New Delhi:With an aim to curb misuse and over-the-counter sale of high-alcohol oral preparations, through a recent Gazette notification, the Ministry of Health and Family Welfare (MoHFW) has proposed to bring all oral drug formulations containing more than 12% alcohol (v/v) and sold in bottles exceeding 30 milliliters under full regulatory control, ending their exemption under Schedule K of the Drugs Rules, 1945 and adding them to Schedule H1 as prescription-only medicines. These proposed draft rules came in exercise of the powers conferred by sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), after consultation with the Drugs Technical Advisory Board. Issued under the Drugs and Cosmetics Act, 1940, after consultation with the Drugs Technical Advisory Board (DTAB), the draft notification seeks to partially withdraw the long-standing exemptions enjoyed by certain preparations under Schedule K and bring them under Schedule H1-a category reserved for drugs requiring strict prescription control and monitoring. Earlier the Teamhad reported that the Drugs Consultative Committee (DCC) had 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. DCC was apprised that the proposal was deliberated in the 92nd DTAB meeting wherein the DTAB agreed that the rules may be amended and the exemption provided for alcoholic preparations containing the alcohol content of 30 ml 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. Schedule H1 is a category under the Drugs and Cosmetics Rules, 1945 that includes prescription drugs that require strict monitoring, including mandatory maintenance of sale records and prescription retention by pharmacies. It was intended to prevent misuse of certain antibiotics, psychiatric drugs, and other high-risk medicines. Now, in line with the above, the recent gazette notification seeks to limit this exemption by excluding oral formulations containing more than 12% alcohol (v/v) that are packed and sold in containers larger than 30 milliliters. The draft amendment stated: The amendment also proposes to add a new entry to Schedule H1, which lists prescription-only drugs requiring stricter monitoring. Schedule H1 is a special category of drugs listed under the Drugs and Cosmetics Rules, 1945, introduced to regulate certain potent or habit-forming medicines that require stricter prescription control than ordinary prescription drugs (which fall under Schedule H). Schedule H1 is a category under the Drugs and Cosmetics Rules, 1945 in India that lists certain drugs, including third- and fourth-generation antibiotics, anti-TB drugs, and habit-forming drugs, which require stricter control due to their potential for misuse. Pharmacies must maintain detailed records of sales, including the patient's and prescriber's details, for three years, and the drugs must be labeled with a red "Rx" symbol and a warning that they cannot be sold without a prescription. New draft amendment proposed: The draft rules are open for public comments for 30 days from the date of publication. Stakeholders and industry representatives can submit objections or suggestions to the Director (Drugs Regulation), Ministry of Health and Family Welfare, either by post to Room No. 407, A-Wing, Nirman Bhavan, New Delhi – 110011, or by email to drugsdiv-mohfw@gov.in In regard to the above, the gazette notification states, To view the official gazette notification, click the link below: Also Read: Alcohol Use Linked to Higher Dementia Risk Across All Consumption Levels: Study Finds