Schedule K: Govt issues final notification on certain conditions for Liquid Antiseptics

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

936
Govt of India Gazette of India Notification
Gazette of India

Last Updated on January 6, 2024 by The Health Master

The Union ministry of health and family welfare has issued the final notification amending the rule by which liquid antiseptics for household use were brought under the Schedule K of Drugs Rules, 1945, to exempt it from certain conditions till November 30, 2022.

The inclusion of liquid antiseptics under Schedule K was subject to four 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; and
  • d) the drugs are purchased from a licensed wholesaler or a licensed manufacturer.

The draft amendment exempts the sellers from the fourth condition, by adding to it, “Provided that the condition (d) shall not be applicable for the drugs manufactured on or before November 30, 2022.”

The Ministry in May this year issued a draft notification and said that it had considered the objections and suggestions received from the public on the draft rules.

On January 20, 2022, the Ministry added liquid antiseptics for household use 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 by including them in the Schedule K of drugs rules.

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

However, even before this, the Drugs Consultative Committee (DCC) 2019 set up a sub-committee to decide on whether the liquid antiseptics on the market should be regulated with a sale license or brought under 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 (chloroxylenol, terpineol, and alcohol) as an antiseptic and disinfectant in the country under Schedule K (Rule 123) of the Drugs and Cosmetics Rules 1945, and identified similar types of products and gave its recommendations.

The sub-committee was constituted under the chairmanship of N K Ahooja, Drugs Controller, FDA Haryana. At its meeting held on July 26, 2019, the Sub-committee invited 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 that the sub-committee did not evaluate due to its specific mandate on three products only.

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 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.

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