Centre Tightens Rules on High Alcohol Medicines; Prescription, Licence Now Mandatory

July 10, 2026

New Delhi: The Central government has tightened regulations governing medicinal formulations containing high levels of ethyl alcohol, making them subject to licensing requirements and prescription-only sale in an effort to prevent misuse while ensuring their availability for genuine medical treatment.

The Ministry of Health and Family Welfare announced that medicinal products containing more than 12 percent v/v ethyl alcohol and packaged in quantities exceeding 30 mL will no longer be exempt from licensing under the Drugs and Cosmetics Act, 1940.

Why has the government changed the rules?

According to the ministry, several medicinal preparations including certain tinctures of cardamom, ginger and other aromatic formulations were previously exempt from licensing requirements under Schedule K.

However, some of these products contain 80–90 percent ethyl alcohol, making them susceptible to misuse for intoxication. The Centre said it had also received concerns from several state governments regarding the abuse of such formulations.

What changes under the new rules?

Under the revised regulations:

• Medicinal formulations containing more than 12% v/v ethyl alcohol in packs larger than 30 mL will require licences for manufacture and sale.
• These products have been brought under Schedule H1 of the Drugs Rules, 1945.
• They can now be sold only on the prescription of a registered medical practitioner.
• Pharmacies will be required to maintain stricter sales records in accordance with Schedule H1 provisions.

Aim is to prevent misuse

The ministry said the move will ensure that alcohol-containing medicines are supplied only through the regulated pharmaceutical distribution system, reducing the risk of diversion and misuse while safeguarding access for patients who genuinely need these medicines.

Gazette notification issued

The revised provisions have been notified through an official Gazette notification issued by the Ministry of Health and Family Welfare.

The government said the amendment is part of its broader efforts to strengthen India’s drug regulatory framework, promote the responsible use of medicines and enhance public health safeguards.