High-Alcohol Medicinal Preparations to Come Under Schedule H1: Govt Panel Approves Rule Change
New Delhi: The Drugs Consultative Committee (DCC) has agreed to amend the Drugs Rules, 1945 to regulate the alcohol content in tinctures and other alcoholic preparations in view of concerns regarding their illegal sale through pharmacies.
During its 66th meeting held on June 17, 2025, the agenda was taken up for discussion as part of ongoing efforts to curb the misuse of high-alcohol-content medicinal products that are being diverted for non-medical purposes.
As per the official meeting minutes, "DCC was apprised that the proposal was deliberated in 92nd DTAB meeting wherein the DTAB agreed that the rules may be amended and exemption provided for alcoholic preparations containing the alcohol content 30ml or above in Schedule K may be removed and such preparations may be included in Schedule H1."
This recommendation from the Drugs Technical Advisory Board (DTAB) was aimed at bringing tighter regulatory control over such preparations by removing the exemption under Schedule K and instead placing them under Schedule H1. To mention, Schedule H1 is a category under the Drugs and Cosmetics Rules, 1945 that includes prescription drugs which require strict monitoring, including mandatory maintenance of sale records and prescription retention by pharmacies. It is intended to prevent misuse of certain antibiotics, psychiatric drugs, and other high-risk medicines.
Also Read: Govt To Amen Schedule K of Drugs Rules 1945 To Exempt Antiseptics From Sale License
The committee was further informed that "a draft notification was prepared in the matter. However, it was decided to discuss the matter in the DCC afresh."
Following a detailed review of the draft notification, the DCC endorsed the proposal. As per the minutes, "DCC discussed the draft notification prepared for the purpose and after detailed deliberation agreed with the proposal to appropriately amend the Drugs Rules, 1945."
The proposed amendment is expected to enhance control over the availability and dispensing of high-alcohol medicinal preparations, addressing rising concerns over their potential misuse, especially in vulnerable populations.
The move also aligns with the broader objective of strengthening the drug regulatory framework to ensure that pharmaceutical products are used strictly for therapeutic purposes.
