The Ministry of Health and Family Welfare has amended the Drugs Rules, 1945 to strengthen regulation of medicinal formulations containing high levels of ethyl alcohol and prevent their misuse.
Under the revised rules, formulations containing more than 12% v/v ethyl alcohol in quantities exceeding 30 mL will no longer enjoy exemption from licensing requirements under Schedule K. Manufacturers and sellers of such products will now be required to obtain the necessary licences under the Drugs and Cosmetics Act, 1940.
The government has also brought these products under Schedule H1, which means they can be sold only on the prescription of a Registered Medical Practitioner and will be subject to stricter record-keeping norms.
Officials said that several aromatic and medicinal preparations, including certain tinctures of cardamom, ginger and similar products, were earlier exempt from licensing requirements. Some of these formulations contain very high concentrations of ethyl alcohol, in some cases up to 80–90% v/v, making them vulnerable to misuse for intoxication. Concerns regarding such misuse had also been raised by some state governments.
The amendment aims to ensure that alcohol-containing medicinal products are supplied only through the regulated pharmaceutical distribution system. The government believes the move will reduce the risk of diversion and misuse while maintaining availability of these medicines for legitimate therapeutic purposes.
The decision is part of the Centre’s broader efforts to strengthen drug regulation, encourage rational use of medicines and protect public health.
