Govt To Amend Schedule K Of Drugs Rules 1945 To Exempt Antiseptics From Sale License

The Ministry of Health and Family Welfare (MoHFW) has issued draught rules proposing that the retail sale of liquid antiseptics be exempted from the requirement of a sale licence by amending Schedule K of the Drugs Rules, 1945, in response to the high demand for liquid antiseptics during the COVID 19 pandemic.
Liquid antiseptics for domestic use will be included to Schedule-K of the Drugs and Cosmetics Rule 1945, according to the proposed guidelines.

The medications listed in Schedule K are excluded from the requirements of Chapter IV of the Act and the Rules issued thereunder to the amount and subject to the conditions indicated in that Schedule, according to the Drug and Cosmetics Rules.
This was in keeping with a proposal made by the Drugs Technical Advisory Board (DTAB) during its 86th committee meeting, which suggested modifying Schedule K of the Drugs Rules.

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   

“39. Liquid Antiseptics for household use

Extent and Conditions 

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:─

(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 wholesale or a licensed manufacturer.