The acting Director of the Medicines Control Agency(MCA), Mr. Essa Marenah, has stressed that laws around the importation of medicinal products “clearly” dictate that any product that comes to The Gambia must be tested.
The MCA acting director was responding to reports that the MCA has upgraded its medicines importation regulations.
Before the arrival of AKI, the agency insisted that all imported medicines must be registered before they could be distributed but it has now upgraded this to mandatory testing following the AKI health emergency.
Here is Mr. Marenah in his own words:
“It’s very easy. Let them(importers) go and check what arein the laws and in the guidelines. It’s very clear… if products come, they need to be tested. You know, maybe all those things were not happening before AKI. So, I think they(importers) have been getting most of the things easy. But AKI taught everyone a lesson.
Even countries that did not experience it but because of Gambia’s experience and four other countries… because it happened in Iraq, Indonesia, it happened in Cameroonand Uzbekistan within 12 months. So, that taught the whole world a lesson. Even those countries that do not experience AKI are testing products when they are imported to make sure that they keep the population safe. So, much more us who experienced it.
Registration is just a process and when you register a product, a particular batch of the product… they submit a sample for registration but after that you have subsequent batches coming all the time.
So, something could go wrong with any of these batches. You cannot say when you register a product, that product should not be tested any longer because, at any point in time, different batches come. If a batch could go wrong…We all know that in manufacturing, one batch being okay doesn’t mean that other batches will be okay. So,registration is to make sure that you satisfy… You are following processes in place or other systems in place… You have the right equipment. It doesn’t mean that human errors cannot happen or foul play cannot happen. So, if you track those ones from batch to batch, you take samples and test them. Even in Europe, we registered some before but they wrote to us to say this particular batch supplied has a problem.
This is why we have alerts coming all the time. It does not mean only contamination is a problem. It has other problems. And even Europe will send this communication to other countries that this particular medicine…we checked and it has a problem. So, people will be issued alerts to withdraw it from their market. Last year, there was an eye drop…it did not come to The Gambia but it killed a lot of people in the US.
So, it doesn’t mean medicines coming from Europe are problem-free. Human beings are producing them. As long as human beings are not perfect, errors are bound to happen. You cannot depend on machines. Who made machines? Human beings and human beings are not perfect. So, you cannot expect machines to be perfect.”
