Panel Moves To Redefine ‘Approved Drug’, Flags Failed Crackdowns

Last Updated:July 10, 2026, 17:13 IST

New sub-committee to build single database, may recommend licence cancellation for unlisted formulations

India is set to overhaul the way it regulates unapproved drugs, with the country’s apex panel of experts recommending a comprehensive new regulatory mechanism to tackle formulations, including fixed-dose combinations, that continue to be sold despite lacking proper approval.

According to the minutes of the 69th meeting of the Drugs Consultative Committee (DCC), seen by News18, held on June 24, the committee took up two connected agenda items — one on curbing the availability of unapproved drugs, including fixed-dose combinations, and the other on updating the Central Drugs Standard Control Organisation’s database to reflect drugs already approved but missing from records.

The move also aims at compiling a list of drugs licensed by state licensing authorities before September 21, 1988.

What the panel discussed and decided

The committee acknowledged that past government interventions have not worked well enough. The minutes note that, “DCC discussed various actions taken by the Government, including the issuance of directions under Section 33P, etc., to resolve the issue; however, these efforts have not translated into sustained compliance, and therefore, there is a need for a comprehensive regulatory framework to address these issues, as these unapproved drugs can pose a risk to the patients."

In a key clarification on what will now count as an approved drug, the committee held that “any formulation not appearing either on the CDSCO List or listed in I.P. 2010 or its earlier edition may be deemed as unapproved", giving authorities grounds to act, including cancellation of licence or market withdrawal, against such products.

To carry this forward, the committee has recommended forming a sub-committee to examine the issue in totality and suggest regulatory measures that can resolve it once and for all, so that a comprehensive database of approved drugs can be built and unapproved products prohibited.

“DCC, after detailed discussion, recommended that a sub-committee be formed to examine the issues in totality and to suggest the regulatory measures that can be taken to resolve these issues once and for all, so that a comprehensive database of approved drugs can be made, and necessary action can be taken for the prohibition of drugs that do not fall under such a database."

The panel also pushed for a permanent fix to the online submission process, recommending that the Drugs Rules be amended to make submission of all applications mandatory on the online system, in line with the Medical Device Rules, 2017, after due diligence. The sub-committee’s report will be placed before the Drugs Consultative Committee (DCC) for further deliberation.

Why the move matters?

The decision addresses a long-standing gap in India’s drug regulatory framework, where formulations without proper approval have continued to reach patients despite repeated government crackdowns. “By proposing a clear, document-based test for what qualifies as approved, and by pushing for a single, updated national database, the committee is attempting to close loopholes that have allowed unapproved drugs, including risky fixed-dose combinations, to stay in the market for years," said a senior government official privy to the development.

If implemented, he said, the move could tighten oversight at both the central and state level, and make online submission the norm rather than the exception, reducing scope for manual gaps that have historically let unapproved products slip through.

About the Author

Himani ChandnaSenior Associate Editor

Himani Chandna, Senior Associate Editor at CNN-News18, tracks healthcare, pharma and medical research, bringing clarity to complex science and policy.

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