Why the Centre Is Tightening Control Over High-Alcohol Medicines

The Centre has tightened regulations on medicinal formulations containing more than 12% ethyl alcohol by withdrawing their licensing exemption under the Drugs Rules, 1945. The move mandates licences, prescription-only sales and stricter record-keeping to prevent misuse of high-alcohol medicinal products as intoxicants. The amendment aims to strengthen regulatory oversight while ensuring genuine medicines remain available through the regulated pharmaceutical supply chain. By Mahima Katal New Delhi, July 11: The Centre has tightened India's drug regulatory framework by withdrawing the licensing exemption for medicinal formulations containing more than 12 per cent ethyl alcohol, a move aimed at preventing their misuse as intoxicants while ensuring continued access for genuine medical treatment. The amendment introduces mandatory licensing and prescription-only sale for such products, signalling a shift towards stricter oversight of alcohol-based medicinal preparations.

According to the Ministry of Health and Family Welfare, medicinal formulations containing more than 12 per cent volume per volume (v/v) ethyl alcohol in quantities exceeding 30 ml will no longer enjoy the exemption available under Schedule K of the Drugs Rules, 1945. Manufacturers and sellers of these products will now be required to obtain licences under the Drugs and Cosmetics Act, 1940.

The government has also brought these formulations under Schedule H1 of the Drugs Rules, making their sale permissible only on the prescription of a registered medical practitioner. Pharmacies will also be required to maintain stricter records of their sale, bringing these products under the same regulatory regime as several other controlled medicines.

The decision follows concerns that certain medicinal preparations exempted under Schedule K contained unusually high concentrations of ethyl alcohol. Products such as tinctures of cardamom, ginger and other aromatic preparations were found to contain alcohol levels reaching as high as 80 to 90 per cent v/v in some cases, making them vulnerable to diversion and misuse for intoxication.

The Health Ministry said it had also received representations from several state governments highlighting the misuse of such formulations. Officials noted that while these products were marketed as medicines, the exemption under Schedule K allowed them to escape licensing requirements despite their high alcohol content.

Sources said the amendment addresses a long-standing regulatory gap that enabled preparations containing ingredients such as cardamom, ginger and other spices to remain outside the prescribed limits on alcohol content. The revised framework ensures that medicinal formulations cannot claim exemption solely because they contain these ingredients if their alcohol concentration exceeds the prescribed threshold.

The ministry said the amendment is intended to create a uniform regulatory framework for all medicinal products containing ethyl alcohol. Existing provisions under the Drugs Rules already prescribe alcohol limits for several traditional systems of medicine. Rule 161 permits Ayurvedic, Siddha and Unani syrups to contain up to 16 per cent alcohol, while Rule 106B limits alcohol content in Homoeopathic medicines to 12 per cent.

By removing the Schedule K exemption for high-alcohol formulations, the government aims to strengthen oversight over their manufacture, distribution and sale. Officials said the measure would significantly reduce the possibility of diversion and misuse while ensuring that legitimate medicinal products continue to remain available through regulated pharmaceutical channels.

The ministry described the amendment as part of the government's broader effort to strengthen drug regulation, encourage the rational use of medicines and safeguard public health. A gazette notification detailing the amendments has been issued by the ministry.