CDSCO clarifies regulatory pathway for formulation intermediates

The Central Drugs Standard Control Organization (CDSCO) has issued a clarification on the regulatory framework for formulation intermediates such as directly compressible granules, taste-masked granules, and modified-release granules and pellets, aiming to bring uniformity in their licensing across the country.

The clarification follows representations received from industry seeking clarity on the regulatory requirements for formulation intermediates used in direct compression and capsule filling. The matter was discussed internally and deliberated at the 68th meeting of the Drugs Consultative Committee (DCC) held on March 20, 2026.

According to the circular, formulation intermediates intended for use in modified-release dosage forms, including sustained release (SR), extended release (ER), prolonged release (PR), and delayed release (DR) formulations, will require prior approval from CDSCO under the New Drugs and Clinical Trials (NDCT) Rules, 2019.

The regulator stated that modified or sustained-release dosage forms are deemed to be new drugs under Rule 2(1)(w) of the NDCT Rules, 2019. Consequently, bulk SR, ER, PR and DR pellets and granules used in such formulations will also require CDSCO approval. Manufacturers must submit applications for both the pharmaceutical formulation and the corresponding formulation intermediate to CDSCO for permission to manufacture for sale or distribution.

For formulation intermediates that are not classified as new drugs, such as directly compressible granules, manufacturers can apply to the respective State Licensing Authority (SLA) for manufacturing licences. However, if such formulation intermediates contain any new or novel excipient, approval from CDSCO will be mandatory.

The circular also states that applications for formulation intermediates should be submitted either to CDSCO or the relevant State Licensing Authority, depending on the applicable regulatory pathway for import, manufacturing and marketing.

The clarification is expected to provide greater regulatory certainty for manufacturers of formulation intermediates while ensuring a uniform licensing approach across states.

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