New Delhi: Through a recent gazette notification, the Ministry of Health and Family Welfare has amended the Drugs and Cosmetics Rules, 1945. The Gazette dated 11th July 2018 talks about the amendment of the Drugs and Cosmetics Rules, 1945, in order to insert Information to be uploaded by the licensee on online portal SUGAM
The said draft rules 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.
These rules have been termed as the Drugs and Cosmetics (…….Amendment) Rules, 2018. (2) They shall come into force on the date of their final publication in the Official Gazette.
As per the amendment In the Drugs and Cosmetics Rules, 1945, after rule 84AA( Additional information to be furnished by an applicant for licence or a licensee to the licensing authority.), the following rule shall be inserted, namely,-
“84AB. Information to be uploaded by the licensee on online portal SUGAM-
- 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.
- 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 email@example.com.
Objections and suggestions which may be received from any person within the 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 will be considered by the Central Government.
Rule 84AA talk about Additional information to be furnished by an applicant for licence or a licensee to the licensing authority. According to the said rule the applicant for the grant of a licence or any person granted a licence under this Part shall, on demand, furnish to the Licensing Authority, before the grant of the licence or during the period the licence is in force, as the case may be, documentary evidence in respect of the ownership or occupation on rental or other basis of the premises, specified in the application for licence or in the licence granted, constitution of the firm or any other relevant matter which may be required for the purpose of verifying the correctness of the statements made by the applicant or the licensee, while applying for or after obtaining the licence, as the case may be.]
Attached is the notice below