Lifescience and Healthcare Update - Ministry of Health and Family Welfare

The Ministry of Health and Family Welfare, in consultation with the Drugs Technical Advisory Board, has released the draft Drugs and Cosmetics (Compounding of Offences) Rules, 2023 ("Draft Rules") to provide the option of compounding certain offences under the Drugs and Cosmetics Act, 1940 (the "Act") such as offences of non-maintenance of statutorily required records and registers under the Act.

As per the Draft Rules, the applicant (company or a person applying to compound any offence under the Act) can be granted immunity from prosecution if the compounding authority is satisfied that the applicant has made true and full disclosure of facts relating to the case. The Draft Rules provides a format of application for compounding, procedure for compounding, and conditions which must be fulfilled for grant of immunity from prosecution.

The Draft Rules is open for objections and suggestions till 25 August 2024.

Access the Draft Rules here.