2025.10.16_ G.S.R. 760(E)_Notification regarding restriction of sale of drug products containing alcohol content under Drugs Rules 1945

On October 16, 2025, the Ministry of Health and Family Welfare issued draft amendments to the Drugs Rules, 1945, aimed at tightening regulations on alcohol-containing formulations. The proposed changes revise Schedule K and Schedule H1, removing blanket exemptions under Chapter IV for certain products. Specifically, oral formulations with more than 12% v/v Ethyl Alcohol, when packed in bottles larger than 30 milliliters, will now fall under regulatory oversight.This amendment seeks to address safety concerns and ensure responsible use of high-alcohol pharmaceutical products. Manufacturers and stakeholders are encouraged to review the draft and provide feedback within 30 days from the date of publication. The move reflects the government’s commitment to strengthening drug control measures and aligning with public health priorities.