Govt Committee Proposes Central Database to Identify and Ban Unapproved Drugs, FDCs from Market

New Delhi: The Drugs Consultative Committee (DCC) has proposed a comprehensive regulatory mechanism to permanently address the long-standing issue of unapproved drugs, including unapproved Fixed Dose Combinations (FDCs), circulating in the Indian market.

During its recent meeting, the Committee extensively deliberated on two key agenda items: a proposal to develop a comprehensive regulatory framework to stop the availability of unapproved drugs, including FDCs, and a proposal to update the Central Drugs Standard Control Organisation (CDSCO) database by incorporating drugs approved by CDSCO but not presently reflected in its database, besides preparing a separate database of drugs that had been licensed by State Licensing Authorities (SLAs) prior to September 21, 1988.

The Committee was apprised of both proposals before undertaking an extensive discussion on the issues.

During the deliberations, the DCC reviewed the various measures already taken by the Government to address the problem of unapproved drugs. It noted that several regulatory interventions, including the issuance of directions under Section 33P, have been undertaken in an effort to resolve the issue.

However, despite these actions, the Committee observed that the initiatives have not resulted in sustained compliance, indicating that the existing regulatory measures have not been sufficient to permanently eliminate the problem. The DCC further noted that the continued availability of such unapproved drugs poses a potential risk to patients, necessitating a more comprehensive and long-term regulatory solution.

Following detailed discussions, the Committee opined that any formulation that does not appear either in the CDSCO list of approved drugs or is not listed in the Indian Pharmacopoeia (IP) 2010 or any of its earlier editions may be deemed to be an unapproved drug.

Based on this view, the DCC stated that the competent authority may initiate appropriate regulatory action against such products.

DCC, after detailed discussion, recommended that a subcommittee 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.

Further to address the issue of online submission permanently, the DCC recommended that the Drugs Rules may be amended to make submission of all applications on ONDLS (online submission of all applications through the Online National Drugs Licensing System) in line with the Medical Device Rules, 2017, after due diligence.