Draft Amendment to Drugs and Cosmetics Rules, 1945

Dec 10, 2018 | by Avantis RegTech Legal Research Team

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Industry Specific Compliance

The Central Government, on December 07, 2018, has proposed to make amendments to the Drugs and Cosmetic Rules, 1945 after consultation with the Drugs Technical Advisory Board. The proposed amendment is published for information of all persons likely to be affected thereby and to invite objections and suggestions. The given that the said draft rules shall be taken into consideration or after the expiry of a period of 7 days from the date on which the copies of the Gazette of India these draft rules are made available to public.

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

“ 98. Modified application of Rule 96 and 97 for certain period.-

Notwithstanding anything contained in these rules the modified or additional requirements of labelling as the case may be specified vide Notification of the Government of India, Ministry of Health and Family Welfare number G.S.R. 408(E) dated the 26th April, 2018 published in Part II, Section 3, Sub-section (i) of the Gazette of India, Extraordinary, shall be on voluntary basis for a period commencing on the day this notification shall come into force and ending on the 31st March, 2019 and thereafter shall be mandatory.”.

Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 414 A, D Wing, Nirman Bhavan, New Delhi – 110011 or emailed at drugs [email protected].


URL: http://www.egazette.nic.in/WriteReadData/2018/193625.pdf


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