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DRA to regulate facemasks

March 10, 2021
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After two lockdowns and nearly 900 cases, the facemask has become the first-line defence against coronavirus. Today, nobody leaves their home without one. But are these mask really protecting people?

Following the first COVID-19 case in March last year, wearing a facemask was made mandatory. Since then, different masks flooded the market with almost no regulation on price and quality. Facemasks are easily available in almost all shops. Most of the masks are imported and some of them cost as high as Nu 200. But the price does not translate to protection.

Nima Norbu, a taxi driver said, “Sometimes when we go out and forget our masks, we buy whatever is available. When it comes to surgical masks, there are so many types.  Some are of poor quality and some are good. Some which are sold in shops seem to be of pretty bad quality. I find the ones in medical shops of better quality.”

“We prefer three-ply masks because I personally feel a two-layer mask doesn’t give you so much protection compared to the three-layer. We also insist on having a metal strip on top. Having metal strips give you extra protection because it is sealed. And cost is another factor. Some masks could be good but it could be expensive which doesn’t make much sense for the customers to buy. That is why we keep price and quality in mind,” added Tenzin Dhonga, the owner of Norling Pharmacy.

But things are set to change. People will soon get face masks that will ensure protection against the virus. The Drug Regulatory Authority (DRA) has come up with an Interim Guideline to ensure that quality masks are distributed in the market.

“We have some test requirements. A few are technical test requirements like flammability, bacteria filtration test, virus filtration test and splash resistance. And we also have self-test requirements that can be done by the public like hydrophobicity, candle blow test and breathability test. These are there in guidelines itself,” said Ganga Devi Giri, Drug Regulatory Officer with the DRA.

The guideline specifies the procedure for import authorization and listing of medical face masks like any other medical products. However, the guideline is yet to be approved.

Ganga Devi Giri said, “Once it’s done, the importers and manufacturers will have to get a clearance from the DRA. After that, there will be an inspector going for a random inspection. They will take some samples from the market and then they will do testing. And if at all, they found a faulty product, meaning the facemask does not meet a requirement set by the regulatory authority, then the product will be recalled from the market.”

Globally, experts are recommending people to double or upgrade masks with the emergence of new variants of Coronavirus emerge.  But how well do face masks protect against a virus? The answer isn’t only using the quality mask but about how properly people us it.

Samten Dolkar

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