Regulation of Formulation intermediates such as Directly Compressible granules, Taste masked granules, Modified release granules / Pellets

CDSCO has issued a regulatory clarification to establish uniform licensing practices for formulation intermediates across India. As per the circular, modified-release dosage forms including Sustained Release (SR), Extended Release (ER), Prolonged Release (PR), and Delayed Release (DR) formulations are classified as New Drugs under the New Drugs and Clinical Trials Rules, 2019.   Consequently, formulation intermediates such as SR/ER/PR/DR granules and pellets require prior CDSCO approval. Manufacturers intending to market these products must submit applications for both the finished formulation and the corresponding formulation intermediate to CDSCO.   or formulation intermediates that are not categorized as New Drugs, manufacturers may apply to the respective State Licensing Authority (SLA) for manufacturing licenses. However, products incorporating new or novel excipients will continue to require CDSCO approval.   The clarification aims to ensure regulatory consistency, product quality, and streamlined compliance across the pharmaceutical industry.