By Dr Abdullahi Ali Noor (Ameriko) - Pharmaceutical Regulatory Expert
Introduction
Somalia faces critical gaps in pharmaceutical regulation and education, creating systemic vulnerabilities that undermine drug quality, patient safety, and national health outcomes. Despite rapidly growing healthcare needs, the country lacks a functional medicines regulatory agency and accredited academic programmes to support the development of the human capital needed to run a professional regulatory agency.
These gaps enable the widespread circulation of substandard and counterfeit products, weak pharmacovigilance systems, limited laboratory testing capacity, and fragmented drug governance. Challenges are further exacerbated by porous borders, unregulated imports, and insufficient oversight of medical devices and advanced therapeutic products.
Historically, Somalia has never had a fully functional Medicines Regulatory Agency since its independence in 1960. Between 1960 and 1969, the Ministry of Health oversaw the importation of medicines, which largely depended on donor countries and institutions.
There was no official local pharmaceutical manufacturing during this time, and the skilled workforce was mainly educated abroad. There was no significant change in the pharmaceutical sector during the 1969–1990 period.
However, in 1989, a law was passed and signed by the President to regulate the importation and registration of medicines. This was Law No. 9, dated 26 January 1989, consisting of seven articles. Article 4 specifically addressed the registration of medicines and the establishment of a registration committee within the Ministry of Health. Unfortunately, the civil war erupted shortly thereafter, and the law was never implemented.
In the aftermath of the civil war, Somalia, as a fragile state, struggled with fragmented governance, weak regulatory oversight, limited human resource capacity, and the widespread circulation of substandard and falsified medical products.
It was not until 19 February 2023 that the Federal Government of Somalia, through the Ministry of Health and Human Services, established an interim National Medicines Regulatory Agency (iNMRA), using Law No. 9 as its legal basis. This followed a series of attempts by previous governments to rebuild health institutions, policies, and international collaborations.
A fully functional NMRA is essential, as pharmaceutical regulation and education form the backbone of an effective health system. Evidence consistently shows that countries with strong regulatory authorities and well-trained pharmaceutical professionals achieve higher levels of drug quality assurance, improved patient safety, and better health outcomes.
According to the World Health Organization (2017), in fragile states such as Somalia, one in every ten medicines circulating in the market is either falsified or substandard. More alarming estimates from the AUDA-NEPAD / African Medicines Regulatory Harmonisation (AMRH) Programme (2023–2024) suggest that between 40 and 60 percent of medicines in fragile states fall into this category.
Peer-reviewed studies published in 2020 support these findings. Given Somalia’s three decades of institutional collapse, it is reasonable to conclude that substandard and falsified medicines have caused immense harm. In the absence of formal mortality and morbidity data, it is widely believed that more Somalis have suffered from unsafe medicines than from bullets and bombs.
Somalia’s pharmaceutical market remains dominated by unregulated imports, informal distribution networks, and inconsistent quality-control practices. These systemic weaknesses pose severe public-health risks in a country burdened by infectious diseases, maternal mortality, and chronic illnesses.
Addressing these challenges requires credible investment in higher education, accredited pharmacy programmes, specialised pharmaceutical laboratories, and a fully operational NMRA.
This article examines the structural gaps in Somalia’s pharmaceutical regulatory and educational landscape and proposes a strategic framework aligned with regional and global best practices.
2. Weak or Non-Functional Medicines Regulatory Authority
To date, Somalia does not have a fully functional National Medicines Regulatory Agency capable of overseeing the pharmaceutical market in all its dimensions. An effective NMRA is expected to regulate medicines, medical devices, vaccines, and advanced therapies, tasks that require a highly qualified workforce and modern regulatory technologies.
Unregulated Pharmaceutical Market
Key challenges include porous borders that allow uncontrolled imports, widespread circulation of falsified and substandard medicines, lack of enforcement of Good Distribution Practices (GDP), and the proliferation of informal retail pharmacies staffed by untrained personnel.
Limited Laboratory and Diagnostic Capacity
Somalia lacks accredited, GMP-compliant laboratories capable of testing medicines before importation and during post-market surveillance. This severely undermines quality assurance and regulatory enforcement.
Misalignment with Regional Harmonisation Efforts
More from Somalia
In an increasingly globalised pharmaceutical market, Somalia remains largely disconnected from regional and international regulatory harmonisation initiatives such as the African Medicines Agency (AMA), joint dossier review mechanisms, and collaborative arrangements with bodies such as the EMA, MHRA, and FDA.
3. Health Impact
The consequences of counterfeit and falsified medicines are often life-altering and, in many cases, fatal. These harms extend across generations. Key impacts include treatment failure, particularly with antibiotics that fuel antimicrobial resistance (AMR). According to WHO estimates, AMR directly caused 1.27 million deaths and contributed to nearly five million deaths globally in 2019.
Substandard and falsified medical products also increase disease prevalence, erode public trust in health systems, and impose significant economic burdens. Families spend scarce resources on ineffective medicines, endure prolonged hospital stays, and face escalating healthcare costs. Globally, an estimated USD 30.5 billion is wasted annually on falsified medicines.
4. Absence of Accredited Pharmaceutical Education Programmes
Education is the foundation of any sustainable sector. Somalia, however, lacks accredited academic programmes in pharmacy, pharmaceutical sciences, regulatory affairs, and pharmacovigilance. This has resulted in a severe shortage of pharmacists, pharmacy technicians, quality-control analysts, regulatory specialists, and pharmacovigilance professionals, further weakening regulatory capacity and health-system resilience.
To be continued — Part II will examine the economic costs of weak regulation and outline a strategic reform pathway.
References
• World Health Organization (2017). Global Surveillance and Monitoring System for Substandard and Falsified Medical Products.
• AUDANEPAD / African Medicines Regulatory Harmonisation (AMRH) Programme (2023–2024).
• WHO (2024). Substandard and Falsified Medical Products: Global Estimates and Impact.
• Peerreviewed studies on substandard medicines in fragile states (2020).
• Law No. 9 of 1989, Government of Somalia.
** Dr Abdullahi Ali Noor (Ameriko) is a pharmaceutical regulatory expert with over 25 years’ experience in European/USA Regulatory. He writes about civic education.
**The opinion expressed in this article are those of the author and do not necessarily reflect the views of Dawan Africa.
