Govt amends Drug Rules to include liquid antiseptic under Schedule K
New Delhi: In order to meet the huge demand for liquid antiseptics during the COVID 19 pandemic, through a recent Gazette Notification, the Ministry of Health and Family Welfare (MoHFW) has exempted the retail sale of liquid antiseptics from the requirement of sale license by amending Schedule K of the Drugs Rules, 1945.
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:—
1. (1) These rules may be called the Drugs (2nd Amendment) Rules, 2022.
(2) They shall come into force on the date of their publication in the Official Gazette.
2. In the Drugs Rules, 1945, in Schedule K, in the table, after serial number 38 and the entries relating thereto, the following serial number and entries shall be inserted, namely:─
Class of Drugs | Extent and Conditions of Exemption |
"39. Liquid Antiseptics for household use | The provisions of Chapter IV of the Act and rules made thereunder, which require them to be covered with a sale license in Form 20 or Form 20A, subject to the following conditions, namely:─ (a) The drugs are manufactured by licensed manufacturers; (b) the drugs do not contain any substance specified in Schedule G, H, H1 or X; (c) the drugs are sold in the original unopened containers of the licensed manufacturer; (d) the drugs are purchased from a licensed wholesaler or a licensed manufacturer." |
To view the official notice, click the link below:
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