On September 6, 2022, the WHO Country Office reported that the Gambian Ministry of Health (MoH) was investigating the deaths of up to 40 children, mostly under 5 years of age, suspected to be linked to the use of “paracetamol syrup.” The deaths were suspected to have been caused by “kidney failure,” with 49 cases reported by August 29.
The Gambian Government, on September 7, 2022, suspended the use of all paracetamol syrups, identifying an initial list of six suspect products. WHO was requested to analyze the syrups for contaminants, and subsequent lab results released on September 19 and 23 detected and quantified DEG and Ethylene Glycol (EG) in samples of the syrups. On October 5, 2022, WHO issued a Medical Product Alert #6 for 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 from WHO’s Regulatory System Strengthening Team highlighted possible causes, including contamination of excipients at the manufacturing point, impacting the global supply chain. She emphasized the significant global public health risk unless the causes are identified.
Uganda’s Medication 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 warned against the consumption of L-Power Coffee, confirmed to be adulterated with Tadalafil, a prescription drug. The NDA intercepted a consignment of L-Power Coffee concealed as a nutritional supplement, leading to a formal recall.
Counterfeit and substandard medical products pose a global public health issue, with adverse effects and a lack of improvement in health conditions, according to NDA’s Public Relations Manager, Abiaz Rwamwiri. He emphasized that these products are produced without regulatory oversight and distributed illegally, constituting a lucrative business run by criminals.
Impact on the IGAD Region
The Intergovernmental Authority on Development (IGAD) Member States face challenges due to varying levels of regulatory capacity, porous borders facilitating illegal trade, and the risk of substandard or falsified products being smuggled. The impact on public health and economic losses necessitates collaborative efforts in the region.
Regulatory Challenges and Recommendations
Regulatory challenges in Africa include constrained access, poor governance, weak technical capacity, lack of awareness, high costs of post-market surveillance, technological sophistication by criminals, political fragility, and security challenges. Dr. Andrea Keyter from WHO identified seven major challenges to regulatory systems in Africa, emphasizing the need for sustainable financing, human resources, infrastructure, and political support.
The WHO is actively supporting African states in strengthening capacities, improving testing capabilities, and investigating contaminated products. Reporting contaminated drugs promptly is crucial to mitigating global public health risks.
The 6th Session of the Scientific Conference of Medicines Regulators in Africa (SCoMRA) highlighted the need for enhanced data sharing, improved legal frameworks, and intersectional collaboration in the fight against substandard and falsified medical products (SFMPs). Sensitization, training, and integration of continental and regional efforts are recommended to combat the growing issue of SFMPs.
