India proposes immediate suspension of licences for failed drugs

India’s Union Health Ministry has proposed draft amendments that would allow regulators to immediately suspend a drug’s manufacturing licence after a government analyst reports failures on specified quality tests. The proposal, which would amend the Drugs Rules, 1945, remains open for public comment and is not yet in force. The proposed suspension could be ordered by the Central Licensing Approving Authority or the relevant state or Union territory licensing authority after a drug is found not of standard quality on tests for assay, dissolution, related substances, impurities or sterility. The ministry said those parameters are used to assess medicine quality. Under the draft, a suspension would remain in place until the manufacturer conducts a root-cause analysis and implements corrective and preventive action to the licensing authority’s satisfaction. The authority would have to verify those measures before the suspension could be revoked. The ministry said the existing process includes a prescribed regulatory procedure, such as a show-cause notice, which can leave a gap between a drug being declared not of standard quality and regulatory action. During that period, the...