Health Ministry proposes immediate licence suspension for drugs failing key quality tests

The Union Health Ministry has proposed changes to the Drugs Rules, 1945, allowing immediate suspension of manufacturing licences for drugs found to be Not of Standard Quality (NSQ) on specified parameters, according to The Hindu. The government said the proposal aims to speed up regulatory intervention and prevent continued manufacture and distribution of substandard medicines.

Under current rules, licence suspension or cancellation follows a prescribed process that includes a show-cause notice. According to the report, this can leave a gap between an NSQ finding and regulatory action, during which the medicine may remain in circulation and become harder to recall. The proposal would allow the Central Licensing Approving Authority or State Licensing Authority to suspend the drug’s manufacturing licence upon receiving a government analyst’s report identifying failures involving assay, dissolution, related substances, impurities or sterility.

The Ministry said a suspension would remain until the manufacturer identifies the underlying reasons for the quality failure and implements appropriate Corrective and Preventive Action (CAPA) to the licensing authority’s satisfaction. The authority would need to verify those measures before lifting the suspension.

Proposed changes to Form 13 would also send the government analyst’s findings to the Drugs Controller General of India, the licensing authority responsible for the manufacturing site, and the drug’s manufacturer and marketer. The government said this would support faster communication, coordinated action and accountability. The draft is open for public consultation, with objections and suggestions invited within 30 days of the relevant Gazette copies becoming publicly available.