Govt Proposes Licence Suspension for Drugs Failing Quality Tests

The Union Health Ministry is looking to tighten drug quality regulations by proposing to immediately suspend manufacturing licenses of pharmaceutical companies for drugs that fail government lab testing.

The change follows a recommendation from the Central Drugs Technical Advisory Board (DTAB) to revise the Drug Rules, with the requirement to suspend until the companies can show or govern regulators the corrective and preventive actions (CAPA) have been implemented.

At present, many firms can continue to manufacture even though one of their drugs has been deemed to be "not of standard quality" (NSQ), raising significant patient safety concerns. During FY 2023–24 there were almost 3,000 cases of NSQ drugs flagged, and 282 cases of spurious drugs flagged out of approximately 106,000 tests conducted.

Industry associations like the Federation of Pharma Entrepreneurs (FOPE) have also raised objections, stating many NSQ results may be the result of technical error and not intentional contravention as well as the variation across labs in terms of standards and testing.

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"The health ministry and the CDSCO is taking a step forward by taking views of the states and pharma bodies as it would require a notification," said a government official on the condition of anonymity.

Stakeholders have recommended government intervention instead to strengthen the drug recall process and drive consistency across lab standards. Over 500 pharma facilities have received risk-based inspections since 2022 and regulators have taken many enforcement actions against firms.

The draft proposal is out for consultation prior to being formally notified.