The Union Health Ministry has tightened regulation for medicinal formulations containing more than 12% ethyl alcohol. The change matters because certain alcohol-rich preparations can be diverted for intoxication, while still being sold as medicines.
Under the amended rules, products above 30 ml with that alcohol content will no longer enjoy exemption from licensing under Schedule K of the Drugs Rules. They will instead require licences under the Drugs and Cosmetics Act, 1940.
The same amendment also places these products under Schedule H1, which means they can be sold only on prescription and with stricter record-keeping.
The ministry said some preparations, including certain tinctures and aromatic formulations, can contain very high alcohol levels and may be misused for intoxication. It also said state governments had raised concerns about such misuse.
Background and earlier position
Schedule K earlier created licensing exemptions for specified categories of drugs. This framework reduced regulatory burden for eligible products, but also created a gap where some alcohol-containing medicinal formulations could be sold with lighter controls.
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