An interim guideline is available on its website for public feedback
The Drug Regulatory Authority (DRA) has drafted an interim guideline for regulating face masks of medical grade, which includes surgical face masks and respirators.
The guideline, however, does not cover face shields and non-healthcare use of cloth masks and respirators intended for industrial use or during construction, as they do not qualify as medical devices. However, it recommends the use of proper material, structure and fit for the manufacturing of non-medical masks (cloth masks).
Officials from DRA said the authority could assess and regulate only those items identified as medicinal products and devices.
An official from the authority said that, when it came to cloth masks and public usage, they could only issue advisories. “It would be great if everyone can use the surgical masks and respirators, but then there’s the question of affordability and accessibility.”
Following the first local outbreak of Covid-19 in August last year, wearing face mask became mandatory for all in the country, especially while going out in public.
While the frequency of wearing face masks among the public has drastically improved over the months, the driving force behind this change in behaviour is often attributed to fear (of implementers) rather than protecting oneself and others from the virus.
There are currently four general types of facemasks available in the country, surgical mask and respirator, non-surgical masks and cloth masks.
As quality of masks is directly related to affordability and accessibility, officials said that the World Health Organisation (WHO) also doesn’t recommend specific quality of masks for different settings. The WHO however, maintains a standard of at least two-layered face masks to be the minimum requirement.
Officials said that some of the developed countries have recommended using different kinds of masks in different settings. “While we’d also like to have such recommendations, we don’t have the capacity to do so.”
The DRA guideline provides some preliminary tests to determine the general performance of the facemasks.
It states that a water resistance test can be conducted by placing a drop of water on the outside surface of the mask. “If the drop forms a bead, the mask is said to be water-resistant.”
It also states that a candle test can be conducted to determine the filtration and fit of a face mask. “If a candle kept at a distance of approximately six inches (15.24cm) can be blown out while wearing a mask, the mask fails its requirement.”
The guideline also states that a mask should not suffocate or cause discomfort while breathing.
The guideline is available for public feedback on the DRA website.
Officials said they would collect the feedback at the end of the month, present it to the drug technical advisory committee before presenting it to the Bhutan Medicine board for approval and implementation.
Meanwhile, some of the international research on the effectiveness of different types of facemasks suggest that a better fitting mask was more important than the material they were made up of to provide the best protection against Covid-19.