Download the notification: The Union health ministry has issued a final amendment vide notification GSR 30(E) dt 20-01-2022 to include liquid antiseptics for household use under the Schedule K of Drugs Rules, 1945 exempting the product category from the requirement of a sale license.

Download notification No. GSR 30(E) dt 20-01-2022

Thru the notification, liquid antiseptics for household use have been added as the 39th entry in Schedule K under the Drugs Rules, 1945.

The exemption is from the provisions mandating sale licenses in Form 20 or Form 20A, which is expected to make the use of liquid antiseptics more accessible to the consumer.

A draft amendment was issued in this regard in September, 2021, after the Drugs Technical Advisory Board (DTAB), in June recommended the exemption of these products from sales licensing through including them in the Schedule K of drugs Rules.

Click to download Schedule K and other schedules of Drugs Act

The liquid antiseptics from companies including Reckitt Benckiser and ITC have been in high demand in the market after the outbreak of C-19 pandemic.

However, even before this, the Drugs Consultative Committee (DCC) in 2019 set up a sub-committee to decide on whether the liquid antiseptic in the market should be regulated with a sale license or brought under the Schedule K of the Rules.

The DCC in its 55th meeting held on January 31 and February 1, 2019, constituted a sub-committee for clarification on the exemption of Dettol antiseptic liquid (cloroxylenol, terpineol, and alcohol) as an antiseptic and disinfectant in the country under Schedule K (Rule 123) of Drugs and Cosmetics Rules 1945, and identified similar types of products and gave its recommendations.

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The sub-committee was constituted under the chairmanship of N K Ahooja, Drugs Controller, Haryana.

As per the terms of reference, the Sub-committee in its meeting held on July 26, 2019 invited the representatives from Reckitt Benckiser, manufacturer of Dettol antiseptic liquid, and ITC Limited, manufacturer of Savlon antiseptic liquid, both leading manufacturers of antiseptic liquids, to offer their views.

After consideration of the available technical and legal information and detailed deliberations, the sub-committee submitted its report for DCC review and deliberations.

The DCC, after detailed deliberation, observed that there are numerous such products in the market which the sub-committee did not evaluate due to its specific mandate on only three products.

Hence, DCC suggested that the scope of the sub-committee shall be revised and broadened to relook the matter for examination of all the available liquid antiseptic solutions in the market.

Later, the matter came up for the approval of DTAB and it has recommended the inclusion of the product category under Schedule K for exemption. The drugs specified in Schedule K are exempted from the provisions of Chapter IV of the Act and Rules to the extent and subject to the conditions specified in that Schedule.

The draft notification was issued on September 13, inviting objections and suggestions from the stakeholders, and the objections and suggestions received from the unlicensed has been considered by the Central government, said the final notification.

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https://thehealthmaster.com/2022/01/27/govt-amends-drug-rules-to-include-liquid-antiseptic-under-schedule-k/