The Central Government has tightened rules on the sale of medicines containing high levels of alcohol to prevent their misuse, especially among young people. Under the revised Drugs Rules, 1945, certain oral liquid medicines with high alcohol content will now be sold only on a doctor’s prescription.
Which medicines are affected?
The new rule applies to oral liquid medicines that:
- Come in bottles larger than 30 ml, and
- Contain more than 12% ethyl alcohol.
Such medicines, including some cough syrups and health tonics, have now been added to the Schedule H1 category, which already includes medicines such as sleeping pills and strong painkillers.
Stricter sale and record-keeping
Once the rule comes into force, customers will need a valid doctor’s prescription to buy these medicines. Medical stores will also have to maintain records of every sale, and manufacturers will be required to display warning labels on the bottles.The government has also removed certain exemptions under Schedule K for these medicines to ensure stricter monitoring of their production, distribution and sale.
Rule to take effect from January 2027
The draft notification was released in October 2025 for public feedback, and after receiving no objections, the government approved the amendment. The new rules will come into force six months after their publication in the Gazette, which is expected to be around January 2027.
The move aims to curb the misuse of alcohol-based medicines and strengthen control over their sale across the country.