The Central Drugs Standard Control Organization (CDSCO) on January 02, 2026, issued the FAQs on Drugs and Cosmetics (Compounding of Offences) Rules, 2025.
The following has been stated namely: -
• The Rules allow certain offences—such as those under Sections 13(1)(b), 27(d), 27A(ii), 28 and 28A of the Act (excluding offences punishable with imprisonment only)—to be compounded either before or after initiation of prosecution, subject to approval by the designated Compounding Authority. Eligible applicants include manufacturers, importers, sellers, distributors, companies, or individuals regulated under the Act.
• The Compounding Authority, appointed by the Central or State Government, examines applications submitted in the prescribed Form under Rule 4. Upon receipt, the authority seeks a factual report from the concerned Reporting Authority (Licensing Authority) and may either allow compounding by specifying the amount payable and granting immunity from prosecution, or reject the application after providing an opportunity to be heard.
• The FAQs further clarify that compounding is not a matter of right and remains discretionary. Immunity from prosecution may be granted only if the applicant makes a full and true disclosure and cooperates fully; such immunity can be withdrawn if conditions are breached, payments are not made within 30 days, or material facts are concealed.
• The document also details procedural timelines, payment conditions, non-refundability of compounding amounts, and the comprehensive information required to be furnished in the application form, ensuring transparency and regulatory certainty for stakeholders.
