Between 2023 and 2024, the Rwanda Food and Drugs Authority (FDA) recalled 14 medicines and over two dozen batches due to safety and quality concerns. The affected products, sourced from various manufacturers, included tablets, suspensions, and injectables. In some cases, the recalls applied to all batches and expiry dates. ALSO READ: FDA vows to strengthen food safety checks Notable examples of the recalled medicines include Hyoscine Butylbromide Tablets BP 10mg, Aminophylline Tablets 100mg, Spamox Oral Suspension, Phytomenadione Injection, Benylin Pediatric Syrup, Warfarin 1mg Tablets, Efferalgan Vitamin C, and Tetracycline Eye Ointment. While recalls continue to happen, here are a couple of things you should know about how the FDA gets information about the substandard products, how such medicines enter the Rwandan market, and the reasons behind the recalls. 1. What are the reasons for recall? Lazare Ntirenganya, the Division Manager of Pharmacovigilance and Clinical Trials at Rwanda FDA, told The New Times that products are recalled when they do not meet established quality standards. Such weaknesses are detected through activities like product assessment, manufacturing inspections, and post-marketing surveillance. “The FDA’s mandate covers quality, safety, and efficacy of medicines, which can be compromised during manufacturing, transportation, storage, or preparation,” he said. ALSO READ: Rwanda FDA bans two drugs amid safety concerns A pharmacovigilance committee, comprising medical experts, assesses reports and recommends actions to mitigate risks. “Quality issues may sometimes be evident without testing, such as changes in colour, smell, or thickness,” said Ntirenganya. In addition, the FDA’s affiliation with WHO’s surveillance system helps identify products flagged in other countries, ensuring they are not on Rwanda’s market. The process of recalling a certain product may also start to be considered when people raise alarm about it. 2. How do substandard products make it to the Rwandan market? Despite the FDA’s preventative measures, some substandard medicines make it to the Rwandan market, sometimes due to untested batches at import. “Not every batch is tested,” Ntirenganya said. As such, some faulty batches can end up in the country. Ntirenganya pointed out that post-marketing surveillance, supported by public reporting, helps identify quality problems after distribution, leading to recalls that protect consumers from potential harm. Decisions to recall also depend on rigorous testing and reports from healthcare facilities, post-marketing data, and information shared through World Health Organization (WHO)’s global surveillance and monitoring system, as noted by FDA. 3. What are the types of recalls? The recall process follows classifications based on the severity of quality issues; Class one for products posing serious health risks, Class one for temporary or reversible adverse effects, and Class three for minor issues like labelling errors. 4. Compensation for affected parties The FDA mandates that importers, wholesalers, and retailers establish compensation mechanisms for recalled products. “Affected facilities are required to return products to suppliers, who can then seek refunds from manufacturers or distributors. They are given compensation in terms of replacements, refunds, or credit notes,” explained Ntirenganya. ALSO READ: Rwanda FDA on measures to prevent reappearance of banned products However, several challenges complicate Rwanda FDA's work in monitoring and intercepting substandard medicines. “Since we rely heavily on imported medical products, the potential for substandard items remains high,” he noted. 5. People advised to report suspicious products To encourage vigilance, Rwandans are advised to report any adverse events experienced after taking medicines. Several reporting channels have been availed by the FDA including a toll-free number, online reporting systems, and a mobile application. The FDA established a structured process for receiving and analysing these reports, with a national pharmacovigilance committee of medical experts who support the analysis of complex cases and recommend appropriate actions or risk mitigation, said Ntirenganya. He also emphasized that awareness among the public about reporting issues is limited, resulting in occasional delays in identifying problematic products. To counter this, Rwanda is piloting a track-and-trace system designed to link products with their origins through technology, helping to detect counterfeit medicines early.
