The Narcotic Drugs and Psychotropic Substances Act, 1985

The Narcotic Drugs and Psychotropic Substances Rules, 1985

The Narcotic Drugs and Psychotropic Substances Act, 1985

Official text

THE NARCOTIC DRUGS

SUBSTANCES

AND PSYCHOTROPIC

RULES, 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)ernment

hereby 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;

(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-propdetary

rvrmes

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

Chemical nameSl. Intemational non-ProPrietary

No. names

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

stereochemical Pyran-ul

varianlr

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 acidl

1ll05A. 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- -MthYl

thioDhenethylamine)

108. GHi (r-HyAroxyt'utyric Acid)

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

hePtanoic 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-onel

4-methYlePhedrone

6[111.] Salts and preparahons of above'

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 or

llguing an import certificate or export authorisation under Chapter

VI of these rules in respect of narcotic drugs or psychotropic

substances;

(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 to

possess, 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 an

institution by whatever name called that offeis services or facilities

requiring diagnosis, treatment or care of illness, disease, iniury,

deformity or abnormality, established and administered or

maintained by the Govemment or Municipal Corporation or

Municipal Council or Zila parishad or any person or body of

personsJ

t[(hd) "patent or proprietary medicine,, shall have the same meaning as

defined in the Drug and Cosmetics Act, 1940 (23 of 19 e;lr[(he) "prescription" means a prescription given by a registered medical

pracfitioner for the supply of any of the essential naicotic drugs to a

patient for medical use in accordance with these rules;l

(i) "Proper Officer,,, in relation to any function to be pertormed under

these rules, means the officer of Narcotics Dejartment who is

assigned those functions by the Narcotics Commiisioner;l[(ia) "recognised medical institution,, means a medical institution

recognised as such under these rulesJ

1(ib) "registered medical practitioner,, means any person registered as a

medical practitioner under the Indian Vediial CounJil Act, 1956

(102 of 1956) or under any law for tlre registration of medical

practitioner for the time being in force, or re-gistered as a dentist

under the Dentists Act, l94g (1,6 of 1948) or uider any law for the

registration of dentists for the_time being in force and his undergone

training in pain relief and palliative cari for prescriDtion of esseitial

l1,l::.I".9r"C," for pain relief and pa iative cire or rraining in opioid

substitution-therapy for prescription of espential narcotiidrugs for

treatment of opioid dependmceJ

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

(k) words and

-expressiors used herein and not defined, but defined in

rne Act shall have the meanints respectively assigned to them in the

ACt.

'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 to

any laboratory in the country, which is permitted to do such analysis; Rnm Dayal v.

Centrol Narcotics Bureau, (1993\ 3 Crimes 818 (MP) (FB).

CHAPTER II

POWERS OF OFFICERS

3. Delegation of powers.-Subject to such directions as may be given by the

Central Govemment, the Narcotics Commissioner appointed by the Central

Govemment under sub-section (1) of section 5 of the Act, may authorise any

officer subordinate to him, to exercise all or any of his powers under these rules.

4. Narcotics Commissioner and other officers to exercise the powers of

their subordinates.-The Narcotics Commissioner and such other officer as may

be appointed by the Central Govemment under sub-section (1) of section 5 of the

Act 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 UI

OPIUM POPPY CULTIVATION AND PRODUCTION OF

OPIUM AND POPPY STRAW

5, Opium poppy cultivation and production of opium or poppy straw.-

The opium poppy for production of opium or poppy straw shall not be

cultivated save on account of the Central Govemment and in the tracts notified

by it from time to time and in accordance with the conditions of a licence issued

by the District Opium Officer under rule 8.

6. Fee for grant of licence.--The licence of cultivation of opium poppy may

be 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 for

cultivation of opium poppy for the production of opium or poppy straw shall be

issued in Form No. 1 appended to these rules.

8. Issue of licence.-Subject to the general conditions relating to grant of

licence notified by the Central Government*, the District Opium Officer may

issue licence to any person for a crop year for cultivation of the opium poppy for

production of opium or poppy straw on receipt of an application made by that

person in Form No.2 appended to these rules.

9. Licence to specify the ar€a, etc.-The licence for cultivation of opium

poppy issued under rule 8 shall specily the area aid designate the Plots to be

cultivated with opium poppy.

10. Designating of Lambardar.-The District OPium Officer may designate

one 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 cultivation

of 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 such

grms 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.delivered

hv 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 of

opi..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

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."

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 such

conJiscation shall be ordered by the General Manager unless the concemed

cultivator is given a reasonable opportunity of showing cause against the

proposed order and is heard in persory if he so desires.

24. Detemination of final price of opium.{l) Subfect to rule 21, the final

price of opium payable to the cultivator shall, having regard to the price fixed by

the Central Govemment under rule 19, be determined by the General Manager

on the basis of analysis report of the Chemical Examiner 1[***l and

communicated to the concemed District Opium Officet.

(2) The price payable in respect of any opium which is delivered to dre

Dishict Opium Officer or any other officer authorised in this behalf under rule

14 and is not initiallv suspected to be adulterated but found to be adulterated on

examination in the Goveinment Opium Factory, shall be subject to reduction at

such rates as may be specified by the Central Govemrnent.

25. Adjustment of cultivators' account and recovery of dues ftom the

cultivators.-The accounts of the cultivators for a particular crop vear shall be

adjusted 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 cultivators

shall be recovered and any amount due to them be paid.

26. Weights and scales.-The weights and scales to be used for weighing the

opium at the weighment centres and the Govemment Opium Factory shall be

caused to be examined at the appropriate tirne by the Deputy Narcotics

Commissioner 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, permit

cultivation of the opium poppy for the exclusive production of poppy shaw in

accordance with a licence issued under rule 8 in such tracts and sublect to such

conditions as may be specified by it, by notification in the Official Gazette in this

behalf:

Provided that the poppy straw produced by the cultivators or a result of the

cultivation of opium poppy for production of opium, shall be deemed to have

been produced under a valid licence issued under rule 8.

2E. Appeals to the Deputy Narcotics Commissioner and Narcotics

Commissioner.-(1)(a) Any person aggrieved by any decision or order made or

passed under these rules relating to refusal, withholding or cancellation of a

licence for opium poppy cultivation by an officer of the Narcotics Department,

lower in rank than the Deputy Narcotics Commissioner, may appeal to the

Deputy Narcotics Commissioner within thirty days from the date of the

communication to him of such decision or order.

O) Notwithstanding anything contained i4 clause (a), if the decision or order

regarding withholding or cancellation of licence for opium poppy cultivation is

passed by dre Deputy Narcotics Commissioner, such appeal shall lie to the

Narcotics Cornmissioner:

Provided that the Deputy Narcotics Commissioner or, as the case may be, the

Narcotics 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 to

reasons beyond his control, allow such appeal to be presented within a further

a period of thirty days.

(2) Every appeal under this rule shall be accompanied by a copy of the

decision or order appealed against and shall be in such form and in such a

marmer as may be specified by the Narcotics Commissioner in this behalf.

29. Appeals to the Chief Conholler of Factories,-{1) Any person aggrieved

by any decision or order made or passed under rule 21 or rule 23 by the General

Manager may appeal to the Chief Controller of Factories within thirty days from

the date of the communication to him of such decision or order:

Provided that the Chief Controller of Factories mav. if he is satisfied that the

appellant was prevented from submitting his appeal wiUrin the said time Iimit

due to reasons beyond his control, allow such appeal to be presented within a

further period of thirty days.

(2) Every appeal under this rule shall be accompanied by a copy of the

decision or order appealed against and shall be in such form and in such manner

as may be specified by the Narcotics Commissioner.

30. Procedure for appeal,-(l) The Appellate Authority shall give an

opportunity to appellant to be heard, if he so desires.

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

appellant 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 the

grounds of appeal was not wilful or unreasonable.

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

be necessary, pass such orders as he thinks fit confirming modifying or

annulling the decision or order appealed against:

Provided that any order relating to the quantum of adulterated opium to be

confiscated in addition to the opium already confiscated under rule 23 shall not

be passed unless the appellant has been given a reasonable opportunity of

showing cause against the proposed order.

(4) The order of the Appellate ,{uthority disposing of the appeal under this

rule shall be in writing and shall state the points.for determination, the decision

thereon and the reasons for the decision.

(5) On the disposal of the appeal, the Appellate Authority shall communicate

the order passed by him to the appellant and the officer who passed the order

or made the decision appealed against.

(6) No further appeal or revision shall lie against the order passed by the

Appellate Authority under this rule.

CHAPTER IV

MANUFACTUR4 SALE AND E)(PORT OF OPIUM

31, Manufacture of opiun.--Opium shall not be manufactured save by the

Central Goverrunent Opium Factories at Ghazipur and Neemuch:

Provided that opium mixtures may be manufach:red from opium lawfully

possessed by a person authorised under the rules made by the State Govemment

for 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 the

export is on behalf of the Central Govemment.

33, Sale to State Govemments or manufacturing chenists.-r[(1) The sale of

opium to the State Govemments or manufacturing chemists or the person or

entity who has been granted licence under sub-section (2A) of rule 36, as the case

may be, shall be only from the Govemment Opium Factories, located at

Neemuch and Ghazipur;

(2) The sale of opium from the Govemment Opium Factory at Neemuch and

Ghazipur to manufacturing chemists or the person or entity who has been

granted licence under sub-rule (2A) of rule 35, as the case may be, shall be only

under a permit granted by or under the orders of the State Govemment within

whose jurisdiction the chemist or the person or entity resides or has his place of

business 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 Sium

Factories at Neemuch and Ghazipurl;

ft) the said factory shall retain the duplicate copy for record, send the

original copy with the consignment of opium and retum the

triplicate copy to the issuing authorify after endorsing thereon the

quantity 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 the

buyer produces a valid quota allocation under rule 678.

. . (2) Every buyer of a opium derivative under sub-rule (1), shall provide

information to the Chief Controller of Factories regarding its utilization or any

other related matter in such form and within such time as may be indicated by

the Chief Controller of Factories.l

. .34. Fixation of sales price of opium.-The price to be charged for opium

sold under this Chapter shall be fixed, from lime to time, by the Central

Government in such manner as it mav deem fit.

CHAPTER V

MANUFACTURED DRUGS

- 35. Gen€ral prohibition.-The manufacture of crude cocaine, ecgonine and

its salts and of diacetyl morphine and its salts is prohibited:

a[Provided that nothing contained in this rule shall apply in case the drugs

are.manufactured by Govemment opium factory or by chemical staff employe-d

under 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 Chapter

VIIA:

Provided further that the Narcotics Commissioner shall consult the Drugs

Controller-General of India before issuhg a licence under this ChaPter.l

36. Manufacture of natural manufactured drugs.-(l) The manufacture of

cocaine and its salts is prohibited save the manufacture of cocaine hydrochloride

by the chemical staff employed under the Central Board of Excise and Customs

from confiscated cocaine.

(2) The manufacture of morphine, codeine, dionine, thebaine, dihydro-

codeinone, dihydrocodeine, acelyldihydrocodeine, acetyldihydrocodeinone,

dihydromorphine, dihydromorphinone, dihydrohydroxycodehone, Pholocodine

and their respective salts is prohibited save by the Govemrnent Opium Factory.

1[(2A) Notwithstanding anything contained in sub-rule (2), the Narcotics

Comrnissioner or such other officer as rnay be authorized by the Central

Govemment may, on and from the commencement of the Narcotic Drugs and

Psychotropic Substances (Amendment) Rules, 2004 grant a licence in Form 3

appended to these rules on such terms and conditions as may be specified in the

licence 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 Central

Govemment determines that such licence is necessary in public interest and is in

consonance with hdia's obligations under Intemational treaties, conventions or

protocolsll

4[(28) It in the opinion of the Cenhal Govemment, the licensee fails to fulfil

the purpose for which he is issued a licence under sub-rule (2A) or the terms and

conditions of the licence, the Central Govemment may, after giving the licensee

a reasonable opportunity of being heard, cancel the licence.l

(3) The manufacture of medicinal hemp shall be under a licence Sxanted by

the State Govemment on pa)'rnent of such fees and in accordance with such

conditions 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 of

the ophion that it is in public interest to do so, the Narcotics Commissioner or

any 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 in

the licence to manufacture PoPpy straw concentrate s[from poppy straw

produced from poppy cultivated under a licence issued under rule 8 of these

rulesl.

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 (wef

13-72010).

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)'

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 and

iottditio* 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 under

iub-clause (b) of clause (xi) of section 2 of the Act including the essential narcotic

drugs notified under clause (viiia) of section 2 of the Act (hereafter referred to as

the drug) but not including preparation containing any manufactured drug from

materials which the maker is lawftrlly entitled to Possess is prohibited save

under and in accordance with the conditions of a licence $anted by the

Narcotics Commissioner or such other officer as may be authorised by the

Central Government in this beha[ in Form No. 3 appended to these rules.

Explanatinn.-For the removal of doube it is hereby clarified that the licence

to manufacture a preparation containing any manufactured drug and including

the preparation notified as essential narcotic drugs under clause (viiia) of section

2 of the Act shall be regulated under the rules made by the State Govemment

under section 10 of the Act.l

2[38, Application for licence.--(1) Every application for a licence or for

renewal thereof under the proviso to rule 35 or rule 35 or rule 37 shall be in such

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

(2) A fee of rupees five thousand shall be payable to the Central Govemrnent

for 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 was

amended 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). Rule

37, 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) of

section 2 of the Act (hereafter referred to as the drug) but not including pleparation

containing any manufactuted drug from materials which the E|aker i5 lawfuly entided to

possess is prohibited save under and in accordance with the conditions of a [Clnce grand

by the Narcotics Commiisioner or euch other officer as may be authorised by the Cenkal

Covemment 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 covernment

for 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 was

amended by G.S.R. 350(E) dated 25th June, 1997 (w.e.L 27+7997) and by G.S.R. 95(E), dated

4th February, 2004 (w.e.f. +2-2004). Rule 38, beiore substitution by G.s.R. 359(E) dated 5th

Mat 2015, stood as under:

"38. Aqlication for liaznce.-Every application for a licence or for renewal thereof under

rule 36 or rule 37 or under the proviso to rule 35 shall be in such form as may be specified

by 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 rule

37, the Narcotics Comrnissioner shall issue or renew the licence in Form No. 3

within thirty working days from the date of receipt of such application.

(4) In case the licence is not issued or renewed within the period specified

in sub-rule (3), the Narcotics Comrnissioner or any other officer authorlsed by

him in this regard shall inlorm the applicant the ieasons thermf.l

1[39. Commencement of manufacture,{1) A person who has been issued a

licence under rule 36 or rule 36A or rule 32 shali not commence manufacture

lth9lt 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 section

10 of the Act_by State Government of the State in which he has his place of

business, for the possessiory sale and distribution of the drug.

(2) The licencee shall send copy of the licences specified in sub-rule (1) to the

Narcotics Commissioner before commencement of manufacture of the drug.

(3) In the event of revocation of licence issued under the Drugs and

Cosmetics Act, 1940 (23 of 1.940) for the manufacture of the drug or ttie rules

framed under section 10 of the Act by State Government of the Sitate in which

he 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, shji

be deemed to be revoked.l

, 40. Manufacture only from _materials lawfu y possessed._21(l)l The

lrcensee shali not manufacture the drug save from mat6riils which he is iiwfutty

entitled to possess.

3[(2) The licencee shall not manufackure the drug without allotment of quota

for 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 was

amended 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 under

the 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 nrles

ftamed under section 10 of the Act by State Govemment of the Stite in which he has

his 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 issuing

authority for the due observance of the conditions of the lictnce and has fumished

proof 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 the

application 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 to

the condition that beforc commencing of the manufactutg the licensee sha obtain the

licence6 req,uLed as per the Drugs and Cosmetica Act, 1940 (23 of 1940) Irom the authority

in-charge of drug conhol in the State and the licence i66ued by the State Govemment under

section 10 of the Act, or any other licence required under any other law for the time being

in force.".

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

15.20ls).

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 drug

to be manufactured by a licensee including the following:-

(a) quantity allotted by the State Govenunent for processing into any

preparation in licensee's own manufacture;

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

counfry;

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

year does not exceed the estimated requirements of this country for the relevant

year as furnished to the Intemational Narcotics Control Board.

42. Security arrangements.-The licensee shall ensure all necessary security

arrantements in the manufacturing premises as may be specified by the issuing

authority.

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 issuing

authority 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 beyond

the control of the licencee.l

(2) The licencee shall give at least fifteen days notice in writing to the issuing

authority prior to the date of recommencement of manufacfure of the drug after

cessation of manufacture of the drug as mentioned at sub-ruIe (1).1

45. Possession, sale and diskibution.-The licensee shall not possess or sell

or distribute the drug otherwise than in accordance with the rules made by the

State Govemrnent under the Act.

3[45A. Destruction of drugs,-(l) A licencee seeking to destroy the drug

shall apply to the Narcotics Comrnissioner in such form and marurer as may be

specified by the Narcotics Commissioner.

(2) The Narcotics Commissioner shall, within a period of thirty days from the

date of receipt of an application under sub-rule (1), appoint a committee

comprising a Gazetted Officer in the office of the Narcotics Commissioner, or

Subs. by G.S.R. 359(E), dated sth May, 2015, for rule 43 and rule tl4 (w.e.f. 5-5-2015). Rule 43

and rule ,14, before substrfutro& rtood as mder:

"43, Adoance notice hr cotnmencefient and ccss^tion of rn4nufacture.--fr€ licensee shall give

at least 15 days' notice in witing to the issuing authority of the date on which he proposes

to comrnence manufacture of the drug and at least one month's notice before he ceases to

manufacture the same.

44. Czssation of manufacllre.-Wherc the lic€nsee ceases manufactu.ring opeEtions fo! any

reasons whatsoever, he 6ha[ forthwith inlorm the issuing authority in thi6 behaff indicating

the date on which he prcpo6es to recomanence dunufacture:

Provided that the issuing authority may prohibit all futther manufacture in case the p€riod of

cessation 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), dated

the. 17th March, 1986, Superintendent of Central Excise of the concemed range

and. an authorised representative of the applicant for supervising the deskuctiJn

of the drug and such destruction shall be carried out within a-period of thirtv

days from the appointment of the committee

(3) The destruction of the drug shall be carried out in accordance with the

provision of the relevant laws for the time being in force.l

45. Maintenance of accounts and submission of retums.-The licensee shall

maintain true accounts of all transactions including the accounts of materials

used for the manufacture of the drug the quantities manufactured, sold or

otherwise disposed of and fumish returns in such forms and in such manner as

may be specified by the Narcotics Comrnissioner.

47,. Inspection of stocks, etc.{l) The stocks of the drug and the materials

used for its manufacture and all accounts and records of transactions relatine

thereto., shall be open to inspection by any officer authorised by the issuin[

authority.

(2) A serially numbered lnspection Book shall be maintained by the licensee

in good condition for the use of such officer.

48. SuEpension and revocation of licence.-(l) Without prejudice to anv

action that may be taken under the provisions of the Act, the issuing authority

may suspend or cancel a licence-

(i) if the licence is transferred or sublet without the prior approval of

the 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 in

force in any State.

(2) No order shall be passed under sub-ruIe (1) unless the liceruee has been

given a reasonable opportunity showing cause against the said order or is heard

in persory if he so desires.

49. Appeal.-(l) The licensee may file an appeal against the decision or order

made or passed under rule 48 ta-

(i) the Narcotics Commissioner where such decision or order was made

or 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 of

Additional Selretary to the Govemment of India, authorised by him

in 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 AND

USE OF ESSENTIAL NARCOTIC DRUGS

52A. Possession of essential nalcotic drug.-(l) No person shall possess any

essential narcotic drug otherwise than in accordance with the provisions of these

rules.

(2) Any person may possess an essential narcotic drug in such quantity as

has been at one time sold or dispensed for his use in accordance with the

provisions of these rules.

(3) A registered medical practitioner may possess essential narcotic drug, for

use 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

TABLE

Sl. No.

(1)

Name of the essential Narcotic Drug Quantity

(2) (3)

1. Morphine and its salts and all preparations containing

more than 0.2 per cent. of Morphine 500 Milligrammes

2. Methyl morphine (commonly known as ,Codeine,) and

!,thyl morphine and their salts (including Donine), all

ollunons and preparations except those which are

compounded with one or more-other hgredienS and

containing not more than 100 milligrammes of the drug

per dosage unit and with a conceniation of not more "

than 2.5% in undivided preparations and which

have been established in- therapeutic practice

2000 Milligrammes

Oi\f!px1 Codeinone (comrnonly known as O,<y-oaonu

and Dihydroxycodeinone), its sa[ts lsuch as Euc;dal

Boncodal Dnarcon Hydrolaudin, Nucodan, percodan,

Scophedal, Tebodol and the like), its esters and the salts

of its ester and preparation, admixture, extracts or

other 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 any

of these drugs

320 Milligrammes

1-phenethyl-4-N - propionylanilino-piperidine (the

intemational-non-proprietary name of which is

Fentanyl) and its salts and preparationg admixture,

extracts or other substances containing any of these

drugs

Two transdermal

patches one each of

12.5 microgram per

hour and 25

microgram per hour:

Provided that the Controller of Drugs or any other officer authorised in this

behalf by him may by special order authorise, G Form 38, any such practitioner

to possess the aforesaid drugs in quantity larger than as spe;ified in the above

Table:

Provided further that such authorisation may be gnnted or renewed, for a

period not exceeding three years at a time.

-. Explanation. --:fhe expression "for use in his practice,, covers only the actual

direct administration of the drugs to a patient under the care of the regisiered

medical practitioner in accordance with established medical standar-ds and

Prac 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 days

before the expiry of the previous authorisation.

(5) (a) The Controller of Drugs may, by order, prohibit any registered

medical 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 such

possession 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 Drugs

the essential narcotic drug then in his Possession and the Controller of Drugs

shall issue orders for the disposal of such drugs.

(5) The Controller of Drugs may, by a genetal or special order, authorise any

person to possess essential narcotic drug as may be specified in that order.

(7) A recognised medical institution may Possess essential narcotic drug in

such 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 these

rules 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 narcotic

drug in such quantity, and in such manner as may be specified in the licence

issued under these rules.

528. Provisions regarding licenced dealer and licenced chemist.-(l) A

licenced 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 narcotic

drug to the authority competent to issue licence to Possess, sell, exhibit or offer

for sale or distribution by retail or wholesale, manufactured drugs under the

rules framed under section 10 of the Act by State Govemrnent of the State in

which he has his place of business.

(2) Every application for issue of licence refened to in sub'rule (1) shall be

in such form and manner as may be specified by the authority referred to in the

said sub-rule.

(3) The licence to possess, sell, exhibit or offer for sale or distribution by retail

or wholesale, essential narcotic drugs shall have the same conditions as are

applicable to a licence to possess, sell, exhibit or offer for sale or distribution by

retail 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 be

sDecified 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 narcotic

dryg ,-Any person who is permitted to possess essential narcotic drug under

rule 52A may import inter-State or export inter-State such drug upto the quantity

he is permitted to possess.

52D, Transpod of essential narcotic drugs,-{l) Subiect to the provisions of

rule 52C, no consignment of essential narcotic drugs shall be transported,

imported inter-State or exported inter-State unless such consignment is

accompanied by a consignment note in Form No. 3C and in the manner as

provided in sub-rules (2) and (3).

(2) The consignment note referred to in sub-rule (1) shall be prepared in

triplicate, and the original and duplicate copies of the said note shall be sent

along with the consignment of essential narcotic drugs to the consignee who

shall retum the duplicate copy of the note to the consignor for his use after

errdorsing on the original and duplicate copies, the particulars of the receipt of

the quantity consigned.

(3) The consignor and coruignee shall preserve such consignment note

referred to in sub-rule (1) for a period of two years:

Provided that the said consignrnent note shall not apply in cases where the

sale of the essential narcotic drug is accompanied by a sale liill or lnvoice or cash

memo or any other document duly signed by the consignor or his authorised

signatory, which shall include the following information about the

consignment:-

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

consignee;

(b) description, batch number and quantity;

Provided further that such documents shall be preserved by the consignor

and consignee for a period of two years.

Explanation.-Where the consignee is a person to whom the essential narcotic

drug has been sold or dispensed for his personal use, research institutio&

registered medical practitioner, recognised medical institutiory or hospitat, the

requirement of incorporating licence number of the consignee shall not be

applicable.

52E. Transmission of essential narcotic drugs by post, courier, rail or

road,-The transmission of essential narcotic drugs by inland post or courier or

by rail or by road by a manufacturer, licensed dealer or licensed chemist is

permitted, subject to the following conditions, namely:-

(i) the parcel of the essential narcotic drugs when sent by post shall be

sent by registered posq

(ii) the parcel of essential narcotic drugs shall be accompanied by a

declaration showing the names of consignor and consignee, the

contents of the parcel in detail, the number of licence or

authorisation 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 a

licencee, 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 may

be, 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 essential

narcotic drugs otherwise than on prescription to-

(a) a manufacturer who has been issued a licence under rule 3Z of these

rules or a manufacture of preparations of essential narcotic drugs

who has been issued a licence under the rules made bv the Stare

Govemment under section 10 of the Act;

(b) a licenced dealer;

(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 prescnptron

and subiect to the provisions of the Drug and Cosmehcs"Rutei, fS4S.

. (3) A recognised medical institution shall dispense or sell essential narcotic

drugs in such manner as specified in these rules.

52G. Registered medical practitioner and conditions relating to their

prescriptions.-No prescription_for the supply of essential narcotic ;rugs shall

?e g]v_gn by a registered medical practitioner otherwise than in accordanie with

the lollowtng conditions, namely:_

(i) the prescription shall._be in writin& dated and signed bv the

practitioner with his full name, address and registration number and

shall specify the name and address of the -person to whom the

prescription is given and the total quantity of the essential narcotic

drug to.be supplied alongwith- daily dose and period of

consumPtron:

Provided that where such drut to be supplied on the prescription

ls a patent or proprietary medicine, it shall be sufficient to state the

quantity 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 dflrgs

otherwise than on prescription tcl"-

(a) a licenced dealer;

(b) a licenced chernist;

(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;

'-' 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 in

person, if he so desires.

(2) The said Appellate Authority may, at the hearing of an appeal allow the

appellant to raise any other ground not specified in the appeal, if the Appellate

Authority is satisfied that omission of that ground was not willful or

unreasonable.

(3) The aforesaid Appellate Authority mav, after making such further

inquiry 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 this

rule shall be in writing and shall state the points of determinatiory the decision

thereon 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 writing

to 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 as

may be in- the possession of an authorised persory on the expiry or cancelition

or surrender of his authorisation, shall be disposed of in such malner as may be

specified by the Controller of Drugs in this behalf.

_ (2) The expired stock of essential narcotic drugs as may be in the possession

of an authorised person or a registered medical prictitionei shall be ddstroyed in

such manner as may be specified by the Controller of Drugs.l

IICHAPTER VB

SPECIAL PROVISIONS RELATING TO

RECOGNISED MEDICAL INSTITUTION

52N. Government, etc. hospital, dispensary to be deemed recognised

medical institution.--Govemment or Municipil Corporation or Muiicipal

Council or Zilla Parishad hospital, dispensary or medical^institution, with at leist

one registered medical practitioner possessing a minimum qualification of a

detr. ee.in rnedicine.or dentistry and who has undergone training in pain relief

and.palliative care for.prescription of essential narcodc drugs for"pain'relief and

pa ia.tiv5 care

.or -

training h opioid substitution therap/ for prescription of

essential narcotic drugs for treatment of opioid dependenci, who'shall prescribe

and drspense essential narcotic drugs, shall be deemed to be a recognised

medical instihrtion under these ruleJ for possessing, dispensing or se lng of

essential narcotic drugs for medical purpose.

_ Explanation.-For the removal of doubts it is hereby clarified that

Covemment or Municipal Corporation or Municipal Council 6r Z la parlshad

hospital, dispensary and medical _institution, shallbe exempt only from making

application to the Controller of Drugs for recogrrition aj recognised medicai

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 drugs

for 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 of

Rccoe;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 authorised

by 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 of

previous 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 issued

under rule 52-O by the Controller of Drugs.

(4) Whenever there is a change in the designated medical practitioner or the

over-all in charge, as the case may be, the recognised medical institution shall

inform the Controller of Drugs within seven days from date of such change for

appropriate endorsement on the Certificate of Recognition.

52R. Duties of designated medical practitioner.-(1) The designated

medical practitioner or the over-all in charge, as the case may be, shall,-

(a) register the patients to whom essential narcotic

dispensed or sold for medical use only;

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

drugs shall be

patient, which

shall be preserved for a minimum period of two years from the date

of last entry;

narcotic drugs in Form No. 3H, which shall be preserved for a

minimum 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 the

subsequent year in Form No. 3-I to the Conholler of Drugs.

(2) In the event of any change in the constitution of the recognised medical

institution, the_ designated medical practitioner or the over-all in-charge, as the

case may be, shall inform the Controller of Drugs in wrifing rvithin thlrty days

from the date of such change for issue of fresh llertificate 6f Recognitioi.

52S. Surrender of recognition.-(l) A recognised medical institution may

surrender its recognition by giving not less than thirty days, notice in writing to

the Controller of l)russ. ' -

_ (2) On surrender J the recognitiory the essential narcotic drugs as may be in

the possession of the recognised medical institution shall be disposed of in such

manner,_ incl rrling transfer to another recognised medical institution, as may be

specified by the Controller of Drugs.

_ -52T. Estimates of requirement.-(1) Every recognised medical irstitution

shall submit an estimate of its annual requirement of lssential narcotic drugs in

lorm !o 3J by the 30th November o? the preceding calendar year to" the

Controller of Drues.

(2) If the requirement of a recognised medical institution exceeds the aturual

estimate submitted to the Controller of Drugs, it shall submit a revised estimate

by the 31st August of the calendar year io which the said annual estimate

pertains, to the Controller of Drugs.

Explanation.-For the removal of doubts it is hereby clarified that a

recognised rnedical institution may sell and disburse esseniial narcotic drugs

over and above the quantity indicaGd in the estimate submiited to the Controllir

or Lrru.gs as specified in this rule, but the designated medical practitioner or the

over-all in_charge, as the case may be, shall r6cord a brief justification for such

increase 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 drug

submitted 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 in

these rules, where home care treatrrent is provided to a Patient registered with

a 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 or

ihe 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 of

opioid 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 VI

IMPORT. EXPORT AND TRANSHIPMENT OF NARCOTIC

DRUGS AND PSYCHOTROPIC SUBSTANCES

1[53. General prohibition.-ImPort into and export out of India of the

narcotic drugs and psychotroPic substances is prohibited excePt with an imPort

certificate oi expori airthorization issued under the provision of this Chapter;

Provided that import into India or exPort out of India of the narcotic dru8s

and psychotropic substances specified in Schedule I of these rules shall be for the

purpose 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 the

Govemment 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 was

amended by G-S.R. 350(E), dated 25th Jttrg, 1997 (w.e.t.2741997\. Rule 53, before

substifutio[ stood as under:

"5j, Geaenl prohibitior.-Subiect to the other provisions of this Chapter, the impoit into

and export out of India of the narcotic drugs and psychotropic substances specfied in

Schedule I is prohibited:

Provided that nothing in this rule shal apply in case the drug substance is imPorted into

or exported out of India subject to an import cedificate or export authorisation jssued under

the 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 53A

was ins€rted by s.O. 599(E), dated 10th Au8ust, 1993 (w.e.t 10+1993) and amended by

G.s.R. 556(E), dat,ed l4th Jul'', 195 (w.e.f. 2U7-1995). Rde 53A, before omi6sion, stood as

under:

"534. (1) Subject to the provisions of suhrule (2), no person shall exPort any of the

narcotic drug or psychotropic substance or preparation containitrg any of such rurcotic drug

or psychotropic substance specified in [Schedule ] lo the cormtries or to t]le region of such

country sp€cified thereirL

(2) Notwithstanding anything contained in sub-ru.le (1) above, the Narcoucs

Comrnissioner rnay authoris€ export of 6pecified quantities of such narcotic drug or

psychohopic substance or preparation containing such narcotic dtug or psychotropic

substance on the basi6 of $pecial import licence issued by the Competent Authority oI the

country mentioned in Schedu.b n which intends such import by way of issuance of special

import licence. The shipment of the consignment so allow€d shall be accompanied by a

copy 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 small

quantities of morphine, codeine and thebaine and their salts not exceeding a total

of 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 as

may 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 narcotic

drug, or psychotropic substance 3[..*] shall be imported into India without an

import 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) in

relation to narcotic drug shall submit along with his application the original or

certified copy of the excise permit issued by the concemed State Government.

s[(3) Every application for an import certificate shall be in such form alid

manner and provide such details as may be specified by the Narcotic

Commissioner.]

6[(4) A fee of rupees one thousand shall be paid to the Central Govemment

alongwith ihe appliiation under sub-rule (1.1 foi issue of each import certificate

under this rule.l

56. Issue of import certificate.-7[(1) The Narcotics Commissioner shall issue

or deny the import certificate referred to in sub-rule (1) of rule 55 within a period

of twenty one working days from the date of receipt of an application completed

in all respects and in case the import certificate is not issued within the stipulated

time period or denied, the Narcotics Commissioner or any other officer

authorised 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:-

Subs. by C.S.R. 470(E), dated 21st June, 2011, for "during a financial year for analytical

purposes 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 by

the 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 been

paid."

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 importer

who should hansmit the original copy to the exporting country

and shall produce the duplicate copy at the Customs House,

Land Customs Station or Airport where the consignment anives

or, in the case of imports by parcel Post, at the post office of

delivery, in order to obtain delivery of the consignment of

narcotic drugs or psychotropic substances;

(ii) the l[Commissioner of Customs] or Post Master shall state on the

copy presented by the irnporter that the narcotic drugs or the

psychotropic substances have actually been imported and retum

the document to the importer who shall indicate on it that he has

received the goods;

(iii) the importer shall retum the duplicate copy of the import

certificate incorporating the endorsement from the

l[Commissioner of Customs] or Post Master and his own

endorsement to the issuing authority-(1) where the import

certificate relates to narcotic drug, through the excise authorities

of the State from which excise permit for purposes of sub-rule (2)

of rule 55 was produced; (2) where the irnport certificate relates

to psychotropic substance, tfuough the Drugs Controller of the

concemed State;

(b) triplicate copy should be supplied to the l[Commissioner of

Customs] concemed who shall retum it to the issuing authority

along with the copy of the export authorisation to be received at the

time of receipt of the consignment from the Govemment of the

exporting country, with an endorsement as to actual quantity of

narcotic drugs or psychotropic substances cleared;

drug should be supplied to the excise authorities of the State into

which the narcotic drug is to be imported, and the said copy of the

certificate in relation to psychotropic substance should be supplied

to the Drugs Controller of the concemed State for comparison with

the 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 the

exporting country for comparison with the copy fumished to them

by 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 the

importation of the quantity of the concemed drug or the substance in more than

one 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 be

allowed to be transited through lndia unless such consignment is accompanied

by a valid export authorisation in this behalf, issued by the Govemmenf of the

exporting 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 psychotropic

substances which are essentiaffor treatment of or medical ai-d to, any person on

board the ship or aircraft.

58. Application for export authorisation.-2[(1) No narcotic drug or

psychotropic substance shall be exported out of India without an export

authorization issued by the issuing authority in respect of the consignmeni, in

Form No. 5 appended to these rules.l

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

submit,-

(a) where the export authorisation relates to narcotic drug along with

his application the original or an authenticated copy of the excise

permit issued by the concemed State Governmenu and

(b) the import certificate in original, issued by the Govemrnent of the

importing country certifying the official approval of the concemed

Govemment.

3[(3) Every application for an export authorization shall be in such form and

manner and provide such details as may be specified by the Narcotic

Comrnissioner.l

3[(4) A fee of rupees one thousand shall be paid to the Central Govemment

along with the application under sub-rule (1) for issue of each export

authorization under this rule.l

59. I8sue of export authorisation.-a[(1) The Narcotics Commissioner shall

issue 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 the

Schedule of the Act, shal be exported out of India without an export authodsation in respect

of 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.fied

by the Narcotics Comfilssioner.

(4) No export authorisation shall be iesued unless a fee of rupees one thousand has been

paid."

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,2015

tw.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 authority

indicating on it thi date of export and the quantity exported;

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 additional

number oi iopies of export authoriJation as may be required shall be prepared

and 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 and

rule 53, no consignment of narcotic drug, or psychotropic substance 4f*r! shall

be allowed to be iranshipped at any port in India save with the permission of the

s [Commissioner of Customs].

51, Procedure for transhipmenl-The s[Commissioner of Customs] while

allowing any consigrunent of riarcotic drug or psychotropic substances, 4[***] to

be 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] shall

take 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 a

consignment to a country other than that named in the accompanying copy of

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

the export authorisation subiect to the production of export authorisation issued

by the issuing authority as provided under rule 58, as if the diversion were an

export from India to the country, or territory of new destination.

(b) The l[Commissioner of Customsl shall inforrn the issuing authority

regarding the actual quantity of the narcotic drug or psychotropic substance, thl

diversion of the consignment of which was allowed under clauie (a), whereupon

the issuing authority shall, inform the country from which the export of the

consignment originated.

63. Prohibition of import and export of consignments through a post office

bo&- etc,-The import or export of consignments of any narcotic drug or

psychotropic substance through a post office box or through a bank is prohibited.

CHAPTER VII

PSYCHOTROPIC SUBSTANCES

2[64. Manufacture of psychotropic substances.-(1) No person shall

manufacture any of the psychotropic substances except in accordance with the

conditions of a licence granted under the Drugs and Cosmetics Rules, 1945

(hereinafter referred to as the 1945 rules) framed under the Drugs and Cosmetics

Acl, 1940 (23 of 1940), by an authority in-charge of Drugs C6ntrol in a State

appointed by the State Covemment in this behalf:

Provided that a licence to manufacfure a psychotropic substance specified in

Schedule 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 State

shall consult the Narcotics Commissioner before issuing a licence to manufacture

a psychotropic substance specified in Schedule I.

(2) The authority in charge of drugs control in a State (hereinafter referred

to as the Licensing Authority) shall consult the Narcotics Commissioner with

regard to the assessed aruural requirements of each of the psychotropic

substances in bulk form referred to in sub- rule (1) in the country and taking into

account the requirement of such psychotropic substances in the Statg the

quantity of such substance required for supply to other manufacturers outside

the State and the quantity of such substance required for reasonable inventory to

be held by a manufacturer, shall specify, by order, the limit of the quantity of

such substance which may be manufactured by the manufacturer in the Stite.

(3) The quantity of the said psychotropic substance which may be

manufachrred by a licensee in a year shall be intimated by the Licencing

Authoriiy 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 substances

specified 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 in

Schedule I shall be in accordance with the conditions of a licence Sranted under the Drugs

and Coshetics Rules, 1945 (hereinafter referred to as the 1945 Rr.rles) framed under the

DrLrgs and Cosmetics Act, 1940 (23 of 1940), by an authority in charge of Drugs Control in

a State appointed by the State Goveriment in this behalf:

Provided that the authoity in charge of dru8 control in a State lcfeffed to abovc may

issue a licence to manufacture a psychohopic slrbstance sPecified in Schedule IU for the

purpos€ of export only;

(2) The authority in charge of drugs control rn a State (hereinafter refeffed to as the

Licensing 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 psychokopic

substances in the State, the quantity of such substance required for supply to other

manufacturers outside the State and the quantity of such substance reqdred for rcasonable

inventory to be hcld by a manufacturer, shall specify, by order, the limit of the quantity of

such 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 time

of issuine the licence:

Provided that nothing contained in this rule shall apply in case the psychotropic

srrbstances specified in Schedule I are manufactured, possessed, transported, imported

inter-State, exported inter-State, sold, purchased, consrmed or used subject to other

provisions of this Chapter which applies to psychotropic substances which are not included

in Schedule I dnd for the purpos€s mentioned in Chapter VIIA:

Provided further that the authority in charge of the drug conhol in a State

referred to in sub-ru]e (2) of rule 65 shal consult the Narcotics Commissioner before issuing

a licence under lule 65 in respect of psychotropic substances included in Schedule I and

Schedule 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 the

Secretary, Govemment of India, Ministry of Finance, Department of Revenue or

any other officer, not below the rank of Additional Secretary to the Govemment

of India, authorized by him in this behalf, within thirty days from the date of

communica tion of such order.

(7) Every memorandum of appeal shall be accompanied by a copy of the

order appealed against.

(8) The Appellate Authoriry shall, after making such further inquiry as may

be considered necessary/ pass such orders as it thinks fit, confirming, modifying

or 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 of

every year.l

1[65A. Sale, purchase, consumption or use of psychotropic substances.-No

person shall sell, purchase, consume or use any psychotropic substance except in

accordance with the Drugs and Cosmetics Rules, 1945:l

2[Provided that sale, purchase, consumption or use of a psychotropic

substance specified in Schedule I shall be only for the purposes mentioned in

Chapter VIIA.I

66, Possession, etc., of psychotropic substances.-3[(1) No person shall

possess :!ny psychotropic substance for any of the purposes covered under 1945

rules, unless he is lawfully authorized to possess such substance for any of the

said purposes under these rules:

Provided that possession of a psychotropic substance specified in Schedule

I shall be only for the purposes mentioned in chapter VIIA.I

(2) Notwithstanding anything contained in sub-rule (1), any research

institution or a hospital or disPensary maintained or supported by Govemment

or local body or by charity or voluntary subscription, which is not authorised to

possess any psychotroPic substance under the 1945 Rules, or any Person who is

not so authorised under the 1945 Rules, may Possess a reasonable quantity of

such substance as may be necessary for dreir genuine scientific requirements or

genuine 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 or

dispensary 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

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 the

consignee;

(b) description, batch number and quantity;

Provided further that such document shall be preserved by consignor and

consignee for a period of hvo years for inspection by the officers referred to in

sub-rule (4) above.

Explanation.-Where the consignee is a research institution, registered

medical practitioner, hospital or dispensary, the requirement of incorporating

licence number of consignee shall not be applicable.l

IICHAPTER VIIA

SPECIAL PROVISIONS REGARDING MANUFACTURE,

POSSESSION, TRANSPORT, IMPORT-EXPORI PURCHASE

AND CONSUMPTION OF NARCOTIC DRUGS AND

PSYCHOTROPIC SUBSTANCES FOR'IMEDICAL,

SCIENTIFIC AND TRAINING PURPOSESI

674. Notwithstanding anything contained in the foregoing provisions of

these 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 or

abroad;

(ii) very limited medical requirements of a foreigner by a duly

authorised person of a hospital or any other establishment of the

Govemment especially approved by that Govemment;

(iii) the purpose of de-addiction of drug addicts by Govemment or

local body or by an approved charity or voluntary organisation

or by such other institution as may be approved by the Central

Government.

3[or the authority exercising the powers under sub-clause (iv) of

clause (a)l

3[(iv) the purpose of restraining or immobilising wild animals by or

under the authority of the Government and approved by that

Govemment.l

(b) persons performing medical or scientific functions 3[or the authority

exercising the powers under sub-clause (iv) of clause (a)l shall keep

records 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 SCIENTIFIC

PURPOSES" (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);

dispensed for use to a foreigrer Pursuant to medical Pres:riPliol

only from the authorised licensed pharmacists or other authorised

retiil dishibutors designated by authorities responsible for public

health.l

It67B, (1) Notwithstanding anything contained in these rules, the

government Opium and Alkaloid works may pr(rure, manufacture or imPort

and supply narcotic drugs and psychotropic substances as may be required as

samples by various drug law enforcement agencies, testing laboratories and

haining institutions of the Central and State Govemments.

(2) The Govemment Opium and Alkaloid Works may also supply samples

to organisations other than those covered by sub-rule (1) with the prior approval

of the Cenhal Govemment.

(3) Any enforcement agenct laboratory, haining institution or organisation

requiring the samples shall apply to the Chief Controller of Factories in Form

No. 8.

(4) The quantities of varioug narcotic drugs and psychotropic substances to

he supplied as samples shall be determined by the Central Govemment from

time to time. The organisation obtaining the samples shall designate an officer,

at the time of sending the request for samples, in whose custody the samples

shall be kept.

(5) The organisation requisitioning the samples shall maintain records and

submit 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 a

record of the quantity of drug taken out for training and the quantities actually

used.l

r[67C. Notwithstanding anything contained in these rules, the Narcotics

Commissioner may permit import or export of narcotic drugs and psychotropic

substances for the purpose of controlled deliveries, investigations, intelligmce

collection scientific analysis.l

2ICHAPTER VIIB

REPORT' RETURNS AND ESTIMATES UNDER

INTERNATIONAL CONVENTIONS

67D. Submission of rrcports and retums under intemational conventions.-

(1) All reporS and retums which are required to be submitted under any

intemational convention, shall be submitted to an international agenry by such

officer 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).

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 may

be necessary to submit the retums under sub-rule (1), from the Narcotics

Commissioner, the Chief Conholler of Factories or any other officer of the

Central Govemrnent or any State Government indicating the format in which the

information 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 in

the 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 not

available.

67E. Estimates and quotas.--(1) If, estimates of requirement of any narcotic

drug have to be submitted under any intemational conventioD resolution or

commitment, the same shall be submitted to an intemational atmcy by such

officer 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 by

intemational agencies for India shall be allotted as quotas to users within the

country by such officer as may be notified by the Central Govemment by

notification in the Official Gazette from time-to-time.

(3) The users to whom such quota is alotted shall not exceed the quota

allotted to him and shall submit to the officer appointed under sub-rule (2), such

statistics of consumption and use of the narcotic drugs and r{ithin such time as

may be indicated by the officer.l

CHAPTER VIII

MISCELI,ANEOUS

68. Repeal and savinge.-(l) The Central Opium Rules, 1934, the Dangerous

Drugs (Inport, Export and Transhipment) Rules, 1952 and the Central

Manufactured Drugs Rules, 1952 are hereby repealed.

(2) Notwithstanding such repeal, anything done or any action taken or

purported 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 of

these rules.

IISCHEDULE I

(See rules 53 and 64)

I. Narcotic drugg

1. Coca Leaf

2. Cannabis (Hemp)

3. (a) Acetorphine

O) Dacetylmorphine (Heroin)

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 of

these drugs.

II. Psychotropic subotances

International non-prcprietary

nameS

Chemical names

Mephedrone (RS)-2-methylamino-1 -

(4-methylphenyl) propan-1-one

Salts and pr€para tions

of abovel

,t.*l

,t*-l

'*ii+s*ln-*s#i#i-g,ggr*ll*l'im

I 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:'11

P.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;;

a-x

(')

-r'l

Si8nature and S€al

District Opium Officei

(Enhies to b€ made at the time of final

il** g-* ̂"og4t*'o'9"t

Clas3 of

opium as

assigned

by D.O.O

Weight of

opium

(K8J

Assumed

weight at

70'c(K8.)

Price

payable

on the

basis of

assum€d

weight

70<

witiheld

pending final

examination

of oPium at

factorY

paid at

weighEEnb

Total

weight of

opium at

70"C on

the basis of

factory's

fePor(

Average

yield of

the

cultiva-

tor

lotal

amount

payable

on the

basis ot

factory

repott

Amount

already

paid at

the time

of weigh-

ments

Amount

paid /

received

at the

time of

final

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 POPPY

CULTIVATION FOR PRODUCTION OF OPIUM OF POPPY STRAW

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

Name of the Cultivaror

Father'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, in

whose name?........

:t:11". ,h..,plq, specified. in column 4 has irigation faciliries (kind of irrigation

lacllitres 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 proscribed

trom poppy cultivation or was de-licensed

for tendering adulterated opium, excess cultivntion,

violations of Departmental instructions. If so, the

year and the reasons for proscription.,........,....,...,..

. I hereby certify that the particurars shown above are correct and the land in which

oprum poppy is to be oltivated is lree from litigation.

Attestation

(to be made by Lambardar)

Signature/Thumtsimpression

of 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 licence

1. 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 by

the Licensing Authority.

3. The licensee shall not manufacture or keep the drug or the materials used for the

manufacture of the drug at any other place except his place of business.

4, The licensee shall ensure manufacture of the drug to the standard and

specifications 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 Licensing

Althority in the form specified for such renewal, at least thirty days bifore the expiry o7

nts ltcence.

6. The licensee shall inform the Licensing Authority in writing in the event of any

change 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, the

curent licence shall be deemed to be valid for a maximum period of ihree months from

the date on which the change takes place or the normal ex6irv of the licence whichever

is earlier unless in the meintime, i fresh licence has be6n iaken from the Licensing

Authority 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 and

Psychotropic 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 and

the 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 and

Psychotropic 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 straw

produced in the fields licensed for the PurPose,

premises and shall be produced at the request of an officer detailed for the purpose by

the 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 in

the c;stihrtion of the firm takes place, the cut.int licence shall be deemed to be valid for

a maximum pedod of three months from the date on which the change takes place or

normal 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 in

agrioltural practices;

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

",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 flom

time.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 ESSENTIAL

NARCOTIC DRUGS BY REGISTERED MEDICAL PRACTITTONER

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

.....................is hercby authorised to possess the following essential narcotic drugs on

the premises situated at.,.,............for use in his practice.

Narne of essential narcotic drug Quantity

(2\

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

3. The authorisation is subiect to the conditions stated below and to such other

conditions as may be specified under the Narcotic Drugs and Psychotropic Substances

Act, 1985 (61 of 1985) and the rules made lhereunder,

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

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

Conditionc of authorisation

1, This authorisation is not transferable.

2. This authorisation and any certificate of renewal in force shall be kept on the

approved premises and shall be produced at the request of an officer detailed

for the purpose by the issuing authority.l

{FORM NO. 3C

(S€? rule 52D)

CONSTGNMENT NOTE

Dabe 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 the

Trade Marks, Prc

essential narcotic drugs showing

)rietary Names, Batch number, etc.

Number

of packages

Quantity

Gross Net

5. Mode of hansport (particulars of the transporter, Registration

number of the vehicle or Railway Receipt./lorry Receipt, if

the 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 per

d€scription and quantity mentioned at serial number 4

aDove

Yes / No (If 'no',

details to be

mentioned 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 containing

consignment note indicating the number of pages contained in the consigrunent

note.book.

(3) The consignor shaU maintain a Register showing the details of the books of

consignment note brought in us€ during a palticular year.

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

of transaction.

(5) The records referred to in this note shall be produced before the concemed

authorised officers whenever called upon during the course of their insPection/

investigation.l

{TORM NO. 3D

[See rule 52H(2)]

DAILY ACCOUNTS OF ESSENTIAL NARCOTIC DRUGS

TO 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 Form

No. 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)l

APPLICATION FOR ISSUE/RENEWAL OF CERTIFICATE OF

RECOGNITION AS RECOGNISED MEDICAL INSTITUTION

Name

Complete postal address (with contact number, if any)

Bdef description of the illness

Wirether registered ivith any other registered medical

practjtioner/recognised medical institution

(lf ycs, detail. to te recoded)

Details of the .'ssential narcotic drugs dispensed

Name of the essential

nalcotic drugs

9ignature,/Thumb

impression of

the patient

Notei

1. Name and complete postal address of the institution with

telephone 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 would

prescribe essential narcotic drugs (give details of their training in

pain relief and palliative care or opioid dependence treatment)

6. If there is more than one qualified medical practitioner who

would prescribe essential narcotic drugs, indicate the name of

the 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 are

to be given)

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

PIace.,.,.......,.,..,.,.,.

Seal:

Signature:,....,......,..,......

Full name:

Position:.....,.,..,..,...,..,.1

{FORM NO. 3c

[Sec rule 52-0(2)]

CERTIFICATE OF RECOGNITION

Date of issue.,........,....,

This is to certify that.................................(Name of the institution)..................... situated

a Recognised Medical Institution to possess, dispense and sell essential

narcotic drugs.

2. The institution is a Recognised Medical Institution since..,.... (mention date of the

certificate 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 conditions

as may be specified under the Narcotic Drugs and Psychotropic Substances Act, 1985 (61

of L985) and the rules made thereunder.

Signatur€..'..................'.'..'.'...

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

q-.1

Conditions of r€cognilion

1. This certificate is non-transferable.

2, This certificale and any certificate of renewal in force shall be kept on the

approved premises and shall be produced at the lequest of an officer

authorised 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 INSTITUTION

Name of the Ess€ntial :

Narcotic Drug

Date :

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 in

Form 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 BY

RECOGNISED MEDICAL INSTITUTION)

:":'"'the

vear

Date of submitting

rerum

1. Number and date of the orrent certificate of recognition

2. Name of the Recognised Medical lnstitution

st.

No.

Name of

essential

narcotic

d.ug

Quantity

in original

annual

estimate

Quantity

in revised

annual

estimate

(if any)

Opening

stock

Quantity

procured

during the

yea!

Quality

disbursed

to patients

during the

Yeaf

Closing

stock

(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 peicent

of 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)l

ESTIMATE OF ANNUAL REQUIREMENT OF ESSENTIAL NARCOTIC DRUGS

Estimate for the year Date of submitting

estimate

1. Number and date of the curtent certificate of recoqnition

2. Name of the Recognised Medical InstihJtion

3. Details of the estimated annual requiremmt of essential narcotic drugs

st.

No.

Name of

essential

narcotic

drug

Quantity disbursed

during previous

yeat

Estimated

annual

lequirement

Revised

estimated

annual

requirement*

Reason for

revision

0) (2) (3) (4) (5) (6)

*Please attach copy of the original estimate

Full Name/Designation (if any) Signature of the overall in charge.l

FORM NO. 4

(Sre rule 55)

Official Seal of the Issuing Authority

S. No.......................

F. No.......................

COVERNMENT OF INDIA

MINISTRY 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 empowered

to issue Irnport Certificate under the Narcotic Drugs and Psychotropic Substances

Rules, 1985 hereby approves the importation into lndia of the consignments containing

narcotic 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 imported

before................... by................................to (airport/sea port) in India.

In approving the importahon of the consignment containing th€ said drugs or

substances specified ...................... (lssuing Authority) is satisfied that it

is 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!..............(TheauthoritytowhomarldthePurPosefolwhichit

is 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 Autholity

S.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 IMPORT

UNDER 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 wiih

documentary 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

for

the

(c)

(d)

the factory premises;

(e) maintain separate accounls of actual

formulations produced, consignments

balance;

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 the

narcotic drug to the Narcotics Commissioner;

G) follow the procedures prescribed in rules 42, 45, 46 and 4Z for security

arrangements, maintenance of accounts and submission of retums, possession,

sale and distribution of formulations manufactured from the drug! importj

under 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

, 3.. Any qlantity of morphine, codeine, thebaine and their salts or finished

lormulahons for export that have not been utilized shall be surrendeled to the

Govemment Opium and Alkaloids Works.

4. This document is for.......,...........-,... (It-e authority to whom and the purpose for

which it is being sent to be indicated).

5. The certificate is not valid unless it bears the official seal of the Issuing Authority

on the top right hand comer.l

FORM NO. 5

(See rule 58)

GOVERNMENT OF INDIA

MINISTRY 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 to

issue export authorisation under the Narcotic Drugs and psychotiopic -

Substances

Rules, 1985.hereby authorises and permits the followin! exportatidn of Naicotic Drugs or

Psychotropic 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 drug

substance/preparations substance content

The exportation to be made in one consignment from the designated port of export

on or before the....................................day of..................................(Month), 20-

- The importation of these drugs into the country of destination has been authorised

by official import certificate No................................. dared..,.,................,............ issued

by-....................... (Autho(ity of the importing country).

Date of Issue

Place 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 PurPose

for which it is being sent is to be indicated).

2.Thisauthorisationisnotvalidunlessitbearstheofficialsealofthelssuing

Authority on the toP riSht hand comer.

,[FORM NO. 6l

(See rlule 67\

Date and time of desPatch of

the 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. Quantity

Schedule(s) to the 1945 Rules, Trade Marks; Gross Net

Patent and ProDrietarv Names, etc.

4. Mode of transport (Particulars of the transporter, Registration Number

of 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 such

consignment note-book.

(3) The Consignor should maintain a Register showinS the details of the books of

consignment notes brouSht in use du ng a particular year.

(4) The books containing consignment not used or currently under use and the

upon 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/

authorityl

2, Address

3. Name of the Drug

4. 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),

The Narcotic Drugs and psychotropic Substances Rules, tg^s

r[5. Quantity obtained / purchasedl

6. Date on which obtained/purchased

Details 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 OF

NARCOTIC DRUGS OR PSYCHOTROPIC SUBSTANCES

1. Name of the Organisation or Agency

2. Full postal address of the Organisation or Agency

3. Purpos€ for which sample of standard Narcotic

drug or Psychotropic Su6stances is required

4. Name and quantity of standard sample requiled

5. Name and designation of officer unde! whose

custody the samples shall be kept

6. Copy of Stock Register of narcotic samples

maintained by theorganisation duly verified by the

controlling officer

7. Other relevant information (if any)

Signature........................-....

Designation.............'.'-.........

of Indenting Officer with Rubber Stampl

,IFORM NO. 9

lSee rule 678(5)l

ANNUAL REPORT TO THE CHIEF CONTROLLER OF FACTORIES ON

RECEIPT, 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).

91.

No.

Narcotic drug/

Psychotropic substance

Opening

Balance

Receipt Consumption Closing Balance