69th DCC Recommends Comprehensive Regulatory Mechanism to Curb Unapproved Drugs and FDCs

Minutes of the 69th Drugs Consultative Committee (DCC) meeting held on 24.06.2026 — Agenda Nos. 2 & 3

Meeting: 69th DCC, held on 24.06.2026
Agenda 2: Comprehensive Regulatory Mechanism to stop availability of Unapproved Drugs, including FDCs
Agenda 3: Database update for CDSCO-approved drugs not reflected in the CDSCO database, and preparation of a database of drugs licensed by SLAs prior to 21.09.1988

In its 69th meeting held on 24.06.2026, the Drugs Consultative Committee (DCC) took up two closely linked agenda items concerning the continued circulation of unapproved drugs, including Fixed Dose Combinations (FDCs), and the long-standing gaps in India’s centralized drug approval database. The deliberations signal a decisive move toward a permanent, structural fix rather than case-by-case enforcement.

Background: Why the Issue Was Revisited

The DCC noted that the Government has already taken several steps to address the unapproved drugs problem, including issuing directions under Section 33P of the Drugs and Cosmetics Act. However, the Committee observed that these measures have not translated into sustained compliance. Given the patient safety risk posed by formulations circulating without valid approval, the DCC concluded that a comprehensive regulatory framework is now required to resolve the issue on a lasting basis.

Key Recommendation: A Clear Test for “Unapproved” Status

The most significant outcome of the meeting is the criterion the DCC has proposed for identifying unapproved formulations. As per the discussion:

Any formulation that does not appear on the CDSCO List, and is not listed in I.P. 2010 or its earlier editions, may be deemed unapproved.

Once a product falls under this definition, the competent authority may initiate action against it, including cancellation of manufacturing license and market withdrawal. This gives regulators and State Licensing Authorities (SLAs) a concrete reference point instead of relying on ad hoc verification.

Formation of a Sub-Committee

Recognizing the scale and complexity of the issue, the DCC recommended constituting a sub-committee to:

• Examine the unapproved drugs issue in totality
• Recommend regulatory measures for a permanent resolution
• Enable the creation of a comprehensive, authoritative database of approved drugs
• Facilitate action for prohibition of formulations that fall outside this database

The sub-committee’s report is to be placed before the DCC for further deliberation, indicating that concrete rule-level changes may follow once this exercise is complete.

Database Gaps Addressed (Agenda 3)

Alongside the unapproved drugs discussion, the DCC also took up the parallel issue of database integrity — specifically, drugs that were approved by CDSCO but never reflected in the CDSCO database, and drugs licensed independently by SLAs prior to 21.09.1988. Both categories currently exist in a regulatory grey zone, and the DCC’s direction to build a reliable, consolidated database is expected to close this gap and reduce future disputes over approval status.

Mandatory Shift to ONDLS for All Applications

In a related but separate recommendation aimed at addressing online submission issues permanently, the DCC recommended that the Drugs Rules be amended to mandate submission of all applications through the Online National Drugs Licensing System (ONDLS), aligning the process with the framework already in place under the Medical Device Rules, 2017. The Committee noted this should be implemented after due diligence.

What This Means for Manufacturers and Marketers

While these are recommendations pending sub-committee review and rule amendment, the direction of travel is clear:

1. Manufacturers should proactively cross-check existing product portfolios against the CDSCO List and I.P. 2010 (or earlier editions) to identify any formulation at risk of being classified as unapproved.
2. Companies holding licenses that predate 21.09.1988, or approvals that may not be reflected in the current CDSCO database, should consider compiling supporting documentation in anticipation of the proposed database reconciliation exercise.
3. Regulatory teams should prepare for a transition toward mandatory ONDLS-based filings across all license and approval categories.

How Vaayath Can Help

Vaayath Consulting Services Private Limited assists pharmaceutical manufacturers and marketers in auditing product portfolios against CDSCO’s approved drugs list and I.P. references, compiling legacy licensing documentation for database reconciliation, and preparing for regulatory transitions such as ONDLS-based filings. If your organization holds older SLA licenses or CDSCO approvals that may need verification, our team can help you get ahead of the compliance curve.

Reach out to us at info@vaayath.com to discuss your specific portfolio.