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SEAC, Gujarat: Page 1 of 22 SEAC, Gujarat [TOR – Expansion Case] For TOR Expansion Case Basic Information of the Project: i Name & Address of the Project site (Complete details with plot no./Survey no., Landmark etc.) M/s. Bakul Pharma Pvt. Ltd. Plot No. 6201, GIDC Ankleshwar Dist.-Bharuch, Gujarat ii Name of the Applicant Mr. Rajesh Shah iii Address for correspondence M/s. Bakul Pharma Pvt. Ltd. Plot No. 6201, GIDC Ankleshwar Dist.-Bharuch, Gujarat iv Contact no. and e-mail ID of the Applicant Mo. no.: +919879112388 e-Mail: [email protected] v Aerial distance of nearest Habitat (KM) 1 km vi Longitude & Latitude of the Project Site: (4 corners of the site) Latitude Longitude 21°37'27.37"N 73° 2'38.17"E 21°37'27.21"N 73° 2'40.46"E 21°37'22.42"N 73° 2'40.06"E 21°37'22.61"N 73° 2'37.74"E vii Total cost of Proposed Project (Rs. in Crores): Existing: 7.07 Proposed: 1.00 Total: 8.07 viii Total Plot area (sq. meter) Existing: 9,916 Proposed: Nil Total: 9,916 ix Green belt area / Tree Plantation area (sq. meter) Existing: 2,250 Proposed: 1,050 Total: 3,300 x Category as per the Schedule to the EIA Notification 2006 i.e. 1(d), 2(b), 5(f) etc. 5(f) xi Applicability of General Conditions of EIA Notification 2006: i.e. Ensure that I. Protected areas notified under the Wildlife (Protection) Act, 1972; II. CEPI areas III. Eco-sensitive areas and IV. Inter-state boundaries and international boundaries; are not located within 5 km or 10 km (as the case may be) area from the boundary of the proposed site. I. Not applicable II. Not Applicable III. Not Applicable IV. Not Applicable Online application proposal no.: SIA/GJ/IND2/22012/2018 Date of application for TOR: 14/02/2018 Project status: Expansion Product profile: Existing Products Sr. No. Name of Products Capacity, TPM Status 1 Theobromine EP/BP AND / OR 6.5-10.00 Continue (Product- D2) 2 Doxofylline & Intermediate AND / OR 1.00 Continue
Transcript

SEAC, Gujarat: Page 1 of 22

SEAC, Gujarat [TOR – Expansion Case]

For TOR – Expansion Case

➢ Basic Information of the Project:

i Name & Address of the Project site (Complete details with plot no./Survey no., Landmark etc.)

M/s. Bakul Pharma Pvt. Ltd. Plot No. 6201, GIDC – Ankleshwar Dist.-Bharuch, Gujarat

ii Name of the Applicant Mr. Rajesh Shah

iii Address for correspondence M/s. Bakul Pharma Pvt. Ltd. Plot No. 6201, GIDC – Ankleshwar Dist.-Bharuch, Gujarat

iv Contact no. and e-mail ID of the Applicant Mo. no.: +919879112388

e-Mail: [email protected]

v Aerial distance of nearest Habitat (KM) 1 km

vi Longitude & Latitude of the Project Site: (4 corners of the site)

Latitude Longitude

21°37'27.37"N 73° 2'38.17"E

21°37'27.21"N 73° 2'40.46"E

21°37'22.42"N 73° 2'40.06"E

21°37'22.61"N 73° 2'37.74"E

vii Total cost of Proposed Project

(Rs. in Crores):

Existing: 7.07 Proposed: 1.00 Total: 8.07

viii Total Plot area (sq. meter)

Existing: 9,916 Proposed: Nil Total: 9,916

ix Green belt area / Tree Plantation area (sq. meter)

Existing: 2,250 Proposed: 1,050 Total: 3,300

x Category as per the Schedule to the EIA Notification 2006 i.e. 1(d), 2(b), 5(f) etc.

5(f)

xi Applicability of General Conditions of EIA Notification 2006: i.e. Ensure that

I. Protected areas notified under the Wildlife (Protection) Act, 1972;

II. CEPI areas III. Eco-sensitive areas and IV. Inter-state boundaries and

international boundaries; are not located within 5 km or 10 km (as the case may be) area from the boundary of the proposed site.

I. Not applicable II. Not Applicable III. Not Applicable IV. Not Applicable

➢ Online application proposal no.: SIA/GJ/IND2/22012/2018

➢ Date of application for TOR: 14/02/2018

➢ Project status: Expansion

➢ Product profile:

Existing Products

Sr.

No. Name of Products

Capacity,

TPM Status

1 Theobromine EP/BP AND / OR 6.5-10.00 Continue

(Product- D2)

2 Doxofylline & Intermediate AND / OR 1.00 Continue

SEAC, Gujarat: Page 2 of 22

SEAC, Gujarat [TOR – Expansion Case]

Sr.

No. Name of Products

Capacity,

TPM Status

(Product- B1)

3 Pentoxyphylline AND / OR 1.50 Continue

(Product- A1)

4 Proxyphylline AND / OR 0.125 Continue

(Product- B2)

5 Dorzolamide V AND / OR 0.270 Discontinued

6 Bamifylline HCl AND / OR 1.00 Continue

(Product- B3)

7 Tert Butyl Benzene

Sulphonamide AND / OR 0.30

Continue

(Product- B4)

8 Minoxydil AND / OR 0.50 Continue

(Product- C1)

9 Ganciclovir AND / OR 0.10 Forward integration to

manufacture Product-E2

10 Dorzolamide and

intermediates AND / OR 0.10

Continue

(Product- E1)

Total 10.0 (Max.) --

Product profile after proposed expansion

Sr.

No.

Name of Products &

Intermediates CAS No.

Capacity (TPM)

End Use Intermediate

Finished

Products

➢ GROUP A

A1 Pentoxyphylline &/OR 64935-6 -- 10.00

(Cumulativ

e capacity

of either

one or all

products)

Peripheral artery

disease

A2 Xanthinol Nicotinate &/OR 437-74-1 -- Vasodilator

A3 Caffeine Citrate 69-22-7 -- Central nervous

system stimulant

➢ GROUP B

B1 Doxofylline &

Intermediate &/OR 69975-86-6 --

13.00

(Cumulativ

e capacity

of either

one or all

products)

Central nervous

system stimulant

B1(i)

DOX -I (Bromo

Acetaldehyde

Dimethyl Acetal )

7252-83-7 11.06 Antifungal Drug

B1(ii)

DOX II ( 2-Bromo

Methyl 1,3 Dioxolane

)

4360-63-8 9.96 Anticancer Drug

B2 Proxyphylline &/OR 603-00-9 -- Antifungal Drug

B3 Bamifylline HCl &/OR 20684-06-4 --

Analgesic

,vasodilator ,

bronchodilator

B4

Tert Butyl Benzene

Sulphonamide

&/OR 6292-59-7 --

Intermediate for

Bosantan

(pulmonary

arterial

hypertension

B5 Acephylline &/OR 18833-13-1 -- Bronchodilator

SEAC, Gujarat: Page 3 of 22

SEAC, Gujarat [TOR – Expansion Case]

Sr.

No.

Name of Products &

Intermediates CAS No.

Capacity (TPM)

End Use Intermediate

Finished

Products

Piperazine and

Intermediates

B5(i) Acephylline 652-37-9 9.62 Bronchodilator

B6 Pamabrom &/OR 606-04-2

Diuretic

B6(i) 8 Bromo Theophylline 10381-75-6 9.69 Diuretic

B7 Urapidil 6972-27-6 -- Hypertensive

B7(i) UPD -I (1,3 Dimethyl

Barbituric Acid) 769-42-6 16.19 Hypertensive

➢ GROUP C

C1 Minoxydil &/OR 38304-91-5 --

5.00

(Cumulativ

e capacity

of either

one or all

products)

Male pattern

baldness

C2 Brinzolamide &

Intermediates &/OR 160982-11-6 --

To treat high

pressure inside

the eye due to

glucoma

C2(i)

BNZ -I [3 Acetyl -5-

Chloro -2-

(BenzylThiol )

Thiophene]

160982-09-

02 11.11

To treat high

pressure inside

the eye due to

glucoma

C2(ii)

BNZ II( 3 Acetyl -5-

Chloro Thiophene 2-

Sulphonamide)

160982-10-5 6.11

To treat high

pressure inside

the eye due to

glucoma

C3 Acebrophylline and

Intermediates &/OR 96989-76-3 --

Bronchodilation

,mucoregulation

C3(i) Ambroxol HCl - I 606-00-8 3.57 Bronchodilation

,mucoregulation

C3 (ii) Ambroxol HCl - II 50739-76-9 3.13 Bronchodilation

,mucoregulation

C3(iii) Ambroxol HCl - III 18683-91-5 3.26 Bronchodilation

,mucoregulation

C3(iv) Ambroxol Base - IV 23828-92-4 3.07 Bronchodilation

,mucoregulation

C4 Teneligliptin HBR &/OR 1572583-29-

9 -- Type -2 diabetic

C5 Linagliptin and

Intermediates

&/OR

668270-12-0 -- Anti diabetic

C5(i) 8BMX (8 - Bromo -3-

Methyl Xanthine ) 93703-24-3 3.90 Anti diabetic

C5(ii)

8 BB 3 MX ( 8 -

Bromo -7-(2-butyn-1-

yl)-3,7 - dihydro-3-

Methyl-1H Purine -2,6

-Dione

666816-98-4 4.59 Anti diabetic

C6 3 - Methyl -7- n -

propyl Xanthine 55242-64-3 --

As a intermediate

for vasodilator

SEAC, Gujarat: Page 4 of 22

SEAC, Gujarat [TOR – Expansion Case]

Sr.

No.

Name of Products &

Intermediates CAS No.

Capacity (TPM)

End Use Intermediate

Finished

Products

drug

➢ GROUP D

D1 Theobromine EP/BP &/OR 83-67-0 --

20.00

(Cumulativ

e capacity

of either

one or all

products)

Vasodilator

D1(i) 3- Methyl Xanthine 1076-22-8 30.49 Vasodilator

D2 Levocabastine &

Intermediate &/OR

--

Antihistamine ,

eye disease

D2 (i) Levocabastine - I

30.95 Antihistamine ,

eye disease

D2(ii) Levocabastine- II 26831-90-3 47.62 Antihistamine ,

eye disease

D2(iii) Levocabastine - III 25772-51-4 47.62 Antihistamine ,

eye disease

D2(iv) Levocabastine - IV

Pure 83863-65-4 19.05

Antihistamine ,

eye disease

D3 R& D Products -- --

➢ GROUP E

E1

Dorzolamide &

Intermediates (DRZ-

HCl)

&/OR 130693-82-2 --

1.00

(Cumulativ

e capacity

of either

one or all

products)

Ocular

hypertension treat

of glucoma

E1(i)

DRZ V B2 (5,6-

Dihydro-(R)-4-hydrox-

(S)-6-methyl- 4H-

thieno[2,3-b]

thiopyran -7,7-

dioxide)

147128-77-6 3.00

Ocular

hypertension treat

of glucoma

E1(ii) Dorzolamide VI B

Acetate 147086-83-7 3.30

Ocular

hypertension treat

of glucoma

E1(iii)

DRZ VII B (N-(5,6-

Dihydro-(S)-6-methyl-

4H-thieno[2,3-

b]thiopyran-4-yl)

acetamide 7,7-

dioxide)

147086-83-7 2.75

Ocular

hypertension treat

of glucoma

E1(iv)

DRZ IX B (DZ

Sulphonamide){4-

(Acetamido)-5,6-

dihydro-(S)-6-methyl-

4H-thieno [2,3-

b]thiopyran -2-

sulphonamide 7,7-

dioxide}

147200-03-1 1.75

Ocular

hypertension treat

of glucoma

E1(v) Dorzolamide X B -- 1.75

Ocular

hypertension treat

of glucoma

SEAC, Gujarat: Page 5 of 22

SEAC, Gujarat [TOR – Expansion Case]

Sr.

No.

Name of Products &

Intermediates CAS No.

Capacity (TPM)

End Use Intermediate

Finished

Products

E1(vi) Dorzolamide HCl

Crude -- 1.15

Ocular

hypertension treat

of glucoma

E2 ValGanciclovir &

Intermediate 175865-59-5

Anti viral

E2(i)

DAMP - I (1,3

Dichloro - Propane -2

-ol)

96-23-1 3.91 Anti viral

E2(ii)

DAMP II ( 1,3

Dichloro 2- Methoxy

Methoxy Propane )

70905-45-2 5.08 Anti viral

E2(iii)

DAMP III ( 2 -

Methoxy methoxy -

1,3 Propane Diyl

Diacetate )

103824-51-7 5.94 Anti viral

E2(iv)

DAMP IV ( 1,3

Diacetoxy -2-

(Acetoxy Methoxy )

Propane

86357-13-3 4.27 Anti viral

E2(v) GCV V ( TriAcetyl

Ganciclovir ) 86357-14-4 2.19 Anti viral

E2(vi) GCV VI ( Ganciclovir

) 82410-32-0

1.25 Anti viral

E2(vii) MAG ( Mono Acetyl

Ganciclovir ) 88110-89-8

1.00 Anti viral

ULTIMATE AFTER EXPANSION 49.00

The project falls under Category B of project activity 5(f) as per the schedule of EIA Notification 2006.

SEAC, Gujarat: Page 6 of 22

SEAC, Gujarat [TOR – Expansion Case]

➢ Product wise Raw material consumption after proposed expansion:

(A) For Proposed Products

Prod. Code

Product Name of Raw

Material

CAS no. of raw

materials

Raw Material Quantity, TPM

Existing Proposed Total

➢ GROUP A (Capacity: 10 TPM)

A1 Pentoxyphylline

Theobromine 83-67-0 1.14 6.44 7.58

Chloro Hexanone 10226-30-9 0.96 5.45 6.41

Potassium

Carbonate 584-08-7 0.61 3.48 4.09

Dimethyl Formamide 68-12-2 0.20 1.16 1.36

Methanol 67-56-1 0.26 1.45 1.71

Carbon 7440-44-0 0.12 0.69 0.81

A2 Xanthinol

Nicotinate

Epi Chloro hydrine 106-89-8 Nil 3.7 3.7

Methyl Amino

Ethanol 109-83-1

Nil 3.38 3.38

Sodium

Theophylline 3485-82-3

Nil 5.75 5.75

Iso Propyl Acohol 67-63-0 Nil 30.00 30.00

Nicotinic Acid 59-67-6 Nil 2.43 2.43

A3 Caffeine Citrate Caffeine 58-08-2 Nil 5.00 5.00

Citric Acid 77-92-9 Nil 5.00 5.00

➢ GROUP B (Capacity: 13 TPM)

B1 Doxofylline &

Intermediate

Vinyl Acetate 108-05-4 0.59 7.15 7.74

Methanol 67-56-1 1.15 13.79 14.94

Bromine 7726-95-6 1.11 13.27 14.38

Methylene

Dichloride 75-09-2 0.19 2.30 2.49

Para Toluene

Sulfonic Acid 104-15-4 0.02 0.20 0.22

Mono Ethylene

Glycol 107-21-1 0.30 3.63 3.93

Dimethyl Formamide 68-12-2 0.11 1.27 1.38

Theophylline 58-55-9 0.77 9.85 9.96

SEAC, Gujarat: Page 7 of 22

SEAC, Gujarat [TOR – Expansion Case]

Prod. Code

Product Name of Raw

Material

CAS no. of raw

materials

Raw Material Quantity, TPM

Existing Proposed Total

Potassium

Carbonate 584-08-7 0.32 3.83 4.15

Carbon 7440-44-0 0.04 0.51 0.55

B2 Proxyphylline

Theophylline 58-55-9 0.175 18.025 18.20

Iso Propyl Acohol 67-63-0 0.05 5.15 5.2

Propylene Oxide 75-56-9 0.17 17.51 17.68

Caustic Soda Lye 1310-73-2 0.05 5.15 5.2

Methylene

Dichloride 75-09-2

0.1 10.3 10.4

Carbon 7440-44-0 0.02 2.06 2.08

B3 Bamifylline HCl 8 Benzyl

Theophylline 2879-15-4

0.74 8.87 9.61

2 Ethyl Amino

Ethanol 110-73-6

0.38 4.59 4.97

Soda Ash 497-19-8 0.59 7.10 7.69

Ethylene dichloride 107-06-2 3.30 39.66 42.96

1:4 Dioxane 123-91-1 2.74 32.87 35.61

Ethyl Acetate 141-78-6 0.22 2.61 2.83

Sodium Sulphate 7757-82-6 0.22 2.61 2.83

Carbon 7440-44-0 0.04 0.53 0.57

Ethyl Acetate 141-78-6 0.04 0.53 0.57

Methanol 67-56-1 1.74 20.87 22.61

IPA Hydrochloric

Acid 7647-01-0

0.74 8.87 9.61

Acetone 67-64-1 0.61 7.30 7.91

B4 Tert Butyl

Benzene

Sulphonamide

Chlorosulphonic

Acid 7790-94-5

1.26 53.34 54.60

Tertiary butyl

benzene 98-06-6

0.50 21.17 21.67

Methylene Di-

Chloride 75-09-2

0.52 21.84 22.36

SEAC, Gujarat: Page 8 of 22

SEAC, Gujarat [TOR – Expansion Case]

Prod. Code

Product Name of Raw

Material

CAS no. of raw

materials

Raw Material Quantity, TPM

Existing Proposed Total

Ammonia 7664-41-7 0.60 25.40 26.00

Hexane 110-54-3 2.94 124.46 127.4

B5 Acefylline

Piperazine and

intermediates

Theophylline 58-55-9 Nil 7.69 7.69

Monochloro Acetic

Acid 79-11-8

Nil 5.62 5.62

Caustic Soda Lye 1310-73-2 Nil 7.69 7.69

Hydrochloric Acid 7647-01-0 Nil 3.27 3.27

Carbon 7440-44-0 Nil 0.19 0.19

Piperazine 110-85-0 Nil 3.38 3.38

B6 Pamabrom Theophylline 58-55-9 Nil 8.07 8.07

Acetic Acid (Glacial) 64-19-7 Nil 4.84 4.84

Sodium Acetate 127-09-3 Nil 8.07 8.07

Bromine 7726-95-6 Nil 8.07 8.07

2 Amino -2 Methyl 1

Propanol 124-68-5

Nil 3.31 3.31

B7 Urapidil 1,3 Dimethyl Urea 96-31-1 Nil 12.26 12.26

Malonic Acid 141-82-2 Nil 15.89 15.89

Acetic Anhydride 108-24-7 Nil 1.28 1.28

Iso Propyl Alcohol 67-63-0 Nil 66.47 66.47

Phosphorous

Oxytrichloride 10025-87-3

Nil 19.13 19.13

Methylene

Dichloride 75-09-2

Nil 2.45 2.45

➢ GROUP C (Capacity: 5 TPM)

C1 Minoxydil 2,4 Di Amino-6-

chloro Pyrimidine 156-83-2

1.10 9.90 11

Hydrogen Peroxode 7722-84-1 1.00 9.00 10

Sodium sulphite 7757-83-7 0.15 1.35 1.5

Piperidine 110-89-4 1.85 16.65 18.5

Methanol 67-56-1 0.80 7.20 8

SEAC, Gujarat: Page 9 of 22

SEAC, Gujarat [TOR – Expansion Case]

Prod. Code

Product Name of Raw

Material

CAS no. of raw

materials

Raw Material Quantity, TPM

Existing Proposed Total

Carbon 7440-44-0 0.05 0.45 0.5

C2 Brinzolamide &

Intermediates

3 Acetyl 2,5 Dichloro

Thiophene 36157-40-1

Nil 8.33 8.33

Thiourea 62-56-6 Nil 3.59 3.59

Benzyl Chloride 100-44-7 Nil 6.41 6.41

Iso Propyl Alcohol 67-63-0 Nil 14.89 14.89

Sodium Hydroxide 1310-73-2 Nil 6.72 6.72

Sodium Hypo

Chlorite (10%) 7681-52-9

Nil 11.11 11.11

Ethyl acetate 141-78-6 Nil 11.11 11.11

Chlorine gas 7782-50-5 Nil 10.56 10.56

Ammonia 7664-41-7 Nil 45.00 45.00

Methyl Tertiary Butyl

Ether 1634-04-4

Nil 2.78 2.78

Pyridinium Per

Bromide 39416-48-3

Nil 7.89 7.89

Con Sulfuric Acid 7664-93-9 Nil 6.22 6.22

Methylene Di-

Chloride 75-09-2

Nil 2.22 2.22

C3 Acebrophylline

and

intermediates

Methyl Anthranilate 134-20-3 Nil 1.79 1.79

Methanol 67-56-1 Nil 1.79 1.79

Bromine 7726-95-6 Nil 2.32 2.32

Hyrogen Peroxide 7722-84-1 Nil 0.71 0.71

Ammonia gas 7664-41-7 Nil 0.09 0.09

Tetra hydrofuran 109-99-9 Nil 4.73 4.73

Sodium BoroHydride 16940-66-2 Nil 1.26 1.26

Hydrochloric Acid 7647-01-0 Nil 0.85 0.85

Toluene 108-88-3 Nil 0.71 0.71

Mangnese Dioxide 1313-13-9 Nil 3.13 3.13

Trans 4 Amino

Cyclo Hexanol 27489-62-9

Nil 1.09 1.09

SEAC, Gujarat: Page 10 of 22

SEAC, Gujarat [TOR – Expansion Case]

Prod. Code

Product Name of Raw

Material

CAS no. of raw

materials

Raw Material Quantity, TPM

Existing Proposed Total

Carbon 7440-44-0 Nil 0.36 0.36

Iso Propyl Alcohol 67-63-0 Nil 12.28 12.28

Con Hydrochloric

Acid 7647-01-0

Nil 1.07 1.07

Caustic Lye 1310-73-2 Nil 0.46 0.46

Acephylline 652-37-9 Nil 1.93 1.93

C4 Teneligliptin

HBR

Piperazine

Compound 401566-79-8

Nil 3.33 3.33

Toluene 108-88-3 Nil 14.17 14.17

Acetic Acid 64-19-7 Nil 1.10 1.10

Ester compound 401564-36-1 Nil 3.33 3.33

Sodium Tri acetoxy

Borohydride 56553-60-7

Nil 3.33 3.33

Sodium Bicarbonate

(10%) 144-55-8

Nil 20.00 20.00

Iso Propyl Alcohol 67-63-0 Nil 23.33 23.33

Carbon 7440-44-0 Nil 0.17 0.17

Aq HBr (48%) 10035-10-6 Nil 6.00 6.00

Methanol 67-56-1 Nil 12.83 12.83

C5 Linagliptin and

intermediates

3-methyl Xanthine 1076-22-8 Nil 2.75 2.75

Glacial Acetic Acid 64-19-7 Nil 14.45 14.45

Sodium Acetate 127-09-3 Nil 2.75 2.75

Bromine 7726-95-6 Nil 2.75 2.75

Dimethyl Formamide 68-12-2 Nil 66.51 66.51

Pottasium

Bicarbonate 298-14-6

Nil 9.68 9.68

1-Bromo -2-Butyne 3355-28-0 Nil 2.34 2.34

Tertiary butyl

ammonium Bromide 1643-19-2

Nil 0.05 0.05

2-(Chloro methyl ) 4

Methyl quinozoline 91348-86-6

Nil 3.58 3.58

SEAC, Gujarat: Page 11 of 22

SEAC, Gujarat [TOR – Expansion Case]

Prod. Code

Product Name of Raw

Material

CAS no. of raw

materials

Raw Material Quantity, TPM

Existing Proposed Total

Methanol 67-56-1 Nil 59.63 59.63

Methyl Isobutyl

Ketone 108-10-1

Nil 2.29 2.29

R – Piperidine -3-

Amine

dihydrochloride

334618-23-4

Nil

3.12 3.12

Acetic acid Solution

(6 %) 64-19-7

Nil 5.78 5.78

2 - Butanol 78-92-2 Nil 0.92 0.92

Caustic solution

(9%) 1310-73-2

Nil 22.94 22.94

Methyl tertiary butyl

ether 1634-04-4

Nil 34.40 34.40

Ethyl Acetate 141-78-6 Nil 25.23 25.23

C6 3 - Methyl -7- n -

propyl Xanthine

3 Methyl Xanthine 1076-22-8 Nil 6.00 6.00

n propyl Bromide 106-94-5 Nil 5.52 5.52

Potassium

Carbonate 584-08-7

Nil 6.00 6.00

Di methyl Formaide 68-12-2 Nil 2.36 2.36

Hydrochloric Acid 7647-01-0 Nil 0.24 0.24

➢ GROUP D (Capacity: 20 TPM)

D1 Theobromine

EP/BP

Nitroso 6972-78-7 10.67 10.67 21.34

Formic Acid 64-18-6 24.39 24.39 48.78

Catalyst A -- 1.83 1.83 3.66

Catalyst B -- 33.535 33.535 67.07

Caustic Lye 1310-73-2 152.44 152.44 304.88

Hydrochloric Acid 7647-01-0 28.05 28.05 56.10

Catalyst C -- 8.08 8.08 16.16

Poly ethyl glycol 400 25322-68-3 2.99 2.99 5.98

Dimehtyl sulfate 77-78-1 9.91 9.91 19.82

Activated Carbon 7440-44-0 0.23 0.23 0.46

SEAC, Gujarat: Page 12 of 22

SEAC, Gujarat [TOR – Expansion Case]

Prod. Code

Product Name of Raw

Material

CAS no. of raw

materials

Raw Material Quantity, TPM

Existing Proposed Total

Hydro 7775-14-6 0.185 0.185 0.37

D2 Levocabastine

& Intermediate

Propylene Oxide 75-56-9 Nil 15.71 15.71

Mono Ethanol

Amine 141-43-5

Nil 4.76 4.76

Sodium Carbonate 497-19-8 Nil 14.29 14.29

Para Toluene

Sulphonyl Chloride 98-59-9

Nil 50.00 50.00

Methylene Di-

Chloride 75-09-2

Nil 32.86 32.86

Iso Propyl Alcohol 67-63-0 Nil 61.90 61.90

Petroleum ether 8032-32-4 Nil 166.67 166.67

Xylene 1330-20-7 Nil 4.29 4.29

Thionyl Chloride 7719-09-7 Nil 2.86 2.86

Toluene 108-88-3 Nil 476.19 476.19

Sodium Amide 7782-92-5 Nil 19.05 19.05

Phenyl Acetonitrile 140-29-4 Nil 47.62 47.62

Methanol 67-56-1 Nil 347.62 347.62

Potassium

Hydroxide 1310-58-3

Nil 20.95 20.95

Mono Ethylene

Glycol 107-21-1

Nil 211.43 211.43

Con Hydrochloric

Acid 7647-01-0

Nil 43.81 43.81

D3 R& D Products -- --

-- -- --

➢ GROUP E (Capacity: 1 TPM)

E1 Dorzolamide &

Intermediates

(DRZ-HCl)

Methyl Hydroxy

Butyrate 3976-69-0

0.43 3.83 4.25

Para Toluene

Sulphonyl Chloride 98-59-9

0.88 7.88 8.75

Pyridine 110-86-1 1.03 9.23 10.25

Tetra hydrofuran 109-99-9 2.05 18.45 20.5

Magnesium Turning 7439-95-4 0.12 1.08 1.2

SEAC, Gujarat: Page 13 of 22

SEAC, Gujarat [TOR – Expansion Case]

Prod. Code

Product Name of Raw

Material

CAS no. of raw

materials

Raw Material Quantity, TPM

Existing Proposed Total

2 Bromo Thiophene 1003-09-4 0.60 5.40 6

Sulphur 7704-34-9 0.13 1.17 1.3

Toluene 108-88-3 0.32 2.88 3.2

Hydrochloric Acid 7647-01-0 0.75 6.75 7.5

Sodium Sulphate

(anhydrous) 7757-82-6

0.13 1.13 1.25

Toluene 108-88-3 0.01 0.05 0.05

Tri Ethyl Amine 121-44-8 0.48 4.28 4.75

Con Hydrochloric

Acid 7647-01-0

3.40 30.60 34

Tri fluoro acetic

anhydride 407-25-0

0.60 5.40 6

Common salt 7647-14-5 0.25 2.25 2.5

Sodium Boro

Hydride 16940-66-2

0.19 1.71 1.9

Sulphuric Acid 7664-93-9 4.65 41.81 46.45

10 % Caustic

Solution 1310-73-2

0.10 0.90 1

Ethyl Acetate 141-78-6 1.15 10.35 11.5

Sodium Tungstate 13472-45-2 0.08 0.68 0.75

Hydrogen Peroxide

(50%) 7722-84-1

0.45 4.05 4.5

Sodium

Sulphite(10%) 7757-83-7

2.00 18.00 20

Activated Carbon 7440-44-0 0.08 0.72 0.8

Thionyl Chloride 7719-09-7 0.50 4.50 5

Dimethyl Formamide 68-12-2 0.33 2.97 3.3

Potassium Acetate 127-08-2 0.30 2.70 3

Acetonitrile 75-05-8 2.60 23.40 26

Caustic Soda Lye 1310-73-2 2.88 25.88 28.75

Chlorosulphonic 7790-94-5 1.00 9.00 10

SEAC, Gujarat: Page 14 of 22

SEAC, Gujarat [TOR – Expansion Case]

Prod. Code

Product Name of Raw

Material

CAS no. of raw

materials

Raw Material Quantity, TPM

Existing Proposed Total

Acid

Ammonia 7664-41-7 0.40 3.60 4

Boron trifluoride

Etherate 109-63-7

0.49 4.41 4.9

Acetone 67-64-1 0.01 0.05 0.05

Sodium Bicarbonate 144-55-8 2.88 25.88 28.75

Iso Propyl Alcohol 67-63-0 0.73 6.53 7.25

Acetonitrile 75-05-8 0.35 3.15 3.5

Di Para Tolyl L –

Tartaric Acid 32634-66-5

0.18 1.58 1.75

IPA.Hydrochloric

Acid 7647-01-0

0.25 2.25 2.5

E2 Ganciclovir &

intermediate

Epi Chloro Hydrine 106-89-8 0.30

2.67 2.97

Hyrochloric Acid

(30%) 7647-01-0 0.42 3.74

4.16

Methylene Di-

Chloride 75-09-2 0.22 1.94

2.16

Chloroform 67-66-3 0.04 0.35 0.39

Methylal 109-87-5 0.53 4.78 5.31

Phosphorous

Pentoxide 1314-56-3 0.23 2.11

2.34

Potassium Acetate 127-08-2 0.61 5.48 6.09

Dimethyl Formamide 68-12-2 0.10 0.92 1.02

Toluene(Recovered) 108-88-3 1.38 12.45 13.83

Acetic Anhydride 108-24-7 0.45 4.05 4.50

BF3 Etherate 109-63-7 0.02 0.14 0.16

Sodium

bicarobonate 144-55-8 0.31 2.82

3.13

Diacetyl Guanine 3056-33-5 0.27 2.46 2.73

N-7 Isomer -- 0.22 1.97 2.19

SEAC, Gujarat: Page 15 of 22

SEAC, Gujarat [TOR – Expansion Case]

Prod. Code

Product Name of Raw

Material

CAS no. of raw

materials

Raw Material Quantity, TPM

Existing Proposed Total

Methanol 67-56-1 0.54 4.88 5.42

ActivatedCarbon 7440-44-0 0.02 0.20 0.22

Acetone 67-64-1 1.56 14.07 15.63

Di methyl amine

(40%) 124-40-3 1.56 14.07

15.63

Dimethyl sulphoxide 67-68-5 0.14 1.24 1.38

Trimethyl ortho

Acetate 1445-45-0

0.34 3.02 3.36

Para Toluene

Sulphonic Acid 104-15-4 0.01 0.12

0.13

Isopropyl acetate 108-21-4 0.47 4.22 4.69

CBZ -L- Valine 1149-26-4 0.27 2.39 2.66

DicycloHexyl

Carbodimide 538-75-0 0.22 1.94

2.16

petroleum Ether 8032-32-4 0.98 8.79 9.77

Piperidine 110-89-4 0.17 1.55 1.72

Aq. HCl (5%) 7647-01-0 4.30 38.67 42.97

Palldium charcoal 7440-05-3 0.01 0.05 0.06

Hydrogen gas 12385-13-6 0.003 0.03 0.03

SEAC, Gujarat: Page 16 of 22

SEAC, Gujarat [TOR – Expansion Case]

➢ Compliance status of the existing project:

Sr. no.

Particulars Brief Information/Details Remarks

1 Earlier EC details The unit has obtained Environmental Clearance (EC) for their existing unit with proposed expansion in year 2009. However, due to MoEF&CC Office Memorandum J-11013/5/2010-IA.II(I) dated 13/01/2010 for restricting expansion / new projects in certain critically polluted area of the country, the unit has not implemented proposed expansion granted through EC. The unit has kept its original production continued which has been granted vide CC&A.

2 Compliance of EC Not applicable

3 Status of inspection by RO-MoEFCC, Bhopal.

Not applicable

4 Status of submission of half yearly return to concern authorities.

Not applicable

5 Compliance of existing CC&A Unit is complying with all the conditions stipulated in existing CC&A

6 Legal actions/Closure directions/SCN etc. issued by GPCB.

None

7 Any Public Complaints None

8 Is there any litigation pending before any court of Law against the Project?

No

➢ Water, Air and Hazardous waste management:

Sr. No.

Particulars Details

A Water

i

Source of Water Supply (GIDC, Bore well, Surface water etc...)

GIDC

Status of permission from the concern authority.: Permission obtained from GIDC vide letter no. GIDC/DEE(W/S)/757 dated 13/04/2017

ii Water consumption (KL/day)

-

Category Existing KL/day

Proposed (Additional)

KL/day

Total after Expansion

KL/day Remarks

(A) Domestic 10.0 3.0 13.0

(B) Gardening 3.0 7.0 10.0

(C) Industrial

Process 48.0 43.0 91.0

APCM -- 9.5 9.5

Boiler 25.0 10.0 35.0

Cooling 30.0 0.0 30.0

SEAC, Gujarat: Page 17 of 22

SEAC, Gujarat [TOR – Expansion Case]

Washing *10.0 15.0 20.0

*as per existing practice 5KLD treated effluent is

reused, which will be satisfied through fresh water after proposed

expansion.

ETP-RO Washing 2.0 3.0 5.0

Total (A+B+C) **128.0 90.5 213.5

(FRESH)

** For existing, Fresh: 123 Reuse: 5

-

iii Waste water generation (KL/day)

-

Category Existing KL/Day

Proposed (Additional)

KL/day

Total after Expansion

KL/day Remarks

(A) Domestic 8.0 2.0 10.0

(B) Industrial

Process 56.70 62.8 119.5

APCM -- 12.5 12.5

Boiler 2.0 1.0 3.0

Cooling 2.0 0.0 2.0

Washing 10.0 10.0 20.0

ETP-RO Washing 2.0 3.0 5.0

Total Industrial waste water

*72.2 89.3 162.0

*Generation: 72.2 Reuse: 5.0

Discharge: 67.7

-

iv Treatment facility with capacity (ETP, CETP, MEE, STP etc).

ETP : Hydraulic Load 37 KLD ETP capacity 100KLD CETP of ETL : 20.0 KLD Ammonical stream Common MEE of ACPTCL : 95.3 KLD Common Incineration : 9.8 KLD

v Mode of Disposal & Final meeting point

Domestic: 10 KLD To soak pit through septic tank OR send to CETP of ETL

Industrial: 162 KLD To FETP of NCTL : 46.7 KLD To CETP of ETL: 20 KLD To Common MEE: 95.3 KLD

vi Reuse/Recycle details (KL/day) NIL

B Air (Existing and Proposed)

i Flue gas emission details No. of Boilers/TFH/Furnaces/DG sets etc. with capacities viz. TPH, Kcal/hr, MT/hr, KVA etc.

SEAC, Gujarat: Page 18 of 22

SEAC, Gujarat [TOR – Expansion Case]

-

SR.

no.

Source of

emission

With

Capacity

Stack

Height

(meter)

Name

of the

fuel

Quantity of

Fuel MT/hr &

MT/Day

Type of

emissions

i.e. Air

Pollutants

APCM

NAAQS

(National

Ambient

Air Quality

Standards)

1

Boiler *

(2 TPH)

25.0 Natural

Gas

Existing:

1,760SCM/Day

Proposed:

4,240

SCM/Day

Total: 6,000

SCM/Day

PM SO2 NOx

Adequate

Stack

Height as

per CPCB

guidelines PM: 100 µg/m3

SO2:

80 µg/m3

NOx: 80 µg/m3

Boiler

(5 TPH)

2 DG Set

(140 KVA) 3.0 Diesel

40 Lit/hr PM SO2 NOx

Adequate

Stack

Height as

per CPCB

guidelines

3 DG Set

(125 KVA) 3.0 Diesel

4 DG Set

(500 KVA) 15 Diesel 105 Lit/hr

PM SO2 NOx

Adequate

Stack

Height as

per CPCB

guidelines

*Existing boiler of 2 TPH and DG sets of 140 KVA & 125 KVA to be dismantled after proposed

expansion due to installation of Steam boiler of 5 TPH & DG set of 500 KVA.

-

ii Process gas i.e. Type of pollutant gases (SO2, HCl, NH3, Cl2, NOx etc.) (Existing and Proposed)

-

Sr.

no.

Source of

emission

Type of

emission

Stack/Vent

Height

(meter)

APCM

NAAQS

(National

Ambient Air

Quality

Standards)

1

Reactors of

Process Plant

(Theobromine

EP/BP and

Dorzolamide &

Intermediates)

Fumes &

Vapors of

HCl gas

HCl gas

SO2 gas

19.0 Two stage alkali

scrubber

HCl < 20

SO2 < 40

2

Reactors of

Proces Plant

(Levocabastine)

HCl gas

SO2 gas

NH3 gas

20 Two stage alkali

scrubber

HCl < 20

SO2 < 40

NH3 < 175

-

v Fugitive emission details with its mitigation measures. (Existing and Proposed)

There will be a chance of fugitive emission and odour nuisance during manufacturing process as

SEAC, Gujarat: Page 19 of 22

SEAC, Gujarat [TOR – Expansion Case]

well as due to storage & handling of raw materials and products. The unit takes following adequate measures for control of fugitive emission and will implement the same for the proposed expansion.

Probable Sources Control Measures

Manufacturing activities during

charging into reactors

• Liquid raw materials are charged by pumping & closed

loops.

• Dosing is done by metering system to avoid fugitive

emissions.

• Dedicated measuring tanks are provided to each reactor.

• Usage of closed handling system for odorous chemicals

/solvents as far as possible.

Solvent recovery during filling

and withdrawal from tanks and

vessels

• Breather valves, PSVs, Rupture discs will be installed for process/storage tank vents.

• Vapor recovery systems shall be provided at required locations.

• Proper Control of the operating parameters, mainly temperature, vacuums, cooling media circulation, during plant operation and solvent recovery.

Chemical vapor from wet cake

in filtration and drying area

• Covered transfer systems will be adopted, workers shall be provided PPE.

• Fume extraction systems will be provided, wherever required

Emission from bulk storage

tanks during storage, loading,

unloading

• Breather valves, PSVs, Rupture disc, Vapor recovery

system are installed for process/storage tank vents.

• Unit adopts bulk handling of odorous chemicals and avoid

usage of drums/carboys for such materials

Hazardous chemical storage

area

• Dedicated storage area is provided

• Adequate ventilation systems are provided

• All the containers are kept tightly closed

• Trolley/Forklift is used for transfer of drums and

containers

• Transfers of odorous waste is preferably during day time.

Transfers during odd hours is avoided.

Solvent recovery During filling

and withdrawal from tanks and

vessels

• Breather valves, PSVs, rupture discs are installed for

process/storage tank vents.

• Vapor recovery systems are provided at required

locations.

• Operating parameters are controlled properly, mainly

temperature, vacuums, cooling media circulation, during

plant operation.

Chemical vapor from wet cake

in filtration and drying area

• Covered transfer systems are adopted, workers are

provided with PPE.

• Fume extraction systems are provided, wherever

required.

Pump and compressor

Emissions

• Mechanical seals are provided in pumps and agitators

• Standby arrangement for critical equipment and parts is

ensured.

• Drip trays will be placed for each pump to collect

leakages and spillages.

Pressure relief valve emission

from pipelines

• For highly pressurized lines, vent pipes of PRVs are

connected in case of toxic gases.

SEAC, Gujarat: Page 20 of 22

SEAC, Gujarat [TOR – Expansion Case]

Valves, Flanges, plugs and

instrument connections

• Welded pipes are used wherever feasible.

• Suitable gasket materials are used.

• Suitable glad packing is used in valves.

• Periodic inspection and maintenance of pipes and pipe

fittings is carried out.

Release from sampling lines • Closed loop system is used.

Hazardous chemical storage

area

• Provision of dedicated storage area

• Adequate ventilation system to be provided

• All the containers will be kept tightly closed

• Trolley/Forklift will be used for transfer of drums and containers

C Hazardous waste (as per the Hazardous and Other Wastes (Management and Transboundary Movement) Rules 2016. (Existing and Proposed)

i -

Source Type of

waste Category

Quantity per Annum Method of Disposal

Existing Proposed Total

ETP ETP Sludge

& MEE Salt

Sch - 1

35.3 210 MT 30 MT 240 MT

Collection, Storage,

Transportation and

Disposal by TSDF

operated by BEIL

OR

Disposal by Co-

processing at RSPL

Process

Spent Carbon Sch - 1

28.3 21 MT 169 MT 190 MT

Collection, Storage,

Transportation and

Disposal by

incineration at

CHWIF of BEIL

OR

Disposal by Co-

processing to

cement

manufacturers /

RSPL

Organic

Residue

Sch - 1

20.3 11 MT 89 MT 100 MT

Collection, Storage,

Transportation and

Disposal by Co-

processing to

cement

manufacturers /

RSPL

Inorganic

Process

waste

Sch - 1

28.1 35 MT 660 MT 695 MT

Collection, storage,

Transportation and

Disposal by TSDF of

BEIL

SEAC, Gujarat: Page 21 of 22

SEAC, Gujarat [TOR – Expansion Case]

Spent

Solvents

Sch - 1

28.6

970 MT 15215 MT 16185

MT

Collection, Storage

In house (on-site)

recovery and reuse

in the process

OR

Collection, Storage,

Transportation and

sold out GPCB

authorized end-users

Raw

Material

Storage &

Handling

Discarded

Containers

Bags/Liners

Sch - 1

33.1

720

Nos. 780 Nos.

1500

Nos. Collection, Storage,

Decontamination and

Disposal by selling to

scrap vendors 240

Nos. 260 Nos.

500

Nos.

Plant &

Machineries

Spent Oil/

Used Oil

Sch - 1

5.1 0.18 MT 0.12 MT 0.3 MT

Collection, Storage,

Transportation &

Disposal by selling to

registered

reprocessors

-

ii Membership details of CETP, TSDF, CHWIF, Common MEE etc.

Existing: CETP–Enviro Technologies Ltd. (ETL) Ankleshwar Disposal Pipeline – Narmada Clean Tech Ltd. Common MEE – BEIL, ACPTCL TSDF & CHWIF- BEIL Co-processing: Recycling Solution Pvt. Ltd. (RSPL) Proposed CETP–Enviro Technologies Ltd. (ETL) Ankleshwar Disposal Pipeline – Narmada Clean Tech Ltd. Common MEE ACPTCL TSDF & CHWIF- BEIL Co-processing: Recycling Solution Pvt. Ltd. (RSPL),

Cement manufacturing units

ii Details of Non-Hazardous waste & its disposal (MSW and others)

Not applicable

D

i Spent Solvent management (If any)

Existing: Collection, storage & re-use in process after recovery through onsite / off site distillation. Proposed: Collection, storage and send to authorized recyclers for recovery OR Collection, Storage, Transportation and sell to GPCB authorized end-users OR Disposal by co-processing at Cement Industries / RSPL OR Disposal by incineration at CHWIF.

ii VOC emission sources and its mitigation measures

As mentioned in section B (v) above.

SEAC, Gujarat: Page 22 of 22

SEAC, Gujarat [TOR – Expansion Case]

➢ Details of Environmental Consultants:

Sr. no.

Particulars Details

i Name of the Consultant Envisafe Environment Consultants

ii Validity of Certificate of accreditation issued by the NABET, QCI

22/05/2019

iii Accreditation for the categories 5(f)-A & B

iv Any other details --

Name & designation of the Applicant: Rajesh R. Shah

Stamp & Signature of the Applicant:

Date: 14/2/2018

General Instructions

• Format shall be in WORD Format (Page size-A4, Font type- Arial, Font size- 11)

• Provide authenticated (with stamp & Signature) hard copy during presentation.

• Kindly mail to : [email protected] and copy to all members.

• Above data should be as per application Form-1 & PFR.

• Incorporate relevant details in respective column of the above format. Do not attach as Annexure

in Format.


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