India’s Ministry of Health and Family Welfare has proposed amendments to the Drugs Rules, 1945, that would require licensing authorities to immediately suspend the manufacturing licence for a drug declared Not of Standard Quality (NSQ) under specified circumstances. The draft also proposes mandatory root cause analysis (RCA), corrective and preventive action (CAPA), and changes to the distribution of Government Analyst test reports. Two proposed routes for immediate licence suspension The draft notification, G.S.R. 956(E), dated 28 October 2026, proposes amendments to Rules 85 and 122O of the Drugs Rules, 1945. Both...