On September 6, 2022, the World Health Organization (WHO) Country Office disclosed that the Gambian Ministry of Health (MoH) was investigating up to 40 deaths, mostly children under 5 years, suspected to be linked to the use of “paracetamol syrup.” These deaths were believed to be associated with “kidney failure,” with 49 cases reported as of August 29.
Promptly responding to the crisis, the Gambian Government, on September 7, 2022, suspended the use of all paracetamol syrups. An initial list of six suspect paracetamol syrup products was identified, and the WHO was enlisted to support the analysis for the presence of contaminants. Lab analyses released on September 19 and 23 detected and quantified Diethylene Glycol (DEG) and Ethylene Glycol (EG) in samples of the syrups.
On October 5, 2022, WHO issued Medical Product Alert #6, identifying four contaminated syrups, all manufactured in India. The Gambian Medicines Control Authority initiated a national recall of all paracetamol, promethazine, and cough syrups.
Dr. Leticia Megias Lastra, a Technical Officer at WHO, emphasized the potential causes of the incidents, pointing to contamination of excipients at the point of manufacture, impacting the global supply chain. She noted that it could be accidental or intentional substitution of industrial-grade substances, posing a significant global public health risk unless identified.
Uganda’s Adulteration Concerns
In Uganda, the National Drug Authority (NDA) discovered several nutritional supplements, beverages, herbal, and alcoholic products adulterated with drugs for erectile dysfunction. On August 22, 2023, the NDA issued a warning against L-Power Coffee, confirmed to be adulterated with Tadalafil, a prescription drug for erectile dysfunction.
Tadalafil, when not used under strict medical supervision, can lead to severe health issues, including respiratory and cardiac problems, urinary disorders, and even death. Previous discoveries of adulterated products, such as M-Magix Coffee and “Stronger Weekend,” prompted the NDA to underscore the public health risks associated with counterfeit and substandard medical products.
Abiaz Rwamwiri, NDA’s Public Relations Manager, emphasized the global nature of the issue, calling it a lucrative business run by criminals. He highlighted the challenges posed by counterfeit medications, stressing the importance of regulatory oversight.
Concerns in the IGAD Region
The Intergovernmental Authority on Development (IGAD) Member States face varying challenges regarding the impact of Substandard and Falsified Medical Products (SFMPs). Mr. Karim Wanga from the Pharmacy and Poisons Board in Kenya identified issues such as different levels of regulatory maturity, porous borders facilitating illegal importation, and the risk of substandard or falsified products being smuggled.
Regulatory Challenges and Responses
Dr. Andrea Keyter from WHO outlined challenges to regulatory systems in Africa, including changes in leadership, inadequate financing, lack of human resources, and infrastructure deficiencies. Dr. Lastra emphasized WHO’s commitment to supporting African states by strengthening National Regulatory Authorities (NRAs), enhancing testing capacity, and investigating and issuing alerts for contaminated products.
As the Seventh Session of the Scientific Conference on Medicinal Products Regulation in Africa (SCoMRA) approaches in 2025, it is clear that addressing these challenges is crucial to safeguarding public health and fostering the development of robust regulatory systems in the region.