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MINISTRY OF FINANCE

(DEPARTMENT OF REVENUE)

NOTIFICATION

New Delhi. the 26th APril' 201 8

s.o.r76rG)._whercasthecentlalGovernmentissatisfied,onthebasiSofinformationandevidencewhlchhasbecomeavailabletoit'withrespectlothenatureandef'fectofandthescoPe|.orabuseofthefollowingsubstance(natural or synthetic) or natural material i"r uny tuiiot pt"p*ution of such substanccs or materials' and the modification

;iii,;;;;;;.; substances, onA tnui-iiil *..**uiy io add the following substance or natural material or salts or

Dr€paration of such substance or materral in the list of p:ychotropic substances specified in the Schedule to tlre Narcotic

iiffi -J-pty"ft.it"pf" Substances Act, 1985 (61 of 1985) (hereinafter refened to as the said Act);

Now, therefore, in exercise of the powers confcrred by section 3 of rhe said Act' the Cenfial Governnrent hereby

makes rhe following fu.ther amenaments-ii;;;i;;;;"y"h;.pic subsrances specified in the schedule to the said Act.

namely: -

ln the said Act, in the Schedule' after serial number I l0 X and the enties relating thereto' the following serial

numbe. and entries shall be insefted, namely: -

tF. No. N-l1012/3/2017-NC III

VIJAY KUMAR BALYAN' Under SecY'

Note: The Schedule to the Narcoric Drugs and psychotropic Subsrances Act, 1985 (61 of 1985) was

first amended ula"nu-u.tt6';?sGj-;;; t6't 9:!o:r. 1992 and subsequentlv amended

vida numbers s.o' 49(E),;";';;-s{t;"arv' 1!9-3' So 39(E)' dated the lln January'

1996, S.o.475(E), dated itt" ifiill"*' zoor' c's'n 621(E)' dated the l"t August' 2003'

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4 THE GAZBTTB oF INDIA : BXTRAoRDINARY IP^RT tr_sEc. 3(ii)]

SNo. NoD. of N.rcotic Dmgmd PsycboaroplcSubfbme(lDter'r6@d rotFDroDrictuv nrn {INM)

(Xh.r totFproprletary Drdra

CheDic.lNrtnt

So.ll Qo. ity(in CD)

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I 2 4 5 62t8Zt Tr.!|adol 5gm 250 gm-

lF. No. N-ll0l2/3/2017-NC. II]VIIAY KUMAR BALYAN, Under Secv.

Note.: tt€ Fincipal_notification war publisbedjn the Gazene of India, Extraqdinary, part tr, Section 3, Sub-section (ii),:*,":|:n\.:f g 1055 @), dg!ed-t!: l9t October, 20Ol and subs€qucnrty amcnded yr:de numbers S.O. 2941 (E),oarcd t,'e lE- November,2009,.s.o. 1430 (E), dared the 21" Juni, 20ir,s.o. 3?5 (E) datrd rhe 5d February,2015, s. o.237s(E), dated thc l2d July,2ot6, s.o.384 (E), dated the z'r.a"y, zori iri io. ui tfh o"iJ,r,"27' Fcbruary, 20 I 8.

RAKESH mifrf ,,SUKUL ffi'tr

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NOTIFICATION

New Delhi. the 26th APril' 2018

s. o. r762(E)'-rn exercrse of the powers conrerred bf'li'''::ll::i,ill"il:fi *i""'ili:

"""'iHj"fi"j;o*rr."i'pir"'r,tr"pi" subsrances.Acr. 1983 t6l of lgS5t lhe central Louttt.".

,"'or,n',"n, of Rcvenue, purbtrsn€-o rn

1,i,.""i"'i"i' i" *. norilicarion r,T _,oi;TlL'"T;lllfll;.YlTill],ii,"'1,1,fi:,Ii5 ioiJie,. o""a rhe re"'oc'|ober'

rhe Gazette of India, Extraordinary' rarl

2001' namely: - i-., -..-.r-' t?R 7G and the cntries relating thereto' the following

In the said notitication' ln me Table' after serial number 238 ZC and

serial number and entries shall bc inserted' namely: -

INDIAN DRUG MANU URERS'ASSOCIATIONB-4l115 (2* floo4, Safdarjung Enclave, New Delhi 110 029

Phone

Fax

E mail :

Website l

: 91-11 - 2617136791-11 - 41650726

r 91-11 - 26171369

idmadelhi@grnail.comakmadan.idma@gmail.comwww-rdma-assn.oro

I'{D'AAI PHANMACEUT'CALS FOR GLAAAL HEALTH

May 02,2018

Mr. Dinesh Boudh"Dcputy Secretary (Narcotics Control),I)epaltment of Revenue,Ministry of Finance,North Block, New Delhi - 110001

Sutriect: Notification of 'Iramadol as a psychotropic substance - S. O. 1761(E) -regardirrg.

Dear Sir,

Greetings from Indian Drug Manufacturers, Association.

lhe Government of h'rrlia has issued a .otification dated April 26th, 201g - s. o.1761(E), classi{ying "Tramadoi" ant{ it's p1gp41'ations as a psycirotropic substance andbringing it under the purview of the NDpS Act, 19g5 and Rulei, thereunder.

Tramadol is an effective pair-r killer antl prescribed extensively by medical practitioners,across ihe courtry. Brilging thern under tl're NDps ect, rggs without providingreasonable time for Companies manufacturing a.d exporting Tramadol Apls anXprcparations, would result in instant violatior-r of the NDps Act, 1gB5 resulting inselious implications for Comparries, Distribut6rs and Rctailers across the country.

For example, Companies who do not manufacture a.y psvch.tropic substances wouldneed to file for r-rew registrtrtior-r lvith central Bureau of Narcotics, Gwalior which couldtake time or there cciuld be APIs or preparatio.s under clearance for export whichwould amount to'iolation, as no NC)C for export has been obtained frc.,nr iBN as perRule 58 and 59 or labeli'g of rra'rad.l preparations, alreacly in the supply chai'in'thedomestic market rnay

'eed to be redone, as labeli'g requirements for'psychotropic

substances uncler the D&c Act, 1940 need to be cornpliee{. Trre incorrect iabeling'of'lramadol preparations in the supplv chain, curre.tly a'a able with tlistributors "ancl

retai.lers may be interpretecr as a violatio. of NDps Act d,re to this notificatioru havi's

1

Head office: '102-8, poonam Chambers, A'WING, Dr. A.B Road Wortr, Mumbar _ 4OO O.t8 (tndra)Ph: 022 - 24944624. 24974308 rax: ozi'-- zisioiii" E mair: rdma 1@id ma Indra. comRegistered under rhe societies feg. Act xii "r le6o- R;. No. 80m. 11.1/.1961 G.8.8.S.D.Registered under the Bombay pubtic TrusjAct,'i9Stj iA; XxX "i

iivsb) neg. r.ro F_1514 (Bom.) Dt. 11-4-67

INDIAN DRUG MANUFACTURERS' ASSOCIATION

irunecliateeifect'Thisirrluln6,qulclleadtoapanicsituationlearJingtonon.availabiiityof this pain killer for ueed'v Patients'

It is our hulrble submissiolr that n P:'i9!-:f-6 'rlonths

neecl to be' Provided for

Co'rpanies to cornplv,l'.iiil;;.,;ilt;'or Nors nur" o5' 67 58 or 59 and-the'D&c Act

with rcsartls tc, ltb"li"; ;h.r!'ii".t" p"'io'f o *O-:::iJ*nsidze all stakeholders about

ihis not-ification *tr *i"iJ "f'" unubl" th" tu""ttt i'lue"ioty in the supply^ chain to be

extrausted. w" *on to"l*"l'*-' r"''r'::f:.::-tl:^i1'j;llXt,}]}"irT;:;:::::;;

""leJ".-{i" zOrg and also rvhen NDPS am"":^""::,T;;i*""'i";i tta"t li"t"t'

tlonths was gi""" f"';;;;l;pt'o!n"o*ptiunce with the amended order / rute

):,'lffiT.?ru;';'5:,i:';,?itrIf:ifi])4ri-if li{';':*i:i;ii;il'i,u'i't'opi" sttbsttrnces spedfied m lle schedttle rc rn?

i,{: r;; ;t;; ;:; " f su ch no tifir"a t i o t t"'

Wc request your krnd cotrsideration ancl an -URGENT

amendment to the Rules or an

appropriate clarif icatlri pt"t'ra-l"f ti*" f or necessary compliance'

With best regards'

Yours Sil-rcerelY,

b, ,.ll'Ry Ab^'J!"v

DeePnath RoY Chowdhur'v

National President