Local manufacturers of COVID-19 test kits claim our regulatory authority is stifling the distribution and export of these products and they are in massive demand globally. The authority concedes it’s swamped with applications but says manufacturers are submitting incomplete documentation. Biotechnologist Ashley Uys says his company Medical Diagnostech has the capacity to manufacture up to 80,000 antibody test kits a day but there’s a problem.
“We are ready to roll. We are waiting on SAHPRA’s guidelines in terms of amending our license to add COVID-19 as a product to it, and then to recommend their approved validation laboratories,” said Uys. Anther diagnostic manufacturer developing two rapid COVID-19 test kits says he continually hits dead ends.
“We have been asking SAHPRA whether we could do a validation of the prototype that we developed. The answer from them is we must approach the NHLS, which we did,” said Louis Roux, MD of Life Assay Diagnostics.
“The feedback was we should first get permission from SAHPRA. So it’s round and round the mulberry bush you go. You can’t get anywhere. You can’t really proceed. It’s difficult, if not impossible, to supply the local demand, let alone the global demand of this product because we do not have access to material
Roux says the authority put out a general guideline for test kits but claims it’s just too vague. Some companies claim their paperwork goes missing, phone calls are not returned, and there’s no feedback from the regulator but not so says the CEO.
SAHPRA admits it’s struggling with sufficient capacity to deal with the sheer number of applications being submitted for these medical devices. Coronavirus Hotline Number: 0800 029 999 from 8 am to 4 pm, Monday to Friday Help protect your loved ones by sharing this official South African government COVID-19 service with your family, friends and community.
Send HI to 0600 123 456 on WhatsApp. The NICD has another Clinician Hotline to improve #COVID19 communication and support for healthcare providers. The Clinician Hotline is 0800 11 1131, operating 24 hrs. The Public Hotline is 0800 029 999 also operating 24hrs.
In other news – She took her own life in the garden – Nomzamo Mbatha breaks the silence on her Sister’s suicide
They say the more you keep quiet about something, it slowly eats you up without you even realizing it. Actress Nomzamo Mbatha decided to break the silence and share her feelings about her sister committing suicide, she finally found the strength to “silence the shame”.
An emotional Nomzamo took to Instagram to pour out her heart for the whole world to see. She openly shared how finding her baby sister in her family garden after she had taken her own life is still a tragedy that haunts her to this day. Read more