Drugs Rules, 1945 Amended to Tighten Regulation of High Alcohol Content Medicine

The Ministry of Health and Family Welfare has notified the Drugs (Tenth Amendment) Rules, 2026, amending the Drugs Rules, 1945 to revise the regulatory framework applicable to certain oral medicinal formulations containing high concentrations of ethyl alcohol. 

According to the official gazette, the amendment will come into force six months after its publication in the Official Gazette. 

Schedule K Exemption Narrowed 

The amendment modifies Schedule K of the Drugs Rules, 1945, which provides exemptions from certain licensing requirements for specified medicinal products. 

Under the revised provision, all oral formulations containing more than 12% v/v ethyl alcohol that are packed and sold in bottles or packings exceeding 30 millilitres will no longer qualify for the Schedule K exemption. As a result, such products will be required to obtain the applicable licences under the Drugs and Cosmetics Act, 1940. 

The notification inserts the following exception under Serial No. 10 of Schedule K: 

"...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." 

Included in Schedule H1 

The amendment also revises Schedule H1 of the Drugs Rules, 1945. 

A new Entry 52 has been inserted, covering: 

"All oral formulations containing more than 12% alcohol v/v (Ethyl Alcohol) packed and sold in packings or bottles of more than 30 milliliters." 

Products listed under Schedule H1 are required to be sold only against the prescription of a Registered Medical Practitioner and are subject to the record-keeping requirements applicable to Schedule H1 drugs. 

Background for High Alcohol Content Medicine

Certain medicinal preparations, including tinctures of cardamom, ginger and other aromatic preparations, were exempt from licensing requirements under Schedule K. Some of these formulations contain high concentrations of ethyl alcohol, in certain cases up to 80–90% v/v, and that references regarding their misuse were received from certain State Governments. 

The amendment to regulation of high alcohol content medicines is intended to remove the licensing exemption for oral formulations containing more than 12% v/v ethyl alcohol in pack sizes exceeding 30 mL, require licensing under the Drugs and Cosmetics Act, 1940, and place such products under Schedule H1.