FDA warns against unauthorized sale of COVID-19 test kits

Marje Pelayo   •   March 13, 2020   •   1517

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)

PH Defense receives 50K COVID-19 swab test kits from Singapore

Robie de Guzman   •   April 16, 2021

MANILA, Philippines – The Department of National Defense (DND) and the Armed Forces of the Philippines (AFP) have received 50,000 units of COVID-19 swab test kits from the Singapore Ministry of Defense.

The donated test kits were turned over to the DND and the AFP on Thursday, April 15.

The DND said the test kits will be issued to the Veterans Memorial Medical Center (VMMC) and the AFP Medical Center (AFPMC).

The VMMC, which is mandated to provide quality medical care and treatment to veterans and their dependents, is under the purview of the Philippine Veterans Affairs Office (PVAO).

The AFPMC, meanwhile, provides medical care to the military and civilian personnel of the AFP.

“Both PVAO and AFP are government bureaus under the DND,” the department said.

Police seize unregistered COVID-19 test kits, nab 2 suspects in Navotas

Robie de Guzman   •   March 3, 2021

MANILA, Philippines – Boxes containing unauthorized COVID-19 test kits were seized in an entrapment operation in Navotas City, the Philippine National Police (PNP) said on Wednesday.

In a statement, PNP chief General Debold Sinas said police operatives recovered Tuesday 154 boxes each containing 50 pieces of Clungene rapid test kits worth P1,016,000, and marked money amounting to P436,000.

The PNP said the operation conducted at Barangay San Rafael stemmed from information shared by the Food and Drug Administration.

The operation also yielded the arrest of 40-year old Chinese trader Liset Lo Kaw and 23-year old Christian Casanova who marketed the unregistered test kits online.

Sinas said the arrested suspects are leaders of Christian CG, a criminal group engaged in online selling.

“We remind the public to be vigilant and to immediately report any suspicious online transactions. We cannot discount the risks associated with unauthorized medical products that could possibly endanger public health,” the PNP chief said.

“Also, we encourage those who are engaged in food or health product businesses to get pertinent legal documents from the FDA to avoid conflict with the law,” he added.

The PNP said the suspects were brought to Quezon City District Field Unit office for documentation and booking process.

They will face charges for violation of the Food and Drug Administration Act of 2009 in relation to FDA Circular No. 2020-016 or the prohibition of Online selling of FDA Certified COVID-19 Antibody Test Kit.

FDA recalls locally-made COVID-19 test kits for ‘minor defects’

Marje Pelayo   •   May 21, 2020

MANILA, Philippines — Some ‘minor defects’ have been seen in the test kits made by the University of the Philippines – National Institute of Health (UP-NIH), according to the Food and Drug Administration (FDA). 

This prompted the agency to order the recall of all locally-made coronavirus disease (COVID-19) test kits and stop its use in medical facilities until the problem is resolved.

Specifically, FDA Director Eric Domingo said evidence of contamination had been traced in the reagents that were used in the test kits of UP-NIH; hence, they should not be sold or used for now. 

The said locally-made test kits were approved for use by the FDA in April.

Nonetheless, Health Spokesperson Undersecretary Maria Rosario Vergeire ascertained that the UP-NIH is soon to complete correcting the deficiencies in their test kits. 

“They are in the final stages of correcting the identified deficiencies of the kits by RITM and hopefully by next week they can be re-validated by RITM and we can already use the UP testing kits,” Vergeire said. 

As regards the rapid antibody test kits, Malacañang maintained that local government units (LGU) may still use the said kits despite claims by medical societies that the use of such would be a waste of resources when they only give false results. 

According to Presidential Spokesperson Secretary Harry to  Roque, the LGUs just need to confirm the results of the rapid antibody test kits through real-time reverse transcription polymerase chain reaction (rRT-PCR) test within the succeeding 14 days. 

Sa ngayon po, dahil po wala pa tayong sapat na kakayahan at dahil tayo po ay nagbi-build up pa lang ng capacity ng PCR testing, siguro naman walang mawawala kung ira-rapid testing natin ang gusting magpa-rapid testing at yung mga positive, ipa-verify natin sa PCR [For now, since we do not have enough capacity yet and we are still building up our PCR testing capacity, there’s no harm if we still proceed with rapid testing to those who request it, and if it yields a positive result, then have it confirmed through PCR],” Roque explained.

 FDA-approved rapid test kits costs around P3,500 and up depending on the source company and the country of origin. MNP (with reports Aiko Miguel)

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