The Government of India has amended the Drugs Rules, 1945 to strengthen oversight of medicinal products containing high levels of ethyl alcohol.
The Ministry of Health and Family Welfare announced that formulations with more than 12% v/v ethyl alcohol in quantities exceeding 30 mL will no longer enjoy exemption under Schedule K.
Officials confirmed that such products must now obtain licenses under the Drugs and Cosmetics Act, 1940. The amendment also places these formulations under Schedule H1, requiring sale only against a prescription from a registered medical practitioner and stricter record-keeping.
The move follows references from several state governments highlighting misuse of high alcohol-containing medicinal products, including tinctures of cardamom, ginger, and other aromatic preparations. Some of these formulations contain up to 80–90% v/v ethyl alcohol, making them vulnerable to diversion for intoxication.
Authorities emphasised that the amendment ensures supply only through regulated pharmaceutical channels. It aims to reduce misuse while maintaining legitimate therapeutic availability.
The Ministry stated that the initiative aligns with ongoing efforts to strengthen India’s drug regulatory framework, promote rational use of medicines, and safeguard public health.
The Gazette Notification detailing the amendments is available on the Ministry’s website for reference.
