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India Cracks Down on High-Alcohol Meds
10 Jul
Summary
- Oral medicines with over 12% ethyl alcohol now need prescriptions.
- Bottles larger than 30 ml fall under stricter Schedule H1 rules.
- Pharmacies must keep records and prescriptions for three years.
In a significant regulatory update, India has amended the Drugs Rules, 1945, to bring oral medicinal formulations containing more than 12% ethyl alcohol, sold in bottles exceeding 30 ml, under Schedule H1. This classification mandates stricter prescription and dispensing protocols, aiming to curb the misuse of high-alcohol cough syrups and tonics. The amendment ensures these medicines are used responsibly under medical supervision.
Pharmacies are now required to dispense these products only against a registered medical practitioner's prescription. They must also maintain a separate register for every sale and preserve prescriptions and dispensing records for a minimum of three years. This move, implementing recommendations from regulatory committees, strengthens pharmacovigilance and monitoring of medicines with potential for abuse.
Schedule H1, introduced in 2013, already governs third- and fourth-generation antibiotics, anti-tuberculosis drugs, and certain habit-forming substances. While ethyl alcohol is a common and safe solvent in many medicines, its higher concentration in certain formulations has raised concerns about recreational diversion. The government's action aims to balance public health safeguards with continued patient access to necessary treatments.
