The Central Drugs Standard Control Organisation (CDSCO) on July 21, 2026, issued clarification regarding submission of applications under Rule 4 of the Drugs and Cosmetics (Compounding of Offences) Rules, 2025.
This clarification addresses the submission of applications for compounding of offences under Rule 4 of the Drugs and Cosmetics (Compounding of Offences) Rules, 2025. It highlights that applications are incorrectly being submitted to the Central Compounding Authority even in cases that fall under the jurisdiction of State authorities.
To ensure proper implementation, it is clarified that applications must be submitted to the appropriate Compounding Authority based on jurisdiction. If the offence arises from a sample drawn by a State/UT Drugs Inspector, the application must be filed with the respective State/UT Compounding Authority. Conversely, if the sample is drawn by a CDSCO Drugs Inspector or falls under the Central Licensing Authority, the application should be submitted to the Central Compounding Authority.
The determining factor for jurisdiction is the authority that drew the sample. Applications submitted to an incorrect authority may be returned or rejected, leading to delays. Therefore, all stakeholders, including manufacturers and applicants, are advised to carefully identify the correct authority before submission to ensure timely processing.
[Notification No. Legal-13011(11)/17/2026-eoffice(Comp. 37331)]
