For the first time in history, Africa is producing its own life-saving HIV drugs
On May 6, 2025, a shipment left a factory in Kenya bound for Mozambique. It wasn’t just another box of medicine. It contained the first-ever antiretroviral generics made in Africa and approved by the World Health Organization for use across the continent. The drug? TLD - a single pill combining tenofovir, lamivudine, and dolutegravir. It’s the current gold standard for first-line HIV treatment. And for the first time, it was made not in India or Europe, but right here on African soil.
This isn’t a small win. It’s a turning point. For decades, African countries relied on imported medicines - mostly from India - to keep millions alive. But supply chains broke during the pandemic. Delays happened. Stockouts became common. And when people couldn’t get their meds, the virus came back stronger. Now, with local production, that’s starting to change.
Why African-made drugs matter more than ever
Sub-Saharan Africa carries 65% of the world’s HIV cases - but only 17% of the global population. That means the need is enormous. In 2023, over 28 million people in the region were living with HIV. About 83% of them were on treatment. That’s progress. But it’s not enough. To reach the UNAIDS goal of 95-95-95 - meaning 95% know their status, 95% are on treatment, and 95% have the virus suppressed - Africa needs more than just pills. It needs control over its own supply.
Before 2025, African nations imported around 80% of their medicines. That made them vulnerable. A shipping delay in Mumbai could mean a clinic in Lusaka runs out of drugs for weeks. A price hike in Switzerland could force governments to cut treatment programs. Local production fixes that. It cuts out middlemen, shortens delivery times, and brings costs down.
And it’s not just about money. It’s about dignity. When a country can make its own medicines, it doesn’t have to beg for aid. It builds its own health sovereignty.
The breakthrough: TLD made in Kenya
The star of this shift is Universal Corporation Ltd, a pharmaceutical company based in Nairobi. In 2023, it became the first African manufacturer to get WHO prequalification for TLD. That’s not easy. WHO prequalification means the drug meets the same strict standards as those made in the U.S., EU, or Japan. No shortcuts. No compromises.
By May 2025, Universal had produced enough TLD to treat over 72,000 people a year. That’s not the full need - Africa requires about 15 million person-years of first-line ARVs annually - but it’s a start. And it’s the signal the Global Fund needed. For the first time ever, the Global Fund to Fight AIDS, Tuberculosis and Malaria bought African-made ARVs. Not as a pilot. Not as a token. As a core part of its procurement strategy.
Dr. Ussene Hilário Isse, Mozambique’s Minister of Health, put it plainly: “Africa’s growing capacity to locally produce lifesaving medications marks a strategic shift for our continent.”
How did this happen? The players behind the change
This wasn’t magic. It was a coordinated push.
- The Global Fund committed to buying African-made ARVs - creating predictable demand so manufacturers could invest in scaling up.
- WHO provided technical support to help African labs meet international quality standards.
- Unitaid, the Gates Foundation, and CIFF funded new manufacturing plants and trained local workers.
- The Medicines Patent Pool helped transfer technology from big pharma to African firms, letting them legally produce generics without lawsuits.
And then there’s Gilead Sciences - the company that originally developed dolutegravir and cabotegravir. Instead of fighting generics, they licensed them. In July 2025, Gilead announced voluntary licenses with 133 countries, including all of Sub-Saharan Africa. That means companies in Nigeria, South Africa, and Kenya can now legally make generic versions of long-acting injectables like cabotegravir - a twice-yearly shot that’s changing how people stay protected.
Long-acting injections: The next frontier
For years, HIV treatment meant taking a pill every day. That’s hard. Miss a dose, and the virus can start to resist the drugs. Now, there’s a better option: long-acting injectables.
South Africa became the first African country to register the twice-yearly cabotegravir injection in October 2025. It’s a game-changer. One shot every six months. No daily reminders. No stigma tied to picking up pills. And now, six African companies have licenses to make their own versions. Experts predict prices could drop 80-90% below the brand-name cost once generics hit the market.
Even more impressive? Gilead is giving away lenacapavir - a new, ultra-long-acting PrEP drug - at no profit until generics can take over. They’re working with PEPFAR and the Global Fund to get it to 2 million people in high-burden countries by 2026. This isn’t charity. It’s strategy. They’re helping build a market so African manufacturers can eventually take over.
It’s not just pills - diagnostics are getting local too
Getting the medicine is only half the battle. You need to know who needs it.
In Nigeria, Codix Bio received a license from SD Biosensor - with support from WHO’s Health Technology Access Programme - to make HIV rapid diagnostic tests right in Lagos. These are the same finger-prick tests used in rural clinics. Now, they’re being made locally. That means faster delivery, lower prices, and no risk of expiration during long shipments.
This is the full picture: local production isn’t just about pills. It’s about diagnostics, supply chains, training, and regulation. It’s about building an entire ecosystem.
Progress - but the gap is still huge
Let’s be clear: Africa is not yet self-sufficient.
Current African production covers less than 5% of the continent’s ARV needs. The African Union’s Pharmaceutical Manufacturing Plan for Africa (PMPA) wants to raise that to 40% by 2040. That’s ambitious. To get there, three things are critical:
- Regulatory harmonization - Right now, each country has its own drug approval process. That slows things down. Countries need to recognize each other’s approvals.
- Investment in infrastructure - Factories need clean rooms, stable power, cold storage, and trained staff. That costs money.
- Market incentives - If governments don’t commit to buying local, manufacturers won’t invest. The Global Fund’s move is a model. Others need to follow.
And then there’s the challenge of integration. HIV services still often run in separate silos - clinics for HIV, clinics for TB, clinics for malaria. That’s inefficient. The future is integrated health systems where one visit can check for HIV, test for syphilis, and give a vaccine.
What’s next? The road to 2030
By 2030, African-made antiretroviral generics could supply 20-30% of the continent’s needs. That’s not 100%. But it’s enough to make a real difference.
It means fewer stockouts. Fewer delays. Fewer deaths. It means a young woman in rural Malawi can get her TLD pill from a warehouse in Kampala, not a warehouse in Mumbai. It means a man in Kinshasa can get his long-acting injection from a local pharmacy, not a foreign donor program.
And it means something deeper: Africans are no longer just recipients of global aid. They’re makers. Innovators. Leaders in their own health response.
The Global Fund’s Grant Cycle 7 (GC7) will soon announce which countries get priority for African-made ARVs. That’s the next step. More countries. More factories. More people treated.
This isn’t just about HIV. It’s about building a health system that can handle the next pandemic - whether it’s Ebola, Lassa fever, or something new. If Africa can make its own HIV drugs, it can make its own vaccines. Its own antibiotics. Its own future.
FAQ
Are African-made HIV drugs safe?
Yes. All African-made antiretroviral generics must pass WHO prequalification, which requires meeting the same strict standards as drugs made in the U.S., EU, or Japan. Universal Corporation’s TLD, for example, was tested for purity, potency, and stability in independent labs. There’s no difference in safety or effectiveness compared to imported versions.
Why was India the main source before?
India became the global hub for generic HIV drugs because it had strong manufacturing capacity, lower labor costs, and legal flexibility to produce generics before patents expired. In 2000, a year of HIV treatment cost $10,000. By 2015, Indian generics brought it down to under $100. But reliance on India created supply risks - especially during global crises like COVID-19 - which is why Africa is now building its own capacity.
What’s the difference between TLD and older HIV drugs?
TLD combines three drugs in one pill: tenofovir, lamivudine, and dolutegravir. Dolutegravir is a newer drug that works better, has fewer side effects, and is harder for the virus to resist. Older regimens used drugs like efavirenz, which caused dizziness, depression, and sleep problems in many patients. TLD is now the global standard for first-line treatment in low-income countries.
Can African countries make other medicines too?
Yes. The same factories and skills used for HIV drugs can be scaled to produce malaria treatments, TB drugs, antibiotics, and vaccines. Nigeria is already making rapid diagnostic tests. Kenya is expanding into insulin production. The goal isn’t just HIV - it’s building a continent-wide pharmaceutical industry that can meet most of Africa’s health needs.
How much do African-made ARVs cost?
The cost of TLD from African manufacturers is under $30 per person per year - similar to Indian generics. But the real value isn’t just price. It’s reliability. Local production means shorter supply chains, fewer delays, and less risk of expired stock. For governments, that means fewer wasted resources and more people staying on treatment.
Is this just a donor-driven project?
No. While international partners like the Global Fund and WHO provided funding and technical help, the push came from African governments and manufacturers. Kenya, Nigeria, South Africa, and Rwanda have all invested in their own regulatory agencies and factories. This is African-led. Donors are supporting, not directing.
What’s stopping faster growth?
Three things: lack of harmonized regulations across countries, insufficient investment in infrastructure like reliable power and cold storage, and inconsistent government purchasing commitments. If every African country committed to buying 20% of its ARVs locally, manufacturers could scale up faster. Right now, progress is strong but uneven.