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

For decades, Africa relied on medicines made halfway across the world to fight HIV. Pills shipped from India, packed in crates, delayed by customs, and priced beyond reach for many. But something changed in May 2025. For the first time ever, the Global Fund bought an HIV treatment made in Africa - not imported, not copied from overseas, but grown from African labs, factories, and expertise. The medicine? TLD - a single pill combining tenofovir, lamivudine, and dolutegravir. Made by Universal Corporation Ltd in Kenya, it’s now reaching people in Mozambique, and it’s not a one-off. It’s the start of a revolution.

Why African-Made HIV Pills Matter

Sub-Saharan Africa carries 65% of the world’s HIV cases. Yet, until recently, it imported about 80% of its medicines. That’s not just expensive - it’s dangerous. When global supply chains broke during the pandemic, clinics ran out of antiretrovirals. Patients missed doses. Viral loads spiked. Resistance grew. The system wasn’t just broken - it was fragile by design.

African-made antiretrovirals fix that. When a pill is produced in Nairobi, Lagos, or Cape Town, it doesn’t need to cross oceans. It doesn’t sit in warehouses for months. It gets to clinics faster, cheaper, and more reliably. And it’s not just about speed - it’s about control. When African manufacturers make the drugs, they can tailor formulations to local needs. No more unused tablets. No more side effects that don’t match the population. This is medicine built for African bodies, African climates, and African health systems.

The TLD Breakthrough: A New Standard

TLD isn’t just any HIV pill. It’s the current gold standard for first-line treatment. Compared to older regimens, dolutegravir - the key ingredient - works better, causes fewer side effects, and blocks resistance more effectively. Before TLD became widely available in Africa, many patients were stuck on older drugs that required multiple pills a day, had harsh side effects like dizziness and weight gain, and were easier for the virus to outsmart.

Universal Corporation Ltd became the first African company to get WHO prequalification for TLD in 2023. That’s not easy. WHO prequalification means the product meets the same strict quality, safety, and effectiveness standards as drugs made in the U.S. or Europe. It’s the green light the Global Fund needs to buy it. And in May 2025, they did - ordering enough TLD to treat over 72,000 people in Mozambique every year.

This wasn’t luck. It was strategy. The Global Fund didn’t just hand out money - they created predictable demand. They told manufacturers: ‘We’ll buy this, if you make it right.’ That gave companies the confidence to invest in factories, hire engineers, train quality control teams, and upgrade labs. For the first time, African pharmaceutical companies weren’t just suppliers - they were partners in global health.

From Pills to Diagnostics: Building the Whole System

Getting the pills is only half the battle. You also need to know who has HIV, and whether the treatment is working. That’s where diagnostics come in.

Codix Bio, a Nigerian company, is now manufacturing HIV rapid diagnostic tests under a license from SD Biosensor, with support from WHO’s Health Technology Access Programme and the Medicines Patent Pool. These tests - small strips that give results in 20 minutes - used to be imported from Asia. Now, they’re being made in Lagos. That means more testing centers, faster results, and fewer people lost in the system.

This isn’t just about HIV. It’s about building infrastructure that can respond to future outbreaks. The same labs that test for HIV can test for tuberculosis. The same supply chains that deliver pills can carry malaria drugs. The same workers trained to handle sterile production can make vaccines. Africa isn’t just fixing one disease - it’s building a health system that can stand on its own.

Nigerian technician holding an HIV test strip, with medical icons floating around them.

The Long-Acting Future: Injections That Last Six Months

What if you didn’t have to take a pill every day? What if one injection could protect you from HIV for six months?

That’s now a reality. In October 2025, South Africa became the first African country to register cabotegravir long-acting - a twice-yearly injection for HIV prevention and treatment. It’s a game-changer for people who struggle with daily pills - teenagers, truck drivers, sex workers, people in remote villages.

And here’s the best part: six African manufacturers have already been licensed by Gilead to make generic versions. Experts predict these generics could cost 80-90% less than the brand-name version. That means this life-changing treatment won’t just be available - it’ll be affordable.

Gilead is also expanding access to lenacapavir, a newer long-acting drug for pre-exposure prophylaxis (PrEP). They’ve signed deals with the U.S. State Department and the Global Fund to supply it at no profit until generics arrive. By the end of 2025, 18 high-burden African countries will have regulatory approval. By 2026, it’ll be widely available.

The Numbers Don’t Lie

In 2010, 1.3 million people died from AIDS-related causes globally. In 2022, that number dropped to 630,000 - a 52% decline. Why? Because more people got on treatment.

In Eastern and Southern Africa, 93% of people living with HIV know their status. 83% are on treatment. 78% have suppressed viral loads - meaning they can’t transmit the virus. In Western and Central Africa, those numbers are lower - 81%, 76%, 70% - but still improving. These aren’t abstract stats. These are people living full lives, raising kids, working, thriving.

But demand is huge. Africa needs about 15 million person-years of first-line ARVs every year. Right now, African manufacturers can cover a fraction of that. But new factories are coming online by the end of 2025. With support from Unitaid, the Gates Foundation, and CIFF, production capacity is set to triple in the next three years.

Teenager receiving a long-acting HIV injection, with a glowing six-month timer above their arm.

Challenges Still Remain

This progress isn’t automatic. It’s hard-won.

Regulatory systems across Africa still vary. What’s approved in Kenya might take years to clear in Nigeria. Harmonizing standards is slow. Funding is uneven. Some governments still prefer to buy cheaper, older drugs from India rather than invest in local production - even if those drugs are less effective.

And while TLD is a breakthrough, it’s still just one drug. We need more. More formulations. More combinations. More drugs for children, pregnant women, and people with drug-resistant HIV.

The African Union’s Pharmaceutical Manufacturing Plan for Africa (PMPA) aims to raise local production from 2-3% to 40% of the continent’s needs by 2040. That’s ambitious. But it’s possible - if countries keep investing, if donors keep backing manufacturers, and if African leaders prioritize health sovereignty over short-term cost savings.

What Comes Next?

The next step? African scientists leading research. Right now, most HIV treatments were designed in labs in the U.S. or Europe. They work - but they’re not always optimized for African populations. What if drugs were developed based on African genetic data? What if side effect profiles were studied in African clinics, not just in clinical trials abroad?

That’s the next frontier: Africanizing research and development. Not just making pills - designing them.

And integration. HIV programs have long operated in silos. Testing centers separate from clinics. Pharmacies disconnected from community health workers. The future lies in weaving HIV services into primary care - so that getting an HIV test is as normal as checking your blood pressure.

By 2030, African-made antiretrovirals could supply 20-30% of the continent’s needs. That’s not enough to end the epidemic - but it’s enough to make the system resilient. Enough to stop relying on distant factories. Enough to give millions of people not just medicine - but dignity, control, and hope.

This isn’t about charity. It’s about justice. It’s about saying: Africa doesn’t need to wait for permission to save its own people. It just needs the tools - and the trust - to do it.

Are African-made HIV generics as effective as those made in India or Europe?

Yes. All African-made antiretrovirals that are WHO-prequalified - like the TLD pill from Kenya - meet the same strict international standards for quality, safety, and effectiveness as drugs made anywhere else. WHO prequalification requires rigorous testing and inspections. The TLD pill used in Mozambique was tested against global benchmarks and found to be identical in performance. The difference isn’t in the medicine - it’s in the supply chain. Local production means faster delivery, lower cost, and more reliable stock.

Why did it take so long for Africa to start making its own HIV drugs?

For years, the global health system relied on low-cost generics from India, which drove prices down dramatically - from $10,000 per patient per year in 2000 to under $100 by 2015. That made it easy to outsource production. But this also discouraged investment in African manufacturing. Companies didn’t see a market. Governments didn’t prioritize local pharma. Patent barriers and lack of funding kept local startups from scaling. The shift began when donors like the Global Fund and Unitaid started guaranteeing purchases - creating stable demand. That gave African manufacturers the confidence to build factories, hire experts, and meet international standards.

Can African countries produce other medicines besides HIV drugs?

Absolutely. The same factories making TLD can produce malaria drugs, antibiotics, and vaccines. The same labs testing HIV samples can screen for tuberculosis. The same supply chains delivering ARVs can carry insulin or antihypertensives. The skills are transferable. Nigeria is already making rapid diagnostic tests. Kenya is expanding into hepatitis C treatments. South Africa is preparing to produce long-acting injectables. This isn’t just about HIV - it’s about building a foundation for full pharmaceutical self-reliance.

How are African manufacturers able to offer lower prices?

They cut out the middlemen. No shipping across oceans. No import taxes. No distributor markups. No currency fluctuations. Local production reduces logistics costs by 30-50%. Also, African manufacturers benefit from lower labor costs and direct government support. But the biggest factor is scale. As more factories open and production increases, prices will keep dropping. The goal isn’t just affordability - it’s sustainability. When African countries can produce their own medicines, they don’t have to wait for donor funding to restock.

What’s the biggest threat to this progress?

Complacency. Some governments still believe imported drugs are ‘safer’ or ‘better,’ even when local products are WHO-approved. Others lack the political will to invest in regulatory systems or offer incentives to manufacturers. Donor fatigue is another risk - if funding dries up before local industries are fully mature, progress could stall. The biggest danger isn’t technical - it’s political. Without sustained leadership from African governments and continued support from global partners, this momentum could fade.

4 Responses

Rachael Gallagher
  • Rachael Gallagher
  • November 25, 2025 AT 12:06

This is what happens when you stop begging for handouts and start building your own damn future. Africa didn’t wait for permission. They made the pill. And now the world has to pay attention.

steven patiño palacio
  • steven patiño palacio
  • November 25, 2025 AT 20:13

The real story here isn’t just the medicine-it’s the shift in power. For decades, African health was dictated by external actors. Now, African scientists, engineers, and manufacturers are setting the standard. This is sovereignty in action.

akhilesh jha
  • akhilesh jha
  • November 27, 2025 AT 03:18

I’ve seen the factories in Hyderabad. I’ve seen the labs in Nairobi. The difference isn’t in the chemistry-it’s in the context. This pill wasn’t designed for a Western clinical trial. It was designed for a mother in Maputo who walks three hours to the clinic. That changes everything.

Jeff Hicken
  • Jeff Hicken
  • November 28, 2025 AT 08:21

so like... they just made a pill and now everyone’s like WOW? what about the side effects? did they test it on actual people or just on paper? also why is everyone acting like this is the first time africa did anything? lol

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