New Delhi: The Ministry of Health and Family Welfare has implemented strict amendments to the Drugs Rules, 1945, to eliminate the regulatory loopholes surrounding medicinal formulations containing high concentrations of ethyl alcohol. By rolling back historical licensing exemptions, the central government aims to curb the widespread diversion of these therapeutic products for recreational intoxication.
Previously, common pharmaceutical preparations such as aromatic tinctures of ginger, cardamom, and other traditional herbs enjoyed a special exemption from standard licensing protocols under Schedule K of the Drugs Rules. This exemption applied even though several of these liquid formulations possessed an exceptionally high alcohol content, ranging between 80 to 90 per cent volume by volume. Following multiple representations from various state governments highlighting the widespread abuse of these over-the-counter medicines as cheap liquor substitutes, federal authorities moved to eliminate the legal carve-out.
Under the newly notified guidelines, the ministry has mandated that any medicinal formulation containing more than 12 per cent volume by volume ethyl alcohol packaged in quantities exceeding 30 mL will stripped of its Schedule K status. Consequently, all manufacturers, distributors, and retailers of these specific products must now secure formal operating licences under the overarching Drugs and Cosmetics Act, 1940.
To complement the licensing mandate, the amendment reclassifies these high-alcohol formulations under Schedule H1 of the Drugs Rules. This regulatory shift means that these products can no longer be purchased freely over the counter; instead, they can only be dispensed upon the physical presentation of a valid prescription issued by a registered medical practitioner. Furthermore, pharmacies will be bound by rigorous record-keeping protocols, including maintaining specialized registers to track sales volumes and customer information.
Health ministry officials emphasized that the revised framework is designed to seamlessly integrate these potent formulations into the heavily monitored pharmaceutical supply chain. By tracking manufacturing outputs and retail sales, the government intends to drastically minimize the risk of illegal diversion while ensuring that legitimate patients retain uninterrupted access to these medicines for genuine therapeutic purposes
