Working with collaborators in Cameroon, Ethiopia, Kenya and Malawi, researchers at the University of Notre Dame, Indiana, analysed drug samples from the four countries.<\/p>\n
Of 189 samples that had not expired at the time of testing, about one fifth failed. This consisted of 20 different brands of generic drug made by 17 manufacturers (a full list of the failed drugs is here<\/a>).<\/p>\n \u201cWe were all taken aback when we saw the results,\u201d said Marya Lieberman, the professor who led the research.<\/p>\n More than 30 manufacturers made products to a good standard. But for patients receiving the poor-quality drugs, the effects could be devastating. \u201cOnce a person has been diagnosed with cancer, there\u2019s a limited window of opportunity for treatment to work,\u201d said Lieberman. \u201cAnd if someone is treated with an ineffective product, they can lose that precious window.\u201d<\/p>\n The majority of failed drugs had too little active ingredient (for most this meant less than 88% of the amount stated on the label) while some contained too much (more than 112%). Both thresholds were decided by researchers based on international standards.<\/p>\n \u201cBoth scenarios are horrendous in my eyes,\u201d said Shereen Nabhani-Gebara, vice chair of the British Oncology Pharmacy Association. \u201cIt takes a lot of courage for someone with cancer to accept a diagnosis, but then to be short-changed like this when they are trying their best is heartbreaking \u2013 because this is someone\u2019s life.\u201d<\/p>\n Tracking the threat<\/strong><\/p>\n Over the past six years, these brands of drugs have been shipped to more than 100 countries in every populated continent on the planet. They range from low- and middle-income nations like Nepal, Ethiopia and North Korea, to wealthy countries such as the US, UK and Saudi Arabia.<\/p>\n The worst-performing drug in the study is made by Indian manufacturer Venus Remedies. It is a drug called cyclophosphamide, which is often used to treat cancers including lymphoma and breast cancer.<\/p>\n All eight samples of this Venus Remedies drug failed, with six containing less than half the amount of active ingredient claimed by the manufacturer. One contained just over a quarter of the stated dose, which according to several cancer pharmacists would be as effective as no treatment at all.<\/p>\n The drug has been shipped to six countries, with its largest importer being Ethiopia.<\/p>\n \u201cBoth scenarios are horrendous in my eyes,\u201d said Shereen Nabhani-Gebara, vice chair of the British Oncology Pharmacy Association. \u201cIt takes a lot of courage for someone with cancer to accept a diagnosis, but then to be short-changed like this when they are trying their best is heartbreaking \u2013 because this is someone\u2019s life.\u201d<\/p>\n Tracking the threat<\/strong><\/p>\n Over the past six years, these brands of drugs have been shipped to more than 100 countries in every populated continent on the planet. They range from low- and middle-income nations like Nepal, Ethiopia and North Korea, to wealthy countries such as the US, UK and Saudi Arabia.<\/p>\n The worst-performing drug in the study is made by Indian manufacturer Venus Remedies. It is a drug called cyclophosphamide, which is often used to treat cancers including lymphoma and breast cancer.<\/p>\n All eight samples of this Venus Remedies drug failed, with six containing less than half the amount of active ingredient claimed by the manufacturer. One contained just over a quarter of the stated dose, which according to several cancer pharmacists would be as effective as no treatment at all.<\/p>\n The drug has been shipped to six countries, with its largest importer being Ethiopia.<\/p>\n Professor Marya Lieberman led the research and was \u2018taken aback\u2019 by the outcome.<\/p>\n Wondemagegnhu Tigeneh, a clinical oncologist in the Ethiopian capital Addis Ababa, told TBIJ that he has treated patients with chemotherapy drugs he believes did not work.<\/p>\n \u201cI have a suspicion that the active ingredient was lower than expected,\u201d he said, remembering a drug he gave to a recent patient who had responded well to the first three rounds of treatment. But on the next round, their progress suddenly stopped.<\/p>\n Because he has no means to test them, Tigeneh can never be sure of the quality of a given drug. But in his 20 years treating cancer, he has learned to notice tell-tale signs. Sometimes, for instance, there is a complete absence of side effects such as nausea or hair loss. \u201cThat makes it difficult to trust that particular drug,\u201d he said.<\/p>\n Then there are the patients whose disease he struggles to get under control, such as a patient whose response to treatment halted without warning. Rather than reducing the size of the tumour enough to enable surgery, his team has been forced to move onto a second-line treatment. If that fails, the next stage is palliative care. \u201cIt\u2019s very sad,\u201d said Tigeneh. \u201cWe didn\u2019t used to see things like this.\u201d<\/p>\n Cancer patients in Ethiopia have far better access to treatment facilities now than they did 20 years ago. It doesn\u2019t seem, however, that the standard of medicines has kept pace. A 2020 study of cancer drugs in the country included 20 samples of cisplatin which were all found to be substandard, averaging just over half of the stated content. One researcher who tests the quality of drugs in the country told TBIJ that they find bad medicines wherever they go.<\/p>\n Venus Remedies told TBIJ that the study results were \u201cnot scientifically plausible\u201d given the company\u2019s \u201cvalidated manufacturing systems and quality controls\u201d. It said it has 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.<\/p>\n The manufacturer said storage conditions in the supply chain, which can affect drug quality, might have affected the test results. The company said cyclophosphamide is highly temperature-sensitive.<\/p>\n 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. Lieberman said that, although her results are not intended for regulatory purposes, her researchers\u2019 methods are based on those used by regulatory labs and were verified for suitability, accuracy, and precision. Both the findings and methods have been scrutinised by independent academics.<\/p>\n Toxic effects<\/strong><\/p>\n Some 2,000 miles south of Addis Ababa, in Malawi, specialist cancer care has only been available for around 15 years. In one of the poorest countries in the world, patients depend on healthcare being free at the point of need. This means clinics rely on generic drugs.<\/p>\n A pharmacist specialising in cancer care in central Malawi told TBIJ of seeing patients at his hospital overdose on methotrexate, a drug used to treat leukaemia and lymphoma.<\/p>\n Malawi has also imported two of the brands of methotrexate the researchers in this investigation found to contain too much active ingredient: Zuvitrex, made by Zuvius Lifesciences, and Unitrexate, made by United Biotech. Neither company responded to multiple requests for comment.<\/p>\n This sort of excess can be just as harmful as a deficit. A bad overdose can leave a patient with lifelong side effects or even kill them. As Nabhani-Gebara said: \u201cMore is not better.\u201d<\/p>\n The Malawian pharmacist said patients at his hospital have suffered severe vomiting and nausea after overdosing on methotrexate, while others had to be moved onto a second-line treatment, which may not be as effective. For some patients, the side effects were so severe that they had to pause treatment entirely \u2013 giving the cancer a chance to grow.<\/p>\n When a sample of the methotrexate used at the hospital was tested as part of a research project taking place at the time, it was found to be too high in active ingredient. \u201cIt\u2019s very worrying,\u201d the pharmacist said.<\/p>\n Cancer patients gather at a hospital in MalawiDiego Menj\u00edbar.<\/p>\n He told TBIJ that he and his colleagues have on occasion had to stop using an entire batch of chemotherapy medicine and send samples to the Malawi drug regulator after the medicine changed colour: a sign something is wrong with it.<\/p>\n \u201cWe had patients scheduled for clinic,\u201d he said, \u201cand then we had to break the news to them that we don\u2019t have medicines.\u201d<\/p>\n Failing safety nets<\/strong><\/p>\n Countries all over the world have systems in place to stop bad drugs reaching patients. However, there are huge disparities in their effectiveness. According to Chaitanya Kumar Koduri of the US Pharmacopeia, an organisation that sets standards for medicines in the US and internationally, \u201c70% of countries cannot take care of their own medicine quality\u201d.<\/p>\n Most governments have a national regulator, but their remit and resources vary hugely. And even the better-funded regulators are far from foolproof. The US Food and Drug Administration (FDA), for instance, is struggling to keep up with inspections of manufacturing plants domestically and in India and China, and has admitted that its inspections have not been a reliable indicator of drug quality.<\/p>\n The FDA recently declared new plans to expand unannounced inspections at foreign manufacturing facilities, saying this will help expose those who falsify records or hide violations.<\/p>\n It told TBIJ \u201cthat inspections and reviews will continue to ensure [drug] safety and efficacy\u201d.<\/p>\n One of the countries where medicine regulation ranks the lowest, according to the WHO, is Nepal. It is also one of the biggest importers of the failed chemotherapy brands in this investigation.<\/p>\n Despite there being more than 20,000 brands of medicine on the market there, the country\u2019s regulator has set a target of testing just 22 drugs in the next 12 months \u2013 and none of them chemotherapy drugs.<\/p>\n Narayan Prasad Dhakal, the regulator\u2019s director general, told TBIJ that its lab cannot currently test cancer drugs and admitted that the situation around quality-testing is \u201ca concern\u201d. He also said that while his department has the power to recall cancer drugs based on external evidence, it has never done so.<\/p>\n The issue is especially fraught for patients who may have travelled from remote, rural areas to get treatment that then may not even work.<\/p>\n Laxmi Kumari, whose two-year-old son is being treated for cancer in Kathmandu, Nepal\u2019s capital, has had to procure chemotherapy drugs from private pharmacies. The treatment has cost the family nearly two lakh rupees (\u00a31,160), equivalent to several months\u2019 average salary in Nepal, and yet they have no reassurance that it will be effective.<\/p>\n \u201cWe have no way of knowing the quality of the medications being used in his treatment,\u201d said Laxmi. \u201cWe rely entirely on what the doctors recommend.\u201d<\/p>\n \u201cNeither patients nor their families have any way of knowing the quality of these drugs,\u201d said Smriti Pokharel of the Wish Nepal Foundation, which helps children from low-income families access cancer treatment.<\/p>\n \u201cEven doctors face challenges in verifying their quality. No one seems willing to take responsibility for ensuring proper treatment for cancer patients.\u201d<\/p>\n Race to the bottom<\/p>\n Generic drug manufacturers are operating in a global market that healthcare professionals and experts agree is driven by one thing: price. It\u2019s a market in which those operating under a less watchful eye can find ways to undercut their competitors.<\/p>\n This could mean scrimping on the amount or quality of the active ingredient \u2013 the most expensive component \u2013 or using cheap or outdated machinery. Research shows that the majority of substandard drugs occur due to problems with manufacturing, quality control, packaging or storage.<\/p>\n India, where about 20% of the world\u2019s generic drugs come from, plays a pivotal role in ensuring people everywhere can access affordable medicine. Sixteen of the 17 manufacturers of failed drugs in this investigation are based in India.<\/p>\n While the majority of India-made drugs are safe, the country\u2019s generics industry has long been dogged by scandal. In 2013, Indian manufacturer Ranbaxy agreed to pay a fine of $500m after its US subsidiary pleaded guilty to the improper manufacturing, storing and testing of drugs.<\/p>\n In 2022 and 2023, Indian-made cough syrups were linked to the deaths of children in Gambia, Cameroon and Uzbekistan. And as recently as August 2024, it was reported that the regulator had found more than 50 drugs on the market to be substandard or fake, including some paracetamol and antacids.<\/p>\n The results can be fatal. Four children died in Colombia after being given contaminated cancer drugs in 2019. Three years later, another batch of bad medicine caused the deaths of at least 10 children in Yemen who were being treated for leukaemia.<\/p>\n The price-driven market creates a dangerous dynamic in which the number of companies making a particular drug shrinks and shrinks until global supply is precariously dependent on just a handful of manufacturers. Should one company slip up, thousands of patients can be left without the drugs they depend on.<\/p>\n It\u2019s a situation that played out in the US recently. Between 2018 and 2022, Intas Pharmaceuticals \u2013 the parent company of Accord Healthcare, which made the worst-performing cisplatin tested in this investigation \u2013 grew its US market share of cisplatin from 24% to 62%. It also increased its share in methotrexate fivefold in the same time period. All the while, prices of both these chemotherapy drugs dropped.<\/p>\n Then at the end of 2022, a surprise inspection by the US drug regulator revealed a \u201ccascade of failure\u201d at an Intas factory in India, where staff were seen shredding and pouring acid on quality records. The shutdown that ensued sent shockwaves across the US, with nearly every major cancer centre reporting shortfalls in chemotherapy drugs during the spring or summer of 2023,\u00a0according to the New York Times<\/a>.<\/p>\n Accord Healthcare said the batch of cisplatin that failed the researchers\u2019 testing had met all established quality standards, and shared data from internal and external studies indicating its quality. It said it has not received any market concerns related to this batch.<\/p>\n In India, the world\u2019s largest producer of generic drugs, questions have been raised over whether manufacturers are properly punished for producing drugs that aren\u2019t fit for purpose \u2013 and whether foreign regulators have proper oversight.<\/p>\n \u201cThe Indian government\u2019s interest is in trying to protect the industry,\u201d said public health activist and former Big Pharma whistleblower Dinesh Thakur.<\/p>\n Sixteen of the 17 manufacturers identified in this investigation are based in India, and five have been previously flagged by a regulator for producing substandard batches of drugs. One of them, Zee Laboratories, has been flagged 46 times since 2018.<\/p>\n India\u2019s drug regulator told TBIJ that Zee Laboratories has been audited and given a \u201cstop production order\u201d, which was lifted after the company resolved the problems in question. It did not give details about when this was, which issues it pertained to or whether the company faced any consequences.<\/p>\n![\"\"](\"https:\/\/www.europesays.com\/uk\/wp-content\/uploads\/2025\/06\/Screenshot-2025-06-28-at-3.16.07\u202fPM-1024x663.png\")
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