Drugs and Cosmetics (.......Amendment) Rules, 2018

Jul 13, 2018 | by Avantis RegTech Legal Research Team

The Ministry of Health and Welfare vide notification dated July11, 2018 has published draft rules to amend the Drugs and Cosmetics Rules, 1945. This rule will be taken into consideration on or after the expiry of a period of thirty days from the date on which copies of the Gazette of India containing these draft rules are made available to the public.

In the Drugs and Cosmetics Rules, 1945, after Rule 84AA, the following rule shall be inserted, namely,-

 “84AB. Information to be uploaded by the licensee on online portal SUGAM

(1) The licensee licensed under this PART shall register with portal SUGAM (www.cdscoonline.gov.in) and upload information as per the format provided in the portal pertaining to the licences granted for manufacture for sale or distribution of drugs and it shall be updated from time to time.

 (2) The information uploaded by the licensee with SUGAM portal under sub-rule(1), shall be verified by the concerned Licensing Authority.”

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 mailto:[email protected]

[G.S.R. 629( E)]


URL: http://egazette.nic.in/WriteReadData/2018/187248.pdf


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