Health Ministry proposes immediate suspension of manufacturing licences for drugs found not of standard quality

4 November 2026

The Union Health Ministry has proposed amending the Drugs Rules, 1945 to allow immediate suspension of a manufacturing licence when a drug is declared Not of Standard Quality. The power would apply where the failure is on Assay, Dissolution, Related Substances, Impurities or Sterility. The Central Licensing Approving Authority or the State Licensing Authority, as applicable, could act straight away on receiving the Government Analyst's report. At present a show-cause notice must come first, which can keep a substandard drug in circulation while the process runs. The suspension would continue until the manufacturer completes a Root Cause Analysis and a Corrective and Preventive Action plan to the Licensing Authority's satisfaction. Form 13, the Government Analyst's test report, would also go to the Drugs Controller General of India, the State or Union Territory Licensing Authority where the site is, and the manufacturer and marketer. The 65th Drugs Consultative Committee and the 92nd Drugs Technical Advisory Board had recommended the change, and objections may be filed within 30 days.