Nima Wangdi

The Drug Regulatory Authority (DRA) is conducting a technical evaluation of the applications for the sale and supply of Covid-19 antigen self-test kits in the country.

There are five applicants.

According to DRA, the emergency use authority (EUA) will be issued to those who meet the requirement. “They should then obtain the import authorization (IA) after which they can import the self-test kits.”

A recent DRA notification stated that in the interest of public health and in obedience to the Medicines Act, only technical authorisation holders shall be permitted to undertake the sale and distribution of Covid-19 antigen self-test kits.

DRA stated the applicants are required to present sample test kits on which evaluation will be carried out looking at the safety and the quality. “Detecting false positive and false negative could be dangerous.”

It stated that for any new technology, the Ministry of Health as an end-user should issue a policy clearance confirming that the technology is genuinely required in the country.

The ministry issued the policy clearance on April 5.

“The sale or distribution of any self-test kits without EUA and IA, even for personal use is considered illegal,” the notification stated.

According to DRA, they have deputed inspectors, who would monitor and seize any self-test kits that are being used.

DRA stated there were some cases in which a few companies were trying to sell self-test kits before the policy clearance and regulatory guidelines were made. “We could not catch hold of them and fine directly since they were also unaware of the policies.”

DRA officials said their inspectors contacted them and asked them to stop doing it. “We will penalise them accordingly if they are found doing it again since we have already made them aware.”

The health ministry also notified recently that the people using self-test kits to report their positive results to 1010 for registration and monitoring by clinical teams. “Registering with 1010 will also enable them to facilitate immediate follow-up for vulnerable groups and also help monitor Long Covid conditions.”

According to the health ministry, with the introduction of self-test kits, it is likely to reduce the government’s expenditure on test kit procurement but the ministry will continue providing test services as usual.

An official said self-test kits should be convenient for people as most of them are easy to use. “However, people should read the manuals carefully.”