The recent revelation that nearly 20% of tested chemotherapy drugs failed basic quality standards is more than just alarming. It is a global public health crisis with devastating consequences, especially for patients in low- and middle-income countries (LMICs). VIDEO: Rwanda to host Africa’s first eye and cancer drug facility Cancer is already a death sentence for too many in resource-limited settings. Substandard medicines only compound this tragedy, turning hope into harm. ALSO READ: Rwanda could eliminate cervical cancer by 2027, says minister A landmark study by the University of Notre Dame, published in collaboration with the Bureau of Investigative Journalism, tested 189 samples of common cancer drugs sourced from over 100 countries. The findings were sobering: one in five samples failed. ALSO READ: Cancer, kidney transplant services to be covered under Mutuelle de Santé Some had too little of the active ingredient to be effective – others had dangerously high concentrations, risking severe toxicity. In both scenarios, patients are being failed by the very systems that are meant to protect them. The human toll Cancer patients in LMICs already face enormous hurdles – late diagnoses, limited treatment infrastructure, and high out-of-pocket costs. ALSO READ: Rwanda moves to make cancer treatment more affordable for population For many, a course of chemotherapy is a financial sacrifice requiring the sale of property, depletion of savings, or support from an extended network of family and friends. Imagine the anguish of learning that such sacrifice was for nothing – that the medicine bought with hope was little more than a placebo, or worse, a poison. ALSO READ: Top 10 most common cancers in Rwanda When cancer drugs fail to work as expected, the results are not merely academic. Patients relapse. They suffer preventable pain. They die. Substandard drugs erode trust in health systems, burden overworked clinicians, and fuel the misconception that cancer is inevitably incurable in Africa, Asia, and parts of Latin America. Root causes of a broken system This problem is not new. For decades, health systems in LMICs have been vulnerable to substandard and falsified medicines, particularly where regulation is weak and supply chains are opaque. The Notre Dame study shines a bright light on the systemic drivers of poor-quality cancer treatments. Weak regulatory oversight: More than two-thirds of countries lack robust capacity to assure the quality of medicines. National regulatory agencies are often underfunded, understaffed, and underpowered. In some countries, cancer drugs are approved and sold without any post-market surveillance or testing. Over-reliance on imports without due diligence: Most cancer medicines in LMICs are imported generics, often procured through tenders prioritizing cost over quality. This opens the door to manufacturers that may cut corners to win contracts, with little risk of consequence. Limited global accountability: Many of the manufacturers identified in the Notre Dame study are based in India, the world’s largest exporter of generic drugs. While Indian manufacturers have played a crucial role in expanding global access to essential medicines, regulatory enforcement within India remains uneven. Even when violations are identified, penalties are light and rarely publicized. Lack of transparency and patient protection mechanisms: Patients and clinicians have no way of knowing whether a drug is of acceptable quality. In countries like Nepal, which import large volumes of chemotherapy drugs, there is no routine testing, no public reporting, and no mechanism for timely recalls. What needs to change – now! It is unacceptable that in 2025, cancer patients in LMICs must gamble with their lives every time they begin treatment. To stop this crisis, coordinated action is needed at national, regional, and global levels. Strengthen national regulatory authorities: LMICs must be supported to build the technical capacity and independence of their national regulatory agencies. This includes investment in laboratories, surveillance systems, and risk-based post-marketing quality monitoring. Implement regional regulatory collaboration: Continental bodies such as the African Medicines Agency (AMA) must play a leadership role in setting quality standards, pooling regulatory resources, and facilitating the joint inspection of manufacturers exporting to the region. Prioritize quality in procurement: Donors, development banks, and national procurement agencies must stop equating affordability with acceptability. Quality-assured procurement should be the rule, not the exception. This includes relying on stringent regulatory authority approvals, WHO prequalification, and independent quality audits. Establish transparent recall and alert systems: LMICs should develop mechanisms to swiftly communicate quality failures to health workers, patients, and the public. Global databases of substandard medicines must be made accessible and routinely updated. Support local manufacturing under strict oversight: Long-term solutions must include building regional capacity to produce quality-assured cancer drugs under Good Manufacturing Practice (GMP) standards. Regional production reduces reliance on unvetted foreign sources and enables greater control. A matter of equity and dignity The promise of modern medicine must not end at the borders of high-income countries. Cancer should not be a death sentence simply because of where a person lives. Nor should a mother in Ethiopia or a teacher in Malawi be forced to trust a vial of medicine that may be useless – or lethal. This is not just a technical issue. It is a moral one. Every life deserves the dignity of safe and effective treatment. Governments, industry, and global health institutions must act now – not with more rhetoric, but with real accountability and resources. We cannot wait for the next heartbreaking study to take this seriously. The time to act is now. The author is the Global Head, Regulatory Strategy at Bio Usawa Biotechnology, Ltd.
