Kenya-based firm emerges first African manufacturer of WHO pre-certified HIV medicine

Sub-Saharan Africa has taken a cautious but critical step toward greater health self-reliance as locally produced HIV medicines and diagnostic tests began reaching national programmes.
This includes for the first time, procurement of African-made treatment for Mozambique.
The development marks a milestone for a region that bears nearly 65 per cent of the global HIV burden and has long depended on imports of lifesaving anti-retroviral medicines and testing kits.
The human immunodeficiency virus (HIV) weakens the body’s immune system, reducing its ability to fight infections and certain cancers.
Without timely intervention, it can progress to acquired immunodeficiency syndrome (AIDS), the most advanced stage of infection.
The World Health Organisation in a statement on Friday said that a Kenya-based pharmaceutical company, Universal Corporation Limited, became the first African manufacturer to receive WHO prequalification to produce HIV medicine.
The company received prequalification to produce tenofovir disoproxil fumarate, lamivudine and dolutegravir (TLD); a first-line anti-retroviral therapy for HIV.
Now, in a major step forward, the Global Fund; a worldwide partnership financing HIV, tuberculosis and malaria responses is procuring the locally produced HIV treatment for Mozambique, making it the first time African-manufactured TLD has been deployed through this channel.
“The procurement of the African-manufactured first-line HIV treatment by the Global Fund for Mozambique is a great milestone towards strengthening supply chain systems in Africa. This will contribute to better health outcomes for people living with HIV who need uninterrupted medicine supplies,” said the Director of WHO’s Global HIV Programmes, Meg Doherty.
WHO stated that the achievement was part of a broader push to bolster local production capacity and improve access to essential health technologies across Africa.
The UN agency has been partnering with countries, manufacturers and global health organisations including the Global Fund and Unitaid to expand quality-assured African manufacturing.
“Local production of quality-assured health products is an urgent priority. With every African manufacturer that meets WHO prequalification standards, we move closer to a more self-reliant, resilient and equitable health system,” noted the WHO Director for Regulation and Prequalification, Rogerio Gasper.
Despite the milestone, WHO cautioned that production alone was not enough. To ensure long-term sustainability, the agency called for advanced market commitments, fair procurement policies and ongoing technical support.
WHO also pointed to diagnostics as a critical gap. With shifting donor funding, many countries are under pressure to maintain HIV testing programmes, which are the frontline of prevention and treatment.
In a related effort, Codix Bio, a Nigerian diagnostics company, recently received a sublicence to manufacture rapid diagnostic tests for HIV.
Locally produced HIV rapid tests will help increase affordability, and address supply chain vulnerabilities and delays
“Having locally produced HIV rapid tests will help increase affordability, and more broadly address supply chain vulnerabilities and delays in access to diagnostics,” said Ms Doherty.
As part of its guidance, the UN health agency is also encouraging countries to adopt low-cost, WHO-prequalified rapid HIV tests, especially as the first test in national algorithms, which can significantly cut costs while maintaining service delivery.
While the latest update marks tangible progress, more action is needed.
“Locally manufactured TLD is a major step towards that goal,” WHO said, adding that more action was needed.
(NAN)
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