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AUROBINDO PHARMA LIMITED, UNIT - IX SY.NO. 305, 369 to 371, 373, 374 AND 377, GUNDLAMACHANOOR VILLAGE, HATNOOR MANDAL, SANGAREDDY DISTRICT, TELANGANA EXECUTIVE SUMMARY SUBMITTED TO TELANGANA STATE POLLUTION CONTROL BOARD, REGIONAL OFFICE, SANGAREDDY

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Page 1: hZK /E K W, ZD >/D/d U hE/d r /ytspcb.cgg.gov.in/publichearings/Aurobindo Pharma... · Pharma features among the top 10 companies in India in terms of consolidated revenues. Aurobindo

AUROBINDO PHARMA LIMITED, UNIT - IX SY.NO. 305, 369 to 371, 373, 374 AND 377,

GUNDLAMACHANOOR VILLAGE, HATNOOR MANDAL, SANGAREDDY DISTRICT, TELANGANA

EXECUTIVE SUMMARY

SUBMITTED TO TELANGANA STATE POLLUTION CONTROL BOARD,

REGIONAL OFFICE, SANGAREDDY

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Aurobindo Pharma Limited. Unit IX Executive Summary

Team Labs and consultants E-1

EXECUTIVE SUMMARY

Introduction

Among the largest ' Vertically Integrated ' pharmaceutical companies in India, Aurobindo

has robust product portfolio spread over major product areas encompassing CVS, CNS,

Anti-Retroviral, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic with

approved manufacturing facilities by USFDA, UKMHRA, WHO, MCC-SA, ANVISA-

Brazil for both APIs & Formulations.

Aurobindo Pharma Limited established in 1986 with a single unit manufacturing Semi-

Synthetic Penicillin (SSP) and now a well-integrated pharma company, Aurobindo

Pharma features among the top 10 companies in India in terms of consolidated revenues.

Aurobindo exports to over 125 countries across the globe with more than 70% of its

revenues derived out of international operations.

M/s. Aurobindo Pharma Limited, Unit IX obtained Environment Clearance Vide file no.

F. No. J-11011/83/2004-IA II (I) dated 21.06.2005. The unit had renewed consent for

operation vide order no. TSPCB/ SRD/ CFO & HWA/HO/ 2019 dated 10.06.2019 valid

till 31.03.2024. It is proposed to expand the API manufacturing capacity from 34.7 TPM to

173 TPM in existing site area of 25.04 acres. The capital cost for the proposed expansion

project is Rs. 50 crores. The cost estimate form environment management is 6.12 crores

and annual recurring expenditure is 11.8 crores. The expansion involves additional

production blocks, utilities and enhancement of treatment facilities, storages and

additional equipment to enhance the capacity, at the existing site in Sy.Nos. 305, 369 to

371, 373, 374 and 377 Gundlamachanoor village, Hatnoor mandal, Sangareddy district,

Telangana. Prior environmental clearance is mandated by Ministry of Environment and

Forests, vide SO 1533, dated September 14, 2006, for synthetic organic chemicals

manufacturing activity. The terms of reference for the environmental impact assessment

studies was obtained from MoEF&CC vide letter no F.No. J-11010/198/2017-IA II (I)

dated 31.07.2017 as part of environmental clearance process. The certified compliance

letter from the regional office of MoEFCC, Bangalore is obtained vide letter no. F. No. EP

/12.1/346/AP/1135 dated 18.07.2018.

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Aurobindo Pharma Limited. Unit IX Executive Summary

Team Labs and consultants E-2

Location of the Project:

The plant site is located at Sy.Nos. 305, 369 to 371, 373, 374 and 377 Gundlamachanoor

village, Hatnoor mandal, Sangareddy district, Telangana. The site is situated at the

intersection of 170 38’53.03” (N) latitude and 780 10’ 24.11” (E) longitudes. The site is

surrounded by Narsapur – Sangareddy state highway in west direction, Covalent

laboratories Pvt. ltd., in East and south directions and Cirex Pharmaceuticals Ltd., in north

direction. The main approach road is NH 9 (Hyderabad – Mumbai) passing at a distance

of 9.5 Km in south direction. The nearest habitation from the plant site is Gundlamachnoor

village at a distance of 0.74 kms in southeast direction. The nearest town Sangareddy is at

a distance of 8.7 km in southwest direction. The nearest railway station of Patancheru is at

a distance of 16.7 km in southeast direction and the nearest airport is located at a distance

of 52 km in southeast direction. Nakkavagu stream is at a distance of 1.2 km in west

direction, flowing from south to north. Manjra river stream is at a distance of 2.25 km in

west direction, flowing from southwest to northeast. There is no reserve forest, national

park, sanctuary, biosphere reserves and critically polluted area within 10 km from the site.

Product Profile

The manufacturing capacity after expansion is presented in following tables;

Manufacturing Capacity - After Expansion S.No Name of Product Capacity

TPM Kg/Day

1 Ciprofloxacin Hydrochloride 12 400

2 Metropolol (base) 11.25 375

3 N-Isopropyl-2-methyl-2-n-propyl-3-hydroxypropyl carbamate 6 200

4 Losartan Potassium 7.5 250

5 Aminocarbinol Tartate 6.75 225

6 N-[2-Amino-4,6-dichloro-5-Pyrimidinyl] formamide 6.75 225

7 (2S,3S,5S)-2-Amino -3-Hydroxy-5-[2S-(1-Tetrahydropyrimid-2-Oxly)-3-Methyl butanoyl} Amino-1,6-Diphenylhexane, (S)-Pyroglutamic acid Salt

6.75 225

8 Trityl losartan 6 200

9 [R-(R*,S*[[2-Methyl-1-(1-oxopropoxy) propoxy] (4-phenyl butyl) phosphinyl] acetic acid Cinchonidine salt (MOPPA)

6.75 225

10 Prenyl Half Ester 6 200

11 Metaprolol Tartrate 6.75 225

12 Candesartan Methyl Ester 4.5 150

13 N-Methyl Paroxetine 3.75 125

14 N,N-Dimethyl -3-Chloropropyl Amine (Citalopram – int –A) 3 100

15 N-[2-Amino-4,6-Dichloro-5-Pyrimidinyl] Foramamide (Dichloro 3 100

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Aurobindo Pharma Limited. Unit IX Executive Summary

Team Labs and consultants E-3

Compound of Famicyclovir)

16 Iron sucrose 3 100

17 2,6-Dimethyl Phenoxy acetic acid 3.3 110

18 Lamivudine 3 100

19 Simavastatin 3 100

20 Zidovudine 3 100

21 Poly Phosphate Ester 3 100

22 4-(Dimethylamino) Butanal Diethyl Acetal 3 100

23 Cilexetil Chloride 3 100

24 O Acetyl Thio Ester 3 100

25 Bis Methyl Silyl Urea (BSU) 3 100

26 4-Amino-2-Hydroxymethyl-1-Butanol Hydrochloride 3 100

27 (2S,3S,5S)-5-amino)-2-[N-[5-Thiazolyl) Methoxy Carbonyl] Amino]-1,6-Diphenyl-3-Hydroxyhexane

2.63 87.67

28 Indinavir Sulfate 1.5 50

29 N- {[N-Methyl -N{(2-Isopropyl-4-Thiazolyl) Methyl] Amino} Carbonyl}-L-Valine

1.5 50

30 L-Valine Methyl Ester 1.5 50

31 N-(Trifluoro Acetyl)-L-Lysine (Lisinopropril) 1.5 50

32 2-Ethoxy-1-Naphthoic Acid 1.5 50

33 Sevelamer Hydrochloride 1.5 50

34 AR Modafinil 1.5 50

35 (Bromomethyl)Biphenyl Methyl Ester (Telmisartan Stage II) 1.13 37.67

36 1-Bromo-4a,5,9,10-Tetrahydro-3-Methoxy-6-Oxo-6H-Benzofuro{3a,3,2-ef}[2] Benzazepin-11-(12H)-Carboxaldehyde (Bromoformylnarnorvedine)

1.05 35

37 Rabeprazole Sodium 0.75 25

38 Methyl (2E)-3-[4-(4-Florophenyl)-6-Isopropyl-2-[N-methyl (N-Methyl sulfonyl) amino]Pyrimidine-5-yl]acrylate ([E] Pyrimidine Alkene) (substituted HydroxyPentanoic Acid

0.75 25

39 Pitavastatin Intermediate 0.75 25

40 Benzyl(2S,3aR,7aS) Octahydro-1H-Indole-2-Carboxylate Hydrochloride (BOHI HCl)

0.6 20

41 1-[4-(Pyridin-2-yl) phenyl]-5(s)-2,5-Bis-[(tert-Butyloxycarbonyl)-Amino]-4(S) Hydroxy-6-Phenyl-2-Azahexane (DIBOC Intermediate)

0.45 15

42 N-[(S)-Ethoxy Carboxyl-1-Butyl]-(S)-Alanine-(ECBA) 0.38 12.67

43 Benzyl(2S,3aS,7aS) Octahydro-1H-Indole-2-Carboxylate P-Toluenesulfonic acid (BOHI ESTER)

0.38 12.67

44 6-Hydroxy-2-(4-hydroxyphenyl) benzo[b]thiophene (Dihydroxybenzothiophene)

0.38 12.67

45 Nelfinavir Mesylate 0.3 10

46 (3S,4aS,8aS )-2-(2R)-2-{(4S)-2-(3-Hydroxy-2-methyl phenyl-4,5-dihydrooxazol-4-yl]-2-hydroxyethyl} decahyro isoquinoline-3-carboxyic acid-tert-butylamide

0.3 10

47 Trans-4-Cyclohexyl-L-Proline 0.3 10

48 3-Chloro-trans-Octahydro-1H-Quindin-2-One (Bohi) 0.3 10

49 2-(2-Ethoxy Phenoxy) Ethyl Methane Sulfonate (EPE Mesylate) 0.3 10

50 8-Methoxy Quinoline borondifluroride Chelate 0.3 10

51 N-(Methoxy Carbonyl)-(L)-TertLeucine (MOC Leucine) 0.3 10

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Aurobindo Pharma Limited. Unit IX Executive Summary

Team Labs and consultants E-4

52 3-(Methylamino)Propionitrile 0.3 10

53 N-(4-Aminobenzoyl)-β-Alanine (4ABBA) 0.15 5

54 (6S)-(-)2,6-Diamino -4,5,6,7-tertahydrobenzothiazole (Pramipexoldiamine)

0.15 5

55 (2S,4S)-FMOC-4-Cyclohexyl-Pyrrolidine-2-Carboxylate (FMOC-ChxPro-OH)

0.03 1

56 BT Hydrazine Sulfonic acid 0.02 0.67

57 Silodosin (Intermediate) 0.38 12.67

58 Fosaprepitant Dimeglumine 0.38 12.67

59 Mirabregon 0.75 25.00

60 Colesevelam 1.13 37.67

61 3-Hexyn-2-ol 0.08 2.67

62 Methoxitil 0.08 2.67

63 Rivastigimine 0.08 2.67

64 Bezafibrate 0.08 2.67

65 2-Isopentyl-2-Isopropy-1,3-Dimethoxypropane 0.38 12.67

66 Efavirenz 1.50 50

67 Tramadol HCl 3.75 125

68 Lorcaserin Hydrochloride 0.30 10

69 Teriflunomide 0.15 5

70 Apixaban 0.08 2.67

71 Canagliflozin 0.03 1

72 Atovaquone 0.75 25

73 Sodium ferric gluconate 2.25 75

74 Fluvastatin Sodium 2.25 75

75 Diprotected Rosuvastatin 2.25 75

76 Lamivudine Coupled Ester 1.13 37.67

77 Oxocompound Free Base 0.08 2.67

78 Sofosbuvir 0.08 2.67

79 Raltegravir Potasium 1.01 33.67

80 Flecanide acetate 0.38 12.67

81 Nebivilol 0.38 12.67

82 Clobazam 0.12 4

83 Nefopam HCl 0.08 2.67

84 Carbimazole 0.08 2.67

85 Ledipasvir 0.08 2.67

86 R & D Pilot Plant Trial Run Products (Bulk Drugs and Intermediates)

0.5 16.67

Total 173 5766.7

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Aurobindo Pharma Limited. Unit IX Executive Summary

Team Labs and consultants E-5

List of By-products – After Expansion S.No Name of Product Stage Name of By-Product Quantity

(Kg/day)

1 N-Isopropyl-2-methyl-2-n-propyl-3-hydroxypropyl carbamate

I Dimethylaniline HCl 182.8

Isopropylamine HCl 88

2 Losartan Potassium IV Trityl alcohol 172.8

3 Candesartan Methyl Ester I Tri n-Butyl tin Azide 109.7

4 N-Methyl Paroxetine I Triethylamine HCl 62.6

5 Lamivudine III Acetic acid 63.3

6 Simavastatin II Imidozole hydrochloride 85.8

7 Zidovudine I Trimethyl ether 101.9

8 4-Amino-2-Hydroxymethyl-1-Butanol HCl

I Sodium Diethyl Phosphate 129.2

9 Indinavir Sulfate VIII Spent Sulfuric acid 300.6

10 Deprotected Rosuvastatin II Spent Acetic Acid (20%) 2500

Manufacturing Process

Chemical synthesis produces majority of bulk drugs and intermediates currently in the

market. Chemical synthesis consists of four process steps - reaction, separation,

purification, and drying. Large volumes of solvents are used during chemical syntheses as

medium, extractions, and solvent interchanges. The manufacturing process of all the

compounds, reactions involved, material balance are presented at separate annexure of

EIA report.

Utilities

The proposed expansion requires additional steam for both process and effluent treatment

system. It is proposed to establish coal fired boiler of 1 x 12 TPH capacity in addition to

existing 1 x 12 TPH coal fired boiler, while keeping the existing 1 x 8 TPH coal fired boiler

as standby after expansion. The DG sets required for emergency power during load shut

down is estimated at 2140 kVA and accordingly 2 x 380 DG sets are proposed in addition

to exiting 2 x 500 kVA and 1 x 380 kVA DG sets.

List of Utilities

S.No Utility Permitted Proposed After Expansion

1 Coal Fired Boilers (TPH) 12 8

12 2 x 12 1 x 8*

2 DG Sets (kVA)** 2 x 500 1 x 380

2 x 380 2 x 500 3 x 380

* Shall be kept as standby **DG sets will be used during load shut down by TRANSCO

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Aurobindo Pharma Limited. Unit IX Executive Summary

Team Labs and consultants E-6

Water Requirement

Water is required for process, scrubbers, washing, cooling tower makeup, steam

generation and domestic purposes. The total water requirement after expansion increased

from 43.1 KLD to 726.4 KLD. The fresh water consumption is optimized by reusing treated

wastewater to an extent of 292.5 KLD, thus reducing fresh water consumption to 433.9

KLD during operation. The fresh water shall be drawn from ground water in addition to

reuse of treated wastewater. The water balance for daily consumption is presented in

below table.

Water Balance Purpose INPUT(KLD) OUTPUT (KLD)

Fresh Water Recycled Water Loss Effluent

Process & Washings 134.9 144.5*

Scrubber 20 20

QC and R&D 15 15

SRS System 35 35

RO/DM regeneration 20 20

Boiler 75 57.5 17.5

Cooling Tower 79 265 329 15

RO Back wash 20 20

Domestic 25 2.5 22.5

Garment Washings 5 5

Gardening 5 27.5 32.5 Gross Total 433.9 292.5 421.5 314.5

Total 726.4 736 * Effluents contains unreacted raw materials, water formed in reaction, soluble solvents, by-products etc.

Baseline Environmental Data

The baseline data was collected in the study area during March -May 2018. The baseline

data includes collection of Samples of ground water, surface water and soil, monitoring of

ambient air quality, noise levels, ecological status and meteorological parameters. The

analytical results show that the values are within the prescribed limits for air quality. The

ground water quality is observed to be above the limits for potable purpose when

compared to the prescribed standards of IS: 10500 – 2012 at few locations.

Identification and Quantification of Impacts

The impact assessment report has identified various sources of pollution and quantified

the pollution loads due to proposed project. The sources of pollution are air emissions

from utilities and process; liquid effluents from process, utilities and domestic usage; solid

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Aurobindo Pharma Limited. Unit IX Executive Summary

Team Labs and consultants E-7

wastes from process, treatment systems and utilities; and noise pollution from utilities,

and process equipment. A detailed impact assessment was made using rapid impact

assessment matrix method. The salient features are presented as follows.

Impacts on Air quality: The impacts on air quality shall be due to the emissions from,

coal fired boilers, and standby DG sets. The incremental concentrations are quantified

using ISC-AERMOD model based on ISCST3 Algorithm for proposed utilities of 2 co-

located API manufacturing units, namely; Aurobindo Pharma Limited, Unit IX and Cirex

Pharmaceuticals Ltd., located at Gundlamachanoor village, Hatnoora mandal, Sangareddy

District, Telangana. The results indicate marginal increase in ambient air quality

concentration. The predicted values for SPM, PM10, PM2.5, SO2 and NOx are 1.95, 0.77, 0.34,

2.23 and 2.35 g/m3 respectively and the maximum values are observed at a distance of

0.5 km in northwest direction, and the cumulative values of baseline air quality combined

with predicted values are found to be within the prescribed limits of National Ambient

Air Quality Standards. The mitigative and control measures of air pollution shall ensure

that the impact on air quality is local – within the site area and its surroundings. The

fugitive and diffuse emissions were quantified and a box model was used to predict air

borne concentrations, and the results indicate work room concentrations, less than

threshold limit values (TLV) for various solvents.

Impacts on Water: Water is essentially used for process and utilities and domestic

purposes. The required water is drawn from ground water/reuse of stored runoff, in the

order of 433.9 KLD in addition to reuse of treated wastewater in the order of 292.5 KLD.

No impact on water quality is expected due to discharge of effluents as zero liquid

discharge is envisaged, which ensures reuse of treated wastewater for cooling towers

makeup.

Impacts on Noise quality: The noise levels may increase due to compressors, DG set and

other activities which emit noise levels of above 85 dB (A) at a reference distance of 1m

from the source. The predicted cumulative noise levels (as calculated by the logarithmic

model without noise attenuation) ranged between 47 and 65 dB (A). The increase in noise

levels shall have impact restricted to the site area.

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Aurobindo Pharma Limited. Unit IX Executive Summary

Team Labs and consultants E-8

Impacts on Soil: The solid wastes generated from process, utilities and effluent treatment

plant may have significant negative impacts if disposed indiscriminately. The total solid

waste will be stored separately in Hazardous waste storage area. Solid waste will be sent

to cements plants for co-incineration based on calorific value or sent to TSDF. The

operational phase impacts observed to be negative, shall be neutral after mitigation due to

effective implementation of management measures in handling, storing and transferring

of solid waste, effluents and chemicals, and development of green belt.

Impacts on Flora and Fauna: There are no endangered species of flora and fauna in the

impact area. The impact on biotic environment is neutral with the effect confined mainly

to the site area.

Environmental Monitoring Programme

It is proposed to monitor Ambient Air Quality (AAQ) for PM10, PM2.5, SO2 and NOX,

work room for VOC concentrations, stack emissions of boiler and DG sets for PM, SO2

and NOx, noise levels on quarterly basis. Water, treated wastewater are monitored on

daily basis, while Soil analysis is done once in a year.

Alternatives

The proposal is for expanding the existing unit, and the land area available for expansion

is sufficient and hence there is no requirement of alternative site or additional site area.

Additional Studies - Risk Assessment

Risk assessment was conducted and the heat radiation damage distances of pool fire in the

tank farm was limited to 31 m for a heat radiation of 4 KW/m2, and the same was within

the plant premises.

Project Benefits

The proposed project will provide employment to 200 people. The proposed project will

also generate indirect employment to the locals during construction phase in the order of

100 people for a period of 18 – 24 months. The proposed expansion shall have positive

impact on socioeconomic environment due to provision of employment both direct and

indirect and proposed CER activities.

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Aurobindo Pharma Limited. Unit IX Executive Summary

Team Labs and consultants E-9

Environment Management Plan

The management plan is drawn in consultation with project proponents and technical

consultants after evaluating various mitigation and control measures to address the

impacts identified, predicted and monitored. The impacts during construction stage are

temporary and less significant, the management plan for impacts identified during

operation stage is described as follows;

Liquid Effluents

The effluent generated from the proposed expansion is mainly from process & washings,

SRS system, scrubbing, QC and R&D, utility blow downs, RO back wash and RO rejects

and domestic wastewater. The effluents from process & washings, scrubbers, SRS system,

QC and R&D wastewater and RO/DM rejects are considered as HTDS stream, while

wastewater from utility blow downs, RO back wash are considered LTDS stream. HTDS

effluents will treat in stripper followed by MEE and ATFD, and MEE and ATFD in the

case of effluents from RO/DM rejects and scrubber. All LTDS effluent along with

condensate from MEE and ATFD shall be treated in biological treatment followed by RO

system. RO Rejects are sent to MEE and permeate is used for cooling towers make up.

Salts from ATFD are disposed to TSDF. Sludge from various units of Biological treatment

are thickened in sludge handling system and sent to TSDF. Wastewater from domestic

usage and garment washings are treated in sewage treatment plant and treated

wastewater is reused for on land irrigation.

Effluent Generated and Mode of Treatment Description Quantity (KLD) Mode of Treatment

Permitted After Expansion

HTDS Effluents

Process and washings

6.4 144.5 Sent to stripper. Stripper condensate shall be disposed to cement industries for co-processing/TSDF. Stripper bottom is sent to MEE followed by AFTD. Condensate from MEE and ATFD shall be sent to biological treatment plant followed by RO. RO rejects are sent to MEE and permeate is reused in cooling towers boiler make-up.

Scrubber 20

SRS System 35

RO/DM Rejects 20

QC and R&D 1.5 15

Total - I 7.9 234.5

LTDS Effluents

Boiler Blow downs 2.8 17.5 Sent to biological treatment system followed by

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Aurobindo Pharma Limited. Unit IX Executive Summary

Team Labs and consultants E-10

Cooling Towers Blow downs

15 RO. RO permeate reused for cooling towers makeup. RO rejects are sent to MEE.

RO Back Wash 0.5 20

Total – II 3.3 52.5

Domestic 1 22.5 Sent to sewage treatment plant and treated wastewater is reused for on land irrigation to develop green belt.

Garment Washings 5

Total – III 1 27.5

Grand Total (I+II+III)

12.2 314.5

Air Pollution

The sources of air pollution are proposed 1 x 12 TPH and existing 1 x 12 TPH and 1 x 8

TPH coal fired boilers and backup DG sets of 2 x 380 kVA in addition to existing 2 x 500

and 1 x 380 kVA capacity. Existing 1 x 12 TPH coal fired boiler will be kept as standby

after expansion. The proposed air pollution control equipment for 1 x 12 TPH coal fired

boiler is bag filter. DG sets shall be provided with effective stack height based on the

CPCB formula.

The process emissions contain ammonia, carbon dioxide, carbon monoxide, hydrogen,

nitrogen, oxygen, hydrogen bromide, hydrogen chloride and sulfur dioxide. Ammonia,

hydrogen chloride, hydrogen bromide, and Sulphur dioxide are sent to scrubber in series.

The resultant solutions after scrubbing are sent to ETP. Carbon dioxide, carbon monoxide,

Nitrogen, and Oxygen are let out into atmosphere following a standard operating

procedure, while Hydrogen gas is let out into atmosphere through a water column.

Emissions are also released from various operations of manufacturing like centrifuge,

drying, distillation, extraction etc. These emissions mainly contain volatile contents of the

material used for processing. It is proposed to provide vent condensers in series to

reactors, distillation columns, driers and centrifuge etc. to mitigate VOC emissions release.

Other vents are connected to common headers and scrubbers.

Solvent Use and Recycle

Solvents are used for extraction of products and as reaction medium. Used solvents are

recovered by distillation for reuse. Residues from distillation columns and mixed solvents

shall be sent to TSDF for incineration or cement plants for co-incineration. If any of the

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Aurobindo Pharma Limited. Unit IX Executive Summary

Team Labs and consultants E-11

distilled spent solvents are not reused due to statutory reasons the same shall be sold to

end users.

Solid Waste

Solid wastes are generated from process, solvent distillation, effluent treatment system,

DG sets and boilers. Stripper distillate, process residue and solvent residue are sent to

cement plants for co-incineration based on acceptability as the same contain significant

calorific value and are predominantly organic in nature. If these wastes are not suitable

for co-incineration, the same are sent to TSDF facility. The evaporation salts from ATFD,

and sludge from ETP are sent to TSDF for landfill. Waste oil and used batteries from the

DG sets are sent to authorized recyclers. Other solid wastes expected from the unit are

containers, empty drums which are returned to the product seller or sold to authorized

buyers after detoxification. Coal ash from boiler is sold to brick manufacturers.

Noise Pollution

Noise is anticipated from compressors and DG sets. DG sets shall be provided with

acoustic enclosure. Engineering controls like acoustic enclosures, barriers, shields, and

anti-vibrating pads will be provided to ensure reduction of noise levels and vibration.

Employees working in noise generating areas shall be provided with appropriate

personnel protective equipment.

Occupational Safety and Health

Direct exposure to chemicals or its raw materials may affect health of employees. Direct

exposure to hazardous materials is eliminated by providing closed handling facilities.

Personal Protective Equipment (PPE)i.e., hand gloves, safety goggles, safety shoes, safety

helmets, respiratory masks etc. are provided to all the employees working in the plant.

Company has a policy of providing PPEs to all personnel including contract workers.

Periodic medical checkup in addition to checkup during recruitment is adopted to

monitor health status of employees.

Prevention, maintenance and operation of Environment Control Systems

The pollution control equipment, and the effluent treatment system is monitored

periodically to estimate their efficiency and performance potential as part of adoptive

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Aurobindo Pharma Limited. Unit IX Executive Summary

Team Labs and consultants E-12

management. Proactive maintenance and monitoring program for all equipment and

machinery is adopted to identify the problems/under performance of the equipment.

Necessary measures will be adopted to rectify the identified problems/defects. The

management agrees that the results of monitoring will be reviewed periodically to adopt

new measures if necessary, for efficient pollution control.

Transport systems

All the raw materials and finished products are transported by road. Dedicated parking

facility is provided for transport vehicles. There will be 10 addition truck trip per day to

the factory for transporting raw materials and products due to proposed expansion.

Traffic signs are placed in the battery limit. The drivers of vehicles will be provided with

TREM cards of chemicals and materials to be transported, and will be explained the

measure to be adopted during various emergencies

Reduce, Recycle and Reuse

A number of measures are proposed to achieve high yields and reduce generation of

wastes. It shall be endeavor of the R&D team to improve yields through constant research

and development activities. The solvents shall be recycled for reuse in the process after

distillation. Mother liquors from the first crop shall be reused for process. Treated

wastewater from ZLD system is reused for cooling towers make-up. Treated wastewater

from sewage treatment plant is reused for greenbelt development. It is also proposed to

explore recovery of various salts from MEE salts, and from process effluents to reduce

effluent loads, and quantity of solid waste. Proposed rainwater harvesting system shall

have a storage capacity of 1040 KL, and the stored run off will be used for plant operation

for approximately 28 days.

Green Belt Development

The management developed green belt in a total area of 8.27 acres and proposed to

increase density to enhance environmental quality through mitigation of fugitive

emissions, attenuation of noise levels, balancing eco-environment, prevention of soil

erosion, and creation of aesthetic environment

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Aurobindo Pharma Limited. Unit IX Executive Summary

Team Labs and consultants E-13

Corporate Environment Responsibility

The ministry of Environment, Forest and Climate Change issued an office memorandum

mandating corporate environment responsibility expenditure contingent on the capital

cost of the project, in addition to the expenditure on environmental management. The

proposed project is a brown field project, the management proposed to spent 1% of the

proposed expansion capital cost i.e., Rs. 50 lakhs towards corporate environment

responsibility. Activities are identified to be implemented by the project proponent in

consultation with local public representatives and revenue authorities.

Environment Management Department

The Environment Management Cell of the project is headed by the President, Senior vice

president, vice president operations, DGM- EHS, followed by manager, assistant manager,

Dy. Manager and technicians/fitters.