Malaysian Pharmacists Society president Amrahi Buang said self-test kits were not toys but medical devices that must comply with gold standards in terms of functionality and safety.
“It is important that Covid-19 self-test kits are sold in licensed pharmacies and private healthcare facilities so (that) the government can closely monitor them as any complaints about these kits can be reported to the Medical Device Authority (MDA) under the health ministry,” he told FMT.
Amrahi said fake self-test kits or the wrong use of these kits would produce inaccurate results such as false negatives, which would not help in combating the pandemic.
He said registered pharmacists selling these kits would be able to educate the public on how to use them properly and help consumers report their results through the MySejahtera application.
He added that effective enforcement must be done by MDA and the domestic trade and consumer affairs ministry in order to ensure that these safeguards are implemented throughout the country.
Amrahi also said the Malaysian Communications and Multimedia Commission (MCMC) must closely monitor the online sale of unapproved or fake kits in order to safeguard and protect the health of consumers.
Malaysian Medical Association (MMA) president Dr Subramaniam Muniandy said it was a good decision by the government to only allow healthcare facilities and pharmacies to sell these kits.
“Without this policy, the sale of these kits will be difficult to monitor and regulate. There are already so many fake and unapproved kits being sold by unauthorised sellers,” he said.
He said these unauthorised sellers might have multiple suppliers from all over the world, some of whom may unknowingly sell fake or even recycled test kits.
“We advise that if a seller is not from a healthcare facility or pharmacy, do not buy the kits from them. Instead, report them immediately to the authorities,” he said.
Subramaniam also urged the domestic trade and consumer affairs ministry, MCMC and the police to work together to check on this.
Some people are selling self-test kits on social media and shopping platforms claiming that these had been approved by MDA and the health ministry.
Currently, only 14 self-test kits have been approved by MDA. Among them are the Salixium Rapid Antigen Rapid Test Kit which uses oral and nasal samples, Gmate Saliva Antigen Rapid Test Kit, and BERIGHT Antigen Rapid Test Kit which uses only saliva samples.
According to the health ministry, those using the test kits must report their test results through the MySejahtera application to enable the ministry to monitor their status.
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