July 10, 2026 12:51 PM
Centre amends Drugs Rules to regulate high-alcohol medicinal formulations
The Ministry of Health and Family Welfare has amended the Drugs Rules, 1945 to strengthen regulatory oversight and prevent the misuse of medicinal formulations containing high levels of ethyl alcohol. Under the amendment, the existing exemption under Schedule K from licensing requirements for certain ethyl alcohol-based formulations has been removed. The move aims to regulate products that contain high concentrations of alcohol and could potentially be diverted for non-medical use. Certain med...