Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com
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Last Updated on July 25, 2024 by The Health Master
Compounding of Offences
Govt of India has issued a draft notification vide GSR No. 374 dated 10-07-2024 regarding the Compounding of Offences under the Drugs and Cosmetics Act 1940.
These rules may be called as Drugs and Cosmetics (Compounding of Offences) Rules, 2023,
Brief procedure for compounding of offences is as under:
Applying for Compounding
- Applicant can apply for compounding before or after legal proceedings begin.
- Use Form-1 (specified in the rules) along with relevant information and documents.
- Submit the application to the compounding authority.
Processing the Application
- The compounding authority will request a report from the reporting authority about the offence.
- The reporting authority has one month to respond (with extensions possible).
- The compounding authority will review the application and the report:
- They may approve the application and set a compounding fee.
- They may reject the application, but only after giving the applicant a chance to be heard and providing reasons for rejection.
- Applicant will receive a copy of the order (approval or rejection).
If Approved
- Applicant have 30 days to pay the compounding fee.
- Proof of payment must be submitted to the compounding authority.
- The compounding fee is non-refundable (except in rare cases).
- Approval for compounding is not guaranteed.
Immunity from Prosecution
- The compounding authority may grant the applicant immunity from prosecution if:
- Applicant cooperates with the proceedings.
- Applicant makes a full and truthful disclosure of facts.
- This immunity can be subject to conditions.
Withdrawing Immunity
- Immunity can be withdrawn if:
- Applicant fails to pay the compounding fee on time.
- Applicant violates any conditions of immunity.
- Applicant conceals information or provide false evidence during the process.
- If immunity is withdrawn, the applicant can be prosecuted for the original offence or any related offences.
Compiled by:
Rakesh Dahiya, SDCO cum Licensing Authority, FDA Haryana
Compounding Of Offence Under Jan Vishwas Act
New Amendments to Section 32B of the Drugs and Cosmetics Act, 1940
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