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Covid-19 basic protection: Under scrutiny  

09 May 2021

  • Focus on facemask and hand sanitiser quality standards 

By Sarah Hannan    Over a year after the Covid-19 outbreak in Sri Lanka and with the country now facing its third wave, face masks and hand sanitisers have become essential items that are purchased by the public on a regular basis.  Prior to the outbreak, face masks were only available at pharmacies and in the case of hand sanitiser, they were available in supermarkets, cosmetic shops, and pharmacies.  Today, however both these items that are making up the basic personal protective equipment (PPE) for the general public, are readily accessible even in makeshift points of sale on the roadside.  The pricing of each of these products too vary while the quality of the products have also come into question.  The Sunday Morning spoke to the National Medicine Regulatory Authority (NMRA) CEO Dr. Kamal Jayasinghe on how the regulatory body is ensuring that face masks and hand sanitisers that are sold in the market meet the quality standards.  “Speaking of the facemasks that are recommended for day-to-day use by the public, we urge that people use the three-ply surgical masks and the KN-95 respirators, which are sold by registered suppliers with the NMRA. When purchasing face masks, people should look for the manufacturer’s name, address, and whether it carries the NMRA registration details on the package,” Dr. Jayasinghe noted.  Dr. Jayasinghe further noted that the NMRA can only regulate the three-ply surgical masks and the KN-95 respirators that are registered with them and are unable to regulate or ensure quality standards for fabric face masks.  He also noted that some distributors tend to forge the NMRA authorisation on to their packaging and these distributors are closely monitored through their market investigation team.  “If we find out that they are not registered with the NMRA, we take necessary legal action against the distributor and the manufacturers,” Dr. Jayasinghe added.  In terms of ensuring the quality of hand sanitiser products the NMRA noted that the manufacturers are to follow the World Health Organisation (WHO) recommended formulas.  “In addition to that, we will closely monitor the products sold by registered manufacturers to ensure that they maintain the stipulated standards, by regular sample testing,” Dr. Jayasinghe elaborated.  Based on the WHO recommendation, the NMRA recommends that the finished products of a regulated hand sanitiser contain alcohol in the following concentrations; ethanol 75-85% (v/v) or isopropyl alcohol 74-76% (v/v).  “To ensure that the public only has access to hand sanitisers produced under recommended WHO quality standards, we issued an extraordinary gazette under No. 2208/27 on 31 December 2020 banning import, manufacture, store, distribute, or display for sale, expose, or offer for sale, wholesale or retail any hand sanitisers unless such hand sanitiser is registered with the NMRA with effect from 1 February 2021,” the Consumer Affairs Authority (CAA) Spokesperson Asela Bandara said.  Apart from that, earlier this year, the CAA had also issued a gazette stipulating the maximum retail price for three-ply face masks at Rs. 15 and KN 95 masks at Rs. 150.  The CAA and the NMRA meanwhile have requested the public to keep them informed of any traders that are selling face masks or hand sanitisers that are found to be of lower quality and are selling at a higher price.


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