The Health Ministry has proposed amendments to the Drugs Rules, 1945, enabling immediate suspension of manufacturing licences for medicines failing critical quality tests for assay, dissolution, impurities, related substances or sterility. Licences could be restored only after verified corrective action. Draft rules are open for public comments for 30 days.
Union Health Ministry Proposes Immediate Suspension of Manufacturing Licences for Drugs Found Not of Standard Quality on Specified Critical Parameters
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Ministry of Health and Family Welfare (India)