xlil"';kdllri,l

Neutand

December 16, 2013

The Director(S)Member Secretary, lndustrial projects, EIA DivisionMinistry of Environment and ForestsParyavaran Bhawan, CGO ComplexLodhi Road, New Delhi 110003

Dear Sir,

Sub: M/s Neuland Laborator¡es Lim¡ted, Unit l, Sy Nos: 347, 474 & 49012, IDA Bonthapally,Jinnaram, Medak Dist, Andhra Pradesh - Submrssion of Application for TOR Approval -Proposed capacity enhancement of bulk drugs - Reg

We, M/s. Neuland Laboratories Limited are operating bulk drugs manufacturing unit at Sy Nos:347,

474 & 49012, IDA Bonthapally, Jinnaram, Medak Dist, Andhra Pradesh since 1984. As the unit was

established prior to 1994 EC Notif¡cation, EC requirement was not there. To meet the present market

demand, we propose fo expand production capacity from current 203.34 KglDay lo 1825.7 Kg/Day as

per the 2006 notification which covers drugs and intermediates. The industry has been categorized

under Category B and it is located in lDA, Bonthapally, a notified industrial development area.

As the term of the State Level EIA Appraisal Committee got exp¡red in Andhra Pradesh, the State

Pollution Control Board is not accepting any new application for proposed capacity enhancement.

ln view of this, we are herewith submitting the Pre-feasibility Report and Form I along with proposed

TORs directly to your office for consideration of granting TOR for proposed expansion activity.

Thanking you si¡

Yours trulyfor Neuland Laboratories Limited

\ ¡/

"l' llt' '

lapãs {-haKra bortyVP-Coripoiate EHS

l

Encl: a/a

Neuland Laboratories L¡mited

FORM- I & STANDAIID TEMPLATE FOR

CAPACITY EXPANSION

NEULAND LABORATORIES IjI]D, UNIT-ISY NOS: 347,414 &,49012,IDA, IIONTHAPALLY (V)

JTNNARAM (M), MEDAK (D)ANDHRA PRADI]SIJ

Studies & Documentation BVSubmitted bv MlS pridhvi Enviro Tech pvt. LtdM/S NEULAND LABORATORIES L|M|TED, 184/C, Lawn HouseSY.NO 347,474 & 49012, BONTHAPALLY(V) VengatRao NagarJINNARAM(M), Hyderabad-Sooo38MEDAK (D) PftO4O-4Or79770ANDHRA PRADESH FaX: 040-66730926

E-Mail:pvr@ p rid hvie nviro. com

SUBMITTED TOMINISTRY OF ENVIRONMENT & FORESTS, GOI

PARYAVARAN BHAWAN, CGO COMPLEX,LODHI ROAD, NEW DELHI.llOOO3

B,4.SIC INIIOIìI\IATION IIOII TOIì PROPOSAL OIìM/S NltUl,AND LABORÄTOIìIIìS LII\{Ìl'ED, UNI'I:I, Sl'.No. 347,474 &49012, tD

^,, BONt'ItAPALt,y(\/), JTNNARÂM (M), MIJDAK DtSl'RrC'1"

ANDIIRA PII,ADTìSII

Agenda ltemNo.

Name of thePro¡ect

M/S Neuland Laborator¡es Limited, Unit-lCapacjty Expansion of (5 D Organic chernicals and lnternlediatesmanufacturino ¡nit.lf, expans¡on, state status of implementation of project for which EC has beenaccorded : NO previous EC's

Name of theProjectProponent:

Nir. Tapas Chakraborty, VP - Corporate EHSM/S NËULAND LABORATORIES LIMITED, UNtT-t, Sy. NO.347,474 &4gOlZ,lDA, BONTHAPALLY(V), JTNNARAM (M), MEDAK DtSTRtCT,AN DH RAPRADESH.

Name of theConsultant &OCI No:

M/S Pridhvi Env¡rotech Pvt. LtdSy.No 118 in list of accredited consultants ( rev 13 Oct, 2013)

Sl. No. Salient Features

I

Location of projeclVillage i

Taluk :

D¡trict :

State :

Co-Ord¡nates:

Sy.NO. 347,474 & 49012lDA, Bonthapally (V)J¡nnaram MandalÀ,4edak DistrictAndhra Pradesh17039'11.3" N Lat¡tude &780?1'54 5" F IÕnoihide

2Capacity & Unit Configurations: Capacity expansion from 203.34 Kg/Day

to 1825.70 Kd/DâvNumber of Days operâtion ¡n a Full year

Products to be manufacturedITPD/MTÞAì

given ¡n Prefeas¡bil¡ty Report

Land reouirement: Total land area is 11.2 acres4 Status of Lânci acorlisitiôn: Land is in oossession of the comoanv

i5l

I

I

l

Break - Up of Land - Use ofprojuct S¡te:

Forests land ( Type and density ): None

Detailed land use shall be provided withEIADouble Crop agricultural land :

Single crop agr¡cultural land :

Waste landGrazing land :

Others (spec¡fy) ì

Land is in possession of the companywhich is converted to indust͡al use

Whether project located ¡n thenot¡fied lndustrial area

Yes, in IDA Bonthapally

7 Fuel to be used Coal ¡s used for boiler

IQuality of Fuel Required perAnnum

Coal i-0800 TPA

ISource of Water: Purchased from private parties through

tânkers .& nLrlll¡c sunnlv.

10Water Quant¡ty: Fresh water requirement after Expans¡on

_ 47O KLDLL Ouantitv of ¡ndustr¡al effluenl 285,0 KLD - lndustr¡a: waste water

generation and domestic waste 35,0 KLD - Donrestic

L2

Eff Iuent treatrnent processproposed

lndustrial Efffuents are proposed to beevaporated in MEE followed by ATFD.Domestic effluents along w¡th MEEcondensate proposed to be treated inb¡ologrcal treatment system followed byRO, RO Permeate proposed to be reused and RO rejects goes back to MEE,

L3 Disposal of treated effluent Zero L¡qurd Drscharoe

L4

Membersh¡p of CETP society (ifexisting)

Yes, incase of breakdown of MEE/ROfacilities, we will send pretreated effluentTO PFTI

15 Deta¡ls of orocess emissions HCL, SOz, Hz and COr emissions

16

Proposed aìr pollut¡on controldevice alongwitlr stack he¡g ht

Process emissiotls are scrubbedFug¡tive Emissions-Vent condensors andch¡llersStack heights are provided as per theguidelines of CPCB for effect¡veclisoersiion of emissnnc

17Deta¡ls hazardous wasteñenêrât¡ôn

Details g¡ven jn prefeas¡bility report

18lVanagement of hazardous wastelTreatment & disoosal)

TSDF and authonzed recyclers

L9 Membershio of TSDF lif existino) Yes

20Quant¡ty of Fly Ash to beGenerated:

21 TPD, wrll be sold to brickmanufactLrrers

21 Green belt area orooosed 3,36 Acres

22CRZ Clearance status, if any Not applicalrle as th¡s does not comes

under CRZ clearance

¿J

Names & distance of Nat¡onalparks, Wildlife sanctuaries,Biosphere reserves, Heritage sitesR¡vers, Tanks, Reserve Forestsetc,, Iocated within 10 Km from theolant boundarv:

There are no Nat¡onal parks, wildlifesanctuaries, biiosphere reserves etc.,within 10 KM fronr the site.

24

Any ¡itigation/Court case pertainingto the project:

There is no specific case againtst theproject, WP No. 1966U2002 was f¡ledon industflal pollut¡on ¡n Medak DistrictHofble high court, cOl arìd later on thecase was transferred to National GreenTribunal v¡de appl¡cat¡on No, 90/2013.The industry will follow any directionsissued by the Natronal creen Tribunal,as part of outcome of the the commoncase oend¡no with the Hon'ble authoritv

25Cost of the Project: Rs ( in Crores) Current Rs. 145,41 Crores

ProÞosed - 75.0 Crores26

Cost of project earmarked forpollut¡on control measures

Current Rs. 10.0 Crores Proposed 10,0Crore earmarked for environmentalinfrastructure

other declarâtion

Cert¡fied that the allove information 's

true to the best of my knowledge and belief

(sIGNÄTURìi OF AUIIORTZED REPRESEN'I'ATTIVE)

Place: IIYDERABAD

_,;l.4\ ,.."

'

\ -Ì.'NAMt-t,,& b ¡ts lGt'l n.ftotrl,Mr 'làpas Chakraborty (VP-Corporaf e-ËI{S)Phone 08458-3927 63, 088865017 92e-n.rai1 : tapasc@neulandlabs, com

N eu lan d Labo rato ries I i m ited, U n it- I

APPENDIX - I

(See Paragraph - 6)

FORM I

l) Basic lnformation

S,NO Item Details

L

Name of the ProjecVs

Expansion of existing llulk & ¡ntermed¡ate

manufactur¡ng unit of Neuland Laboratories

Lrd.,

? S, No in the Schedule 5 f - Drugs & Drug lntermediate (B Categor)

3 Proposedcapacity/area/len gth/tonnage tobe handled/command area/leasearea,/number of wells to be drilled

Capac¡ty Expansion 203,34 Kgs/day to!825.70 Kgs/day

4 New/Expan sion/lr4od ern izatio n Expansion

5 Existing Capacity/Area etc. 203,34 Kgs/day arìd 11.2 Acres

6 Category of Project i.e 'A' oÍ 'B' "8"

7 Does ¡t attract the generalcondition? If yes, please specify

No

I Does it attract the Spec¡ficcond¡tion? If yes, please specify.

No

9 Location

PloUSurvey/Khasra No.

V¡llage

Tehsil

District

State

Neuland Laborator¡es L¡mited, Unit-l

Sy.No.374, 474 &49012

lDA,BonthapaÌl¡

Jinnaram Mandal

Medak District-50231-3

Andhra Pradesh,

10Nearest railway stat¡on/airportalong with distance in kms,

Gaudavalli Railway Station * 11.0 Kms

Shamshabad, Hyderâbad - 45.0 Kms

17 Nearest Town, C¡ty, D¡strictHeadquârters along w¡th d¡stancein kms.

DA, Bonthapally - Located at 1.0 Km

12 Panchavats, Zilla Office ol the Gram Panchayat, lDA,

Form-1

N eu I an d Labo rator ies I ¡ m ited, U n ¡t-l

Parishad, Municipal Corporat¡on,Local body (complete postaladd¡'ess with telephone nos, tobe given)

Bonthapally (V), J¡nnaram (ÌM), Medak Dist

L3

Name of the Applicanl

Mr. Tapas Chakraborty

VP-Corporate-EHS

L4 Registered Address Neuland Laboratories Limited

Sanali lnfo Park,'A'Block, cround Floor,

8-2-1201LL3, Road No:2, Banjara Hil¡s,Hyderabad - 500034,

15 Address for Correspondence:

Name l\4r. Tapas ChakraboÍty

Desig nation(Owner/Partner/C EO) VP - Corporate EHS

Address Sy. Nos: 347,474 & 49012, lDA,Bonthapally(V), Jinnaram (M), Medak Dist

Pin Cocje 502313

E-mail tapasc@ neL¡landlalls, conl

Telephone Number o 40 -3927 63, 0888650 1 7 9 2

FaX No. o40-302rL602

16 Deta¡ls of alternative Sitesexam¡ned, ¡f any. Location ofthese sites should be shown on atopo sheet.

- NA-

77 lnterlinked Projects -NA-

18 Whether separate applicat¡on of¡nterlinked project has beensubm¡tted?

-No -

19 lf yes, date of subm¡ssion -NA -

20 lf no, reason

2I Whether the proposal involvesapproval/clearance under: if yes,deta¡ls of the same and theirstatus to be given.(a) The Forest (Conservat¡on)Act, 1980? (b) TheWildlife lProtection) Act. 1972?

-NA- ii

l

Form-1

Neu lan d Labo rato r¡ es I i m ited, U nit- I

(c) The C.R.Z Not¡ficat¡on, 1991,?

)) Whether there rs anyGovernment Order/PolicyrelevanUrelating to the site?

GO MS No G4 on l¡ft¡ng of ban onexpansion of Drugs and Drug lntermediateunits w¡th ZLD facillities

)a Forest land involved (hectares) No

24 Whether there is any locationpend¡ng against the projectand /or land in which the projectis propose to be set up?

(a) Narïe of the Court(b) Case No(c) Orders/directions of the Court,if any and its relevance with theproposed project,

There is no specif¡c case against theproject, WP No. 19661/2002 was filed onindustrial pollution ¡n Medak D¡strict ¡nHor'ble higlr court, cOl and later on thecase was transferred to National GreenTribunal vide application No, 90/2013. Theindustry will follow any directions issued bythe Nat¡onal Green Tribunal, as pan ofoutcome of the the common case pendingw¡th the Hon'ble authority.

li

t

Form-1

N eu I an d Laborato ries I i m ìted, U n it- I

(ll) Activity

l-. Construct¡on, operat¡on or decommissioning of the Project invofvingact¡ons, which wíll cause physical changes in the locality (topography, landuse, changes ¡n water bodies, etc.)

S.No.

lnf ormation/checkl istconfirmation

Yes/No

Details thereof (withapproximate quantities /rates,

wherever possíble) with sourceof informat¡on data

1.1. Permanent or temporary changein land use, land cover ortopography includ ing increase inintensity of land use (withrespect to local land use plan)

NO The proposal is for expansion oftlìe manufactur¡ng capacity of theexisting Drugs & Druglnterrnediate manufacturing unit.

L.2 Clearance of existing land,vegetation and buildings?

NO Expansion project

1.3 Creation of new land uses? NO Ex¡st¡ng land use - lndustrial.

L.4 Pre-constructron investigationse.g. bore houses, so¡l test¡ng?

NO Existing unit.

1,5 Construction works? YES Construct¡on act¡v¡ty involvescreat¡or'ì of additional ut¡lit¡es , Noaddit¡onal product¡on blocksplanned

1.6 Demol¡t¡on works? NO

tr71l

ii

Temporary sttes used forconstruction works or hous¡ng ofconstruct¡on workers?

NO The construction labor from localvillages shall be employed,

1.8 Above ground bu¡ld¡ngs,structures or earthworksincluding linear structures, cutand fill or excavat¡ons

YES No nrajor cut and f¡ll orexcavat¡on is ant¡cipated.

1.9 Undergrourrd works includingmining or tunneling?

NO

1.10 Reclamation works? NO

1.11 Dredging? NO

L.12 Otfshore structures? NO

1.13 Production and manufacturingpfocesses?

YES Deta¡ls given in PrefeasibilityReport

L,T4 Facilities for storage of goods ormaterials?

YES Common fac¡lity for storage ofrâw materials and solvents will lle

N e u land Labo rato ries I i m ited, U n it-l

used

1.15 Fac¡lities for treatment ordisposal of solid waste or liquideffluents?

YES Details given in Prefeasib¡lityRepo

r.1b Facil¡ties for long term housing ofoperat¡onal workers?

NO

i;

L.17 New road, rarl or sea traff¡cdur¡ng construct¡on or operat¡on?

NO

1.18 New road, rail, air waterborne orother transpoft ¡nfrastructufeincluding new or altered routesand stations, ports, airports etc?

NO

1,19 Closure or divers¡on of existingtransport routes or infrastructuÍeIeading to changes in trafficmovements?

NO

L.20 New or diverted transm¡ss¡onlines or oioelines?

NO

L.2L Irnpoundment, damming,culvert¡ng, realignment or otherchanges to the hydrology ofwatercourses or aquifers?

NO

3..22 Stream cross¡ngs? NO

L, ¿.) Abstraction or transfers of waterfrom ground or surface waters?

NO Project needs about 470 KLD offresh water which is proposed tolle extracted from ground waterresources

L.24 Changes in water bodies or theland suface affecting drainageor run-off?

NO

1 .25 Transport of personnel ormatefl als for construction,operation or d ecomm ìssio n ing ?

NO Existing p¡anl

L.26 Long-tenÌr dismantling ordecommissioning or restoÍationworks?

NO Existing plant

L.27 ongoing activity duringdecommissioning which couldhave an impact on theenv¡ronrnent?

NO Ex¡st¡ng plant

lnflux of people to an area ineitlìer temDorar¡lv or

NO The proposed expans¡on shallincrease the emnlovmênf

Form-1

N eu I and Laborato r¡ e s I ¡ m ¡ted, U n it-l

pernlanently? potentiâl and hence may lead tomigrat¡on to surrounding v¡llages,

L.29 lntroduct¡on of alìen species? NO

1.30 Loss of native species or geneticd¡versity?

NO There are no losses oftree/shrub species.

1.31 Any other actions? NO

2. Use of Natural resources for construction or operation of the Project(such as land, water, materials or energy, especially any resources wh¡ch arenon-renewable or in short supply):

S.No lnf ormation/cheCki isiconfirmation

Yes/No Details thereof (w¡th approxlmatequantities /rates, wherever

possible) with source ofinformation data

2.L Land especra y un0eveloped oragricultural land (ha)

NO Exist¡ng Unit

?.? Water (expected source &competing users) unit: KLD

YES Ground Water: 470 KLD(Water Balance Enclosed inPrefeasibilitv ReDortl

2.3 Minerals (N4T) NA

Construction mater¡al - stoneaggregates, sand / soillexÞected source - MT)

NO

2.5 Forests and timber (source -MT)

NO

2.6 Energy ¡ncluding electr¡city andfuels (source, competing users)Unit: fuel (MT), energy (MW)

YES The required energy shall be drawnfrom AP CENTRAL POWERDISTRIBUTIONCOI\4PANY ThEpower shall be drawn from existingDG sets of 2x7 25 KVA during loadshutdowns. Additional DG sets of 3x 1"25 KVA, 1X2s0 KVA & 2 X 725KVA shall be provided to cater toany future energy requirementdurino loacJ shut clowns.

2.7 Any other natural resources (useaoorooriate standard units)

NO

Form-1

N e u I and Lab orato ri es I i m ited, U n it- I

3, Use, storage, transpon, handling or product¡on of substances or mater¡alstwhich could be harmful to human health or tlre environment or ra¡se concernsabout actual or perceived r¡sks to human health.

4, Product¡on of solid wastes during construction or operation ordecommissioning (MT/month)

S. NO,confirmation

Yes/No Details thereof (w¡th approx¡matequant¡ties/rates, whereverpossible) with source of

information data

3.1 Use of substances or materials,which are hazardous (as perN4SIHC rules) to human healthor the environment (flora, fauna,and water supplies)

YES Hazardous chemicals will be usedfor manufacturing of Bulk Drugs &Drug lntermediate. Specif¡cmeasures shall be taken for thestorage of hazardous chemicals andsolvent shall be stored ¡n closed

Changes in occurrence ofdisease or affect diseasevectofs (e.9, insect or waterborne diseases).

NO No suclì diseases are expected

J.J Affect the welfare of people e,g.by changing living conditions?

YES Shall increase the employmentpotential for locals and affect thel¡v¡ng conditions for betternlent

J. ¿+ Vulnerable gÍoups of peoplewho could be affected by theproject e,g, hospital patients,children, the elderly etc,,

NO No sens¡tive receptors are presentin the immediate vicinity of the sjte,The project shall not have anys¡gnificant ¡mpact on vulnerablegroups of people.

Any other causes NO

llS.ño. inf o ffnatiöñlõÈìt¿kaCaconfirmation

Yes/No Details thereof (w¡th appióiimãiéquantitíes/rates, whereverpossible) with source of

information data

4.1 Spoil, overburden or mineWASTES

NO

4.2 Municipal waste (domest¡c andor comnrercial wastes)

NO Wâstes from canteeÌì, othercommercìal wastes like paper,empty containers etc,, the canteenwaste is sent to local piggeries andPaper waste is recycled,Commercial waste shall be in rangeof 100 kg/day,

Neu I and Laborato ri e s I ¡ m¡ted, U n it- t

Hazardous wastes (as perHazardous Waste ManâgentenlRules)

YES Hazardous waste generation dur¡ngconstruction slrall be lrnited towaste oils, balter¡es and containersof pa¡nts etc,

4.4 Other industrial process wastes YES Details given in Prefeasibil¡tyRepoft

4.5 Surplus product NO

4,6 Sewage sludge or other sludgefrom efff uent treatnlent

YES Details given in PrefeasibilityReport

4.7 lonstruct¡on or derïolit¡onvastes

NO Would be used for leveling in thepremises.

4.8 Redundant maclrinery orequipment

NO

4.9 Contaminated soils or othermater¡als

NO

4,LO Agncultural wastes NO

4,LL Other solid wastes NO Details given in PrReport

5. Release of pollutants or any hazardous, toxic or noxious substances toair (Kg/hr)

S.No.I nfo r m ati o n lC h e c kl i st

confirmation

Yes/No Details thereof (with approximatequantities/rates, whereverpossible) with source of

information data

5. -L Emiss¡ons from combust¡on offossil fuels from stationary ormobile sources.

YES Pulverized coal is used as fuel.Particulate matter, SOr, NO* are thee nr ission s.

5.1 Emiss¡ons from productionpfocesses

YES SOr, HCI are Scrublled

5..l Emissions from materialshandling including storage ortranspoft

NO Material transfer takes place inclosed pipeline systems.

5,4 Emissions from construct¡onactjvities including plant andenrJinment

NO Water sprinklers w¡ll be used tosuppress dust

EA Dust or odors from handì¡ng ofmaterials including construct¡onmaterials, sewage and waste

NO During expansion act¡v¡ty fortemporary period. Existinginfrastructure will be used forsewage handling.

Form-1

Neu lan d Lab o rato ries I ¡ m ¡ted, U n it- I

5.6 Emissions from incineration ofwaste

NO

d-7 Em¡ssions from llurn ing ofwaste in open a¡r (e.9, slashrnaterials, construction debris)

NO

5,8 Emissions from any othersources

NO

6. Generation of Noise and V¡brat¡on, and Emissions of Light and Heat:

Ir

T.Risks of contamination of land or water from releases of pollutants intothe ground or into sewers, surface waters, groundwater, coastal watersor the sea:

S.No. I nf o rm ation/Checkl istconfirmation

Yes/No Details thereof (w¡tn àppióilmãequant¡ties/rates, whereverpossible) with source of

ínformation data w¡th source ofinformation data

6.1 From operation of equipmente.g. engines, ventilat¡on plant,crushers

YES Material transport and constructionequipment shall be source of noisewhile transfer pumps, vacuun.tsystenìs, DG sets are the sourcesof noise durinq operation.

6.2 From ¡ndustr¡al or sim¡larprocesses

YES Fron'r DG sets, and controlled byproviding Acoustic Enclosures,

6.3 From construction or demolition NO No s¡on¡ficant impact is anticipated.

6.4 From blasting or piling NO I

6.5 From construction oroperat¡onal traff¡c

NO The increased vehicle movementshall not have any significantimpact,

6.6 Frorï light¡ng or coolingsystenìs

NO

6.7 From any other sources NO

S.No. lnformat¡on/Checkl istconfirmat¡on

Yes/No Details thereof (with approximatequant¡t¡es/rates, whereverposs¡ble) w¡th source of

information data

7,L From handling, storage, use orspillage of hazardous mater¡als

NO All the lìazardous mater¡als isstored on elevated plat foÍm andstored ¡n a closed storagetanks/contaÌners

Neuland Laboratories Iim¡ted, Unit-l

(Liner/N/S/G I/HDPE) in a coveredshed w¡th sp¡ll collection andcontrol systems and nocontarì1¡nat¡on of soil is ex¡tected.

7.2 From discharge of sewage orother effluents to water or theland (expected mode and placeof discharge)

NO All the wastes from dornesticoperatìons are sent to effluenttreatment plant and the treatedwater ¡s be¡ng used for ut¡lities andgardeninq

By depos¡tion of pollutantsemitted to air into the land orinto water

NO All the emissions from process arecontrolled by providing controlequip|nent like scrubbers, and Bagf¡lters etc.

7.4 From any other sources NO

ls there a r¡sk of long tenÌ bu¡ldup of pollutants rn environmentfrom these sources?

NO

8.Risk of accidents during construction or operation of the Project, whichcould affect human health or the environment

S. No. lnfornlation/Checkl ¡stconfirmation

Yes/No Details thereof (w¡thapproximate quant¡t¡es/rates,

wherever possible) w¡th sourceof information data

8.1 From explosions, spillages,fires etc from stoÍage, handling,use or production of hazardoussubstances

YES All lnbuilt Safety precaut¡ons willbe adopted and there w¡ll not beany damage to environntent orhuman health,

4.2 Frorn any other causes NA

oô Could the project be affected bynatural disasters caus¡ngenv¡ronmental damage (e.g?Floods, earthquakes,landslìdes, cloudburst etc)?

NO

Form-L

N eu lan d Laborato r¡es I i m ¡ted, U n it- I

LFactors which should be considered (such as consequential development)which could lead to environmental effects or the potential for cumulativeimpacts with other ex¡sting or planned activities in the locality

(lll) Environmental Sensitivity

Name/

ldentity

iiiài diaiãñce lwittriñll15 km.) Proposed ll

project location llboundary I

S.No.

I n fo rm atio n/C heck Iistconfirmation

Yes/No Details thereof (w¡th approximateq uantit¡es/rates, whereverpossible) with source of

¡nformation data

9.1 Lead to development ofsupporting fâcilit¡es, ancillarydevelopnrent or developrnentst¡mulated by the project whichcould have impact on theenvironment e.g:

. Support¡ng ¡rìfrastructure(roads, power supply, waste orwater treatment, etc.)

. hous¡ng development

. extractive industries

. supply ¡ndustries

. other

YES The project shall enhance thesocio-econornic status of the areaby increasing the demand forhousing, improv¡ng theemployment. There are no majorsupport industr¡es required for thisplant.

9.2 Lead to after-use of the site,which could haven impact on theenvironment

NO

9.3 Set a precedent for laterdevelopments

NO

9.4 Have cumuiative effects due toproximity to other exist¡ng orplanned projects with similareffects

NO The baseline environmental status ll

of the surround¡ng areas is withinthe prescribed.limits as observedlronl tlre Secor'ìdary data,

Areas protected under ¡nternationalconvent¡ons, nat¡onal or local legislationfor their ecolog¡cal, landscape, cultural orother related value

Fonrì-1

N eu land Laborato ries I i ni ¡ted, U n it- I

2 Areas which are important or sens¡tive forecological reasons - Wetlands,walet toutses u¡ t-.¡[ller waler l¡r-,¡tjies,coastal zone, biospheres, mountains,

NO

Areas used by protected, ¡mportant orsensitive species of flora or fauna forbreeding, nesting, foraging, resting, overw¡ntering, migration

NA

4 lnland, coastal, marine or undergroundwaters

NO

E State, National boundaries NO 'l

6 Routes or facilit¡es used by the publ¡c foraccess to tecreatiùrì ur utlrer tuutist, pilqri r

afeas

NO

7 Defense installations YES A¡r Force Academy,Dund¡gal-3.5 Kms

B Densely populated or bu¡lt-up area YES lDA, Bonthapally *located at 1".0 Kmtowards northeastdirection from theproposed project site

q Areas occr¡pied hy sens¡t¡vc man-ÍìaclcIand uses (hospitals, schoo/s, places ofwo rshi p, co mmu n ity faci I itie s)

NA Place of worship andschool at. 2.O Kmdistance from site.

10 Areas containing important, high quality orscarce resources (ground water resources,surface resources, forestry, agriculture,fishe r ie s, tou r ¡s m, mi nerals)

NO

II Areas already subjected to pollut¡on orenvironmental damage. (those whereexisting legal envtronmental standards areexceeded)

NO

72 Areas susceptible to natural hazard wh¡chcould cause the project to presentenvironmental problems (earthquakes,subsrdence, landslides, erosion, floodingor extreme or adverse climat¡c cond¡t¡ons)

NO

Neuland Laboratories limited, Unit-l

(lV) Proposed Terms of Reference for EIA studies Scope of Work of EIA

,..The EIA shall cover the following:

of the proposed pro¡ect:

first task:" Descr¡ption of the proposed project" forms a vital component of thenvironmental lmpact Assessment (ElA) as it provides the basis for evaluating the l¡kelyuses of Env¡ronmental lmpacts.

xisting Environment and Basel¡ne Conditions:

baseline assessrïent will be carried out to identify potentially sensit¡ve and criticals that may be affected by the project in an area of 10 km surrounding the project

. The crit¡cal and sens¡tive targets shall be plotted on land use map of projectt area. The existing environment and baselíne condit¡ons should be established

of existing information published and secondary data.

tion w¡th relevant statutory authoritres, and Field visits lor su pplenrentat¡on olgaps.

key subject areas which the EIA shall address irrclude Ecology and Naturet¡on, A¡r quality, surface and water qualÍty ¡n project ¡mpact area, soil qual¡ty,

al heritaqe, landscape, land use, noise quality, etc. Natural habitats like nat¡onalwildlife reserves, sanctuar¡es, sacred grove, protected areas, forests, wetlands,

rìvers and waterways if any, shaìl also be identif¡ed and marked,

sessment of Environmental lmpacts:

upon the results from the rev¡ew of existing infonration, field v¡sits, site dataand consultat¡on, for each component of environment (physical, biological and

economic) the posjt¡ve, negative, direct and ¡nd¡rect, temporary and permanentwill be evaluated along with an indication of the degree of irnpact, i.e,, whether

impact is signifrcant, moderate, minor or negligible. The degree of impact shall alsoquantified by us¡ng state of the art a¡r quality ¡mpact prediction models based on

T3 algorithms

Management Plan And M¡t¡gat¡on Plan:

each signifrcant negat¡ve irnpact identified, specialist shall work closely with theineering team/technrcal consultants to suggest practicable measures to avo¡d or

the ¡mpact, The mitigation of environmental ¡mpacts w¡ll be lry three

. lntroduction of m¡tigation features through the engineering practices,

. lmplementation of environmental controls dur¡ng construction and operat¡on,

. Legislative control involving compliance w¡th lndian env¡ronmental laws.

Environmental management plan shall include an estimate of cap¡tal and recurrìngof m¡t¡gat¡on measures and will identify the lnst¡tutional framework for

Form-.1

N eu I an d Laboratori e s I i m itect, U n it- I

ation.

Plan:

identif¡ed the signif¡cant environmental impact that ¡s likely to arise as a result ofproject, the pro.lect team shall specily what nronitor¡ng is requlred during the various

of the pÍoject cycle.

monitoring plan will identify parameters and frequency of monitor¡ng and responsible

I hereby g¡ve the undertaking that data and inforrnat¡on g¡ven ¡n the applicationand enclosures are true to the best of my knowledge and bel¡ef and I am awarethat if any part of the data and information submitted is found to be false orm¡sleading at any stage, the project will be rejected and clearance given, if any tothe project will be revoked at our risk and cost.

Date: lÌi-, ' il- . \'5

Place: l|,;f !t¡!+¡o'l.llll,;-

sig natu reioïl'ñe applicantWith Name añd Full Address

(Proiect ProponenUALthorized Signatory)

Mr. Tapas ChakrabortyVP-Corporate EHSSy Nos : 347, 474 & 49012,lDA, Bonthapally (V),Jinnaram (M),Medak Dist.

Form-1 I+

Neu lan d I abo rato r¡ es I ¡ m ited, U nit- 7

PRE-FEAS IB ILITY REP ORT

FOR TERMS OF REFERENCES FOR

CAPACITY EXPANSION

l)ccember. 2013

NEULAND LABORATORIES LTD, UNIT-ISY NOS: 347,474 &.49012,1D4, BONTHAPALLY (V)

.TTNNARAM (M), MF.DAK (D)ANDI]RA PRADESI]

ì.

I:' Studies & Documentation BvI Submitted by MlS Pridhvi Enviro Tech pvr. udi M/S NEULAND LABORATORIES LIMITED, 18¿UC, Lawn House' SY.NO 347,474 & 49012, BONTHAPALLY(V) VengalRao Naga¡r JINNARAM(M), Hydcrabad-500038:' MEDAK (D) Pht O4O-40I7977O

ANDHRA PRADESH Fax: 040-66730926E-Maif : pvr@pridhvienviro. com

SUBMITTED TOMINISTRY OË ËNVIRONMËNT & FORËSTS, GOI

PARYAVARAN BHAWAN, CGO COMPLEX,LODHI ROAD, NEW DELHI.].1OOO3

N e u lan d laborato ri es I i m ited, U n it- L

LIST OF TABLES

LIST OF FIGURES

LIST OF ANNEXURES

Table No

1.0

DescriptionSal¡ent Features of the Project

Page No2

2.0 List of Ex¡sting Products and Capacity 7

3.0 Proposed Products and Capacity 7

4.0 Water balance Current 7 Proposed I5,0 Sol¡d Waste Generation and Disposals 13

6.0 List of Reserve Forests T4

7.O Utilities and Effluent Handling Facilities Ex¡stingand Proposed

20

8,0 Land Statement 2L

9.0 Enr ssior-r Source * Cu[rent & Proposed

10.0 Sto age Facilities of Bulk Drugs ¿J

Figure No Description Page No1.1 Schematic Treatment scheme of High TDS Effluent LT

L.2 Low TDS Effluent Treatment Svstem t21.3 Topomap of the 10 KN/ study area 16

L.4 Drstance of the site from critically polluted stretches 17

1.5 Plant & Green belt Photoqraphs

1.t, Site Layout Plant 19

Annexure Description

CFO & CFO Renewal Application Copy

il List of Raw Mater¡als

ill Typical details of proposed products

Neu lan d laborato r ies I i m ited, U n ¡t- 7

CONTENTS

S. No Descr¡ption Page No

1 lntroduct¡on T

Introduction of the Project 2

About the Group & P¡'omotets J

3 Project Descr¡ption 7

3.1 Production Capacity 7

3.1.1 Proposed Expansion 7

3.2 Manufacturing Process B

3.3 Raw mater¡als I3.4 Water Requrrement I3.5 Waste generat¡on and control systems 10

3.5.1- Liquid effluents 10

3.5.2 Solid waste management r34 Site Analysis L4

4.1 Plant Locat¡on t45 Planninq in Brief 20

6 Resource requ¡rement 20

6.1 Power requirement and supply/ Source 20

6.2 Production facilities, Ut¡l¡t¡es and effluent handlingfacilities

20

6.3 Land requirement 21

7 Air Pollution 2T

8 Bulk chemicals Storage t1

I Project F¡nanc¡al 24

Pre-Feasibil¡ty Repoñ

1. lntroduction

Ne u I an d Labo rato r ies I i m ite d, U n ¡tl

M/s Neuland Laboratories Lim¡ted (NLL), Bonthapally un¡t is located at Sy. Nos:

347,474 & 49012, lDA, Bontapally(V), J¡nnaram (l\4), Medak D¡srrict - 502313 of

Andhra Pradesh. The Unit was established in the year 1984 in lDA, Bonthapally,

Medak D¡str¡ct to produce pharmaceutical products.

Neuland Laboratories L¡mited (NLL) obtained CFO (APPCB CFO Order No,

APPCB/PTN/PTN/382/HO/CFO|201-2-3O5O Dt. 01.10.201-2). As the un¡t was

established prior to 1994 notification, EC requ¡rement was not there.

ln order to meet the market demand it is proposed to expand the production

capacity from 203.34 Kg/Day to 1825.70 Kg/Day. As 2006 notification covers both

drugs & Drug f ntermeadiates, it is now applied for EC for expanding the capacity.

Copy of CFO and CFO renewal applicatiion is enclosed as Annexure - |

Pre-Feasib¡lity Report Neuland Laboratôries l¡míted, Un¡t-t

2. lntroduct¡on of the Project

The salient features of the project and site are given ¡n the foflowing table:

TABLE I-,0

Salíent Features of the Project

Locat¡on M/s Neuland Laboratorjes Lim¡ted, Un¡t 1, Sy

Nos: 347, 474 & 49012, lDA, Bonthapally (V),

Jinnaram lMl. Medak 502313Longitude and lat¡tude Between 17039'11.3" N Latitude and78o2I'54

E LonoitudeYear of establishment 1984Product category 5(f), Drugs & Drug lntermedratesProposed category as per

EIA notification

"8" (Located in Notified lndustrial estate)

Proposed Activity Productiorr capacity ex¡rarrsiorr frorn

203.34 Kd/D to 1825.70 Kq/DTotal investment on the plant FYII-]-2- Rs 145.41- Crores

Proposed Additional - Rs 75 CroresTotal lnvestment Environmental

lnfrastructure

Current : Rs. L0.0 Crores

Prooosed Additional : Rs 10 CroresTotal area of the plant 11.2 Acres

Total area of qreen belt 3. 36 AcresWater requirement Total Fresh water requirement - 470 KLD

Source of water Public supply, tankers from outsideNearest habitation and

distancefrom the site

tDA, Bonthapally - located at 1 Km from the

srteNearest surface water bodies Rajanala Cheruve , 0.7 Kms

Nearest reserve forest J¡nnaram RF - 1.3 KmsEnvironmentally sensitive

areas wíthin 1-0 km radius

None

Any national parks,wildlife

sanctuaries within l-0 km radius

None

Nearest air port and di-91a.¡,9.9-_--

Nearest railway stat¡on

and distance

_s_¡ gu:laþed, Hyderabad -Gaudavalli Railway Station - 11.0 Km

P re -Feas i b i I ¡ty Re po rt Ne u I antt Labo rato rí es I i m itecl, U n it- I

i) About Promoters & Group

Corporate lnformation and Regulatory History

Neuland Laboratories Limited (NLL) is a Public Limited Company Focused on

manufacture of APls, contract research and contract manufactur¡ng. f t established

its manufacturing unit in the year 1984 at lDA, Bonthapalli (V), Jinnaram (M)

Medak Dist. Since its inceptìon NLL has been exporting tts products to var¡ous

foreign countries and has beerr earning precious foreign exchange for the country.

NLL has been employing hundreds of persons both direct and indirect in itsmanufacturing unit. NLL undertakes Research and Development act¡vìties ¡n the

field of APls. As a part of sustainable development and environmental friendly

processes, NLL has been undertaking technology ¡mprovement in the process of

manufacture of life saving bulk drugs. NLL is audited, approved and certified by

various international agencies such as USFDA (USA), ccMP, EDQIV, PI\¡DA,

EHS, lSO, and TGA. NLL has established a repetit¡on in maintaining high

standards of quality and committed to the people and products for nearly 30 years

in the market.

The Company's core business and operational expertise for nearly 30 years since

inception has been manufacturing of Active Pharmaceutical lngredients (APls).

Neuland has earned the identjty of a Preferred & Reliable source in the

pharmaceutical industry primarily due to:

. Consistency in product quality;

. Knowledge and ability to deal with niche chemistry; and

' On-time delivery perfornrance.

Neuland has 2 USFDA and EUGMP compliant manufacturing facilities with

collective capac¡ty of 600 KL to produce various APls across diverse therapeutic

areas. The Company's strengths rn synthetic chemistry, process development,

controlled supply chain and project management approach, built into all our

operat¡ons and product development programs makes Neuland an ideal API

partner for generics.

P re- F eas i bi I i ty Repo rf Ne u I an d Labo rato ri e s l¡ m ite d, U n it-l

Neuland's Contract Manufacturing Services derives its strength from its proven

expertise in manufacturing at varied scales, a deep understanding of complcx

chemistry and the company's manufacturing facilities that are compliant with the

guidefines of the leading regufatory authorities like USFDA, PMDA, EDeM and

TGA.

For more than twenty-eiqht years, Neuland has been at the forefÍont of aiding and

accelerating the drug substance development and manufacturing process.

Neuland offers ¡ntegrated and versatile GMP manufacturing facilities capable of

handling conrplex react¡ot1s tuued to ensure seafiìlcss transfcr thc processes from

small-scale through validation to commerc¡al manufactur¡ng thus helping our

customers expedite the discovery -to-market time lines,

Neuland's Vision

To be a Superior and Reliable Science and Technology driven company in

manufacturing APls, and providing contract research services to the global

pharmaceutical industry.

Neuland's Mission

Tt¡ be an erlrJ{o-end resource for the pharmaceutical industry and deliver the best

to the customers, be accountable and transparent in every transaction.

Both our API Manufacturing facilities are certified for ISO L4003,:2004 as well as

for BS OHSAS 18001:2007 standarcls. These certifications demonstrate our

commitment and care towards EHS.

The spirit of research and professionalism pervades Neuland's corporate culture.

From inception, Neuland has strives to offer the best quality products to itscustomers in the pharrnaceutical industry backed by manufacturing capab¡lities

and con'rpetence to deal wi[li corrrplex chenristry. Neuland will contlnue todifferentiate itself by offering products

P re- F eas i bi I ity Re po rt N e u I an d Laborato ri es I i m ited, U ¡1 ¡t-l

and servìces that are not only superior in quality but also reliable. Neuland today

supports some of the successful cornpanies in the pharmaceutical irrdustry in both

research and manufacturing. Neuland focuses purely on a service provider model,

whethef in manufacture of APls, contract research or contract manufacturing

services.

Neuland is proud to be a responsible corporate citizen. We have assumed a

degree of responsibility for the cause of society apart from enhancìng shareholder

value. Corporate social responsibrlity has been placed in a position of crucial

significance through a strong mutual relationship between our businesses

and the society, This ethos makes us revisit our facilities, standards, work

practices and requ¡rements from a wider perspect¡ve.

Our activities for the cause of society have emerged in response to both the needs

as expressed by the community and an assessment of the situat¡on by our

management. The key thrust areas we work relate to education, health, capacity

building and development of community & its assets.

Neuland's contnbution rncludes providing funds for creat¡ng infrastructure &

facjlities to nearby schools, providing funds towards teacher's salar¡es, enabling

drinking water supply to cater to the drinking water needs of nearby village. A few

specific initiatives taken by the Company are detailed below:

. Closely associated with a charitable organ¡zation called "AlMIMAVODl" * Ahome for destitute women.

. Regular contributions towards primary education, development of cement

concrete roads as well as building a school in villages neighboring the

Company's production facilities.

. Constructed an overhead drinking water tank w¡th a capacity of 100,000

litres for the benefit of the villagers of Bonthapally village.

Pre -F eas i b i I ity Re po rt Ne u I and Laborato rie s I i m ¡tecl, U n it-l

NLL's headquarters, process R&D centre and manufacturing facilities are located

in Hyderabad, lndia. NLL offers research and developnrent, process development

services and cGMP production of pre-clinical through commercraf stage small

molecufes, NCEs and APls. NLL has been providing high quality API development

and manufacturing services to the Pharmaceutical and Biotech industries for

nearly 30 years, and has supported a number of lND, NDA and MAA filings.

NLL's facilities have been inspected by the vast majority of the leading

regulatory agencies in the world including USFDA, EDQM, PMDA (Japan),

KFDA (Korea), TGA (Australia), AFSSAPS (France), Elt/A, BfArM (German),

ANVISA (Brazil) among otheÍs. NLL is also certified for ISO 14001, BS OHSAS

18001, ISO 9001- and ISO 27001.

Pre-Feas¡bility Repoìf Neuland Lahoratories litnited, IJn¡t-t

3.0 Project Description

3.1 Production Capacity

Table below gives consented products and capacities. The total production

capacity is 203.34 Kg/D.

TABLE 2.0

LIST OF EXISTING PRODUCTS & CAPACITY

Prod ucl QuantitieslKo/D)

Enalaoril Maleate 50Midaza pine 20Sotalol HCI 25Levetiracetam 50Benzyl Salbutamol (ln-termed iate)

16.67

loratrooium Bromide 0.5Ofloxacin 2.67Ramioril 20Itraconazole 1.67Ola nzaoine 1.67Moxifloxacin t

Escitalopram Oxalate 1.67Levofloxacin 16.67Ropinirole HCI 0.5Total 203.34

3.L.L Proposed Expanstion

It ¡s now proposed to increase the productÌon capac¡ty by including several new

products. The capacity will be increased from current 203.34 Kg/D to 1825.70

Kg/D. Below table provides list of new products and their proposed capactttes.

TABLE 3,0

PROPOSED PRODUCTS & CAPACITY (Tentative)

ProductQuantities

lKnllì\

Enalaoril Maleate

2ôõ. I

P re-Feas ¡ b i I ity Repo rt Neuland Laborator¡es l¡mited, Unit-l

M irta 100Sotalol HCI 200Levef¡râcetam 400Benzyl Salbutamol (ln-termed iate) otf .o /lpratropium Bromide 0.33Ofloxacin JJ-JJRaminril 66.67Itraconazole 0.33OlanzaoineMoxifloxacin ct .1.1

Escitalooram Oxalate .1.1 .1.')

Levofloxacin 166 67Ropinirole HCI J. JJCiprofloxacin Base '16.67

Albutaro l/Sa lbutamolSulohate 16.67Doneoezil HCI 16.67Dorzolamide HCI 16.67Salmeterol XinafoateBasifloxacin 1.67Rabeorazole sodium 100MZ Alcohol (lntermedi-aie) 100Rufinam ide 100R&D Activities 100Total 1825.7

3,2 Raw Materials

List of raw material for proposed products are given tn the Annexure ll.

3,3 Mânufacturing Process

The Manufacturing process for the above APf's involves chemical process, The

details of process for various products is g¡ven at Annexure-lll.

Pre-Feas¡bil¡ty Repo¡Î Neuland Laborator¡es l¡mited, Un¡t-l

3.4 Water requ¡rement

The water reqlrirement is n'ìet from pubiic supply & road tankers. The requirement

for water ¡n this un¡t is for process alrd domestic purposes. The water balance for

daily consumpt¡on is presented below

TABLE 4.0

Water Balance- Current & Proposed (Tentative)

. Boiler-10O KLD, CT-99 KLD, DM/SW-25 KLD, TOTAL-224 KLD

s.No

Stream

Waterreq u irement

in KLD

Waste Waterd ischarge

¡n KLD

Method ofTreatment &

d isnosalCurrent After

Expansion

Current AfterExpansion

)rocess 17.27 90 rt.ô qn )F, Stripper,úEE. ATFD

ìeactor & FloÁ/ashings

3.0 40 3.0 40 l¡olog¡cal treatment ¿

ìo system

lo¡ler, CT,)M/SW nlants

18.5 224 5.0 105 Jrologrcal treatment ¿

ìO svstemì&D, Scrubb( 2.45 20 2.45 ¿U X, Str¡pper, MEE,

\ÏFD)rocess ROleiect

30 30 )F, Stripper, MEË,\TFD

)omesttc 6.5 36 5.0 35 3iological treatment iìO svstem

ìardening 3.0 30

lotal 50.72 470 33.05 320

P re- F eas ì b i I ity Repo rt N eu lan cl Labo rato ries I ¡ m ited, U n it- I

3.5 Waste Generation & Control System

3,5.L Liquid Effluents

As detailed in table 4.0 waste water generat¡on after expansion would be 320.0KLD. lt is proposed to segregate effluents into high COD and High TDS streamand Low COD and Low TDS Streams.

Process wastewater streams from the manufacturing blocks are transferredthrough closed pipeline network to wastewater treatment plant as high strengthand low strength wastewaters to (Str¡pper, MEE and ATFD) and (Biologicaltreatment and RO) facilities respect¡vely.

Low strength process wastewater, at treatment area, is subjected to pre{reatment,v¡2., equal¡zation, neutrallzat¡on and removal of suspended solids followed bybiological and RO treatment. RO permeate is reused as boiler feed/cooling watermake up. RO reject ¡s treated in MEE and ATFD.

High strength process wastewater, at treatment area, is subjected to pre-treatment, viz., equal¡zation, neutralization and removal of suspended solidsfollowed by Stripper, MEE and ATFD. Treatment system for high strength streamsincludes stripper, multiple effect evaporator (MEE) and agitated thin film dryer(ATFD) systems. The combined high strength process streams, after pre-treatment, ¡s subjected to sequent¡al treatment ¡n str¡pper, MEE and ATFD wheretraces of volatile solvents present ¡n wastewater are removed at stripper followedby concentrat¡on of wastewater in MEE and separat¡on of solids and salts atATFD.

The fract¡on containirrg solvents separated at stripper is further subjected totreatment in fract¡onat¡ng distillation column for enrichment of solvent and removalof water, The solvent fraction separated is disposed to author¡zed third party forreuse.

Water removed as condensate at N4EE and ATFD along with low strength processeffluent streams are subjected to biological treatment followed by reverse osmosis(RO). Permeate of RO is reused in boiler as feed water and cooling towers asmake up water. RO reject is sent back to MEE followed byATFD for treatment.Thus, entire wastewater is treated and reused. Accordingly the Unit achieved ZeroProcess Liquid Discharge System.

The domest¡c effluents would be treated in SIP and used for gardentng purpose.

The schematic dlagrams of ETP proposed aÍe given in Figure L.1- and Figure 1.2below.

\Þ

Pre'Feas¡bility Report Neuland Laboratories l¡mited, unit-t

Fig 1.1schematic treatment scheme of high TDS effruents

Effluent fromProcess and

Sludge toTSDF

Aq. Distillate to-------+P lants /

TSDF recovery

f:ñF-'-ll-t-

Sludge to TSDF

Condensate toBiological

Treatment &RO System

Conensate toBiologicalTreatment

Pre-Feasibility Report

Fig 1.2Low TDS Effluent Treatment System

SIudge to TSDF{--Sludge

Cake

Neuland Laborato r¡es Iimited, Unit-l

Return sludge line

Permeatefor re-use

Pre-Feas¡bility Repoft Neuland Laboratories li,nited, Unit-l

3.5.2 Solid waste management

Hazardous & non-Hazardous waste generated from the proposed expansionproject are detailed below. Mode of disposal are also identified and l¡sted.

Adequate storage of hazardous waste is ensures at the site.

TABLE 5,0

Solid Wastes and Disposal

Quantity - Rcmarks

Current,nfterSxpansioni(Tentative)

I: solo to eii;t l10.5 TPD 21-TPDf i manufactures

!

zso.s xs¡o j

62e6 Kg/D '

,rooI

3oo.o Ks/D ] 3ooo Ks/D I t;;r '---l__Ìt__

I

300.0 Kg/D, 3000 Kg/D TSDF

i TsDF/cement32.37 KglD) 290 Kg/D I manufacturers

Authorised

TSDF fac¡lity ¡s about 6.7 Kni form the s¡te which ¡s created for catering the

indLrsties in this area. Iransport of Hazardous wastes to TSDF is done by thc

TSDF facility. ln case other hazardous wastes, authorized recyclcrs will transport

the wastes.

Pre-Feasibil¡ty Repoñ

4.0 Site Analysis

4.1 Plant Ís location

M/s Neuland Laboratories Limited (NLL), fDA, Bonthapally unit is located at Sy

Nos: 347, 474 & 49012, Bonthapaìly (V), Jinnaram (lV), Medak 502313 of Andhra

Pradesh.

The site ¡s situated between 17039'11.3'N Latitude and 7Bo2L'54.5" E Long¡tude.

The land area of the pìant is 1l-.2 acres. The nearest habitation from the site is

Bonthapally (V) at a distance of 1.0 Km from the site. The nearest railway statìon

is Gaudaballi located at distance of 11.0 Km from the site. The nearest a¡rport is

located at a distance of 45 Krlr at Hyderabad. There are no ecologically serrsitive

areas like nat¡onal parks, sanctuaries within 10 km radius of the site. Rajanal

Cheruve is at 0.7 Km from the site. The site is ata distancel1.g Km from IDA

Bollaram and I7.4 Km form IDA Pattancheru, both are under Morotorium under

CEPI index. As site is L0 Km away from the critically polluted stretches, this does

not come under general conditions of EIA notification 2006.

Apart from the ra¡nfed tanks/ Kuntas, there are no Major surface water sources are

there ¡n the study zone. There are no environmentally sensitive areas in the study

zone. There are 1"9 Reserve forests ¡n the study zone & details are given in the

table below.

TABLE 6.0

L¡st of Reserve Forests in L0 Km redius

Reserve Forest

N e u I and Laborato ri es I i m itecl, U n ¡t- I

P re - F eas i b i I ity Re po rt Neu lan d Labo rato r ¡ es I ¡ ¡n itecl, U n ¡t- I

o

I1011

t415

lft

17 i

l

lI

.l

Topo sheet of the proposed area and 10 KM Distance is given at Figure 1.3

D¡stance of the site from critically pollutecl stretches is given at F¡gure L.4

Plant & Green belt Photographs are given at Figure 1.5

Site layout is given at Figure 1,6

Pre-Feøs¡bility Repoft N EU LAN D LABORATORI ES LIMITED

Figure 1.3Topo map ofthe 10 km study area

M/S Newland Laboratores,Bonthapall¡ (v), Jinnaram (M)Medak (Dist)

rOPO PLAN OF THE STUDYARÊA

Survey Ol lndiâToDo Numbers :E44lvl6

Legend

l8 Projecl Sl€

f¡_ sr,¿y ¡,u"

P re -F ea s i b i I ity Re po rt

Figure 1.4Distance of the s¡te from Critically polluted stretches declared under CEpI index

N EU LAND LABORATORIES L'MITED

Kasu Brahñânandareddi national park 26.4Km Distance from sile ln south Direct¡on

M/S Newland Laboratores,Bonthapallì (v). Jinnaram (M)Medak (Dist)

È)f NH-7

LOCA'¡ION II4AP OF THE STUDYARÊA

Lalitude E 78'21'5rt.5'Longírude N 17"3911.3"

Sutuey of fnd¡â lopo N¡imbeßE1KM1, Ê¡KM2. E44M5 . E44M6E44t\47 E¡t4t\¡10

Legend

f-l e.¡"o sir"

-.''-" NH ^ I4**Sft NH, 7

ææ Ef¡ãrum |¡'dustriat Arca

.qf* pâbncheru!1r rndùstñar Areê

ffi senetments

f ro'""ra,",

[] s,oye'",

l:2,50000

Pre-Fedsìbil¡ty Repoft N EU LAND LABORATORI E5 LI MITED

Figure l.gPlant & Green belt Photographs

N EU LA N Ð LAg O RATORI ES LI M ITED

Figure 1.fSite Lay out

I

I

I

I

I

I

I

I

I¡

i

IJNIT- 1 . B OI.l]f TI-E.P.q,LL]SITE L.{I'OUT

Pre-Feasibil¡ty Repoft

5.0 Planning in Brief

Neuland Laborator¡es limited, Unit-l

The project is envisated to be started in January 201,4 and completed by August

201,4 in phased manner and the production shall be started thereafter on rece¡pt

necessary permission trorÌl the MoEF and APPCB. Consultants are identified for

preparing the detailed project repoÍt.

6.0 Resource requirements

6.1- Power Requ¡rement and Supply/Source

The requirement of power will be 6846 HP. Cu¡.rently the power is procured from

Central Drstribution Company of AP Electricy Board. lt is proposed to establlsh

100 % backup power usÌng DG sets.

6.2 Production facilities, Util¡ties & Effluent Handling Facilities

rABLE 7.0

Utilities & Effluent handling facilities - Existing & Proposed

Production Facilities

ÌAddition After l

lbxpanstontl

P re- F eas¡ bi I ¡ty Re po rt Neu I an d Labo rato r i es I i m¡ted, U n ¡t- I

40

100

jB0i_*l

6.3 Land requirement

Ihe unit currently have Ll-.2 Acres and out of which 3,36 acres of green belt is

developed. The land requirement for proposed expansion act¡vities will be 0.37

Acres which can be met from existing open area. Below table provides the land

statement. Detailed site layout plan outlin¡ng current and proposed expansion

activities ¡s given at Figure 1.5

TABLE 8.0

Land Statement

S. N( Puroose Units ExtentI Built area sqm 729752 Green belt Sqm 1"3075a open area sqm 1-a 1 À¡:

Total Sqm Á ÉaaE

4 Area required for proposedcvnancinn

sqm 1508

7.0 Air Pollution

The Sources of air emlssions from the

(working) & 3 TPH (stand-by) Coal Fired

boiler and addt¡onal DG sets.

plant are 1x B TPH Coal f¡red boier

boilers, proposed 1x B TPH coal f¡red

The Process emissions from the second phase contain HCl, SOr, Hz,COz. HCI

and SOz emissions are scrubbed w¡th caustic and waste send to MEE. The other

),1

P re-F easi b i I ¡ty Re po rt Neuland Laborator¡es l¡mited, Unit-l

gases are expected in the process are carbon dtoxide & Hz, wlriclr are let out in to

atmosphere.

Following table provided information about the air polluton sources and proposed

control measures:

TABLE 9,0

Emission Source- current & Proposed

Pre-Feas¡bility Repo¡t Neuland Laboratofies tiìnited, lJnit_t

8.0 Bulk Chemical Storages:

Follwing bulk chernical storage facilities are proposed for expansion activity

TABLE ]-O,O

Storage facility of Bulk chemicals

Existing

S. N( CapacitylKt ì

Name of the solvent MOC

1 JU Methanol MS20 Toluene MS

J 40 IMS MS4 l-0 IPA MSt r0 Hexane lvis6 20 Acetone

Acetic AcidMS

7 10 MSI 10 Chloroform MSI 12 Formaldehvrje IVS

10 40 EthVl Acetate MSTotal Maximum storage capacity :2OZ KL

Proposed (Tentat¡ve)

Total Maximum storage capac¡ty : 382 KL

S. Nc Capac¡tyIKLI

Name of the solvent l\i4OC

1 3x30 Methanol IMS2 4 x20 Toluene MSa 40 IIVS tvt54 10 IPA MSE 3x10 Hexane l\/l-s

6 3x20 Acetone MS7 1,0 Acetic Acid l\4s

10 Chloroform MSL2 Formaldehvde MS

10 40 Ettrvl Acetate MS

Pre-Feas¡b¡lity Repo¡t Neuland Laboratories limited, Unit-l

9,0 Project Financial

The estimated cost of the expansion project is approximatedly Rs. 75 Crores. Out

of th¡s Rs l-0 Crore will be for environment and safety equipment and rest for other

process equipment.

Tentative Project Cost (Crores)

Plant & Mâch¡nery includingut¡l¡ties

30

Civil Buildings 1Ã

Steel Structures 10

Environment & Safety equipment 1U

3 (10% on ptun, a t.nu.f,.urgPipe lirres & lrisulatiol

Electricals & lnstru m mentation 3 (100/o on plant & machinery)

Erection & commissioning &painting

L5 (50/o on plant & machinery,structure)

Furn¡ture, Fixtures, computers,lightìng, contigenc¡es etc.,

Total 7tr,

----i

I

L

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CFO & CFû lìenewal Copy

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ilt:

AÌjD!R4¿R AES!|POIIUIÌOIV _co^ f Ror _E!)¡llD r'J,.r, n.io 23rs;ruoPARYAVÂRAN aHÄVÀä, ts, trOUS¡tUnL tsrele, rê, 0<0 23ùlOf,3l

SAN-ÃTHNÁGÄR' FÌYDER.AEiAÐ - 5OO 0lS_ Gri]lÌs : Kalùsya Nivac¿n¿Vy'cl,snc . utjtcb âp.nr.-.;rì

RgD {ATEGORYg¡l¿ar4lJlr oF co¡¡sewÌ g Àrr.nioRtsÀIloN oRDÊR

BY RËG{sÍERÊo POST IT¡¡.TH A[I${OWÍ.T,DGEMENT DUE

Corìsei¡ Ords tdû :À-Fpcs/p-f¡l/Fr¡¡,rgszlt{ô,ltfo/2t12- 3O 5n Dâte: û1.10,2012

{Conieni order for ExÈ-ti¡¡g/N€r,!. or altered disdrarge of scwa8e and/or trade eflluents/oùtletunder. Section 25126 of rhe Water (prevèntion & Control of pollution) Act, 1974 ancJamendments thereot Operation of the plant under sect¡on 21 of Air (prevcntiorì & Conlrol ofPollut¡o¡ì) Act 1981 and ainendments thereof and Autho¡-isâtion / Ràncwal ol Authorisalionunder Rule 5 ol the llazardous Wãstes (Mãnagement, lJandl¡ng & Transboundary, Movement)Rules 2OÐ8 & Amendments thereof),

c'oNSEHl is herebi g(anted undcr sect¡on 2s/?6 of rhe waler {prevention & control ofPo¡httr-on) Act, 1974, under secfion 21 of Air (t)revention & Control of pollûtion) Act 1981 andAû'lhor¡saäon unde. the prov¡sions of llw (MH '& TM) Rüles, ZOOB (here¡n¿tter refcrred to ¿s'Ìfie Âcts', 'the Rules') and the rules anrj orders made there Lrnder 10

M/s l{eulaûd lzbo.atories Ltd.,, S't - No. 47 4 & g4f, 4gol2,rBohthspalJy Viltaße,

i Veerabhadraswamy Temple Road,

. JinÞar¿m Mandal, Medak District - SO2 313E-ma¡l: unltl(ÐìeulandlêbsÍom

(Here¡nafter refe(ed to as 'the ApÞlic.ant') authoriz¡ng to operate the ¡nduslr¡ât plant tod¡scharge the eflluenG from the outlets and the quantity of em¡ssions per hour frorn lhech¡mneys ¿s detailed belovr' :

l) Out lets for dischârte of effluents:

The ¡ndustry sholl not use the sook p¡ts Íor ¡¡,ài ¿¡riosot of ¿"^est¡, e¡¡trint:s oy s.o-Xto- onasholl d¡spose olf the same ¡n the ex¡stÌng FES.** The ¡ndustry ¡s pe¡m¡lted to d¡spose off tlìe pre-treated effluents to cËTp, Jeedimetl¿ orllyfor a period of 15 days ¡n the calendar year during annual shut down / maintena¡rc¡: of thåtreât¡nent systems_ Thc same shall be ¡rìti¡¡ated to the R.O, Sangareddy _ ll and shalllr¡â¡nta¡n records.

ir

ii

OutletNo.

Outlet Description Max Da¡ly Point of Disposal

1. Process & Wash HTD5cff u êhl s

5.1 (LD " Êorced evaporat¡on in the FE System(FÉs).

' fhe condensete ftrst forerun todislillate for recovery of solvents atons¡te & to reuse.

' The secondary condensate to re-r¡sefor coolinE Tower mâke-uo

t2I

LTDS ãfter treatmentProcess & wäsh effluents(12.5 KLD) + WashlnÊs -3.0 KLD + Boiler blowdowr¡, DM Plant & Cool¡ngbleed off - 5.0 KLD J. R&D,

QC & Scrubber - 2.45 KtD'I' Domestic Eff¡uents - 5_0KLD*

27.95 KLD* . RO-l permeate 10 reuse of Boi¡er,feed and cooling torver make up.

. RO-l rejects to RO-ll

" RO ll pefineâtc lo rruse ¡n Coolingtower and bo¡ler feed make up.

. RO Il reiects to FES.

Ar1".l*J t" I TPil õJ nr"-¿ soiln,

¡i¡) HAZA RDoUs wAsTE AUTHORISAnoN (FORM * ll) [sce Rule 5 (4]l

1. Number of Authorisãt¡on and date of ¡ssue - APPCB/RCP/M DKII- 94lltWM Dt: o7/1o/2-o72

12. M/s Nculand l.aboratories 1ld., 5y. No- 414 & 347' 490/2, Bontlìap¿lly villaßc,

I I Veerabhadraswamy Templc Road, Jinnaram Mandã1, Medak Districf, is hereby ßranted ¿n

I I authorlzation to operate ã fac¡lity for collect¡on. recept¡on, storaße, treatment, trãnsportj I and disposal of lJ¿zardous Wastes namely:

wAsl€s wlTH

34.3 of Schedule - |

i)

il

()

l)

?8-2 ofSchedule - |

36.4 ofSchedule - |

28,5 of schedule - |

TSDF. Dundìgal,Ranßareddy oistrictfor inc¡nerat¡on /Authoriscd cenìentplants forprocessinß.

Mixed SpentSôlvent-s

()

..)

I

ii

ii

'îù.

,/

Quantity ofHazðrdous Waste

230.9 Kgs/Day

3OO.O0 Kgs/Day

32.37 Kgs/DaY

Disposal Opt¡ons

rsDl--;"d*iItêñBareddy L)istri.tfor Secured l¿ndfìlf¡ng.

salts (From Forced

Ev¿por¿L¡ur &

ETP Sludge

sp""t c*b-i

Spent Res¡dues

{Distilfãtion Bottom

s.No

f'¡amê of th€llazardous Wa'tc

Q,J¿nt¡ty ofHãzardous

Wâçtc

D¡sposàl oplions

L spent Solvent 785ôfschedule-l 8346.36Lís/day

Recovered w¡th¡ô thepremìses and reused inthe process dulyseñd¡ng residues toTSDË, Dundigal for¡n.iûr'r¡fion.

2 llçêd O¡l 5,1 of Schedule - | 1,16 Ltrs/dôY Authôr¡sedfepro'cessors Irecyclers.

3. Empty Container &Conta¡ner liners ofhazârdous wastes &chemicalsã- HDPE Ðrumstì, M5 Drumsr Cårbôysd, F¡b€r Bôardse- Foly bêeçi Us€:d b€tdes{BroniÈlr€ "- ' ./t.ahe.ætoy FB:Ð. û{ClìemirèB)

33-3 ofSchedule -l

50 Nos/month50 Nos/month150Nos/month125Nos/nìontl'ì200Nos/month500

Äfter complctedetoxifìcation, it shall

be dispose of tooútside êgencies

tl

i. ,,

!..r

',)

i¡

lilr

This roñsent or.lêrindicãted only;

is valid for mãnufadure ôf thc folfowíhg products w¡lh quanlities

lqljl¡!

L

iÌll

l--r!o, i -----fÍqd991l . -.--qAu.$¡ty

The iodtpetmítteproducereguldr

Gtøup Akg/doy

Enalapril Maleate 50.oo

2 M¡11a¿àpine 20.003_ Sotalol Hydrochldr¡de 2S.00á I Levet¡racetanr

I-luBrorAL --Þq_.00145.00

C-AMPAIGN PRODUCTS {GROUP B)

5 Benzvl Salbuta mol 'tl; 67

6 lpratrop¡m Bromide o501 Ofioxâcin )61

from ((worst

8. 20.00

9. llraconàzolê 7.67

10. Olaniaoine 7.6758-34Totøl

11 Moxifloxac¡n 5.00!2 Escitalopram Oxalte13 Levoflxacin 16.61

74. Rooìn¡role HYdrochloride n50203.34

203.34

¡odustry îsítted to'ICe 4

Jcts ofpA@ 74s

ptoducts onnoøíon bøsis

fromGtoup-Bl.(wotst

I

combinotionJ @ I

s8.3a ks/døy. I

lotøt i

Productio¡¡ i

shall not excecd \I

2ß3a ks/ddv- iI

Th¡s order is sûbject to the provis¡ons of 'tlìe Acts' and the Rules' and orders made thercundcr

þnd further subject to the terms and conditions lncorporatcd in the schedule A, B & C cnclosed

1ö this order.lii

lÍhis Conrbined order of Consent & Hazardous Waste Author¡zatloh shall be valid for â period

ähding with the 31'r dav of octottet,2oL2. ' sd/'MEMBÊR SECRETARY

ToM/s Neuland Laboratories Ltd.,Sy.No.474 &347,490/2,Bonthapal¡y V¡llaEe,Veerabhadraswamy Temple Road,Jinnâram Mândal, Medak D¡strict - 502 313

-nviro-nmental En gineer (FAC)

Iril

I

lr

sc!rrpuLE-41.. The applic¿nt shall makc applicãt¡ons through online for renewâl of Corìsent (Lrnder Water

and A¡r Ac-ts) and Authorisåt¡on under llWM Rules at least 120 days bcfore the datê ofexpiry of this orde¡ along \^,ith prcscrlbed fee under Water and Aìr Acts for olltàin¡n8

Conscût & llW Authorisation olthe Boàrd.2. All other cond¡tions (êxcept condition-No.1) stipulated in the sclìedule - A ol thc earlier

combined cto & HWA o.der No. APPCE/PTN/PÍNl382/l4olclo/200{l-649, dated

10.06,2008 remalns same. lhe industry shall ensure cons¡stent compl¡ance of condit¡ons olthis schedule-4.

l. Any person a8Srieved by an order made bY the Stâte Boârd Úlìder Section 25, Sccl¡on 26,

Sectlon 27 of Watcr Act, 1974 or Sect¡on 21 of Air Act, 19Bl may wlth¡n thil ly d¿ys from the

date on which the order is commun¡cãted to him, prefer an ãppcal ês pêr Andhra Pradesh

Water Rules, 1976 and Air Rules 1982, to such atrthorily (hereinafter refcrred to as the

Appellate Author¡ty) as the statc Goventmcnt nìay think fìt to constitule under section 2,8

of the Water(Prevention and Control of Pollution) Act, l'974 ¿nd scdion 3l of the

Air(Prevention and conlrol of Pollution) Ac-t, 1981.

5CH EDU LE -ESÞeclal condit¡ons1. The industry shãll extend Bank Gu¿rêntee of Rs.4O lakhs submitted to the Board under jAP,

for a period of one year ¡mmed¡ately2. The effluent discharged to CETP, Jeedimctla dorìng annual shttt down / mainten¿nce of

tre¿tment systems (for a perìod ol 15 days ¡n the calendar Vear) shâll not cont¿in

OutletNo.

Parameter timit¡ng Standards

2.

lD5 {lnotnanrcl 5.000 ms/l

ìempêrâture oc. _ _

O¡l and Greäse _.-_ ---Phenolic Compounds (as C6ll5oH)

45.O- '' ,0 o0

"16115.00 m8/'

Ammonical NitroEen (as N) 50 0ô mc/l

cvanide (ês cN) 2.00 msJl

clìromium ltotall las Crl æqr343.00 mÊ/l1.00 me/l

N¡ckel {as N¡) 3.00 mell15.o0 mÊll0.20 ms/l0.01mgl

o 0S mÞll

Fluoride __ 15.00 m&'l

Boron (as I __-._ z_OU mgll

coD

:

1:

lri

iiìlii

i*

liri

The i*duçry st¡¿ll segregale cffluent h¿v¡ng TDs (¡norgðnic) concentralion more thãû 5'0m

ft€fáit ênd drsposed by using R.O system & MEE. only the effluent with TDs (lnorgânìc) less

¿fuE! 5.ûûe ragÆt sfrali be sent to PEÍL ãfter treatment- The industry shâll fum¡sh the

re¡rÌsed ql!êv*Èies effiJeûts duly followiog the segregêt¡on cr¡tería mentio¡f'd âhol'e

Tfiê ¡rrd{rdÌy * $ t=ke deÞs to reduce watet consumption tô the extent põssible ês Pe¡ lhe

water €olìstr.rjp$ûFl reps,rted wh¡le obtâiníng earl¡er consent from the B{}a,rd ¿rnd sha$

fumish the d€ta*s€f.B¿ãÉer corlsùmption foI each pÚrpÛsewit]ìin â frrfll¡i8ht lû ùe Eriard-

I

,-)

5. The industry shaff take steps to reduce wâter consumplion to the extent poss¡ble arìd

I,titl1',

'Ihe ¡ndustry shãll file the wðter cess returns in |-orrnl as reqúired under sect¡on (5) olwãter (Prevcntíon and Control of Pollution) cess Act, 1977 olì or before tlìe sth of cvery

calendar month, showing the quântity of water consunred ¡n the prcvious month along withwater meter readinSs. The industry shall remit wateÍ Cess as pcr the àssessme¡t orders as

and when ¡ssùed by Board.The €missions shall not contêin constitucnts ¡n exccss of the prescrìbed ¡inlits ffentioned

Chimney No, Pâtametef Emiss¡on Standards

9..

:iili:

10.

7\.

12.

13-

rhe ¡ndultry shall coÃ-pry raitrì-isr¡.r¡i.¡tt for oc tãìt ài-."p".itv upio 800 KW as per

the Nôt¡ficâtion G,S.R.s2O (E), dated 01.07.2003 under the Environment ( Protect¡on )

Amendment Rules, 2OO3 ênd G.S.R.44S(E), dated 12 07.2004 under the Environment (

Protection )Second Amendment Rules, 2004. ln case of DG sets of capac¡ty more than 800

Kw shall comply with emission Iim¡ts as per the Not¡ficalion G.5.R.489 (E), dâied 09 07 2oo2

at seriãl no.96, uhder lhe fnv¡ronment ( Protect¡on ) Act, 19ti6

The ¡ndustry shall comply with ambíent ai. quality stândafds of PMlo(Particulãte lr4atter size

less than 10 pm) - 100 ¡rg,/ m3; PMr s(Particulate Matter size less thên 2 5 frrn) - 60 lr8/ nr3;

So, - 80 Fg,/ m3; No, - 80 t-r8,/m3, outside the f¿ctory prem¡ses ãt the periphery of the

¡rìdustry.stãndãrds fo[ other pârâmeters as mentioned ¡n the National Ambient A¡r Qual¡ty

standâfds cPcB Notification No.8-29016/2O/90lPcll, dafed 18.1.1.2009

Noíse Levels; Dayt¡me (6 AM to 10 PM)- 75 dB (A)

Night time (10 PM to 6 AM) - 70 dB (A).

The ¡ndustry shâll not inüease the cãpac¡ty beyond the permitted capacitv mentioned in

this order, w¡thout obta¡ning CFE & CFo ofthe Board.

The ¡ndustry sholl not ñonuføcture øny Product other thon the mentloned în this oder,

wlthout CFE & CFO oÍ the Bodrd. lJn-consented boilet shøll not be operøted

The ¡ndustry shdll prov¡de Stripper, MEE ond ATFD for dispos¡ng the h¡gh TDS efflucnts and

report the compl¡once to RO, Søngd.eddyJl w¡thíh one month'vide order dt' 31.07.2007, the Board hã5 directed youf ¡ndUstry fÔl lmplementation of lô¡nt

Actlon Plan accepted by the Hon'ble Supreme court vide order dated 17 07-2007 in

W.P.(c). No. 441/2005. 476/2005 & batch of câses The ¡rìdustryshall cxpl¡c¡tly comply with

the d¡reLlions g¡ven by tlìe Board without af¡y deviation from the Joint Action Plan accepted

by the Hon'ble supreme court ol lndia,The ¡ndustry shall re-use tlìe treated low TDS water w¡th¡n the premises and shall stop

disposal of low TDS efluents to CETP as directed ¡n the CFE order.Thc ¡ndustry shall not use hlgh coD / high TDS ef{luents in the cooling towers undcr any

circumstances.The ¡ndustry shall mã¡ntain llow mcter w¡th digitãl totali?er fo quanlify the effluents

evãporating in FE system ãnd report the compliance to the Board,

The lndustry shall install flow meters to measure the condensate generat¡ng from FE System

and reus¡ng Ih the process within a month. The First l'orerun of condensale from ff system

shall be quantified and shall furnish the details of lts characteristics & ftìode of rl¡spo$al tothe Board.

1.4,

ii1Fl

li16:

L7.

i

il

5. I Gêr deninø¡r r¡gal ion

2.45 KL D

50.72 KLD

rèi Tlìe ¡ndustry shall mallìtain the lollow¡n8 records ând thc sâme shâll Lrc m;rdc rvâìlable lotlr c Bo¡rd olficials durir¡8 tlìe insp.cliôn

a. Daify Froduction details, RG'l records and Central Êxc¡se Retunls

b. Quantity of Effluents generatcd and forced evaporåted

c. Log Books for pollution control systen]s

d. Da¡ly sol¡d waste generated ãnd disposed to LsDF-

The industry shall provide separate wâter meters w¡th necessary plpel;ne for as5ess¡n81he

quãntity of wåter used for eãch of the purPoses mentioned below

a. lndustr¡âl coolinß, boiler feed.b- Domest¡c purposes-

c- Processing, whereby watcr gêts polluted end pollutânts are eâsily bìode8rirdabìe'

d. Proccss¡ng, whereby water Scts polluted and Þollutants are not easilY

biodcgradablc.The industry shall evaluate the Performãnce of solvent recovery svstcm for each stream_

w¡se ¿nd shall furnish plan of action to rnaintaìn the effìciency of solvent fecovery more

thên 95% for each stream \4/ise.

The industry shall not send the spent & mixed solvents oLìtside part¡es

The industry shãll not adopt treâtment of ef{luents eltlìer d¡rectly / ¡ndirectly from other

sister conccrn unÌts wìthoìrt prior permigsion from the Board'

The industry shall lnstall ãnd operate dedicated multi stêge scmbbers to contaìn process

emiss¡ons using appropri¿te scrubbing solut¡on The details of chemlcals consumpt¡oll shall

be recorded & kept accessible for the inspect¡û8 officials of the Board

The indulry shãll not disch¿rge any wastewâter with / without treatment outside lhe

factory premlses or onland within the premiscs

25- Th¡ck green belt shall be developed & mainta¡ned bythe ¡rìdustry with tall Srowing trees in

19

21.2h,ìl

,ii

3p.

,[isþlii

the vacânt spaces ofthe un¡t.The indûíry shall submit mock drill report carr¡ed oul at least once ¡n sìx months' ¿s

required under the Manufacture, Sîorage and lmport of Itazardous Chemicals Rules' 1989'

The industry shãll elablish AÂQM stations where maximum GLCS are expected & shêll

establish network of ^AQM

stations due co-ordinãtion w¡th othcr incJuslr¡es Ìn the industriàl

cluster in consultat¡on w¡th Regional Officer of the Board'

The índustry shall ¡nstall anã commlssion Online monitor¡n8 station for stack and AAQ iiì

consultat¡on witlì RO, S¿nBareddy-tl and connect the sãme to the Boârd w¡thin two months-

The ¡ndustry shall explore monitoring of Hazardous A¡r Pollutants {llAP) & odorous

compounds and shall subm¡t act¡on plan to the Board'

All the rules & regulatlons notiíìed by l¡inìstry of la\Y znd Justice, Government of lndiã

re8ard¡nB Public Liab¡l¡ty lnsur¿nce Act, 1991 shall be followed

The effluents shall be stored only ln abgve Bround storage tanks'

The tndustry sholl eomotk øn omount of Rs 27'2 ldkhs per onnuñ for 70 yedrs towords the

Enteryî¡se Soc¡ol Res¡ons¡bílity (ESR) oct¡v¡ties' The ¡ndustry shall carmork thís omount

tôwords thê Enteryr¡se Soc¡at Respons¡b¡lity (ESRJ octlv¡ties ønd spend tl¡e omoDnt under ESR

octívÌtíes l]ntough EsR/(sR Cett ín the olfice af the Сstr¡.f Collectot'

The industry shall ensure contiÌìuâl compliànce of cfE (changê of product mir) obtêìned

fromtheBoârdvideorderNo.APPCB/PTN|PÍN|3sz/cçE|Ho/2Û09-2420,dâ1ed11.02'2010-The tndustry sholl comply w¡th Task Force d¡rections ¡ssued by the Bocrd from t¡ñe to tìme'

All the rules & regulations notified by Ministry of Law and lustice' Government of lnd¡a

regarding Public Liability lnsur¡nce Act, 1991 shall be followed'

The applicant shall submit Environmånt slatement in Form V before 30ú Seplember of

"rr.ry yà".

". po. Rule No.14 of E(P) Rulcs, 1986 & amendment-s thereof-

the conditions åre wíthout prejud¡cs to the rights and contentìons of lhis BÐard iÛ ãny

Hon'ble Court of {-aw-

33.

34.

36-

37-

{, .1

\)

(.r

\. ..1

I

4.

I

lil¡rl

6.

7

SCHEùULE_C

I co'DrtoNs oF AurHoRrsÂnor* *lä*rffL "*.*uroo

HÄÈ4Ðu.r€ HÀzÀRùo{Jsrar-srrs 1

1- lhe irìdustry shall g¡ve top priorìty for l+.ðde Rjrrìfrli2ã^,is.r ã d d{:è/rc{ prodlr¿ìiot! pr¿cìk¡:s_

2- lhe induslry shall not sto¡e hâzardÒus rì¡:ãsîe for roore -.ien 9ô de¡s .ls FH:r the H¿zafdoìr:Wastes (Mânagement- Hàndling and Transtroundary Movenìent) Rules, ZO0g andamendments thereof.

3. The iùdustry sh¡lfstore Used / Wastc Oil and Used Lead Acid Batteries ¡n a secured way ¡nthelr premises till itç d¡sposal.

The irìdustry sh¿ll not dispose Waste oils to tlìe traders ôhd the same stratt Oe aisposca tothe authorized Reprocessors/ Reryclers.

The industry shall dispose Used Lead Acid B¿tleries to the manufactLfers / dealers onb0ybàck bàsis.

lhe ¡ndustry shal¡ not dispose spent solvents / mixed spent solvents to the traders_

'Ihe ¡ndustry shâll tâke hecessary prâct¡cål steps for prevent¡on of oi¡ spillages and cêrryover of oilfrom the premises.

B. The ¡ndustry shall mahìta¡n 6 coÞy manifest system for trânsport¿tion of wâste generãtedand a copy shall be submitted to Board Office and concerned Regional Oflìce.

9. Ihe industry shall r¡rainta¡n good housc keeping & ma¡ntaín propcr records for HazardousWastes stated in Author¡sation.

10. The industry shalf maintain proper records for Hazardous Wastes stãted jn Authotisation ih. FORM-3 i.e., quantity of lncinerable wêste, land disposal waste, rcryclable waste ctc., and

lile annual returns ¡n Êorm- 4 as per Rule 22(2) of the Hãzardous Wastes (Mânagement,Ì Hândl¡ng & Transboundary Movement) Rules, 2OOB and amendments thereof.

jit. the inaustry sh"ll subm¡t the cond¡t¡on w¡se compl¡ance repoft of the conditions stipulatedll in Schedule B & C of rhis Order on half yearfy bas¡s to Board Ofl¡ce, Hyderabad andì concerned Regiônal Oflìce.

12. The industry shãll dispose of e-waste tô the ¿uthorised recyclers only.

13. The industry shall conform to the co-processing gu¡del¡nes of CpCB in send¡hg wâstes toêo-processing for cement plants-

sd/-MEMBER SECRÊTÀRV

TÛ

M/s Neufand Laboratories Ltd.,Sy. No,474 &347,490/2,Bonthapally VillaBe,

Veerabhadrâswamy Temple Roâd,J¡nnaram Mâr¡dal,

Medak D¡strict - 5oz 313.liili

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_- ¡r¡111.¡lrlL nt, ù¡;tììtir,r LlLl..

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conrÞliances Pend¡lìg From lndustry Side, K¡ndly enter you REPLTEs - for Pt to pt Instructions (euery and Rel)lyMenu) Lâst Insp: BI7A5-05/12/2012

V¡sit Iñst¡'uct¡ol'ì Rep ly Dt

ïûN-IrÈìù1Ll fiìÞr'r\ Nüde lli;1,i8.:5.3,:5 .{INDi

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ANNEXURE _ II

LIST OF'RAW MATERIAI,S

PRODUCT : Enalaprìl Nlaleate

r'_: - _.8qry tr¡etSri¡r

lq!,o¡¡, cgloony] q]'envi PIop),!Ale tilte lHydrochloric Acid (35%)

lr.Þót;nc]Phosphorus Pentachloride'Toluene

I

LW?!erIsexamãr¡vi oäiraiaìãlAcetânìidelN.4ur"i" A"id

irfC1qy]"'¡"lvet¡yþe Ç¡1e¡¡oe l

lecC!o-!1" l

PRODUCT : À4irtazapine

li;îrF:lî::¡,:. 8ù:ii'åËÊåaìliîlr::-:aj:li':,,::ar::i

fry-qple.ee -- ------:Agltllted ceeo!

]cllopltm l

l{9op1o1y! e1¡91 l

[E !f'.yLA99 !qlo]Sodium Hydroxide

lgqdiuT J![e!9 ]

lsulfuric Acid

l ollgne l

lvirridelzo'/o¡ ln Totuene ]

PRODUCT : Sotalol Hydrochloride

PRODUCT : Levelíracetaû1

PRODUCT : Benzyl Salbutamol

PRODUCT : lpratropium Bromide

PRODUCI : Ofloxacin

PRODUCT : Ramipril

PRODUCT : ¡loxifloxacin

PRODUCT . Escitaf opranl Oxalale

PRODUCT : Levofloxacin Hemihydrate

PRODUCT : Ropinìrole lJydrochloride

PRODUCT : Ciprofloxacin Base

ll1,Sl!îî*il1¡IÍMËËääi:!,,,t':iiijaì:,,.:Ì-Ciprofloxacin Hydrochloride

]

tAmmonia Solution (20%)

benzoyl) malonic

PRODUCI : Albuteroi Sulphate

PRODUCT : Donepezil Hydrochlor¡de

PRODUCT : Do¡zolamide Hydrochloride

PRODUCT: Rufinamide

PRODUCT: R&D Products

sultonic anhydride

AI.{¡{EXURE - III

TYPICÁLDETAILS OFPROPOSED PRODUCTS

rir\4(P)r

PROÞUCT : Ënâtapril MaleateDescription :

Ethoxy Carbony¡ Phenyl Propyl AIan¡¡e ¡s reacted w¡th Plìosphorus Pentachlor¡de ancl Hydrochloric Acrd inToluene and Methylene Chlor¡de and Methanol to get (Stage-1) Cornpound.

Stage-1 compound is reacted with L-Prôline, Hexamethyl Disilazane, Acetar¡ide and Water in TrieflìylamineMethylene Chloride, Melhanol and Acetone to get Enalapril.

Page I

Flow ChaÉ

Ethoxy Carbonyl Phenyl Propyl Alan¡neHydrochloric Ac¡d (35%)Phosphorus PentachlorideMefhylene ChlorideTolueneWater

Stage-lHexamethyl DisilazaneAcetarnideMaleic AcidTriethylarnineMethylene ChlorideAcetoneWaler

ìr]\40)1

Enalapril Maleate

Sol.RecoveryEvaporâtion Loss

EffluentOrganic Residue

Process EmissÌons

Sol.Recover¡rEvaporation Loss

EfflueniOrganic Residtre

Pagc I

StaqeJ

+ PC ts

Phospphoruspentachlor¡de

t\¡.wt 208.5

POCt3

Phospphorusoxychloride

t!1.wl 153.5

HCt

Hyrochloricacid

tM wt 36.5

H¡c----^-.--zo ^,,r Y'"

-\ -cl Hcl

IÌ NHìI\20

ECPP Alanine chloride

.Hydrochloride

tvl.wt 334

I

+ +" HCt

Hyrochloricacidl\¡.wt 36.5

I

:

.)

l

ECPP Alanine chloride L-ProlineHydrochlor¡de

M Wr 334 M W1 115

HexametlryldisllazaneM.Wt 115

Water

MWI 18

Acetam¡delvl wr 59

+ (cH3)"sioH * 1cl.¡.sict + NH4cl +

Trimethylsilyl Trimethyl AmmioniumChloride silyl non chloride

r\r w 108.5 N¡.Wt 90 l\4.Wt 53.5Enalapril

M.Wt 376

Staoe-ll lB)

Itl.Wf : 376

rl

cH3coNH2

Acetamidet\¡.\\ 59

H.C- --.t -6 COOH.

_=-.: I.i: ou NHI

Enaìapril MaleateM Wt 492

Ï' -",. Hcr f1*uftt' "'î(,u2 ""co66 -¡' (cH3)3sì - NH -si (cH3)3 * H:o * cH2coNH2

o¡

H.C. ,ç COOH,.

^":Yï'Orffi'rli"\12 o

N4.Wt : 1 16

\4il,0r)2

PRODUCT : M¡rtazapine

Description:Mirtazapine Acad is reacted vr'¡tlì vilride in presece of tolune to get (Slage-1 ) CompouncJ

Slage 1 compound is reacted in Chloroform and Diisopropyl Ether to get lr¡iñazaÞine.Mìdazapine (Tech) ìs PLr¡ified in Diisopropyl ether to get N4iÍazapine (pure).

Flow Chart

MiÍazapine acidV¡trade(7oo,¿) in TolueneTofueneSodium sulfateActivated CarbonEthyl Abetate

:l

slage-1Sulfuric AcidChloroformDr¡sopropyl e{herSod¡um HydroxideAclivatcd Carbon

lVirlazaprne (Tech)

lDi isopropyl etherAclivated Ca¡bon

Sol RecoveryEvaÞoratÌon Loss

EfflLrentO¡garic Residue

Sof.RÊcoveryEvaporation Loss

EffluentOrganic ResÌdue

Spent CarLron

Sol.RecoveryEvaporatron LossOrganic Residue

Spent Ca¡bon

Mirtazapine

Prigc I

Staqe-l

Mirtazap¡ne Acid

(ttl.Wt : 297)

.r\r-'o¡r r,\\.^-,--.-t )'!-,1,.r.

Mirtazapine Alcohol

(M Wt: 283)

Staqe'll

MIRTAZAPINE

+ (cll3OCH2CH2o)2AlH 2Na+ 3H2O

Water

(M Wt: 18)

Vitrìde

(M Wt: 202)

I

{

+ 2CH3OCH2CH2OH + A|(OH)3 + NaOH

2- N¡ethoxy ethar'ìol Aluminium Hydroxide Sodium hydroxide

([/ Wt 76) (M Wt 78) (M Wt : 40)

4 Na2SOa + 3H2Otlìl-on f*l + H2so4 + 2NaoH -- ----->-vNt#

(..ñ-cHs

aY-dli- u /-'N- tru-{()\-N

'cH¡

Nlidazapine Alcohol Sulfuric Ac¡d Sodium Hydrox¡de Mirtazapine

(M Wt: 283) (M Wt: 98) ( M Wt: 40) ( M Wt: 265)

Sodium suìphate Water

(N4 Wt: 142) (M W 18)

srì(r,)i

PRODUCT : Sota lal HydrochlorideDescription:Aoiline is rcacted \¡Jilh Mclhane Suffonyl Chloride âû¿ sodiunì Biôarbona¡l3 in Toluonc lo sDl (stas¿,1)

Srage 1 cor¡pound is reaolcd v,/¡lh Chforo Acelyl Chloridc in Ethylcnc Drchtorrde and Acerone to gerArìiìroEl¡er (Slage-2) Cornpound.

Slâge 2 co'Ìpounil is rcâcled v,'ilh lsopropyl anìrne rn M(rlhânot lo gel (stâs1ê.3) conìÞourìd.

Slàge-3 conìpound is.èa.led wirh Hydroga io and lsopropyl Afcohol lo gel Sotalol Hydrochlo¡ide

Flow C hârt

[¡elhane Sulfonyf ChlorideSodiunì Bicarbonate

Melhanc SulfonânilidoI\4ef hylene Dichloride

Âluûìiniunì ChlorideChloro Acetyl Chforide

Wâler

Slage-2 i .

lsoprôÞyfamine illelhanol I l

Melhanolic Hcl (30¡/o Hcr)

S1âge-3Hydroge¡ Gas

Pafladium Cârbon (5%)Carborì

Sol.RecoveryEvaporalion Loss

Efllue¡ìlOrgânic Residuc

Porcess Enì¡ssions

SolRecoleryËvaporalron Loss

EffluenfOrganic Residue

Process Emissions

Sol.RecoveryEv:+orâtiôrì Loss

EflìuentOrgålltc Residr¡e

Sol.RecoveryEvâporåtioD Loss

ElfluenlOrgån¡c Residue

SpenlCarbonProcess Emissions

Sotalal Hydrochloride

Pågc l

SOTALOL HYDROCHLORIDE

Staqe-l

NHzIoAniline

M Wt: 93

Staoe-ll

lVlethane Sulfonyl

Chloride

M Wt : 114.5

Sodium

Bicarbonate

M Wt: 84

18

"f D + "L<"' .- ,"olí"-Nú "-'- o

MethanesulfonÞnilide ChloroacetylChloride

M Wt ;171 [/ Wt : 113

StaqeM

4-(2-Chloro acetYl) MethaneSulfonanil¡de

¡,n Wt : 247 .5

Staqe-lV i

lsopropyl Amine

M Wt: 59

^ o r5¡/'.--Nçctrt +"'é1 \ ,,) cH" ' Hcr

CHi--t't¡ "'-

4-(2-lsopropyl amino acetyl)Methane Sulfonan¡lideHydrochloride

M Wt: 306.5

OH

H? -,--- 'ù o.,9 ñô--Y"n'' .r",cnás'rur/\Z cH:

Hydrogen

MWt:2

?-\

+ cH3so2ct ç NaHCo3 -- J' .,fr'e?*uç "'

*""' + coz + Hzo

Methane Sodium Carbon Water

sulfonanilide chloride Diox¡de M wit\4 Wt : 171 Ìvl Wt : 58.5 M Wt : 44.

o-.--. À -cro.,g I -T

ìs )!- ,,)cHÁ-'til¡ 't-

4-(2-Chloro acetyl) MethaneSulfonanilide

MWt:247.5

o-...t Ä -r.rn ,c¡.o.p f-Y ï -'Hcr

's )! ,.,) CH.CHã--NH -'-

4-(2-lsopropyl amino acetyl) MethaneSulfonanilide HYdrochlorÌde

M Wt: 306.5

Sotalol HCl.

M Wt: 308.5

HCt

l-iydrochlor¡c acid

M Wt : 36.5

r-]IP)4

PRODUCT : Levetiracetam

Description:2-Amino butyric Acìd is reacted wth Thionyl Chlor¡de, lMethanol, Anìmonia and Hydrochlorio Acid in f\¡ethanol2-Amino bulyramide HCI is reacted w¡th 4-Chlorobutryl Chloríde and PotassiLrnì Carbonate ¡n Acetone and Di¡sopropyl ether to get (Stage 1) Compound.

Stage '1 conìpound is reacted with Potassium Hydroxide in f\.iethylene Chloride ând Ethyl Á,cetâle to getLevetiracetam (-fech)

Levetiracetam (Tech) is purified in EthylAcetate and Acetone to get Levetirâcetam (pharma).

FIow Ghart

t_lL]

J

LI!iL]L-]

J

ü

2-Amino buiyric AojdIhionyl ChlorideMethanolArtrtronia gasllydruujrforic Aold gasAcetoneDj isopropyl ether

2-Amino butyranlìde HCI4-Chlorobutryl ChloridePotassiurìr CarbonâteAcetonit¡ileDiísopropyl ether

Staoe-1Pota3sium lHydroxidé[¡ethylen¿ ChlorideCatalystSodium SulfateElhyl AoctotcCarbonMolecufar Sfeves

Levet¡racetarn-TechEthylAcetateAcetone

Sol.RecoveryEvaporatio¡r LossOrganic Residue

lnorgånrc Sollcl WasteProcess Émissions

Sol.RecoveryE\,âporat¡on LossOrganic Residue

lnorgeñtc Solid \¡JasteProcess Emissions

S.'l Re.ôvÊtyEvaporation LossOrgânic Residue

lnorganic Soiid WasteSpent Carbon

Sof.Recover!,Evaporation Lossórgaôic lìesidue

Leveti¡acetam

Pagc 1

LEVETIRACETAM

-slêsg:l

,CH"HCII -*"..HzN y

o

2-Am¡no Butyram¡de

(M Wt: 138.5)

_cH"O(Jl ,J. -run"r NHY\--cl o

N-(1-CaibamylPropyl)-4-Chlo'ro Butyramide

(M Wt: 206.5) l

Staoell

^ ,.CHs

Jj- t NH-

I'NHY\..-cl o

N-(1-CarbamylPropyl)-4-Chlo¡o Butyrarìride

(M Wt: 206.5) I

o

",A..,-----",

4- Chloro Butyrylchlor¡de

(M Wt: 141)

I

,l

+ K2CO3

Potassium Carbonate

(M Wt: 138)

+

+ 2RCt

Potassium chloride

(M Wt : 74.5)

coz

Carbon D¡oxide

(N¡ Wt: 44)

Hzo

Water

(M Wt: 18)

+ Kct {- Hzo

Potassium Water

Chloride (À,4 Wt: 18)

(M Wt : 74.5)

.L+

KOH

Potassium hydroxlde

(lM Wt: 56)

_c H"o(.\-_-l_-.*r,( I tl\ro

Levetìracetanr

(N¡ Wt: 170)