CDSCO Issues Clarity on New Drugs, DC Granules & MR Pellets Licensing

The pharmaceutical manufacturing industry has long faced regulatory ambiguity regarding formulation intermediates — semi-processed dosage form precursors that are not finished drug products but are commercially supplied to other manufacturers for direct compression or capsule filling. Products such as directly compressible (DC) granules, taste-masked granules, modified release (MR) granules, and pellets occupy a grey zone between excipients and finished dosage forms.

Various stakeholder representations had been received by CDSCO's New Drugs Division requesting regulatory clarity on whether such intermediates required Central (CDSCO) approval or could be licensed through the State Licensing Authority (SLA). After internal technical deliberations, the matter was placed before the 68th Meeting of the Drugs Consultative Committee (DCC) held on 20 March 2026 (Hybrid mode). Following DCC's recommendations, this circular (F. No. ND-11012(17)/1/2026-eoffice), dated 24 June 2026, was issued by Dr. Rajeev Singh Raghuvanshi, Drugs Controller General (I).

The circular establishes a two-track licensing framework based on whether the formulation intermediate constitutes a "new drug" under Rule 2(1)(w) of the NDCT Rules, 2019.

Manufacturers of modified release formulation intermediates (SR/ER/PR/DR pellets and granules) must submit a combined pharmaceutical formulation application covering both the finished dosage form and the formulation intermediate simultaneously to CDSCO, for grant of permission to manufacture for sale or distribution. This ensures a holistic technical review of the release-modifying technology at both the intermediate and the final product stage.

For directly compressible granules, taste-masked granules, and other non-new drug intermediates, the applicant must approach the concerned State Licensing Authority with the relevant application accompanied by requisite data. Important carve-out: if such an intermediate contains a new or novel excipient — regardless of whether the intermediate itself is not a new drug — CDSCO approval is additionally required before the SLA license can be granted.

The circular is equally applicable to importers. Applications for import and marketing of formulation intermediates must be submitted to CDSCO or SLA as appropriate, based on the product classification outlined above.

This circular has significant practical implications for pharmaceutical manufacturers and importers across India:

• Immediate portfolio audit: Any company currently manufacturing or supplying SR/ER/PR/DR pellets or granules without CDSCO marketing permission is now in a non-compliant position and must initiate remediation.
• Combined application strategy: For MR products, new applicants must plan regulatory submissions to include both the intermediate and finished dosage form in a single CDSCO dossier.
• Excipient due diligence: Even for SLA-route intermediates, manufacturers using any novel excipient must obtain prior CDSCO clearance — otherwise, the SLA license itself may be on uncertain regulatory ground.
• Uniform national framework: A primary driver of this circular was ensuring consistent licensing standards across all Indian states. State Drugs Controllers have been directly addressed, reducing scope for state-level inconsistency.
• Importers equally covered: Both domestic manufacturers and importers of formulation intermediates must comply with this two-track framework.