While Sub-Saharan Africa bears the highest HIV burden globally and is home to almost 65% of all people living with HIV, for decades, access to HIV treatment across the African region depended almost entirely on imports of lifesaving drugs and diagnostic tests manufactured thousands of miles away. 

To boost supply chain resilience and regional self-reliance, WHO’s Global HIV, Hepatitis and Sexually Transmitted Infections Programmes Department, in collaboration with the Regulation and Prequalification Department, has been actively advocating for locally manufactured quality-assured medicines and diagnostics. This work is carried out in close partnership with countries, manufacturers in Africa and partners such as the Global Fund and Unitaid. 

In 2023, Universal Corporation Ltd (UCL), a Kenya-based pharmaceutical company led by Mr Palu Dhanani, became the first African manufacturer to receive WHO prequalification to produce tenofovir disoproxil fumarate, lamivudine and dolutegravir (TLD), a WHO-recommended first-line antiretroviral therapy for HIV infection.

“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. Regulation and prequalification are not just technical processes; they are catalysts for health sovereignty and timely access to lifesaving medicines and diagnostics,” said Dr Rogerio Gaspar, WHO Director for Regulation and Prequalification.