DETAIL PROJECT REPORT

OF
INTAS PHARMACEUTICALS LTD., VALIA

MoEFCC / SEAA File No : J-11011/583/2017 – IA II(I)

Date of issue EC : 26th February 2019
Category of project : 5(f)-A: Synthetic Organic Chemicals (Pharmaceutical Bulk Drugs &
Intermediates).
DETAIL PROJECT REPORT

INTRODUCTION:

M/s. Intas Pharmaceuticals Limited, Valia is a medium scale unit located at Survey
No. 44/B, Survey No. 130, & Plot No. 7/2, Village: Naldhari, Siludi – Valia Road, Near
Ankleshwar, Taluka: Valia, District: Bharuch in Gujarat. The plant was commissioned
by M/s. Zora Pharma in May 1986 for manufacturing of synthetic organic chemicals. In
the year 2009, the unit has been taken over by the management of M/s. Intas
Pharmaceuticals Ltd. The copies of NOC/ CTE & CC&A/ CTO is attached as Annexure
– 1.

At present, the unit is engaged in manufacturing of various Pharmaceutical Intermediates

with the total production capacity of 241 TPM. Now, the unit proposes to expand with
manufacturing of various other pharmaceuticals bulk drugs & intermediates with total
production capacity of 287.77 TPM. Most of the products that Intas Pharmaceuticals Ltd.
Intends to manufacture are widely used as bulk drugs and intermediates in the domestic
as well as international market.

In the domestic market, Intas is the 4th largest company in Indian Chronic Pharma market
with a market share of 5.32%. It also has presence in cardiovascular system (CVS),
diabetology, gynecology, infertility, respiratory care, gastroenterology, pain management
as well as other therapeutic segments in India. Besides rapidly growing domestic
prominence, Intas is also present in more than 70 countries worldwide with robust sales,
marketing and distribution infrastructure in markets like North America, Europe, Central
& Latin America, Africa, Australia, New Zealand, Asia-Pacific as well as
Commonwealth of Independent States (CIS) and Middle East and North Africa (MENA)
countries.

Intas group contributes to various CSR / CER activities in the field of education & skill
development, healthcare, water & sanitation, infrastructure development and other social
welfare activities.

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 DETAIL PROJECT REPORT

BASIC DETAILS:

M/s. Intas Pharmaceuticals Limited

Survey No. 44/B, Survey No. 130, & Plot No. 7/2, Village: Naldhari, Siludi – Valia
Name and Address of the
company Road, Near Ankleshwar, Taluka: Valia, District: Bharuch, Gujarat

Mr. RD Mehta
Responsible Person for Mobile No. : 9824040226
making application

Investment in Crore 103.16 Cr. (Additional 4.5 crores of additional land )

Scale / Category Medium / Red, 5(f)-A: Synthetic Organic Chemicals

Type of Industry –
API & Intermediates
(Sector)
EC issued through vide file No. J-11011/583/2017 – IA II(I), dated 26th February
Details of EC
2019 (Copy of Existing EC is Attached as Annexure – 2 (a))
Status of six month - Submitted to MoEFCC, Regional office, Bhopal on 18th June 2019
compliance report
(Acknowledgement copy of letter submitted to RO-MoEF&CC, Bhopal is
Attached as Annexure – 2 (b))
To incorporated newly purchased additional adjoining land of 61900 Sq. M in

Intent of Application proposed expansion project for manufacturing of Synthetic Organic Chemicals
(Pharmaceutical Bulk Drugs & Intermediates)
- Unit has obtained EC vide File No. J-11011/583/2017 – IA II (I), dated
26/02/2019 for 61666 Sq. M land area i.e. including Survey No. 44/B
(30566 Sq. M) & Survey No. 130 (6000 Sq. M), & Plot No. 7/2 (25100 Sq.
M).
Detail of amendment
sought for - After obtaining EC unit has purchased additional adjoining land of 61900
Sq. M area i.e. including Survey No. 127 (52000 Sq. M) & Survey No. 126
(9900 Sq. M). Hence unit has total land area: Existing 61666 Sq. M +
Proposed 61900 Sq. M = 123566 Sq. M

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 DETAIL PROJECT REPORT

- So, basically this amendment in EC proposed to add additional newly

purchased land i.e. 61900 Sq. M and total area after proposed amendment
will be 123566 Sq. M.
Land documents is attached as Annexure -3 & plant layout is attached as
Annexure – 4.
TOR granted on 10th February 2018 and Public hearing was conducted on 24th July
Details of TOR / Public
hearing 2018 by SPCB (GPCB)

Consent status & Validity AWH – 90925 & Valid up to 01/11/2022

Waste water disposal The Total water requirement after proposed expansion is estimated to be 318
facility
cum/day. The total industrial Effluent generation after proposed expansion will be
110.8 KLD will be treated through Effluent Treatment Plant and Domestic effluent
will be taken to STP for treatment. High COD effluent will be segregated & treated
in Solvent Stripper followed by MEE and ATFD. Entire treated water will be
recycled in process and for green belt development. There will be no discharge of
treated waste water from the Unit.
There will be no change in water consumption and waste water generation due
amendment in EC.
Water consumption, WW Water Consumption
Generation and its disposal
- Total Water Requirement for the Project (F + R) : 318. KLD
with CETP (In brief for
18(1)(B) aces) - Total Fresh water requirement (F) : 186.0KLD
- Quantity to be recycled/reused (R ) : 132 KLD
- There shall be no change in water requirements after proposed amendment
Waste Water Generation / disposal
- Industrial waste water generation i.e. 110.8 KLD will be treated separately
MEE followed by ATFD & conventional ETP and after removing TDS. Net
quantity of industrial effluent after final treatment will be 109.4 KLD. This
will be used for cooling tower makeup.

- 23 KLD sewage will be treated in proposed STP and treated sewage will be
reuse for greenbelt development.

There will be no change in waste water generation quantity after proposed

amendment

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 DETAIL PROJECT REPORT

Air pollution control There is no source of Process gas generation from existing plant. There will be
measure (APCM)
process gas generation in the form of SO2, NH3 & HCl gas from the proposed
manufacturing processes. The adequate scrubbing system will be provided for
control of gaseous emission.
There will be no change in fuel consumption, process / utility emission and air
quality due amendment in EC
Hazardous waste disposal Unit is member of M/s. BEIL, Ankleshwar for landfil waste generated from ETP
facility
operation and common incinerations facility for various incinerable waste. There
will be no change in hazardous waste generation due amendment in EC
Other information if any - Due to this amendment there will be,
1. No change in total quantity of production or product profile
2. No change in water consumption & waste water generation
3. No change in air emission and no change in quantity of hazardous waste
generation
4. No change in total no of plant, civil structure, equipment and
machineries, which already approved in above said EC
- Due to additional land there will be only change in layout plan.

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DETAIL PROJECT REPORT

PRODUCT DETAILS (EXISTING + PROPOSED) AS PER APPROVED EC

Sr. No. Products *Capacity (TPM)

Total (after
Intermediates (Existing) E1 E2 P proposed
changed)
1 Crotonic Acid OR 1:3 Butandiol 50 19.68 (-19.68) Nil
2 Hexa Methyl Di Silazane (HMDS) 50 20 (-20) Nil
3 Floroquinolonic Acid (FQ Acid) 66 17 (-17) Nil
4 Sodium Methoxide Solution 75 75 200 275
5 R-(-) 3 Carboxymethyl-5- Methyl hexanoic Acid Nil 4 (-4) Nil
6 R(+/-) 3Carboxymethyl -5-Methyl hexanoic Acid Nil 4 (-4) Nil
7 R(+)-α- Methyl Benzylamine Nil 0.5 (-0.5) Nil
8 Lacosamide (Stage(III) Nil 0.5 (-0.5) Nil
9 Chloroform Nil 100 (-100) Nil
General API (Proposed)
1 Dabigatran Etexilate Mesylate Nil Nil 0.80 0.80
2 Lurasidone HCL Nil Nil 0.10 0.10
3 Lacosmide Nil Nil 0.50 0.50
4 Bendamustine HCL Nil Nil 0.01 0.01
5 Trazodone HCL Nil Nil 4.00 4.00
6 Gemcitabine HCL Nil Nil 0.20 0.20
7 Capecitabine Nil Nil 6.00 6.00
8 Erlotinib HCl Nil Nil 0.10 0.10
9 Imatinib Mesylate Alpha Nil Nil 0.50 0.50
10 Nilotinib Nil Nil 0.15 0.15
11 Dasatinib Nil Nil 0.05 0.05
12 Pazapanib HCl Nil Nil 0.06 0.06
13 Sorafenib Nil Nil 0.10 0.10
Intermediates (Proposed)
14 N-BZ-Bis-Lactam Nil 0.04 0.05
0.02
15 N-BOC-Bis-Lactam Nil 0.04 0.05
16 5-(4-(4-(5-Cyano-1H-indol-3-yl)-butyl)-piperzin-1-
Nil 0.3 (-0.25) 0.05
yl)benzofuran-2-carboxamide
17 2-acetamido-2-phenethylpropane-1,3-diyl-diacetate Nil Nil 0.05 0.05
Total 241 241 46.77 287.77
*E1: As per Earlier CC&A & ToR Application, E2: Total After change in Product Mix as per current CC&A, P: Proposed
Change wrt E2, T: Total after proposed expansion & as per ToR application

Note: Product profile & product quantity remain same & unchanged after proposed amendment

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DETAIL PROJECT REPORT

WATER

Water consumption (KL/day)

Proposed Total after

Existing
Category (Additional) Expansion Remarks
KLD
KLD KLD
I. Domestic 6.0 22.0 28.0 Fresh water

Nil 17.0 17.0 Fresh

II. Gardening 23.9 (-23.9) Nil Reuse-ETP

Nil 23.0 23.0 Reuse-STP

III. Industrial

a. Process/APCM 25.5 (-4.1) 21.4 Fresh

b. Boiler 7.5 35.5 43.0 Fresh

3.0 7.6 10.6 Fresh

c. Cooling
Nil 109.4 109.4 Reuse (ETP)

d. Washing & Other 3.0 24.0 27.0 Fresh

e. WTP Nil 39.0 39.0 Fresh

Total Industrial Water 39.0 211.40 250.4 Fresh + Reuse
Requirement (a+b+c+d+e)
Nil 109.4 109.4 Reuse

39.0 102.0 141.0 Fresh

Total Water Requirement
45.0 141.0 186.0 Fresh
(I+II+III)

Note:

- Total Water Requirement for the Project (F + R) : 318. KLD

- Total Fresh water requirement (F) : 186.0KLD
- Quantity to be recycled/reused (R ) : 132 KLD
There will be no change in water requirements after proposed amendment

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DETAIL PROJECT REPORT

Waste water

Waste Water Generation (KL/day)

Proposed Total after

Existing
Category (Additional) Expansion
KLD
KLD KLD
i. Domestic 6.0 17.0 23.0
Nil Nil Nil
i. Gardening Nil Nil Nil
Nil Nil Nil
ii. Industrial
a. Process/APCM 19.2 6.1 25.3
b. Boiler 2.5 3.0 5.5
14.0 14.0
c. Cooling Nil

d. Washing & Other 2.2 24.8 27.0

e. WTP Nil 39.0 39.0
Total Industrial Water Generation /
23.9 86.9 110.8
Discharge (a+b+c+d+e)

Total Waste Water Generation /

29.9 103.9 133.8
Discharge (I+II+III)

Note:

- Industrial waste water generation i.e. 110.8 KLD will be treated separately MEE followed by ATFD
& conventional ETP and after removing TDS. Net quantity of industrial effluent after final treatment
will be 109.4 KLD. This will be used for cooling tower makeup.

- 23 KLD sewage will be treated in proposed STP and treated sewage will be reuse for greenbelt
development.

There will be no change in waste water generation quantity after proposed amendment.

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DETAIL PROJECT REPORT

DETAILS OF RECYCLE & REUSE SCHEME

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DETAIL PROJECT REPORT

AIR

Flue gas emission details

Sr. Dia. & Type of Concn. Of Air Pollution

Stack Attached to Status
No. Ht. (m) Fuel Pollutants Control Measure
1 Boiler (3 TPH) Existing- 0.6 & 21 FO/LDO Adequate Stack
Stand By Height
2 Boiler (4 TPH) Existing Biofuel PM≤150 Multi Cyclone
(agro mg/nm3 Separator followed
waste)&/ by Bag Filter
OR Coal) followed by water
SO2 ≤ 100 scrubber
3 Thermic Fluid heater Existing 0.3 & 11 FO/LDO ppm Adequate Stack
(1 Lac Kcal/hr.) Height
4 DG set (500 KVA & Existing 0.2 & 9 Diesel Adequate Stack
125 KVA) NOx ≤ 50 Height
5 Boiler (6 TPH) Proposed 1 & 21 Biofuel ppm Multi Cyclone
(agro Separator followed
waste) by Bag Filter
&/OR followed by water
Coal scrubber
6 DG Sets (2 nos. x 500 Proposed 0.3 & 12 Diesel Adequate Stack
KVA) Height

Details of Process Gas Stack & APCM

Pollutant Air Pollution Control Equipment

Sr. Stack attached to Ht. & Concentrat
No. Reactor Dia. (m) ion,
mg/Nm3 2nd Stage
1st Stage

1 Reactor 10 & 0.3 SO2 < 40 Alkali Scrubber Alkali Scrubber

(A) (B)

2 Reactor 10 & 0.3 NH3 < 175 Acidic Scrubber Acidic Scrubber
(C) (D)

3 Reactor 10 & 0.3 HCl < 20 Alkali Scrubber Alkali Scrubber

(E) (F)

Note:
There will be no change in utility, total nos of process stacks or emission after proposed amendment.
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DETAIL PROJECT REPORT

HAZARDOUS WASTE

Quantity per Annum Method of Disposal

Type of Waste Cat.
E A T
ETP Sludge Sch.-1 6 MT 54 MT 60 MT Collection, Storage,
35.3 Transportation and Disposal by
MEE Salt Nil 440 MT 440 MT
Land filling at common TSDF
Sch-1
Spent Hyflow Nil 5 MT 5 MT
28.2
Collection, Storage,
Inorganic Process Waste( Transportation and Disposal by
Sch-1
Sodium Sulphate/Sodium Nil 310 MT 310 MT Selling to GPCB authorized
28.1
Bicarbonate) end users OR Disposal by land
filling at common TSDF
Collection, Storage,
Transportation and Disposal by
Sch-1
Spent Carbon 3 MT 5 MT 8 MT Incineration at CHWIF OR
28.3
Disposal by Co-processing at
Cement Manufacturers/RSPL
Collection, Storage,
Transportation and Disposal by
Selling to GPCB authorized
Sch-1 18,100 19,000
Spent / Mix Solvent 900 MT end users OR In-house
28.6 MT MT
recovery and reuse OR Dispose
by co-processing OR Disposal
by incineration at CHWIF.
Collection, Storage,
Transportation and Disposal by
Sch-1
Distillation residue 6 MT 84 MT 90 MT incineration at CHWIF OR
20.3
Disposal by Co-processing at
Cement Manufacturer /RSPL
Collection, Storage and send to
Bleed Liquor From Scrubber - Nil 20 MT 20 MT
ETP for treatment
12 MT 5 MT 17 MT Collection, Storage,
Sch-1
Discarded Containers / Bags 48000 20000 68000 Decontamination and Disposal
33.1
Nos. Nos. Nos. by selling to scrap vendors
Collection, Storage,
Transportation sell to
Sch-1
Spent Oil / Used Oil 0.04 KL 0.56 KL 0.60 KL registered Preprocessor / MoEF
5.1
approved recyclers OR Reuse
as Lubricant within premises

Note:

There will be no change in hazardous waste generation quantity after proposed amendment.

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DETAIL PROJECT REPORT

HEALTH AND SAFETY ASPECTS

 MEASURES IN PLACE FOR ENSURING HEALTH OF EMPLOYEES

Intas Pharmaceuticals Ltd. is a reliable organization and the safety of our employee and contract workmen is
our prime concern. Our people are our assets and their welfare is our responsibility. The promise of caring,
sharing & growing is an integral part of Intas.

Separate EHS department has been established with dedicated safety officer & environmental cell. Intas also
having well equipped OHCS with ambulance to take care of emergency.

Safety training and awareness workshop are conducted regularly for all company employee(s) and contact
workmen’s. EHS training is also a part of induction program for new joiners’. Toolbox training and safety talk
are being regularly conducted for contract workers.

Ensuring health of employees following health checkups are conducted:

- Pre-employment Medical Check up

- Annual Medical Checkup of all employees
- Quarterly Medical Checkup of all employee
- Exit medical checkup
-

 SAFETY EQUIPMENT PROVIDED TO EMPLOYEES

Sr. No. Name Usage

1 Helmet Head protection

2 Ear plug/ ear muff Ear protection
3 Face shield / Goggles / welding shield Eye protection / face protection

4 PVC suit Body protection

5 Organic vapor mask While handling organic liquid

6 Dust mask While working in dusty atmosphere

7 SCBA Where presence of toxic gas

8 Safety shoes / gum shoes Leg protection

9 Hand gloves Hand protection

10 Safety shower Body wash in case of chemical spillage on body

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DETAIL PROJECT REPORT

 FIRE PREVENTION & CONTROL MEASURES

- All electrical installations are flameproof (wherever required) as per the Indian electrical rules.
- Earth fault detector are provided to tanks, reactor and vessels.
- Earth fault detector with interlocking system shall be provided to pumps, transferring solvents.
- Plant lay out as per the Indian standard.
- PRV, SRV, rupture disc, flame arrestor are provided at required location.
- Vent line from all tank, reactor and vessels will be finally connected with scrubbing system.
- All material are handling in close system, no open handling of materials.
- Smoke detection system shall be provided at required location.
- Well-designed fire hydrant system.
- Sufficient numbers of portable fire extinguisher provided as per requirements at different plant location
- Trained fireman available round the clock at site
- Emergency rescue team developed at site and refresher training has been conducted on regular basis.

 EMERGENCY PREPAREDNESS

- Emergency action plan available at site.

- Regular mock drill has been conducted to evaluate emergency preparedness.
- Well-equipped ECC is developed at site.
- Emergency siren available at site.
- Dedicated emergency number is define to communicate emergency at ECC.
- Mutual aid with neighboring industries.
- Unit is member of Disaster Prevention & management Center to handled emergency, DPMC is 2 kms
from site.
- Wind direction indication provided at site.

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PERFORMANCE INDICATOR OF EMS

Table No. 1

Result of water sample collected by GPCB

Parameter (Mg/l) / Prescribed limit (Mg/l) as per CC&A

Sample
Sr. Sampling
Collection pH SS COD BOD O&G NH3-N
No. Point
Date
5.5 – 8.5 100 100 30 10 50
From final
treated
1 15/05/2019 8.01 16 23 5 BDL 10.58
wastewater
Holding tank
From final
treated
2 08/03/2019 8.30 22 62 17 0.2 18.7
wastewater
Holding tank
From final
treated
3 04/08/2019 7.74 14 79 24 BDL 11.2
wastewater
Holding tank
From final
treated
4 17/07/2018 7.63 12 28 8 BDL BDL
wastewater
Holding tank
From final
treated
5 7.73 08 40 11 BDL 3.36
19/12/2017 wastewater
Holding tank
From final
treated
6 04/10/2017 6.94 14 42 12 BDL 8.96
wastewater
Holding tank

**All the parameters are well within the limits

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DETAIL PROJECT REPORT

Table No. 2

Results of air sample collected by GPCB

Parameter (mg/m3) / Prescribed limit (mg/m3) as per

CC&A
Sr. Sample Sampling
No. Collection Date point PM SO2 NOX
100 100 50
1 15/05/2019 11.0 3.43 BDL
Stack attach
2 23/11/2017 5.0 3.37 4.81
to Boiler
4 27/12/2016 15 2.84 4.77

**All the parameters are well within the limits

Summary:

- Unit has obtained EC through vide File No. J-11011/583/2017 – IA II (I), dated 26/02/2019 for
61666 Sq. M land area i.e. including Survey No. 44/B (30566 Sq. M) & Survey No. 130 (6000 Sq.
M), & Plot No. 7/2 (25100 Sq. M).
- After obtaining EC unit has purchased additional adjoining land of 61900 Sq. M area i.e. including
Survey No. 127 (52000 Sq. M) & Survey No. 126 (9900 Sq. M). Hence unit has total land area:
Existing 61666 Sq. M + Proposed 61900 Sq. M = 123566 Sq. M
- So, basically this amendment in EC proposed to add additional newly purchased land i.e. 61900
Sq. M and total area after proposed amendment will be 123566 Sq. M.
- So far project implementation is concern, it is not yet implemented.

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