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

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