The South African Health Products Regulatory Authority (SAHPRA) has moved to reassure the public following the publication of a study in The Lancet Global Health that revealed the presence of substandard anti-cancer medications in several sub-Saharan African countries. The study, published in the July 2025 edition of the journal, investigated the quality of seven chemotherapy drugs in Ethiopia, Kenya, Malawi, and Cameroon.
The medicines examined in the study included cisplatin, oxaliplatin, methotrexate, doxorubicin, cyclophosphamide, ifosfamide, and leucovorin. However, SAHPRA emphasized that the brands identified in the study are neither registered nor marketed in South Africa.
“SAHPRA is committed to the three pillars of quality, safety, and efficacy,” said Dr. Boitumelo Semete-Makokotlela, CEO of SAHPRA. “I am satisfied that our rigorous regulatory processes have borne fruit and that all patients, especially cancer patients, can rest assured that their health and well-being are not compromised.”
Under South African law, all medicines must meet strict standards as outlined in the Medicines and Related Substances Act 101 of 1965 and its General Regulations. This includes mandatory batch testing before release and additional post-importation testing for foreign-manufactured drugs.
In response to the study, SAHPRA initiated internal checks to determine whether any South African-registered cancer medicines containing the same active pharmaceutical ingredients (APIs) might be affected. The agency confirmed that none of the locally registered or marketed cancer drugs were implicated in the findings.
SAHPRA also conducts ongoing risk-based post-market surveillance, which includes sampling and testing of high-risk medical products. According to the authority, these measures have proven effective in ensuring that cancer medications available in South Africa meet all required specifications.
The findings from The Lancet Global Health have raised concerns about the broader issue of medicine quality in low- and middle-income countries, where regulatory oversight may be limited. However, SAHPRA’s proactive stance and robust regulatory framework appear to have shielded South African patients from the risks identified in the study.
As cancer rates continue to rise across the continent, the assurance of safe and effective treatment options remains a critical public health priority. SAHPRA’s response underscores the importance of strong regulatory systems in safeguarding patient health.
