HARGEISA — The Somaliland Quality Control Agency has suspended the sale, distribution and use of two pharmaceutical products manufactured by YENISOM Healthcare, a Mogadishu-based drug manufacturer, citing the company’s failure to comply with mandatory quality assurance procedures for pharmaceutical products.
The two medicines specifically named in the order are YENIPROFEN, which is Ibuprofen 400mg, and YENIXIUME, which is Esomeprazole 40mg.
The agency stated that the reason for the suspension is that the drugs did not undergo the compulsory verification and quality assurance procedures required for products entering Somaliland’s markets. The order did not indicate that the drugs had been found to be harmful to health or of poor quality. The suspension was attributed to procedural and quality-check failures, which is distinct from a confirmed health risk.
YENISOM Healthcare is a pharmaceutical manufacturer based in Mogadishu, established in February 2022, and produces a variety of generic medicines.
The decision comes as Somalia has been expanding domestic pharmaceutical production in recent years, highlighting the importance of aligning licensing, quality control and market access systems across different Somali regions.
There has been no official response from YENISOM Healthcare directly addressing the suspension. The company, however, states on its official website that it operates according to international standards in pharmaceutical production and quality assurance.
The case raises questions about whether the company’s products have been licensed and quality-checked by federal regulatory bodies, and whether YENISOM will take steps to meet the requirements set by the Somaliland Quality Control Agency.
The Federal Government has been working to strengthen medicine regulation through the establishment of the National Medicines Regulatory Authority (NMRA), with the Minister of Health reaffirming the ministry’s commitment to operationalize the interim NMRA to ensure that all Somalis have access to safe, quality medicines. The NMRA’s role is crucial in improving the healthcare system and guaranteeing the availability and accessibility of regulated and effective medicines across the country.
The Federal Government has previously announced plans to regulate the importation of medical products and medicated cosmetics, requiring importers to apply for registration, permit licenses, and inspection services, and to adhere to quality control standards.
The government has also taken steps to address the issue of increasing addiction and misuse of prescription drugs, with the Ministry of Health planning to license doctors to prescribe drugs and requiring hospitals to submit the names of pharmacists and pharmacy technicians for licensing.
Critical Note
The suspension of YENISOM Healthcare’s products in Somaliland highlights the challenges of regulatory coordination across Somalia’s divided administrative landscape. While Somaliland operates its own quality control mechanisms, the absence of a unified federal regulatory framework for pharmaceuticals creates uncertainty for manufacturers seeking to access markets across the country. This incident also underscores the importance of strengthening quality assurance systems for locally produced medicines, as Somalia seeks to reduce its reliance on imported pharmaceuticals and build domestic manufacturing capacity. The government would be well advised to work towards harmonising regulatory standards across all regions to ensure that patients have access to safe, quality-assured medicines, regardless of where they are produced or distributed.
