&imwidth=800&imheight=600&format=webp&quality=medium "Prescription only: India changes rules for alcohol-based cough syrups and oral medicines")
India has tightened rules governing the sale of oral medicines that contain alcohol. In an order dated 8 July 2026, the Indian Ministry of Health and Family Welfare said that starting January 2027, oral medicines containing more than 12 per cent ethyl alcohol and sold in bottles larger than 30 ml will no longer be sold over the counter (OTC).
What exactly has changed?
The amendment makes two key changes to the Drugs Rules, 1945. Under the Drugs (Tenth Amendment) Rules, 2026, oral medications containing more than 12 per cent alcohol can no longer be sold over the counter. This means they will be treated as prescription medicines under Schedule H1 of the Drugs Rules, 1945 and a prescription from a medical professional would be required for their purchase. Additionally, these products will now have to comply fully with the provisions of the Drugs and Cosmetics Act.
In simple terms, medicines that meet both conditions, more than 12 per cent ethyl alcohol and a bottle size above 30 ml, will no longer be freely sold across pharmacy counters. The new rules will come into force six months after their publication in the Official Gazette, meaning the changes are expected to take effect in January 2027.
Why has the government done this?
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While the notification does not explicitly state the reason, the move is widely seen as an effort to prevent the misuse of alcohol-based medicinal formulations, particularly cough syrups and similar oral medicines that are sometimes consumed for intoxication rather than treatment.
The Health Ministry said the amendments were made after consultation with the Drugs Technical Advisory Board, the country's highest technical body on drug regulation. The initiative is in line with the Government's continued efforts to strengthen the regulatory framework for drugs, promote the rational and responsible use of medicinal products and safeguard public health.
