FDA warns against unauthorized sale of COVID-19 test kits

Marje Pelayo

MANILA, Philippines – The Food and Drugs Administration (FDA) warns individuals and establishments taking advantage of the current health emergency to exploit consumers through unauthorized sales of coronavirus disease (COVID-19) test kits.

FDA Administrator Director-General Eric Domingo said they received several reports regarding merchants offering the said test kits not only in Metro Manila but in other provinces as well.

There are online sellers who also do the same, the official said.

To curb this unauthorized practice, the FDA issued a warning to the public not to be swayed by unauthorized sellers of COVID-19 test kits.

“Ang babala lang natin kahit po gamitin ninyo ito, hindi naman natin alam kung valid at acceptable ang mga resulta na ito,” Domingo warned.

“Sino naman po ang doktor na maniniwala sa resulta ng mga ito at gagamitin siya to manage a patient?” he added.

Domingo said only the Research Institute for Topical Medicine (RITM) and the University of the Philippines (UP) National Institute of Health are the two authorized institutions to distribute the COVID-19 test kits.

The FDA in its official website warns concerned establishments not to distribute, advertise, or sell COVID-19 testing kit unless authorized by FDA.

Otherwise, the FDA said, regulatory actions and sanctions shall be strictly pursued.

“This is to ensure the provision of accurate and reliable information regarding result of the COVID­-19 test to be conducted” the FDA said.

Domingo said they are coordinating with the Bureau of Customs (BOC) to block the entry of COVID-19 testing kits from abroad because at present, no imported COVID-19 test kits are authorized for use in the Philippines at present.

“Kasi every time naman na may darating na testing kit or medical device kailangan hihingan nila ito ng Certificate of Product Registration or ang Certificate of Exemption, (Every time testing kits or medical devices are delivered to the country, (the BOC) would ask for the items’ certificate of product registration o certificate of exemption,)” the Official said.

So far, only a certificate of exemption was issued for the COVID-19 testing kits produced by the UP-NIH after evidence that the kits are beneficial for the early detection of COVID-19 cases in the Philippines.

“Para lang po alam ng lahat talagang wala pang registered na COVID-19 test kit po dito sa Pilipinas lalong-lalo na po itong mga imported na mga produkto na makikita natin, (Just so you know, there is no registered COVID-19 test kit yet here in the Philippines especially these imported products that we see in local markets,)” Domingo stressed.

Field testing of the UP-invented test kits will begin on Monday (March 16).

READ: PH to start validating Filipino-made COVID-19 test kits

Once approved, a total of 1,000 test kits will be made available weekly, Domingo assured.

The locally made COVID-19 test kits may help in testing asymptomatic patients, in tracing the patients’ travel history abroad especially in coronavirus-affected countries, and those with exposure to a coronavirus-infected patient.

For now, the FDA is still waiting for the government’s approval for the locally-made test kits before the agency can issue a certificate of product registration that will signal its use by hospital laboratories.

The FDA emphasized that COVID-19 test kits are no similar to pregnancy kits and blood sugar test kits that are readily available in markets which can be used at home and yield instant results. – MNP (with inputs from Aiko Miguel)

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