DTAB to exempt antiseptics from sale license
New Delhi: Holding that liquid antiseptics should not be restricted to licensed premises but should be permitted to be sold in all shops, especially during the current COVID pandemic, the Drugs Technical Advisory Board (DTAB) has recently 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.
This comes in wake of a proposal that was made in accordance with the recommendations of a subcommittee constituted by Office Memorandum vide X-19013/04/2018- DC(1) dated 20.02.2019 & 05.03.2019, under the Chairmanship of N.K. Ahooja, State Drugs Controller, Haryana.
In a recent 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 & 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.
As a result, in its meeting 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 share their perspectives.
After extensive consideration, 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 licensed premises but should be permitted to be sold in all shops, especially during the current COVID pandemic. The committee recommended that the Drugs and Cosmetics Rules may be amended as proposed by the sub-committee, subject to the conditions mentioned in the report.
Recommendations of the Sub-committee:
The Sub-Committee had examined the issue in detail and had made the following recommendations: -
i) Antiseptics in general are extensively used during post disaster prevention and spread of infection, environmental and social hygiene to prevent disease outbreaks, and rural maternal health to address infection after child birth. They are also used amongst all age groups and amongst all populations in different regions, in both rural and urban areas. They are also recommended by WHO for the prevention and treatment of maternal peripartum infections.
It is necessary to make antiseptics accessible to the entire population. Restricting the sale of antiseptics from only licensed premises denies access and availability to rural and remote areas. Further, the safety of the available antiseptics does not raise any concern.
ii) After careful consideration of the representation of the firms, M/s Reckitt Benckiser and M/s ITC, related judgments, the Sub-Committee recommended that all antiseptic formulations for external use including Dettol and savlon, may be exempted from being covered under a sale license.
iii) Antiseptics should continue to be manufactured under a valid licence and there should not be any requirement for a licence for their sale, as is the case of disinfectants, which also do not need a sale license.
iv) Accordingly, the Schedule K may be amended by inserting the category of Antiseptics under Sl.No.12.
Thereafter, the Subcommittee's report was submitted to the Drugs Consultative Committee at its 58th meeting on July 14, 2020, where the DCC noted that there are other similar products on the market that the subcommittee did not assess due to its particular mandate of only three products.
Subsequently, DCC suggested that the scope of the sub-committee should be revised and broadened to relook at the matter for examination of all the available liquid antiseptic solutions on the market.
As a result, the subcommittee investigated into the items in the market. (The details are available in the annexure to this report). Cetrimide, Chlorhexidine, or Chloroxylenol are active components in commercially available liquid antiseptics.
In light of the above, after investigating the products on the market, the Sub-Committee had made the following recommendations: -
i) The sub-committee has taken into consideration the concerns of the DCC to prevent misuse/abuse of the product if exempted from the requirement of a sale license.
ii) Enhancing the accessibility of Liquid Antiseptics to remote locations and places which are deprived of the presence of retail medical shops is necessary, especially during pandemics and epidemics .
iii) The safety of the ingredients of the currently available antiseptics does not raise any concern.
iv) In view of the above, the sub-committee recommends that the retail sale of Liquid Antiseptics may be exempted from the requirement of a sale license. Accordingly, Schedule K may be amended by inserting the following in the appropriate position:
Class of Drugs
Extent and Conditions of Exemption
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:-
wholesaler or a licensed manufacturer
The DTAB board was also apprised that the above proposed amendments were deliberated at the 59th DCC meeting held on 02.03.2021 and the DCC agreed to the amendments.
In light of the preceding suggestions, DTAB, at its 86th committee meeting, proposed amending Schedule K of the Drugs Rules, saying,
"DTAB after deliberation in the matter to the recommendations of the 59th DCC, recommended to amend the Schedule K of the Drugs Rules, 1945 as per the recommendations made by the sub-committee."