The Centre has tightened regulations governing medicinal formulations containing high levels of ethyl alcohol by withdrawing the licensing exemption for products containing more than 12 per cent alcohol by volume (v/v) in quantities exceeding 30 ml, in a move aimed at preventing their misuse for intoxication.
The Ministry of Health and Family Welfare said the amendment removes the exemption available under Schedule K of the Drugs Rules, 1945, for such formulations, including certain tinctures and aromatic preparations that contain up to 80-90 per cent ethyl alcohol.
The decision follows concerns raised by several state governments over the misuse of these products.
Under the revised rules, the affected formulations will require licences under the Drugs and Cosmetics Act, 1940, and will also be brought under Schedule H1, making them available only on the prescription of a registered medical practitioner with stricter record-keeping requirements.
