NEW DELHI: Oral medicinal formulations containing more than 12% ethyl alcohol and sold in bottles larger than 30 ml will soon require a doctor’s prescription after the Centre amended the Drugs Rules to curb their misuse.
The decision follows complaints from states, including Uttar Pradesh and Madhya Pradesh, about the alleged misuse of certain medicinal tinctures as alcoholic beverages. Traditionally, tinctures made from ingredients such as cardamom and ginger have been used as digestive and therapeutic preparations. However, officials said some products contain 60-80% ethyl alcohol and have allegedly been marketed as medicines despite their high alcohol content, making them susceptible to misuse.
The health ministry clarified that the amendment applies to specific herbal and medicinal liquid preparations, including cardamom and ginger tinctures. These are concentrated herbal extracts prepared using ethyl alcohol as a solvent, not the culinary spices themselves. While cardamom and ginger have well-established medicinal uses, some tincture formulations reportedly contain 80-90% ethyl alcohol, increasing the risk of diversion for intoxication.
Under the Drugs (Tenth Amendment) Rules, 2026, such formulations will no longer qualify for exemption under Schedule K of the Drugs Rules, 1945. Instead, they will be classified under Schedule H1, allowing their sale only on the prescription of a registered medical practitioner. Pharmacies will also be required to maintain records of every sale. The new rules will take effect six months after their publication in the Official Gazette.
The amendment means that oral medicinal formulations containing more than 12% ethyl alcohol can no longer claim exemption under Schedule K solely because they contain ingredients such as cardamom, ginger or other spices.
Existing provisions under the Drugs Rules already prescribe alcohol limits for traditional medicines. Ayurvedic, Siddha and Unani syrups may contain up to 16% ethyl alcohol, while Homoeopathic medicines are limited to 12%. Officials said the latest amendment is intended to create a more uniform regulatory framework for medicinal products with high alcohol content.
According to the ministry, the changes are aimed at strengthening oversight of medicines containing elevated levels of ethyl alcohol, ensuring they are supplied only through the regulated pharmaceutical system, reducing the risk of diversion and misuse, and preserving their availability for legitimate therapeutic use.
