The Central Drugs Standard Control Organization (CDSCO), on June 24, 2026, issued a circular clarifying the regulatory framework governing formulation intermediates, including directly compressible granules, taste-masked granules, and modified release granules/pellets, to ensure uniformity in the licensing process across the country. The clarification follows the recommendations of the 68th Drugs Consultative Committee (DCC) meeting held on March 20, 2026, after examining representations received from stakeholders.
The circular clarifies that new drugs, including sustained release (SR), extended release (ER), prolonged release (PR), delayed release (DR), gastro-resistant and enteric-coated formulations, and bulk formulation intermediates intended for such formulations, shall require marketing permission from CDSCO under the New Drugs and Clinical Trials (NDCT) Rules, 2019. Manufacturers are required to submit applications for both the pharmaceutical formulation and the corresponding formulation intermediate to CDSCO for permission to manufacture, import, market, or distribute such products.
Further, the circular provides that formulation intermediates not classified as new drugs, such as directly compressible granules, shall be regulated by the State Licensing Authority (SLA), and manufacturers must apply to the concerned SLA for the requisite manufacturing licence. However, where such formulations or formulation intermediates contain new or novel excipients, prior approval from CDSCO shall be mandatory. Accordingly, applicants are required to submit applications either to CDSCO or the State Licensing Authority, as applicable, depending on the nature of the formulation intermediate.
[Circular No. F. No. ND-11012(17)/1/2026-eoffice]
