SAHPRA affirms quality of cancer medicines

The South African Health Products Regulatory Authority (SAHPRA) says all anti‑cancer medicines available in South Africa meet national standards for quality, safety, and efficacy. The statement follows a Lancet Global Health study that found poor‑quality oncology drugs in countries such as Ethiopia, Kenya, Malawi, and Cameroon.

According to SAHPRA spokesperson Yuven Gounden, a comprehensive internal review concluded that no registered cancer medication in South Africa was affected by the findings:

“SAHPRA is satisfied that the marketed and registered cancer medicines meet the appropriate specifications… no substandard cancer medicines were detected.”

The Lancet Global Health investigation assessed 251 samples from four sub-Saharan countries, analysing packaging, labelling, visual appearance, and measuring active pharmaceutical ingredients (APIs). The failure rate for drug samples, according to the Medical Brief, ranged between 14% and 24%, primarily due to incorrect API levels (ranging from 28% to 120% of the expected content). Experts say that visual inspection alone identified just one in ten faulty samples, underscoring the need for stronger drug quality checks.

 

According to the Mail & Guardian, the study’s alarming results are consistent with broader data indicating up to 10% of medicines in LMICs, and potentially higher in Africa, are substandard or falsified, posing a serious public health risk.

SAHPRA, established in 2018 to unify South Africa’s drug regulation, replaced the former Medicines Control Council and Radiation Control Division. Its responsibilities—mandated by the Medicines and Related Substances Act—include regulating and licensing all health products, and overseeing drug safety via scientific evaluation protocols.

The authority is investing in regulatory capacity building for Africa, including training programs focused on safety, efficacy, and quality, ensuring member states like Namibia and Kenya can strengthen their regulatory systems, Eyewitness News reports. South Africa itself has achieved WHO regulatory maturity level 3, a benchmark shared by only eight African nations, indicating a well-functioning and integrated regulatory authority.

Access to reliable, effective cancer drugs is already constrained in much of Africa. With oncology medicines representing a small fraction of pharmaceutical markets, but accounting for the highest price tags and largest access gaps, regulatory failures can have devastating consequences.

SAHPRA’s assurance comes at a critical moment—it underscores the importance of robust regulatory oversight and collaborative regional frameworks in protecting patient health across the continent.

Meanwhile, cancer patients in Namibia who require specialised radiation therapy no longer have to travel to South Africa, following the 2015 opening of the Namibian Oncology Centre, which is equipped with the country’s first Elekta digital linear accelerator.