India Mandates Prescriptions for High-Alcohol Medicinal Tinctures to Curb Misuse
The Indian government has announced that oral medicinal formulations containing more than 12% ethyl alcohol and sold in bottles larger than 30 ml will now require a doctor's prescription. The decision comes after complaints from states like Uttar Pradesh and Madhya Pradesh about the misuse of certain medicinal tinctures.
The Ministry of Health and Family Welfare has amended the Drugs Rules through the Drugs (Tenth Amendment) Rules, 2026. The products affected include herbal and medicinal liquid preparations such as cardamom and ginger tinctures. These are concentrated herbal extracts made using ethyl alcohol as a solvent and have traditionally been used as digestive aids. However, some formulations contain 60-80% ethyl alcohol, making them susceptible to misuse for intoxication.
Under the new rules, these formulations will no longer be exempt under Schedule K of the Drugs Rules, 1945. Instead, they will be classified under Schedule H1, which mandates sale only against a prescription from a registered medical practitioner. Pharmacies must also maintain records of every sale. The rules will come into effect six months after their publication in the Official Gazette.
Existing regulations already set ethyl alcohol limits for traditional medicine systems: Ayurvedic, Siddha, and Unani syrups can contain up to 16% alcohol, while homoeopathic medicines are limited to 12%. The latest amendment aims to create a uniform regulatory framework for all medicinal products with high alcohol content, ensuring they are supplied through regulated channels and reducing the risk of diversion and misuse while preserving their availability for genuine therapeutic use.
