India to Crack Down on Drugmakers Selling Unlisted, Irrational Formulations
Quick Look
- India's government plans to penalize drugmakers with unlisted products to stop sales of irrational fixed-dose combinations.
- Expert committees suggest license cancellation for unapproved formulations, as previous measures failed to ensure compliance.
AI-generated summary
Why It Matters
The Indian government is developing a comprehensive framework to address the sale of irrational fixed-dose combinations (FDCs) and unapproved drug formulations, as previous interventions have not ensured lasting compliance.
New Delhi: The government is set to crack down on drugmakers whose products are not listed in its Central Drug Administration database as part of efforts to curb the sale of irrational fixed-dose combinations (FDCs), according to people familiar with the matter.
An FDC drug contains two or more active ingredients in a fixed dosage ratio. The drugs are deemed rational when claims regarding their benefits are supported by evidence-based data and clinical studies.
The Drugs Consultative Committee (DCC), an expert committee under the drug regulator, has said that drug formulations not listed in the official Central Drugs Standard Control Organisation (CDSCO) list and not included in the Indian Pharmacopoeia (I.P.) 2010 or any earlier edition, may be treated as "unapproved", the people cited earlier said.
It suggested that regulators would be empowered to cancel the licence of the drugmakers concerned and withdraw the products from the market. The move is part of a broader effort by the drug advisory body to stop sale of unapproved formulations.
The committee, in its recent meeting, noted that previous government interventions, including directions issued under Section 33P of the Drugs and Cosmetics Act, had failed to produce lasting compliance.
Section 33P of the Drugs and Cosmetics Act, 1940 empowers the central government to issue directions to state licensing authorities on regulatory matters.
The Centre has previously used this power to direct states/regulators to act against unapproved drugs but the DCC found these directions alone hadn't produced lasting compliance.
The panel concluded that a more comprehensive framework was needed to resolve the problem "once and for all".
The DCC has also recommended forming a sub-committee tasked with examining the issue in full and proposing concrete regulatory measures. The sub-committee's findings will be brought back before the DCC for further review.
The committee was reviewing a proposal for a comprehensive mechanism to stop the sale of unapproved drugs and FDCs, and a separate proposal to reconcile gaps in the CDSCO drug database, including formulations approved by the CDSCO but missing from its records, as well as older drugs licensed by state licensing authorities (SLAs) before September 21, 1988.
What to Watch
AI outlook — possibilities, not facts
Drug formulations not listed in official databases or pharmacopoeias may face license cancellation and market withdrawal.
Likely · Within months
Open Questions
- What specific penalties will be imposed on non-compliant drugmakers?
- What is the timeline for the new comprehensive framework?
- How will the sub-committee's findings be integrated?
