Amendments to existing lawsLegislation Updates

The Drugs and Cosmetics (Amendment) Rules, 2019 have been notified by the Central Government on 10-01-2019, after consultation with the Drugs Technical Advisory Board (DTAB), in exercise of the powers conferred under Sections 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), to further amend the Drugs and Cosmetics Rules, 1945 (“Principal Act”). These amendment rules shall come into force from 10-01-2019.

Amendment in the Principal Act :-

After Rule 84AA, the following rule shall be inserted, i.e.

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

(1) The licensee granted license under this Part shall register with portal SUGAM ( and upload information, as per the format provided in the said portal, pertaining to the licences granted for manufacture for sale or distribution of drugs and the information so provided 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.”.