Govt allows compounding of specific offences under Drugs and Cosmetics Act

On 24-4-2025, the Ministry of Health and Family Welfare notified the Drugs and Cosmetics (Compounding of Offences) Rules, 2025 providing framework for resolving specific offences under Drugs and Cosmetics Act, 1940 through compounding, allowing offenders to settle cases without lengthy prosecution procedures. The provisions came into force on 25-4-2025.

Key Points:

1. These rules come under the ambit of Drugs and Cosmetics Act, 1940.

2. Appointment of compounding authority:

   • Central Government will appoint officer not below the rank of Licensing Authority/the Central Licensing Authority/ the Central License Approving Authority as compounding authority.

   • State Government will appoint any officer below the rank of Licensing Authority/the Central Licensing Authority/ the Central License Approving Authority as compounding authority.

3. Form and manner of application:

   • Applicant can make an application to the compounding authority either or before or after institution of prosecution;

   • Application can be made individually by the company or by the person involved in manufacturing, import, sale, distribution.

4. Procedure for compounding:

   • On receipt of application, compounding authority can call for a report from the reporting authority with reference to the particulars furnished in the application or any other information relevant for examination of application;

   • Report has to be furnished by the reporting authority within a period of 1 month from the date of receipt of communication from compounding authority.

     This period can be extended by the compounding authority;

   • Compouding authority can allow the application indicating the compounding amount and grant him immunity from prosecution;

   • Copy of every order will be sent to the applicant.

   • Applicant within a period of 30 days from the receipt of order allowing the compounding of offences will have to pay the compounding amount and will have to furnish the proof of payment to the compounding authority;

   • Once the compounding amount has been paid, it cannot be refunded in cases where Court rejects grant of immunity from prosecution;

   • The applicant cannot claim, as of right, that his offence should be compounded.

5. It is the discretion of Compouding authority to grant immunity from prosecution for the offences with respect to the case covered by the compounding of offence.

6. An immunity granted to a person will stand withdrawn:

   • if such person fails to pay any sum specified in the order of compounding passed by the Compounding authority;

   • If such person has concealed any particulars/ material/ has given false evidence.