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 medicinal preparations, including tinctures of cardamom, ginger and other aromatic formulations, were earlier exempted from licensing requirements under Schedule K. Some of these products contain ethyl alcohol concentrations as high as 80–90 per cent v/v, raising concerns over their possible misuse for intoxication. The issue was also flagged by several state governments.
To address these concerns, the government has mandated that all formulations containing more than 12 per cent v/v ethyl alcohol in quantities exceeding 30 ml will no longer be covered under the Schedule K exemption. Such products will now require mandatory licences under the Drugs and Cosmetics Act, 1940.
The amendment also places these formulations under Schedule H1 of the Drugs Rules, 1945, requiring them to be sold only against prescriptions issued by a Registered Medical Practitioner and subjecting them to stricter record-keeping requirements.
The government said the regulatory changes will enhance monitoring of alcohol-containing medicinal products, ensure their distribution through authorised pharmaceutical channels and reduce the risk of diversion and misuse while maintaining their availability for legitimate medical purposes.
The initiative is part of the government’s broader efforts to strengthen the drug regulatory framework, promote rational use of medicines and safeguard public health.
