xlil"'; kdllri,l Neutand December 16, 2013 The Director(S) Member Secretary, lndustrial projects, EIA Division Ministry of Environment and Forests Paryavaran Bhawan, CGO Complex Lodhi 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 truly for Neuland Laboratories Limited \ ¡/ "l' llt' ' lapãs {-haKra borty VP-Coripoiate EHS l Encl: a/a Neuland Laboratories L¡mited
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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.
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
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
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
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.)
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.
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):
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,
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
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.
_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),
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.
{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
. 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
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
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
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
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
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-
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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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':.'i ¡ r\l) H câdinsI (ìtI! t p{lìlr l)ì1)tilc t)rerisct\ ñ .\c.Uriì¡ùt\2 !)ùÌ tlpd¡lc Sr.ì(kr/li'l l'/l l,\ZDlt,ro(l r('ls-lu\\. \tircriat.ì Q!!!! l)ìr:ì\r l ilc ì rl r.r-t¡ctuIn r)t \\'¡tcr'- ( (ss
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.
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
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).