THE NARCOTIC DRUGS AND PSYCHOTROPIC SUBSTANCES RULES,

THE NARCOTIC DRUGS AND PSYCHOTROPIC SUBSTANCES RULES, 1985I

r:5″,: ol rhe powers,co.nferred. .W section 9, read with section 76 of the Narcotic

Irrugs and Psychotroptc

^-..1: Substqnces Act, 19gS (61 of 19gS), the Cmtrai Gm)ernment

hereby makzs the following rules, namely:_ CHAPTER 7

t. shorr dtte and

rules may be called Narcotic Druts and psyc”h”o-tr-op”i:clt:t:rnt”tilr*” -‘-

^ (2) They shall come into force on the date2 of their publication in the officiar Gazette.

2. Definitions.-ln these rules, unless the context otherwise requires,_

(a) “the Act,’, means the Narcotic Drugs and psychotropic Substances Act, 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 Deputy

Chief Chemist or Shift _Chemist o. a””i”t””t-Ciluinical Examiner, Government Opium and Alkaloid Works, Nee*””n o., as the case may be, Ghazipurl

(d) “Chief Controller of Factories,, means the Chiel Controller Govemment Opium and Alkaloid Factorie;; -.*’ of

a[(da) “Controller of Drugs,, means the officer appointed as the controllins authority bv the St-ate Govemment undei’rule 50 of ili ;il]1i5

C^os-metics irules, 1945 -“dt;;”;;;-irrii, c*-etics Act, 1940 (23 ot 1,940);l “”i’

‘y”u.; of ihe fotto*ir,f

corporate, proliretorstrip firm,

assocration of

of any year to the 30th Septemb-er

a[(ea) “Firm” means a *T.iTy, j

.firm,

parhership firm, Iimited ,body

personsl

{[[(eb) “Form,, means a Form oppended to these Rulesl

Substances’Rules, 19St:-

(e) “crop year” means the.period beginning on and from the 1st October

liability partnership

(0 “General Manager,, 19-ang the General Manager, coveinment

opium and Alaaloid Works, N””;;;-;.;’;’r*hl’ _ay bu, Ghazipur; “a””

(g) “issuing authority,, means the. Ngcgtic

officer who may be

t. %de G.S.R. 837(E), dated t4th Novem t”t’ pt. rt sec. 3(t, dated 14rh Novembe., ,’l;;1

2. Came into force on 14-11-1985.

3. 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).

or any other authori*d h ;;”*;;;;i”‘rry Ii,J c””o”r

-Commissioner

Published in the Gazette of lndia, Extra.,

the

Sch.l

The Narcotic Drugs and Psychotropic Substances Act’ 1985

i0;. iii:’suiAsanstreL 104. VINYLBITAL

105.

1ll05A. ETRypTAMINE r,iii. ‘ rraiiicairlrNoxe ro!c. zrpspnor

105D. AMINoREX

iosr. snorrzorer

10sF. MEsocARB 11106.

l{Je. .rrr0.

{110A. KETAMNE

‘tll0B. MEPHEDRoNE T*tntt**ca*t-* \*-“‘MC)

4-methYlePhedrone 6[111.] Salts and preparahons of above’

108.

Other non-propdetary rvrmes

Chemical name

Sl. Intemational non-ProPrietary

No.

e1 l]i::*;,ff:n f”;L,i,;,f;1,p,k& Jfiii,i:xit’i,’.ii stereochemical Pyran-ul

names

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

varianlr 92 BUPRENORPHINL

2l’ cy( loProPyl-7-F-[{S)l-hvdro\y- t-2′

?;;:’rutl*i-trr;!fu ffi do-ethano’o- 5-allyl-5-isotutylbarbituric acid

(+)-(i)-r-l(R)l-aminoethyll benzyl alco- hol

s,5diallybarbituric acid N’ethyl-F-methylPhenethylamin€ N-€thvl-3-phenly-2-norbomanmine

93. BUTALBITAL 94 CATHINE

(+lnorpseudo- ePhedrire

95. A-sL;rLiAOMBrArrRalB\aIrTNAgL NiTFSNOREX ;Z’. N-ethylamPhetamine

97. FENCAMEFAMIN ,A. riNlnononsx

99. MEFENOREX

r0o. MTDA’.LAM

101. .EMoLTNE

tO2, pyROvAERoNE

‘

rutobaibital

1. i:.:f /,H”?di:i'” 2. H'”#”‘a”.9,;;E i’lf

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

arninol

irt{:i ctrtoroproPlt)-a-methylPhenethy-

iillf,i””-i;iii”,;_:i’i,tj”lJ,l)”:il:Jit: 3–,ffi1-.r.3-.t”1;,y-‘;*g,i,io?l’*f-‘””t-

[i.;,ti:X’#*jl1{.l,)i;4-1-1prpe.”,i,,u”tnu- nol)

(2-amino-5-phenyl-2-oxazoline)

lt;t_..f;T.T?:r-‘,1-‘”:L1f)””,:til3;litr\ll; diazePine)

Et”1**t*R:il”^tl-N-henvrerbamovr) tof;u”,{i;o#ti-“‘,ii,,-.,

4-lvfl A (;t MethYI- -MthYl thioDhenethylamine)

GHi (r-HyAroxyt’utyric Acid) zoloidem'{INN)l

et’I:’Jfi firll,?i.’L;X*t1i-‘ti’;.”.r

!’.Ht;-,*””‘nti’n*ethv)

4-methyl-2–( l-Ptrr,olidinyl) 5-sec-birtvl-s-ethvlbarbituric acid 5-(1-methylbutyl)-5vinylbarbituric acid 5-butyl-5-;thylbarbituric acidl (3-(2-;minobutyl) ,indole) iz-imethvlamino)-r phenvlpropan-1-one)

hePtanoic acid)l

(methvr anino)

:;ilf,l”1t$31″iil-t (frS’2-methylamino-1-(4-melhvlPhenyl) ProPan-r-onel

valeroPhenone

Rule 2l

The Narcotic Drugs and psychotropic Substances Butes, tgAS

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;l

r[(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

time to time by the Narcotics

poppy cultivation is permitted, who shall perform such functions and on such

grms and conditions as rnay be specified -from Comrnissioner.

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

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

t:i:9Tole

nearo ln person, it he so desrres.

– (3) Where opium poppy has been cultivated under a licence which is

subsequently withheld, or cincelled, the standin! iion, if ,”y, sf,un Ue destroyeJ

under the supervision of the proper officer in ,i”f, ,ii”.”.'”, may be specified by the Narcotics Commissioner.

PT:”9:t”.with regard to m€asur€ment of land cultivated with opiurr -p-o_1p1p.y.-{l) All prots of land cultivated.with opium poppy in accordance with the licence issued under these rutes, shalt be measured in metres by the prooer officer 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’attest the 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 regardins tne correcbless of the measurement.

(2) The measurement conducted by the proper officer shall be subject to such further checks bv such officers as may ‘Ue specified by the Narcotics Comrnissioner in this behalf.

. .I3. Procedur€ with regard to. preliminary weighment._(t) The cultivator shall, during the course of f,arvesting, produce daily”before the Lambardar, day’s collection of opium rrom hts irdp r-i;”1gil;i. ^’ “- each

(2) The Lambardar shall make arrangements io weigh such opium and make

necessary entdes in the records to.be maintained by hi_ir as may.be specifiJby the Narcotics Commissioner in this behalf.

(3) The cultivator and the Lanbardar shall attest the entries made in such records under their simature/thu-b-ir”pi”;ri;;- , iii “i”t” showing the quantity of opium weighid on a particular day.

,_ ,(4) Th.e proper officer shall conduct check weighment of the opium collected

by the cultivators with reference to_ the entries iri *,” i”..t”ra”r,s record and

indicate his finding rherein which shalt b;;G&;; h””;;d the Lambardar under their signatire with dare.

(5) The variations between the qr.rantity of opium produced by the cultivator

indicated in the Lambardar’s record and is founa bi the ;r;;er officer during

It :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?;”

fl::l

,opportuniry

of showing cause against the said order or is

of oqiu.m-produced.– All opium, the ^”t.

produce of land cultivated

_^,,.”t1._?-‘1fi””ry

wlm 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

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

“lir- ‘Govemment Factory seParately, after having it properly oifi.”. to the Opium

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

in this’behalf, is suspected of being adulterated with any foreign

“itfroti””a Opium Factory seParatel, r”Utiu”.”, it shall be forwarded io the Govemment

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

“o as provided hereinafter’ payable to the cultivators to be determined

21. Weighment and examination of the opium at the–Govemment Opium Factorv,-Tfie opium forwarded by the Dishicl Opium Officer shall be received’

manner as may be specified by the

-“iJla,

r””il””i.”

Nircotics Commissioner.

and classified”in the Govemment Opium Factory under the

“*a-ii’t”a,

the 6eneral Manager in such

“t

22, Confiscation of adulterated oPium’-All such opium received separately it, if found to be adulterated on examination by- the Chemical “p”*adm;;ir-,e;[r 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

-ticinces

for the subsequent crop year and any balance that may remain due from the cultivators

adjusted by the Dstrict Opium Officer at lhe time of issuing of

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)’ 95 (E), dated 4th February,2OO4, for sub-rules (1) and (2) (w.e.f, a-2-2/JJ4).

2. Subs._by g”.4S.”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.

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

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

3. 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).

5. 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.”,

2. 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).

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

Sl. No. (1)

TABLE

Name of the essential Narcotic Drug

(2)

Morphine and its salts and all preparations containing more than 0.2 per cent. of Morphine

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

Quantity (3)

500 Milligrammes 2000 Milligrammes

Oi\f!px1 Codeinone (comrnonly known as O,<y-oaonu 250 Milligrammes 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

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

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

320 Milligrammes

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

-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.”.

rules or

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; (c) a licenced chemist;

(d) a registered medical practitioner;

(e) a person who has been authorised by the Controller of Drugs under these rules; or

(f) a recognized medical institution.l

(2) A licenced chemist shall sell essential narcotic drug only on 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:

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

* may be specified in the said order;

;;”;;i;;;;;

;iff;;tlt io him.

d”y, f.o- tfi” date of communication of such decision or order

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

”

-in sci’entlfic research t6 possess and use, for educational or scientific

^a.,tt”t

(b) a pilot of an aircraft or captain of a ship to possess and use’ on the

‘ ‘ aiicraft or ship, as the case may be, in any emergency’ essential narcotic drui in such quantity’and in suih marurer as may be specified in the said order;

(c) a person in-charge of an ambulance or a fust-aid station or a first-aid ‘-‘ bJx to porr”tt uid use. in an emergency, essential narcotic drug in sucf, qrlantity and in such manner-as may be specified in the said

oroer’

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

– rJ*i”i .la”tl”der this rule ihall maintain day io day accounts in resPect -of ;il ii;;:ffi taessential narcotic drug in ForrnNo 3D and the records of the a”iiy *”.t”s shall be preserved for a ininirnum period of two years from the

date of last entry.

(3) Everv reeistered medical practitioner shall also maintain a seParate

.u.oJ i” f”tt” N”o. ge fo. each patient and such record shall be preserved for a minimum period of two years from the date of last entry’

52-I. Suspension and cancellation of authorisation’-(1) Without pre)udice to a.,v actiori that may be taken under the provisions of the Act’ the Controller ; i;{; ;;”;i;. thJ reasons to be recordid in $/ritin& cancel or suspend the authoriation under rules 52A or 52H,-

(a) if the purpose for which the authorisation was granted ceases to exisu or

(b) in the event of any breach, by the.holder of such authorisation or by his servant or by any on6 acting with his express .or implied permission on his-behajf, of any of the terms and (onditions ol such authorisation or of any authorisaiion previously held by him’

(2) No order shall be passed under sub-rule (1) unless the authorised person tru, i””n eirr”., u .ea.o.,abl” opportunity of showing cause against the said order or is hear-d in person, if he so desires’

52J. Appeal.-(l) Appeal against a decision-or order made or passed. under .rrt. si-l .iv Ue fitea 6v *te p”erson against whom such decision or order has

; 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

(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

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

pa ia.tiv5 care

.or –

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

(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 drugs shall be dispensed or sold for medical use only;

(b) maintain separate record in Form No. 3E for each patient, which shall be preserved for a minimum period of two years from the date of last entry;

(c) maintain record of all receipts and disbursements of essential 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.)]

1. 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).

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

3. 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).

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

5. 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).

issuing authority shall prepare seven copies of the import certificate v1***1 and deal with them in the manner hereunder provided, namely:-

-The

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;

(c) quadruplicate copy of the import certificate in relation to narcotic 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., namely:-

tp**1 -i deal witir them in *re manner hereunder provided,

(a) the original should be supplied to the consignor which shall accomPany the consigrunent;

(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

t. 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),

2. 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).

3. Subs. by G.S.R. 224(E), dad 25th March, 2015, for “Collecloi of Customs” (w.e.f. 2t3-2015).

4. 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).

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

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.”.

“rplain

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

p*p”se. under these rules.” “iid

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

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’

ilt,;’;t; ;il-f”iru,

of o..r.hot.ooi. *brtun.” itt”tt U” ti”*potted, imPorted inter-State or exPorted

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

-coruignment

t;#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

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-

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)’

b” tr;d;i;;i””po.t

.ut” (ti

‘””s

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; (c) mode and particulars of transport:

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);

(c) a narcotic drug and psychohopic substance may be supplied or 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.

l. Ins. by G.S-R. 639(E), dated 13th Octobet, 2006 (w.e.f. 191G2006).

2. 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.

I. Narcotic drugg 1. Coca Leaf

2. Cannabis (Hemp) 3. (a) Acetorphine

O) Dacetylmorphine (Heroin)

IISCHEDULE I (See rules 53 and 64)

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

Mephedrone

Salts and pr€para tions of abovel

Chemical names

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

,t.*l ,t*-l

‘*ii+s*ln-*s#i#i-g,ggr*ll*l’im

‘f t##t*:lr”i;*+,,+lgg*lE#.1,*,+l;,

I Jury, r995 (w.e.f.

G.” ^a Parentage of Viltage P.fr;/”i””i.’ t”h,tt the licens€e

Atea measured Atea test_rneasured

Area harvested

il** g-*^”og4t*’o’9″t

(s.I.) (Inspector,/D.O.O.)

Clas3 of Weight

as opium opium (K8J

assigned by D.O.O

Assumed

Price payable on the basis of

assum€d weight 70<

witiheld pending final examination of oPium at

factorY

paid at weighEEnb

Total weight of

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/ 6 received

at the 6’ time of

final *

at 70’c(K8.)

at 70″C on

weight

opium

fORM No. 1 (See rlule 7\

GoVERNMENToFTNDIA,cENT:::,:Ttii'”:J’*t:lti

Plot No.(s) as Per o !€venue records F

a- x

“.t:’11 “‘**.”‘o”3Jji-;;’;;;””*'”L.””-e Number Area Licensed

the basis of factory’s fePor(

Payments

B Oi

-r’l o

a;;

(Enhies to b€ made at the time of final d

6 Si8nature and S€al *

District Opium Officei

Signature and Seal Distlict Opium Officer

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

7. 8.

Name of the Cultivaror

Father’s

FORM NO. 2 (See rule 8)

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

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 measured…… Average yield at 70qC_. -. – _ -.. -….

Area licensed…….,. Area harvested……

B. Whether the cultivator has ever been proscriH on account of excess cultivation and 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. The cultivator is eligible/ineligible for grant of a licence.

Area allotted by the District Opium Officer.

Crop year…………….,….,…

Signature(SubJnspector lncharge)

-Dstrict Signature of

Opium Officer

988

The Narcotic Drugs and Psychotropic Substances Rules’ 1985 lForm 2

Conditions of lic€nce

onlv fol production 1.ThelicenseeshallnottransferthisIicenceando-tlLti”vatePgP'”Pi’6y”ia”ii”ihelice”ce’

tn’:;;;?i;i'””a pt'<‘”1

will be cultivated by the cultivator shall be free from

“”i.’J

of opium or F,oppy straw

2. The land in which PoPPy

litigation.

“””t

3′ rhe ricensee, sha’ -q1,$”9i1Y”,”SltT:f-.:*#il”33fi::i”tJ^x1″tr

[:’f5i iil”‘i:H]?””””‘1′,:il’i:,ru.i;ru;;i l””r’ uv rh;L'”bu’du’ a”it “””v’,”a” stiff of the Narcotics

*”tei;;;; ;rriJ out bj’ the.

shall submit to Preliminary tile entire quantity collected by

DeDartment in the village aunng #hi”‘n f[ tiufi-ptoa”t”

n’* at the and notified for n. ,n” licensee shall bring to’ and -deliver !l”t^t’-1″:1 so

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

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

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

by him at tn” t’In”-ot. *”il’tti”nt and his opium shall be weiqhed

authorised

the supervision of In” ui”t”tt up’ui’6i?ii”t

by the Narcotics Co”tmils’o”et.’n at;;;;;; Piy”hot.opi” Substances Rules’ 1985′

retains, embezzles ihe Nlr’cotlcs Drugs and PsychotroPic to be Drosecuted as Per tne Pt8liJi;;’;i

‘t” ti

“ifite.r Drugs and “”y.t’n* 14 of the Narcotic

be liable

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

or otherwise itteiiliy-ii”pot t-of l”y p”.t of th-e sa-me he shall

Substarices Act, 1985′

7. The licens€e shall extract as m”iiu^c’lhr.ropium :” i” I:?:T!Y

possible from all

with

implements, Pots and cloth u”ta Ty

opium in consequence ot such use’ “”llecting be made to him at

for oprum delivered^b.y the licensee-shall

8. The final Payment b7it”t or any other officer authorised in

approp ate time fixed oy tn” ‘-r’JtitiSi”rn

rh; dhalf.

of accounts any sum is.found dueJrom

9. lf on the final adiustment officer authorised in this behalf in

shall pav it to the Dstrict L’lprum bii”lioi-y’ “tft”t

from him it may be

the manner specified’

recovered from him ln tnt rnu”nil Psychotropic Substances Act’ 1985′

liceice.

lt tn” ?iit to’pay tfte sum due

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

tit” ft””*. *itittt t”t”” him ineligible for grant of the lrcence’

“g”i,.ii with the piovisions of Narcotic Drues and Psvchotropic

L1. The licensee shall comptf

Substances Act, 1985, th” Rtl”‘*’f;;;;i’ti”t”t^a”t

iJil”p”i”.ti u.ttfto.ities of the Narcotics DePartment from time to time’

12. The Iicensee shall be punishable

Druss and PsychotroPic Stu”ollt”” ‘cti i985 fot “ty breach of the conditions

of the

with rule

authorised ii this behaU

t Covemment or

oPium and ihpregnated

“t”n”””p”iJ”iiu”a 6y”tc-n 72 of the Narcotic Drugs and

and any orier issu;d by the under.the relevant of the Narcotic

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\’

-Provisions

the licensee’ he

if-any fact is revealed

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

Name of drug (1)

(2\

Quantity

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).

Date……………,.,.

Conditione of licence 1. This licence is not transferable.

Signature……………………. Designation………,….,…….

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:

Licence No.

lIFORM NO. 3A

(See rule 36,4.) 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 (i)

(ii)

(iii)

Quantity

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,

(c) This licence 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 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,

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

“,rp”-i* rates as rnay be decided by the Govemment flom concintrate of PoPPy straw at iuch

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

o) (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 essential narcotic drugs showing Trade Marks, Prc )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) Signature of the Consignee with date Note:

(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 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

Full Narne,/Designation (if any) Note:

Signature

(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

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

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

Notei

Name of the essential 9ignature,/Thumb nalcotic drugs impression of

the patient

(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

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

Conditions of r€cognilion 1. This certificate is non-transferable.

{FORM NO. 3c [Sec rule 52-0(2)]

CERTIFICATE OF RECOGNITION No……………….. 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.

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

1. Ins. by G.S.R. 359(E), dated 5th May, 2015 (w.e.f. t5-2015).

Signatur€..’………………’.’..’.’…

Designation……,……..,……,….. q-.1

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

1. Opening stock

Date :

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

:”:'”‘the

st. No.

(1)

Number and date of the orrent certificate of recognition

{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)

vear

Date of submitting rerum

Name of the Recognised Medical lnstitution

Name of essential narcotic d.ug

Quantity in original annual estimate

(3)

Quantity in revised annual estimate (if any)

(4)

Opening stock

(s)

Quantity

procured during the yea!

(6)

Quality disbursed to patients during the

Yeaf (7)

Closing stock

(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

1. 2. 3. st.

No.

Number and date of the curtent certificate of recoqnition

Name of the Recognised Medical InstihJtion

Details of the estimated annual requiremmt of essential narcotic drugs

Estimate for the year

Date of submitting estimate

Name of essential narcotic drug

(2)

Quantity disbursed Estimated during previous annual

yeat lequirement (3) (4)

Revised estimated annual requirement*

(5)

Reason for revision

(6)

*Please attach copy of the original estimate Full Name/Designation (if any)

FORM NO. 4 (Sre rule 55)

Signature of the overall in charge.l

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)

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 rPssyyvcnhoitruoPoPiric -Substances Rules, l98t hereby, Ccertificate unde! the Narcontic DuruS8s ando

il;;;; (1)

th; ftdtl”iio” i”to Indii of the frillowini consignments of narcotic drugs:-

(2)

(3) …………………………………………)

Bv M/s….,……,……’… .from M/s’..’…….””””””‘to manufacture – formulations for

“tp”-ilf- analytical PurPoses (strike out whichever is not. aPPlicable) subiect to the 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;

(c) 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;

(d) obtah transport permit from their State Excise authority/State Food and Drugs Administration permitting transPort of their consignment from Pcrt of entry to the factory premises;

(e) maintain separate accounls of actual quantity of narcotic drug imPorted, formulations produced, consignments dispatched and the quantity lying in balance;

l. lns. by S.O. 1651(E), dated 13th luly, 2010 (w e.f. 13-7-20t0)’

S. No. “””” ‘ F. No. …..””” ” “” “‘

98L

t[(iii) (a)

TtD Natcrl{tc Drugs md psydtottopic Substancr,s Rules, lgAO [Fom 44

submit a.monthly retum of rec€ipt/import, cpnsumption and export of the narcotic drug to the Narcotics Commissioner;

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.

If the import is for analytical purpo6€s, the importer shall,_

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.,….,.

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…..

…port of entry……..

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; Patent and ProDrietarv Names, etc.

Gross Net

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 register as teferled to at item (3) have to shall be produced to the officers whenever called 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

l. 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).

2. Ins. by G.S.R- 350(E), dat€d 25th June,1997 (w.e.t. 27-6-1997).

3. 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

lFom 7

r[5. Quantity obtained / purchasedl

6. Date on which obtained/purchased Details of Use:

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 -and

under section 4l or 42 of the Narcotic Drugs 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)

,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

Narcotic drug/ Opening Receipt Consumption Closing Balance No. Psychotropic substance Balance

Signature…..,……,……………..

Designation…,,.,..,……………. of Indenting Officer with Rubber Stamp.l

1. Subs. by C.S.R. 905(E), dated 28th December, 2011, for item 5 (w-e.f.2V12-2O71).

2. tns. by G.S.R. 639(E), dated 13th October, 2006 (w.e.t 13-10-2006).

91.

Signature……………………-….

Designation………….’.’-……… of Indenting Officer with Rubber Stampl

deemag and chest clinic

THE NARCOTIC DRUGS AND PSYCHOTROPIC SUBSTANCES RULES,

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THE NARCOTIC DRUGS AND PSYCHOTROPIC SUBSTANCES RULES,

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Pages

Leave a comment Cancel reply

SEARCH THIS SITE

Recent Posts

categores

alexaVerifyID”

facebook page

Goodreads

Follow Blog via Email

Blogroll

dr.pkgupta

contact information

Flickr Photos

archives

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twitter

list of top posts

CLICK HERE for more interaction on media

google