Govt to Regulate High-Alcohol Drug Preparations Under Schedule H1

The Drugs Consultative Committee (DCC) has approved an amendment to the Drugs Rules, 1945, to move drug formulations containing 30ml or more alcohol from Schedule K to Schedule H1. Currently exempt from strict regulation, these high-alcohol products—like Aromatic Cardamom Tincture with up to 87% alcohol—have been misused as cheap liquor, raising public health concerns.

The shift to Schedule H1, which governs prescription drugs with high abuse potential, will restrict over-the-counter sales and mandate stricter control. The DCC also proposed limiting pack sizes to 30ml to prevent misuse.

The proposal, supported by the Drugs Technical Advisory Board (DTAB), aims to close regulatory loopholes that allow abuse of such products, particularly among economically vulnerable groups.

This decision follows multiple DCC and DTAB meetings held between 2023 and 2025.

08-07-2025