The Union Health Ministry has removed exemptions from licensing for certain medicinal products containing high levels of ethyl alcohol to improve oversight and curb misuse. In a statement released on Friday, July 10, 2026, the ministry noted that items such as tinctures of cardamom, ginger and similar aromatic preparations had previously been exempt under Schedule K of the Drugs Rules, 1945. Some of these products include ethyl alcohol concentrations reaching 80-90 percent, raising concerns about potential misuse for intoxication. Several state governments had also flagged the issue. Under the new rules, any formulation exceeding 12 percent ethyl alcohol by volume in quantities over 30 milliliters will require licenses under the Drugs and Cosmetics Act, 1940. These products will also move to Schedule H1, requiring a prescription from a registered medical practitioner and detailed record-keeping. The changes aim to ensure such medicines remain available only through regulated channels, reducing diversion risks while supporting legitimate medical use and protecting public health.
