look news india
The Central Government has taken a very strict and historic step to curb the increasing misuse of cough syrup and alcohol-based medicines and their use as an intoxicant. In a major amendment to the Drugs and Cosmetics Rules, 1945, the government has put all oral medicines containing more than 12% ethyl alcohol and sold in bottles larger than 30 ml in the ‘Schedule H1’ category. After this decision, now such medicines will not be sold over-the-counter at any medical store without a valid prescription from a doctor.
Complete accounting of sales will have to be maintained, doctor’s prescription will have to be maintained for 3 years
After being included in Schedule H1, the government will now have a direct and strict eye on the purchase and sale of these medicines. All medical stores and pharmacies in the country will have to enter complete records of every sale of these medicines in a separate register, which will include complete details of the doctor, patient and medicine. Not only this, it will be mandatory for the chemist to keep the original prescription written by the doctor safe with him for three years so that the drug inspector can check it at any time. Some exemptions already available (under Schedule K) have also been completely abolished for these medicines.
There will be a red ‘Rx’ warning on the bottle, strict action will be taken if rules are broken
According to the new rules, now a big change will be seen on the packaging and labels of these medicines. On the labels of these medicines containing more than 12% alcohol, it is clearly written in red colour.RX‘ ‘ mark has to be made. Along with this, a mandatory warning will also have to be written on the packet: “Do not take this medicine without doctor’s advice, it can be dangerous for health.” This proposal got the green signal in the meeting of the Drugs Consultative Committee (DCC) held in June 2025, after which on the recommendation of the Drug Technical Advisory Board (DTAB) and health experts, the government approved it by issuing an official gazette notification.
Medicines have not been stopped, only misuse has been curbed
The government has clarified that these medicines have not been completely banned, but this rule is being implemented to ensure their safe and responsible use. Actually, alcohol is used as solvent or preservative in cough syrup and tonic, which is safe in prescribed quantity. But consuming it in large quantities without medical advice causes serious damage to the liver, especially the health of children and the elderly. This new rule will become completely effective in the entire country from the date of notification or within the next six months.