New Delhi: In a significant move to prevent the misuse of medicines containing high levels of alcohol, the Union Ministry of Health and Family Welfare has amended the Drugs Rules, 1945, bringing certain oral medicinal formulations under stricter regulation.
The Centre has placed all oral medicines containing more than 12% ethyl alcohol and sold in bottles larger than 30 ml under Schedule H1, a category that requires tighter monitoring and controlled dispensing.
Why the rules have been changed
The decision aims to curb the misuse of cough syrups and other oral medicinal preparations with high alcohol content. According to the ministry, some formulations previously exempt from licensing requirements under Schedule K contain ethyl alcohol concentrations as high as 80–90 per cent, making them vulnerable to misuse for intoxication.
The move follows concerns raised by several state governments regarding the growing misuse of such medicinal products.
What Schedule H1 means
Medicines listed under Schedule H1 can only be sold with a valid prescription and are subject to stricter record-keeping by pharmacies. By including these high-alcohol formulations under Schedule H1, the government hopes to promote responsible dispensing, strengthen pharmacovigilance and prevent their misuse.
The ministry said the amendment forms part of its ongoing efforts to improve drug regulation, encourage the rational use of medicines and safeguard public health.
When the new rules will take effect
The revised regulations, notified as the Drugs (Tenth Amendment) Rules, 2026, will come into force six months after their publication in the Official Gazette. This will allow manufacturers, distributors and pharmacies sufficient time to comply with the new requirements.