Health Ministry makes doctors' prescription mandatory for high-alcohol medicines

New Delhi: Aiming to curb the misuse of medicinal products with high alcohol content, the Union Government has introduced an amendment to the Drug Rules, 1945, under which the existing exemption (under Schedule K) from licensing requirements for formulations containing ethyl alcohol has been removed.

According to the recent Gazette notification dated 08.07.2026, these products have been shifted to Schedule H1 of the Drugs Rules, 1945, making a registered medical practitioner's prescription mandatory for these products containing more than 12% v/v ethyl alcohol.

The amendment has been issued by the Ministry of Health and Family Welfare through Notification G.S.R. 607(E) dated July 8, 2026, and published in the Gazette of India (Extraordinary) on July 9, 2026. The new rules will come into force six months from the date of publication in the Official Gazette.

Certain medicinal products, including tinctures of cardamom, ginger and other aromatic preparations, have been exempted from licensing requirements under Schedule K of the Drugs Rules, 1945. Some of these formulations contain high concentrations of ethyl alcohol, in certain cases up to 80–90% v/v, making them susceptible to misuse for intoxication. References were also received from certain State Governments in this regard, the Ministry said on Friday.

To address this concern, the Government has mandated that all formulations containing more than 12% v/v ethyl alcohol, in quantities exceeding 30 mL, shall no longer be covered under the exemption provided to them under Schedule K. Consequently, such products will be required to obtain the requisite licenses under the Drugs and Cosmetics Act, 1940, it added.

As part of the amendment, the Central Government has inserted a new Entry No. 52 in Schedule K of the Drugs Rules, 1945. The new entry covers all mouthwash preparations containing more than 12 per cent alcohol (ethyl alcohol by volume/volume) packed and sold in bottles or packs exceeding 30 ml. Corresponding changes have also been made in the exemption provisions under Schedule K.

Announcing the Drugs (Tenth Amendment) Rules, 2026, the Gazette notification mentioned the following:

In the Drugs Rules, 1945, ─

(i) in Schedule K, under the heading Extent and Conditions of Exemptions, against the serial no. 10, after the words “Act and rules thereunder”, the words, figures, symbols, letters and brackets “except for all oral formulations containing more than 12% alcohol v/v (Ethyl Alcohol) packed and sold in packings or bottles of more than 30 milliliters.”, shall be inserted;

(ii) in Schedule H1, after the entry “51. Pregabalin”, the following entry shall be inserted, namely: ─ “52. All oral formulations containing more than 12% alcohol v/v (Ethyl Alcohol) packed and sold in packings or bottles of more than 30 milliliters.”.

Schedule K of the Drugs Rules specifies categories of drugs that are exempt from certain provisions of the Drugs and Cosmetics Act and the Rules made thereunder, subject to prescribed conditions. With the latest amendment, the specified category of alcohol-based mouthwash preparations will no longer enjoy the earlier exemption after the six-month transition period, UNI has reported.

The Ministry said the draft amendment had earlier been published through G.S.R. 760(E) dated October 16, 2025, inviting objections and suggestions from stakeholders. Copies of the draft notification were made available to the public on October 18, 2025, but no objections or suggestions were received during the consultation period.

The six-month implementation window is intended to provide manufacturers, distributors, and other stakeholders sufficient time to comply with the revised regulatory requirements before the amended provisions become operational.

The Ministry said that the amendment is expected to strengthen regulatory oversight over those medicinal products containing alcohol, ensuring their supply only through the regulated pharmaceutical supply chain. It will significantly reduce the possibility of diversion and misuse while ensuring their continued availability for legitimate therapeutic use.