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The Central Drugs Standard Control Organisation (CDSCO) has issued a Public Notice regarding the Compounding of Offences under the Drugs and Cosmetics Act, 1940, based on the newly notified Drugs and Cosmetics (Compounding of Offences) Rules, 2025.
This notice addresses two key questions that the industry has been seeking clarity on:
- Who is the authority responsible for compounding offences?
- What is the procedure for applying for compounding?
If you’re part of the pharmaceutical, medical device, or cosmetics ecosystem, this update is essential.
What is Compounding of Offences?
Compounding of offences is a legal mechanism that allows certain minor regulatory violations to be settled by paying a prescribed amount, instead of going through a lengthy court prosecution.
It is applicable only for specific, non-serious offences and is not available for violations impacting patient safety or involving fraud.
Background: What’s New?
Less courtroom litigation. More regulatory resolution.
As per Rule 3 of the Drugs and Cosmetics (Compounding of Offences) Rules, 2025, the Government of India has appointed:
Dr. Rajshree
Additional Director General of Health Services (DGHS)
She will function as the Central Compounding Authority for matters related to compounding of offences under the Act.
What This Means for Industry
- All eligible applications for compounding will be examined by the Central Compounding Authority
- A single central authority ensures uniformity, transparency, and consistency in decisions
How to Apply for Compounding of Offences
Stakeholders intending to apply for compounding must follow Rule 4 of the 2025 Rules. Applications must be submitted:
- In the prescribed format
- Physical copy to be submitted
- Advance copy via email to: raj.shree64@cghs.nic.in
Only complete, accurate, and well-justified applications will be considered.
Kindly refer to the official CDSCO public notice for complete details.
Additional Guidance Available
To facilitate understanding and implementation of the Drugs and Cosmetics (Compounding of Offences) Rules, 2025, CDSCO has uploaded the following resources on its official portal:
- Guidelines on Compounding of Offences – Click here
- Standard Operating Procedure (SOP) – Compounding of Offences Rules, 2025 – Click here
- FAQs on Drugs and Cosmetics (Compounding of Offences) Rules, 2025 – Click here
Why This Matters
From a regulatory affairs perspective, this moves signals:
- A more structured enforcement mechanism
- Reduced burden on courts
- Faster closure of non-serious regulatory lapses
- Greater predictability for industry stakeholders
In essence, the system reinforces compliance while offering a fair and transparent mechanism to address minor lapses.
For More Details and support in filing of the applications for compounding, Contact us at info@vaayath.com
