The Ministry of Health and Family Welfare has amended the Drugs Rules, 1945 to tighten regulation of certain medicinal formulations containing high levels of ethyl alcohol. The change matters because products earlier exempted under Schedule K can now be subject to licensing and prescription-based sale.

The government said some exempted products, including tinctures of cardamom, ginger and other aromatic preparations, contain up to 80–90% v/v ethyl alcohol in some cases. According to the ministry, such formulations were vulnerable to misuse for intoxication, and references were also received from some State Governments.

Under the amended framework, formulations containing more than 12% v/v ethyl alcohol in quantities exceeding 30 mL will no longer enjoy the exemption under Schedule K. These products must obtain the required licences under the Drugs and Cosmetics Act, 1940.

The amendment also moves such products to Schedule H1 of the Drugs Rules, 1945. Schedule H1 requires sale against the prescription of a Registered Medical Practitioner and stronger record-keeping, which is intended to keep supply within the regulated pharmaceutical chain.

Background and earlier position

Schedule K has traditionally provided exemptions from certain licensing requirements for specified categories of drugs. In this case, the exemption covered some medicinal products with alcohol content, even when the concentration could be high enough to create misuse risks. The new amendment narrows that space by linking access to licensing and prescription controls.

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