The Ministry of Health and Family Welfare has amended the Drugs Rules, 1945 to bring stricter controls on medicinal formulations containing high levels of alcohol and prevent their misuse.
Under the new rules, medicines containing more than 12% v/v ethyl alcohol in quantities above 30 ml will no longer get exemption under Schedule K. Such products will now require mandatory licensing under the Drugs and Cosmetics Act, 1940 and will be included under Schedule H1, making them available only on the prescription of a Registered Medical Practitioner.
Earlier, certain formulations such as tinctures of cardamom, ginger and other aromatic preparations were exempt from licensing requirements despite containing high concentrations of alcohol, in some cases reaching 80–90% v/v. Concerns were raised over their potential misuse for intoxication.
The amendment aims to strengthen monitoring of alcohol-based medicinal products, prevent diversion and ensure that such formulations remain available only through regulated pharmaceutical channels for legitimate medical use. The move is part of the government’s efforts to promote safe and responsible use of medicines and protect public health.
Nurturing Creativity – Keekli Charitable Trust, Shimla
