SA Launches National Action Plan to Combat Substandard Medical Products


Kempton park: Health Minister Dr Aaron Motsoaledi has reaffirmed his department’s commitment to ensuring that all medicines, vaccines, and health products are safe, effective, and of the highest quality. The Minister was speaking at the launch of Africa’s first comprehensive National Action Plan (NAP) aimed at combating the serious threat posed by substandard and falsified medical products (SFMP) at the Protea Hotel OR Tambo Airport, Kempton Park, Gauteng.



According to South African Government News Agency, this initiative positions the country as a leader on the continent in the fight against fake and poor-quality medicines. The Minister emphasised that this plan is crucial in the effort to protect innocent lives. ‘Substandard and falsified medical products are a threat to individual lives and the integrity of health systems globally,’ said Motsoaledi.



The World Health Organisation (WHO) estimates that SFMP contribute to a significant number of deaths worldwide each year, many of which go undetected. The South African Health Products Regulatory Authority (SAHPRA), in collaboration with the Department of Health and the WHO, officially unveiled this landmark NAP. The NAP was developed by a multistakeholder committee following the guidelines of the WHO’s draft handbook pilot. This launch signifies the conclusion of the pilot phase, allowing the WHO to implement the handbook across all Member States.



According to Motsoaledi, a large percentage of SFMP found worldwide are present in Africa, raising substantial public health concerns. The Minister believes that this situation poses challenges to achieving Sustainable Development Goal (SDG) 3, which aims to ensure universal health access for all. He stated that the development of the NAP provides a framework for addressing the threat of SFMPs. In addition, it supports the enhancement of technical capacity and fosters collaboration among all stakeholders involved in the manufacture, importation, distribution, and supply of medical products.



‘All actors within the supply chain, particularly at key pinch points in both the public and private sectors, must be equipped with the knowledge, skills, and equipment to identify and report suspicious products to SAHPRA. All activities should mitigate the risk of SFMP. This includes increased vigilance at ports of entry, through to post-market surveillance of high-risk products, inspection of manufacturers, distributors and wholesalers.’



During the Fifth Ordinary Session of the African Union Specialised Technical Committee on Health, Population, Nutrition, and Drug Control, held in Ethiopia last year, Motsoaledi said delegates expressed concern regarding the growing prevalence of SFMP on the continent. He stressed that this poses a serious threat to public health and also causes significant economic losses throughout Africa.



Meanwhile, the number of incidents involving SFMP reported from Africa through the WHO Global Surveillance Monitoring System has been increasing over the years. According to the Minister, in October 2022, several children’s deaths in Gambia were linked to SFMP. ‘The launch represents a milestone in protecting the integrity of South Africa’s health system and medicines supply chain. The network that strives to protect public health by sharing knowledge, resources, and best practices for the betterment of our health system.’



He expressed his gratitude to the WHO for selecting South Africa for this opportunity. The Minister announced that South Africa is prepared to present this pilot initiative in collaboration with the 14th Member State Mechanism on Sustainable Financing, scheduled for November 2025 in Geneva, Switzerland.