The South African Health Products Regulatory Authority (SAHPRA) has clarified that recent findings published in The Lancet about substandard cancer drugs have no bearing on or relation to South African medications.
The Lancet Global Health 2025; 13: e1250 had published an investigational study on substandard anti-cancer medications in Sub-Saharan African countries, including Ethiopia, Kenya, Malawi and Cameroon, but as SAHPRA pointed out, this study did not include South Africa.
The seven medicines/dosage forms mentioned in the study are cisplatin, oxaliplatin, methotrexate, doxorubicin, cyclophosphamide, ifosfamide and leucovorin, none of which is either registered or marketed in South Africa.
SAHPRA, in terms of the Medicines and Related Substances Act 101 of 1965, as amended, and its General Regulations, requires medicines marketed in the country to meet prescribed requirements and adhere to set standards.
Every batch of medicine produced must undergo testing to ensure the integrity of the product is consistent with approved specifications before the release for sale, and imported medicines must additionally comply with the Guideline for Post-Importation Testing.
After publication of the article, SAHPRA launched internal processes to verify whether any of the South African-registered cancer medicines with the mentioned Active Pharmaceutical Ingredients (API) might have been affected or implicated.
However, it has confirmed that cancer products registered and marketed in South Africa were not implicated/affected by the investigational study and its findings.
SAHPRA conducts risk-based post-market surveillance (PMS), sampling, and testing on high-risk medical products, and is satisfied that the marketed and registered medicines meet the appropriate standards.
“I am satisfied that our rigorous regulatory processes have borne fruit and all patients, especially cancer patients, can rest assured that their health and well-being are not compromised,” said SAHPRA CEO Dr Boitumelo Semete-Makokotlela.
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