Fake Medicines in SA: When Inequality Becomes Fatal

South Africa's fake medicine crisis is not just a regulatory failure. It is the predictable outcome of a healthcare system designed under Apartheid to serve the few, leaving the majority to fend for themselves in the shadows of the black market.

The Human Cost of a Broken System

Anna* knew the risks. She knew the unregulated injections she was buying from an unregistered seller could be dangerous, even deadly. But she had already lost 30kg on GLP-1 RA medicines prescribed by her doctor for insulin resistance, and the impact on her body, her life, and her self-esteem had been massive.

When global shortages hit GLP-1 RA stocks in local pharmacies, brands like Ozempic and Mounjaro vanished from shelves. Anna turned to the black market. For around R1 650, a fancy-looking box with a three-month supply arrives at her door in a small cooler box.

I knew then already that what I was buying was unregulated and potentially inferior or even dangerous, but I was finally starting to feel good about myself.

She tried to do it the right way. But regulated products were out of stock, prohibitively expensive, and came with stigma from pharmacists who quizzed her on whether she deserved the treatment.

If I could have kept doing it the proper way, I would have, but there were just too many obstacles.

Anna's story is not an anomaly. It is a symptom of a system that has never been built to serve Black and poor South Africans adequately.

A Crisis Hitting Black Communities Hardest

Weight-loss medicines are only one category of health products frequently purchased outside formal channels, according to the South African Health Products Regulatory Authority (Sahpra). The others tell a damning story about who bears the brunt of this crisis.

Commonly affected products include painkillers, antibiotics, sexual enhancement products, skin-lightening products, and chronic medicines. These are products that prey on the anxieties and vulnerabilities of communities historically denied access to quality healthcare, communities still living in the shadow of Apartheid's deliberate neglect.

Mokgadi Fafudi, Sahpra manager of regulatory compliance, confirms the scope of the problem. The numbers are staggering. Sahpra's 2021/2022 annual report recorded 101 health product quality complaints. By 2022/23, that figure nearly tripled to 297. In 2024/2025, the organisation received 588 reports of possible non-compliance. For 2025/26, that number already exceeds 570 cases.

But these figures are almost certainly a fraction of the real problem.

The Global Picture, The Local Pain

The World Health Organisation estimates that one in 10 medicines in low- and middle-income countries are substandard or falsified. A 2024 report from the WHO's Global Surveillance and Monitoring System confirms that all regions are affected and seeing increases.

Faridun Nazriev, external relations and communications officer at the WHO Country Office in South Africa, calls combating substandard and falsified medical products one of the urgent global challenges of this decade.

The WHO distinguishes between substandard products, which fail to meet quality standards due to poor manufacturing or inadequate quality control, and falsified products, which deliberately misrepresent their identity, composition, or source for financial gain.

Dr Andy Gray, a senior lecturer in Pharmacology at UKZN and co-director of the WHO Collaborating Centre for Pharmaceutical Policy and Evidence-Based Practice, cautions against confusing these with compounded medicines, which are custom formulations for specific patients, or generic medicines, which have been tested and approved by Sahpra as safe and effective alternatives to originator medicines.

Gray also notes that the WHO no longer uses the term counterfeit, as it refers specifically to intellectual property breaches like trademarks, not patient safety.

Porous Borders, Broken Promises

Fentse Maseko, who works in the Department of Pharmacology and Pharmacy at Wits University and has researched this issue extensively, points to the structural drivers. In many low- and middle-income countries, particularly in remote and underserved areas, limited access to medicines forces patients into informal markets. In South Africa, porous borders and rising costs compound the problem.

Let us be clear about what this means. The majority of South Africans, Black South Africans, still live in areas where accessing a properly stocked pharmacy is a luxury. The legacy of the Group Areas Act and the deliberate underdevelopment of Black communities under Apartheid did not disappear in 1994. It simply evolved.

The sale of substandard and falsified medicines thrives in this gap between constitutional promise and lived reality. Fafudi confirms these medicines are sold through informal markets, unregulated outlets, online platforms, and cross-border smuggling networks.

But Gray warns the problem reaches deeper than street vendors. These medications may be infiltrated into wholesalers or state medicine depots, then distributed. They may be sold directly to pharmacies or prescribers and then sold to patients. The infiltration of the formal supply chain is particularly alarming for a public healthcare system meant to serve the poorest.

The Consequences Are Devastating

Refiloe Mogale, executive director for the Pharmaceutical Society of South Africa (PSSA), does not mince words.

Substandard and falsified medicines are a serious threat to patient safety and public trust. These products can lead to treatment failure, harm, or even death.

Maseko warns that substandard antibiotics fuel the growing crisis of antimicrobial resistance. When first-line treatments fail because the medicine was fake, patients need more expensive second or third-line treatments, further straining a public healthcare system already buckling under the weight of historical neglect.

Regulation: Too Little, Too Slow

Sahpra conducts post-market surveillance and inspections, runs a whistleblower reporting system, manages product recalls, and monitors illegal advertising and online sales. It works with specialised units in the South African Police Service and customs on joint operations conducted at least monthly.

There are legal consequences too. Under the Medicines and Related Substances Act 101 of 1965, fines or prison sentences of up to 10 years can be imposed.

But the PSSA says this is nowhere near enough.

Key gaps are visible in insufficient regulatory capacity, weak border control, limited enforcement scale and the under-resourced National Action Plan. The system is overwhelmed by the speed and sophistication of the problem.

Gray agrees, calling for Sahpra to move from a largely reactive stance to a more proactive one, sampling medicines from the distribution chain and submitting them for checking, then reporting findings to the public.

What Needs to Change

The PSSA recommends implementing a national medicine registry with a track-and-trace system and stricter control of online medicine sales, including mandatory certification and monitoring.

Sahpra says future plans include strengthening supply chain traceability, enhancing detection systems, regulating online medicine sales, and increasing public awareness campaigns.

A National Action Plan, launched late last year by Sahpra with support from the national Department of Health and the WHO, aims to equip all actors within the supply chain with the knowledge, skills, and equipment to identify and report suspicious products.

Health Minister Aaron Motsoaledi said at the launch that all activities should mitigate the risk of substandard and falsified medical products, from increased vigilance at ports of entry through to post-market surveillance of high-risk products and inspection of manufacturers, distributors, and wholesalers.

On a global scale, Nazriev says the WHO prioritises prevention, detection, and response, including local regulation and cross-border collaboration, given the transnational nature of supply chains and criminal networks.

Structural Change, Not Just Warnings

Sahpra advises the public to buy only from licensed and authorised pharmacies and healthcare providers, to be cautious of unusually low prices, miracle cure claims, and poor packaging, and to always check packaging and expiry dates. Suspicious products can be reported on the Sahpra website. Jas Bhana, chief executive of the Innovative Pharmaceutical Association of South Africa, adds that the public can also report to the national Department of Health or their nearest pharmacy.

But individual vigilance is not a substitute for structural change. Maseko emphasises that consumer awareness must go hand in hand with systemic reform.

The reality is that as long as quality healthcare remains a privilege rather than a right in South Africa, as long as the pharmaceutical industry prioritises profit over people, and as long as the infrastructure of care in Black communities remains underfunded and overlooked, the black market will continue to fill the void.

Whether the National Action Plan and Sahpra's promises will translate into meaningful change for people like Anna remains to be seen. What is certain is that without confronting the root causes of inequality, the fake medicine crisis will only deepen.