The Ministry of Health and Family Welfare has published draft rules proposing amendments to the Drugs Rules, 1945, which would introduce new restrictions on the retail sale and distribution of certain oral drug formulations containing alcohol.
The proposed amendment, titled the Drugs (… Amendment) Rules, 2025, seeks to limit the over-the-counter sale of these specific products by adding them to the restricted Schedule H1.
Key Regulatory Changes
The draft rules introduce two coordinated changes affecting the sale of oral formulations containing more than 12 percent alcohol by volume (v/v):
- Removal of General Exemption (Schedule K, Serial No. 10): The existing exemption under Schedule K (which grants relief from many provisions of Chapter IV of the Act, simplifying retail) is being restricted. The exemption will no longer apply to all oral formulations containing more than 12 percent v/v (Ethyl Alcohol) that are packed and sold in containers larger than 30 milliliters.
- Inclusion in Schedule H1: Concurrently, all oral formulations containing more than 12 percent v/v (Ethyl Alcohol) and packed in containers larger than 30 milliliters are proposed to be added as a new entry (Serial No. 51) under Schedule H1.
Schedule H1 drugs are subject to stricter dispensing rules, including mandatory labeling (Rx symbol on the strip/bottle and outer carton) and enhanced record-keeping by pharmacists, limiting their over-the-counter availability. These changes aim to mitigate potential public health risks associated with the accessibility and potential misuse of high-alcohol-content medicines.
Public Consultation
The draft rules are published for public consultation. The Central Government will consider objections and suggestions received within a period of thirty days from the date the copies of the Gazette (published on October 16, 2025) are made available.
Objections and suggestions may be submitted to the Director (Drugs regulation), Ministry of Health and Family Welfare, or emailed to drugsdiv-mohfw@gov.in.