Govt brings high-alcohol medicines under Schedule H1; prescription now mandatory
PTC Web Desk: The Central Government has introduced stricter rules for the sale of certain medicines that contain a high amount of alcohol. Under a new notification issued through the Gazette of India, oral medicines containing more than 12% ethyl alcohol and sold in bottles larger than 30 ml will now be included under Schedule H1 of the Drugs Rules, 1945.
With this change, these medicines can no longer be sold freely over the counter. They will only be available against a valid prescription and pharmacies will have to maintain detailed records of every sale.
The decision comes after concerns that some alcohol-based cough syrups, tonics and other liquid medicines were being misused because they were easily available without proper medical supervision. Health authorities believe stricter regulation will help prevent misuse while ensuring that patients who genuinely need these medicines continue to receive them through a doctor's prescription.
The move is aimed at improving patient safety and strengthening the monitoring of medicines that have a higher risk of misuse.
The revised rule applies to oral medicines containing more than 12% ethyl alcohol and products sold in bottles larger than 30 ml. These medicines will now be treated as Schedule H1 drugs, which are subject to stricter regulatory controls.
Retail pharmacies will now have to follow additional rules while dispensing these medicines.
They must sell the medicine only after receiving a valid prescription from a registered medical practitioner, maintain a separate register recording every sale and preserve prescriptions and sale records for at least three years, so they can be inspected by drug authorities whenever required.
These requirements already apply to several antibiotics, anti-tuberculosis medicines and other drugs that require close monitoring.
Schedule H1 is a special category under the Drugs Rules introduced in 2013 to monitor medicines that require tighter control than ordinary prescription drugs. Medicines listed under Schedule H1 carry stricter conditions, including sale only on a doctor's prescription, special warning labels on the packaging, mandatory record-keeping by pharmacies and inspection of records by drug regulators.
The list initially included certain antibiotics, anti-TB medicines and habit-forming drugs. Over the years, more medicines have been added based on recommendations from expert committees.
Notably, ethyl alcohol is widely used in medicines because it helps dissolve active ingredients and improves the stability of many formulations. When taken as prescribed, these medicines are considered safe.
However, problems can arise if medicines with high alcohol content are consumed in excessive amounts or without medical advice. Children, elderly people, patients with liver disease and those taking medicines that affect the central nervous system may be at greater risk of side effects.
Medical experts have also pointed out that some alcohol-containing medicines can contribute to measurable blood alcohol levels if consumed improperly, making careful prescribing and patient counselling important.
However, the new rule does not ban these medicines. Patients who require them can continue to receive treatment after consulting a doctor. However, they will now need a valid prescription to purchase the medicine.
- With inputs from agencies
