Africa’s health leap forward: First locally made HIV drugs reach Mozambique

Sub-Saharan Africa has achieved a pivotal milestone in health independence with the introduction of locally manufactured HIV medicines and diagnostic tests into national programs.

For the first time, Mozambique is receiving African-produced HIV treatment, marking a significant step for a region that shoulders nearly 65% of the global HIV burden and has historically relied on imported antiretroviral drugs and testing kits.

HIV, a virus that compromises the immune system’s ability to combat infections and certain cancers, can progress to AIDS, its most severe stage, without timely treatment. On Friday, the World Health Organization (WHO) announced that Universal Corporation Ltd, a Kenyan pharmaceutical company, became the first African manufacturer to earn WHO prequalification for producing tenofovir disoproxil fumarate, lamivudine, and dolutegravir (TLD), a key first-line HIV therapy.

In a groundbreaking move, the Global Fund, a global partnership funding responses to HIV, tuberculosis, and malaria, has begun procuring this African-made TLD for Mozambique.

“This procurement is a landmark achievement in strengthening Africa’s health supply chains,” said Dr. Meg Doherty, Director of WHO’s Global HIV Programmes.

“It ensures uninterrupted access to vital medicines, improving outcomes for people living with HIV.”

The WHO emphasized that this development aligns with efforts to enhance local production and access to critical health technologies across Africa.

The agency has been collaborating with countries, manufacturers, and global health partners like the Global Fund and Unitaid to build quality-assured manufacturing capacity. “Local production of high-quality health products is a pressing priority,” stated Rogerio Gaspar, WHO Director for Regulation and Prequalification.

“Each African manufacturer meeting WHO standards brings us closer to a self-reliant and equitable health system.”

However, the WHO cautioned that production alone isn’t enough. Sustainable progress requires robust market commitments, fair procurement policies, and ongoing technical support.

The agency also highlighted a critical gap in diagnostics, as shifting donor funding threatens HIV testing programs, which are essential for prevention and treatment.

In a parallel effort, Codix Bio, a Nigerian diagnostics company, has secured a sublicense to produce rapid HIV diagnostic tests.

“Locally made rapid tests will enhance affordability and address supply chain challenges, reducing delays in access to diagnostics,” Doherty noted.

The WHO is also urging countries to adopt cost-effective, WHO-prequalified rapid HIV tests as the first step in national testing protocols to maintain service delivery while cutting costs.

While this milestone signals significant progress, the WHO stressed the need for further action. “Locally produced TLD is a major stride, but we must do more to ensure sustainable health solutions for Africa,” the agency stated.