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Rules for Compounding of Offences under Drugs and Cosmetics Act, 1940 Notified

Section 32B provides for compounding of offences punishable under the following Sections Drugs and Cosmetics Act, 1940 and Rules thereunder.

1. Section 13(1)(b) – Import of drug or cosmetic which is of Not of Standard Quality or misbranded or without licence or contravening any other provisions under Act or rules,
2. Section 27(d) – Drug which is declared to be of Not of Standard Quality or misbranded or contravening any other provisions under Act or rules,
3. Section 27A(ii) – Manufacture or sale of cosmetic in contravention of any provisions of Chapter IV or any Rule, other than spurious cosmetics or adulterated cosmetics.
4. Section 28 – Non disclosure of name of the manufacturer and
5. Section 28A – Non maintenance of documents and non-disclosure of information.

Now, Central Government vide notification GSR 259 (E) dated 24.04.2025, has framed Drugs and Cosmetics (Compounding of Offences) Rules, 2025. It provides procedure to followed during compounding. Said rules provide for the definitions for the authorities such as compounding authority and reporting authority. Rules provides a prescribed Form for making application for compounding the offences.

In view of the provisions of Rule 2, any applicant which includes manufacturer as well seller can apply for compounding in prescribed form to the Compounding Authority appointed by the Central Government and State Government appointed under Rule 3.  The licensing authority appointed by the State Government and Central Licensing Authority or Central License Approving Authority are Reporting Authority. The Compounding Officer, Reporting Officer and the applicant need to follow the detailed procedure laid down under the said rules during the compounding of offences.