The Central Drugs Standard Control Organization (CDSCO) has issued a Guidance Document to facilitate implementation of the Drugs and Cosmetics (Compounding of Offences) Rules, 2025. The document outlines eligibility, application procedures, roles of authorities, compounding process, immunity provisions, and withdrawal conditions. It aims to promote uniformity, transparency, and ease of compliance for manufacturers, importers, distributors, and other regulated entities under the Drugs and Cosmetics Act, 1940.
The Central Drugs Standard Control Organization (CDSCO) has published a comprehensive Guidance Document to support stakeholders in complying with the Drugs and Cosmetics (Compounding of Offences) Rules, 2025, notified under Sections 32B and 33 of the Drugs and Cosmetics Act, 1940.
Key points include:
- The guidance explains the legal framework for compounding of specified offences, enabling companies or individuals to avoid prosecution subject to conditions and approval by the designated Compounding Authority (Additional Director General of Health Services, CDSCO).
- It details the form and manner of application, procedural timelines, reporting mechanisms, and decision-making steps, including grant or rejection of compounding and payment of compounding amounts.
- The document also elaborates on immunity from prosecution, circumstances for withdrawal of immunity, and responsibilities of applicants and reporting authorities.
- Annexures include a prescribed application form and a process flow chart, ensuring clarity, consistency, and efficient regulatory compliance across CDSCO offices.