South Africa Launches Africa’s First National Plan to Combat Fake Medicines

South Africa has taken a pioneering step in protecting public health with the launch of Africa’s first comprehensive National Action Plan (NAP) aimed at tackling the growing threat of substandard and falsified medical products (SFMPs). The initiative was officially unveiled by Health Minister Dr. Aaron Motsoaledi at a ceremony held at the Protea Hotel OR Tambo Airport on Tuesday.

Safeguarding Medicines, Vaccines, and Health Products

In his address, Dr. Motsoaledi reaffirmed his department’s unwavering commitment to ensuring that all medicines, vaccines, and health products in South Africa are safe, effective, and of the highest quality. He stressed that counterfeit and poor-quality medicines not only endanger lives but also undermine the credibility of entire health systems worldwide.

“Substandard and falsified medical products are a threat to individual lives and the integrity of health systems globally,” the Minister warned.

Global Threat, African Burden

The World Health Organisation (WHO) has estimated that SFMPs contribute to a significant number of deaths globally each year, though many cases remain undetected. The problem is particularly severe in Africa, where a large percentage of SFMPs found globally are present.

This situation, Motsoaledi noted, poses a direct obstacle to achieving Sustainable Development Goal 3 (SDG 3), which seeks to guarantee universal access to healthcare. In addition to health risks, he said, the spread of fake medicines results in serious economic losses, compounding the challenges faced by developing economies.

Collaborative Approach to Regulation and Enforcement

The new NAP was developed by a multi-stakeholder committee in line with the WHO’s draft handbook pilot, marking the conclusion of its trial phase. The plan is designed to strengthen South Africa’s health product regulatory systems and provide a framework for:

• Enhancing technical capacity in medicine regulation,

• Strengthening collaboration across the supply chain,

• Improving vigilance at key points, from ports of entry to post-market surveillance,

• Conducting inspections of manufacturers, distributors, and wholesalers,

• Training both public and private sector actors to detect and report suspicious products.

The South African Health Products Regulatory Authority (SAHPRA) played a central role in developing the NAP, working alongside the Department of Health and the WHO.

Rising Incidents and Regional Concerns

The launch comes against a backdrop of rising concern. At the Fifth Ordinary Session of the African Union Specialised Technical Committee on Health, Population, Nutrition, and Drug Control in Ethiopia last year, delegates expressed alarm at the growing prevalence of SFMPs across the continent.

The WHO’s Global Surveillance Monitoring System has recorded an increase in reported SFMP cases from Africa in recent years. A tragic example occurred in October 2022, when the deaths of several children in The Gambia were linked to falsified medicines.

“These incidents highlight the urgency of protecting the medicine supply chain,” Dr. Motsoaledi said. “The launch represents a milestone in protecting the integrity of South Africa’s health system and medicines supply chain.”

Leadership Role in Africa and Beyond

By leading this initiative, South Africa positions itself as a continental leader in combating fake and substandard medicines. Dr. Motsoaledi expressed gratitude to the WHO for selecting the country to pilot the NAP.

He also announced that South Africa will present the initiative at the 14th Member State Mechanism on Sustainable Financing, scheduled to take place in November 2025 in Geneva, Switzerland.

“This network is about protecting public health by sharing knowledge, resources, and best practices,” he said. “It will strengthen our health system and safeguard the lives of our people.”

Looking Ahead

With the successful launch of the NAP, South Africa is expected to serve as a model for other African countries, demonstrating how strong regulation, international collaboration, and community vigilance can come together to combat SFMPs. The initiative not only strengthens public health systems but also reaffirms South Africa’s leadership role in building safer, more resilient healthcare across the continent.