THE NARCOTIC DRUGSSUBSTANCES

AND PSYCHOTROPICRULES, 1985I

^-..1: r:5",: ol rhe powers,co.nferred.

.W section 9, read with section 76 of the NarcoticIrrugs and Psychotroptc Substqnces Act, 19gS (61 of 19gS), the Cmtrai Gm)ernmenthereby makzs the following rules, namely:_

CHAPTER 7

t. shorr dtte and ""--":lt:t:rnt"tilr*" rules may be called theNarcotic Druts and psychotropic Substances'Rules, 19St:- -'-

^ (2) They shall come into force on the date2 of their publication in the officiarGazette.2. Definitions.-ln these rules, unless the context otherwise requires,_(a) "the Act,', means the Narcotic Drugs and psychotropic SubstancesAct, 1985 (61 of 1985);

(b) "Appellate Authority,, means any authority to whom an appeal may- lie under any provision of thesJ rules;r[(c) "Chemical Examiner-_ means the Chemical Examiner or DeputyChief Chemist or Shift

_Chemist o. a""i"t""t-Ciluinical Examiner,Government Opium and Alkaloid Works, Nee*""n o., as the casemay be, Ghazipurl(d) "Chief Controller of Factories,, means the Chiel Controller ofGovemment Opium and Alkaloid Factorie;; -.*'a[(da) "Controller of Drugs,, means the officer appointed as the controllinsauthority bv the St-ate Govemment undei'rule 50 of ili ;il]1i5

C^os-metics irules, 1945 -"dt;;";;;-irrii, ""i' c*-etics Act,1940 (23 ot 1,940);l(e) "crop year" means the.period beginning on and from the 1st October

_ of any year to the 30th Septemb-er of ihe fotto*ir,f 'y"u.;

a[(ea) "Firm" means a *T.iTy, j ,body corporate, proliretorstrip firm,parhership firm, Iimited liability partnership .firm,

assocration ofpersonsl{[[(eb) "Form,, means a Form oppended to these Rulesl(0 "General Manager,,

19-ang the General Manager, coveinmentopium and Alaaloid Works, N"";;;-;.;';'r*hl' "a"" _ay bu,Ghazipur;

t.

2.

3.

(g) "issuing authority,, means the. Ngcgtic -Commissioner or any otherofficer who may be authori*d h ;;"*;;;;i"'rry Ii,J c""o"r

%de G.S.R. 837(E), dated t4th Novempt. rt sec. 3(t, dated 14rh Novembe., ,'l;;1 t"t' Published in the Gazette of lndia, Extra.,

Came into force on 14-11-1985.Subs. G.S.R. 82, dated 14th February 1995, for claus€ (c) (w.e_f 25_2-1995).Ins. by C.S.R. 3s9(E), dated 5th Mai, 2Ol5 (w.e.f. 5_5_2015).

Sch.l The Narcotic Drugs and Psychotropic Substances Act' 1985 61

Other non-propdetaryrvrmes

e0. METAMFETAMINE Fi8fiff#F"" G)-N-p-dimethvlPhenethvlamine

Chemical nameSl. Intemational non-ProPrietaryNo. names

e1 l]i::*;,ff:n f";L,i,;,f;1,p,k& Jfiii,i:xit'i,'.iistereochemical Pyran-ulvarianlr

92 BUPRENORPHINL 2l' cy( loProPyl-7-F-[{S)l-hvdro\y- t-2'

?;;:'rutl*i-trr;!fu ffi do-ethano'o-

93. BUTALBITAL 5-allyl-5-isotutylbarbituric acid

94 CATHINE (+lnorpseudo- (+)-(i)-r-l(R)l-aminoethyll benzyl alco-

ePhedrire hol

95. ALLOBARBITAL NiTFSNOREX s,5diallybarbituric acid

;Z'. -s;riAMrrral\arNg

N-ethylamPhetamine N'ethyl-F-methylPhenethylamin€

97. FENCAMEFAMIN ' N-€thvl-3-phenly-2-norbomanmine

,A. riNlnononsx !'.Ht;-,*""'nti'n*ethv) arninol

99. MEFENOREX irt{:i ctrtoroproPlt)-a-methylPhenethy-

r0o. MTDA'.LAM iillf,i""-i;iii",;_:i'i,tj"lJ,l)":il:Jit:101. .EMoLTNE 3--,ffi1-.r.3-.t"1;,y-';*g,i,io?l'*f-'""t-tO2, pyROvAERoNE 4-methyl-2--( l-Ptrr,olidinyl)

. valeroPhenone

i0;. iii:'suiAsanstreL 5-sec-birtvl-s-ethvlbarbituric acid

104. VINYLBITAL 5-(1-methylbutyl)-5vinylbarbituric acid

105. rutobaibital 5-butyl-5-;thylbarbituric acidl1ll05A. ETRypTAMINE (3-(2-;minobutyl) ,indole)r,iii. ' rraiiicairlrNoxe iz-imethvlamino)-r phenvlpropan-1-one)

ro!c. zrpspnor [i.;,ti:X'#*jl1{.l,)i;4-1-1prpe.",i,,u"tnu-nol)

105D. AMINoREX (2-amino-5-phenyl-2-oxazoline)

iosr. snorrzorer lt;t_..f;T.T?:r-',1-'":L1f)"",:til3;litr\ll;diazePine)

10sF. MEsocARB Et"1**t*R:il"^tl-N-henvrerbamovr)11106. tof;u",{i;o#ti-"',ii,,-.,4-lvfl A (;t MethYI- -MthYlthioDhenethylamine)

108. GHi (r-HyAroxyt'utyric Acid)

l{Je. zoloidem'{INN)l.rrr0. et'I:'Jfi firll,?i.'L;X*t1i-'ti';.".rhePtanoic acid)l

{110A. KETAMNE :;ilf,l"1t$31"iil-t (methvr anino)

'tll0B. MEPHEDRoNE T*tntt**ca*t-* (frS'2-methylamino-1-(4-melhvlPhenyl)\*-"'MC) ProPan-r-onel4-methYlePhedrone

6[111.] Salts and preparahons of above'

1.2.3.

H'"#"'a".9,;;E i:.:f i'lf /,H"?di:i'"

$,.'ir,"F.iit;fi.**Ifr+"Eirrtr#?il,.u*"u2ndranuary,2004

Rule 2l The Narcotic Drugs and psychotropic Substances Butes, tgAS 63

Covernment for issuing a licence under Chapter V of these rules orllguing an import certificate or export authorisation under ChapterVI of these rules in respect of narcotic drugs or psychotropicsubstances;

(h) "licence" means a licence issued under these rules;r[(ha) "Licenced chemist" mean:i a person who has obtained a licence to

possess, sell, exhibit or offel for sale or distribution bv retail.essential narcotic drugs under these rulesJ

l[(hb) "Licenced dealer" mears a person who has obtained a licence topossess, sell, exhibit or offer for sale or distribution bv wholesale.essential narcotic drugs under these rulesJ

l[(hc) "medical institution" means a hospital, dispensary, clinic or aninstitution by whatever name called that offeis services or facilitiesrequiring diagnosis, treatment or care of illness, disease, iniury,deformity or abnormality, established and administered ormaintained by the Govemment or Municipal Corporation orMunicipal Council or Zila parishad or any person or body ofpersonsJ

t[(hd) "patent or proprietary medicine,, shall have the same meaning asdefined in the Drug and Cosmetics Act, 1940 (23 of 19 e;lr[(he) "prescription" means a prescription given by a registered medicalpracfitioner for the supply of any of the essential naicotic drugs to apatient for medical use in accordance with these rules;l

(i) "Proper Officer,,, in relation to any function to be pertormed underthese rules, means the officer of Narcotics Dejartment who isassigned those functions by the Narcotics Commiisioner;l[(ia) "recognised medical institution,, means a medical institutionrecognised as such under these rulesJ

1(ib) "registered medical practitioner,, means any person registered as amedical practitioner under the Indian Vediial CounJil Act, 1956(102 of 1956) or under any law for tlre registration of medicalpractitioner for the time being in force, or re-gistered as a dentistunder the Dentists Act, l94g (1,6 of 1948) or uider any law for theregistration of dentists for the_time being in force and his undergonetraining in pain relief and palliative cari for prescriDtion of esseitiall1,l::.I".9r"C," for pain relief and pa iative cire or rraining in opioidsubstitution-therapy for prescription of espential narcotiidrugs fortreatment of opioid dependmceJ

() 'fthedule" means a Schedule annexed to these rules;(k) words and

-expressiors used herein and not defined, but defined inrne Act shall have the meanints respectively assigned to them in theACt.

'1. lns. by G.S.R.359(E), dated 5th May,2015 (w.e.i 5-5_2015).

64 The Narcotic Drugs and Psychotropic Substances Rules, 1985 lRule 2

COMMENTS

Article(s) seized in comection with an offence may be sent for chemical analysis toany laboratory in the country, which is permitted to do such analysis; Rnm Dayal v.Centrol Narcotics Bureau, (1993\ 3 Crimes 818 (MP) (FB).

CHAPTER IIPOWERS OF OFFICERS

3. Delegation of powers.-Subject to such directions as may be given by theCentral Govemment, the Narcotics Commissioner appointed by the CentralGovemment under sub-section (1) of section 5 of the Act, may authorise anyofficer subordinate to him, to exercise all or any of his powers under these rules.

4. Narcotics Commissioner and other officers to exercise the powers oftheir subordinates.-The Narcotics Commissioner and such other officer as maybe appointed by the Central Govemment under sub-section (1) of section 5 of theAct may perforrn all or any of the functions, or exercise any of the powers,assigned under these rules to the officers subordinate to them.

CHAPTER UIOPIUM POPPY CULTIVATION AND PRODUCTION OF

OPIUM AND POPPY STRAW5, Opium poppy cultivation and production of opium or poppy straw.-

The opium poppy for production of opium or poppy straw shall not becultivated save on account of the Central Govemment and in the tracts notifiedby it from time to time and in accordance with the conditions of a licence issuedby the District Opium Officer under rule 8.

6. Fee for grant of licence.--The licence of cultivation of opium poppy maybe granted by the District Opium Officer on payment of a fee of l[rupees twenty-fivel.

7. Form of licence for cultivation of the opium poppy,-The licence forcultivation of opium poppy for the production of opium or poppy straw shall beissued in Form No. 1 appended to these rules.

8. Issue of licence.-Subject to the general conditions relating to grant oflicence notified by the Central Government*, the District Opium Officer mayissue licence to any person for a crop year for cultivation of the opium poppy forproduction of opium or poppy straw on receipt of an application made by thatperson in Form No.2 appended to these rules.

9. Licence to specify the ar€a, etc.-The licence for cultivation of opiumpoppy issued under rule 8 shall specily the area aid designate the Plots to becultivated with opium poppy.

10. Designating of Lambardar.-The District OPium Officer may designateone of the cultivators of opium poppy as Lambardar in each village where opium

1. Subs. by G.S.R. 543, dated 24th October, 1994 (w.e.l 5-11-194).

' The Central Govemment has notiJied the general conditions for Srant of licence for cultivationof opium poppy on account of the Central Goverrment during the Opiurn Crop Year

cornmencing on the lst day of October, 2005 and ending with the 30th day of SePtember, 2006

Published in this Volume).

Rule 141 The Narcotic Drugs and psychotropic Substances Rutes, lgES 65

poppy cultivation is permitted, who shall perform such functions and on suchgrms and conditions as rnay be specified

-from time to time by the Narcotics

Comrnissioner.

.. tl; *llT:tiing. or canceltation of ticence.-{l) An officer higher in rankthT. th" ?:Fgt Opium Officer map for sufficient reasons to be"recorded inwnnng, wtthhold or cancel a licence already issued.

. (2) No order_shall be passed under sub-rule (1) unless the cultivator has been

fl::l ?_ t:i:9Tole

,opportuniry of showing cause against the said order or isnearo ln person, it he so desrres.

- (3) Where opium poppy has been cultivated under a licence which issubsequently withheld, or cincelled, the standin! iion, if ,"y, sf,un Ue destroyeJunder the supervision of the proper officer in ,i"f, ,ii".".'", may be specifiedby the Narcotics Commissioner.

--_11. PT:"9:t".with regard to m€asur€ment of land cultivated with opiurrpoppy.-{l) All prots of land cultivated.with opium poppy in accordance withthe licence issued under these rutes, shalt be measured in metres by the prooerofficer in the presence of rhe cultivator .;.;;;J';;J;;"t;ilil;;.#fi"

village and the concemed curti'ator and tr,e L.mua.aai ot-th-e village sha'attestthe entdes made in the recorrls to te mairrtairrJ ly tf,r" Llrntarai., ".

_"11"specif_ied by the Narcotics Commissioner in this b;haU; ,r.J". tnet signature/*:Tl:lf:::-l .with dare, in token of h""i"s ,-;fi"fiJ4;_"elves regardinstne correcbless of the measurement.

(2) The measurement conducted by the proper officer shall be subject to suchfurther checks bv such officers as may 'Ue specified by the NarcoticsComrnissioner in this behalf.

. .I3. Procedur€ with regard to. preliminary weighment._(t) The cultivatorshall, during the course of f,arvesting, produce daily"before the Lambardar, eachday's collection of opium rrom hts irdp r-i;"1gil;i. ^' "-(2) The Lambardar shall make arrangements io weigh such opium and makenecessary entdes in the records to.be maintained by hi_ir as may.be specifiJbythe Narcotics Commissioner in this behalf.(3) The cultivator and the Lanbardar shall attest the entries made in suchrecords under their simature/thu-b-ir"pi";ri;;- , iii "i"t"

showing thequantity of opium weighid on a particular day.

,_ ,(4) Th.e proper officer shall conduct check weighment of the opium collectedby the cultivators with reference to_ the entries iri *," i"..t"ra"r,s record andindicate his finding rherein which shalt b;;G&;; h"";;d the Lambardarunder their signatire with dare.

(5) The variations between the qr.rantity of opium produced by the cultivatorindicated in the Lambardar's record and is founa bi the ;r;;er officer duringIt :1""t,_"trutt be inquired into by the pi.p"i.ffi.i. i" Jr'# ,o *"".,"* ,h"liability of the cultivator for punisirment' uni", ,."ii"" fS?;" ^"t._^,,."t1._?-'1fi""ry

of oqiu.m-produced.-- All opium, the produce of land cultivatedwlm oprum poppy, shall be delivered by the cultivatlrs to the oistrict Opium

66 The Narcotic Drugs and Psychotropic Substances Rules' 1985 [Bule 14

Officer or any other officer duly authorised in this behalf, by the Narcotics

Commissionei at a place as may be specified by such officer'

15. Opium to be weighed, examined and classified'-All opium.deliveredhv the culiivators to the District Opium Officer or any other officer authorised as

aioresaid, shall, in the presence of the concemed cultivator or any Person

u"tt o.ir"i by him and the Lambardar of the village, be weighed, examined and

classified aciording to its quality and consistence and forwarded by the Dishict

Ooium Officer to the Government Opium Factory in such marmer as may De

specified by the Narcotics Commissioner.

16. Procedure where cultivator is dissatisfied with classification ofopi..m.-et v cultivator who may be dissatisfied with the classification of his

"lir- a"."iu the officer referrei to in rule 15 may have it forwarded by such

oifi.". to the 'Govemment Opium Factory seParately, after having it properly

r"ut"a itt his presence and ir the presence of the concemed Lambardar'

17, Procedure for sending opium suspected to be adulterated'- When

opium delivered by a cultivatoi to'the Distriat Opium Officer or any otherofficer

"itfroti""a in this'behalf, is suspected of being adulterated with any foreign

r"Utiu".", it shall be forwarded io the Govemment Opium Factory seParatel,

uit".'it ir'p.op"rly sealed in the presence of the cultivator and the concerned

Lambardar.18. Drawing of samples from opium sent to Govemment OPium Factory

under rule 16 oir rule u:-The sealed opium received separately in accordance

*ith ..,t" 16 or rule 17, shall be opened and sample drawn thereof in ihe

Dresence of the cultivator, if he so desires, to whom, a notice intimating the date

and ti-e in this behalf, shall be sent well in advance'

19. Fixation of price of opium.-(1) The Central Covemment shall' from

time to time, fix the price of opium, to be paid to the cultivators' in such marmer

as it may deem fit.(2) Such price shall be fixed per kilogram of opium of a standard consistence'

20. Provisional payment of price'{l) The District Opium Officer shall'

having regard to the weight and consistence of opium delivered by. individual

.rftitlt"ii work out the ileight of such opium at the standard consistence and

determine provisionally the total price Payable to such cultlvators'

(2) The said officer, shall, pay to the cultivators, ninety Per cent' of the price

"o d"i".-i""a which shall be

'sublect to adjustment -against the final price

payable to the cultivators to be determined as provided hereinafter'

21. Weighment and examination of the opium at the--Govemment Opium

Factorv,-Tfie opium forwarded by the Dishicl Opium Officer shall be received'

-"iJla, "*a-ii't"a, and classified"in the Govemment Opium Factory under the

r""il""i." "t

the 6eneral Manager in such manner as may be specified by the

Nircotics Commissioner.22, Confiscation of adulterated oPium'-All such opium received separately

""d;;-;[ it, if found to be adulterated on examination by- the Chemical

p*amir,er in the Govemrnent Opium Factory may be liable to confiscation by the

General Manager.

Rufe 281 The Narcotic Drugs and Psychotropic Substances Bules, 1985 67

23. Adjudication of confiscation of adulterated opium.-No suchconJiscation shall be ordered by the General Manager unless the concemedcultivator is given a reasonable opportunity of showing cause against theproposed order and is heard in persory if he so desires.

24. Detemination of final price of opium.{l) Subfect to rule 21, the finalprice of opium payable to the cultivator shall, having regard to the price fixed bythe Central Govemment under rule 19, be determined by the General Manageron the basis of analysis report of the Chemical Examiner 1[***l andcommunicated to the concemed District Opium Officet.

(2) The price payable in respect of any opium which is delivered to dreDishict Opium Officer or any other officer authorised in this behalf under rule14 and is not initiallv suspected to be adulterated but found to be adulterated onexamination in the Goveinment Opium Factory, shall be subject to reduction atsuch rates as may be specified by the Central Govemrnent.

25. Adjustment of cultivators' account and recovery of dues ftom thecultivators.-The accounts of the cultivators for a particular crop vear shall beadjusted by the Dstrict Opium Officer at lhe time of issuing of

-ticinces for the

subsequent crop year and any balance that may remain due from the cultivatorsshall be recovered and any amount due to them be paid.

26. Weights and scales.-The weights and scales to be used for weighing theopium at the weighment centres and the Govemment Opium Factory shall becaused to be examined at the appropriate tirne by the Deputy NarcoticsCommissioner or the General Manager, as the cas€ may be.

27. Cultivation of opium poppy for exclusive production of poppy straw.-The Central Goverrment may, if it considers it expedient so to do, permitcultivation of the opium poppy for the exclusive production of poppy shaw inaccordance with a licence issued under rule 8 in such tracts and sublect to suchconditions as may be specified by it, by notification in the Official Gazette in thisbehalf:

Provided that the poppy straw produced by the cultivators or a result of thecultivation of opium poppy for production of opium, shall be deemed to havebeen produced under a valid licence issued under rule 8.

2E. Appeals to the Deputy Narcotics Commissioner and NarcoticsCommissioner.-(1)(a) Any person aggrieved by any decision or order made orpassed under these rules relating to refusal, withholding or cancellation of alicence for opium poppy cultivation by an officer of the Narcotics Department,lower in rank than the Deputy Narcotics Commissioner, may appeal to theDeputy Narcotics Commissioner within thirty days from the date of thecommunication to him of such decision or order.

O) Notwithstanding anything contained i4 clause (a), if the decision or orderregarding withholding or cancellation of licence for opium poppy cultivation ispassed by dre Deputy Narcotics Commissioner, such appeal shall lie to theNarcotics Cornmissioner:

Provided that the Deputy Narcotics Commissioner or, as the case may be, theNarcotics Commissioner may, if he is satisfied that the appellant was prevented

1. Omitted by C.S.R. 82, dated 14th February, 1995 (w.e.f. 25-2-1995).

68 The Narcotic Drugs and Psychotropic Substanc€s Rules, 1985 lRule 28

from submitting his appeal within the time limit specified in clause (a) due toreasons beyond his control, allow such appeal to be presented within a furthera period of thirty days.

(2) Every appeal under this rule shall be accompanied by a copy of thedecision or order appealed against and shall be in such form and in such amarmer as may be specified by the Narcotics Commissioner in this behalf.

29. Appeals to the Chief Conholler of Factories,-{1) Any person aggrievedby any decision or order made or passed under rule 21 or rule 23 by the GeneralManager may appeal to the Chief Controller of Factories within thirty days fromthe date of the communication to him of such decision or order:

Provided that the Chief Controller of Factories mav. if he is satisfied that theappellant was prevented from submitting his appeal wiUrin the said time Iimitdue to reasons beyond his control, allow such appeal to be presented within afurther period of thirty days.

(2) Every appeal under this rule shall be accompanied by a copy of thedecision or order appealed against and shall be in such form and in such manneras may be specified by the Narcotics Commissioner.

30. Procedure for appeal,-(l) The Appellate Authority shall give anopportunity to appellant to be heard, if he so desires.

(2) The Appellate Authority may, at the hearing of an appeal, allow theappellant to go into any ground of appeal not specified in the grounds of appeal,if the Appellate Authority is satisfied that omission of that ground from thegrounds of appeal was not wilful or unreasonable.

(3) The Appellate Authority may, after making such further inquiry as rnaybe necessary, pass such orders as he thinks fit confirming modifying orannulling the decision or order appealed against:

Provided that any order relating to the quantum of adulterated opium to beconfiscated in addition to the opium already confiscated under rule 23 shall notbe passed unless the appellant has been given a reasonable opportunity ofshowing cause against the proposed order.

(4) The order of the Appellate ,{uthority disposing of the appeal under thisrule shall be in writing and shall state the points.for determination, the decisionthereon and the reasons for the decision.

(5) On the disposal of the appeal, the Appellate Authority shall communicatethe order passed by him to the appellant and the officer who passed the orderor made the decision appealed against.

(6) No further appeal or revision shall lie against the order passed by theAppellate Authority under this rule.

CHAPTER IVMANUFACTUR4 SALE AND E)(PORT OF OPIUM

31, Manufacture of opiun.--Opium shall not be manufactured save by theCentral Goverrunent Opium Factories at Ghazipur and Neemuch:

Provided that opium mixtures may be manufach:red from opium lawfullypossessed by a person authorised under the rules made by the State Govemmentfor the said purpose.

Rule 351 The Narcotic Drugs and Psychotropic Substances Rules, 1985 69

32, Export of opium.-The export of opium is prohibited save when theexport is on behalf of the Central Govemment.

33, Sale to State Govemments or manufacturing chenists.-r[(1) The sale ofopium to the State Govemments or manufacturing chemists or the person orentity who has been granted licence under sub-section (2A) of rule 36, as the casemay be, shall be only from the Govemment Opium Factories, located atNeemuch and Ghazipur;

(2) The sale of opium from the Govemment Opium Factory at Neemuch andGhazipur to manufacturing chemists or the person or entity who has beengranted licence under sub-rule (2A) of rule 35, as the case may be, shall be onlyunder a permit granted by or under the orders of the State Govemment withinwhose jurisdiction the chemist or the person or entity resides or has his place ofbusiness in the forms prescribed by that Govemmentl

. (3) The permit referred to in sub-rule (2) shall be issued, in quadruplicate

ano,-(a) the quadruplicate copy shall be retained by the issuing authority and

the remaining copiei forwarded to the 2[Goveriment SiumFactories at Neemuch and Ghazipurl;

ft) the said factory shall retain the duplicate copy for record, send theoriginal copy with the consignment of opium and retum thetriplicate copy to the issuing authorify after endorsing thereon thequantity actually supplied and the date of despatch.

3133A. Sale of opium derivatives from the Government Opium Factories,-(1) The Govemrnent Opium Factories may sell the opium derivatives only if thebuyer produces a valid quota allocation under rule 678.

. . (2) Every buyer of a opium derivative under sub-rule (1), shall provideinformation to the Chief Controller of Factories regarding its utilization or anyother related matter in such form and within such time as may be indicated bythe Chief Controller of Factories.l

. .34. Fixation of sales price of opium.-The price to be charged for opiumsold under this Chapter shall be fixed, from lime to time, by the CentralGovernment in such manner as it mav deem fit.

CHAPTER VMANUFACTURED DRUGS

- 35. Gen€ral prohibition.-The manufacture of crude cocaine, ecgonine andits salts and of diacetyl morphine and its salts is prohibited:

a[Provided that nothing contained in this rule shall apply in case the drugsare.manufactured by Govemment opium factory or by chemical staff employe-dunder the Central Board of Excise and Customs or any person authorised'by'the

t.s*" b)' "4".

95 (E), dated 4th February,2OO4, for sub-rules (1) and (2) (w.e.f, a-2-2/JJ4).2. Subs._by g.S.R. 95 @), dated 4th February,2004, for ,,Govemment Opium Factory, chazipur,,

(w.e.1.4-2-2004).

3. Ins. by S.O. 1651(E), dad 13th Jul, 2010 (w.e.t t3-7-2OtO).4. Iru. by c.S.R. 350 (E), dated 25th Jure, 1997 (w.e.f.274-19n.

70 The Narcotic Drugs and Psychotropic Substances Rules, 1985 [Rule 35

Narcotics Commissioner by a special licence for purposes mentioned in ChapterVIIA:

Provided further that the Narcotics Commissioner shall consult the DrugsController-General of India before issuhg a licence under this ChaPter.l

36. Manufacture of natural manufactured drugs.-(l) The manufacture ofcocaine and its salts is prohibited save the manufacture of cocaine hydrochlorideby the chemical staff employed under the Central Board of Excise and Customsfrom confiscated cocaine.

(2) The manufacture of morphine, codeine, dionine, thebaine, dihydro-codeinone, dihydrocodeine, acelyldihydrocodeine, acetyldihydrocodeinone,dihydromorphine, dihydromorphinone, dihydrohydroxycodehone, Pholocodineand their respective salts is prohibited save by the Govemrnent Opium Factory.

1[(2A) Notwithstanding anything contained in sub-rule (2), the NarcoticsComrnissioner or such other officer as rnay be authorized by the CentralGovemment may, on and from the commencement of the Narcotic Drugs andPsychotropic Substances (Amendment) Rules, 2004 grant a licence in Form 3appended to these rules on such terms and conditions as may be specified in thelicence to any person or entity for manufacture of morphine, codeine, dionine,thebaine, dihydrocodeinone, dihydrocodeine, acetyldihydrocodeine, acetyldi-hydrocodeinone, dihydromorphine, dihydromorphino-ne, dihydrohydroxy-codeinone, pholcodine and their respective salts 2[r[***1, -if the CentralGovemment determines that such licence is necessary in public interest and is inconsonance with hdia's obligations under Intemational treaties, conventions orprotocolsll

4[(28) It in the opinion of the Cenhal Govemment, the licensee fails to fulfilthe purpose for which he is issued a licence under sub-rule (2A) or the terms andconditions of the licence, the Central Govemment may, after giving the licenseea reasonable opportunity of being heard, cancel the licence.l

(3) The manufacture of medicinal hemp shall be under a licence Sxanted bythe State Govemment on pa)'rnent of such fees and in accordance with suchconditions as may be prescribed by that Govemment in this behalJ.

4[35A. Manufacture of natural manufactured drugs from poppy straw.-(1)Notwithstanding anything contained in rule 36, if the Central Govemment is ofthe ophion that it is in public interest to do so, the Narcotics Commissioner orany other officer authorised by the Central Govemrnent in this behalf may issue

a licence in Form No. 3A on such terms and conditions as may be specified inthe licence to manufacture PoPpy straw concentrate s[from poppy strawproduced from poppy cultivated under a licence issued under rule 8 of theserulesl.

Ins. by G.S.R. 95(E), dated 4th FebrlJ^ry,2004 (w,e.f, 4-2-2004\.

Added by G 5 R. 736(E), dated 22nd December, 2005 (w,e,f, 22-12-2005),

The words "from Indian opir.rm" ornitted by SO. 1561(E), dated 13th July,2010 (wef13-72010).

1ns. by S.O. 1661(E), dated 13th July, 2010 (w.e.f. 13-7-2010).

Subs. by G.S.R. 359(E), dated 5th May,2015, for "ttom poPPy shaw" (w.e f 5-5-2015)'

I.2.

3.

5.

Rule 381 The Narcotic Drugs and Psychottopic Subs| ,nca,s Rules, 1985 7'l

(2) The licensee may also manufacture morphine, codeine, thebaine'

dionine, dihydrocodeinone, dihydrocodone, ac-etyldihydrocodeine,

acetyldihydrocodeinone, dihydromorphine, dihydromorphinone,dihridrohvdroxvcodeinone, pholcodeine and their resPective salts from the

pofpy rtiu* concentrate manufactured under sub-rule (1)'

(3) ff, in the opinion of the Central Govemrnent, the licensee fails to fulfil the

purpose for whicir he is issued a licence under sub-rule (1), or the terms andiottditio* of the licence, the Central Govemment, may after giving the licensee

a reasonable oPportunity of being heard, cancel the licence.]r[37. Manufacture of synthetic manufactured drugs.-Subject to the

provisions of rule 36, the manufacture of manufacfured drugs notified underiub-clause (b) of clause (xi) of section 2 of the Act including the essential narcoticdrugs notified under clause (viiia) of section 2 of the Act (hereafter referred to as

the drug) but not including preparation containing any manufactured drug frommaterials which the maker is lawftrlly entitled to Possess is prohibited save

under and in accordance with the conditions of a licence $anted by theNarcotics Commissioner or such other officer as may be authorised by theCentral Government in this beha[ in Form No. 3 appended to these rules.

Explanatinn.-For the removal of doube it is hereby clarified that the licenceto manufacture a preparation containing any manufactured drug and includingthe preparation notified as essential narcotic drugs under clause (viiia) of section2 of the Act shall be regulated under the rules made by the State Govemmentunder section 10 of the Act.l

2[38, Application for licence.--(1) Every application for a licence or forrenewal thereof under the proviso to rule 35 or rule 35 or rule 37 shall be in suchform and manner as may be specified by the Narcotics Commissioner.

(2) A fee of rupees five thousand shall be payable to the Central Govemrnentfor each licence issued under rule 37 or for renewal thereof.

subs. by C.S.R. 359(E), dated 5th May, 2015, for lule 37 (w.e.t t12015). Earlier rule 37 wasamended by G.S.R. 95(E), dated 4th Febflrary, 2c[4 (w .e.t. 4-2-2N4); by S.O. 165@), dated 13th

July, 2010 (w.e.f. 13-7-2010) and by C.S.R. 426(E), dated 1st Jult 2014 (w.e.f. 1-7-2014). Rule37, before substitution by G.S.R. 359(E) dated 5th May, 2015, stood as under:

"37. Manufacture of synthetic taflufaclured dr!gs.-{l) Subject to the provisions of nrle 36,the manuJacture of manufactured &ugs notified undet s$b-claus€ (b) of clause (xi) ofsection 2 of the Act (hereafter referred to as the drug) but not including pleparationcontaining any manufactuted drug from materials which the E|aker i5 lawfuly entided topossess is prohibited save under and in accordance with the conditions of a [Clnce grandby the Narcotics Commiisioner or euch other officer as may be authorised by the CenkalCovemment in fhis behau, h Form No. 3 appended to thes€ rules.

(2) A fee of rupees five thousand shall be payable in advance to the Central covernmentfor e.- r licence issued under this rule for renewal thereof.".

Subs. by G.S.R. 359@), dated 5th May,2015, for.ule 38 (w.e.f. t5-2015). Earlier ru.le 38 wasamended by G.S.R. 350(E) dated 25th June, 1997 (w.e.L 27+7997) and by G.S.R. 95(E), dated4th February, 2004 (w.e.f. +2-2004). Rule 38, beiore substitution by G.s.R. 359(E) dated 5thMat 2015, stood as under:

"38. Aqlication for liaznce.-Every application for a licence or for renewal thereof underrule 36 or rule 37 or under the proviso to rule 35 shall be in such form as may be specifiedby the Narcotics Commissioner.".

72 The Narcotic Drugs and psychotropic Substances Rules, I^BS lRute 98

(3) On receipt of an application for issue or renewal of a licence under rule37, the Narcotics Comrnissioner shall issue or renew the licence in Form No. 3within thirty working days from the date of receipt of such application.

(4) In case the licence is not issued or renewed within the period specifiedin sub-rule (3), the Narcotics Comrnissioner or any other officer authorlsed byhim in this regard shall inlorm the applicant the ieasons thermf.l

1[39. Commencement of manufacture,{1) A person who has been issued alicence under rule 36 or rule 36A or rule 32 shali not commence manufacturelth9lt 9ltalning the licences required under the Drugs and Cosmetics Act, 1940(23 of 7940) for the manufacture of the drug and the i es framed under section10 of the Act_by State Government of the State in which he has his place ofbusiness, for the possessiory sale and distribution of the drug.

(2) The licencee shall send copy of the licences specified in sub-rule (1) to theNarcotics Commissioner before commencement of manufacture of the drug.

(3) In the event of revocation of licence issued under the Drugs andCosmetics Act, 1940 (23 of 1.940) for the manufacture of the drug or ttie rulesframed under section 10 of the Act by State Government of the Sitate in whichhe has his place of business, for the possessiory sale and distribution of the drug,the licence issued under rule 36 or rule gOe or ntle 37, as the case may be, shjibe deemed to be revoked.l

, 40. Manufacture only from _materials lawfu y possessed._21(l)l Thelrcensee shali not manufacture the drug save from mat6riils which he is iiwfuttyentitled to possess.

3[(2) The licencee shall not manufackure the drug without allotment of quotafor that drug under sub-rule (2) of n:Je 67E1.

1. Subs. by G.S.R. 359(E), dated 5rh May, 2015, tot rute 39 (w.e.i 5-12015). Earlier rule 39 wasamended by S.O. 166(E), dated 12th luf, 2010 (w.e.f. t3-Z-2010). Rule 39, before substitution,stood as rrnderi

"39. Conditions hr issu. o/lr'cencee.<1) No licence shall be issued under rule 3z for underthe proviso to rule 35 unless the applicant therefore has-(i) produced t9 h:,trliiq authority- licences gia.H to him under (a) the Drugs and

Cosmetics Act, 1940 (23 of 1940) for the manujacture of the drug, and (b) thi nrlesftamed under section 10 of the Act by State Govemment of the Stite in which he hashis place of bushess, for the po&session, sale and distribution of the drugs; and

(ii) made a deposit of Rs. 5,000.00 as security in the manner specified by the issuingauthority for the due observance of the conditions of the lictnce and has fumishedproof to the satisfaction of the issuing authority that he is equipped as to the land,building and other paraphernalia to properly carry on the busine'ss described in theapplication and is of good financial standing.

(2) Licence refened to in sub-rule (2A) of nde 36 and rule 364. shall be issu€d subiect tothe condition that beforc commencing of the manufactutg the licensee sha obtain thelicence6 req,uLed as per the Drugs and Cosmetica Act, 1940 (23 of 1940) Irom the authorityin-charge of drug conhol in the State and the licence i66ued by the State Govemment undersection 10 of the Act, or any other licence required under any other law for the time beingin force.".

2. Rule 40 re-numbered as sub-rule (1) thereof by G.S.R. 359(E), dad 5th May, 2015 (w.e.l15.20ls).

3. Ins. by G.S.R. 359(E), dated 5th Mar 2015 (w.e.f. tt2015).

Rufe 45Al The Narcotic Drugs and Psychotropic Subsi€,nc€s Rulos, 1985 73

41. Limits of manufacture.-The issuing authority, while issuing the licence,

shall take into account all relevant factors for permitting the quantity of the drugto be manufactured by a licensee including the following:-

(a) quantity allotted by the State Govenunent for processing into anypreparation in licensee's own manufacture;

(b) quantity required for suPPly to other firms within or outside the

counfry;(c) quantity required for reasonable inventor)':

Provided that the total quantity of the drug manufactured during any one

year does not exceed the estimated requirements of this country for the relevantyear as furnished to the Intemational Narcotics Control Board.

42. Security arrangements.-The licensee shall ensure all necessary securityarrantements in the manufacturing premises as may be specified by the issuingauthority.

1[43, Advance notice for cessation and recommencement of manufacture'-(1) The licencee shall give at least one month's notice in writing to the issuingauthority before he ceases to manufacture the drug for any reasons whatsoever:

2[Provided that the notice referred to in this sub-rule shall not apply in case

the cessation of manufacture is on account of unforeseen circumstances beyondthe control of the licencee.l

(2) The licencee shall give at least fifteen days notice in writing to the issuingauthority prior to the date of recommencement of manufacfure of the drug aftercessation of manufacture of the drug as mentioned at sub-ruIe (1).1

45. Possession, sale and diskibution.-The licensee shall not possess or sellor distribute the drug otherwise than in accordance with the rules made by theState Govemrnent under the Act.

3[45A. Destruction of drugs,-(l) A licencee seeking to destroy the drugshall apply to the Narcotics Comrnissioner in such form and marurer as may bespecified by the Narcotics Commissioner.

(2) The Narcotics Commissioner shall, within a period of thirty days from thedate of receipt of an application under sub-rule (1), appoint a committeecomprising a Gazetted Officer in the office of the Narcotics Commissioner, or

2.

Subs. by G.S.R. 359(E), dated sth May, 2015, for rule 43 and rule tl4 (w.e.f. 5-5-2015). Rule 43and rule ,14, before substrfutro& rtood as mder:

"43, Adoance notice hr cotnmencefient and ccss^tion of rn4nufacture.--fr€ licensee shall giveat least 15 days' notice in witing to the issuing authority of the date on which he proposesto comrnence manufacture of the drug and at least one month's notice before he ceases tomanufacture the same.

44. Czssation of manufacllre.-Wherc the lic€nsee ceases manufactu.ring opeEtions fo! anyreasons whatsoever, he 6ha[ forthwith inlorm the issuing authority in thi6 behaff indicatingthe date on which he prcpo6es to recomanence dunufacture:

Provided that the issuing authority may prohibit all futther manufacture in case the p€riod ofcessation of manufacture exceedt 30 daJr6.",

Ins. by G.S.R. 500(E), dated 17th June, 2015 (w.e.f, 17+2015).Ins. by G-S.R. 359(E), dated 5th Ma, 2015 (w.e.f. tt2015).

74 The Narcotic Drugs and psychotroptic Substances Butes, lgg, lRule 4SA

Narcotics Control Bureau constituted ulde notification number S.O. 96(E), datedthe. 17th March, 1986, Superintendent of Central Excise of the concemed rangeand. an authorised representative of the applicant for supervising the deskuctiJnof the drug and such destruction shall be carried out within a-period of thirtvdays from the appointment of the committee

(3) The destruction of the drug shall be carried out in accordance with theprovision of the relevant laws for the time being in force.l

45. Maintenance of accounts and submission of retums.-The licensee shallmaintain true accounts of all transactions including the accounts of materialsused for the manufacture of the drug the quantities manufactured, sold orotherwise disposed of and fumish returns in such forms and in such manner asmay be specified by the Narcotics Comrnissioner.

47,. Inspection of stocks, etc.{l) The stocks of the drug and the materialsused for its manufacture and all accounts and records of transactions relatinethereto., shall be open to inspection by any officer authorised by the issuin[authority.

(2) A serially numbered lnspection Book shall be maintained by the licenseein good condition for the use of such officer.

48. SuEpension and revocation of licence.-(l) Without prejudice to anvaction that may be taken under the provisions of the Act, the issuing authoritymay suspend or cancel a licence-

(i) if the licence is transferred or sublet without the prior approval ofthe issuing authority; or

(ii) in the event of any breach of any conditions of the licence; or(iii) if the licensee is convicted for any offence under the Act or under

any other law relating to the narcotic drugs for the time being inforce in any State.

(2) No order shall be passed under sub-ruIe (1) unless the liceruee has beengiven a reasonable opportunity showing cause against the said order or is heardin persory if he so desires.

49. Appeal.-(l) The licensee may file an appeal against the decision or ordermade or passed under rule 48 ta-

(i) the Narcotics Commissioner where such decision or order was madeor passed by any officer subordinate to him; and

(ii) the r[Secretarp Govemrnent of India, Ministry of Finance,Department of Revenue or any other officer, not below the rank ofAdditional Selretary to the Govemment of India, authorised by himin this behaUl, in any other case,

within 30 days from the date of communication to him to such decision or order.(2) Every memorandum of appeal shall be accompanied by a copy of the

decision or order appealed against.(3) Every appeal under this rule shall be filed in such form and in such

manner as may be specified by the r[Central Govemment].

1. Subs. by S.O. 739(E), dated llth April,201l, for "Board" (w.e.( 174-2011I

Rufe 52Al The Narcotic Drugs and Psychotropic Substances Rules' 1985 75

50. Procedure for appeal'--(l) The Appellate -Authority shall give an

opportunity to the apPellant to be heard in person, it he so desues'

(2) The Appellate Authority may, at the hearing.of.an aPPeal allow the

appeliant to gJ ittto utty ground of appeal not specified in the grounds of appeal'

ii'tft" npp"fT"," nuth6r'iry is satisfied that omission of that ground from the

groutrds-of appeal was not wilful or unreasonable'

(3) The Appellate Authority may, after making such further inquiry as may

U. r',"""""".y, iru"s such orders is it tfiink fit, confirming, modifying or annulling

the decision or order appealed agahst.

(4) The order of the Appellate Authority disposing of the appeal under this

rule'shall be in writing u.td shull state the points for determinatiory the decision

thereon and the reasons for the decision.

51. Surrender o{ licence'-A licensee may, if he so desires, surrender his

licence, by giving not less than 15 days'notice in writing to the issuing authority'

52. Disposal of stocks of drugs on cancellation of licence, etc'-Such stocks

or drugs as- may be in the possession of a licensee, on the expiry or cancellation

or suriender oi hi. licet "i, shall be disposed of in such manner as may be

specified by the Narcotics Commissioner in this behalf.

1TCHAPTER VA

POSSESSION, TRANSPORT, IMPORT INTER-STATE, EXPORT

INTER-STATE, SALE, PURCHASE CONSUMPTION ANDUSE OF ESSENTIAL NARCOTIC DRUGS

52A. Possession of essential nalcotic drug.-(l) No person shall possess anyessential narcotic drug otherwise than in accordance with the provisions of these

rules.

(2) Any person may possess an essential narcotic drug in such quantity ashas been at one time sold or dispensed for his use in accordance with theprovisions of these rules.

(3) A registered medical practitioner may possess essential narcotic drug, foruse in his practice but not for sale or distribution, not more th2n thg qttantity

mentioned in the Table below, namely:-

1. Chaptei VA (containing rule 52A to ru.le 52M) inserted by G.S.R. 359(E), dated 5th May, 2015(w.e.t 5-5-2015).

76 The Narcotic Drugs and psydotropic gubstances Rules, ,9g5 lRule 52A

TABLESl. No.

(1)

Name of the essential Narcotic Drug Quantity(2) (3)

1. Morphine and its salts and all preparations containingmore than 0.2 per cent. of Morphine 500 Milligrammes

J.

2. Methyl morphine (commonly known as ,Codeine,) and!,thyl morphine and their salts (including Donine), allollunons and preparations except those which arecompounded with one or more-other hgredienS andcontaining not more than 100 milligrammes of the drugper dosage unit and with a conceniation of not more "than 2.5% in undivided preparations and whichhave been established in- therapeutic practice

2000 Milligrammes

Oi\f!px1 Codeinone (comrnonly known as O,<y-oaonuand Dihydroxycodeinone), its sa[ts lsuch as Euc;dalBoncodal Dnarcon Hydrolaudin, Nucodan, percodan,Scophedal, Tebodol and the like), its esters and the saltsof its ester and preparation, admixture, extracts orother substances containing any of these drugs

250 Milligrammes

Dhydrocodeinone (commonly known as Hydrocodone),ils salts (such as Dicodide, Cbdinovo, Dconone.Hycodan, Multacodin, Nyodide, ydroced and the lile)and its esters and salls of its ester, and preparation,admixture, extracts or other substances iontalnlng anyof these drugs

320 Milligrammes

1-phenethyl-4-N - propionylanilino-piperidine (theintemational-non-proprietary name of which isFentanyl) and its salts and preparationg admixture,extracts or other substances containing any of thesedrugs

Two transdermalpatches one each of12.5 microgram perhour and 25microgram per hour:

Provided that the Controller of Drugs or any other officer authorised in thisbehalf by him may by special order authorise, G Form 38, any such practitionerto possess the aforesaid drugs in quantity larger than as spe;ified in the aboveTable:

Provided further that such authorisation may be gnnted or renewed, for aperiod not exceeding three years at a time.

-. Explanation. --:fhe expression "for use in his practice,, covers only the actualdirect administration of the drugs to a patient under the care of the regisieredmedical practitioner in accordance with established medical standar-ds andPrac ces.

(4) For renewal of the authorisation referred to in the second proviso to sub-rule (3)_ application shall be made to the Controller of Drugs atliast thirty daysbefore the expiry of the previous authorisation.

(5) (a) The Controller of Drugs may, by order, prohibit any registeredmedical practitioner from possessing for use in his practice under sub-rule (3)any essential narcotic drug, where such practitioner-

Bule 52Bl The Narcotic Drugs and PsyclntroPic Substanc€s Bules, 1985 77

(i) has violated any provision of these rules; or(ii) has been convicted of any offence under the Act; or

(iii) has, in the opinion of the Controller of Drugs, abused suchpossession or otherwise been rendered unfit to Possess such drug'

(b) When any order is passed under clause (a) of this sub-rule, the registered

rnedical practitioner concemed shall forthwith deliver to the Controller of Drugsthe essential narcotic drug then in his Possession and the Controller of Drugsshall issue orders for the disposal of such drugs.

(5) The Controller of Drugs may, by a genetal or special order, authorise anyperson to possess essential narcotic drug as may be specified in that order.

(7) A recognised medical institution may Possess essential narcotic drug insuch quantity and in such manner as specified in these rules.

1[(8) A manufacturer may poss€ss essential narcotic drug in such quantity as

mav be specified in the licence issued under rule 36, rule 35A, or rule 37 of theserules or

-the licence issued for manufachrring the preparations of essential

narcotic drugs under the rules made by the State Govemment under section 10

of the Act:Provided that there shall be no limit to the possession of essential rurcotic

drug by the Govemment Opium Factories.I

(9) A licenced dealer or a licenced chemist may possess essential narcoticdrug in such quantity, and in such manner as may be specified in the licenceissued under these rules.

528. Provisions regarding licenced dealer and licenced chemist.-(l) Alicenced dealer or a licenced chemist shall apply for a licence to possess, sell,exhibit or offer for sale or distribution by retail or wholesale, essential narcoticdrug to the authority competent to issue licence to Possess, sell, exhibit or offerfor sale or distribution by retail or wholesale, manufactured drugs under therules framed under section 10 of the Act by State Govemrnent of the State inwhich he has his place of business.

(2) Every application for issue of licence refened to in sub'rule (1) shall bein such form and manner as may be specified by the authority referred to in thesaid sub-rule.

(3) The licence to possess, sell, exhibit or offer for sale or distribution by retailor wholesale, essential narcotic drugs shall have the same conditions as areapplicable to a licence to possess, sell, exhibit or offer for sale or distribution byretail or wholesale, manufacfured drugs under the rules framed under section 10

of the Act by the State Govemment.(4) The licence under this rule shall be obtained within a period of one

hundred and eighty days from the date of commencement of these rules.

1. Subs. by G.S.R. 500(E), dated 17th June, 2015, for sub-rde (8) (w.e.f. 1762015). Sub-ru]e (8),before substitution stood as under

"(8) A dunufacture! may po*ses6 essential narcotic durg in such quantity as may besDecified in the licence issued under rule 37 of these ru.les.".

78 The Narcotic Drugs and Psychotropic Substances Rutes, t98O [Rute 52C

52C. Import Inter-State and Export Inter-State of essential narcoticdryg ,-Any person who is permitted to possess essential narcotic drug underrule 52A may import inter-State or export inter-State such drug upto the quantityhe is permitted to possess.

52D, Transpod of essential narcotic drugs,-{l) Subiect to the provisions ofrule 52C, no consignment of essential narcotic drugs shall be transported,imported inter-State or exported inter-State unless such consignment isaccompanied by a consignment note in Form No. 3C and in the manner asprovided in sub-rules (2) and (3).

(2) The consignment note referred to in sub-rule (1) shall be prepared intriplicate, and the original and duplicate copies of the said note shall be sentalong with the consignment of essential narcotic drugs to the consignee whoshall retum the duplicate copy of the note to the consignor for his use aftererrdorsing on the original and duplicate copies, the particulars of the receipt ofthe quantity consigned.

(3) The consignor and coruignee shall preserve such consignment notereferred to in sub-rule (1) for a period of two years:

Provided that the said consignrnent note shall not apply in cases where thesale of the essential narcotic drug is accompanied by a sale liill or lnvoice or cashmemo or any other document duly signed by the consignor or his authorisedsignatory, which shall include the following information about theconsignment:-

(a) name, address and licence number of the consimor and theconsignee;

(b) description, batch number and quantity;(c) mode and particulars of transport:

Provided further that such documents shall be preserved by the consignorand consignee for a period of two years.

Explanation.-Where the consignee is a person to whom the essential narcoticdrug has been sold or dispensed for his personal use, research institutio&registered medical practitioner, recognised medical institutiory or hospitat, therequirement of incorporating licence number of the consignee shall not beapplicable.

52E. Transmission of essential narcotic drugs by post, courier, rail orroad,-The transmission of essential narcotic drugs by inland post or courier orby rail or by road by a manufacturer, licensed dealer or licensed chemist ispermitted, subject to the following conditions, namely:-

(i) the parcel of the essential narcotic drugs when sent by post shall besent by registered posq

(ii) the parcel of essential narcotic drugs shall be accompanied by adeclaration showing the names of consignor and consignee, thecontents of the parcel in detail, the number of licence orauthorisation or recognition held by the consignee;

Fule 52Gl The Narcotic Drugs and Psychotropic Substances Rutes, lgBS 79

(iii) the consignee shall show distinctly in his account books, if he is alicencee, the name of the consignee and the consignor respectively,and the quantity of the essential narcotic drug imported inter-State,exported inter-State or transported by and to him, as the case maybe, from time to time, by post or by courier or by road or by rail.

52F. Sale.-l[(l) A manufacturer or licenced dealer shall sell essentialnarcotic drugs otherwise than on prescription to-

(a) a manufacturer who has been issued a licence under rule 3Z of theserules or a manufacture of preparations of essential narcotic drugswho has been issued a licence under the rules made bv the StareGovemment under section 10 of the Act;

(b) a licenced dealer;(c) a licenced chemist;(d) a registered medical practitioner;(e) a person who has been authorised by the Controller of Drugs under

these rules; or(f) a recognized medical institution.l

(2) A licenced chemist shall sell essential narcotic drug only on prescnptronand subiect to the provisions of the Drug and Cosmehcs"Rutei, fS4S.

. (3) A recognised medical institution shall dispense or sell essential narcoticdrugs in such manner as specified in these rules.

52G. Registered medical practitioner and conditions relating to theirprescriptions.-No prescription_for the supply of essential narcotic ;rugs shall?e g]v_gn by a registered medical practitioner otherwise than in accordanie withthe lollowtng conditions, namely:_

(i) the prescription shall._be in writin& dated and signed bv thepractitioner with his full name, address and registration number andshall specify the name and address of the -person to whom theprescription is given and the total quantity of the essential narcoticdrug to.be supplied alongwith- daily dose and period ofconsumPtron:

Provided that where such drut to be supplied on the prescriptionls a patent or proprietary medicine, it shall be sufficient to state thequantity and strength of the medicine to be supplied;

L Subs. by G.S.R..500(E), dated 17rh June, 2015, for sub-nrle (1) (w.e.f, tZ_6-2015). Sub_nrle (1),betore substitution stood as under:

"52F. Sale.<1) A manufacturer or licenced dealer shall s€ll ess€ntial narcotic dflrgsotherwise than on prescription tcl"-(a) a licenced dealer;(b) a licenced chernist;(c) a registered medical practifoner;(d) a person who has been authorised by the Cont oller of Drugs undcr these rules; or(e) a recognized medical institution.".

80 The Narcotic Drugs and Psychotropic Sub€tances Bules' 1985 [Ruls 52G

(ii) the prescription shall not be given for the use of the prescriber

himself'

52H. Authorisation and accounts.{l) The Controller of Drugs may by a

general or special order authorise:

(a) any person in-charge of an educationa-l instihtion or engaged- -in' '

sci'entlfic research t6 possess and use, for educational or scientific

purPoses only, essential narcotic dru& in such quantity and in such

^a.,tt"t * may be specified in the said order;

(b) a pilot of an aircraft or captain of a ship to possess and use' on the' ' aiicraft or ship, as the case may be, in any emergency' essential

narcotic drui in such quantity'and in suih marurer as may be

specified in the said order;(c) a person in-charge of an ambulance or a fust-aid station or a first-aid'-' bJx to porr"tt uid use. in an emergency, essential narcotic drug in

sucf, qrlantity and in such manner-as may be specified in the said

oroer'(2) Every registered medical practitioner, and a person authorised by general

- rJ*i"i .la"tl"der this rule ihall maintain day io day accounts in resPect -of;il ii;;:ffi taessential narcotic drug in ForrnNo 3D and the records of the

a"iiy *".t"s shall be preserved for a ininirnum period of two years from the

date of last entry.(3) Everv reeistered medical practitioner shall also maintain a seParate

.u.oJ i" f"tt" N"o. ge fo. each patient and such record shall be preserved for a

minimum period of two years from the date of last entry'

52-I. Suspension and cancellation of authorisation'-(1) Without pre)udice

to a.,v actiori that may be taken under the provisions of the Act' the Controller

; i;{; ;;";i;. thJ reasons to be recordid in $/ritin& cancel or suspend the

authoriation under rules 52A or 52H,-(a) if the purpose for which the authorisation was granted ceases to

exisu or(b) in the event of any breach, by the.holder of such authorisation or by

his servant or by any on6 acting with his express .or implied

permission on his-behajf, of any of the terms and (onditions ol such

authorisation or of any authorisaiion previously held by him'

(2) No order shall be passed under sub-rule (1) unless the authorised person

tru, i""n eirr"., u .ea.o.,abl" opportunity of showing cause against the said order

or is hear-d in person, if he so desires'

52J. Appeal.-(l) Appeal against a decision-or order made or passed. under

.rrt. si-l .iv Ue fitea 6v *te p"erson against whom such decision or order has

;;";;i;;;;; ; tr'. s".."turyio the state cove-mment r^esponsible for

i-pi"t .""tutiotl of the Drugs and C6smetic Rules' 1945 in the State within a

;iff;;tlt d"y, f.o- tfi" date of communication of such decision or order

io him.(2) Every memorandum of appeal shall be accompanied by a copy of the

decision or order appealed against'

Rule 52Nl me Narcotic Drugs and Psychotropic Substances Rules, 1985 81

52K. Procedure for appeal.-(l) The Appellate Authority referred to in sub-rule (1) of rule 52J shall give an opportunity to the appellant to be heard inperson, if he so desires.

(2) The said Appellate Authority may, at the hearing of an appeal allow theappellant to raise any other ground not specified in the appeal, if the AppellateAuthority is satisfied that omission of that ground was not willful orunreasonable.

(3) The aforesaid Appellate Authority mav, after making such furtherinquiry as may be necessary pass such order as it thinks fit, confirming,modifying or annulling the decision or order appealed against.

(4) The order of the Appellate Authority disposing of the appeal under thisrule shall be in writing and shall state the points of determinatiory the decisionthereon and the reasons for the decision.

52L. Surender of authorisatiorv etc.-An authorised person, if he so desires,surrender his authorisation by giving not less than fifteen days notice in writingto Ure lssumg authority.

52M. Disposal of stocks of essential narcotic drugs on expiry, surender,cancellation of authorisation, €tc.-(l) Such stocks of ejsential narcotic drugs asmay be in- the possession of an authorised persory on the expiry or cancelitionor surrender of his authorisation, shall be disposed of in such malner as may bespecified by the Controller of Drugs in this behalf.

_ (2) The expired stock of essential narcotic drugs as may be in the possessionof an authorised person or a registered medical prictitionei shall be ddstroyed insuch manner as may be specified by the Controller of Drugs.l

IICHAPTER VB

SPECIAL PROVISIONS RELATING TORECOGNISED MEDICAL INSTITUTION

52N. Government, etc. hospital, dispensary to be deemed recognisedmedical institution.--Govemment or Municipil Corporation or MuiicipalCouncil or Zilla Parishad hospital, dispensary or medical^institution, with at leistone registered medical practitioner possessing a minimum qualification of adetr. ee.in rnedicine.or dentistry and who has undergone training in pain reliefand.palliative care for.prescription of essential narcodc drugs for"pain'relief andpa ia.tiv5 care

.or - training h opioid substitution therap/ for prescription of

essential narcotic drugs for treatment of opioid dependenci, who'shall prescribeand drspense essential narcotic drugs, shall be deemed to be a recognisedmedical instihrtion under these ruleJ for possessing, dispensing or se lng ofessential narcotic drugs for medical purpose.

_ Explanation.-For the removal of doubts it is hereby clarified thatCovemment or Municipal Corporation or Municipal Council 6r Z la parlshadhospital, dispensary and medical _institution, shallbe exempt only from makingapplication to the Controller of Drugs for recogrrition aj recognised medicai

t S"frE,X{;",f""lXq$;!;* " -" uzz and rure 52zA) in-s€rted by c.s.R.35e(E) dared

82 The Narcotic Drugs and Psychotropic Substances Rules, 1985 lRule 52N

institution, but all other provisions of this Chapter shall be equally applicable to

such deemed recognised medical institution as are applicable to other recognised

medical inshtution.52-O. Recognition of medical institutions.-(1) A medical institution

seeking, to be a recogrrised medical institution or renewal of such recognition,

underlhese rules for possessing, dispenshg or selling essential narcotic drugsfor medical purposes ihall apply in Form No. 3F to the Conholler of Drugs

(2) The Controller of Drugs, on receipt of application referred to in sub-rule(l) may, subiect to any inquky which may be necessary, issue a Certificate ofRccoe;ifion in l-orm No. 3i and such certificate shall be issued within sixty days

from-the date of receipt of such application.

(3) In case the Certificate of Recognition is not issued wiihin the period

meniicned in sub-rule (2), the Controller of Drugs or any other officer authorisedby him in this regard shall inform the applicant the reasons thereof

(,1) The Certilicate of Recognition shall be issued for a period not exceeding

three years at a tine.(5) For renerval of the recognition referred to in sub-rule (1), application shall

be made to the Controller oi Drugs at least sixty days before the expiry ofprevious recognition.

(6) The Certificate of Recognition shall be obtained within a period of one

hundred and eighty days from the date of commencement of these rules'

(7) tn the event of a change in the constitution of a recognised medical

instiiutlon, the current recognitilon shall be deemed to be valid for a maximum

pcriod of ninetv days from the date on which the change takes place'

52P. Suspension and Cancellation of recognition'-(1) Without preiudice to

anv action that may be taken under the provisions of dre Act, for the reasons to

be'recorded in wiiting, the Controller-of Drugs may susPend or cancel the

recognition referred to in rule 52-O,-(i) if the essential narcotic drugs obtained by a recognised medical

institution were supplied for non-medical use; or

(ii) in the event of any breach of the conditions of the recognition; or

(iii) in the event of violation of any of the provisions of the Act or rules

and orders made thereunder.

(2) No order shall be passed under sub-rule (1) unless the recognised medical

instiiution has been given a reasonable opPortunity of showing cause against the

said orders or is heard in person, if he so desires.

52Q. Designated medical practitioner.-(1) Every recogn'ised medical

institution shali"designate one orhore registered medical practitioner who has

,]na".*o.t" training i"n pain relief and palliative care for prescription of essential

nur.otY. drug, for!ain'relief and palliitive care or training in oPioid substitution

theraDv for presciiption of essential narcoric drugs for treatment of opioid

J*"ni"n.", who shall prescribe and dispense essential narcotic drugs'

(2) When more than one registered medical practitioner is designated' one of

them shall be designated as over-all in charge'

Rufe 52Tl The Narcotic Dtugs and Psychotropic Suhstances Rules, 1985 83

(3) The name of the designated medicaf practitioner or the over-all in charge,as the case may be, shall be endorsed on the Certificate of Recognition issuedunder rule 52-O by the Controller of Drugs.

(4) Whenever there is a change in the designated medical practitioner or theover-all in charge, as the case may be, the recognised medical institution shallinform the Controller of Drugs within seven days from date of such change forappropriate endorsement on the Certificate of Recognition.

52R. Duties of designated medical practitioner.-(1) The designatedmedical practitioner or the over-all in charge, as the case may be, shall,-

(a) register the patients to whom essential narcoticdispensed or sold for medical use only;

(b) maintain separate record in Form No. 3E for each

drugs shall be

patient, whichshall be preserved for a minimum period of two years from the dateof last entry;

(c) maintain record of all receipts and disbursements of essentialnarcotic drugs in Form No. 3H, which shall be preserved for aminimum period of two years from the date of lasi entry; and

(d) file retum for a calendar year on or before the 31st of March of thesubsequent year in Form No. 3-I to the Conholler of Drugs.

(2) In the event of any change in the constitution of the recognised medicalinstitution, the_ designated medical practitioner or the over-all in-charge, as thecase may be, shall inform the Controller of Drugs in wrifing rvithin thlrty daysfrom the date of such change for issue of fresh llertificate 6f Recognitioi.

52S. Surrender of recognition.-(l) A recognised medical institution maysurrender its recognition by giving not less than thirty days, notice in writing tothe Controller of l)russ. ' -

_ (2) On surrender J the recognitiory the essential narcotic drugs as may be inthe possession of the recognised medical institution shall be disposed of in suchmanner,_ incl rrling transfer to another recognised medical institution, as may bespecified by the Controller of Drugs.

_ -52T. Estimates of requirement.-(1) Every recognised medical irstitutionshall submit an estimate of its annual requirement of lssential narcotic drugs inlorm !o 3J by the 30th November o? the preceding calendar year to" theController of Drues.

(2) If the requirement of a recognised medical institution exceeds the aturualestimate submitted to the Controller of Drugs, it shall submit a revised estimateby the 31st August of the calendar year io which the said annual estimatepertains, to the Controller of Drugs.

Explanation.-For the removal of doubts it is hereby clarified that arecognised rnedical institution may sell and disburse esseniial narcotic drugsover and above the quantity indicaGd in the estimate submiited to the Controlliror Lrru.gs as specified in this rule, but the designated medical practitioner or theover-all in_charge, as the case may be, shall r6cord a brief justification for suchincrease while filing retum in Form No. 3{.

The Narcotic Orugs and Psychotropic Substmces Rules, t985 [Rule 52U

52U. Possession of essential narcotic drug by recogrrised medical

institution.-A recognised medical institution shall possess essential narcotic

drugs in quanuties not exceeding the quantities mentioned in the estimate or

reviled esiimate, as the case may be, of the arrrual requirement of such drugsubmitted to the Controller of Drugs under rule 52T'

52V. Miscellaneous'{1) The expired stock of essential narcotic drugs s-hall

be destroyed by the recognised medical institution in the presence of an officer

nominated by the Controller of Drugs.(2) The unused essential narcotic drugs retumed by the patimts shall be

considered as receiPts by the recogrised medical irstitution'(3) Essential narcotic drugs shall not be transferred, loaned or sold by the

recognised medical irutitution to other institutions without the prior approval of

the Controller of Drugs.

52W. Home care treatment'-{1) Notwithstanding anything contained inthese rules, where home care treatrrent is provided to a Patient registered witha recognised medical institution by deputing .qualified personnel of such

,e.os,i"d medical institution tc the'homa or residence or place of stay, either

oerrianent or temporary, of such patient, the designated medical practitioner orihe over-all h chaige, ai the case may be, shall, authorise such personnel to carry

such quantity of eisential narcotic drugs as may be required for treatment of

such patient:

Provided that home care treaunent shall not be provided for treatment ofopioid dependence.

(2) The designated medical Practitioner or the over-all in charge shall

maintiin proper iecord of such isiue and also of the unused essential narcotic

drugs reciived from such personnel after comPletion of visit to the patient'

52X. Maintenance of records.-All records generated under this Chapter

shall be kept for a period of two years from the date of last entry'

52Y. lnspection of stocks.-The stocks of essential narcotic drugs under the

custodv of a recogrised medical institution shall be open for inspection by the

iont.oil". of Druls or any other officer authorised by him in this regard'

522, Appeal.-(l) A recognised medical instirution aggrieved by any

decision or'oirder passed by th6 Controuer of Drugs under, this Chapter may

i"o""f t. the Secre'tary to tlie State Govemment responsible for implementation

;i b;; and Cosmetic Rules, 1945 within a period of sixty days from the date

of comirunication to him of such decision or order'

(2) Every memorandum of appeal shall be accomPanied by a copy of the

decision or order appealed against.

522A. Pmcedure for appeal.-(l) The APpellate Authority referred to in

sub-rule (1) of rule 522 shall give an oPPortunity to the aPPellant to be nearo rn

person, if he so desires.

(2) The Appellate Authority referred to in sub'rule (1) of rule 522 may' at-the

hearinq of at'jppeal allow the appellant to raise any other ground not specified

i|-[;;;;, ii ih; Appellate Arithoritv is sabsfied ihat omission of that ground

from the'appeal was hbt willful or trnreasonable'

Rule 541 The Narcotic Drugs and Psychotropic Substancas Rules, 1985 85

(3) The Appellate Authority referred to in sutsrule (1) of rule 522 may,.after

makins such iirther inquiry asmay be necessary, pass such order as it thinks fit'confiniing modilying br irurulling the decision or order appealed against'

(4) The order of the Appellate Authority disposing of the appeal under this

rule'shall be in writing aniihall state the Points for determinatioo the decision

thereon and the reasons for the decision.l

CHAPTER VIIMPORT. EXPORT AND TRANSHIPMENT OF NARCOTIC

DRUGS AND PSYCHOTROPIC SUBSTANCES1[53. General prohibition.-ImPort into and export out of India of the

narcotic drugs and psychotroPic substances is prohibited excePt with an imPortcertificate oi expori airthorization issued under the provision of this Chapter;

Provided that import into India or exPort out of India of the narcotic dru8sand psychotropic substances specified in Schedule I of these rules shall be for thepurpose mentioned in Chapter VIIA.I

,1..,.-l

54. Import of opium, etc.-The import of-(i) opium, concentrate of poppy straw, and

(ii) morphine, codeine, thebaine, and thet salts is prohibited save by theGovemment Opium Factory:

3[Provided that nothing in this rule shall apply to imPort of morphine,codeine, thebaine and their salts by manufacturers notified by the Govemment,

Subs. by G.S.R. 224(E), dated 25th March, 2015, for rule 53 (w.e.f. 2t+2015). Earlief rule 53 wasamended by G-S.R. 350(E), dated 25th Jttrg, 1997 (w.e.t.2741997\. Rule 53, beforesubstifutio[ stood as under:

"5j, Geaenl prohibitior.-Subiect to the other provisions of this Chapter, the impoit intoand export out of India of the narcotic drugs and psychotropic substances specfied inSchedule I is prohibited:

Provided that nothing in this rule shal apply in case the drug substance is imPorted intoor exported out of India subject to an import cedificate or export authorisation jssued underthe provision of this Chapter and for the purpos€ mentioned in Chapter \'IIA,"

Rule 53A omifted by G.S.R, 224(E), dated 25lh March, 2015 (w.e.f. 25-92015). Earlier rule 53Awas ins€rted by s.O. 599(E), dated 10th Au8ust, 1993 (w.e.t 10+1993) and amended byG.s.R. 556(E), dat,ed l4th Jul'', 195 (w.e.f. 2U7-1995). Rde 53A, before omi6sion, stood asunder:

"534. (1) Subject to the provisions of suhrule (2), no person shall exPort any of thenarcotic drug or psychotropic substance or preparation containitrg any of such rurcotic drugor psychotropic substance specified in [Schedule ] lo the cormtries or to t]le region of suchcountry sp€cified thereirL

(2) Notwithstanding anything contained in sub-ru.le (1) above, the NarcoucsComrnissioner rnay authoris€ export of 6pecified quantities of such narcotic drug orpsychohopic substance or preparation containing such narcotic dtug or psychotropicsubstance on the basi6 of $pecial import licence issued by the Competent Authority oI thecountry mentioned in Schedu.b n which intends such import by way of issuance of specialimport licence. The shipment of the consignment so allow€d shall be accompanied by acopy of such special import licence du.ly endorsed by the Narcotics Commissioner."

In6. by S.O. 1661(8, dated 13th Iult 2010 (w.e.f. 13-7-2010).

86 The Narcotic Drugs and Psychotropic Substances Rules, 1985 lRule 54

for use in manufacture of products to be exported or to imports of smallquantities of morphine, codeine and thebaine and their salts not exceeding a totalof 1 kilogram l[during a calendar year for analytical purposes by an im-porter],after following the procedure under rule 55 and subject to such conditions asmay be specified in the import certificate issued in Form No. 4A.l

55. Application for import certi ficate.-2[( I ) Subject to rule 53, no narcoticdrug, or psychotropic substance 3[..*] shall be imported into India without animport certificate in respect of the consignment issued by the issuing authority,in Form No. 4 {[or Form No. 4A, as the case may be] appended to these rules.l

(2) The importer applying for an import certificate under sub-rule (1) inrelation to narcotic drug shall submit along with his application the original orcertified copy of the excise permit issued by the concemed State Government.

s[(3) Every application for an import certificate shall be in such form alidmanner and provide such details as may be specified by the NarcoticCommissioner.]

6[(4) A fee of rupees one thousand shall be paid to the Central Govemmentalongwith ihe appliiation under sub-rule (1.1 foi issue of each import certificateunder this rule.l

56. Issue of import certificate.-7[(1) The Narcotics Commissioner shall issueor deny the import certificate referred to in sub-rule (1) of rule 55 within a periodof twenty one working days from the date of receipt of an application completedin all respects and in case the import certificate is not issued within the stipulatedtime period or denied, the Narcotics Commissioner or any other officerauthorised by him in this regard shall inform the applicant the reasons thereof.l

6[(1,4.)] -The issuing authority shall prepare seven copies of the import

certificate v1***1 and deal with them in the manner hereunder provided,namely:-

1.

2.

3.

4.

5.

Subs. by C.S.R. 470(E), dated 21st June, 2011, for "during a financial year for analyticalpurposes by any impoiter notified by the Govemment" (u'.e.I. 21-6-2011).

Subs. by G.S.R. 556(E), dated 14th July, 1995 (w.e.f. 20-7-1995).

The words "specified in the Schedtrle oI the Act" omitted by G.S.R. 224(E), dated 25th March,2015 (w.e.f. 25-3-2015).

lns. by S.O. 1661(E), dated r3th July, 2010 (w.e.f. 13-7-2010).

Subs. by G.S.R. 224(E), dated 25th March,2015, for sub-rute (3) (w.e.f. 25-3-2015). Sub-rule (3),

before substitution stood as under:"(3) The application for the import certificate shall state such detaiLs as may be specified bythe Narcotics Commissioner."

Subs. by C.S.R. 224(E), dated 25th March, 2015, for sub-rr:le (4) (w.e.f. 25-3-2015). Earlier sub-rule (4) was inserted by S.O. 1661(E), dated 13th July,2010 (w..e.f. 13-7-2010). Sub-rule (4),

bcfore substifution stooid as under:"(4) No import certificate shall be issued unless a fee of rupees one thousand has beenpaid."

7. Ins. by C.S.R. 224(E), dated 25th March,2015 (w.€.f. 2s-3-201s).

8. Sub-rule (1) re-numbered as sub-tule (1A) tlerof by G.S.R. 224(E), dated 25th March, 2015(w.e-f. 25-3-2015).

9. The words "referred to in sub-rule (1) of rule 55" omitted by G.S.R. 224(E), dated 25th March.2015 (w.e.t 25-3-2015).

Rule 561 The Narcotic Drugs and Psychotropic Substances Rules, 1985 87

(a) (i) original and duplicate coPies should be supplied to the importerwho should hansmit the original copy to the exporting countryand shall produce the duplicate copy at the Customs House,Land Customs Station or Airport where the consignment anivesor, in the case of imports by parcel Post, at the post office ofdelivery, in order to obtain delivery of the consignment ofnarcotic drugs or psychotropic substances;

(ii) the l[Commissioner of Customs] or Post Master shall state on thecopy presented by the irnporter that the narcotic drugs or thepsychotropic substances have actually been imported and retumthe document to the importer who shall indicate on it that he hasreceived the goods;

(iii) the importer shall retum the duplicate copy of the importcertificate incorporating the endorsement from thel[Commissioner of Customs] or Post Master and his ownendorsement to the issuing authority-(1) where the importcertificate relates to narcotic drug, through the excise authoritiesof the State from which excise permit for purposes of sub-rule (2)of rule 55 was produced; (2) where the irnport certificate relatesto psychotropic substance, tfuough the Drugs Controller of theconcemed State;

(b) triplicate copy should be supplied to the l[Commissioner ofCustoms] concemed who shall retum it to the issuing authorityalong with the copy of the export authorisation to be received at thetime of receipt of the consignment from the Govemment of theexporting country, with an endorsement as to actual quantity ofnarcotic drugs or psychotropic substances cleared;

(c) quadruplicate copy of the import certificate in relation to narcoticdrug should be supplied to the excise authorities of the State intowhich the narcotic drug is to be imported, and the said copy of thecertificate in relation to psychotropic substance should be suppliedto the Drugs Controller of the concemed State for comparison withthe copy produced before them, by the importer under sub-clause (a)of this sub-ruIe.

(d) qunituplicate copy should be supplied to the Govemment of theexporting country for comparison with the copy fumished to themby importer under sub-clause (a) or this sub-rule;

(e) srxtuplicate copy should be retained to the Drugs Controller,Govemment of India;

(f) segtuplicate copy should be retained by the issuing authority in his

(2) An import certificate issued under sub-rule (1) of rule 55 may allow theimportation of the quantity of the concemed drug or the substance in more thanone conslgnment.

'1. Subs. bv C.S.R. 224(E), dated 25th March,2015, for,'Collector of Customs,, (w.e.f. 25-3-2015).

88 The Narcotic Drugs and psychotropic Substances Rulas, tgAS lRute 57

57. Transit.-Subject to the provisions of section 79 of the Act and rute 53,no consignment of any narcotic dru& or psychotropic substances l[**t shall beallowed to be transited through lndia unless such consignment is accompaniedby a valid export authorisation in this behalf, issued by the Govemmenf of theexporting country:

Prorrided . drat

_ th.e .provisions of this rule shall not apply to the carriage by

any ship or aircraft, of small quantities of such narcotic drugs and psychotropicsubstances which are essentiaffor treatment of or medical ai-d to, any person onboard the ship or aircraft.

58. Application for export authorisation.-2[(1) No narcotic drug orpsychotropic substance shall be exported out of India without an exportauthorization issued by the issuing authority in respect of the consignmeni, inForm No. 5 appended to these rules.l

(2) The exporter applying for an export authorisation under sub-rule (1) shallsubmit,-

(a) where the export authorisation relates to narcotic drug along withhis application the original or an authenticated copy of the excisepermit issued by the concemed State Governmenu and

(b) the import certificate in original, issued by the Govemrnent of theimporting country certifying the official approval of the concemedGovemment.

3[(3) Every application for an export authorization shall be in such form andmanner and provide such details as may be specified by the NarcoticComrnissioner.l

3[(4) A fee of rupees one thousand shall be paid to the Central Govemmentalong with the application under sub-rule (1) for issue of each exportauthorization under this rule.l

59. I8sue of export authorisation.-a[(1) The Narcotics Commissioner shallissue or deny the export authorization referred to in sub.rule (1) of rule 58 within

1. The words "specified in Schedule of the Act" omifted by G.S.R. 224(E), dated 25th MarclL 2015(w.e.f. 2t3-2015), Earlier these wotds were amended by G.S.R. 556(E), dated l4th luly, 1995(w.e.f.2G7-1995\.

2. Subs. by G.S.R. 224(E). dated 25th March, 2015, for sub-rule (1) (w.e.f. 25.3.2015). Earlier sub-rule (1), was substituted by G.S.R. 555(E), dad 14th July, 1995 (w.e.f. 20-7-1995). Sub-rule (1),before substih,rtion by G.S,R. 224(E), dated 25th Mardr, 2015 stood ae under:"(1) Subiect to ru.les 53 and 53A, no narcotic drugs, or psycbokopic sub6t nces specified in theSchedule of the Act, shal be exported out of India without an export authodsation in respectof the consignarcnt issued by the issuing authority in Form No. 5 appended to thes€ rules."

3. Suls. by G.S.R. 224(E), dated 25th MatclL 2011 for sub-rule (3) and (4) (w.e.t 53-2015).Eadier Sub-rule (3) was omitd and sub-rule (4) renumbered a6 sub-rule (3) thereof by S.O.556(E), dated 14th July, 1995 (w.e.f. 2G.7-1995) and sub-rule (4) was iiserted by S.O. 1661(E),dated 13th July, 2010 (w.€.t 137-2010). SuLrule (3) and (4), before substitution by c.S.R.224(E), dated 25th March, 2015 stood as undei

"(3) 'Ihe appucation for the expo authodsation shall state such details as may be speci.fiedby the Narcotics Comfilssioner.(4) No export authorisation shall be iesued unless a fee of rupees one thousand has beenpaid."

4. Ins. by G.S.R. 224(E), dated 25th March,2015 (w.e.i 2Ur2015\.

Rule 621 The Narcotic Drugs and Psychotropic Substances Rules' 1985 89

a Deriod of twentv one working days from the date of receipt of an apPlication

;.il;[iJ in iu'respects and"in iase the export authorization is not issued

with]n the stipulated time period or denied, the Narcotics Commissioner or any

other officer 'authorised b| him in this regard shall inform the aPPlicant the

reasons thereof.]rl(1A)l The issuing authority shall prepare five copies of the expo

"otfroi""'tio., tp**1 -i deal witir them in *re manner hereunder provided,

namely:-(a) the original should be supplied

accomPany the consigrunent;to the consignor which shall

Suberule (1) renumbered as sub-n le (1A) thereot by G,S.R. 224(E), dated 25th Match,2015tw.e.i 25-3-2015),

The wo.ds "referred to in sub-rule (1) of rule 58" omitted by G.S.R. 224(E), dated 25th March,2015 (w.e.f. 2192015).Subs. by G.S.R. 224(E), dad 25th March, 2015, for "Collecloi of Customs" (w.e.f. 2t3-2015).

The words "specified in Schedu.le of the Act" omitted by G.S.R. 224(E), dated 25th March, 2015(w.e.f. 25-3-2015). Earlier these wotds wele arrrended by G.S.R.556(E), dated 14th Jufy, !995

lw .e.1. 20-7-1995).

Subs. by G.S.R. 224(E), dated 25th Marclr 2015, fot "Collector of Customs" (w.e.f. 2!&2015).

(b) the duplicate coPy should be forwarded to the 3[Commissioner of' Customsl of the irort who will retum it to the issuing authorityindicating on it thi date of export and the quantity exported;

(c) the triplicate copy should be forwarded to the Govemment of the

importing country;(d) the quadruplicate coPy should be forwarded to the excise authority' '

of the State in whicli ihe exporter has his place of business;

(e) quintuplicate coPy should be retained by the issuing authority in his

office;(2) Where the consignment of narcotic drug or psychotroPic substance is to

be tiaruhipped or traniited through one or more countries, such additionalnumber oi iopies of export authoriJation as may be required shall be preparedand s€nt to the concemed country or, as the case may be, countries.

60. Transhipment,-Subiect to the provisions of section 79 of the Act andrule 53, no consignment of narcotic drug, or psychotropic substance 4f*r! shallbe allowed to be iranshipped at any port in India save with the permission of thes [Commissioner of Customs].

51, Procedure for transhipmenl-The s[Commissioner of Customs] whileallowing any consigrunent of riarcotic drug or psychotropic substances, 4[***] tobe transhipped sl]€.ll, inter alia, *tbty himself that the corsignment is

accompanied by a valid export authorisation issued by the exPorting country.

62. Diversion of consignment.--(1) The s[Comrnissioner of Customs] shalltake all due measures to prevent the diversion of such consignment to a

destination other than that named in the aforesaid export authorisation.

(2)(a) The s[Commissioner of Customs] may Permit diversion of such aconsignment to a country other than that named in the accompanying copy of

t.

2.

3.

4.

90 The Narcotic Drugs and psychotropic Substances Rulos, lgBS lBute 62

the export authorisation subiect to the production of export authorisation issuedby the issuing authority as provided under rule 58, as if the diversion were anexport from India to the country, or territory of new destination.

(b) The l[Commissioner of Customsl shall inforrn the issuing authorityregarding the actual quantity of the narcotic drug or psychotropic substance, thldiversion of the consignment of which was allowed under clauie (a), whereuponthe issuing authority shall, inform the country from which the export of theconsignment originated.

63. Prohibition of import and export of consignments through a post officebo&- etc,-The import or export of consignments of any narcotic drug orpsychotropic substance through a post office box or through a bank is prohibited.

CHAPTER VIIPSYCHOTROPIC SUBSTANCES

2[64. Manufacture of psychotropic substances.-(1) No person shallmanufacture any of the psychotropic substances except in accordance with theconditions of a licence granted under the Drugs and Cosmetics Rules, 1945(hereinafter referred to as the 1945 rules) framed under the Drugs and CosmeticsAcl, 1940 (23 of 1940), by an authority in-charge of Drugs C6ntrol in a Stateappointed by the State Covemment in this behalf:

Provided that a licence to manufacfure a psychotropic substance specified inSchedule I shall be issued only for the purposes mentioned in Chapter VIIA:

Provided further that the authority in charge of the drug control in a Stateshall consult the Narcotics Commissioner before issuing a licence to manufacturea psychotropic substance specified in Schedule I.

(2) The authority in charge of drugs control in a State (hereinafter referredto as the Licensing Authority) shall consult the Narcotics Commissioner withregard to the assessed aruural requirements of each of the psychotropicsubstances in bulk form referred to in sub- rule (1) in the country and taking intoaccount the requirement of such psychotropic substances in the Statg thequantity of such substance required for supply to other manufacturers outsidethe State and the quantity of such substance required for reasonable inventory tobe held by a manufacturer, shall specify, by order, the limit of the quantity ofsuch substance which may be manufactured by the manufacturer in the Stite.

(3) The quantity of the said psychotropic substance which may bemanufachrred by a licensee in a year shall be intimated by the LicencingAuthoriiy to the licensee at the time of issuing the licence.l

1. Subs. by G.S.R. 224(E), dated 25th March, 2015, for "Collector of Customs" (w.e.f. 25-3-2015).2. Subs. by G.S.R.224(E), dated 23rd March,2015, for rule 64 (w.e.t 23-3-2015). Rula 64, befor€

suhbstitution, stood as under:"64. GcneruI prohibitior.-No person 6hall manuJactu-re, possess, tralrsport, import inter-

State, export inter-State, sell, puichase, consurne or use any of the psychotropic substancesspecified in Schedule t."

Rule 651 The Narcotic Drugs and Psychotropic Substances Rules' 1985 91

1[65. Registration and submission of returns'-(l) A person who has been

issued liceni to manufacture one or more psychotropic substances shall register

with the Narcotics Commissioner for each of the substances in the form and

manner as may be specified by the Narcotics Commissioner:

Provided that the requirement of registration under this sub-rule shall be

complied within a period of one hundred and eighty days from the date of

coming into force of these rules.

(2) A person who has registered with the Narcotics Commissioner under

.uU-rrt" (f ) shall file quarterly- retum with the Narcotics Commissioner in such

form and manner as may be specified by the Narcotics Commissioner'

(3) The rehrm for a quarter shall be filed befole the last day of the month

following that quarter.(4) If the retum for a quarter is not filed before the due date by a person

registered under sub-rule (1), the Narcotics Commissioner may issue notice to

"rplain the reasons therefor and after considering the reasons submitted, if any,

may pass orders for revoking the registration.

(5) The registration under sub-rule (1) shall be deemed to be revoked, if the

quarterly return for three successive quarters js not filed.

1. Subs. by C.S.R. 224(E), dated 25th March, 2015, for rule 65 (w c.i 25-3-2015). Earliar rule 65 was

amended by G.S.R. 350(E), 25th June, 1997 (w e.f.27-6-1991 andby G.S R 214(E), dated 19th

March.2002 (w.e.f. 19-3-2002). Rlrle 65, before substitution, stood as under:

"65. Manufacture ol psychotropic subslances.-(1) Subject to the Provisions of sub-rule (2),

the manufacture of any of the psychotroPic substances other than those specilied inSchedule I shall be in accordance with the conditions of a licence Sranted under the Drugsand Coshetics Rules, 1945 (hereinafter referred to as the 1945 Rr.rles) framed under theDrLrgs and Cosmetics Act, 1940 (23 of 1940), by an authority in charge of Drugs Control ina State appointed by the State Goveriment in this behalf:

Provided that the authoity in charge of dru8 control in a State lcfeffed to abovc mayissue a licence to manufacture a psychohopic slrbstance sPecified in Schedule IU for thepurpos€ of export only;

(2) The authority in charge of drugs control rn a State (hereinafter refeffed to as theLicensing Authorit') shall consult the Drugs Controller (India) in regard to the assessed

annual requirenents of each of the psychotlopic substances in bulk form referred to in sut-rule (l) in the country and taking into account the requirement of such psychokopicsubstances in the State, the quantity of such substance required for supply to othermanufacturers outside the State and the quantity of such substance reqdred for rcasonableinventory to be hcld by a manufacturer, shall specify, by order, the limit of the quantity ofsuch substance which may be manufactured by the manulactu-rer in the State.

(3) The quantity oI the said psychotropic substance which may be oanufactured by a

licensee in an year shall be intimated by the Licencing Authority to the licens€e at the timeof issuine the licence:

Provided that nothing contained in this rule shall apply in case the psychotropicsrrbstances specified in Schedule I are manufactured, possessed, transported, importedinter-State, exported inter-State, sold, purchased, consrmed or used subject to otherprovisions of this Chapter which applies to psychotropic substances which are not includedin Schedule I dnd for the purpos€s mentioned in Chapter VIIA:

Provided further that the authority in charge of the drug conhol in a Statereferred to in sub-ru]e (2) of rule 65 shal consult the Narcotics Commissioner before issuinga licence under lule 65 in respect of psychotropic substances included in Schedule I andSchedule lll.".

92 The Narcotic Drugs and Psychotropic Substancas Rules, 1985 [Ruta 65

(6) An appeal against an order passed under sub-rule (4) may be made to theSecretary, Govemment of India, Ministry of Finance, Department of Revenue orany other officer, not below the rank of Additional Secretary to the Govemmentof India, authorized by him in this behalf, within thirty days from the date ofcommunica tion of such order.

(7) Every memorandum of appeal shall be accompanied by a copy of theorder appealed against.

(8) The Appellate Authoriry shall, after making such further inquiry as maybe considered necessary/ pass such orders as it thinks fit, confirming, modifyingor annulling the order appealed against.

Explanation.-For the purposes of this rule, the expression "quarter" shall be

January to Marcll April to June, July to September and October to December ofevery year.l

1[65A. Sale, purchase, consumption or use of psychotropic substances.-Noperson shall sell, purchase, consume or use any psychotropic substance except inaccordance with the Drugs and Cosmetics Rules, 1945:l

2[Provided that sale, purchase, consumption or use of a psychotropicsubstance specified in Schedule I shall be only for the purposes mentioned inChapter VIIA.I

66, Possession, etc., of psychotropic substances.-3[(1) No person shallpossess :!ny psychotropic substance for any of the purposes covered under 1945rules, unless he is lawfully authorized to possess such substance for any of thesaid purposes under these rules:

Provided that possession of a psychotropic substance specified in ScheduleI shall be only for the purposes mentioned in chapter VIIA.I

(2) Notwithstanding anything contained in sub-rule (1), any researchinstitution or a hospital or disPensary maintained or supported by Govemmentor local body or by charity or voluntary subscription, which is not authorised topossess any psychotroPic substance under the 1945 Rules, or any Person who isnot so authorised under the 1945 Rules, may Possess a reasonable quantity ofsuch substance as may be necessary for dreir genuine scientific requirements orgenuine medical requirements, or both for such period as is deemed necessary

6y the said research institution or, as the case may be, the said hospital ordispensary or person;

Provided that where such PsychotroPic substance is in possession of an

individual for his personal medical use the quantity thereof shall not exceed one

hundred dosage units at a time:

l. hs. by S.O. 1661(E), dated 13th July,2010 (w.e.f. 13-7-2010)

2. Ins. by C.S.R. 224(E), dated 25th March,2015 (w.e.f. 25-3-2015)

3. Subs. by G.S.R. 224(E), dated 25th Marclv 2015, Ior sub-rule (1) (w e f' 25-3-2015) Sub-rule (1)'

before substitution, stood as under:

"(1) No person shal Possess any PsychokoPic substance for any of the Pu_rPoses coveled

tv tir" fg+6 n,rf"", uttless he is lawftrlly authorised to Poss€ss such substance fot any of the

"iid p*p"se. under these rules."

Rulo 671 The Narcotic Drugs and Psychotropic Substances Rules' 19&5 93

l[Provided further that an indivi{r]al may possess. the.quantity of exceeding

one hundred dosage umts at a time 2[but not exceeding- three Jrundred dosage

ilt,;';t; ;il-f"iru, p"tto.,ut long tlrm medical use if specifically prescribed

by a Registered Medical Practitioner'l

(3) The research institution, hospital and gb.P"*."Y re{el:d to in sub-rule

(2) shall maintain proper accounls jnd records in relation to the purchase and

:;;"-il;. of th! piychotropic substance in their possession'

67. Transport ol psychotropic subetance'-3[(1). No -coruignment

of

o..r.hot.ooi. *brtun." itt"tt U" ti"*potted, imPorted inter-State or exPortedt;#il"t;tht;".t.r, -*ign-"nt is accompanied by a corsignment note in

;;;;;;p";il to tt""t" riles and in the manner as provided hereinafter:

Provided that a psychotropic substance. specified in Schedule I shall be

tr""r;;;h"J, ir";;rtei i-iter-staie or exported inter-state only for the purposes

mentioned in ChaPter VIIA:

Provided further that a psychotropic substance specified.in Schedule I shall

b" tr;d;i;;i""po.t o"i oi r"dia 6 y after-an export authorization is issued

by the Narcotics Commissioner under rule 59'l

(2) The consignment note referred h sub-rule (1) shatl be prepared in

tripticlte, anJ tne"o.iginat and- duplicate copies. of the said.note shall be sent

at6ng *iUr the consipfrment of psychotropii substances. to the consignee who

,h"ll"."tu- the dupiicate .opy oi the noie to the consignor for his use after

il;.;il;" th" otlgi"ul *,i'duplicate coPies the Particulars of the receipt of

the quantity consigned..r**l(4) The consignor and consignee shall keep such consignment note for a

period of two veais and the said iote may be inspected at any time by an officer

authorised in itris Uetralf by the Central Govemment's[Provided that consignment note in Form 6 shall not apply in.cases.where

the sale of the psychotroiics substance is accompanied- by a sale bill or invoice

oi-.utn *"*o'"i uty ottt". document duly signed by. the consignor or his

autho.ised signatory, which shall include the following information about the

consignment:-1. Irls. by G.S.R. 639(E), dated 13th October, 2006 (w e { 13-i0-2006)'

2. Ins. by G.S.R. 2(E), dated lst January, 2008 (w e f 1-l-2008)'

3. Subs. by G.S.R. 224(E), dated 25th March, 2015, for sub-rule (1) (w e f' 2S3-2015) Eadier sub-

.ut" (ti '""s urr,"niJ by G.s.R. 104(E), dated 25th February, 2005 (w'e f 25-2-2005) sub-

rule (l), bcfore substutution stood as under:

"(1) Subiect to the Provisions of lulc 64, no consiSnment of PsychotroPic substance shall

be transpo*ed, imPorted inter-State or exPorted inter_State -uilFss such consiSnhent is

ac"o-puhed by a cbtsignment note in lForm 6] appended to ther Rrn6 and in t]rc manncr

as provided hereinafter. "

4. sub-mte (3) oaitted by G.S.R. 224(E), dated 23th March, 2015 (w e'f 2t3-2015) Sub-lule (3)'

before omissioD stood as under:

"(3) The consignor shall make necessary entries on the triplicate coPy of the said note

with reference to the receipt of quantity of the psychotroPic substances indicated on that

duplicate copy of the note."

5. ln-s. bv G.S.R. 104(E), dated 25th February, 2005 (w e'f 25-2-2005)'

94 The Narcotic Drugs and Psychotropic Substanc€s Rutes, lgBS [Rule 67

(a) name, address and licence number of the consisnor and theconsignee;

(b) description, batch number and quantity;(c) mode and particulars of transport:

Provided further that such document shall be preserved by consignor andconsignee for a period of hvo years for inspection by the officers referred to insub-rule (4) above.

Explanation.-Where the consignee is a research institution, registeredmedical practitioner, hospital or dispensary, the requirement of incorporatinglicence number of consignee shall not be applicable.l

IICHAPTER VIIASPECIAL PROVISIONS REGARDING MANUFACTURE,

POSSESSION, TRANSPORT, IMPORT-EXPORI PURCHASEAND CONSUMPTION OF NARCOTIC DRUGS AND

PSYCHOTROPIC SUBSTANCES FOR'IMEDICAL,SCIENTIFIC AND TRAINING PURPOSESI

674. Notwithstanding anything contained in the foregoing provisions ofthese rules-

(a) a narcotic drug and psychotropic substance may be used for-(i) scientific requirement including analytical requirements of any

Govemment laboratory or any research institution in India orabroad;

(ii) very limited medical requirements of a foreigner by a dulyauthorised person of a hospital or any other establishment of theGovemment especially approved by that Govemment;

(iii) the purpose of de-addiction of drug addicts by Govemment orlocal body or by an approved charity or voluntary organisationor by such other institution as may be approved by the CentralGovernment.3[or the authority exercising the powers under sub-clause (iv) ofclause (a)l

3[(iv) the purpose of restraining or immobilising wild animals by orunder the authority of the Government and approved by thatGovemment.l

(b) persons performing medical or scientific functions 3[or the authorityexercising the powers under sub-clause (iv) of clause (a)l shall keeprecords conceming the acquisition of the substance and the details of

L Chapter VllA (containing section 67A) ille. by G.s.R. 350(E), <lated 25th June, 1997 (w.c.f.274-1997\.

2. Subs. by G.S.R. 639(E), dated 13th October,2006, foT "MEDICAL AND SCIENTIFICPURPOSES" (w.e.f. l3-10-2006).

3. lns. by C.S.R.905(E), dated 28th December,2011 (w.e.i 28-12-2011].

Rufe 67Dl The Narcotic Drugs and Psychottopic Substances Rules, 1985 95

their use in Form 7 of these rules and such records are to be

preserved for at least two years alter their (sic);

(c) a narcotic drug and psychohopic substance may be supplied ordispensed for use to a foreigrer Pursuant to medical Pres:riPliolonly from the authorised licensed pharmacists or other authorisedretiil dishibutors designated by authorities responsible for publichealth.l

It67B, (1) Notwithstanding anything contained in these rules, thegovernment Opium and Alkaloid works may pr(rure, manufacture or imPortand supply narcotic drugs and psychotropic substances as may be required as

samples by various drug law enforcement agencies, testing laboratories andhaining institutions of the Central and State Govemments.

(2) The Govemment Opium and Alkaloid Works may also supply samplesto organisations other than those covered by sub-rule (1) with the prior approvalof the Cenhal Govemment.

(3) Any enforcement agenct laboratory, haining institution or organisationrequiring the samples shall apply to the Chief Controller of Factories in FormNo. 8.

(4) The quantities of varioug narcotic drugs and psychotropic substances tohe supplied as samples shall be determined by the Central Govemment fromtime to time. The organisation obtaining the samples shall designate an officer,at the time of sending the request for samples, in whose custody the samplesshall be kept.

(5) The organisation requisitioning the samples shall maintain records andsubmit an annual report to the Chief Controller of Factories in Form No. 9.

(6) When a sample is used for trainin& the organisation shall maintain arecord of the quantity of drug taken out for training and the quantities actuallyused.l

r[67C. Notwithstanding anything contained in these rules, the NarcoticsCommissioner may permit import or export of narcotic drugs and psychotropicsubstances for the purpose of controlled deliveries, investigations, intelligmcecollection scientific analysis.l

2ICHAPTER VIIBREPORT' RETURNS AND ESTIMATES UNDER

INTERNATIONAL CONVENTIONS67D. Submission of rrcports and retums under intemational conventions.-

(1) All reporS and retums which are required to be submitted under anyintemational convention, shall be submitted to an international agenry by suchofficer the Central Government may, by notification in the Official Gazefte,appoint in this behalf from time-to time.

Ins. by G.S-R. 639(E), dated 13th Octobet, 2006 (w.e.f. 191G2006).Chapter VIIB (containing sections 57D and 67E) ins. by S.O. 1661(E), dated 13th Jtrly, 2010(w.e.t 13-7-2010).

l.2.

96 The Narcotic Drugs and P€ychotropic Substances Bules, 1985 lRule 67D

(2) The officer appointed under sub-rule (1) may call for such inputs as maybe necessary to submit the retums under sub-rule (1), from the NarcoticsCommissioner, the Chief Conholler of Factories or any other officer of theCentral Govemrnent or any State Government indicating the format in which theinformation is required and the time by which it is required.

(3) The officer from whom inputs have been called for under sub-rule (2),shall provide all inputs which are sought and which are available with hirn inthe format in which it has been called for and within the time indicated in sub-rule (2) and shall also indicate the information not maintained by him or notavailable.

67E. Estimates and quotas.--(1) If, estimates of requirement of any narcoticdrug have to be submitted under any intemational conventioD resolution orcommitment, the same shall be submitted to an intemational atmcy by suchofficer the Central Govemment may, by notification in the Official Gazette,appoint in this behalf from time.to.time.

(2) The estimates for use and consumption of narcotic drugs approved byintemational agencies for India shall be allotted as quotas to users within thecountry by such officer as may be notified by the Central Govemment bynotification in the Official Gazette from time-to-time.

(3) The users to whom such quota is alotted shall not exceed the quotaallotted to him and shall submit to the officer appointed under sub-rule (2), suchstatistics of consumption and use of the narcotic drugs and r{ithin such time asmay be indicated by the officer.l

CHAPTER VIIIMISCELI,ANEOUS

68. Repeal and savinge.-(l) The Central Opium Rules, 1934, the DangerousDrugs (Inport, Export and Transhipment) Rules, 1952 and the CentralManufactured Drugs Rules, 1952 are hereby repealed.

(2) Notwithstanding such repeal, anything done or any action taken orpurported to have been done or taken under any of the rules repealed by sub-rule (1) shall, in so far as it is not inconsistent with the provisions of these rules,be deemed to have been done or taken under the corresponding provisions ofthese rules.

IISCHEDULE I(See rules 53 and 64)

I. Narcotic drugg

1. Coca Leaf

2. Cannabis (Hemp)

3. (a) Acetorphine

O) Dacetylmorphine (Heroin)

(c) Dhydrodesoxymorph.ine (Desmorphine)

1. Subs. by G.S.R. 639(E), dated 13th October,2006, for Schedule I (w.e.f. 13-10-2006).

Sch. llll The Narcotic Drugs and psychotropic Substancas Rulas, I,AS 97

(d) Etorphine(e) Ketobemidone

and their salls, preparations, admixturet extracts and other substances containing any ofthese drugs.

II. Psychotropic subotances

International non-prcprietary

nameSChemical names

Mephedrone (RS)-2-methylamino-1 -(4-methylphenyl) propan-1-one

Salts and pr€para tionsof abovel

,t.*l,t*-l

'*ii+s*ln-*s#i#i-g,ggr*ll*l'imI Jury, r995 (w.e.f.'f

t##t*:lr"i;*+,,+lgg*lE#.1,*,+l;,

@fORM No. 1

(See rlule 7\

GoVERNMENToFTNDIA,cENT:::,:Ttii'":J'*t:lti

"'**."'o"3Jji-;;';;;""*'". ".t:'11P.fr;/"i""i.' t"h,tt L""-e Number Area Licensed Plot No.(s) as Per

!€venue recordsViltageG." ^a Parentage of

the licens€e

Atea measured

Atea test_rneasured

Area harvested

(s.I.)

(Inspector,/D.O.O.)

a;;

o

FE

IDa.

a-x6*(')

da6

6'*BOi

-r'lo

Si8nature and S€al

District Opium Officei

(Enhies to b€ made at the time of final

il** g-* ̂"og4t*'o'9"tClas3 ofopium as

assignedby D.O.O

Weight ofopium(K8J

Assumedweight at70'c(K8.)

Pricepayableon thebasis ofassum€dweight70<

witiheldpending finalexaminationof oPium atfactorY

paid atweighEEnb

Totalweight ofopium at70"C onthe basis offactory'sfePor(

Averageyield ofthecultiva-tor

lotalamountpayableon thebasis otfactoryrepott

Amountalreadypaid atthe timeof weigh-ments

Amountpaid /receivedat thetime offinal

Payments

Signature and Seal

Distlict Opium Officer

Form 2l The Natr'lr/tic Orugs and psychotropb Su&tances Rules, t gBS 98A

FORM NO. 2(See rule 8)

APPLICATION FOR GRANT OF LICENCE FOR OPIUM POPPYCULTIVATION FOR PRODUCTION OF OPIUM OF POPPY STRAW

Crop year................,....,...

2.

5.

6.

7.

8.

9.

Name of the CultivarorFather's

Vi11age.................................,............Tehsi|..._.__.--....... .Dstrict............-...-..............Khasra No. of the plot of land in which poppy is to be cultivated.Whether the plot is in the name of the applicant as pe! revenu€ records. If not, inwhose name?........

:t:11". ,h..,plq, specified. in column 4 has irigation faciliries (kind of irrigationlacllitres available, i.e., well, tubewell, etc., ......,..................Area required for opium poppy oltivation,.Whether the applicart cultivated the poppy in .............................tn:.past,.rt so, the latest year in which he.,._-._...,_._.-....,.,.curuvated PoPPy.Whether the applicant was ever proscribedtrom poppy cultivation or was de-licensedfor tendering adulterated opium, excess cultivntion,violations of Departmental instructions. If so, theyear and the reasons for proscription.,........,....,...,..

. I hereby certify that the particurars shown above are correct and the land in whichoprum poppy is to be oltivated is lree from litigation.

Attestation(to be made by Lambardar)

Signature/Thumtsimpressionof cultivator

(To be completed by the Sub-tnspector Incharge)A. Performance of the cultivator during the preceding crop year.

croP year.... .......... Area licensed.......,.Area measured...... Area harvested......Average yield at 70qC_. -. - _ -.. -....

B. Whether the cultivator has ever been proscriH on account of excess cultivationand violation of Departmental instructions, etc,, if so the particulars thereof,

Si8nature....................,......(Sublnspector Incharge)

The particulars above recorded by the_ Sub.Inspector have been verified by me. Thecultivator is eligible/ineligible for grant of a licence.

Signature(SubJnspector lncharge)Area allotted by the District Opium Officer.

Signature of -Dstrict

Opium Officer

988 The Narcotic Drugs and Psychotropic Substances Rules' 1985 lForm 2

Conditions of lic€nce

1. The licensee shall not transfer this Iicence and oltivate PgPPy onlv fol production

of opium or F,oppy straw """t tn':;;;?i;i'""a

-tL" pt'<'"1 '"i'6"ia"i i" ihe lice"ce'

2. The land in which PoPPy will be cultivated by the cultivator shall be free from

litigation.3' rhe ricensee, sha'

-q1,$"9i1Y","SltT:f-.:*#il"33fi::i"tJ^x1"tr ""i.'J[:'f5i iil"'i:H]?""""'1',:il'i:,ru.i;ru;;i l""r' """v',"a"

uv rh;L'"bu'du' a"it

shall submit to Preliminary *"tei;;;; ;rriJ out bj' the. stiff of the Narcotics

DeDartment in the village aunng #hi"'n f[ tiufi-ptoa"t" tile entire quantity collected by

n'* n. ,n" licensee shall bring to' and -deliver at the !l"t^t'-1":1

and notified for

*.ii^".L'"ii'"iiu- .ou"tt"i bi'r'im fro,n the crop and. shall accePt for opium so

ffii;t;;il; ite price fixed by'the central Govemmenl [or that croP year'

; th" licensee shall deliver the oPium either himself or through any person

authorised by him at tn" t'In"-ot. 't" *"il'tti"nt and his opium shall be weiqhed under

the supervision of In" ui"t"tt up'ui'6i?ii"t ti ""y.t'n* "ifite.r authorised ii this behaU

by the Narcotics Co"tmils'o"et.'n at;;;;;; with rule 14 of the Narcotic Drugs and

Piy"hot.opi" Substances Rules' 1985'

6. lf the licensee does not surrender his entire- Produce tl .?Pl:l]:t t Covemment or

retains, embezzles or otherwise itteiiliy-ii"pot t-of l"y p".t of th-e sa-me he shall be liable

to be Drosecuted as Per tne Pt8liJi;;';i ihe Nlr'cotlcs Drugs and PsychotroPic

Substarices Act, 1985'

7. The licens€e shall extract as much.opium :" i" I:?:T!Y possible from all

implements, Pots and cloth u"ta Ty "ii^'lrr

""llecting

oPium and ihpregnated with

opium in consequence ot such use'

8. The final Payment for oprum delivered^b.y the licensee-shall be made to him at

approp ate time fixed oy tn" '-r'JtitiSi"rn b7it"t or any other officer authorised in

rh; dhalf.9. lf on the final adiustment of accounts any sum is.found dueJrom the licensee' he

shall pav it to the Dstrict L'lprum bii"lioi-y' "tft"t officer authorised in this behalf in

the manner specified' lt tn" "t"n""""

?iit to'pay tfte sum due from him it may be

recovered from him ln tnt rnu"nil piJ"iiu"a 6y"tc-n 72 of the Narcotic Drugs and

Psychotropic Substances Act' 1985'

lO. The licence may be withheld or cancelled at any :tTe^

if-any fact is revealed

"g"i,.ii tit" ft""*. *itittt t"t"" him ineligible for grant of the lrcence'

L1. The licensee shall comptf with the piovisions of Narcotic Drues and Psvchotropic

Substances Act, 1985, th" Rtl"'*'f;;;;i'ti"t"t^a"t and any orier issu;d by the

iJil"p"i".ti u.ttfto.ities of the Narcotics DePartment from time to time'

12. The Iicensee shall be punishable under.the relevant -Provisions

of the Narcotic

Druss and PsychotroPic Stu"ollt"" 'cti i985 fot "ty breach of the conditions of the

liceice.

FORM NO. 3

1[See rules 36 and 371

LICENCE FOR MANUiACTURE OF MANUFACTURED DRUGS

*', . .---...-...:-..--; h3,:i; rii""li,T",; ;;;;ruilil ?;iili;;

;u..,.,i;il";J drugs on the Premises situated at" " " " " " """ "" """

r- iJ*Tv Cs.n. 95(E) dated 4th February' 2004' for "(Sae rule 37)" (w e t 4-2'2004\'

Date...............,.,.

Conditione of licence1. This licence is not transferable.2. This licence and any certificate of renewal in force shall be kept on the approved

premises and shatl be proiuced at the request of an officer detailed'foi the purpiose bythe Licensing Authority.

3. The licensee shall not manufacture or keep the drug or the materials used for themanufacture of the drug at any other place except his place of business.

4, The licensee shall ensure manufacture of the drug to the standard andspecifications laid down by or under the Dlugs and Cosmetics-Act, 7940 (23 ot 1.940).

5. The licensee, if he desires the renewal of his licence, shall apply to the LicensingAlthority in the form specified for such renewal, at least thirty days bifore the expiry o7nts ltcence.

6. The licensee shall inform the Licensing Authority in writing in the event of anychange in the constitution of the llthe person-or the entity] operati-nq undet the licence.Where any change_-in the constitution bf the r[the person or ine ent-ityl takes place, thecurent licence shall be deemed to be valid for a maximum period of ihree months fromthe date on which the change takes place or the normal ex6irv of the licence whicheveris earlier unless in the meintime, i fresh licence has be6n iaken from the LicensingAuthority in the name of the l[the person or the entity] with the changed constitution:

Form 3Al The Narcotic Drugs and Psychotropic Substances Rules, 1985 98C

Name of drug Quantity(1)

(2\

2. The licence shall be in force frorn.......,....to..............3. The licence is subiect to the conditions stated below and to such other conditions

1s m3y be specified in the rules for the tirne being in force under the Narcotic Drugs andPsychotropic Substances Act, 1985 (61 of 1985).

Signature.........................

Designation.........,....,.......

lIFORM NO. 3A(See rule 36,4.)

Licence No. Date of issue

, .Y/". :,- . . . ........is hereby licensed to manufactule concentrate of poppy straw andthe following manufactured drugs on the premises situated at.,..,...................

Name of the drug Quantity(i)

(ii)

(iii)2. The licence shall be in force from......,.,.,....-._..._.._-.-.......to_...The licence is subject to the conditions stated below and to stch other conditions as

may.be specified in the rules for the time leing in force under the Narcotic Drugs andPsychotropic Substances Act, 1985 (61 of 1985).-

Date...........,.......,.... Siqnarure......_.................

Desi1nation........................

1. Subs. by G.S.R. 95(E), dated 4th February,2OO4, tor',$rlf.\,, \w.e.t. 4-2-2OM).2. Ins. by S.O. 1661(E), dated 13th July, 20lO (w.e.f. 13-7-2010).

98D The Narcotic Drugs md Psydptropic Subslanc€/s Rules, 1985 lForm 3A

Conditions of Licence(a) This licence shall not be transferable;

(b) The licensee shall manufacture concmttate of PoPPy straw hom the PoPPy strawproduced in the fields licensed for the PurPose,

(c) This licence and any certificate of renewal in force shall be kept on the approvedpremises and shall be produced at the request of an officer detailed for the purpose bythe Licencing Authority;

(d) The licensee shall ensure that the dru8s that he manufactures are as Per the

specifications laid down by or under the Drugs and Cosmetics Act, 1940;

(e) The licensee shall, if he desires, submit aPPlications for renewal of his licence at

least thirty days before the exPiry of his licence.

(Q The licensee shall inform the Licencing Authority in writing in the event of any

chanse in the constitution of the firm operating under the licence. Where any change inthe c;stihrtion of the firm takes place, the cut.int licence shall be deemed to be valid fora maximum pedod of three months from the date on which the change takes place ornormal expiry of the licence whichever is earlier unless in the meantime, a fresh licence

has been taken from the Licencing Authority in the name of the firm witl the changed

constitution;(g) The licensee shall be fully responsible [o ensure the security of the factory

prem-Gs and ensure that no diversion takes Place in them;

(h) The licensee should provide security equiPmmt such as surveillance cameras and

other iacilities as may be specified by the Narcotics Commissioner to ensure security on

the fields;(i) The licensee should rePort to the Narcotics Commissioner if he finds any farmer

lancing or divertinS;

(j) The licensee shall keep the Central Bureau of Narcotics informed of all matte$

relati'ng to cultivation, production, transPolt, etc., of poppy strar^/ and changes inagrioltural practices;

(k) The licensee shall defray the cost of the Central Bureau of Narcotics staff posted,

to ",rp"-i*

the oltivation of opium for production of PoPP-y- straw and productiorr of

concintrate of PoPPy straw at iuch rates as rnay be decided by the Govemment flomtime.to-time;

(t) The licensee shalt notify well before the sowing season, the Price which they are

willing to pay for the Pods;(m) The licensee should identify and enter into agreements with the farmers who are

willing to cultivate opium poppy lor production of poppy straw for sale to the licencee;

(n) The farmers with whorn the licensee has entered into agreemens will be licensed

to gi;; oplrr* poppy subject to such velifications as may be felt necessary by the

Narcotics Commissioner,(o) Such other conditions as may be specified by the Narcotics Commissioner from

timeto-time.l

Form 3Cl The Nat@tlc DrugE and Psycl1f,ttopic Sub6,tanc€,s Bules, 1985 98E

{FORM NO. 38

[See rule 52A(3)l

SPECIAL AUTHORISATTON FOR POSSESSION OF ESSENTIALNARCOTIC DRUGS BY REGISTERED MEDICAL PRACTITTONER

Authorisation No.........Date of issue........

.....................is hercby authorised to possess the following essential narcotic drugs onthe premises situated at.,.,............for use in his practice.

Narne of essential narcotic drug Quantityo)(2\

2. The authorisation shall be in force from..........,.....to......,......,..

3. The authorisation is subiect to the conditions stated below and to such otherconditions as may be specified under the Narcotic Drugs and Psychotropic SubstancesAct, 1985 (61 of 1985) and the rules made lhereunder,

Signature.,.........,...,

Designation................

Conditionc of authorisation1, This authorisation is not transferable.

2. This authorisation and any certificate of renewal in force shall be kept on theapproved premises and shall be produced at the request of an officer detailedfor the purpose by the issuing authority.l

{FORM NO. 3C(S€? rule 52D)

CONSTGNMENT NOTEDabe and time of dispakh of the consignment..-...,..,...,.........-.....,..

1. Name and complete postal address of the consignor

2. Whether Manufacturer or Licenced Dealer

(Quote Licence Number and the Issuing Authority)

Name and complete postal address of the consignee

Description and quantity of the consignmmt

Particuiars of theTrade Marks, Prc

essential narcotic drugs showing)rietary Names, Batch number, etc.

Numberof packages

Quantity

Gross Net

5. Mode of hansport (particulars of the transporter, Registrationnumber of the vehicle or Railway Receipt./lorry Receipt, ifthe transport is by railways good transports)

Full Name/Designation (if any) of the Consignor with date

To be filled by the consignee

1. Ins. by G.S.R. 39(E), dated 5th May,2015 (w.e.i 5-F2015).

98F The Narcotic Drugs and Psychotrory Substances Rules, 1985 [Form 3C

6. Date and time of leceipt by the consignee and his remarks

7. Whether the consignment received in full as perd€scription and quantity mentioned at serial number 4aDove

Yes / No (If 'no',details to bementioned below.)

Full Name,/Designation (if any)

Note:

Signature of the Consignee with date

(1) This consignment note shall be serially numbered on annual basis.

(2) The consignor shall record a certificate on the cover page of each book containingconsignment note indicating the number of pages contained in the consigrunentnote.book.

(3) The consignor shaU maintain a Register showing the details of the books ofconsignment note brought in us€ during a palticular year.

(4) This consignment note shall be retained for a period of two years ftom the dateof transaction.

(5) The records referred to in this note shall be produced before the concemedauthorised officers whenever called upon during the course of their insPection/investigation.l

{TORM NO. 3D

[See rule 52H(2)]

DAILY ACCOUNTS OF ESSENTIAL NARCOTIC DRUGSTO BE MAINTAINED BY REGISTERED MEDICAL PRACTITIONER

Full Narne,/Designation (if any) Signature

Note:(1) This record shall be maintained on day to day basis and entries shall be made for

each day.(2) Entries shall be completed for each day before the close of the day'

(3) The pages of the register shall be serially numbered

AND AUTHORISED PERSONS

Name of the

Opening stock

Quantity received

Received from Give details)

Note/Bill/Invoice,/Cash Memo, Number etc.

Quantity dispensed

Name and address of the person to whom disPensed

(include patient registration number maintained in FormNo. 3E, where applicable)

Closing stock

1. trLs. by G.S.R. 359(E), dated 5th May,2015 (w.e.t 5-5-2015).

Form 3Fl The Narcotic Drugs and Psychotropic Substances Rules, 1985 98G

(4) Separate record shall be maintained for each essential narcotic dru8.(5) This record shall be retained for two years from the date of last entry.(6) This record shall be Produced before the concerned authorised officers whmever

called upon during the course of their insPection/investiSation.l

{FORM NO. 3E

[See rule 52H(3)]DETAILS OF THE PATIENT

TO WHOM ESSENTIAL NARCOTIC DRUGS DISPENSED(TO BE MAINTAINED BY REGISTERED MEDICAL PRACTITIONER/

RECOGNISED MEDICAL INSTITUTION)Registration Number Date

(1) This record shall be retained for two years ftom the date of last entry.(2) This record shall be produced before the concemed authorised officers whenever

called upon during the course of their inspection/investigation.l

lIFORM NO. 3F

[See rule 52-O(l)lAPPLICATION FOR ISSUE/RENEWAL OF CERTIFICATE OFRECOGNITION AS RECOGNISED MEDICAL INSTITUTION

Name

Complete postal address (with contact number, if any)

Bdef description of the illness

Wirether registered ivith any other registered medicalpractjtioner/recognised medical institution(lf ycs, detail. to te recoded)

Details of the .'ssential narcotic drugs dispensed

Name of the essentialnalcotic drugs

9ignature,/Thumbimpression of

the patient

Notei

1. Name and complete postal address of the institution withtelephone number, facsimile number and e-mail ID(relevant supporting documents to be submitted)

2. Name of the Head/ln-charge of the Institution

3. Number of persons employed

(i) Doctors(ii) Nursing staff(iii) Others

1. Ins. by G.S.R. 359(E), dated 5th May,2015 (w.e.f. t5-2015).

98H The Narcotic Drugs and Psydlottopic Substances Rulee, 1985 lForm 3F

Number of patients treated during the previous calendar year(i) in patients(ii) out patients(iii) home care

Name(s) of the qualified medical pracritioner(s) who wouldprescribe essential narcotic drugs (give details of their training inpain relief and palliative care or opioid dependence treatment)

6. If there is more than one qualified medical practitioner whowould prescribe essential narcotic drugs, indicate the name ofthe medical practitioner who shall be overall in charge

7. N'rmber and date of the certificate of recognition issued earlier(attach copy)

8. Whether the recognition of the instihrtion was withdrawn earlier(if the recognition was withdrawn earlier, the details areto be given)

Date.,..,.,...............,

PIace.,.,.......,.,..,.,.,.

Seal:

Signature:,....,......,..,......

Full name:

Position:.....,.,..,..,...,..,.1

{FORM NO. 3c[Sec rule 52-0(2)]

CERTIFICATE OF RECOGNITIONDate of issue.,........,....,

This is to certify that.................................(Name of the institution)..................... situateda Recognised Medical Institution to possess, dispense and sell essential

narcotic drugs.

2. The institution is a Recognised Medical Institution since..,.... (mention date of thecertificate issued for the first time)..........,

3. This certificate shall be in force from............to.............

4. The certificate is subjet to the conditions stated below and to such other conditionsas may be specified under the Narcotic Drugs and Psychotropic Substances Act, 1985 (61of L985) and the rules made thereunder.

Signatur€..'..................'.'..'.'...

Designation......,........,......,.....q-.1

Conditions of r€cognilion1. This certificate is non-transferable.

2, This certificale and any certificate of renewal in force shall be kept on theapproved premises and shall be produced at the lequest of an officerauthorised for the purpos€ by the issuing authority.l

No....................

1. Ins. by G.S.R. 359(E), dated 5th May, 2015 (w.e.f. t5-2015).

Fom 3-tl The Na,@tic Drugs and Psyclotropic SubetancE.s Fules, 1985 981

rlFoRM NO, 3H

[Sre rule 52R(1)(c)]

DAILY ACCOUNTS OF ESSENTIAL NARCOTIC DRUGS TO BE

MAINTAINED BY RECOGNISED MEDICAL INSTITUTIONName of the Ess€ntial :

Narcotic DrugDate :

1. Opening stock

2. Quantity received

2(i) Received from (give details)

2(iD Consignment Note/Bill/lnvoice/Cash Memo, Number etc'

3. Quantity dispensed

Specify registration number of the Paten(s) maintained inForm No. 3E and quantity disFnsed to each)

5. Closing stock

Full Name/Designation (if any) Signature of the overall in charge

Note:(1) This record shall be maintained on day to day basis and entries shall be made

for each day.(2) Enhies shall be completed for each day before the close of the day.(3) The pages of the register shall be sedally numberd.(4) Separate record shall be maintained for each essential narcotic drug.(5) This record shall be retained for two years from the date of last entry.(6) This record shall be produced before the concemed authorised officers

whenever called upon during the course of their insPection/investiSation.l

{FORM NO. 3.I

[See rule 52R(1)(d)]ANNUAL RETURN OF PROCUREMENT/DISBURSEMENT OF

ESSENTIAL NARCOTIC DRUGS (TO BE FILLED BYRECOGNISED MEDICAL INSTITUTION)

:":'"'the vear

l;

Date of submittingrerum

1. Number and date of the orrent certificate of recognition

2. Name of the Recognised Medical lnstitution

st.No.

Name ofessentialnarcotic

d.ug

Quantityin original

annualestimate

Quantityin revised

annualestimate(if any)

Openingstock

Quantityprocured

during theyea!

Qualitydisbursedto patientsduring the

Yeaf

Closingstock

(1) Q) (3) (4) (s) (6) (7) (8)

L Ins. by G.S.R. 359(E), dated 5Or Mar 2015 (w.e.f. t5-2015).

98J The Narcotic Dtugs and Psychotopic Substances Bules, 1g8S lForm gJ

, .,/The designated m€dical practitioner or the over-all in charge, as the cas€ may be,shall recold a brief iustification where ihe actual disbursement is-more than ten peicentof the estimate or revised estimate, as the case may be.

Full Name,/Designation (if any) Signature of the overall in charge.]

{FORM NO. 3J

lsee rule 52T(1)lESTIMATE OF ANNUAL REQUIREMENT OF ESSENTIAL NARCOTIC DRUGS

Estimate for the year Date of submittingestimate

1. Number and date of the curtent certificate of recoqnition2. Name of the Recognised Medical InstihJtion3. Details of the estimated annual requiremmt of essential narcotic drugsst.

No.Name ofessentialnarcotic

drug

Quantity disbursedduring previous

yeat

Estimatedannual

lequirement

Revisedestimated

annualrequirement*

Reason forrevision

0) (2) (3) (4) (5) (6)

*Please attach copy of the original estimateFull Name/Designation (if any) Signature of the overall in charge.l

FORM NO. 4(Sre rule 55)

Official Seal of the Issuing AuthorityS. No.......................

F. No.......................

COVERNMENT OF INDIAMINISTRY OF FINANCE(Department of Revenue)

CERTIFICATE OF OFFICIAL APPROVAL OF IMPORT(The Narcotic Drugs and Psychotropic Substances Rules, 1985)

.-.-...-.--.--....r..-..:---.--...-(The Issuing Authority) being the authority empoweredto issue Irnport Certificate under the Narcotic Drugs and Psychotropic SubstancesRules, 1985 hereby approves the importation into lndia of the consignments containingnarcotic drugs or psychotropic substances as specified in the Schedule below by-

M/s..........................From M/s.......,....... ......subiect to the condition

that the consignment containing such drugs or substances shall be importedbefore................... by................................to (airport/sea port) in India.

In approving the importahon of the consignment containing th€ said drugs orsubstances specified ...................... (lssuing Authority) is satisfied that itis required solely for medical and scimtific purposes.

Address of the lssuing Authority Designation of the Issuing Authority

1. Ins. by G.S.R. 359(E), dated 5th May,2015 (w.e.f. 5-5-2015).

Form 4Al The Nat@tic Drugs and Psychotropic Substances Flules' 1985 98K

Schedule specifying the narcotic drugs or psychotropic substances contained in the

consignment to be imPorted.

l.Thisdocumentisfo!..............(TheauthoritytowhomarldthePurPosefolwhichitis being sent to be indicated).

. 2. The certificate is not valid unless it bears the official seal of the IssuinS Authority

on the top riSht hand comer.Official Seal of Issuing AutholityS.No'F.No.

{FORM NO. 4A(Sec rules 54 and 55)

(Official seal of the Issuing authority)S. No. """" 'F. No. .....""" " "" "'

MINISTRY OF FINANCE(GOVERNMENT OF INDIA

(DEPARTMENT OF REVENUE)

CERTTFICATE OF OFFICIAL APPROVAL OF IMPORTUNDER T1IE PROVISO TO RULE 54

(The Narcotic Drugs and PsychotroPic Substances Rules, 1985)

fThe lssuins Authority) being empowered to issue InPort'. r. rr-'oc"end Psvchitrooic -Substances Rules, l98t hereby,herebyCertificate unde! the Narcotic Dru8s and PsychotroPiccertificate unde! the Narconc uruSs ano rsycnotruPrc

il;;;; th; ftdtl"iio" i"to Indii of the frillowini consignments of narcotic drugs:-(1)

(2)(3) ................................................)

Bv M/s....,......,......'... .from M/s'..'.......""""""'to manufacture - formulations

"tp"-ilf- analytical PurPoses (strike out whichever is not. aPPlicable) subiect to

f ollowing conditionsr-Conditions of imPort certificate

(i) The consignment containing the drugs shall be imported before"" """""""" .'

by............-...........to (airport/sea-port) in India.

(ii) If the import is for manufacture of formulations for export, the manufacturer

shatl,-(a) ensure that no Part of the drug imported under this certificate shall be sold or

used to manufachlre formulations lor domeshc sale;

(b) ensure that the formulations manufactured out of the dru8 imPorted against

this certifical.e shall not be diverted for domestic sale;

furnish to the Narcotics Commissioner and the Drugs Controller General of

indiu d"tuilt of export of drugs on completion- of exPort along wiihdocumentary evidenie such as shipping bills, bills of lading and invoices;

obtah transport permit from their State Excise authority/State Food and Drugs

Administration permitting transPort of their consignment from Pcrt of entry to

forthe

(c)

(d)

the factory premises;

(e) maintain separate accounls of actualformulations produced, consignmentsbalance;

quantity of narcotic drug imPorted,dispatched and the quantity lying in

l. lns. by S.O. 1651(E), dated 13th luly, 2010 (w e.f. 13-7-20t0)'

98L TtD Natcrl{tc Drugs md psydtottopic Substancr,s Rules, lgAO [Fom 44

(0 submit a.monthly retum of rec€ipt/import, cpnsumption and export of thenarcotic drug to the Narcotics Commissioner;

G) follow the procedures prescribed in rules 42, 45, 46 and 4Z for securityarrangements, maintenance of accounts and submission of retums, possession,sale and distribution of formulations manufactured from the drug! importjunder this certificate.

t[(iii) If the import is for analytical purpo6€s, the importer shall,_(a) ensure that no part of the drug imported under this certificate shall be used for

any purpose other than for analytical purpose;@) inform the Narcotics Commissioner aboua the complete utilisation of the

Narcotic Drug imported; and(c) follow the procedures specilied in ruleq 4Z 45, 46 and 4Z]

, 3.. Any qlantity of morphine, codeine, thebaine and their salts or finishedlormulahons for export that have not been utilized shall be surrendeled to theGovemment Opium and Alkaloids Works.

4. This document is for.......,...........-,... (It-e authority to whom and the purpose forwhich it is being sent to be indicated).

5. The certificate is not valid unless it bears the official seal of the Issuing Authorityon the top right hand comer.l

FORM NO. 5

(See rule 58)

GOVERNMENT OF INDIAMINISTRY OF FINANCE(Department of Revenue)

AUTHORISATION FOR OFFICTAL APPROVAL OF EXPORT(The Narcotic Drugs and psychotropic Substances Rules, 19g5)

........f[he lssulng Authority) being the authority empowered toissue export authorisation under the Narcotic Drugs and psychotiopic -

SubstancesRules, 1985.hereby authorises and permits the followin! exportatidn of Naicotic Drugs orPsychotropic Substances from India:-

Poit of export.,....,. ...port of entry........Narcotic Drugs or Psychotropic Substances to be exported:

Item No. Number of packages Name of the drug Basic drugsubstance/preparations substance content

The exportation to be made in one consignment from the designated port of exporton or before the....................................day of..................................(Month), 20-

- The importation of these drugs into the country of destination has been authorisedby official import certificate No................................. dared..,.,................,............ issuedby-....................... (Autho(ity of the importing country).

Date of IssuePlace of lssue..... Designation of the Issuing Authority

L lns. by G.S.R. 470(E), dated 21st )rure, 2011 (w.e.f. 2t-6-2011).

Form 7l The Nat(',tic Drugs ancf Psychottopb Substand€,s Rules, 1985 98M

1. This document is for.......'.................'...""""(the authority to whom and the PurPosefor which it is being sent is to be indicated).

2.ThisauthorisationisnotvalidunlessitbearstheofficialsealofthelssuingAuthority on the toP riSht hand comer.

,[FORM NO. 6l(See rlule 67\

Date and time of desPatch ofthe consignment.

1.. Name and address of consignor (manufacturer/dealer/distributor and his Licence

No. etc. (Issued under the Drugs and Cosmetics Rules, 1945)'

2. Name and address of the consignee (manufacturer/dealer/distributor) and his

Licence No. (lssued under the Drugs and Cosmetics Rules, 1945)'

3. Description and quantity of the consiSnment.

Pa*iolars of the drugs with reference to the No. of packages. QuantitySchedule(s) to the 1945 Rules, Trade Marks; Gross NetPatent and ProDrietarv Names, etc.

4. Mode of transport (Particulars of the transporter, Registration Numberof the vehicle, R.R. if the Transport is by Railway, etc ,)

5. Date and time of receipt bv the consimee and his temarks.

Signsture of the consignee with dste Signaturc of the Consignor aith date

(Name in capital letters) (Name in capital letters)Not€,-(l) This Consignment Note should be serially numbered on annual basis.(2) The Consignor should record a Certificate on the cover page of each book

containing consignment note indicating the number of Pages contained in suchconsignment note-book.

(3) The Consignor should maintain a Register showinS the details of the books ofconsignment notes brouSht in use du ng a particular year.

(4) The books containing consignment not used or currently under use and theregister as teferled to at item (3) have to shall be produced to the officers whenever calledupon during the cou$e of thei! inspections.

,IFORM NO. 7

(See rules 35,53,64 a d 67 A)3[1, Name of the laboratory/research institution,/hospital,/dispensary/person/

authorityl2, Address3. Name of the Drug4. From whom the drug was obtained/purchased

Form No. 6 deleted and Form No. 7 re-numbered as Form 6 by G.S.R. 556 (E), dated 14th July,1995 (w.e.f . 20-7 -1995).Ins. by G.S.R- 350(E), dat€d 25th June,1997 (w.e.t. 27-6-1997).Subs. by C.S.R. 905(E), dated 28th December 2011, {or item 1 (w.€.f. 28-12-2011),

l.

2.

3.

The Narcotic Drugs and psychotropic Substances Rules, tg^s

r[5. Quantity obtained / purchasedl6. Date on which obtained/purchasedDetails of Use:

lFom 7

Note.- (1) This form shall be kept for 2 years from the last date of consumption.(2) This shatl be produced for verification by any of the officers empowered

under section 4l or 42 of the Narcotic Drugs -and psychotropic Suistances

Act or any officer-in-charge of a police station.]

{FORM NO. 8(See rule 678)

APPLICATION/REQUISITION FOR STANDARD SAMPLES OFNARCOTIC DRUGS OR PSYCHOTROPIC SUBSTANCES

1. Name of the Organisation or Agency2. Full postal address of the Organisation or Agency3. Purpos€ for which sample of standard Narcotic

drug or Psychotropic Su6stances is required4. Name and quantity of standard sample requiled5. Name and designation of officer unde! whose

custody the samples shall be kept6. Copy of Stock Register of narcotic samples

maintained by theorganisation duly verified by thecontrolling officer

7. Other relevant information (if any)Signature........................-....Designation.............'.'-.........

of Indenting Officer with Rubber Stampl

,IFORM NO. 9lSee rule 678(5)l

ANNUAL REPORT TO THE CHIEF CONTROLLER OF FACTORIES ONRECEIPT, CONSUMPTION AND BALANCE OF SAMPLES OF

NARCOTIC DRUGS OR PSYCHOTROPIC SUBSTANCES

Signature.....,......,.................

Designation...,,.,..,................

of Indenting Officer with Rubber Stamp.l

Subs. by C.S.R. 905(E), dated 28th December, 2011, for item 5 (w-e.f.2V12-2O71).tns. by G.S.R. 639(E), dated 13th October, 2006 (w.e.t 13-10-2006).

1.

2.

91.

No.Narcotic drug/

Psychotropic substanceOpeningBalance

Receipt Consumption Closing Balance