High-Alcohol Oral Drugs Over 12% to Come Under Prescription-Only H1 Category, Health Ministry Drafts Rules

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 Medical Dialogues Team had 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:

In the Drugs Rules, 1945, in Schedule K against the serial no. 10, under Extent and Conditions of Exemptions the words “All provisions of Chapter IV of the Act and rules thereunder” shall be substituted with the words as under:

“All provisions of Chapter IV of the Act and rules thereunder except for all oral formulations containing more than 12% alcohol v/v (Ethyl Alcohol) packed and sold in packings or bottles of more than 30 milliliters.”

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:

In the Drugs Rules, 1945, under Schedule H1, after the last entry, following entry shall be inserted, namely: -

“51. All oral formulations containing more than 12% alcohol v/v (Ethyl Alcohol) packed and sold in packings or bottles of more than 30 milliliters.

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,

"The following draft of certain rules further to amend the Drugs Rules, 1945, which the Central Government proposes to make, 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, is hereby published for information of all persons likely to be affected thereby, and notice is hereby given that the said draft rules shall be taken into consideration on or after the expiry of a period of thirty days from the date on which the copies of the Gazette of India containing these draft rules are made available to the public.

1. (i) These rules may be called the Drugs (...... Amendment) Rules, 2025.

(ii) They shall come into force on the date of their final publication in the Official Gazette.

2. (i) In the Drugs Rules, 1945, in Schedule K against the serial no. 10, under Extent and Conditions of Exemptions the words “All provisions of Chapter IV of the Act and rules thereunder” shall be substituted with the words as under:

“All provisions of Chapter IV of the Act and rules thereunder except for all oral formulations containing more than 12% alcohol v/v (Ethyl Alcohol) packed and sold in packings or bottles of more than 30 milliliters.”

(ii) In the Drugs Rules, 1945, under Schedule H1, after the last entry, following entry shall be inserted, namely: - “51. All oral formulations containing more than 12% alcohol v/v (Ethyl Alcohol) packed and sold in packings or bottles of more than 30 milliliters.

To view the official gazette notification, click the link below: