F. No. J-11011/36/2013-IA-II (I)

Government of IndiaMinistry of Environment, Forest and Climate Change

(IADivision)

Yogendra Pal SinghScientist 'D'F. No. J-11011/36/2013-IA-II (I)

Indira Paryavaran BhawanAliganj, Jor Bagh Road

New Delhi - 110003

Telefax: 91-11-24695365E-mail: yogendra78@nic.in

Dated: 10th July, 2017

To,Shri Shridhar KelaMI s Quest Healthcare Pvt. Ltd.,No.1, 2nd Floor, 100 Feet Road,Koramangala, s» Block,Bangalore-560095

Subject: Proposed Active Pharmaceutical Ingredients and formulationsmanufacturing unit ( total capacity - 40 MTPA)at plot 81 A, SIPCOT-1,Industrial Area, village Zuzuwadi, TalukHosur, Krishnagiri district,Tamil Nadu by MIs Quest Healthcare Pvt. Ltd.-reg. EnvironmentalClearance.

Ref.:2017.

Your online proposal no. IA/TN/IND2/50589/2012; dated 15th March,

Sir,This has reference to your online proposal IA/TN/IND2/50589/2012; dated

15th March, 2017 along with project documents including Form I, Terms ofReferences, Pre-feasibility Report and EIA/EMP Report regarding above mentionedproject.

2.0 The Ministry of Environment, Forest and Climate Change has examined theapplication. It is noted that proposal is for Proposed Active Pharmaceutical Ingredientsand formulations manufacturing unit (total capacity - 40 MTPA)at plot 81 A, SIPCOT-1, Industrial Area, village Zuzuwadi, TalukHosur, Krishnagiri district, Tamil Nadu byM/s Quest Healthcare Pvt. Ltd. The land area for proposed project is 16,023.32 m-'(3.95 Acres). Industry will develop greenbelt in an area of 35 % i.e., 5,608.16 m2 area.

3.0 The estimated project cost is 2,507 Lakhs. Total capital cost earmarked towardsenvironmental pollution control measures is Rs. 186 Lakhs and the Recurring cost(operation and maintenance) will be about Rs. 42 Lakhs per annum. Total employment

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will be 220 persons as direct & indirect employment. Industry proposes to allocate Rs.125 Lakhs of 2.5 % towards ESC.

4.0 Followingare the list of proposed products:

Product listProduct Capacity (TPM)

1 Mineral Salts of Gluconate, Citrate, Lactate. 1500Lactobionate, Fumerate, Orotate, Pidolate,Aspartate, Ascorbate, Glubionate, and othermineral salts.

2 Perazindimaleate 93 GlyceroPhosphates 304 CarbasalateCalcium 95 Iron Sucrose 366 TMS (Tiemonium methyl sulphate) 187 Alendronate sodium 158 Beta Glycero Phosphate 11.99 Phenrocoumon 310 Strontium ranelate 611 Calcium D saccarate 1812 Calcium Dobesylate 1513 Ethamslate 614 Benfotiaine 1815 Tolperisone HCI 916 Dobutamine Hc1 617 Calcium Folinate 0.1

Total 1710

5.0 It is reported that there is no national parks, wildlife sanctuaries, BiosphereReserves, Tiger / Elephant Reserves, WildlifeCorridors etc. lies within 10 km distance.Thenpennaiyar river is flowing at a distance of 7.8 km in East direction. KalavarapalliReservoir is situated at a distance of 7 km in East direction. Basthi Lake is situated ata distance of 4.5 km in ESE direction. Bidaraguppe lake is situated at a distance of4.5 km in NWdirection. Darga Lake is situated at a distance of 4.5 km in SE direction.Santhapuram Lake is situated at a distance of 1.6 km in SE direction.

6.0 Total water requirement is 205 m3/day of which fresh water requirement of 145m3/ day and will be met from SIPCOT. Treated effluent of 85 KLD will be treatedthrough Effluent Treatment plant. ETP treated effluent is further treated in ReverseOsmosis plant. The Reverse Osmosis permeate is used in utilities. RO rejects is treatedin MEE along with other high TDS effluent. Plant will be based on Zero Liquiddischarge system.

Power requirement will be 1.2 MW will be met from Tamil Nadu Generation andDistribution Corporation Limited (TANGEDCO)with DG sets of 4 x 380 KVAand 2 x

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180 KVAcapacity, are used as standby during power failure. Stack height of 10 m(380 KVA) and 9 m (180 KVA) each will be provided as per CPCB norms to theproposed DG set which will be used as standby during power failure.

Briquettes fired boiler of 4TPH will be used. Bag filter with a stack of height of 30 mwill be installed for controlling the particulate emissions (with in statutory limit of 115mgyNm-]

Wet scrubber will be used to control the process emissions i.e. Particulate/Acidmist. Lye solution will be used to control Acid vapours.

The domestic garbage will be sent to nearby Municipality. Process Waste, ETPSludge, Residue from Solvent Recovery and Residue from MEE will be sent to TSDF fordisposal. Used / Spent Oil will be sent to waste oil recyclers. Boiler Ash will be sent forbrick making. STP Sludge will be used as manure for gardening.

7.0 Public hearing is exempted under the provisions as per para 7 III. Stage (3) (b)of the EIAnotification, 2006.

8.0 All Synthetic Organic Chemicals (Bulk drug intermediates) Industrieslocated inside the notified industrial area/estate are listed at S.N. 5(f) undercategory 'B'. However, project site is located within 10 Km of inter-state boundary(TamilNadu & Karnataka) and treated as category 'A' project due to applicability ofgeneral condition of the EIA notification, 2006 and appraised at Central level.

9.0 The proposal was considered by the Expert Appraisal Committee (Industry) inits 22ndEAC meeting held during 17th-18th April, 2017. Project Proponent and the EIAConsultant namely M/s. ABC Techno Labs India Limited have presented EIA / EMPreport as per the TOR. EAChas found the EIA / EMP Report to be satisfactory and infull consonance with the presented TORs. The Committee recommended the proposalfor environmental clearance.

10.0 Based on the information submitted by the project proponent, the Ministry ofEnvironment and Forests hereby accords environmental clearance to above projectunder the provisions of ElA Notification dated 14th September 2006, subject to thecompliance of the following Specific and General Conditions:

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A. Specific Conditions:

1. As proposed Industry shall develop 10 m wide peripheral greenbelt ofperennial trees like Neem, Seasam etc. Total 35 % i.e., 5,608.16 m2 area,including green belt area, of the project cover area will be developed asgreen area.

F. No.J-llOll/36/2013-IA-II (I)'

11. At least 5 % of the total cost of the project shall be earmarked towards theEnterprise Social Commitment (ESC)and shall be used only for MookandPally, Zuzuvadi and Bedarapalli villages. Followingactivities shall be undertaken under ESC activities:

a. RO plants shall be installed in Mookand Pally, Zuzuvadi andBedarapalli villages to ensure safe drinking water availability. Theexpenditure on maintenance on these RO plants will be owned bythe Project proponent.

b. 5000 trees shall be planted in fiveyears in nearby villages with theconsultation of the villagers. Survival rate of plants shall bereported to RO, MoEF&CCin 6 monthly compliance report.

111. A regular environment manager having post graduate qualification inenvironmental sciences/ environmental engineering to be appointed forlooking after the environmental management activities of the proposedplant.

IV. The unit shall adhere to Zero Liquid Discharge (ZLD).v. Continuous online (24 x7) monitoring to be installed for flowmeasurement

and measurement of pollutants within the treatment unit. Data to beuploaded on company's website and provided to the respective RO ofMEF&CC,CPCBand SPCB.

VI. The unit shall make the arrangement for protection of possible fire hazardsduring manufacturing process in material handling. Fire fighting systemshall be as per the norms.

V11. Occupational health surveillance of the workers shall be done on a regularbasis and records maintained as per the Factories Act.

V111. Storage of hazardous chemical shall not exceed more than one week.IX. Allworkers should wear mask during working hours.x. Only inorganic waste shall be sent outside for disposal.

Xl. The by-products which fall under the purview of the Hazardous WasteRules, be handled as per the provisions of the said Rules and necessarypermissions shall be obtained under the said rules.

B. GENERAL CONDITIONS:

1. The project authorities must strictly adhere to the stipulations made by thestate Pollution Control Board (SPCB), State Govemment and any otherstatutory authority.

11. No further expansion or modifications in the plant shall be carried out withoutprior approval of the Ministry of Environment and Forests. In case of deviationsor alterations in the project proposal from those submitted to this Ministry forclearance, a fresh reference shall be made to the Ministry to assess theadequacy of conditions imposed and to add additional environmental protectionmeasures required, if any.

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iii. The locations of ambient air quality monitoring stations shall be decided inconsultation with the State Pollution Control Board (SPCB) and it shall beensured that at least one stations is installed in the upwind and downwinddirection as well as where maximum ground level concentrations areanticipated.

IV. The National Ambient Air Quality Emission Standards issued by theMinistry vide G.S.R. No. 826(E) dated 16th November, 2009 shall be followed.

v. The overall noise levels in and around the plant area shall be kept well withinthe standards by providing noise control measures including acoustic hoods,silencers, enclosures etc. on all sources of noise generation. The ambient noiselevels shall conform to the standards prescribed under Environment(Protection) Act, 1986 Rules, 1989 viz. 75 dBA (day time) and 70 dBA (nighttime).

VI. The Company shall harvest rainwater from the roof tops of the buildings andstorm water drains to recharge the ground water and use the same water forthe process activities of the project to conserve fresh water.

VlI. Training shall be imparted to all employees on safety and health aspects ofchemicals handling. Pre-employment and routine periodical medicalexaminations for all employees shall be undertaken on regular basis. Trainingto all employees on handling of chemicals shall be imparted.

V111. The company shall also comply with all the environmental protection measuresand safeguards proposed in the documents submitted to the Ministry. All therecommendations made in the EIA/EMP in respect of environmentalmanagement, risk mitigation measures and public hearing relating to theproject shall be implemented.

lX. The company shall undertake all relevant measures for improving the socio--economic conditions of the surrounding area. CSR activities shall beundertaken by involving local villages and administration.

x. The company shall undertake ceo-developmental measures includingcommunity welfare measures in the project area for the overall improvement ofthe environment.

Xl. A separate Environmental Management Cell equipped with full fledgedlaboratory facilities shall be set up to carry out the Environmental Managementand Monitoring functions.

XlI. The company shall earmark sufficient funds towards capital cost and recurringcost per annum to implement the conditions stipulated by the Ministry ofEnvironment and Forests as well as the State Government along with theimplementation schedule for all the conditions stipulated herein. The funds soearmarked for environment management/ pollution control measures shall notbe diverted for any other purpose.

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F. No. J-llOllj36j2013-IA-II (I)

X111. A copy of the clearance letter shall be sent by the project proponent toconcerned Panchayat, ZilaParisadjMunicipal Corporation, Urban local Bodyand the local NGO, if any, from whom suggestionsj representations, if any,were received while processing the proposal.

XlV. The project proponent shall also submit six monthly reports on the status ofcompliance of the stipulated Environmental Clearance conditions includingresults of monitored data (both in hard copies as well as bye-mail) to therespective Regional Office of MoEF, the respective Zonal Office of CPCB andSPCB. A copy of Environmental Clearance and six monthly compliance statusreport shall be posted on the website of the company.

xv. The environmental statement for each financial year ending 31st March inForm-Vas is mandated shall be submitted to the concerned State PollutionControl Board as prescribed under the Environment (Protection) Rules, 1986,as amended subsequently, shall also be put on the website of the companyalong with the status of compliance of environmental clearance conditions andshall also be sent to the respective Regional Officesof MoEFbye-mail.

XVI. The project proponent shall inform the public that the project has beenaccorded environmental clearance by the Ministry and copies of the clearanceletter are available with the SPCBjCommittee and may also be seen at Websiteof the Ministry at http://moef.nic.in. This shall be advertised within seven daysfrom the date of issue of the clearance letter, at least in two local newspapersthat are widely circulated in the region of which one shall be in the vemacularlanguage of the locality concerned and a copy of the same shall be forwarded tothe concerned Regional Officeof the Ministry.

XVll. The project authorities shall inform the Regional Officeas well as the Ministry,the date of financial closure and final approval of the project by the concernedauthorities and the date of start of the project.

11.0 The Ministry may revoke or suspend the clearance, if implementation of any ofthe above conditions is not satisfactory.

12.0 The Ministry reserves the right to stipulate additional conditions, if foundnecessary. The company in a time bound manner will implement these conditions.

13.0 The above conditions will be enforced, inter-alia under the provisions of theWater (Prevention& Control of Pollution)Act, 1974, Air (Prevention &. Control of WaterPollution) Act, 1981, the Environment (Protection) Act, 1986, Hazardous Waste(Management, Handling and Trans-boundary Movement) Rules, 2016 and ~ PublicLiabilityInsurance Act, 1991 along with their amendments and rules. ~\';:..y('"

41·2-b\'1(Yogendra Pal singh)

Scientist 'D'

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_,F. No. J-ll011/36/2013-IA-II (I)

Copy tor-

1. The Principal Secretary, Department of Environment, Ground Floor, PanagalBuildings 1, Jeenis Road, Saidapet, Chennai - 600 015.

2. The Chief Conservator of Forests, Regional Office (Southern Zone, Bangalore)Kendriya Sadan, 4th Floor, E&F Wing, IIBlock Koramangala, Banglore-560034.

3. The Chairman, Central Pollution Control Board Parivesh Bhavan, CBD-cum-OfficeComplex, East Arjun Nagar, New Delhi - 110 032.

4. The Chairman, Tamil Nadu Pollution Control Board, Corporate Office, 76, AnnaSalai, Guindy, Chennai - 600 032.

5. Monitoring Cell, Ministry of Environment, Forest andParyavaran Bhavan, Lodhi Road, New Delhi.Guard File/Monitoring File/Notice Board.

Climate Change, Indira

A2?t~lf1(Yogendra Pal singh)

Scientist 'D'

6.

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