Government amends Drugs Rules, 1945 to Strengthen Regulation of High Alcohol-Containing Drug Formulations

The Ministry of Health and Family Welfare has amended the Drugs Rules, 1945 to remove the Schedule K exemption for medicinal formulations that contain more than 12 % v/v ethyl alcohol and are sold in quantities exceeding 30 mL. Such products, which previously included tinctures of cardamom, ginger and other aromatic preparations, will now be placed under Schedule H1 and will require a licence under the Drugs and Cosmetics Act, 1940 as well as a prescription from a registered medical practitioner. The change mandates stricter record‑keeping and is intended to curb diversion and misuse of high‑alcohol drug formulations while maintaining their legitimate therapeutic availability.