The Ministry of Health and Family Welfare on January 10, 2019 has published the Drugs and Cosmetics (Amendment) Rules, 2019 to further amend the Drugs and Cosmetics Rules, 1945.
Draft Rules were published vide Notification No. G.S.R. 629(E) dated 11th July, 2018, inviting objections and suggestions from persons likely to be affected thereby, before the expiry of a period of 30 days from the date on which the copies of the Official Gazette containing the said notification were made available to the public that is July 12, 2018.
Whereas objections and suggestions received from the public on the said rules have been considered by the Ministry of Health and Family Welfare and after consultation with the Drugs Technical Advisory Board, following amendments has been made in the Drugs and Cosmetics Rules, 1945, namely:
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 granted license under this Part shall register with portal SUGAM (www.cdscoonline.gov.in) 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.”.
The Rules shall come into force on the date of their publication in the Official Gazette i.e. January 10, 2019.
[Notification No. G.S.R. 19(E)]