CDSCO Releases Guidelines for Compounding of Offences Under Drugs and Cosmetics Act

The Central Drugs Standard Control Organisation (CDSCO) has issued guidelines and SOPs under the Drugs and Cosmetics (Compounding of Offences) Rules, 2025, to assist stakeholders in settling minor or technical regulatory violations. The guidance clarifies application procedures, eligibility, authority roles, compounding powers, immunity provisions, and associated forms, promoting transparency and uniform compliance.

Applicants, including companies and individuals engaged in manufacturing, import, sale, or distribution of drugs, can submit applications physically with an advance copy by email to the Compounding Authority. Reports are sought from the relevant central or state licensing authorities, with defined timelines for submission. The Compounding Authority may approve or reject applications, granting immunity from prosecution if full disclosure and cooperation are ensured, while non-compliance or concealment may lead to withdrawal of immunity.

The provision stems from the Jan Vishwas Amendment, 2024, introducing Section 32B to streamline minor offence resolution without overburdening the judicial system, effective from December 31, 2024.

06-01-2026