Govt amends Drug Rules to include liquid antiseptic under Schedule K

As per the notification, the Ministry of Health and Family Welfare added liquid antiseptics for household use in schedule K after making an amendment to the Drugs Rules, 1945.

According to the Drug and Cosmetics Rules, the drugs specified in Schedule K shall be exempted from the provisions of Chapter IV of the Act and the Rules made thereunder to the extent and subject to the conditions specified in that Schedule.

This came in line with a draft notification published after consulting with DTAB in September 2021, which recommended the exemption of these products from sales licensing through including them in the Schedule K of Drugs Rules.

The Medical Dialogues Team had reported earlier that the Drugs Technical Advisory Board (DTAB) had recommended that the retail sale of liquid antiseptics may be exempted from the requirement of a sales license by amending Schedule K of the Drugs Rules, 1945.

It was further reported that in the latest DTAB meeting, the board was informed that the Drugs Consultative Committee (DCC) had formed a sub-committee in its 55th meeting held on 31.01.2019 and 01.02.2019 to clarify the exemption of Dettol antiseptic liquid (cloroxylenol, terpineol, and alcohol) as an antiseptic and disinfectant in the country under Schedule K (Rule 123) of the Drugs and Cosmetics Rules 1945.

However, after extensive evaluation, the subcommittee provided amended recommendations on the exemption of liquid antiseptics from the requirements of a selling licence. The committee expressed that access to liquid antiseptics should not be restricted to licenced premises but should be permitted to be sold in all shops, especially during the current COVID pandemic.

Accordingly, last year, the government published a draft of certain rules further to amend the Drugs Rules, 1945, as required under sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) via notification of the Government of India in the Ministry of Health and Family Welfare (Department of Health and Family Welfare) number G.S.R. 628 (E), dated September 13, 2021, in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i), inviting objections and suggestions from persons likely to be affected thereby, before the expiry of a period of thirty days from the date on which the copies of the Official Gazette containing the said notification were made available to the public.

Furthermore, the copies of the said official gazette were made available to the public on September 13, 2021, and the objections and suggestions received from the public on the said draft rules have been considered by the Central Government.

After extensive evaluation, in exercise of the powers conferred by sections 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board, hereby makes the following rules further to amend the Drugs Rules, 1945, namely:—

To view the official notice, click the link below: