Philippine FDA Should Move Quicker to Recall Rapid Testing Kits Already Rejected by China

Amidst calls for the resignation of Health Secretary Francisco Duque and some controversy surrounding the firing or resignation of IATF special consultant Dr. Tony Leachon, it looks like the country is being flooded with inferior Covid-19 Rapid Testing Kits.

Lower House Health Committee Vice Chairman Cong. Michael T. Defensor is at a loss over the Philippine Food and Drug Administration’s slowness in stopping the sale of Covid Rapid Testing Kits (RTKs) already rejected by their country of origin.

At the same time, Defensor scored the FDA for not coming up with a clear standard for approving Covid RTKs.

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“FDA should immediately order a product recall of untested RTK brands and ban their importation to prevent people from wasting their money on these unreliable testing kits. Dapat hindi labo-labo, and hindi dapat kung ano anong brand na lang ang pinayagan ng FDA. Dapat ipaliwanag ng FDA ang batayan ng approval nila,” said Defensor.

Defensor suggested that since it lacks the capacity to test RTK brands, it would be practical to approve the brands endorsed by its counterpart in China, the National Medial Products Administration.

The following RTK brands that passed NMPA’s scrutiny are:

  • Guangzhou Wondfo
  • Innovita Biological Technology Co
  • Goangdong Hecin
  • Vazyme Biotech
  • Zhuhai Livson

The FDA, however, approved brands rejected by NMPA:

  • Onsite Covid-19 by CTK Biotech
  • Qingdao HIghtop
  • Diagnosure by Hangzhou Biotest Biotech
  • Bioscience Chongqing
  • Zybio
  • Zhejiang Orient Gene or Healgen
  • Maglumi 2019 NCOs by Shenzen New Industries
  • Viva Diag by Vivacheck Biotech Hangzhou
  • Shanghai Outdo Biotech
  • Beijing Lepu Medical Technology
  • Hecin Scientific
  • Shanghai Kehua Bio Engineering
  • Medical System Biotechnology
  • Clongene by Hangzhou Clongene Biotech
  • Wantai Sars Cov Beijing Wantai
  • Hangzhou Alltest Biotech

One Reply to “Philippine FDA Should Move Quicker to Recall Rapid Testing Kits Already Rejected by China”

  1. Spain bought also some , Rapid Testing Kits, from China, some month ago…they were defective; and they were returned.

    A Quality Control and Quality Assurance label must be on the products, to assure that the products
    are working properly, and were properly tested, before its shipment.

    The Philippines must set up, a Quality Control Department, to oversee, that the products we are importing are working properly. Do not just presume that the products you are buying abroad are working properly, especially now we have a pandemic of COVID 19.

    It is easy to sample and test the products !

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