Doctors will soon see tighter dispensing rules for oral medicinal products with higher alcohol content as the Ministry of Health and Family Welfare has amended the Drugs Rules, 1945, to reduce the risk of misuse. Under the Drugs (Tenth Amendment) Rules, 2026, oral formulations containing more than 12% v/v ethyl alcohol and sold in bottles or packs larger than 30 mL will now require a prescription from a registered medical practitioner. These products have been added to Schedule H1, bringing them under stricter regulatory control.
The amendment was notified on July 8, 2026, published in the Gazette of India on July 9, and will take effect after a six month transition period. The decision follows concerns that certain medicinal preparations, including tinctures of cardamom, ginger, and other aromatic preparations, contain high concentrations of ethyl alcohol, in some cases reaching 80% to…
