Government Tightens Rules for Ethyl Alcohol-based Medicines

On 10th July 2026, the Ministry of Health and Family Welfare amended the Drugs Rules, 1945 to strengthen regulation of medicinal formulations containing high levels of ethyl alcohol.

Key Points

Schedule K Amendment: The exemption from licensing under Schedule K has been removed for specified high ethyl alcohol-based medicinal formulations.
Licensing Requirement: Formulations containing more than 12% v/v ethyl alcohol in quantities exceeding 30 ml will now require a licence under the Drugs and Cosmetics Act, 1940.
Schedule H1 Inclusion: These formulations have been brought under Schedule H1 and will be sold only on the prescription of a Registered Medical Practitioner.
Objective: The amendment aims to prevent diversion and misuse of alcohol-rich medicinal products for non-medical consumption.
Regulatory Oversight: The new rules strengthen monitoring, authorised distribution and record-keeping for such medicinal formulations.