Clarification on Proper Submission of Applications under Rule 4 of the Drugs and Cosmetics (Compounding of Offences) Rules, 2025

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Dated: 23.07.2026

Clarification on Proper Submission of Applications under Rule 4 of the Drugs and Cosmetics (Compounding of Offences) Rules, 2025

The Central Drugs Standard Control Organisation (CDSCO) has issued a circular dated 21 July 2026 to clarify the correct procedures and jurisdiction for submitting applications under Rule 4 of the Drugs and Cosmetics (Compounding of Offences) Rules, 2025. This guidance is crucial for manufacturers, importers, distributors, licence holders, and all stakeholders involved in the drugs and cosmetics sector in India.

Background

With the implementation of the Drugs and Cosmetics (Compounding of Offences) Rules, 2025, there has been confusion regarding the appropriate authority for submitting applications for compounding offences.

The circular addresses instances where applications were incorrectly submitted to the Central Compounding Authority, even when the offence was under the jurisdiction of the State Drug Control Administration.

Key Clarifications from the Circular

Jurisdiction-Based Submission
- Applications for compounding an offence must be submitted to the Compounding Authority that has jurisdiction over the specific offence.
State/UT Jurisdiction
- If a sample is drawn by a Drugs Inspector appointed by a State or Union Territory (UT) Government, and the alleged offence falls within the jurisdiction of the State/UT Drugs Licensing Authority, the application should be submitted to the respective State/UT Compounding Authority.
Central Jurisdiction
- If a sample is drawn by a Drugs Inspector from the CDSCO or if the offence pertains to matters under the Central Licensing Authority, the application must be submitted to the Central Compounding Authority.
Determining the Competent Authority
- The authority that drew the sample determines the competent Compounding Authority:
  - CDSCO Drugs Inspector: Application goes to the Central Compounding Authority.
  - State/UT Drugs Inspector: Application goes to the respective State/UT Compounding Authority.
Consequences of Incorrect Submission
- Applications submitted to an authority without jurisdiction are liable to be returned or rejected. Applicants may be advised to resubmit to the correct authority, which can cause unnecessary delays.

Practical Steps for Stakeholders

Verify Jurisdiction: Before submitting an application under Rule 4, confirm whether the offence falls under State/UT or Central jurisdiction based on who drew the sample and the nature of the alleged offence.
Submit to the Correct Authority: Ensure the application is directed to the appropriate Compounding Authority to avoid processing delays or rejection.

Example Scenarios

Scenario 1: A manufacturer in Maharashtra has a sample drawn by a Maharashtra State Drugs Inspector. The application for compounding must be submitted to the Maharashtra State Compounding Authority.
Scenario 2: An importer has a sample drawn by a CDSCO Drugs Inspector at a port of entry. The application should be submitted to the Central Compounding Authority.

Conclusion

This circular aims to standardize the process for submitting applications under Rule 4 of the Drugs and Cosmetics (Compounding of Offences) Rules, 2025, ensuring clarity and efficiency. Stakeholders are strongly advised to ascertain the competent authority before submission to prevent delays and ensure compliance with regulatory requirements.

In case you face any issues related to Indirect Tax-Customs, GST, Foreign Trade Policy (FTP), Arbitration matters and Central Licensing and related advisory matters in India then please feel free to get in touch with SJ EXIM Services.

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Source: CDSCO

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