File No.

APPCB-11021/117/2020-TEC-CFE-APPCB

ANDHRA PRADESH POLLUTION CONTROL BOARD

Paryavaran Bhavan, APIIC Colony Road, Gurunanak Colony,
Autonagar, Vijayawada- 520007.
Website: www.pcb.ap.gov.in

CONSENT TO ESTABLISHMENT ORDER

Order No.379/APPCB/CTE/RO-VSP/HO/2015 Dt.01/06/2024

Sub: APPCB – CTE - M/s. Caplin Point Laboratories Limited (Formerly Southern
Pharma India Pvt. Ltd.,), Plot. No. 28H and 28I, APSEZ, Atchuthapuram and
Rambilli (M), Anakapalli District – Consent to Establish of the Board for
Change of product mix under Sec. 25 of Water (P & C of P) Act, 1974 and
under Sec. 21 of Air (P&C of P) Act, 1981 - Issued - Reg.

Ref: 1. CTO Order dt.20.06.2018 & CTO amendment for name change vide
order dt.20.12.2023.
2. Industry’s CTE (Exp) application received through A.P. OCMMS on
29.04.2024.
3. Z.O, Visakhapatnam report dt.23.05.2024.
4. CTE Committee meeting held on 28.05.2024.
5. Email received from RO, Visakhapatnam on 29.05.2024.

M/s. Caplin Point Laboratories Limited, vide reference 3rd cited, submitted an
1. application to the Board seeking Consent to Establish (CTE) for Change of product
mix to produce the products with installed capacities as mentioned below, with an
additional investment of Rs. 22.777 Crores. (Total after expansion – Rs. 51.507
Cr)

As per CTO Order dt.20.06.2018:

S. Name of the Product Quantit No. of Name of the starting Raw Quantit
No y Stages Material y
(Kg/day (Kg/day)
)
1 Amlodipine Besylate 60 1 Phthalimido amlodipine 77.9
2 Atorvatatin Calcium 150 8 3-methyl-2-butanone 43.8
3 CetrizineDihydrochlorid 100 4 Para chloro benzophenone 66.7
e
4 Domperidone 120 4 Benzene-1,2-diamine 111.1
5 Esomeprazole 130 2 5-Methoxy-2-[[(4-methoxy- 325.8
Magnesium 3,5-dimethylpyridin-2-
yl)methyl]thio]-1H-
benzimidazole
6 Fexofenadine 100 6 2-[4-(4-chloro-1-oxobutyl) 120.5
Hydrochloride phenyl]-2-methylpropanoic
acid (BW-08)
7 Fluconazole 40 5 1,3 Difloro benzene 32.9
8 Glucosamine HCl 1000 1 Glucosamine 977.2
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9 Glucosamine Sulfate 500 1 Glucosamine HCl 367

Potassium Chloride
10 Glucosamine Sulfate 500 1 Glucosamine HCl 387.7
Sodium Chloride
11 Lansoprazole 45 4 2- Chloro -3- methyl-4- ( 2,2,2 69.3
- trifluoroethoxy) Pyridine.HCl
12 Losartan Potassium 150 4 Bromination of 2-cyano-4’- 83.3
methyl-1,1’-biphenyl (OTBN)
13 Omeprazole 100 1 5-Methoxy-2-[[4-methoxy-3,5- 135.27
dimethyl-2-pyridinyl)-methyl]
thio]-1H-benzimidazole
14 Pantoprazole Sodium 100 2 2-Chloromethyl-3,4-dimethoxy 82.5
pyridine
15 Pregabalin 150 2 R-(+)-3-(carboxymethyl)-5- 193.4
Methyl hexanoic acid
16 Rabeprazole Sodium 35 3 Chloro compound 113.8
17 RosuvastatinClacium 100 4 N-[4-(4-fluorophenyl)-5- 108.9
formyl-6-isopropyl-pyrimidin-
2-yl]-N-methyl-
methanesulfonamide
18 Sertaline Hydrochloride 100 3 Racemic C&T Sertraline 126.6
19 Sildenafil citrate 100 3 2-Ethoxy benzoic acid 92
20 Telmisartan 100 2 Bibenzimidazole 84.2
21 Valsartan 130 4 L-valine 54.6
Total (Worst Case - 3 2000
Products on
campaign basis)

After CTE (CPM):

S. Name of the Product Quantity Quantity

N (Kg/Month) (Kg/Day)
o.
1 Adenosine 60.00 2.00
2 Argatroban Monohydrate 30.00 1.00
3 Atropine Sulfate Monohydrate 30.00 1.00
4 Bepotastine Besilate 30.00 1.00
5 Calcium D-Gluconate Monohydrate 1260.00 42.00
6 Cisatracurium Besylate 150.00 5.00
7 Dexmeditomidine Hydrochloride 1710.00 57.00
8 Edaravone 30.00 1.00
9 Etomidate 150.00 5.00
10 Foscarnet Sodium 180.00 6.00
11 Irbesartan 150.00 5.00
12 Lacosamide 120.00 4.00
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13 Magnesium sulfate heptahydrate 30.00 1.00

14 Milrinone 60.00 2.00
15 Moxifloxacin Hydrochloride 120.00 4.00
16 Nicardipine Hydrochloride 90.00 3.00
17 Norepinephrine Bitartrate 540.00 18.00
Monohydrate
18 Propofol 20550.00 685.00
19 Rocuronium Bromide 120.00 4.00
20 Ropivacaine hydrochloride 990.00 33.00
monohydrate
21 Sugammadex Sodium 2580.00 86.00
22 Tirofiban hydrochloride 30.00 1.00
monohydrate
23 Zinc sulfate heptahydrate 30.00 1.00
24 Zoledronic acid Monohydrate 30.00 1.00
Total 29070.00 969.00

2. As per the application, the above activity is to be located within the existing
industry premises located at Plot. No. 28H and 28I, APSEZ, Atchuthapuram and
Rambali (M), Anakapalli District in an area of 8056.0 Sq.mts.

3. The industry was inspected by the Senior Environmental Engineer, Zonal Office,
Visakhapatnam & Environmental Engineer, Regional Office, Visakhapatnam, A.P
Pollution Control Board on 22.05.2024 and observed that the site is surrounded by

North :Vacant Area followed by road.

South :Kekule Pharma Ltd
East :APIIC Vacant Industrial Plots.
West :APIIC Internal Roads followed by M/s.ParekhPlast India Ltd - Vizag Plant

4. The Board, after careful scrutiny of the application, verification report of the Zonal Officer,
and recommendations of the CTE Committee, hereby issues CONSENT TO ESTABLISH
FOR CHANGE OF PRODUCT MIX to the project under Section 25 of Water
(Prevention & Control of Pollution) Act 1974 and Section 21 of Air (Prevention & Control
of Pollution) Act, 1981 and the rules made there under. This order is issued to
manufacture the products as mentioned at para (1) only.

5. This Consent order now issued is subject to the conditions mentioned in the Annexure.

6. This order is issued from pollution control point of view only. Zoning and other regulations
are not considered.

7. This order is valid for a period of 7 years from the date of issue.

Encl: Annexure.

B SREEDHAR IAS, MS(BS), O/o MEMBER SECRETARY-APPCB

 File No.APPCB-11021/117/2020-TEC-CFE-APPCB

To
M/s. Caplin Point Laboratories Limited
(Formerly Southern Pharma India Pvt. Ltd.,),
Plot. No. 28H and 28I, APSEZ, Atchuthapuram and
Rambali (M), Anakapalli District.
Email: hr@caplinpoint.net

Copy to: 1. The JCEE, Z.O: Visakhapatnam for information and necessary action
2. The E.E., R.O: Visakhapatnam for information and necessary action.
 File No.APPCB-11021/117/2020-TEC-CFE-APPCB

ANNEXURE

1. The proponent shall obtain Consent to Operate (CTO) from APPCB, as

required Under Sec.25/26 of the Water (P&C of P) Act, 1974 and under sec.
21/22 of the Air (P&C of P) Act, 1981, before commencement of the trail
runs.

2. The applicant shall provide separate energy meters for Effluent Treatment
Plant (ETP) and Air Pollution Control equipments to record energy
consumed. An alternative electric power source sufficient to operate all
pollution control systems shall be provided.

3. The industry shall construct separate storm water drains and provide rain
water harvesting structures. No effluents shall be discharged in to the storm
water drains.

Water:

4. The source of water is APIIC and the maximum permitted water

consumption is as following:

S. Purpose Quantity as per CTO Quantity after

No. dt.20.06.2018 (KLD) CTE (CPM) (KLD)
1. Process 9.46 5.00
Washings 1.00 1.00
(Reactor, Floor washings,
2.
container washings, vehicle
washings, etc.,)
3. Boiler Feed 16.00 16.00
4. Pretreatment of SRS 1.00 0.00
5. RO/ DM Plant regeneration 2.00 2.00
6. Cooling tower make-up 24.00 24.00
7. Scrubber system 3.00 0.50
8. Domestic 4.00 4.00
9. Gardening 1.00 4.50

Total 61.46 KLD 57.00 KLD

Separate meters with necessary pipe-line shall be provided for assessing the
quantity of water used for each of the purposes mentioned above.

5. The maximum waste water generation shall not exceed the following:

S. No. Source Quantity as per CTO Quantity after CTE

dt.20.06.2018 (KLD) (CPM) (KLD)
HTDS LTDS Total HTDS LTDS Total
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1. Process 9.68 ---- 9.68 5.52 0.45 5.97

2. Washings (Reactor, Floor 1.00 ---- 1.00 1.00 0.00 1.00
washings, container
washings, vehicle
washings, etc.,)
3. Pretreatment of SRS 1.00 ---- 1.00 0.00 0.00 0.00
4. Scrubber system 3.00 ---- 3.00 0.50 0.00 0.50
5. RO/ DM Plant regeneration 2.00 ---- 2.00 2.00 0.00 2.00
6. Cooling tower make-up ---- 3.00 3.00 0.00 3.00 3.00
7. Boiler Feed ---- 1.50 1.50 0.00 1.50 1.50
8. Domestic ---- 3.50 3.50 0.00 3.50 3.50
Total 16.68 8.00 24.68 9.02 8.45 17.47

Treatment & disposal:

After CTE (CPM):

Source Treatment Mode of final disposal

HTDS & HCOD effluent Equalization tank cum To M/s. AETL
Neutralization (CETP of Atchutapuram)
LTDS effluent including Equalization tank cum To M/s. AETL
utilities blow down Neutralization (CETP of Atchutapuram)
Domestic waste water Septic tank Overflow to the CETP along
with LTDS effluent

6. Effluents shall not be discharged on land or into any water bodies or aquifers
under any circumstances.

7. The industry shall properly operate and maintain online real time monitoring
system along with web camera facilities and shall ensure that it is connected
to APPCB / CPCB websites as per CPCB directions.

8. Floor washing shall be admitted into the effluent collection system only and
shall not be allowed to find their way in storm drains or open areas. All pipe
valves, sewers, drains shall be leak proof.
9. The effluents shall be stored in above ground level collection tanks
separately. The industry shall provide hoods over the effluent storage
tanks, and the vents shall be connected to scrubbers.
10. The industry shall provide tank in tank system for effluent collection at
production blocks. Free board shall be maintained in the tanks to
prevent spillages.
11. The industry shall construct rain water runoff tank for collection and storage
of first flush storm water. The industry shall maintain dry condition outside
drains in un-rainy season.

Air:

12. The Air pollution Control equipment shall be maintained properly to comply
 File No.APPCB-11021/117/2020-TEC-CFE-APPCB

with the following for controlling air pollution after expansion:

After CTE (CPM):

S. Details of Stack Stack 1 Stack 2

No.
1. Attached to Coal fired DG Set
Boiler
2. Capacity 1 X 3.0 TPH 1 X 750 KVA
3. Fuel Coal HSD
4. Stack Height 30 mts 10m
5. Details of Air Pollution Control Bag filter Acoustic enclosures
Equipment

13. A sampling port with removable dummy of not less than 15 cm diameter shall
be provided in the stack at a distance of 8 times the diameter of the stack
from the nearest constraint such as bends etc. A platform with suitable ladder
shall be provided below 1 meter of sampling port to accommodate three
persons with instruments. A 15 AMP 250 V plug point shall be provided on
the platform.

14. The industry shall provide the monitoring system to all the stacks / vents in
the plant. Regular monitoring shall be carried out and report shall be
submitted to the Regional officer.

15. The industry shall provide multi-stage scrubbers to the process vents to
control the process emissions. The industry shall provide online pH
measuring facility with auto recording system to the scrubbers provided to
treat the process emissions, and connect the same to APPCB server.

16. The industry shall provide VOC monitoring system with auto recording
facility, and connect the same to APPCB server.

17. The industry shall implement adequate measures to control all fugitive
emissions from the plant.

18. The proponent shall ensure compliance of the National Ambient Air quality
standards notified by MoEF, GoI vide notification No. GSR. 826 (E), dated.
16.11.2009 during construction and regular operational phase of the project
at the periphery.

19. The generator shall be installed in a closed area with a silencer and suitable
noise absorption systems. The ambient noise level shall not exceed 75
dB(A) during day time and 70 dB(A) during night time.

20. The proponent shall not use or generate odour causing substances or
Mercaptans and cause odour nuisance in the surroundings.

21. The industry shall send the used / spent solvents to the recyclers (or)
 File No.APPCB-11021/117/2020-TEC-CFE-APPCB

process them at their own solvent recovery facility within the premises.

22. The evaporation losses in solvents shall be controlled by taking the following
measures:

i. Chilled brine circulation shall be carried out to effectively reduce the

solvent losses into the atmosphere.
ii. Transfer of solvents shall be done by using pumps instead of manual
handling.
iii. Closed centrifuges shall be used to reduce solvent losses.
iv. All the solvent storage tanks shall be connected with vent condensers
to prevent solvent vapours.
v. The reactor vents shall be connected with primary & secondary
condensers to prevent escaping of solvent vapour emissions into
atmosphere.

Solid / Hazardous Waste:

23. The industry shall comply with the following for disposal of Solid waste:

S. No. Description Stream Quantity Mode of Disposal

after CTE
(CPM)
1. Organic solid waste 28.1 of 891 Kg/day Shall be routed through
schedule I APEMC to the authorized
Cement industries for co-
processing (or) TSDF,
Parawada for incineration
2. Solvent residue 28.1 of 302 Kg/day Shall be routed through
schedule I APEMC to the authorized
Cement industries for co-
processing (or) TSDF,
Parawada for incineration.
3. Process Inorganic 28.1 of 2.50 Shall be routed through
salts schedule I Kg/day APEMC
to TSDF, Parawada for
secured land filling.
4. Spent Carbon 28.3 of 6.0 Kg/day Shall be routed through
schedule I APEMC
5. Hyflow 28.1 of to the authorized Cement
schedule I industries for co-processing
(or) TSDF, Parawada for
incineration
6. ETP Sludge 35.3 of 50 Kg/day Shall be routed through
schedule I APEMC
TSDF, Parawada for secured
land filling.
7. Containers & 33.1 of 300 Shall be routed through
Container liners of schedule I Nos./year APEMC
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Hazardous Chemicals to authorized agencies, after

& Hazardous waste complete detoxification for re-
use/ recycle.
8. Waste oil & Grease 5.1 of 55 LPM Shall be routed through
schedule I APEMC
to authorized Re-processors /
Recyclers / to the Cement
industries for co-processing in
the kiln.
9. Spent Solvents 28.6 of 11.45 KLD Shall be routed through
schedule I APEMC
Recovery within the premises /
to authorised agency for
recovery.
10. Coal ash -- 2.625 TPD To Brick manufactures

11. Used Lead acid -- 4 Nos./year Shall be routed through

batteries APEMC
to dealers on buy back system

24. The proponent shall place the chemical drums and / or any drums in a shed
provided with concrete platform only. The Platform shall be provided with
sufficient dyke wall and effluent collection system. The industry shall provide
containers detoxification facility. Container & Container liners shall be
detoxified at the specified covered platform with dyke walls and the wash
wastewater shall be routed to low TDS collection tank.

25. The following rules and regulations notified by the MoEF&CC, GoI shall be
implemented.

a)Regulation of Persistent Organic Pollutants Rules, 2018.

b)Hazardous waste and other wastes (Management and Transboundary Movement)
Rules, 2016.
c)Plastic Waste Management Rules, 2016.
d)Manufacture, Storage and Import of Hazardous Chemicals Rules, 1989
e)Fly Ash Notification, 2016.
f) Batteries (Management & Handling) Rules, 2010.
g)E-Waste (Management) Rules, 2016.
h)Construction and Demolition waste Management Rules, 2016.
i) Solid Waste Management Rules, 2016.
j) The Public Liability Insurance Act, 1991 and its amendments thereof.

Other Conditions:

26. The industry shall provide online connectivity to the Board website for
online pH meters, and online VOC meter, a hood on top of the effluent
storage tanks, and scrubbers etc. before starting the operations of the
unit.
 File No.APPCB-11021/117/2020-TEC-CFE-APPCB

27. The industry shall submit the by-products returns (generation and
disposal) every month to the Regional Office. If the by-products are not
sold, they shall be treated along with the effluent and disposed of
through APEMCL.

28. “The industry shall comply with the industry specific standards with respect
to emissions tank farm vents stipulated by the MoEF & CC, GoI, New Delhi
vide Notification GSR541(E), dt.06.08.2021.”

S. Details of process Emission Control system Emission

No. emissions Standard
1. HCl Multi stage scrubbers in 35 mg/Nm3
2. NH3 series. 30 mg/Nm3
3. Chlorine 15 mg/Nm3
4. Benzene 5 mg/Nm3
5. Toluene 100 mg/Nm3
6. Acetonitrile 1000 mg/Nm3
7. Dichloromethane 200 mg/Nm3
8. Xylene 100 mg/Nm3
9. Acetone 2000 mg/Nm3

29. The industry shall display online data outside the main factory gate on
quantity and nature of hazardous chemicals being used in the plant, water &
air emissions and solid waste generated within the factory premises, as per
Hon’ble Supreme Court order.

30. The industry shall prepare a safety report and carry out an
independent safety audit report of the respective industrial activities
including chemical storages / isolated storages by an expert not
associated with such industrial activity as required under Rule 10 of
MSIHC Rules, 1989 and get it approved by the Factories Dept., and
submit the compliance along with copy of the safety report, safety
audit report and safety certificate at concerned Regional Office,
APPCB.

31. The industry shall submit a copy of the NOC issued by the Andhra
Pradesh State Disaster Response and Fire Service Dept., (APSDRFSD)
at concerned Regional Office, APPCB.

32. The industry shall submit risk assessment report covering worst
scenario clearly describing impact within the industry premises and
outside the industry premises and emergency response system.

33. The industry shall obtain PESO clearance & policy under PLI Act before
applying for CTO of the Board.
 File No.APPCB-11021/117/2020-TEC-CFE-APPCB

34. The industry shall inventorize the storage quantities of hazardous chemicals
(raw materials), products, as per the hazard nature of reactivity / toxicity /
flammability / explosive stored/handling in the premises as defined in the
Management of Storage, Import of Hazardous Chemicals (MSIHC) Rules,
1989 and the details shall be furnished to the Factories Department and to
the Regional Office, APPCB on monthly basis duly certifying the same.

35. The industry shall identify major accident hazard chemicals & list out the
hazardous chemicals endangered to human health & environment and the
details shall be furnished to the Factories Department and to the Regional
Office, APPCB time to time duly certifying the same by the industry. Further
the industry shall extend training to the working personnels while handling
hazardous chemicals for prevention of accidents and necessary antidotes to
ensure the safety, as per the MSIHC Rules, 1989.

36. The industry shall carryout calibration of safety equipments and leak
detection systems at regular intervals and shall certify the same with the
Factories Department. That certified copy shall be submitted to the APPCB,
Regional Office. The industry shall install fluorescent Wind Vane at the
highest point in the industry premises.

37. The industry shall comply with the Technical suggestions at Chapter
No. 7.3 & 7.4 for Hazardous Chemical handling industries by High
Power Committee (HPC) of Govt. of Andhra Pradesh. The HPC report
is available at www.ap.gov.in.

38. The industry shall utilize DG power for captive consumption only & power
shall not be supplied to grid and shall follow the amendments issued by
MoEF & CC/CPCB from time to time on DG sets in respect of conditions &
standards.

39. Thick green belt shall be maintained all along the boundary & vacant spaces
with tall growing trees with good canopy and it shall not be less than 33% of
the total area.

40. The industry shall submit compliance to the conditions stipulated in the
CTE orders to the concerned Regional Officer of APPCB every six
months and shall upload the same at APPCB website viz.,
https://pcb.ap.gov.in/UI/Submission_Compliance_of_EC_CTE_CTO_Directio
n.aspx .

41. The industry shall submit the information regarding usage of Ozone
Depleting Substance once in six months to the Regional Office and Zonal
Office of the Board.

42. Concealing the factual data or submission of false information / fabricated

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data and failure to comply with any of the conditions mentioned in this order
attracts action under the provisions of relevant pollution control Acts.

43. Notwithstanding anything contained in this conditional letter or consent, the

Board hereby reserves its right and power Under Sec. 27(2) of Water
(Prevention and Control of Pollution) Act, 1974 and Under Sec.21(4) of Air
(Prevention and Control of Pollution) Act, 1981 to revoke the order, to review
any or all the conditions imposed herein and to make such modifications as
deemed fit and stipulate any additional conditions.

44. Any person aggrieved by an order made by the State Board under Section
25, Section 26, Section 27 of Water Act, 1974 or Section 21 of Air Act, 1981
may within thirty days from the date on which the order is communicated to
him, prefer an appeal as per Andhra Pradesh Water Rules, 1976 and Air
Rules,1982, to such authority (hereinafter referred to as the Appellate
Authority) constituted under Section 28 of Water (Prevention and Control of
Pollution)Act,1974 and Section 31 of the Air (Prevention and Control of
Pollution) Act, 1981.

B SREEDHAR IAS, MS(BS), O/o MEMBER SECRETARY-APPCB

To
M/s. Caplin Point Laboratories Limited
(Formerly Southern Pharma India Pvt. Ltd.,),
Plot. No. 28H and 28I, APSEZ, Atchuthapuram and
Rambali (M), Anakapalli District.