MCAZ de-registers more than 100 withdrawn medicines
The Medicines Control Authority of Zimbabwe has de-registered more than 200 specific makes and tablet sizes of some drugs saying the move has nothing to do with safety concerns but is purely a marketing decision by those who make or supply the market no longer having a market for the product or no longer having the registered brand for sale.
The authority gazetted the de-registration of around 200 medicines as well as the withdrawal of a number of medicines submitted for registration.
Fees have to be paid for the initial registration and there is need to maintain the registration. So when a manufacturer or importer no longer has a market in Zimbabwe, because something else has replaced the original medication or a brand has been discontinued or even the formula used in the tablets has changed, the supplier will want the original registration cancelled.
The Medicines Control Authority of Zimbabwe must register every brand of every type of human and veterinary medicine before these can go on general sale, whether over the counter or through prescription. Manufacturers and importers go through the process when making or importing a new remedy or even just a new brand of an already approved medicine.
And when that particular brand, or tablet size or other factor changes and the original approval is no longer needed, the maker or importer seeks to have this discontinued line deregistered.
Speaking to The Herald yesterday, MCAZ head of evaluations and registration Dr William Wekwete said the decision was informed by some suppliers who were bringing in alternative drugs assuring the nation that it was nothing amiss.
“That one is a normal process which entails that when medicines are approved, cancelled, refused or withdrawn the authority has to publish that information.
“Among reasons for cancellation: the manufacturer assesses the market and sees that a certain tablet is in excess and says I do not want to retain it then they notify us and they are cancelled. It is not that there are safety issues but purely a marketing decision from the company,” said Dr Wekwete.
He gave an example of the cancellation of nevirapine, a drug used to control HIV.
“If you look at the treatment guideline, the combinations with nevirapine are now very few; there are other new regimens with other combinations.”
The notices using different sections of the Medicines and Allied Substances Control Act saw the deg-registration of a modest group of veterinary medicines, a much larger group of human medicines, the voluntary withdrawal of some complementary medicines, using vitamin tablets, before registration was complete and a similar withdrawal after submission for registration of some human medicines.
The country’s health system is being transformed to match best international practices and Zimbabwe is driven by science in this regard, MCAZ also played a critical role in ensuring the safety of Covid-19 vaccines administered on people.
MCAZ is responsible for protecting public and animal health by ensuring that accessible medicines and allied substances and medical devices are safe, effective and of good quality through enforcement of adherence to standards by manufacturers and distributors.
The mandate of MCAZ is to protect public health ensuring that medicines and medical devices on the market are safe, effective and of good quality. Herald.