25 Jun Protecting Patients: Ensuring Safe, Quality and Effective Health Products
Since its establishment in 2018, the South African Health Products Regulatory Authority has maintained a strong focus on patient safety as a central pillar of its mandate. In terms of the Medicines and Related Substances Act, 1965 (Act 101 of 1965), the Authority is responsible for ensuring that medicines, medical devices, and other health products available in South Africa meet the required standards of safety, quality, and efficacy. Concurrently, SAHPRA is tasked with facilitating timely access to these products, thereby balancing rigorous regulatory oversight with the need to ensure that patients receive essential treatments without undue delay. This balanced approach is fundamental to sustaining public confidence in the national healthcare system.
The safety of patients comes first
The launch of the National Action Plan on substandard and falsified (SF) medical products is both a lifeline for our people and a blueprint for Africa. Through strong collaboration, SAHPRA has addressed challenges of fragmented approaches and created a unified approach, ensuring that all families, from rural health facilities to urban pharmacies, have access to safe medicines. The NAP will detect and remove counterfeit medicinal products and empower communities to report threats, enabling them to actively protect their health.
SAHPRA takes a proactive approach by establishing effective monitoring, enhancing regulatory systems, and conducting inspections to ensure regulated entities comply with safety standards. Our focus areas include good manufacturing, clinical, laboratory, distribution, warehouse, and vigilance practices.
Universal access to safe and quality medicinal products forms the cornerstone of effective public health protection
The South African Health Products Regulatory Authority (SAHPRA) has partnered with the United States Pharmacopeia (USP) to strengthen regulatory systems in South Africa. This collaboration aims to ensure the safety, quality, and efficacy of medicines, medical devices, and in vitro diagnostics across the country. Through a Memorandum of Understanding, USP will support SAHPRA’s efforts to achieve World Health Organization (WHO) Maturity Level 4, the highest standard for regulatory performance according to the WHO Global Benchmarking Tool (GBT). This will help improve access to essential health products and enhance oversight of the local manufacturing sector. The collaboration also supports SAHPRA’s broader regulatory harmonisation agenda, including risk-based inspections, post-market surveillance, and strengthened quality control systems for health products.
It further advances regional cooperation to improve access to quality-assured health products and support innovation across Africa.
A Clarion Call to Support the National Action Plan
In September 2025, South Africa launched its National Action Plan (NAP) to combat the persistent threat of substandard and falsified medical products, marking a major step towards strengthening public health protection and regulatory oversight. The South African Health Products Regulatory Authority (SAHPRA), in partnership with the National Department of Health and the World Health Organization (WHO), introduced the plan to address a crisis that continues to endanger lives. According to WHO, at least one in ten medical products in low and middle-income countries, including South Africa, is substandard or falsified. These products contribute to treatment failure, severe health complications, and thousands of preventable deaths each year.
Globally, falsified medicines are estimated to cost health systems over US$30 billion annually, while also increasing financial pressure on already burdened households in South Africa.
No Compromises on Regulatory Compliance
In recent months, SAHPRA has made critical regulatory decisions to ensure access to quality-assured medical products and to protect vulnerable communities from falsified or substandard health products. One example is the recall o specific batches of Citro-Soda Regular products following the identification of a potential risk of foreign material contamination during an inspection at the Adcock Ingram facility in Clayville, Johannesburg, along with broader quality concerns, including non-compliance with Good Manufacturing Practices (GMP); this precautionary action underscores SAHPRA’s commitment to protecting public health and ensuring that all health products meet required safety, quality, and efficacy standards.
Another example involves a medical product found to contain selenium-zinc picolinate. SAHPRA requested that health professionals cease all distribution, sale, and dispensing of, and remove all selenium and zinc picolinate-containing products intended for children from stores, storage facilities, and shelves.
The role of media in creating awareness about falsified and substandard medicines
The media plays a vital role in creating awareness about the increase in Substandard and falsified medical products. By leveraging its mass communication platforms, the organisation maximises its share of voice, extending its reach and enhancing consumer education on falsified and substandard medical products. SAHPRA identifies the media as a vital stakeholder, working in close partnership to distribute information and warnings, empower the public, and spotlight risks to public health.
Report unsafe or non-compliant health products to SAHPRA
To ensure SAHPRA is accessible to the public and enable South Africans to report non-compliance and falsified medical products, a range of communication channels are available for public engagement and feedback.
- https://medsafety.sahpra.org.za and report any unusual side effects.
- General Enquiries: enquiries@sahpra.org.za
- Adverse Side Effects: Download the MedSafety App through this link
