The Ministry of Health and Family Welfare has notified the Drugs and Cosmetics (Compounding of Offences) Rules, 2025 (hereinafter “the Rules”), effective immediately from 25th April, 2025. These new rules outline the procedures and framework for compounding of certain offences under the Drugs and Cosmetics Act, 1940, potentially offering an alternative to prosecution for less severe violations.
Key Highlights:
- The Rules provide for appointment of compounding authority, both by the Central and State Governments, not below the rank of the reporting authority as defined within the rules. These authorities will be responsible for exercising the powers and functions of their respective governments in matters arising from these rules.
- The Rules state that the Individuals or companies involved in the manufacture, import, sale, distribution, or any other activity covered under the Drugs and Cosmetics Act and its rules can submit an application, before or after the initiation of prosecution, in the prescribed form along with relevant information and documents to the designated compounding authority for the compounding of an offence.
- The Rules lay down the procedure for compounding of offences, under which the compounding authority is mandated to request a report from the reporting authority under whose jurisdiction the alleged offence occurred. After considering the application and the report, the compounding authority can issue an order either allowing the application or rejecting the application.
- The compounding authority, on being satisfied that the applicant has cooperated in the proceedings and has made a full and truthful disclosure of the facts related to the case, may grant immunity from prosecution for the specific offence covered by the compounding, subject to any conditions deemed appropriate by the authority.
- If the person granted immunity fails to pay the compounding amount within the stipulated time or if the compounding authority is satisfied that the applicant had concealed any material particulars or provided false evidence during the compounding proceedings, the said immunity may also be revoked/withdrawn under the given Rules.
Source: Ministry of Health and Family Welfare
