RWANDA— The Rwanda Food and Drugs Authority (Rwanda FDA) has recalled all batches and banned the importation of a drug used to treat epilepsy and bipolar disorder, citing quality deficiencies.
The medication in question is gastro-resistant Sodium Valproate tablets BP 300mg and gastro-resistant Sodium Valproate BP 500mg, manufactured by Indian Pharmaceutical manufacturer 4Care Lifescience PVT Ltd.
The Rwanda FDA has issued a circular to various stakeholders, including medical stores, Rwanda Medical Supply branches, pharmaceutical wholesalers, importers, retail pharmacies, public and private health facilities, and health professionals.
The circular informs them of the recall and the ban on the importation of the affected medication.
According to the UK National Health Services, this medication is primarily used in the treatment of epilepsy and bipolar disorder, with occasional use for migraine headaches.
The investigation into the quality of the medication began in January 2023. Upon further investigation and laboratory quality control analysis, it was found that the reported batches did not meet the required quality standards.
The identified quality issue was that the tablets tended to become semi-solid and cracked.
Importers and suppliers have been instructed to report the quantities imported, distributed, returns, and final stocks on hand to the Rwanda FDA within 10 days from the publication of the recall notice, which was on the 10th of May 2023.
The Rwanda FDA will communicate officially when the importation of the medication will be allowed again, following the recertification of the mentioned products.
The Rwanda FDA has taken a strong stance against low-quality medicines. In January 2023, the regulatory body banned ‘Male Private Part Enlargement natural’ medicines imported from Tanzania due to their negative health consequences.
This action was taken to ensure the public health of the population. Another banned Tanzania natural medicine is Ngetwa3, which allegedly heals various diseases.
The Rwanda FDA did not specify the diseases it is meant to treat but mentioned the inconsistency of the medication.
In 2022, the Rwanda FDA recalled Broncalene, a syrup commonly used for healing dry cough, due to safety and health concerns.
This decision was made after a study conducted by the French pharmaceutical agency revealed that its active ingredient, pholcodine, posed a higher risk of causing anaphylactic allergic reactions when combined with surgical-related medicine.
Additionally, based on recommendations from the National Pharmacovigilance Advisory Committee, the Rwanda FDA banned Ketoconazole oral tablets, used for the treatment of fungal infections.
The authority concluded that the risks of liver injury associated with Ketoconazole outweighed its benefits for treating fungal infections.
In February, the Rwanda FDA also banned Paracetamol Suspension 120 mg/5ml, a children’s medication manufactured by Kenyan Laboratory & Allied Ltd. The reasons for the ban were not specified.
The magnitude of the problem
The magnitude of the problem surrounding substandard and falsified medical products is significant.
Recent research from the World Health Organization (WHO) reveals that approximately 1 in 10 medical products circulating in low- and middle-income countries are of poor quality or falsified.
Since 2013, the WHO has received 1500 reports of substandard or falsified products, with antimalarials and antibiotics being the most reported.
Out of these reports, 42% originate from the WHO African Region, 21% from the WHO Region of the Americas, and another 21% from the WHO European Region.
According to a BMJ global health report, two major factors contribute to the high prevalence of poor-quality medicines in sub-Saharan Africa.
First, there is an increasing reliance on medicines imported from countries with varying levels of regulatory oversight.
Secondly, many African regulators lack the necessary resources to effectively monitor the quality of imported, manufactured, and distributed medicines within their territories.
To address this issue, the establishment of a structured and robust reporting system is crucial. Such a system enables a swift response to emergencies and the issuance of alerts in the most severe cases.
Furthermore, it facilitates in-depth analyses of the medical products most at risk, identifies vulnerabilities and weaknesses in health systems, assesses the harm caused to public health, and highlights the need for investment, training, and the implementation of stronger regulations and standards.
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