The time for half-measures and empty promises has passed. African governments must take immediate, decisive action to combat the proliferation of substandard and falsified medical products that are killing our children and bleeding our economies dry.
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Every year, 122,000 children under the age of five in sub-Saharan Africa die needlessly from substandard or falsified anti-malaria medication. Let that number sink in. These are not statistics – they are our children, our future, lost to a preventable crisis that demands urgent action.
The World Health Organization has directly linked 300 deaths in The Gambia, Indonesia and Uzbekistan to contaminated batches of pediatric syrup. Meanwhile, low and middle-income countries lose an estimated $30-billion annually to substandard and falsified medicines through wasted treatment and lost productivity.
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These figures should shock every African leader into action. Yet we continue to witness the same patterns of negligence, weak governance, and misplaced priorities that allow this deadly trade to flourish.
The Hard Truth About Our Failures
Having spent decades studying this crisis, I can tell you that substandard and falsified medical products persist across Africa because of a toxic combination of factors: weak political will from governments, limited accountability, corruption in regulatory and law enforcement systems, and fragmented coordination between agencies.
The market conditions make matters worse. High demand for cheaper medicines creates opportunity for criminals, while complex cross-border supply chain regulations and low barriers of entry for illicit operations provide the perfect environment for this trade to thrive.
The regulatory landscape is particularly damning. Only eight out of 54 African countries operate stable and well-functioning regulatory systems at WHO’s recommended maturity level: Egypt, Ghana, Nigeria, Rwanda, Senegal, South Africa, Tanzania and Zimbabwe. This means 46 countries are failing to protect their citizens from potentially deadly medications.
Even more concerning, fewer than a dozen African Union member states have completed or formally initiated the domestication of the AU Model Law. The sanctions for those responsible remain laughably weak. In my own country, Tanzania, the legal maximum fine for falsified medicine offenses is just five million Tanzanian shillings – roughly $2,000 – or three years in jail. This is hardly a deterrent for criminals making millions from this trade.
Supply Chain Vulnerabilities Are Killing Us
The weaknesses in our supply chain environment are equally alarming. There are massive leakages between legal and illicit distribution channels. In the Sahel region, 40 percent of detected substandard and falsified medical products were found inside regulated supply chains. This means our own systems are being compromised.
Border control remains woefully inadequate. Customs officials at major ports inspect fewer than 10 percent of containers, relying primarily on risk-based X-ray screening. Meanwhile, 37 percent of vaccines in low and middle-income country supply chains show freezing exposure during storage, potentially destroying their effectiveness.
The Path Forward: Six Critical Actions
To secure Africa’s medicine supply by 2030, we must address six fundamental areas:
First, regulatory gaps must be closed immediately. We need properly financed national regulatory bodies and swift ratification of the African Medicines Agency treaty. Every African country must achieve WHO maturity level 3 status.
Second, supply chain weaknesses require urgent attention. We must eliminate leakages between legal and illicit channels and strengthen border controls with enhanced inspection protocols.
Third, manufacturing quality assurance deficits cannot be tolerated. Industry must implement good manufacturing practices and serialisation technologies while sharing supply chain information transparently.
Fourth, market surveillance systems must be strengthened. Regulators must adopt risk-based post-market surveillance and publish transparent data on medicine quality.
Fifth, governance and resource allocation need fundamental reform. The criminalisation of the substandard and falsified medicine trade with stiffer penalties is non-negotiable. Current fines that amount to pocket change for criminals must be replaced with sentences that reflect the gravity of these crimes.
Sixth, public awareness campaigns are essential. Citizens must understand the dangers and know how to identify legitimate medicines.
Universal Health Coverage Depends on This
We cannot achieve universal health coverage while substandard and falsified medicines undermine patient treatment, fuel drug resistance, and kill our people. These products don’t just harm individual patients – they destroy confidence in our entire healthcare system.
The economic argument is equally compelling. At $30-billion in annual losses, we’re talking about resources that could fund hospitals, train healthcare workers, and expand access to quality medicines across the continent.
The Time for Action is Now
African leaders must understand that this is not just a health issue – it’s a security threat, an economic crisis, and a moral emergency rolled into one. Every day we delay action, more children die, more families are destroyed, and more resources are wasted.
We have the knowledge, the frameworks, and the examples of success from countries that have made progress. What we need now is the political will to act decisively.
The choice is clear: we can continue with business as usual and watch thousands more children die, or we can take the bold steps necessary to protect our people and secure our future.
History will judge us by the choice we make.
Eliangiringa Kaale is a leading expert on pharmaceutical regulation and quality assurance at Muhimbili University of Health and Allied Sciences in Tanzania.
This is the text of an address to the AUDA-NEPAD Working Group on Substandard and Falsified Medical Products in Addis Abbaba.
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