top of page
Search

India CDSCO: 10th edition of the Indian Pharmacopoeia 2026 & Guidance on Compounding of Offences under the Drugs and Cosmetics Act, 1940

The 10th edition of the Indian Pharmacopoeia 2026 was launched by the Union Health Minister in the first week of January 2026 with 121 new monographs, Indian Pharmacopoeia 2026 ha now 3,340 monographs. The Indian Pharmacopoeia is now recognized in 19 countries.


This guidance has been issued by the Central Drugs Standard Control Organization (CDSCO) to support regulated stakeholders in understanding the newly notified compounding mechanism under Indian drug regulatory law.

This guidance provides clarity on eligibility, procedures, authorities involved, immunity provisions, and application requirements to ensure transparency, uniformity, and ease of compliance.

ree

1. Preface

The Drugs and Cosmetics (Compounding of Offences) Rules, 2025 have been framed under Section 32B read with Clause (r) of sub-section (2) of Section 33 of the Drugs and Cosmetics Act, 1940. These rules establish a legal framework that allows certain offences under the Act to be compounded, thereby avoiding prosecution, subject to conditions and at the discretion of the designated Compounding Authority.


This guidance document has been prepared by CDSCO to assist manufacturers, importers, distributors, and regulatory officers in understanding and complying with the newly introduced rules. It explains the application process, eligibility criteria, powers of authorities, immunity provisions, and associated forms, with the objective of promoting regulatory clarity and consistent implementation.


2. Key Definitions

The guidance defines key regulatory terms essential for interpretation:

  • Applicant: Any company or person involved in manufacturing, import, sale, distribution, or other regulated activities under the Act.

  • Compounding Authority: An officer appointed by the Central or State Government (not below the rank of a reporting authority) authorised to process and decide compounding applications.

  • Reporting Authority: The Licensing Authority or Central Licensing Authority or Central Licence Approving Authority, as applicable, having jurisdiction over the place where the offence was committed or alleged.


3. Form and Manner of Application

Stage of Application

An application for compounding may be filed before or after the institution of prosecution.

Authority to Apply To

Applications must be submitted to the Compounding Authority under Section 32B of the Act.

Application Requirements

Applications must:

  • Be submitted in the prescribed form

  • Include all relevant documents and information

Who Can Apply

Applications may be submitted individually by:

  • Companies, or

  • Persons involved in manufacturing, import, sale, distribution, or other activities covered under the Act and Rules


4. Procedure for Compounding of Offences

The guidance details a stepwise and time-bound procedure:

  1. Application submitted physically, with an advance copy emailed to the Compounding Authority

  2. E-file generated by the concerned department

  3. Report sought from the Reporting Authority

  4. Reporting Authority requests input from zonal/sub-zonal/port offices

  5. Zonal offices submit reports within prescribed timelines

  6. Reporting Authority forwards consolidated report within one month

  7. Compounding Authority reviews the application and report

  8. Application is either allowed (with compounding amount and immunity) or rejected

  9. Personal hearing is mandatory before rejection

  10. Applicant must pay the compounding amount within 30 days

  11. Amount paid is non-refundable, except where immunity is denied by a court

Applicants do not have a right to compounding; it remains discretionary.


5. Immunity from Prosecution – Powers of Compounding Authority

The Compounding Authority may grant immunity from prosecution if satisfied that the applicant:

  • Has cooperated during proceedings, and

  • Has made full and true disclosure of facts

Immunity may be granted with conditions deemed appropriate and applies only to the specific case being compounded.

6. Withdrawal of Immunity from Prosecution

Automatic Withdrawal

Immunity is automatically withdrawn if the applicant:

  • Fails to pay the compounding amount within the stipulated time, or

  • Fails to comply with conditions of immunity

Withdrawal by Authority

Immunity may also be withdrawn if the applicant:

  • Conceals material facts, or

  • Provides false evidence during proceedings

In such cases, prosecution may proceed as if immunity was never granted.


7. Form for Application (Summary)

The application form requires detailed information including:

  • Applicant and contact details

  • Product and licence information

  • Details of offence, sampling, and seizure

  • Status of prosecution

  • History of previous offences

  • Declarations and verification

This ensures a complete factual basis for decision-making.

8. Authorities Involved

  • Compounding Authority: Additional Director General of Health Services (CDSCO)

  • Reporting Authority: Central Licensing / Licence Approving Authorities

  • Applicant: Responsible for submission and compliance with orders

Each authority plays a defined role to ensure procedural integrity.

Annexures

  • Annexure I: Application Form for Compounding of Offences

  • Annexure II: Process Flow Chart detailing end-to-end compounding workflow


For more deatils click on the this link.



I Sometimes Send Newsletters

Thanks for submitting!

  • LinkedIn
  • Facebook
  • Twitter
  • Instagram

DISCLAIMER

The views expressed in this publication do not necessarily reflect the views of any guidance of government, health authority, it's purely my understanding. This Blog/Web Site is made available by a regulatory professional, is for educational purposes only as well as to give you general information and a general understanding of the pharmaceutical regulations, and not to provide specific regulatory advice. By using this blog site you understand that there is no client relationship between you and the Blog/Web Site publisher. The Blog/Web Site should not be used as a substitute for competent pharma regulatory advice and you should discuss from an authenticated regulatory professional in your state.  We have made every reasonable effort to present accurate information on our website; however, we are not responsible for any of the results you experience while visiting our website and request to use official websites.

bottom of page