Govt to amend Schedule K of Drugs Rules 1945 to exempt antiseptics from sale license
New Delhi: Observing 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 issued draft rules proposing that the retail sale of liquid antiseptics may be exempted from the requirement of a sale license by amending Schedule K of the Drugs Rules, 1945.
As per the draft rules, liquid antiseptics for household use will be added to Schedule-K of the Drugs and Cosmetics Rule 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 the Drugs Technical Advisory Board (DTAB) recommendation, which proposed amending the Schedule K of the Drugs Rules at its 86th committee meeting.
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 sale 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.
In light of the above recommendations, the government has released a draft of certain rules to amend the Drugs Rules, 1945, that will be called the Drugs and Cosmetics (…..Amendment) Rules, 2021, 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) and in consultation with the Drugs Technical Advisory Board for information of all persons likely to be affected thereby. Further, notice is given that the said draft rules shall be taken into consideration on or after the expiry of a period of draft rules are made available to the public.
Further, the gazette notification stated that objections and suggestions which may be received from any person within the period specified above will be considered by the Central Government;
"Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 434, C Wing, Nirman Bhavan, New Delhi - 110011 or emailed at firstname.lastname@example.org." the notification added.
As per the proposed amendment;
In the Drugs Rules, 1945, in Schedule K, 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 thereunder, which require them to be covered with a sale license in Form 20 or Form 20A subject to the following conditions:─
To view the Gazette notification, click on the link below: