Notification, 2015

Text

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EXTRAORDINARY

PUBLISHED BY AUTHORITY

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 1 st 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:-

RULES

1. (1) These rules may be called the Drugs and Cosmetics (4 th Amendment) 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 (4 th Amendment) 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 (4 th Amendment) Rules, 2015.

(1E) Whoever contravenes the provisions of rules (1B) to (1D) shall be punishable under section 33-I of the Act. 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.

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Provisions this notification answers to

Read out of the instrument itself: an enabling provision is one it says it was made under, which is the power it rests on. The rest it names without resting on.

Other instruments under the same Act

All of the The Drugs and Cosmetics Act, 1940