In a world where cancer affects millions, access to affordable treatments is a lifeline—especially in low- and middle-income countries. But what if those lifesaving drugs are substandard or counterfeit? A groundbreaking 2025 investigation by The Bureau of Investigative Journalism (TBIJ), published in The Lancet Global Health, has uncovered a shocking reality: Nearly one in five generic cancer drugs tested failed basic quality checks, putting patients at risk of ineffective therapy, severe side effects, or even death. These drugs, essential chemotherapies shipped to over 100 countries, highlight a global crisis in pharmaceutical supply chains. Let’s break down the study’s findings, the drugs involved, and what it means for cancer care.
The Investigation: How Researchers Uncovered the Crisis
Led by scientists at the University of Notre Dame in collaboration with teams in Cameroon, Ethiopia, Kenya, and Malawi, the study tested 189 unexpired samples of seven key cancer drugs from the World Health Organization’s (WHO) Model List of Essential Medicines. These generics, produced mainly by Indian manufacturers, are the backbone of global cancer treatment, meeting much of the demand in resource-limited settings.
Methodology Highlights:
- Drugs Analyzed: Cisplatin (for testicular and ovarian cancers), cyclophosphamide (lymphoma, breast cancer), doxorubicin (breast cancer, leukemia), ifosfamide (testicular cancer), leucovorin (used with other chemo agents), methotrexate (leukemia, breast cancer), and oxaliplatin (colorectal cancer).
- Testing Process: Samples were collected from hospitals and pharmacies in Sub-Saharan Africa and analyzed using regulatory-standard lab methods for active pharmaceutical ingredient (API) content. Failure was defined as less than 88% or more than 112% of the labeled API amount—stricter than WHO’s 85-115% threshold to account for variability.
- Scope: The 20 failing generics came from 17 manufacturers, with all but one based in India. These drugs were traced to shipments in over 100 countries, from Nepal and Ethiopia to the U.S., U.K., and Saudi Arabia.
The results? About 20% of samples failed, with most containing dangerously low API levels—some as little as 25% of what’s promised. This isn’t isolated; it echoes broader concerns about substandard meds in global health.
Key Findings: A Shocking List of Failing Drugs
The investigation revealed widespread quality lapses, primarily low active ingredients that render drugs ineffective. Excess API in some cases posed toxicity risks. Here’s a breakdown of notable failures from the TBIJ’s full list:
| Drug Name (Generic) | Manufacturer | Failure Details | Examples of Impact |
|---|---|---|---|
| Cyclophosphamide (e.g., Adcyclo, CTX-GLS, Nuphos) | Beta Drugs, GLS Pharma, Zee Laboratories, Venus Remedies | Low API (one sample <25%; all 8 Venus samples failed, 6 <50%) | Used for breast cancer and lymphoma; ineffective dosing could miss cure windows. |
| Doxorubicin (e.g., Adriplus, Adrosal, Doxoruba, Doxobyra, Doxozest, Zuvidox) | Bruck Pharma, VHB Medi Sciences, Getwell, Medyra Pharmaceutical, Zee Laboratories, Zuvius Lifesciences | Low API (e.g., all 2 Doxoruba samples failed; 2/3 Doxobyra) | Key for leukemia and breast cancer; substandard versions lead to treatment resistance. |
| Methotrexate (e.g., B-TRAX, Gintrex, Mytrexate, Namantrex, Plastomet, Trexol, Unitrexate, Zuvitrex) | Health Biotech, United Bioceuticals, Stafford Laboratories, Naman Pharma Drugs, Khandelwal Laboratories, Venus Remedies, United Biotech, Zuvius Lifesciences | Mostly low API (e.g., 4/5 Namantrex suspected counterfeit); some excess (e.g., Zuvitrex and Unitrex in Malawi) | For leukemia and rheumatoid arthritis-related cancers; excess caused vomiting, forcing treatment switches. |
| Cisplatin (e.g., Cisplatine Accord, Cytocis) | Accord Healthcare, Cytopharma | Low API (1/4 and 1/1 failed) | Ovarian and lung cancers; low doses risk progression to advanced stages. |
Out of the 20 failing products, 18 had low API, one had excess, and one was flagged as potentially counterfeit. Indian firms dominated the failures, with Venus Remedies’ cyclophosphamide being the worst offender—all samples from Ethiopia and Malawi were subpar. In Sub-Saharan Africa, where cancer rates are rising but resources are scarce, one in six chemo drugs failed—up to 20% in some nations like Ethiopia.
Global Reach: A Crisis Beyond Africa
While testing focused on Sub-Saharan Africa—where cancer deaths are projected to double by 2040—the faulty drugs were exported worldwide. Trace shipments showed them reaching North Korea, Yemen, and even high-income countries via aid or imports. Ethiopia, the largest importer of Venus Remedies’ cyclophosphamide, highlighted supply chain vulnerabilities. In wealthier nations, stricter regulations catch some issues, but global trade means risks spill over—patients everywhere could unknowingly receive substandard meds.
This isn’t new; counterfeit cancer drugs have been a “global scandal,” with past reports of fake Avastin in the U.S. But this study spotlights generics, which make up 90% of cancer drugs in low-income areas.
Health Implications: Ineffective Treatment and Hidden Dangers
For cancer patients, substandard drugs are a nightmare. Low API means tumors don’t shrink, allowing spread and reducing survival odds—potentially turning curable cases deadly. In Malawi, excess methotrexate caused brutal side effects like nonstop vomiting, halting treatment and pushing patients to pricier alternatives or palliative care.
Experts warn of broader fallout: Increased drug resistance, higher healthcare costs (up to $150 billion globally from delayed care), and eroded trust in generics. Dr. Paul Harron, a pharmacologist involved, stressed: “Patients deserve drugs that match their labels—no more, no less.” In Africa, where 70% of childhood cancer deaths occur due to poor treatment access, this could be catastrophic.
Why It Happens and What Needs to Change
Blame falls on lax manufacturing, weak oversight, and profit-driven shortcuts. Many Indian firms, supplying 20% of global generics, face pressure to produce cheaply without robust quality controls. WHO prequalification helps, but some bypass it. National regulators in places like Nepal lack testing capacity.
Calls to action include:
- Stricter Global Standards: Expand WHO’s essential medicines list and enforce certifications.
- Better Inspections: The U.S. FDA plans more unannounced foreign audits; other nations should follow.
- Supply Chain Transparency: Track shipments to block substandard exports.
- Investment in Local Production: Boost manufacturing in Africa to reduce import reliance.
As lead researcher Dr. Philip Low noted, “This is a solvable problem—stronger safety nets can protect vulnerable patients.”
The Bottom Line: A Wake-Up Call for Global Cancer Care
his TBIJ study exposes a ticking time bomb in cancer treatment: Globally used generics failing purity tests at 20%, risking lives from Africa to everywhere. While generics are vital for affordability, quality can’t be compromised. Patients, advocates, and policymakers must push for accountability—your next dose could depend on it.
If you’re undergoing cancer treatment, discuss drug sourcing with your oncologist. Seen issues with meds? Share in the comments. Let’s amplify this for change.