Making medicines locally: quality and regulation

Where Xidig members may contribute

• Regulation: pharmacists and regulatory specialists supporting the regulator's guidelines, inspections and registration, through recognised programmes.
• Quality assurance: laboratory testing, sampling and post-market surveillance.
• Training: pharmacy education and continuing professional development.
• Data: a reliable picture of what medicines Somalia imports, from where, and at what price.
• Supply chain: storage, cold chain and distribution practice. See Cold chain for fish, milk and meat in Somalia for related skills.

Possible services, research, supplier or collaboration roles

• A market study of medicine imports by product and source country, using partner-country data.
• Quality testing: a survey of medicine quality on the Somali market, with the regulator.
• Registration support services for importers once rules are published, done transparently and without conflicts of interest.
• Training modules on good manufacturing, storage and distribution practice.

Who may find this useful

• Pharmacists, regulatory affairs specialists and quality managers, in Somalia and the diaspora.
• Importers and distributors preparing for new registration rules.
• Public-health researchers and students.
• Investors considering pharmaceutical manufacturing. This is not investment advice.

What a local maker would face

The law.

• Passed the lower house: the House of the People approved the Somalia Medicines Bill on 3 January 2026. "A total of 141 Members voted in favour, one Member abstained, and no votes were cast against" (NMRA).
• Still to come: "review and approval by the Upper House of Parliament and signature by the President". Xidig found no later announcement from the regulator or Parliament.
• Current basis: the regulator's website still cites "Law No. 9 of 1989", which "Regulates human medicines and medical devices in Somalia".
• Continental model: in December 2024 the bill was being aligned with "the African Union Model Law on Medical Products Regulation" (AUDA-NEPAD).

The regulator.

• Mandate: the NMRA lists "Inspection of manufacturing facilities, pharmacy outlets, and distribution channels", "Product evaluation, registration, Licensing and Market Surveillance and control" and "Quality control of medical products".
• Published rules: Xidig found no Somali GMP guideline, inspection procedure or registration guideline on the NMRA website.
• Interim powers: resolutions in December 2024 allowed the interim authority to "continue its regulatory activities, even before the Somali Medicines Bill is enacted" (AUDA-NEPAD).
• Import controls: a Ministry of Health directive announced in December 2024, effective 10 January 2025, gave the interim regulator import and export control and pre-shipment inspection, to "prevent substandard and falsified products from entering the market".
• International benchmark: WHO grades regulators on a maturity scale. Xidig found no published maturity level for Somalia. A 2024 journal article, citing a 2017 WHO/IGAD assessment, says only 16% of the indicators for a regulatory system were in place.

Regional links.

• Neighbouring regulators: AUDA-NEPAD and IGAD committed to "twinning programs with established regulatory authorities in Uganda, Rwanda, and Kenya". Kenya's Pharmacy and Poisons Board hosted a Somali delegation in September 2025 on product listing, licensing, import control and market surveillance.
• African Medicines Agency: on the African Union's treaty list dated September 2023, Somalia had not signed or ratified the treaty. By May 2026, 32 countries had ratified it. Xidig found no record of Somalia doing so.

Quality.

• A regional survey (samples from December 2018 to February 2019), covering Djibouti, Ethiopia, Kenya, Somalia, Sudan and Uganda, found that "21% of oxytocin injection samples tested did not meet quality specifications", while all amoxicillin samples passed (IGAD).
• Essential medicines: The most recent Essential Medicines List Xidig found (September 2026) dates from 2019.
• Pharmacovigilance: WHO supported a pharmacovigilance unit and adverse-reaction reporting in the federal Ministry of Health in 2019.

Where the 70% figures come from. The government's proposal says Somalia relies on imports for 70% of its essential medicines, and on the same page cites a 70% reliance on international and NGO sectors (see More about the source).

• WHO (2024) says "about 60–80% of the country's medicines are imported and distributed by the private sector".
• A health-sector investment case for 2022–2027 says "70 percent of the country's medicines are estimated to be delivered by the private sector" (Global Financing Facility).
• AUDA-NEPAD (2024) says "approximately 70% of medicines procured by the private sector are unregulated".
• None of these says exactly that 70% of essential medicines are imported. In our view, since there appears to be little or no local production, the real import share is likely higher than 70%.

Is anything made locally?

• A December 2024 journal article states: "There are no local pharmaceutical manufacturing companies in the country". Its authors write about "Somalia and Somaliland", so its geographic scope is not fully clear.
• Video reports of a "first pharmaceutical factory" in Mogadishu circulate online. Xidig could not confirm them from an official or wire-service source, so this report does not treat local production as established.

The market.

• Mirror data: UN trade data show India exported US$48.9M of pharmaceutical products to Somalia in 2025 (via Trading Economics).
• Somalia's own data: UNCTAD records Somalia's total pharmaceutical imports at only US$16.9M in 2024. That is less than India's reported exports alone, so it cannot be a complete total. WITS has no usable Somali import data.
• So: nobody can yet say reliably how big the market is, or which products a local plant should make first.

The workforce.

• A July 2026 commentary cites "a ratio of 0.02 pharmacists per 10,000 people", while noting "these data are now dated". It also cites a 2020 study in Mogadishu in which "only 12% of surveyed pharmacy staff were qualified pharmacists".

The continental picture. African countries import most of their medicines: more than 80% of pharmaceutical and medical consumables, according to an AUDA-NEPAD official writing in 2020. The African Union's Pharmaceutical Manufacturing Plan for Africa and the continental free trade area aim to give manufacturers bigger markets. The same official argued that countries need to "strengthen and harmonize their regulatory systems to assure the quality of medical products and ensure that local manufacturers adhere to international standards".

Dependencies and implementation constraints

• The law: final approval and commencement of the Medicines Bill.
• Published standards: GMP and registration rules, and a regulator able to inspect a factory.
• Market access: buyers such as the government and aid agencies usually require quality-assured products, often with international certification.
• Inputs: active ingredients and packaging are imported; power and water must be reliable.
• Skills: pharmacists, chemists and quality staff.

Risks and unknowns

• Building before the rules: a plant built before standards exist may not be able to sell to major buyers.
• Competition: imported generics are cheap, and a small plant may struggle on price.
• Quality failures: poor-quality local products would harm patients and trust.
• Unclear demand data, and an unclear 70% baseline.

Questions members should verify before acting

1. Has the Medicines Bill been approved by the Upper House and signed? When does it take effect?
2. What GMP, registration and inspection rules will apply to a local manufacturer?
3. Which products would the proposal make first, and who would buy them?
4. Where would the plant be, and who would run it?
5. What are the real import volumes for the products in question?

What is confirmed, and what isn't

Confirmed

• The House of the People's approval of the Medicines Bill on 3 January 2026, and the remaining steps.
• The regulator's stated mandate and its 1989 legal basis.
• The IGAD survey's quality findings and the 2019 Essential Medicines List.
• India's reported pharmaceutical exports to Somalia in 2025.

Our interpretation

• Regulation and quality assurance come before local production.
• The government's 70% figures probably come from estimates of the private sector's role, not of imports.

Not yet verified

• The Upper House vote and presidential assent.
• Any currently operating medicine factory in Somalia.
• Somalia's status with the African Medicines Agency in 2026.
• The total value of medicine imports.

Relevant next steps

• Follow the National Medicines Regulatory Authority for the Medicines Bill and new guidelines.
• Pharmacists and regulatory specialists: contact the regulator or recognised institutions about training or technical support.