The Central Drugs Standard Control Organisation (CDSCO) has clarified the regulatory requirements for formulation intermediates following representations from industry stakeholders seeking greater clarity on the licensing process for products such as directly compressible granules, taste-masked granules, and modified-release granules and pellets used in pharmaceutical manufacturing.

According to the circular, the concerns were examined through internal technical discussions and subsequently deliberated during the 68th meeting of the Drugs Consultative Committee (DCC), held in hybrid mode on March 20, 2026. Based on the committee's recommendations, CDSCO has now issued detailed guidance to ensure uniform implementation of the licensing framework across the country.

The clarification states that modified-release dosage forms—including Sustained-Release (SR), Extended-Release (ER), Prolonged-Release (PR), Delayed-Release (DR), gastro-resistant and enteric-coated tablets and capsules—continue to be classified as "new drugs" under the New Drugs and Clinical Trials (NDCT) Rules, 2019. Consequently, formulation intermediates such as SR, ER, PR and DR pellets and granules intended for manufacturing these products will require prior approval from CDSCO. Manufacturers must submit applications for both the finished pharmaceutical formulation and the associated formulation intermediate in accordance with the NDCT Rules.

For formulation intermediates that do not fall under the definition of new drugs, including directly compressible granules and similar products, manufacturers may apply to the respective State Licensing Authority (SLA) for manufacturing licences. However, the clarification specifies that if such formulations or intermediates contain any new or novel excipients, prior approval from CDSCO will be mandatory.

The regulator said the clarification is intended to establish consistency in the licensing process for formulation intermediates while addressing regulatory concerns raised by industry stakeholders. The circular has been communicated to all State and Union Territory Drugs Controllers, as well as CDSCO's zonal, sub-zonal and port offices, for uniform implementation.