14 October 2019


Notifications & Circulars

Ministry of Health and Family Welfare

20.03.2019

Civil

Drugs and Cosmetics (Ninth Amendment) Rules, 2019

MANU/HFAM/0117/2019

Whereas a draft of certain rules further to amend the Drugs and Cosmetics Rules, 1945 was published as required under sub-section(1) of section 12 and sub-section(1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) vide notification of the Government of India in the Ministry of Health and Family Welfare (Department of Health and Family Welfare) number G.S.R. 1185(E), dated the 7th December, 2018, in the Gazette of India, Extraordinary, Part II, section 3, sub-section (i), inviting objections and suggestions from persons likely to be affected thereby, before the expiry of a period of seven days from the date on which the copies of the Official Gazette containing the said notification were made available to the public;

And whereas, copies of the said Official Gazette were made available to the public on the 7th December, 2018;

And whereas, objections or suggestions received from the public on the said rules have been considered by the Central Government;

Now, therefore, in exercise of the powers conferred by sections 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board, hereby makes the following rules further to amend the Drugs and Cosmetics Rules, 1945, namely:-

1. (1) These rules may be called the Drugs and Cosmetics (Ninth Amendment) Rules, 2019.

(2) They shall come into force on the date of their publication in the Official Gazette.

2. In the Drugs and Cosmetics Rules, 1945, after rule 97 the following rule shall be inserted, namely:-

"97A. Modified application of rules 96 and 97 for certain period.-

Notwithstanding anything contained in these rules, the modified or additional requirements of labelling as may be specified in the notification of the Government of India in the Ministry of Health and Family Welfare number G.S.R. 408(E), dated the 26th April, 2018, shall be on voluntary basis for a period commencing on the date of coming into force on this rule and ending on the 31st day of March, 2019, and thereafter shall be mandatory.".

Tags : Rules Amendment Drugs and Cosmetics

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