Union Ministry of Health and Family Welfare Amends Drugs Rules, 1945; Exemption for Sale of Cough Syrups in Small Villages Withdrawn

• Ministry of Health and Family Welfare (MoHFW) amended the Drugs Rules, 1945 to remove the long-standing exemption that permitted over-the-counter (OTC) sale of cough syrups in villages with population < 1,000 without a licensed pharmacy.
• Cough syrups now fall fully under the Drugs and Cosmetics Act, 1940 licensing regime — saleable only through duly licensed pharmacies, against valid prescriptions.
• Direct policy response to the 2025 India cough syrup crisis involving diethylene glycol (DEG) contamination flagged by the WHO Medical Product Alert N°5/2025.
• Examinable as: GS-II (Health governance, regulation) and GS-III (Pharma sector, S&T safety).