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INTRODUCTION
India’s pharmaceutical and healthcare regulatory landscape continued to evolve during the first half of 2026, with authorities introducing measures aimed at simplifying regulatory processes, strengthening regulatory oversight and improving post-market surveillance. Key developments included the operationalisation of the framework for compounding of offences, prior intimation mechanisms under the New Drugs and Clinical Trials Rules, 2019, regulatory guidelines for sampling and measures relating to pharmacovigilance, medical devices, drug regulation and pricing framework. These developments reflect continued efforts to promote regulatory efficiency and risk-based oversight while maintaining safeguards for product quality, patient safety and compliance.
COMPOUNDING OF OFFENCES UNDER THE DRUGS AND COSMETICS ACT, 1940
The Central Drugs Standard Control Organisation (“CDSCO”), through a Public Notice dated January 1, 2026, informed stakeholders of the procedure for submitting applications under the Drugs and Cosmetics (Compounding of Offences) Rules, 2025 (“Compounding Rules”)1. The CDSCO also issued Frequently Asked Questions (“FAQs”)2, a Standard Operating Procedure (“SOP”)3 and Guidelines4 to facilitate implementation of the framework.
These documents collectively clarify the scope of compoundable offences, eligibility criteria and the application procedure. The offences eligible for compounding include specified contraventions relating to the manufacture, sale, stocking, exhibition or distribution of drugs and cosmetics, as prescribed under Section 32B of the DCA and the Compounding Rules. Applications are submitted to the Central Compounding Authority, which considers the application based on a report furnished by the Reporting Authority5. The Compounding Authority may determine the compounding amount or reject the application after providing the applicant an opportunity of being heard. Where an application is allowed, the prescribed amount must be paid within thirty (30) days.
It also provides for immunity from prosecution where the applicant cooperates in the proceedings and makes a full and true disclosure of relevant facts. However, this immunity may be withdrawn in cases including non-payment, non-compliance with applicable conditions, concealment of material particulars or provision of false evidence.
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1Accessible here: https://cdsco.gov.in/opencms/ 2Accessible here: https://cdsco.gov.in/opencms/ 3Accessible here: https://cdsco.gov.in/opencms/ 4Accessible here: https://cdsco.gov.in/opencms/ 5‘Reporting Authority’ means the Drugs Controller General of lndia |
This article was authored by Shlok Siddhant, Naveli Sharma, Tanya Kukade and Dr. Milind Antani
