The Central Drugs Standard Control Organization (CDSCO) on January 01, 2026, issued the Guidelines on Compounding of Offences under the Drugs and Cosmetics Act, 1940 as per Drugs and Cosmetics (Compounding of Offences) Rules, 2025.
The following has been stated namely: -
• The document is to assist all stakeholders, including manufacturers, importers, distributors, and regulatory officers, in understanding and complying with the newly notified rules.
• This is applicable to the CDSCO Head Office, Zonal, Subzonal office & Port office.
• The Form and Manner of Application has been stated.
• The Forms are attached in the Annexures.
[Notification No. CDSCO/Compounding Authority Ver.:00]