The Central Drugs Standard Control Organization (CDSCO), under the Directorate General of Health Services, has issued a comprehensive circular clarifying the regulatory and licensing framework for various formulation intermediates, including directly compressible granules, taste-masked granules, and modified-release pellets.
The directive follows technical deliberations at the 68th Meeting of the Drugs Consultative Committee (DCC) to establish national uniformity in the licensing system. As per the clarified guidelines, all modified-release dosage forms such as sustained-release (SR), extended-release (ER), prolonged-release (PR), and delayed-release (DR) granules or bulk pellets are officially deemed “New Drugs” under the New Drugs and Clinical Trials (NDCT) Rules, 2019. Consequently, manufacturers of these modified-release intermediates must secure explicit marketing permission and manufacturing approval from the central CDSCO.
For standard formulation intermediates not classified as new drugs, such as standard directly compressible granules, applicants are directed to submit their data to the respective State Licensing Authority (SLA) for manufacturing licenses. However, the CDSCO emphasizes that if any intermediate contains a new or novel excipient, central CDSCO approval remains strictly mandatory.
Written by: Pragna Biswas
Graphics by: Pramit Hazra
