DOH exec: FDA clearance needed to import test kits

MANILA, Philippines — While the Department of Health (DOH) has received donations of testing kits for coronavirus disease 2019, an official clarified yesterday that importation of testing kits is not allowed despite the rising cases in the country.

“Not yet until the FDA (Food and Drug Administration) can provide clearance to all these kits being introduced in the country,” DOH Undersecretary Ma. Rosario Vergeire told The STAR.

Vergeire said the FDA is still validating the accuracy of the testing kits donated by South Korea and China to DOH.

On Monday, Health Secretary Francisco Duque III said 500 testing kits from South Korea arrived on Friday and up to 10,000 more test kits are expected to be delivered this week.

The DOH received 2,000 testing kits from China and another 10,000 units may arrive today, Duque said.

“This will allow us to test more people,” Duque told reporters. “We will have enough testing kits to examine the throat and nose swabs of the PUIs (patients under investigation). We need to ensure their quality and accuracy.”

Health officials earlier admitted that the lack of testing kits may have caused the “under reporting” of COVID-19 cases.

Duque said most of the testing kits being used by the government came from the World Health Organization (WHO).

The test kits developed by the University of the Philippines Manila-National Institute of Health are still being evaluated for accuracy and safety.

Duque said the government has approved the allocation of P240 million funding to the DOH for COVID-19 testing.

“That’s on top of the donations coming from South Korea and China,” he said. 

According to FDA director general Eric Domingo, the agency has not issued a Certificate of Product Registration for any COVID-19 testing kit.  

Domingo said this means that no such product is allowed to be sold and used in the Philippines.

He said only the testing kits donated by the WHO are being used by the Research Institute for Tropical Medicine.

The FDA issued a certificate of exemption for the local testing kits developed by scientists from the University of the Philippines-National Institute of Health and funded by the Department of Science and Technology.

US gives P139-M aid

 The United States government yesterday committed to give $2.7 million or more than P139 million in assistance to support the DOH’s response to COVID-19.

The US embassy in Manila said the United States Agency for International Development (USAID) will collaborate with its Philippine counterparts to establish and implement internationally-recognized infectious disease threat prevention and response strategies.

The embassy said the assistance would strengthen specimen transport systems to accurately and rapidly detect cases of COVID-19.

 The assistance will also help protect health workers and patients by ensuring that hygiene products, masks, waste management supplies and other necessary commodities are available, delivered and managed appropriately.

 The US had earlier announced to provide $37 million in assistance to the Philippines and 24 other countries affected by COVID-19.  –  With Sheila Crisostomo, Pia Lee Brago, Raymund Catindig