By Kuda Pembere
The Medicines Control Authority of Zimbabwe (MCAZ) intends to introduce regulations governing the registration and use of in vitro diagnostics (IVDs) in the country.
This follows concerns and reports that there is a proliferation of substandard and counterfeit IVDs in the country.
IVDs according to the World Health Organization (WHO) are tests that can detect disease, conditions and infections. In vitro simply means ‘in glass’, meaning these tests are typically conducted in test tubes and similar equipment, as opposed to in vivo tests, which are conducted in the body itself.
“Medicines Control Authority of Zimbabwe has come up with regulations to control in vitro diagnostics. This includes things like your test kits, HIV test kits, pregnancy test kits, COVID test kits. We want to make sure that these are of good quality, they are safe and they are effective.
That when you are tested or you are diagnosed, we know that the device is giving you the good result that you require so that you can have good treatment and there’s no time wasted,” MCAZ Head of Licensing and Enforcement Mrs Caroline Dandira-Samatanga said speaking with journalists on the sidelines of a consultative meeting with stakeholders on IVD regulations.
She added that that faulty medical devices have been and could be in use but the Authority enforcement-wise is hamstrung due to absence of IVD regulations.
“So we’ve been coming up with regulations and a number of issues have been recorded where poor quality diagnostics have also been in use. As you may remember during the COVID-19 test kits,” Mrs Dandira-Samatanga said. “We didn’t know if they were of good quality and we want to be as prepared as we can be going forward.”
Mrs Dandira-Samatanga added, “Should we come across another pandemic, we know that anything that is coming in, this is the procedure we are going to take. We already have some on the market, but we are not sure. Nobody is regulating them as yet, but we want to make sure that they are of good quality, they are safe and also effective.”
She said a grace period to register IVDs already on the market will be afforded to various players.
“We will come up with transitional arrangements and communicate as much as possible with stakeholders on what they are going to do, how they are going to handle those that are already on the market.
“We will register them and give people time to regularize,” the Head of Licensing and Enforcement noted adding they await the Ministerial nod to start planning.
A partipant during the consultative meeting said the regulations should be wary of the distribution channels so that the IVDs would not end up in untrained professionals.
“So what I’m saying, when we have medical devices, which is an IVD, the idea is to ensure public safety. When we make these IVDs available to the public, it is in the interest of the public.
” So we can’t, when we have a regulation, the regulation is in such a way that it will not deny anyone if you are a manufacturer, if you aee distributor, if you are a, um, anyone who is along the value chain, you will stand to benefit if you follow the regulations.
” So I’m saying, if we are to get products, any products, at a retail supermarket, maybe of the medical devices products, the question would be, how did they get to that retail supermarket?
“What are the issues or the mechanism which have been put in place to protect the use of that product when it is a retail supermarket?
“Are the people at the retail supermarket trained to understand the public safety on use of that product?” said the participant. ” Because medical products, they have got side effects.”
The participant added that classification of IVDs would help in seeing which devices would be readily available for public and those which require trained professionals.
‘Even if you are saying testing, you know, the IVDs, those products which you use for testing, you need to know what we call like detection limits, how they work, their sensitivity.
“Are they able to detect someone who is infected or not infected. And some, they’ve got a certain range of sensitivity to say they are not able to pick those who are infected and some are not also able to detect those who are not infected.
“So there is more in just having like, it can be a rapid test, a rapid HIV, a rapid pregnancy. It’s, it’s, there is more to it which maybe the public don’t know. And they end up using those products without having that knowledge.
“So we are saying with the regulation, we would know to say which product would we say can go to the public.
“That’s why we are talking of classification. If we agree, it’s good the regulator is involving all the stakeholders,” noted the participant. “So the professionals, the suppliers, they will have their input. So we want to agree and say, ah, if this product gets into a supermarket, is it okay? I think you agree with me it is not okay. I think you agree with me it is not okay.”
