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CDSCO

Compounding of Offences under the Drugs and Cosmetics Act, 1940 in accordance with the Drugs and Cosmetics (Compounding of Offences) Rules, 2025


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Importer & Manufacturer   |   Source: CDSCO
Published On: 01-01-2026

Enforcement Date: 01 January, 2026
Compounding of Offences under the Drugs and Cosmetics Act, 1940 in accordance with the Drugs and Cosmetics (Compounding of Offences) Rules, 2025

The Central Drugs Standard Control Organization (CDSCO) has issued a public notice informing stakeholders about the implementation of the Drugs and Cosmetics (Compounding of Offences) Rules, 2025. Dr. Rajshree, Additional DGHS, has been appointed as the Central Compounding Authority. Stakeholders may apply for compounding of offences by submitting the prescribed application form in physical copy along with an advance email copy, as per Rule 4 of the Rules.


The Central Drugs Standard Control Organization (CDSCO), under the Directorate General of Health Services, has issued a Public Notice regarding the compounding of offences under the Drugs and Cosmetics Act, 1940, in accordance with the Drugs and Cosmetics (Compounding of Offences) Rules, 2025, notified vide G.S.R. 259(E) dated 24 April 2025.


Key points include:

  1. As per Rule 3, the Government of India has appointed Dr. Rajshree, Additional Director General of Health Services (DGHS), DGHS (HQ), New Delhi, as the Central Compounding Authority.
  2. Stakeholders intending to apply for compounding of offences must apply in the prescribed format, in physical form, along with an advance copy via email to the notified address, as specified under Rule 4.
  3. The notice also informs that Guidelines, Standard Operating Procedures (SOPs), and FAQs related to compounding of offences have been uploaded on the CDSCO website for stakeholder reference.


The notice is issued for information and necessary compliance by all concerned.

Applicable For: Importer & Manufacturer
Reference Number: F. No. DCG(l)/Legal/Misc.-'l 60/2025-DC Notification Link

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