Antiretroviral Generics in Africa: How Local Production Is Transforming HIV Treatment Access

For years, millions of people living with HIV in Africa relied on medicines shipped from halfway across the world. Tablets made in India, packed in boxes, cleared customs, and traveled through long, fragile supply chains just to reach a clinic in rural Mozambique or a township in Nigeria. That system worked - barely. But it was never sustainable. Then, in May 2025, everything changed. For the first time in history, the Global Fund bought HIV treatment made in Africa. Not just any treatment - TLD, the current gold-standard antiretroviral combo of tenofovir, lamivudine, and dolutegravir - produced by a Kenyan company, Universal Corporation Ltd. And it wasn’t a test run. It was enough to treat over 72,000 people a year.

Why Local Production Matters More Than Ever

Sub-Saharan Africa carries 65% of the world’s HIV cases, yet produces less than 3% of its own medicines. That gap isn’t just a statistic - it’s a lifeline problem. When the pandemic hit, borders closed. Air cargo stalled. Countries scrambled. Some ran out of ARVs for months. People stopped taking their pills. Viral loads rose. Resistance grew. The system didn’t just break - it exposed how dangerous it is to depend on others for your survival.

Local production flips that script. When medicines are made in Africa, for Africa, supply chains shrink. Delivery times drop from months to weeks. Costs fall because you cut out shipping, tariffs, and middlemen. And when a country makes its own drugs, it gains control. No more waiting for donors to decide what’s available. No more price shocks from global markets. This isn’t just about HIV. It’s about health sovereignty.

The TLD Breakthrough: What Changed in 2023 and 2025

The real turning point came in 2023, when Universal Corporation Ltd became the first African manufacturer to get WHO prequalification for TLD. That’s not just a badge. It’s the gold standard. WHO prequalification means the drug meets the same quality, safety, and effectiveness benchmarks as those made in the U.S. or Europe. It’s the green light the Global Fund, UNICEF, and other major buyers need before they spend a single dollar.

Before this, African countries had two choices: expensive brand-name drugs or cheap generics from India. The Indian generics brought prices down from $10,000 per patient per year in 2000 to under $100 by 2015. Huge win. But India’s production wasn’t built for Africa’s needs. It didn’t account for regional drug resistance patterns. It didn’t respond quickly to spikes in demand. And when global supply chains got disrupted, Africa was last in line.

Now, with TLD made in Kenya and shipped directly to Mozambique, the model is different. It’s predictable. It’s faster. It’s owned. The Global Fund didn’t just buy medicine - it bought confidence in African manufacturing. And that’s what’s starting to change everything.

Who’s Building the Future - And Where

Kenya isn’t alone. Nigeria’s Codix Bio just started making HIV rapid diagnostic tests after receiving a technology transfer from SD Biosensor, backed by WHO’s Health Technology Access Programme. That’s huge. You can’t treat what you can’t detect. Now, clinics in rural areas can test and start treatment in the same visit - no need to send samples to Lagos or Abidjan.

South Africa is moving fast too. In October 2025, it became the first African country to register the twice-yearly HIV injection, cabotegravir long-acting (CAB LA). Six local companies got licenses from Gilead to make generic versions. Experts say prices could drop 80-90% once generics hit the market. That means more people can get the treatment - and stick with it. No more daily pills. Just two shots a year. That’s life-changing for someone who works long hours, travels often, or lives far from a clinic.

And it’s not just ARVs. Gilead is working with the U.S. State Department and the Global Fund to supply lenacapavir, a new long-acting PrEP drug, at no profit until generics are ready. They’re submitting regulatory applications in 18 high-burden countries by the end of 2025. That’s not charity - it’s strategy. They’re creating a bridge to local production.

The Numbers Don’t Lie - But They’re Still Not Enough

Let’s put this in perspective. Africa needs about 15 million person-years of first-line ARV treatment every year. Right now, African-made generics cover maybe 1-2% of that. The Global Fund’s first TLD order? Enough for 72,000 people. That’s a drop in the ocean - but it’s the first drop that matters.

The African Union’s Pharmaceutical Manufacturing Plan for Africa (PMPA) wants to get local production up to 40% by 2040. That’s ambitious. And it’s possible - but only if three things happen: better regulation, more investment, and stronger markets.

Right now, every African country has its own drug approval process. One drug approved in South Africa might take two years to get cleared in Nigeria. Harmonizing those rules is the next big challenge. Then there’s money. Building a factory that meets WHO standards costs tens of millions. Who pays? The Gates Foundation, Unitaid, and CIFF are stepping in with market-shaping funds - but it’s not enough. African governments need to invest too. Not just in factories, but in training pharmacists, inspectors, and lab technicians.

What’s Next? The Long-Term Vision

This isn’t just about HIV anymore. It’s about building a system that can respond to the next pandemic, the next outbreak, the next health crisis. When you have labs that can make ARVs, you can make vaccines. When you have supply chains that move medicines fast, you can move insulin, antibiotics, or maternal health drugs too.

And it’s not just about making pills. It’s about making knowledge. African scientists are starting to lead clinical trials for drugs tailored to regional strains of HIV. That’s something no Indian or Western lab could do as well. Because the virus evolves differently here. The people’s needs are different. The access barriers are different. Local production means local research. And that’s where real innovation happens.

By 2030, experts predict African-made ARVs could cover 20-30% of the continent’s needs. That’s not the finish line - it’s the starting line. The goal isn’t just to replace imports. It’s to build an industry that creates jobs, trains engineers, powers innovation, and gives Africa control over its own health future.

Challenges Still Loom

Don’t get it twisted - this isn’t a fairy tale. There are still big problems. Regulatory systems are slow. Power outages shut down factories. Skilled workers leave for better pay abroad. Some governments still buy cheaper, lower-quality imports because they’re easier to get through procurement systems.

And let’s not forget: even with local production, you still need funding. The Global Fund and PEPFAR aren’t going away. But the goal is to make Africa less dependent on them - not to replace them. It’s about shifting from aid to partnership.

Integration is another hurdle. HIV programs have run in silos for decades. Nurses trained only on ARVs. Labs only for HIV testing. Clinics don’t talk to maternal health units. The future means combining HIV services with diabetes care, TB treatment, and mental health support - all under one roof. That’s more efficient. And it’s cheaper.

Why This Is a Game Changer

Twenty years ago, an HIV diagnosis in Africa was a death sentence. Today, it’s a manageable condition - thanks to antiretrovirals. But access was always the bottleneck. Now, the bottleneck is breaking.

The fact that a Kenyan company made a drug that met WHO standards and got bought by the Global Fund? That’s historic. It tells African manufacturers: you can compete. It tells African governments: you can lead. It tells people living with HIV: your treatment doesn’t have to come from someone else’s country.

This isn’t just about pills. It’s about dignity. About self-reliance. About a continent finally writing its own health story - not just reading someone else’s.