Modified-Release Drug Intermediates Need Central Approval, Others Can Seek State Licence, Clarifies CDSCO

New Delhi: In a move aimed at bringing uniformity to the licensing system for formulation intermediates across the country and addressing concerns raised by industry stakeholders, the Central Drugs Standard Control Organization (CDSCO) has issued a clarification on the regulatory framework governing formulation intermediates such as directly compressible granules, taste-masked granules, and modified-release granules/pellets.

Issuing a circular (F. No. ND-11012(17)/1/2026-eoffice) on June 24, 2026, the New Drugs Division of CDSCO said that it had received various representations regarding the regulation of formulation intermediates, including directly compressible granules, taste-masked granules, and modified-release granules/pellets intended for direct compression or capsule filling, with the objective of facilitating the pharmaceutical industry.

According to the circular, the concerns raised by stakeholders were examined through internal technical discussions to ensure uniformity in the licensing system for formulation intermediates across the country. Thereafter, the matter was placed before the 68th Meeting of the Drugs Consultative Committee (DCC), held in hybrid mode on March 20, 2026.

After deliberation, DCC recommended that CDSCO issue clarification on the following:-

1. For New Drugs, including SR/ER/PR/DR formulations and bulk intermediates, for formulation manufacturing. CDSCO marketing permission under the NDCT Rules 2019 will be required.

2. For drugs other than New Drugs, such as directly compressible granules, the manufacturers may approach SLA. Further, in case of use of new/novel excipients, CDSCO approval will be required.

In view of the above, it is hereby informed as follows:

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 (Enteric Coated Tablets/Capsules) shall always be deemed to be a new drug as per the provisions of New Drugs and Clinical Trials Rules, 2019. Accordingly, it is clarified that all modified release dosage forms (SR/ER/PR/DR) including formulation intermediates intended to be used in such formulations i.e bulk SR, ER, PR, DR Pellets, granules will require CDSCO approval. Manufacturers of such formulation 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) All formulation intermediate other than those mentioned in Sr. No. "a" and not classified as new drugs, in such cases, the applicant shall submit application along with requisite data to the concerned State Licensing Authority for license to manufacture for sale or distribution for such formulation intermediate. However, if such formulation or formulation intermediate contains any new or novel excipient, approval from the CDSCO shall be required.

Accordingly, applicants must submit applications for formulation intermediates either to CDSCO or the concerned State Licensing Authority, as applicable, for import, manufacturing and marketing.

The circular has been issued by Dr. Rajeev Singh Raghuvanshi, Drugs Controller General (India) and has been addressed to all State and Union Territory Drugs Controllers, all CDSCO Zonal, Sub-Zonal and Port Offices, with a copy circulated to all stakeholders through the CDSCO website.

To view the official circular, click the link below: