REGD. NO. D. L.-33004199 Ztze Gazette o f J n d i a wmml EXTRAORDINARY Pmr U - r n 3-m-rn (ii)
PART 11--Seetion U u b - ~ e e t i ~ n (ii) PUBLISHED BY AUTHORITY . 15873 @ m, -, XkZ 26, 2 0 1 8 b 6, 1940 No. 15871 NEW DELHI, THURSDAY, APRIL 26, MI(INA1SAKHA 6,1940 2 THE GAZETTE O F INDIA : EXTRAORDINARY [PART U-SEC. 3(ii)] ;' t MINISTRY OF FINANCE @EPARTMENT OF REVENUE) NOTiFlCATlON New Delhi, the 26th April. 2018 S. 0. 1761(E)-Whueas the Central Government is satisfied, on the basis of information and evidence which has become available to it, with respect to the nature and effect of and the scope for abuse of the following substance (naNral or synthetic) or natural material or any salt or preparation of such substances or materials, and the modification with respect to such substances, and that it is necessary to add the following ~ubstance or natural material or salts or preparation of such substance or material in the list of psychotropic substances spec~fied in the Schedule to the NarcMic Drugs and Psychotropic Substances Act. 1985 (61 of 1985) (hereinafter referred to as the said Act):
Now, therefore, in exercisc of the powers conferred by scction 3 of the sud Act the Cenwl Government hereby makes thc following further mcndmenL? in the list of ps)chwopic subslances spec~fied in the Schedule lo ihe said Act, namely: - In the said Act, in the Schedule, after serial number 110 X and the entries dating thereto. the following serial number and entries shall be inserted, namely: - [F. No. N-11012/3/2017-NC. Ul W A Y KUMAR BALYAN, Under Secy.
Chemical name Note: The Schedule to the Narcotic D ~ g s and Psychotropic Substances Act, 1985 (61 of 1985) was f ! amended videnumber S.O. 785(E) dated 26" October, 1992 and subsequently amended vide numbers S.O. 49(E), dated the 8Ih January, 1993, S.O. 39(E), dated the 12" January, 1996, S.O. 4 7 5 0 , dated the illh June, 2003, G.S.R. 621(E), dated the 1" August, 2003, G.S.R. l(E), dated the znd January, 2004, S. 0. 311 Q, dated the lom February, 2011, S. 0.
376 Q, dated the 5" February, 2015, S. 0. No. 2374 (E), dated the 12& July, 2016, S.O. NO.
1383 (E), dated the znd May, 2017 and S.O. No. 821(E), dated the 27" February, 2018.
Other SI. No.
non-proprietary names International non-proprietary names "llOY 1 Tramadol 1 I - - 4 THE G A z ! 3 m OF IM)IA : EXTRAORDINARY [PART l l - 4 ~ ~ . 3(ii)l [F. NO. N-11012/3/2017-NC. JIJ W A Y KUMAR BALYAN, Under Secy.
Note.: The principal notification was published in the Gazette of inha, Exrnmdinary, Pait II. Section 3. Sub-section (ii).
vide number S.O. 1055 (E), dated the 19' October, 2001 and subsequently amended vide numbers S.O. 2941 (El.
dated the 18'" November, 2699, S.O. 1430 a), dated !he 21" June, 201 l.S.O. 375 (E) dated the 5Ih February, 2015,S.0.2375(E), dated the 12'July, 2016, S.O. 384 (E), dated the 2" May, 2017 and S.O. 822 (E), dated the 2 p February, 2018.
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Name at Narcotic D n q and Psychotropic Subwnoee (International nonprepriehuy m e (INN)) 2 TW~OI C M h nmproprteuvy name 3 Cbemiul Name 4 riir.al. 17a2(X).- @ W T : M VTRf m, 1985 (1985 3T 61) iff pmr 2 % mviiiii) 3hC (xxiiii) % $; rn &+d w Vil w3 g, k m, yaza-cr, pma m, i3-s m, ~ i % P T i f f ~ ~ i t ; r . ~ r r . 1055 ( a r ) , M 19 w, 2001, % f ; k m W T ? r % f i , ~mr~mor%m, l l r - 3 , m ( i i ) i f ~ h m m , i f ~ ~ d $ , ~ : - ~&r-*&if, me. 2 3 8 2 ~ 3 h C ? i d i G 4 ' f k & f & ? i % f i ~ ~ i m ? h & 3 & rnM****m, *:- NOTIFICATION New Delhi, the 26th April, 2018 S. 0. 1762(E).-In exercise of the powers conferred by clauses (viia) and (xxiiia) of section 2 of Ihe Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985). the Central Government hereby makes the following further amendments in the notification of the Government of hdia, Ministry of hnance. D e p m e n t of Revenue, p;!Lshed in the Gazette of India. Extraordinary, Part U, Section 3, Sub-section (u) vide number S.O. I055 (E), dated the 19 October.
2001, namely: - I,, the ssid notjticarion, in the nbie , aftcr serial numkr 238 ZG and the enuies relating (hento, the following s e d number and entries shall be inserted, namely: - ('& . - I INDIAN DRUG MANU URERS ASSOClATlON B-41115 (2* floor), Safdarjung Enclave, New Delh~ 110 028 - Phone 91-11 - 26171367 E mall ~drnadelh~@gml corn 91-11 - 41650726 skmadan idma@gma~l w m Fax 91-11 -26171369 Webs~te w ~dmb-assn wg INDIAN PHARMACEUTICALS FOR GLOBAL HEALTH M a y 02,2018 Mr. Dinesh Boudk Deputy Secretaiy (Narcotics Control), Department of Revenue, Ministry of Finance, t North Block, New DeIhi - 110001 Subject: Notification of Tramadol as a Psychotropic substance - S. 0. 1761(E) - regarding.
Dear Sir, Greetings fmm Indian Drug Manufachuem' Association The Government of India has issued a notification dated April 26th 2018 - S. 0.
1761(E), classifying "Tramadol" and it's preparations as a Psychotropic substance and bringing it under the purview of the NDPS Act, 1985 and Rules, thereunder.
Tramadol is an effective pain killer and prescribed extensively by medical practitioners, across the country. Bringing them under the NDPS Act, 1985 without providing reasonable time for Companies manufacturing and exporting Tramadol APIs and preparations, would result in instant violation of the NDPS Act, 1985 resulting in saious implications for Companies, Distributors and Retailers across the country.
For example, Companies who do not manufacture any Psychotropic substances would need to file for new registration with Central Bureau of Narcotics, Gwalior which could take time or there could be APIs or preparations under clearance for export which would amount to violation, as no NOC for export has h e n obtained from CBN as per Rule 58 and 59 or labeling of Tramadol preparations, already in the supply chain in the domestic market may need to be redone, as labe& requirements for Psychotropic substances under the D&C Act, 1940 need to be complied. The incorrect labeling of Tramadol preparations in the supply chain, currently available with distributors and retailers may be interpreted as a violation of NDPS Act due to this notification, having Head OW: 102-0, P 0 0 ~ r n Chambers. 'A' WING, Dr. A.6 Road, Worli, Mumbai - 400 018 (Indig) Ph.: 022 - 24944624, 24974308 Fax: 022 - 24950723 E mail: idmal@idrnaindia.com Registered under the Societies Reg. Act XXI of 1860 Reg. No. Bom. 11111961 G.B.B.S.D.
Registered under the Bornhay PuMi TmMAq 18W (Eom. XXlX of 1950) Reg. No. F-1514 (Bom.) Dt. 13-4-67 immediate effect. This in turn would lead to a panic situation leading to non-availability of this pain killer for needy patients.
It is our humble submissio;~ that a period of 6 months need to be provided for Companies to comply with provisions of NDPS Rule 65, 67 58 or 59 and the D&C Act with regards to labeling. This time period is requimd to sensitize all stakeholders about this notification and would also enable the current inventory in the supply chain to be exhausted. We wish to draw your kind notice to the fact, that when RCS Or& was amended in 2013 and also when NDPS amendment was done in May 2015, a period of 6 months was given for ensuring proper compliance with the amended order / rulm.
We therefore, request that Rule 65 may be amended to indude a proviso, stating "Any new substance which iws an establislted medical or suentific use and included in the list of Psydwtropic substnnces specified in tlte schedule to the Act amM come into e@ct on fhe 180th dnyfmm fke &te of suclz notificahon".
We request your kind consideration and an URGENT amendment to the Rules or an appropriate clarification prwiding time for necessary compliance.
With best regards, Yours Sincerely, Deepnath Roy Qlowdhury National President