In most African countries, regulatory failures are a result of long-standing, well-recognised challenges facing individual medicines regulatory agencies across the continent.
The limitations may be at country level, but the consequences of failure, however, go beyond individual countries to negatively affect other countries on the continent. This is one of the major reasons driving African regulators to create a continental body, the African Medicines Agency (AMA), writes Dr Lenias Hwenda in the Daily Maverick.
The preventable poisoning of children by medicines containing toxic chemicals is a strong reminder of why we urgently need the African Medicines Agency to start its work; to help regulators in countries be more effective at protecting public health.
The AMA will expand the resources and capacity of countries to perform risk-based inspections of manufacturing sites in countries exporting medical products to African – countries such as India and China, among others. This will help to ensure the medicines imported into African markets meet international standards of quality and safety.
The AMA would be able to co-ordinate robust and more frequent market surveillance activities among African countries, including targeted testing based on the risk of sub-standard, falsified medical products entering the African market – as well as informal markets.
There will always be irresponsible manufacturers who knowingly disseminate sub-standard illicit medicines for the money. Our best defence against such unscrupulous businesses is national regulatory agencies that are better equipped to protect public health.
Many countries on the continent face various regulatory constraints, which the AMA can support them to overcome. At their best, African regulators must do better in preventing illicit medicines from ever reaching patients in the first place. That requires better enforcement of laws and other regulatory counter-measures for preventing sub-standard and falsified medicines and prosecuting manufacturers and distributors of illicit products.
The AMA is our best hope. It can minimise the occurrence of fatal failures by complementing national regulators to improve protection of public health.
African patients need the African Medicines Agency yesterday, and all governments who have not yet done so – including the Government of South Africa – must ratify it.
What happened in The Gambia, Indonesia and Uzbekistan is the worst-case scenario of the devastating consequences of regulators failing in their duty to protect.
The children were poisoned by toxic cough syrups containing high levels of diethylene glycol (DEG) and ethylene glycol (EG), lethal chemicals used as industrial solvents and antifreeze agents. These chemicals are fatal even when ingested in small amounts, and should not be swallowed at all. They cause kidney damage and death and definitely should never be a component of any medicine at all.
However, the syrup taken all of the children contained high levels of these toxic chemicals, prompting the World Health Organization (WHO) to make an urgent plea on 23 January for countries to do more to prevent, detect and respond to cases of sub-standard and falsified medical products.
The agency believes more countries may be affected including Senegal, the Philippines, Timor Leste and Cambodia. This means the recorded deaths might be an underestimation of the true statistics: many other victims’ deaths may have been unreported.
Most people will not notice what medicines regulators do until they do not do it. Their duty is to protect populations from harm, from unsafe, sub-standard medication.
This is why here in South Africa, the South African Health Products Regulatory Authority (SAHPRA) works closely with the SAPS, SA 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 to perform their duty, the consequences can be fatal.
That the poisoned cough syrups reached pharmacy shelves at all highlights unfortunate regulatory failures in the factories that manufactured those medicines, in the country that provided oversight over their production, and in the markets 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.
First, failure of the quality assurance processes of the factory producing the cough syrup that include four Indonesian manufacturers: PT Yarindo Farmatama, PT Universal Pharmaceutical, PT Konimex and PT AFI Pharma.
These companies’ quality assurance processes failed to ensure the ingredients used to make the medication were of good quality. They could have avoided this by buying their ingredients from qualified reputable suppliers. They could also have tested their ingredients before use to be certain of their quality.
Then, after making the medicines, they should have tested the products, keeping meticulous records every step of the way to ensure they were safe and worked as expected. Failure to do one or all of these processes resulted in poisonous medicines being released for sale around the world.
It was, however, not too late to prevent them from reaching 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 correct standards were being met.
Medicines regulators are tasked with ensuring all medical products in their markets are approved for sale by an authority with a mandate to do so, and that all suppliers of medical products are appropriately authorised, licensed and their premises regularly inspected.
However, many African regulatory authorities need to have adequate capacity to send inspectors to foreign sites where medicines used in their country are manufactured, to verify these manufacturers are compliant with regulatory requirements.
Suppliers and distributors have a responsibility to check for signs of falsification, including by having a sample of each medicine lot being tested before it is shipped to make sure that it is safe and of good quality. Suppliers and distributors in African countries sometimes skip this step to save costs and time.
All of these checks and balances can fail, and often do. Regulators take the additional step of performing market surveillance: doing routine spot checks of medicines available in their countries.
When done frequently enough, paying adequate attention to areas where risk of unauthorised or sub-standard products is greatest, market surveillance enables effective and rapid detection and removal of harmful products that slip under the radar of regulatory policing, allowing regulators to take action to protect the public as needed.
• Dr Lenias Hwenda is the founder and CEO of Medicines for Africa.
See more from MedicalBrief archives:
WHO probes raw materials link in lethal cough syrups
SA Cabinet approves signing of African Medicines Agency Treaty
Indonesia revokes firms’ licences after 150 deaths from toxic meds
Need to strengthen Africa’s medicines regulatory systems
Probe into Indian cough syrup link to Gambian children’s deaths