The Indian government has amended drug regulations to bring high-alcohol medicinal formulations under stricter control.Previously exempted under Schedule K, these products now fall under Schedule H1, requiring prescriptions and licenses.The move aims to prevent misuse and addiction, as formulations containing up to 80-90% alcohol were being exploited for intoxication.State governments reported complaints about unregulated tinctures sold in large bottles, often with ginger or cardamom.The health ministry clarified these are not Ayurvedic or Unani products but digestive aids, now subject to stricter oversight.All formulations with over 12% alcohol in quantities exceeding 30 mL must now comply with licensing rules under the Drugs and Cosmetics Act.Sales will require prescriptions, and records must be maintained for three years.

The amendment strengthens regulatory control, ensuring these products are available only through legitimate channels while safeguarding public health.