CDSCO has clarified the regulatory pathway for formulation intermediates such as directly compressible granules, taste-masked granules, and modified release granules/pellets. Modified release intermediates (SR/ER/PR/DR) are considered New Drugs and require CDSCO approval under the Rule 2 (1) (w) of NDCT Rules, 2019, while non-new drug intermediates may be licensed by State Licensing Authorities, subject to excipient requirements.
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.