New Delhi: The Union Ministry of Health and Family Welfare has amended the Drugs Rules, 1945 to strengthen regulation of medicinal formulations containing high levels of ethyl alcohol, aiming to prevent their misuse while ensuring continued availability for genuine therapeutic purposes.
Under the amended rules, medicinal formulations containing more than 12% v/v ethyl alcohol in quantities exceeding 30 ml will no longer be exempt from licensing requirements under Schedule K of the Drugs Rules.
The government said certain products, including tinctures of cardamom, ginger and other aromatic preparations, contain 80–90% v/v ethyl alcohol in some cases, making them vulnerable to misuse for intoxication. The decision follows concerns raised by several state governments.
With the amendment, manufacturers of such formulations 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 of the Drugs Rules, meaning they can now be sold only on the prescription of a registered medical practitioner and will be subject to stricter record-keeping and monitoring by pharmacies.
According to the Health Ministry, the revised regulations will strengthen oversight of alcohol-containing medicinal products, ensure they are supplied only through the regulated pharmaceutical distribution system, and significantly reduce the risk of diversion and misuse.
The ministry said the move is part of the government’s ongoing efforts to strengthen drug regulation, promote the rational use of medicines and safeguard public health.
