South Africa pioneers first African plan to combat fake medicines
South Africa, in partnership with the World Health Organisation (WHO) and led by the South African Health Products Regulatory Authority (SAHPRA), has officially launched Africa’s first comprehensive National Action Plan (NAP) to combat Substandard and Falsified (SF) medical products.
Health Minister Dr Aaron Motsoaledi addressed the gathering via Zoom, stating that the government of South Africa, in collaboration with the WHO and led by SAHPRA, is conducting a pilot on the NAP, a member-state mechanism whose success will inform the rollout of the NAP handbook to all UN Member States.
He stated that the NAP is a coordinated five-year strategy to strengthen prevention, detection, and response mechanisms in tackling SF medical products, a growing global threat to patient safety and the integrity of the health system.
He added that WHO defines falsified medical products as deliberately misrepresenting their identity or source and lacking regulatory approval, and that substandard products are authorised medicines that fail quality standards due to poor manufacturing or quality control.
According to Motsoaledi, both can lead to treatment failure, increased drug resistance, and compromised patient safety.
“A significant percentage of substandard and falsified products circulating globally are found in Africa,” Motsoaledi stated.
“This is a serious public health concern that threatens progress towards Sustainable Development Goal 3, which aims for universal health access.”
He noted that WHO assessments using the Global Benchmarking Tool highlight the urgent need to strengthen market surveillance and control functions.
“All parties across the supply chain must be equipped to identify and report suspicious products to SAHPRA,” he said.
South Africa’s pilot project, guided by the WHO Draft Handbook on combating SF medical products, tested practical measures along the supply chain.
The minister said it involved a multisectoral Steering Committee and Technical Working Groups with representatives from government, regulators, law enforcement, academia, industry, and patient groups.
“I commend the collaborative effort of SAHPRA and WHO,” said Motsoaledi
“The lessons learned have refined the plan to be operationally feasible and context-specific. This launch marks a key milestone in safeguarding South Africa’s health system and medicines supply.”
He added that the launch also aims to mobilise political, technical, and financial support for the plan’s implementation.
“Sustained, coordinated action is critical. Regulators across Africa and globally will be watching South Africa’s implementation closely.”
Dr Boitumelo Semete-Makokotlela, CEO of the National Action Plan, highlighted increasing reports of SF medical products through WHO’s Global Surveillance Monitoring System.
“The rise in incidents threatens public health and economic stability,” she said.
“SAHPRA investigations surged from 130 in 2021/2022 to 430 in 2023/2024, with 507 preliminary cases in 2024/2025.”
She warned about dangerous, falsified products confiscated by enforcement agencies, including those containing unapproved Glucagon-Like Peptide-1 (GLP-1) for weight loss, illicit sexual enhancers, skin bleaching creams with corticosteroids, and anabolic steroids.
“These substances require proper market authorisation, which they lack,” Semete-Makokotlela noted.
“The pilot strengthens national capacity and feeds into WHO’s global learning,” she said, emphasising the need for political will, adequate resources, and cross-sector cooperation.
South Africa chairs the WHO Governance Working Group of the Member State Mechanism on SF medical products and leads the SADC SF Focal Points Committee.
The country will present pilot outcomes at the 14th MSM meeting in Geneva in November 2025.
“This initiative places South Africa among the first countries globally to operationalise a comprehensive strategy against substandard and falsified medical products,” said Motsoaledi.
thabo.makwakwa@inl.co.za
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