Central Drugs Standard Control Organization (New Drugs Division), Directorate General of Health Services, has issued a circular addressed to all State/UT Drugs Controllers, all Zonal/Sub-Zonal/Port Offices of CDSCO, and all stakeholders through the CDSCO website.

Representations were received regarding regulation of formulation intermediates such as Directly Compressible granules, Taste masked granules, Modified release granules/Pellets for direct compression/capsule filling.

The matter was placed before the 68th Meeting of the Drugs Consultative Committee (DCC) held on March 20, 2026 through Hybrid mode. Based on DCC recommendation, the following has been stated:

(a) As per Rule 2(1)(w) of the New Drugs and Clinical Trials Rules, 2019, modified or sustained release form of a drug including Gastro-resistant Tablets/Capsules, Delayed release Tablets/Capsules and Enteric Coated Tablets/Capsules shall always be deemed to be new drug. Accordingly, all modified release dosage forms (SR/ER/PR/DR) including formulation intermediates intended for such formulations (i.e. bulk SR, ER, PR, DR Pellets, granules) require CDSCO approval. Manufacturers are required to submit application of pharmaceutical formulation accompanied with that of application for formulation intermediate for grant of permission to manufacture for sale or distribution in accordance with the provisions of New Drug and Clinical Trial Rules, 2019 to CDSCO.

(b) For formulation intermediates other than those mentioned in (a) above and not classified as new drugs, the applicant shall submit application with requisite data to the concerned State Licensing Authority (SLA). However, if such formulation or formulation intermediate contains any new or novel excipient, CDSCO approval shall be required. Accordingly, applicants shall submit the application of formulation intermediates to CDSCO or to the SLA, as the case may be, for import/manufacturing and marketing.