Executive Summary:
This notification from the Ministry of AYUSH amends the Drugs and Cosmetics Rules, 1945, concerning Ayurvedic, Siddha, and Unani drugs. It addresses the naming conventions for these drugs, including restrictions on prefixes/suffixes and the use of drug names for proprietary medicines. Licensees of non-conforming drugs must seek renewal with appropriate names within one year from the commencement of these amended rules. The amendments are called the Drugs and Cosmetics 4th Amendment Rules, 2015 and come into force one year after publication in the Official Gazette.
Key Points / Main Content:
Naming Conventions for Ayurvedic, Siddha, and Unani Drugs:
* Manufacturers cannot use prefixes or suffixes with the name of any Ayurvedic, Siddha, or Unani drug, except as described in authoritative books specified in the First Schedule to the Act.
* A formulation without a specific name described in authoritative books may be named based on its ingredients.
* The name of any Ayurvedic, Siddha, or Unani drug cannot be used for naming any patent or proprietary medicine, except for single plant-ingredient-based formulations licensed as patent or proprietary medicine.
License Renewal:
* Licensees of Ayurvedic, Siddha, or Unani drugs not conforming to the new naming rules must seek renewal with appropriate names within one year from the commencement of the Drugs and Cosmetics 4th Amendment Rules, 2015.
* This renewal requirement does not apply to batches of drugs manufactured before the commencement of the Drugs and Cosmetics 4th Amendment Rules, 2015.
Penalties:
* Contravention of these rules (1B to 1D) will be punishable under section 33I of the Act.
Impact Analysis:
Manufacturers of Ayurvedic, Siddha, and Unani Drugs:
* Impact: Need to comply with new naming conventions and restrictions on the use of prefixes/suffixes.
* Action Required: Review current drug names and modify as necessary to comply with the new rules.
Licensees of Ayurvedic, Siddha, and Unani Drugs:
* Impact: Licensees of non-conforming drugs need to seek renewal.
* Action Required: Licensees of non-conforming drugs must apply for license renewal within one year with appropriate drug names.
Central Government:
* Impact: Responsible for enforcing the amended rules.
Public:
* Impact: Assurance of standardized naming conventions for Ayurvedic, Siddha, and Unani drugs.
Key Entities Referenced
Drugs and Cosmetics Rules, 1945: A set of rules related to drugs and cosmetics, which is being amended by this notification.
Drugs and Cosmetics Act, 1940: An act of the Indian Parliament governing drugs and cosmetics. Section 33N is referenced in the notification.
Ayurvedic, Siddha and Unani Drugs Technical Advisory Board: A board consulted by the Central Government in making rules to amend the Drugs and Cosmetics Rules, 1945.
Drugs and Cosmetics 4thAmendment Rules, 2015: The short title of the rules introduced by this notification, which amends the Drugs and Cosmetics Rules, 1945.
First Schedule to the Act: A schedule to the Drugs and Cosmetics Act that specifies authoritative books related to Ayurvedic, Siddha, and Unani drugs.
Section 3 of the Act: A section of the Drugs and Cosmetics Act that defines Ayurvedic, Siddha, or UnaniTibb drug falling under clause a.
Ministry of AYURVEDA, YOGA AND NATUROPATHY, UNANI, SIDDHA AND HOMEOPATHY: The ministry responsible for this notification.
New Delhi: Location where the notification was issued.
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2186GI/2015 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
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अधीन दंडनीय होगा ।
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(cid:14)कए गए थ े और अंितम संशोधन सा.का.िन.सं 289 (ई) तारीख 15.4.2015 !ारा (cid:14)कया गया।
MINISTRY OF AYURVEDA, YOGA AND NATUROPATHY, UNANI, SIDDHA AND HOMEOPATHY
NOTIFICATION
New Delhi, the 18th May, 2015
G.S.R.390(E).—Whereas the draft of certain rules further to amend the Drugs and Cosmetics Rules, 1945 was
published as required by sub-section (1) of section 33N of the Drugs and Cosmetics Act, 1940 (23 of 1940) in Part II,
Section 3, sub-section (i) of the Gazette of India, Extraordinary, vide number G.S.R 633(E), dated the 1st September, 2014
inviting objections and suggestions from persons likely to be affected thereby before the expiry of a period of thirty days
from the date on which copies of the Official Gazette containing the said notification were made available to the public;
And whereas, the said Gazette was made available to the public on the 1st September, 2014;
And whereas, objections or suggestions received from the public on the said draft rules have been considered by the
Central Government;
Now, therefore, in exercise of the powers conferred by sub-section (1) of section 33N read with clause (e) of sub-
section (2) of the said Section of the Drugs and Cosmetics Act, 1940 (23 of 1940) the Central Government, after consultation
with the Ayurvedic, Siddha and Unani Drugs Technical Advisory Board, hereby makes the following rules further to amend
the Drugs and Cosmetics Rules, 1945, namely:-¹Hkkx IIµ[k.M 3(i)º Hkkjr dk jkti=k % vlk/kj.k 3
RULES
1. (1) These rules may be called the Drugs and Cosmetics (4thAmendment) Rules, 2015.
(2) They shall come into force one year after the date of their publication in the Official Gazette.
2. In the Drugs and Cosmetics Rules, 1945, in rule 157, for sub-rules (1B) and(1C), the following sub-rules shall be
substituted, namely:-
“(1B) No manufacturer shall use any prefix or suffix with the name of any Ayurvedic, Siddha or UnaniTibb drug
falling under clause (a) of section 3 of the Act, except as described in the authoritative books specified in the First
Schedule to the Act:
Provided that a formulation without any specific name, described in the authoritative books may be named on the basis
of the ingredients of that formulation.
(1C) The name of any Ayurvedic, Siddha or UnaniTibb drug falling under clause (a) of section 3 of the Act shall not be
used for naming any patent or proprietary medicine relating to Ayurvedic, Siddha or UnaniTibb systems of medicine
referred to in sub-clause (i) of clause (h) of the said section:
Provided that this rule shall not be applicable for single plant-ingredient based Ayurvedic, Siddha or UnaniTibb
formulation licensed or to be licensed as patent or proprietary medicine under sub-clause (i) of clause (h) of section 3 of
the Act .
(1D) Notwithstanding the period for renewal of licence provided in rules 156 and 156A, the licensee of the Ayurvedic,
Siddha or UnaniTibb drug, which is not in conformity with sub-rules (1B) and (1C), shall seek renewal of the licence
with appropriate name of the drug within a period of one year from the date of commencement of the Drugs and
Cosmetics (4thAmendment) Rules, 2015:
Provided that this rule shall not be applicable to any batch of Ayurvedic, Siddha or UnaniTibb drugs
manufactured prior to the date of commencement of the Drugs and Cosmetics (4thAmendment) Rules, 2015.
(1E) Whoever contravenes the provisions of rules (1B) to (1D) shall be punishable under section 33-I of the Act.
[F. No. K. 11024/01/2011-DCC (AYUSH)]
JITENDRA SHARMA, Jt. Secy.
Note: - The Principal rules were published in Official Gazette vide Notification No. F.28-10/45-H (I) dated 21-12-1945
and the last amended vide GSR 289(E)dated15-04-2015.
Printed by the Manager, Government of India Press, Ring Road, Mayapuri, New Delhi-110064
and Published by the Controller of Publications, Delhi-110054.