India’s pharmaceutical and healthcare regulatory landscape continued to evolve significantly during the first half of 2026, with authorities introducing a range of new measures and frameworks.
The changes were aimed at simplifying regulatory processes, strengthening oversight and improving post-market surveillance across the country’s vast pharmaceutical sector.
Key developments included the operationalisation of the framework for compounding of offences under the Drugs and Cosmetics Act, 1940, a cornerstone piece of legislation governing the sector.
Authorities also introduced prior intimation mechanisms under the New Drugs and Clinical Trials Rules, 2019, alongside updated regulatory guidelines for sampling and pharmacovigilance.
Additional measures covering medical devices, drug regulation and the pricing framework were also brought into effect during this period, reflecting the breadth of the regulatory push.
The Central Drugs Standard Control Organisation, known as the CDSCO, issued a Public Notice dated January 1, 2026, informing stakeholders of the procedure for submitting compounding applications.
The CDSCO also released Frequently Asked Questions, a Standard Operating Procedure and Guidelines to support implementation of the new compounding framework across the industry.
These documents collectively clarify the scope of compoundable offences, eligibility criteria and the application procedure that companies and individuals must follow.
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 Drugs and Cosmetics Act.
Applications are submitted to the Central Compounding Authority, which considers each case based on a report furnished by the Reporting Authority, defined as the Drugs Controller General of India.
The Compounding Authority may determine the compounding amount or reject the application after providing the applicant an opportunity of being heard before a final decision is reached.
Where an application is allowed, the prescribed amount must be paid within thirty days of the determination being communicated to the applicant.
The framework also provides for immunity from prosecution where the applicant cooperates fully in proceedings and makes a full and true disclosure of all relevant facts.
However, this immunity may be withdrawn in cases including non-payment, non-compliance with applicable conditions, concealment of material particulars or the provision of false evidence to the authority.
These sweeping mid-year updates reflect continued efforts by Indian regulators to promote efficiency and risk-based oversight while maintaining robust safeguards for product quality, patient safety and compliance.