When national medicines regulators fail, we need the African Medicines Agency to step in

No parent should ever have to bury their own child. Families in Gambia, Indonesia and Uzbekistan had to bury more than three hundred children under five years old in recent months. Each one of those deaths was preventable.

These children were poisoned by a cough syrup containing high levels of diethylene glycol (DEG) and ethylene glycol (EG) — toxic chemicals used as industrial solvents and antifreeze agents. These chemicals are fatal even when ingested in small amounts. They should not be swallowed at all. When ingested they cause kidney damage and death and therefore should never be a component of any medicine at all.

However, the syrup taken by the deceased children had very high levels of these toxic chemicals. Incidences over the last four months have prompted the World Health Organization (WHO) to make an urgent plea on 23 January 2023 for countries to do more to prevent, detect and respond to cases of sub-standard and falsified medical products.

The WHO believes more countries may be affected including Senegal, the Philippines, Timor Leste and Cambodia. This means that the recorded deaths are likely an underestimation of the true fatality. Many other victims may have gone unreported.

Most people will not notice what medicines regulators do until they do not do it. Medicines regulators have a duty to protect African populations from being harmed by medical products that are of sub-standard quality and safety.

This is why here in South Africa, the South African Health Products Regulatory Authority (Sahpra) works closely with the police, defence force and the Department of Home Affairs to seize shipments of unregistered medicines worth millions of rands, and other products like skin-lightening creams which are banned because they contain nerve toxins like mercury, known to cause paralysis.

When regulators fail in performing their duty, the consequences for the public can be fatal.

That the poisoned cough syrups reached pharmacy shelves in Gambia at all highlights a series of unfortunate regulatory failures in the factory that manufactured those medicines, in the country that provided oversight over their production, and in the market to which those medicines were sold.

We may not know the precise point(s) at which the failure occurred. It is possible that failure happened on multiple levels.

Firstly, failure of the quality assurance processes of the factory that manufactured the cough syrup that include four Indonesian manufacturers, PT Yarindo Farmatama, PT Universal Pharmaceutical, PT Konimex and PT AFI Pharma.

The quality assurance processes of these companies may have failed to ensure that the ingredients used to make the medication were of good quality. They could assure themselves of this by buying their ingredients from qualified reputable suppliers. They could also test their ingredients before use to be certain of their quality.

Then after making the medicines, they should have tested the product made from those ingredients, keeping meticulous records every step of the way to make sure that they were safe and worked as expected. Failure to do one or all of these processes may have resulted in poisonous medicines being released for sale around the world.

It was however not too late to stop them reaching the hands of patients. They could have still been stopped if the regulators of the countries in which the medicines were made and those in the country where the medicines were sold had inspected the manufacturing facilities to make sure that correct standards were being met.