACTURING UNIT of M/s

31

7.0 Rehabilitation and Resettlement (R & R) Plan

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

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

There is no habitation on the proposed expansion project activity area and it is open

industrial land, so R & R policy is not applicable to this project.

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

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

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

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

8. Project Schedule & Cost Estimates

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

the project to be given).

We shall start construction of expansion project after getting EC & CTE and we shall start

production after applying for CCA.

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

project.

The total cost of the project after proposed expansion will be Rs. 5 crores .

9. Analysis of Proposal (Final Recommendations)

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

including tribal population, if any, in the area.

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

unskilled people for the proposed expansion project.

• Social Welfare shall be done.

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

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