The Senegalese National Assembly's parliamentary mission has published a report on its investigation into the commercialization of SOFTCARE brand products in the country. Established in May 2026, the mission was tasked with examining the inspections conducted by the Senegalese Agency for Pharmaceutical Regulation (ARP) between October and December 2025. The investigation aimed to document the facts surrounding the inspections, which revealed critical non-conformities, including expired raw materials and inadequate storage conditions.
The ARP conducted three inspections in 2024 and 2025, uncovering significant discrepancies in the management of raw materials and the absence of a responsible pharmacist during certain periods. The inspections led to the destruction of 2,260 kg of expired raw materials. The reports also highlighted shortcomings in the traceability of raw materials and storage conditions. These findings prompted successive decisions to withdraw and then reintroduce products to the market, sparking internal divisions within the ARP and a communication crisis.
The parliamentary mission carried out contradictory hearings with all stakeholders, analyzed inspection reports, technical documents, and other relevant records. The investigation revealed inadequacies in raw material management, inconsistencies in inspection reports, and dysfunctionalities in the decision-making process and interinstitutional coordination. Although the available evidence does not conclusively prove the use of expired raw materials in the manufacturing process, the mission concluded that serious risks exist, justifying the need for strengthened regulatory frameworks, industrial practices, and institutional governance.
The mission identified gaps in interinstitutional coordination between the ARP, the Ministry of Health, and the Ministry of Trade. These gaps contributed to the crisis and highlighted the need for improved communication and cooperation. The report emphasized that the current regulatory framework requires enhancement to prevent similar issues in the future. The mission's recommendations prioritize the adoption of the implementing decree for Law No. 2023-06, strengthening inspection powers, and formalizing the ARP's internal decision-making process.
Key recommendations from the mission include bolstering the ARP's inspection capabilities and ensuring a more transparent and accountable decision-making process. The report also stresses the importance of enhanced coordination among relevant institutions to ensure effective regulation and oversight of the pharmaceutical industry. By implementing these recommendations, the Senegalese authorities aim to mitigate risks and improve the quality of healthcare products available to the public.
The parliamentary mission's report has been made public, and its findings are expected to inform policy decisions and regulatory reforms in the pharmaceutical sector. The Senegalese government has been urged to take prompt action to address the identified gaps and ensure that the necessary measures are in place to safeguard public health. The report's release marks a significant step towards increased transparency and accountability in the country's pharmaceutical industry.
The investigation into SOFTCARE brand products is part of a broader effort to enhance regulatory oversight and ensure compliance with international standards in Senegal's pharmaceutical sector. The ARP and other relevant institutions are expected to work together to implement the mission's recommendations and strengthen the country's regulatory framework. By doing so, they aim to improve the quality and safety of healthcare products available to the Senegalese population.
Key points
- Critical non-conformities, including expired raw materials and inadequate storage conditions, were found during inspections of SOFTCARE brand products.
- The parliamentary mission recommended strengthening regulatory frameworks, industrial practices, and institutional governance to mitigate risks and improve public health.
- Enhanced interinstitutional coordination and communication are necessary to ensure effective regulation and oversight of the pharmaceutical industry in Senegal.
