South Africa Launches National Action Plan to Tackle Fake Medical Products

In a landmark move to strengthen public health protection and ensure access to safe and effective medicines, South Africa has launched its National Action Plan (NAP) to combat the growing threat of substandard and falsified medical products. The plan, unveiled on 30 September 2025, represents a major milestone in safeguarding national health security and advancing regional regulatory cooperation across Africa.

The South African Health Products Regulatory Authority (SAHPRA) spearheaded the initiative in partnership with the National Department of Health and the World Health Organization (WHO). Together, they aim to combat what has been called a "silent epidemic" — the proliferation of counterfeit and poor-quality medical products that endanger lives and erode public trust in health systems.

A Persistent and Deadly Challenge

According to WHO estimates, one in every ten medical products circulating in low- and middle-income countries (LMICs) is either substandard or falsified. These products lead to treatment failures, drug resistance, and thousands of preventable deaths every year. Economically, they cost global health systems an estimated US$30.5 billion annually, while exacerbating the financial strain on patients and national health budgets.

In South Africa, the problem is particularly alarming, with counterfeit medicines often sold as treatments for HIV, tuberculosis, malaria, and chronic illnesses. These fraudulent products undermine years of public health progress, threatening disease control programs and putting vulnerable populations at risk.

Three Pillars: Prevention, Detection, and Response

The new NAP introduces a three-pronged strategy designed to eliminate falsified and substandard medicines through:

1. Prevention — strengthening surveillance at ports of entry, regulating online pharmacies, and improving supply chain integrity.

2. Detection — enhancing laboratory capacity, data sharing, and rapid testing capabilities for early identification of fake medicines.

3. Response — ensuring swift enforcement through regulatory, judicial, and law enforcement mechanisms, and promoting public reporting and awareness.

The strategy is anchored in the WHO's draft Handbook on Prevention, Detection, and Response to Substandard and Falsified Medical Products, which serves as the global blueprint for tackling counterfeit drugs through coordinated, evidence-based approaches.

A Milestone for Africa's Health Security

At the official launch in Johannesburg, the event brought together senior government officials, regulatory authorities, international organizations, health professionals, law enforcement agencies, civil society, and the pharmaceutical industry. The unified turnout reflected a shared recognition that tackling fake medicines requires a whole-of-society effort.

"This launch is more than a milestone — it is a lifeline for our people and a blueprint for Africa," said Dr Boitumelo Semete-Makokotlela, CEO of SAHPRA. "Through unwavering collaboration, we've transformed a fragmented challenge into a unified front, ensuring that every family, from rural clinics to urban pharmacies, can access medicines they can trust."

Dr Semete-Makokotlela emphasized that the NAP will not only detect and destroy counterfeit products but also empower communities to report suspicious drugs, turning ordinary citizens into "active guardians of public health."

A Whole-of-Government Approach

Minister of Health Dr Aaron Motsoaledi commended the inter-agency collaboration that made the NAP possible. "Fake medicines don't discriminate! They strike the poorest the hardest, stealing futures from our children and hope from our elders," he said. "No single entity can win this war alone. South Africa stands ready to lead, but we triumph together — protecting every African life from this scourge."

The NAP establishes mechanisms for stronger collaboration between regulators, police, customs authorities, the judiciary, and pharmaceutical companies to ensure counterfeit products are intercepted before reaching patients.

It also seeks to strengthen partnerships with regional regulatory bodies, including those under the African Medicines Agency (AMA) and the Southern African Development Community (SADC), to harmonize regulatory frameworks and promote cross-border enforcement.

WHO's Support and Global Alignment

The World Health Organization played a pivotal role in the development of the plan, ensuring alignment with international standards and providing technical, operational, and strategic guidance.

Ms Shenaaz El-Halabi, WHO Country Representative for South Africa, hailed the NAP as a turning point in the fight against counterfeit medicines. "The launch of South Africa's National Action Plan marks a pivotal step in strengthening health systems and safeguarding public health. It reinforces public trust in institutions and demonstrates the power of multi-sectoral collaboration," she said.

At the global level, Mr Hiiti Sillo, WHO Unit Head for Regulation and Safety, praised South Africa's leadership in piloting the WHO Handbook framework. "These products steal trust, waste resources, and most tragically, cost lives," he said. "By investing in strong regulatory systems and coordinated national action, we are laying the foundation for safer healthcare and restoring confidence in the medicines people depend on every day."

Empowering Communities and Building Trust

Beyond enforcement, the NAP also focuses on public education and community engagement. Awareness campaigns will target both healthcare professionals and consumers, encouraging them to verify medical products and report suspicious cases.

A major goal of the NAP is to empower patients to make informed choices and restore confidence in the healthcare system, which has been undermined by the spread of falsified drugs.

The plan calls for integrating reporting tools into digital health platforms, establishing a centralized surveillance database, and improving coordination among laboratories, health facilities, and law enforcement agencies.

A Model for Regional and Global Action

South Africa's initiative sets a precedent for other African countries seeking to strengthen pharmaceutical governance and combat medical counterfeiting. The NAP aligns with the African Union's Pharmaceutical Manufacturing Plan for Africa and the Sustainable Development Goals (SDG 3.8), which aim for universal access to safe, effective, and affordable essential medicines.

By implementing a comprehensive national framework, South Africa is helping to build the continent's collective regulatory resilience, advancing the WHO's vision of ensuring that all people have access to quality-assured, effective medical products.

Toward a Safer Future

The NAP's rollout marks the beginning of a coordinated national effort that could transform public health protection across South Africa and beyond. It combines regulatory innovation, community participation, and international cooperation to eliminate the circulation of dangerous counterfeit medicines.

As Dr Semete-Makokotlela aptly stated, "The NAP is not just a document — it is a promise that every medicine reaching our people will be safe, effective, and worthy of their trust."

Through this initiative, South Africa sends a powerful message across the continent: health security begins with integrity in the medicine supply chain — and no compromise can be tolerated when lives are at stake.