Page 1 of 18

CONSENT ORDER FOR ESTABLISHMENT

Order No. 202 /APPCB/CFE/RO-VZM/HO/2019 Dt: 18.06.2019

Sub: APPCB – CFE - M/s. Dr. Reddy’s Laboratories Limited, (API-SEZ) Unit, Sy. Nos. 57-68, 70-73, 75-77 & 80, Devunipalavalasa (V), Pydibhimavaram Panchayat, Ranasthalam (M), Srikakulam District - Consent for Establishment (CFE) 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) EC order dt. 24.11.2009 and EC (amend) order dt. 22.08.2012 issued by MoE&F, GoI, New Delhi.

2) CFE order dt. 10.10.2012. 3) Industry’s CFE application received through Single Desk Portal on

17.05.2019. 4) R.O’s inspection report dt. 31.05.2019 and mail dt. 14.06.2019. 5) CFE Committee meeting held on 11.06.2019. 6) Industry’s Lr. dt. 11.06.2019, mails dt. 17.06.2019 and 18.06.2019.

1.

In the reference 1st cited, the industry had obtained EC from MoE&F, GoI, New Delhi. Further, the industry had obtained CFE vide reference 2nd cited from the Board with installed capacities as mentioned below:

Production

Capacity

As per EC

24.11.2009 &

22.08.2012

As per CFE order dt. 10.10.2012

Phase - I Phase - II Phase - III Phase - IV Total

API 5224.73 kg/day 1299.16 kg/day

865.80 kg/day

1029.8 kg/day

2029.97 kg/day

5224.73 kg/day

Formulations 0.04666 billion/day (or) 16.8 billions / Annum

0.0233 billion tablets / day

--- 0.0233 billion tablets / day

--- 0.0466 billion tablets / day

2.

In the reference 3rd cited, an application was submitted to the Board seeking Consent for Establishment (CFE) for CHANGE OF PRODUCT MIX to produce the following products with installed capacities as mentioned below, with an additional project cost of Rs. 2.0 lakhs.

As per CFE order dt. 11.01.2017 (Phase-1):

Sl. No

Name of the Products and By-products

Consented capacity (Kg/day)

1 Amlodipin Maleate 8.33

2 Atorvastatin Amorphous/Form P 166.67

3 Candesartan 8.33

4 Cetrizine HCl (US) 8.33

5 Citalopram 20.0

6 Enalapril Maleate 100.0

7 Esomeprazole Mg 81.87

Website :www.appcb.ap.nic.in

ANDHRA PRADESH POLLUTION CONTROL BOARD

D.No. 33-26-14 D/2, Near Sunrise Hospital, Pushpa Hotel Centre,

Chalamalavari Street, Kasturibaipet, Vijayawada – 520010.

Page 2 of 18

8 Fluoxetine HCl 83.33

9 Ketorolac 36.67

10 Lansoprazole 1.67

11 Levetiracetam 175.0

12 Levo-Cetrizine Dihydrochloride 10.0

13 Losartan Potassium 66.67

14 Meloxicam 0.2

15 Memantine HCl 2.1

16 Nateglinide Form H 8.33

17 Norfloxacin 16.67

18 Pantoprazole Sodium 38.0

19 Rabeprazole Sodium 34.5

20 Raloxifene Hydrochloride 4.17

21 Rosiglitazone Maleate 4.17

22 Telmisartan 6.66

23 Venlafaxine Hydrochloride 16.67

24 Boceprevir 15.0

25 Rivaroxaben 18.55

26 Telaprevir 15.0

27 Vilazadone 25.0

28 Atrovastatin Ca 15.0

29 Topiramate 15.0

30 Irbesartan 18.18

31 Nizatadine 45.45

32 R 3A 61.0

33 Lurasidone HCl 15.0

34 Trandolapril 3.3

35 Enoxaparin Sodium 8.0

36 Iron Sucrose 3.33

37 Lorcaserine HCl 3.33

38 Vildagliptin 1.5

39 R & D Pilot Plant Trail Run Products (Bulk drugs & Intermediates)

100.0

40 Dimethyl Fumerate 3.28

41 Apixaban 3.0

42 Aprimilast 3.0

43 Dapagliflozin 3.34

44 Ibrutanib 3.0

45 Mirabegron 3.0

46 Mirabegron Premix 3.0

47 Posaconazole 3.0

48 Palbociclib 3.33

Total 1299.16

1 Formulations (Phase-I) 0.02190 Billion Tablets / Day

2 Derma & Soft Gel 0.00138 Billion Units/Day

3 Metered Dose Inhaler (MDI) 0.000025 Billion Units / Day

4 Liquid Orals --

5 Vaginal rings 0.0000082 Billion Units / Day

6 Solar Panel Based Power Plant 1 MW

Page 3 of 18

After Change of Product Mix:

S. No

Name of the Product

Production capacity (kg/day)

Name of Starting Raw Material

No. of Stages

Quantity (kg/day)

1 Amlodipine Maleate 26 Hydroxy compound 5 39

2 Atorvastatin Amorphous/Form P

166.7 4-Fluoro -2-methyl-1-oxopropyl

3 139.9

3 Candesartan 8.3 Candesartan 2 10.7

4 Cetirizine HCL 27.8 Piperazine derive 3 22.7

5 Citalopram 0.5 5-cyano phathalide 3 0.3

6 Enalapril Maleate 0.5 Enalaprilat 2 0.3

7 Esomeprazole Mg 1 Esomeprazole crude 2 1

8 Fluoxetine HCl 1 Hydroxy amine 2 0.9

9 Ketorolac 36.7 5-Benzoyl-2,3-dibromo-1-(1,1-dicarbmethoxy)-3-propyl pyrrole

3 78.2

10 Lansoprazole 0.5 chloro compound 2 0.5

11 Levetiracetam 1 2- Amino butyric HCl 3 1.3

12 Levo-CetrizineDihydrochloride

16.8 (-)-4-Chloror benzhydryl amine

5 23.6

13 Losartan Potassium 1 Biphenyl comp 5 1.2

14 Meloxicam 0.2 Sodium saccharine dihydrate

4 0.5

15 Memantine HCL 8.5 1,3-DimethylAdamantane 2 17

16 Nateglinide Form H 0.5 R-2-amino-3-phenylproponoic acid

4 0.7

17 Norfloxacin 0.5 Quinolonic Acid 2 0.6

18 Pantoprazole Na 0.5 5-Difuoromethoxy-2-mercapto derivative

2 0.3

19 Rabeprazole Na 0.5 2-Mercapto benzimidazole

3 0.7

20 Raloxifene Hydrochloride

4.2 Benzoic acid derivative 3 7.1

21 Rosiglitazone Maleate

4.2 Chloro pyridine 4 2.4

22 Telmisartan 1.0 Biphenyl ester 4 0.9

23 Venlafaxine Hydrochloride

1.0 p-Methoxy benzyl cyanide 4 1.5

24 Boceprevir 5.0 Fragment B 5 2

25 Rivaroxaben 5.0 R)-5-chloro-N-(2-hydroxy-3-(4-(3-oxomorpholino) phenylamino) propyl) thiophene-2-carboxamide

2 5.5

26 Telaprevir 0.5 APR-4D:(S)-2-((S)-2-cyclohexyl-2-(pyrazine-2-carboxamido) acetamido)-3,3-dimethylbutanoic acid

3 0.4

27 Vilazadone 0.5 3-(4-chlorobutyl)-1H-indole-5-carbonitrile(KSM-1)(d-1.22)

3 0.4

Page 4 of 18

28 Atrovastatin Ca 167 (+) 4-Fluoro-α-2-methyl-1-oxopropyl]-β-oxo-N-b-diphenyl benzene butaneamide

4 187

29 Topiramate 15 D Fructose 4 25

30 Irbesartan 1 2n butyl-4-spirocyclopentane-2-imidazoline-5-one

3 0.7

31 Nizatadine 1 N,N-Dimethylamino-thioacetamide

4 1.1

32 R 3A 1 CNOP-4((R)-3-Aminopiperidine)

1 3.1

33 Lurasidone HCl 1 3-(1-piperzinyl)-1,2-benzothiazole

2 0.6

34 Trandolapril 0.5 (2S,3aR,7aS)-benzyl octahydro-1H-indole-2-carboxylate hydrochloride (CTRA8)

2 0.5

35 Enoxaparin Sodium 1 Heparin Sodium 3 2

36 Iron Sucrose(2% Active Ingredient)

35 Ferric chloride hexahydrate

1 7.4

37 Lorcaserine HCl 3.3 4-Chlorophenethylamine 5 5.5

38 Vildagliptin 1.5 L-Prolinamide 3 1.1

39 R & D Products Pilot PlantRun products(Bulk drugs & Intermediates)

100

40 Dimethyl fumerate 4.8 Fumaric acid 1 4.2

41 Apixaban 3 Ethyl(Z)-2- Chloro-2-(2-(4-Methoxy phenyl) hydrazono acetate(APB-1)

4 2.4

42 Aprimilast 3 (R)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethan-1-amine

3 6.9

43 Dapagliflozin 3.3 (2R,3S,4R,5R)-1-(4-chloro-3-(4-ethoxybenzyl)phenyl)-2,3,4,5,6-pentahydroxyhexan-1-one

4 4.7

44 Ibrutanib 0.3 3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-4-amine

1 0.2

45 Mirabegron 3 2-(2-Amino-1,3-thiazol-4-yl)-N-[4-(2-{[(2R)-2-hydroxy -2-phenylethyl]amino}ethyl) phenyl]acetamide

1 3.5

46 Mirabegron Premix 3 2-(2-Amino-1,3-thiazol-4-yl)-N-[4-(2-{[(2R)-2-hydroxy-2-phenylethyl]

1 3.5

Page 5 of 18

amino}ethyl) phenyl] acetamide

47 Posaconazole 3 4-(4-(4-minophenyl)piperazin-1-yl)phenol

5 3.2

48 Palbociclib 0.2 6-Bromo-2 -Chloror-8-cyclopentyl-5-Methylpyrido [2,3-d]pyrimidin-7(8H)-one

4 0.2

49 TapilamideFumarate 2.8 Maleic anhydride 1 2.5

50 Ferric Carboxymaltose

2.8 Maltodextrin 3 2.2

51 Moxifloxacin Hydrochloride

50 8-Methoxy quinolonic ester

2 50.6

52 Ziprasidone Hydrochloride

20 5-(2-Chloroethyl )-6-Chloro Oxindole

5 17.1

53 Pemetrexed Disodium Heptahydrate

0.5 4-[2-(2-Amino-4-oxo-3,7-dihydro pyrrolo [2,3-d] pyrimidin-5-yl)ethyl] benzoic acid

2 0.5

54 Azacitidine 0.5 5-Azacitidine 1 0.5

55 Levofloxacin Hemihydrate

135 Levoacid 2 148.7

56 Glimepiride (Pure) 7 3-Methyl-4-methyl-3-pyrroline-2-one

4 7.6

57 Metoprolol Succinate (Pure)

312.4 2-[[4-(-Methoxyethyl)phenyl] methyl] oxiran

2 396.8

58 Lacidipine (Pure) 1.5 Triphenyl phosphine 3 13.3

59 Ramipril 66.7 ECPP Alanine 3 95.1

60 Ropinirole Hydrochloride (Pure)

0.2 N-[2-(2-methyl]-N-propylpropan-1-amine

3 0.5

61 Glatiramer acetate 0.2 Alamine NCA 3 0.3

62 Atomoxitine 5.6 (R)-Atomoxetine mandelate salt

1 8.7

63 Olanazipine 17 Malononitrile 4 13.8

64 Sitagliptin Phosphate

2.2 (3R)-3-[(BOC)amino]-4-(2,4,5-trifluorophenyl butanoic acid

3 2.2

65 Canagliflozin Amorphous/ Hemihydrate

0.4 CGC-1 1 0.5

66 Asenapine 0.6 trans-(3aRS,12bRS )-5-Chloro-2,3,3a,12b-tetrahydro-2-methyl-1H-dibenz [2,3:6,7] oxepino[4,5-c]pyrrol-1-one /ASM6

3 1.3

67 Rivetigmine - RVS1 3 3- [1- (dimethylamino) ethyl] phenol /DEP - 5

1 2.8

Total 1299.16 kg/day

Page 6 of 18

1 Formulations (Phase-I)

0.02190 Billion Tablets / day

2 Derma & Soft Gel 0.001332Billion Units / day

3 Metered Dose Inhaler (MDI)

0.000025Billion Units / day

4 Liquid Orals 0.000048 Billion Units / day

5 Vaginal rings 0.0000082 Billion Units / day

6 Solar Panel Based Power Plant

1MW

Note: The present proposal for Change of Product Mix is applicable for Phase – I of CFE. * Iron Sucrose Active ingredient would be 2% hence it should be given in % of volume

By-Products

S. No.

Name of Product Name of By-Product Stage Quantity (kg/day)

Permitted

1 Losartan Potassium Tritanol IV 64.36

After Change of Product Mix

1 Losartan Potassium Tritanol IV 0.97

2. As per the application, the above activity is to be located in the existing premises

located at Sy. Nos. 57-68, 70-73, 75-77 & 80, Devunipalavalasa (V), Pydibhimavaram Panchayat, Ranasthalam (M), Srikakulam District in an area of 273.08 Acres.

3. The above site was inspected by the Environmental Engineer and Asst. Environmental

Engineer, Regional Office, Srikakulam, A.P Pollution Control Board on 25.05.2019 and observed that the site is surrounded by

North : Open lands;

South : Open lands;

East : Pydibhimavaram Industrial area (Dr. Reddy’s Laboratories CTO-VI);

West : Kandivalasa Gedda.

4. The Board, after careful scrutiny of the application, verification report of Regional Officer and recommendations of the CFE Committee, hereby issues CONSENT FOR ESTABLISHMENT 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 issued is subject to the conditions mentioned in the Annexure.

Page 7 of 18

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

CHAIRMAN To M/s. Dr. Reddy’s Laboratories Limited, (API-SEZ) Unit (CPM) R. Sy. No. 57-68, 70-73, 75-77 & 80, Devunipalavalasa Village, Pydibhimavaram Panchayat, Chipurupalli Taluk, Ranasthalam Mandal, Srikakulam District. srinivasarajum@drreddys.com sridhars@drreddys.com prasadvvvvss@drreddy.com Copy to: 1. The JCEE, Z.O: Visakhapatnam for information and necessary action. 2. The EE, R.O: Srikakulam for information and necessary action.

Page 8 of 18

ANNEXURE

1. The proponent shall obtain Consent for Operation (CFO) 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. No effluents shall be discharged in to the storm water drains.

Water:

4. The source of water is Bore Wells: 9 Nos. and the maximum permitted water consumption is as following:

Sl. No.

Description Total (KLD)

1. As per EC (API) 24.11.2009 1739

2. As per EC order (Formulations) 22.08.2012 778

Total quantity as per EC order 2517

3. As per CFE order 10.10.2012 2517

S.No. Purpose

As per CFE order dt. 10.10.2012

After Change of Product Mix

API (KLD)

Formu-lations (KLD)

API (KLD)

Formu-lations (KLD)

1 Process 177.01

430.00

40.31

215.00 2 QC and R &D 80.00 20.00

3 Washings 100.00 25.00

4 Scrubber water 90.00 22.50

5 Steam jet ejectors 24.00 6.00

Sub Total - I 471.01 430.00 113.81 215.00

1 Chiller & Hot water generator makeup

-- 20.00 -- 10.00

2 Boiler make up 397.00 -- 114.25 --

3 Laundry -- 66.00 -- 33.00

4 Cooling makeup 400.52 -- 104.15 --

5 RO rejects – process water 91.00 -- 22.75 --

6 Reject from Raw water pre treatment

73.00 130.00 18.25 65.00

7 Boiler water treatment rejects 16.00 -- 4.0 --

Sub Total - II 977.52 216.00 263.4 108.00

Page 9 of 18

1 Domestic & Canteen 45.00 132.00 35.00 66.00

2 Gardening 245.47 -- 245.47 --

Sub Total - III 290.47 132.00 280.47 66.00

Total (I + II + III) - A 1739.00 778.00 657.68 389.00

Recycled water:

1 Cooling Tower Makeup 306.50 358.00

2 Water for gardening 12.00 60.00

3 Total Recycled Water - B 318.50 418.00

Grand Total (A+B) 976.18 807.00

Total water requirement (976.18 + 807.0) is 1783.18 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:

Sl. No.

Description Total (KLD)

1. As per EC (API) 24.11.2009 1290

2. As per EC order (Formulations) 22.08.2012 844

Total quantity as per EC order 2134

3. As per CFE order 10.10.2012 + Domestic from Formulation section 60 KLD

2078

After Change of Product Mix:

Description Quantity as per CFE Order dt.10.10.2012

(KLD)

After Change of Product Mix (KLD)

Process from API (High COD High TDS – 85.00 KLD + High COD Low TDS – 39.00 KLD Low COD High TDS – 39.00 KLD – 163.00 KLD)

163.00 39.3

Steam Jet Ejectors 24.00 6

Scrubbers 92.00 23

Total – I 279.00 68.3

Stream II: Low COD and TDS

Process from API (LTDS) 34.00 5

QC and R&D 80.00 20

Washings 100.00 25

From Formulation – (Process, Washings & QC and R&D)

400.00 200

Total-II 614.00 250

Page 10 of 18

Stream III: Utilities:

Boiler Blow downs 163.00 45

Cooling Towers Blow down 413.00 105

Rejects from raw water treatment 89.00 25

Boiler Softeners rejects 91.00 25

From Formulation 162

Laundry, Fresh water RO rejects, Cooling tower blow down, Chiller etc.,

324.00

Total-IIII 1080.00 362

Stream IV: Domestic

Bulk Drugs (API) 45.00 35

Formulations 60.00 60

Total–IV 105.00 95

Grand Total (I+II+III+IV) 2078.00 775.3

Treatment & disposal after Change of Product Mix:

Description Effluent quantity

(KLD) Mode of Treatment

Stream I: High COD and TDS

Process 39.3 Treated in effluent treatment plant consist of Stripper, MEE, ATFD and RO.

Condensate from MEE and ATFD will be sent to ETP.

RO permeate reused for cooling tower makeup & Boiler feed.

R.O rejects sent to MEE. (Or)

The industry shall send the effluent to the M/s. Dr. Reddy’s Laboratories Limited (CTO-Unit-VI) for treatment and disposal to utilize the buffer capacity of ETP/ZLD available.

Steam Jet Ejectors 6

Scrubbers 23

Total–I 68.3

Stream II: Low COD and TDS

Process 5 Sent to Biological Treatment System of capacity 550 KLD followed by RO. RO permeate reused for cooling tower makeup & Boiler feed. R.O rejects sent to MEE.

(Or) The industry shall send the effluent to the M/s. Dr. Reddy’s Laboratories Limited (CTO-Unit-VI) for treatment and disposal to utilize the buffer capacity of ETP/ZLD available.

QC and R&D 20

Washings 25

Formulation – (Process, Washings

& QC and R&D) 200

Total-II 250

Page 11 of 18

Stream III: Utilities:

Boiler Blow downs 45 Treated in ETP and Send to RO-I & RO-II. RO permeate reused for cooling tower makeup & Boiler feed. R.O rejects sent to MEE.

(Or) The industry shall send the effluent to the M/s. Dr. Reddy’s Laboratories Limited (CTO-Unit-VI) for treatment and disposal to utilize the buffer capacity of ETP/ZLD available

Cooling Towers Blow down

105

Rejects from raw water treatment

25

Boiler Softeners rejects

25

Formulations 162

Total–III 362

Stream IV: Domestic

Bulk Drugs (API) 12 Treated in STP of capacity 100 KLD, consisting of Grit Chamber, Equalization tank aeration tank, Sand carbon filter, Holding tank and final disposal to on land for green belt development in the premises.

Formulations 60

Total–IV 95

Grand Total (I+II+III+IV)

775.3

Industry adopted zero liquid discharge system. No effluent shall be discharged to outside the industry premises.

6. The ZLD system consisting of stripper, MEE, ATFD system with condenser and Biological ETP, RO plant shall be maintained properly. All the units of the ZLD system shall be impervious to prevent ground water pollution. The units of ZLD system shall be constructed above the ground level. Effluents shall not be discharged on land or into any water bodies or aquifers under any circumstances.

7. The industry shall provide digital flow meters with totalisers at the inlet and outlet of Stripper, MEE, ETP and RO.

8. 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.

9. 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.

Page 12 of 18

Air:

10. The Air pollution Control equipment shall be installed along with the commissioning of the activity and shall comply with the following for controlling air pollution.

As per CFE order dt. 10.10.2012:

S. No.

Details of Stack

Stack – 1 to 4

Stack – 5

Stack – 6&7 Stack–8&9

Stack - 10 Stack–11 - 26

1. Attached to:

Boilers (Coal Fired / Agri

waste Boiler)

Oil fired Boiler (stand

by)

Incinerator Thermic Fluid

Heater

Dedicated Incinerator

for Mercaptan

DG Sets

2. Capacity 4 x 10 TPH

1 x 10 TPH

2 x 500 Kg /Hr.

2 x 0.25 x 106 K. Cal/Hr.

1 x 50 Kg /Hr.

16 x 2000 KVA

(Standby Power

Supply)

3. Fuel quantity

coal 200 TPD

Furnace oil - 20 KLD

Furnace oil - 2 KLD

Furnace oil - 2 KLD

Furnace oil – 2 KLD

HSD - 96 KLD

4. Stack height

4 x 40 m

40 m 40 m each 15 m each

40 m 16 x 9 m (above roof)

5. Diameter 4 x 0.6 m

0.6 m 2.9 m 0.32 m 0.75 m 0.75 m

6. Control Equipment

Multi cyclone followed by Bag filters

----- Cyclone Separator, Scrubbers

----- Primary & secondary

packed bed scrubbers.

Silencers &

Mufflers

7. Conc. of particulate matter

< 115 mg/Nm3

< 115 mg/Nm3

As per G.O.Ms.No.65

-- As per G.O.Ms.No.65

After change of product mix (installed partly):

Sl. No

Details of Stack Stack 1 Stack 2 Stack 3 Proposed

a) Attached to Boiler D.G. Set HSD Boilers

b) Capacity 10 TPH Boiler**

7 x 2000 KVA

2 x 0.85TPH

Page 13 of 18

c) Name of the Fuel Rice Husk: 50 TPD (OR) Biomass

Briquettes: 35 TPD (Or) Coal 30

TPD

Diesel: 300 Lt./Hr.

HSD - 7 lt/hr.

d) Stack height above ground 40 m 30 m 30 m

e) Air Pollution Control Equipment:

Multi cyclones followed by Bag

filter

Acoustic enclosures

Bag filter

** Extracted steam from 6MW Co-gen power plant located in Dr. Reddy’s Laboratories

Limited, Unit CTO-VI, Pydibhimavaram which is adjacent to SEZ plant, shall be utilized to fulfill the steam requirements through a permanent steam line.

11. 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.

12. The industry shall properly operate and maintain 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.

13. The industry shall properly operate and maintain multi-stage scrubbers to the process vents to control the process emissions. The industry shall ensure that online pH measuring facility with auto recording system is connected to the scrubbers.

14. The industry shall properly operate and maintain VOC monitoring system with auto recording facility.

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

16. 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. 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.

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

18. The industry shall send the used / spent solvents to the recyclers (or) process them at their own solvent recovery facility within the premises.

Page 14 of 18

19. 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:

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

S. No.

Description Units

Qty as per EC

24.11.2009 &

22.08.2012

Qty as per CFE 10.10.20

12

Qty after CPM

Mode of Disposal / Treatment

From Bulk Drugs (API)

1 Spent Solvents TPD - 68.9 (as

per CFO order

dt.18.06.2017

68.9 Recovered within the plant premises / cement plants for co-processing

2 Mixed Spent Solvents

TPD - 3.6 (as

per CFO order

dt.18.06.2017

3.6 After primary distillation within the premises, shall be sent to paint industries (or) authorized recovery units / cement plants for co-processing.

3 Solvent Residue TPD 7.19 7.2 2.33 Sent to authorized Cement Industries for co processing (or) TSDF for incineration or Pre processing

4 Process Organic Residue

TPD 4.36 4.37 1.38 Shall be Sent to Cement Industry for co processing or TSDF for incineration or pre processing

5 Date Expired, Discarded and Off specification Drugs/Medicines

TPD - - 0.1 Shall be sent tothe cement industries for co processing(or)TSDF for Incineration / CBMWTF

Page 15 of 18

6 Process Inorganic Residue

TPD 1.05 0.98 0.26 Shall be sent to TSDF for land filling / Pre- processing for Cement Industries

7 Carbon TPD 0.45 0.41 0.08 Sent to TSDF for Incineration or preprocessing (or) Cement Industries for co processing

8 Hyflow TPD 0.14 0.13 0.03

9 Catalyst TPD 0.02 0.034 0.01 Returned to manufacturer

10 Detoxified Container

Nos./ Annum

10,000 10000 2500 Sold to authorize vendors after complete detoxification.

11 Used Batteries Nos./ Annum

24 24 250 Shall be sent to authorized recyclers / OEM / Manufactures / Authorized collection centers

12 Ash TPD 12 12 -- The utilities in CTO-IV unit are being used. 13 Incinerator Ash TPD 0.5 0.5 --

From Formulations

1 Date Expired, Discarded and Off specification Drugs/Medicines

TPD 1.67 1.68 0.84 Shall be sent to the cement industries for co processing (or) TSDF for Incineration / CBMWTF

2 Process wastes and Residues

TPD 0.34 0.34 0.17 Shall be Sent to Cement Industry for co processing or TSDF for incineration or pre processing

3 Spent Organic Solvent (Coating Solutions)

Lts/ Annum

36500 18000 (as per CFO order

dt.18.06.2017

18000 Shall be Sent to Cement Industry for co processing or TSDF for incineration or pre processing

4 Detoxified Containers (HDPE Carboys/glass bottles/MS&HDPE Drums etc)

Nos./ month

- 4000 *5000 Sold to outside parties / recyclers after detoxification

5 Wooden Pallets, paper, aluminium foils, MS Scrap

TPD - 1.34 0.67 Shall be sent to recycler for reuse

6 Bio Medical Waste from QC Lab

kg/day - 10 5.0 To authorized CBMWTF

Page 16 of 18

7 Used Batteries Nos. / year

- 24 250 Shall be sent to authorized recyclers / OEM / Manufactures on buy back basis / Authorized collection centers

Common From Bulk Drugs (API) & Formulations

1 Evaporation Salts

TPD 22.49 (18.87+3

.62)

19.22 (15.6+1.810+1.810)

6.08 Shall be sent to TSDF for land filling / preprocessing (or) to the cement industries for co processing

2 ETP Sludge TPD 2.1 (0.9+ 1.2)

2.04 (0.84+0.6+0.

6)

1.2 Shall be sent to the cement industries for co processing or to TSDF for land filling or pre processing

3 Waste Oil Lts./ Year

4000 6000 (4000+2000)

13000 Sent to Authorized Recyclers (or) to the Cement industries for co processing or TSDF for Incineration

4 Spent ion exchange resin

Lts/ Annum

- - 300 Sent to authorized re processors / recyclers/reuse in Boilers

5 Used filters Contaminated with Oil

Nos./ Annum

- - 25 Sent to authorized re processors / recyclers/ cement industries

6 Used membranes from Water treatment plants

kg / Annum

- - 2000 Shall be sent to TSDF for land filling (or) to the cement industries for co processing

7 Municipal waste Kg/ per day

300 300 To local Municipal dump yard.

S.No Name of the Solid waste Quantity Mode of Disposal

01 General waste (Insulation puff, used PPE, nitrile rubber, insulation wool, paper waste) ( as per CFE order dt. 11.01.2017)

5 Ton per month

Cement industries for co-processing / TSDF / Recyclers

*Detoxified containers for Formulations increased from 2000 Nos./ month to 5000 Nos./ month as major raw materials are being received in HDPE carbuoys of small capacities.

Page 17 of 18

21. 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.

22. 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.

Other Conditions:

23. Existing green belt shall not be disturbed due to the proposed expansion. 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.

24. 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.

25. Concealing the factual data or submission of false information/ fabricated data and failure to comply with any of the conditions mentioned in this order and attracts action under the provisions of relevant pollution control Acts.

26. Notwithstanding anything contained in this conditional 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 in the order, review any or all the conditions imposed herein and to make such alternation as deemed fit and stipulate any additional conditions or revoke the order in the interest of environment protection.

Page 18 of 18

27. Any person aggrieved with this order 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 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.

CHAIRMAN To M/s. Dr. Reddy’s Laboratories Limited, (API-SEZ) Unit (CPM) R. Sy. No. 57-68, 70-73, 75-77 & 80, Devunipalavalasa Village, Pydibhimavaram Panchayat, Chipurupalli Taluk, Ranasthalam Mandal, Srikakulam District. srinivasarajum@drreddys.com sridhars@drreddys.com prasadvvvvss@drreddy.com