A major investigation has found that widely used chemotherapy drugs, many manufactured in India, have failed quality checks, putting cancer patients in over 100 countries at risk. The drugs, mostly generic versions of essential cancer treatments, contained incorrect levels of active ingredients, raising concerns over treatment failure and fatal health complications.
The investigation by the UK-based Bureau of Investigative Journalism (TBIJ) revealed that nearly one in five drug samples tested did not meet international potency standards. Several batches had too little of the key ingredient, while others had excessive amounts, both of which could severely harm patients.
1 in 5 cancer drugs tested failed potency standards
The study analysed 189 samples of seven key chemotherapy drugs – including cisplatin, methotrexate, and cyclophosphamide, all on the WHO’s essential medicines list. The samples were sourced from pharmacies in Cameroon, Ethiopia, Kenya, and Malawi, covering 20 brands made by 17 manufacturers.
Of these, about 20 per cent of the samples failed. Some batches contained less than 88 per cent of the stated drug content, while others exceeded 112 per cent. Both extremes are unsafe: low potency may render treatment ineffective, while high levels can lead to organ damage or death.
16 out of 17 drugs that failed were produced in India, the world’s largest exporter of generic medicines.
Faulty drugs linked to failed treatments
Doctors in several countries told TBIJ that some patients stopped responding to treatment, while others suffered unexpected side effects. In Ethiopia, oncologist Dr. Wondemagegnhu Tigeneh said a patient who initially responded to chemotherapy later showed no improvement. He suspects a faulty drug batch was responsible.
“Sometimes patients show no typical side effects like nausea or hair loss. That makes us question the drug’s effectiveness,” he said.
In cases where first-line treatments fail, doctors are often forced to switch to costlier second-line therapies, which may not work as well. “It’s very sad,” Dr. Tigeneh said. “We didn’t used to see things like this.”
Indian drugmakers under global scrutiny
The report points to 16 Indian pharmaceutical companies whose drugs failed potency tests. Among them is Venus Remedies, whose chemotherapy drug cyclophosphamide failed in all eight samples tested. In one case, the drug contained just 26 per cent of the required dose, making it essentially useless.
However, Venus Remedies’ in its official company statement said that the report overlooked relevant scientific and regulatory context, raising concerns around the completeness and editorial balance of its conclusions. The company expressed that the current depiction risks undermining the reputation and credibility that Venus Remedies has earned over several decades, grounded in ethical practices, stringent quality protocols, and global recognitions such as GMP certifications and Marketing Authorizations.
Zee Laboratories, another Indian company, has been flagged 46 times since 2018 for substandard drugs but continues to export globally. The company did not respond to requests for comment.
FinancialExpress.com could not independently verify the claims made by the journal.
Generic drugs are vital, but the quality in question
Generic medicines play a critical role in cancer care, especially in low- and middle-income countries. They are more affordable and widely used. However, the investigation shows that poor manufacturing standards, weak regulation, and cost-cutting can result in dangerous batches reaching patients.
“If a person is treated with an ineffective cancer drug, they can lose the only window they had for survival,” said Prof. Marya Lieberman, who led the research.
“This is heartbreaking,” said Dr. Shereen Nabhani-Gebara, from the British Oncology Pharmacists Association. “Patients are brave enough to undergo chemotherapy, only to be let down by the very medicines meant to help them.”
Pharma companies deny fault
India has over 20,000 pharmaceutical brands on the market, yet its national drug regulator plans to test only 22 medicines over the next year—none of which include chemotherapy drugs. Narayan Prasad Dhakal, Director General of the Department of Drug Administration, admitted that their labs are currently unequipped to test cancer medications. He called the lack of capacity for chemotherapy testing “a concern,” and acknowledged that while the department has legal authority to recall unsafe cancer drugs based on international evidence, it has never exercised that power.
Meanwhile, some Indian pharmaceutical companies have dismissed the findings of the investigation. Venus Remedies, whose chemotherapy drug failed all eight tested samples, defended its manufacturing process and blamed poor storage conditions during distribution for any drop in potency.
“We are deeply concerned by the portrayal of Venus Remedies in the recent report published by The Bureau of Investigative Journalism (TBIJ), which references assay discrepancies in Cyclophosphamide samples. While we fully support independent scrutiny and scientific dialogue, we must express our disappointment at the omission of critical context that was clearly communicated to the TBIJ representative during prior correspondence,” the official statement of Venus Remedies read.
“Specifically, we highlighted how the Cyclophosphamide samples were handled after collection—particularly relevant since Mr. Paul Eccles acknowledged in his first communication to us that shipping and storage, after procurement from hospital pharmacies, did not adhere to the manufacturer’s recommended storage conditions of below 15 degrees Celsius and, in fact, fluctuated above 30 degrees Celsius. His correspondence also stated that post-collection storage of the tested samples occurred at room temperature,” the statement further read.
The Venus Remedies statement further include, “Given Cyclophosphamide’s well-established temperature sensitivity, this strongly suggests the potential for post-distribution thermal degradation or analytical variability—factors entirely outside the manufacturer’s control. To clarify, the manufacturer’s responsibility for product quality ends at delivery to the authorized distributor; beyond that, proper storage and handling fall to the supply chain and are outside the manufacturer’s control.
Despite this, the report fails to reflect this scientifically relevant factor, which materially impacts assay outcomes. The reported result—where one vial tested at approximately one-quarter of its labelled strength—is inconsistent with our validated manufacturing processes, which include rigorous in-process controls, batch testing, and cold-chain dispatches with temperature loggers. We shared these batch results with the journalist, which confirmed full compliance with regulatory standards. The deliberate exclusion of this information from the published report raises serious concerns about editorial intent and objectivity.”
Accord Healthcare, linked to another failing drug batch, maintained that its products had passed internal and external quality checks and said it had not received any formal complaints.
India’s reputation as global drug hub at risk
India supplies affordable medicines to the world, but this investigation exposes gaps in regulatory enforcement. Public health experts say India must strike a balance between being a high-volume exporter and ensuring quality.
“The Indian government’s priority seems to be protecting the industry,” said public health activist Dinesh Thakur. “But it must also protect patients.”
However, the statement from Venus Remedies stated that, “Venus Remedies has always upheld the highest standards of patient safety, regulatory compliance, and ethical manufacturing, and we remain fully committed to cooperating with authorities and engaging transparently with all stakeholders. We urge all parties to approach such critical matters with scientific rigor and balanced reporting, especially when public trust and patient outcomes are at stake.”
