For years, Africa has been a significant market for imported pharmaceutical products. However, fragile regulatory frameworks across the continent have made it a hotspot for fake and adulterated medicines, jeopardizing patient safety and leading to poor treatment outcomes.
With over 70% of pharmaceutical products used in Africa imported from overseas, robust regulatory functions are crucial for ensuring medicines security. Unfortunately, high levels of falsified and adulterated medicines continue to be reported by regulatory agencies across the continent.
To address this, the African Medicines Agency was recently established to enhance regulatory functions and oversight of pharmaceutical products, aiming to eliminate falsified and adulterated medicines from the continent.
The World Health Organization (WHO) defines falsified medicines as those that deliberately misrepresent their identity, composition, or source. These can include counterfeit, tampered, illegally diverted, or stolen products. Falsified medicines often contain harmful substances, no active ingredients, undeclared ingredients, or incorrect dosages of active ingredients.
This global issue poses significant health risks, especially for patients who cannot distinguish between authentic and fake medicines. These harmful products can cause adverse reactions, fail to treat the intended conditions, and even result in therapeutic failures or death.
Problem with Toxic Cough Syrups
In April 2024, Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) issued a notice recalling a specific batch of Benylin pediatric cough syrup due to dangerously high levels of toxic substances. This proactive measure by NAFDAC is commendable and highlights its commitment to patient safety.
Recent reports have linked toxic cough syrups to child fatalities in Africa and Asia. In 2022, over 70 children in The Gambia died from kidney failure due to diethylene glycol and ethylene glycol in imported cough syrups. Similar incidents have occurred in Cameroon and Uzbekistan, with the same toxic substances implicated. These tragic events represent the highest casualties from medication poisoning in recent years. The Pharmaceutical Security Institute reported a 10% increase in pharmaceutical crime incidents globally in 2022, the highest in recent times.
Role of NAFDAC in Enhancing Regulatory Functions
Recently elevated to Maturity Level 3 (ML3) status, NAFDAC now holds a higher responsibility for regulatory functions and oversight in Sub-Saharan Africa. As the largest importer of pharmaceutical products in Africa, Nigeria plays a crucial role in the continent’s drug regulation landscape and must continue to act as a regional watchdog.
Following NAFDAC’s alert about toxic pediatric preparations, Kenya and South Africa also issued similar warnings, signaling that regulatory bodies are actively working to combat this issue. This collective action demonstrates a commitment to ensuring it’s no longer business as usual for those dealing in falsified medicines.
Challenges and Gaps in Regulatory Functions
Africa’s pharmaceutical regulation issues often stem from inadequate monitoring and enforcement rather than a lack of regulatory laws. While the Acts establishing regional regulatory bodies contain robust provisions, implementation gaps arise during inspection, enforcement, and monitoring.
For instance, corruption at ports allows falsified and adulterated medicines to enter the continent. Similarly, during drug registration processes, substandard medicines are often approved, posing risks to patients and society.
Strategy for Strengthening Regulatory Oversight
The creation of the African Medicines Agency (AMA) aims to centralize and strengthen regulatory functions across Africa, tightening borders and intensifying efforts to eliminate falsified medicines. With NAFDAC’s status as a regional leader and Nigeria’s position as the biggest importer of pharmaceutical products, Nigeria must lead the fight against fake medicines.
NAFDAC’s recent actions regarding the toxic Benylin pediatric cough syrup demonstrate its ongoing commitment to this battle. The agency’s proactive measures and vigilance are crucial in the fight to protect public health in Nigeria and across Africa.
Conclusion
The risks posed by toxic or substandard products are immense. Therefore, NAFDAC must remain relentless in its mission to eliminate falsified and adulterated products from the market. With its recent actions and ongoing efforts, NAFDAC is well-positioned to continue playing a vital role as a regional champion for medicines regulation in Africa.
