The Central Drugs Standard Control Organization (CDSCO) has issued a major clarification regarding the regulatory approval process for formulation intermediates, including directly compressible granules, taste-masked granules, modified-release granules, pellets, and similar intermediates used in pharmaceutical manufacturing. The clarification aims to establish uniform licensing practices across India and eliminate confusion among manufacturers.
According to the official communication, CDSCO had received several representations from the pharmaceutical industry seeking clarity on the regulation of formulation intermediates such as directly compressible granules, taste-masked granules, modified-release granules, and pellets used for direct compression or capsule filling. These concerns were discussed internally and later placed before the 68th meeting of the Drugs Consultative Committee (DCC), held on 20 March 2026 through hybrid mode.
Following deliberations, the DCC recommended that CDSCO issue a clarification distinguishing the approval requirements for new drugs and non-new drugs.
CDSCO Approval Mandatory for Modified Release Formulation Intermediates
CDSCO clarified that under Rule 2(1)(w) of the New Drugs and Clinical Trials (NDCT) Rules, 2019, modified or sustained-release dosage forms—including Sustained Release (SR), Extended Release (ER), Prolonged Release (PR), Delayed Release (DR), gastro-resistant tablets/capsules, and enteric-coated formulations—are deemed to be new drugs.
Consequently, all formulation intermediates intended for manufacturing these dosage forms, including SR, ER, PR, and DR granules or pellets, will require prior approval from CDSCO. Manufacturers must submit applications for both the pharmaceutical formulation and its formulation intermediate simultaneously to obtain permission for manufacture, sale, or distribution under the NDCT Rules, 2019.
State Licensing Authority to Regulate Other Formulation Intermediates
For formulation intermediates that are not classified as new drugs, manufacturers should submit their applications along with the required technical data to the respective State Licensing Authority (SLA) for obtaining manufacturing licences.
However, CDSCO has clarified that if any such formulation or formulation intermediate contains a new or novel excipient, prior approval from CDSCO will still be mandatory before manufacturing can commence.
Key Takeaways for Pharmaceutical Manufacturers
• CDSCO approval is mandatory for formulation intermediates used in SR, ER, PR, DR, enteric-coated, delayed-release, and gastro-resistant dosage forms.
• Manufacturers should submit applications for both the final formulation and formulation intermediate together under the NDCT Rules, 2019.
• State Licensing Authorities (SLAs) will regulate formulation intermediates that are not classified as new drugs.
• If a formulation intermediate contains a new or novel excipient, CDSCO approval will still be required irrespective of the licensing authority.
The clarification provides long-awaited regulatory certainty for pharmaceutical manufacturers producing formulation intermediates. By clearly defining the respective roles of CDSCO and State Licensing Authorities, the notification is expected to promote uniform licensing practices across the country, reduce regulatory ambiguity, and streamline approval procedures for formulation intermediates used in pharmaceutical manufacturing.
