In a landmark study by researchers at the University of Notre Dame, Indiana, USA, who analysed 189 samples of various vital cancer drugs, about one-fifth failed, leaving cancer patients around the world at risk of ineffective treatments and fatal side effects.
The chemotherapy drugs in question form the backbone of treatment plans for numerous common cancers, including breast, ovarian and leukaemia, according to the global Bureau of Investigative Journalism (TBIJ).
Over the past six years, they have been shipped to more than 100 countries, to every populated continent on the planet, to both low- and middle-income countries like Nepal, Ethiopia and North Korea, and wealthy nations like the US, UK and Saudi Arabia.
The test findings of the study, which focused on four countries in sub-saharan Africa and was published in The Lancet Global Health, shocked the researchers, reports EWN.
“We were all taken aback when we saw the results,” said Professor Marya Lieberman, who led the research.
The worst-performing drug is made by Indian manufacturer Venus Remedies. All eight samples of the company’s cyclophosphamide product failed, with six containing less than half the stated active ingredient.
Venus Remedies told TBIJ that the study’s results were “not scientifically plausible”, given the company’s “validated manufacturing systems and quality controls”. It said it had received no complaints or concerns about the batches in question and shared the results of its own testing that indicated they were of a good standard.
The manufacturer said storage conditions in the supply chain, which can have an impact on drug quality, might have affected the researchers’ test results. However, the absence of similar quality issues across the entire data set suggests this is not the case.
Venus Remedies is one of three companies or regulators that queried the methodology used by the lab, saying it deviated from international standards or could give erroneous results. However, Lieberman said that her researchers’ methods follow international standards as closely as possible and employ similar standards to a regulatory lab.
Both the findings and methods have been scrutinised by independent academics.
Two other manufacturers whose products failed the testing, Zuvius Lifesciences and GLS Pharma, have supplied failed brands to more than 40 countries.
Of the 17 companies to have manufactured failed drugs, 16 are based in India. Five have been previously flagged by regulators for producing substandard drugs, including Zee Laboratories, which has been flagged 46 times since 2018.
Some drugs contained so little of their key ingredient that pharmacists said giving them to patients would be as good as doing nothing. Other drugs, containing too much active ingredient, put patients at risk of severe organ damage or even death.
“Both scenarios are horrendous,” said Shereen Nabhani-Gebara, Vice Chair of the British Oncology Pharmacists Association. “It’s heartbreaking.”
Zuvius Lifesciences, GLS Pharma, and Zee Laboratories did not respond to multiple requests for comment.
Doctors from multiple countries told TBIJ of the drugs in question not working as expected, leaving patients suddenly unresponsive to treatment. Other patients suffered side effects so toxic that they could no longer tolerate the medicine.
“It’s very worrying,” a pharmacist in Malawi told TBIJ.
These findings expose huge holes in the global safety nets intended to prevent profit-seeking manufacturers from cutting corners and to protect patients from bad drugs. More than two in three countries worldwide are reportedly unable to ensure the quality of medicines to which their populations are exposed.
One such country is Nepal, which is also one of the biggest importers of the failed chemotherapy brands in this investigation.
The country’s medicines regulator does not have the capacity to test cancer drugs and although it can recall cancer drugs based on external evidence, it has never done so.
“Neither patients nor their families has any way of knowing the quality of these drugs,” said Smriti Pokharel of the Wish Nepal Foundation. “No one seems willing to take responsibility for ensuring proper treatment for cancer patients.”
Much of the global demand for cancer treatment is met by generic drugs, which can be made once the original manufacturer’s exclusivity rights have expired. The bad drugs found by TBIJ in this investigation were all generics.
In India, the world’s largest producer of generic drugs, questions have been raised over whether manufacturers are properly punished for producing drugs unfit for purpose.
“The Indian government’s interest is in trying to protect the industry,” said public health activist and former Big Pharma whistleblower Dinesh Thakur.
India’s drug regulator defended the oversight system, saying that failing drugs are recalled and manufacturers face “either administrative penalties or legal prosecution in court”.
Thakur pointed to limitations in the World Health Organisation’s means of ensuring that people across the world have access to safe effective drugs. He described one WHO standards certificate scheme as “not worth the paper it’s written on”. The WHO did not respond to several requests for comment made by TBIJ.
One cancer pharmacist in Ethiopia estimated that it could take more than a year for a patient to save for cancer treatment. If that medicine then turns out to be faulty, they simply might not be able to afford to pay for another.
“Most people believe cancer is incurable,” they said. “When they end up with a medicine that won’t cure them, that’s another tragedy.”
Study details
Substandard anticancer medications in clinical care settings and private pharmacies in sub-Saharan Africa: a systematic pharmaceutical investigation
Maximilian Wilfinger, Jack Doohana, Ekezie Okorigwe, et al.
Published in The Lancet Global Health in July 2025
Summary
Background
The quality of anticancer drugs is crucial for good patient outcomes, but quality surveillance in low-income and middle-income countries (LMICs) has been deterred by the high toxicity of the drugs. Despite worrisome reports about substandard or falsified products, no systematic studies of anticancer drug quality across multiple LMICs have been reported.
Methods
Between April 6, 2023, and Feb 12, 2024, cisplatin, oxaliplatin, methotrexate, doxorubicin, cyclophosphamide, ifosfamide, and leucovorin dosage forms were collected both covertly and overtly from 12 hospitals and 25 private or community pharmacies in Ethiopia, Kenya, Malawi, and Cameroon, with the goal of obtaining ten different brands and lot numbers of each type of active pharmaceutical ingredient (API). Each product was visually inspected. The percentage of active pharmaceutical ingredient relative to the stated API content was assayed with high-performance liquid chromatography (HPLC). Assay values were compared with US Pharmacopoeia acceptance criteria for different APIs and dosage forms. Samples with assay values that failed to meet the appropriate acceptance criteria were categorised as having failed HPLC assay, samples with assay values that fell within the allowed acceptance criteria were categorised as having passed HPLC assay, and samples with assay values that fell within the 2% margin of error of the acceptance criteria were categorised as inconclusive. Critical failure rates were calculated with 95% CIs and significance testing was done for differences between failure rates. For the comparison of visual inspection with HPLC results, sensitivity was calculated as the number of lots that failed both HPLC assay and visual inspection divided by the total number of lots that failed HPLC assay. Specificity was calculated as the number of lots that passed both HPLC assay and visual inspection divided by the total number of lots that passed HPLC assay.
Findings
A total of 251 samples of chemotherapy drugs (dosage forms) were collected between April 6, 2023, and Feb 12, 2024, and 191 unique brands and lot numbers were obtained. Products from eight of 191 (4%) unique lot numbers (collected in countries coded as W, X, and Y) failed visual inspection. Active pharmaceutical ingredient contents ranged from 28% to 120% of stated contents, and failure rates ranged from 14% to 24% across the different countries; these rates were not significantly different at the 95% CI. Nearly a quarter of the products (59 [24%] of 251) had expired before analysis, some by nearly a year, but the expired products did not fail HPLC assay at a higher rate than the non-expired products. Ten of the 59 post-expiry products failed assay (ie, a 17% failure rate), whereas 38 of the 189 pre-expiry samples failed assay (ie, a 20% failure rate); these rates were not different at the 95% CI. Failing products were found in all four countries and in both major hospitals and private pharmacies (with no difference in failure rates at the 95% CI). The sensitivity of visual inspection for the detection of products failing HPLC assay was 9% (three of 32 lots) and the specificity was 97% (155 of 159 lots). The sensitivity of visual inspection is low because many quality defects, such as a shortage of an uncoloured active pharmaceutical ingredient, are not visually apparent.
Interpretation
Oncology practitioners and health systems in sub-Saharan Africa need to be aware of the possible presence of substandard anticancer products when designing care protocols and evaluating patient outcomes, and regulatory system strengthening is needed to provide better surveillance of this crucial class of medicines.
See more from MedicalBrief archives:
Sub-standard generic medicines killing children globally
Pharmacy middlemen charged with inflating drug prices
No association between price and efficacy of cancer drugs — four-nation study
Chinese regulator defends quality of local generic drugs