Cancer Drugs Used Around The World Failing Quality Tests: Report

Are Generic Drugs Failing?

The study, published in TBIJ, analysed the concentration of ‘active ingredient’ in seven common types of cancer drug: cisplatin, cyclophosphamide, doxorubicin, ifosfamide, leucovorin, methotrexate and oxaliplatin, all of which are considered essential medicines by the World Health Organization (WHO). Working with collaborators around the world, the report examined drug samples from four African countries.
Out of the 189 samples, a shocking one fifth failed. The failed drugs consisted of 20 different brands of generic drugs made by 17 manufacturers.

“We were all taken aback when we saw the results,” Marya Lieberman, the professor who led the research, told TBIJ.
Globally, there is a growing demand for these generic drugs, which has been the case for many years. These are the copied versions of a drug that can be manufactured once the original maker’s rights have expired. These drugs do not require the amount of resources the original drug does. The failed drugs described in this investigation were all generics.
“The data released by the Bureau of Investigative Journalism raises serious concerns regarding the quality of chemotherapy drugs that are being distributed throughout global markets. Cancer medicines that do not meet potency standards are not just production failures, they are risks to patient safety and treatments. Cancer patients face extreme physical and emotional stressors, and on top of that, they are also implicitly putting their lives in the hands of doctors through the drugs they prescribe. If drug quality is weakened in any form, patient trust is weakened, and lives are affected. To think that these medicines are reaching 100 countries is a troubling regulatory concern,” says Dr Ankit Sharma, Head, Strategy & Communications, Heal Health.

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16 Of The 17 Identified Manufacturers From India

India is by far the world’s largest producer of generic drugs. The report raises many questions over whether manufacturers are properly held accountable for producing drugs that do not meet the required criteria – and whether foreign regulators have proper oversight or overlook malpractices in the mass production of these drugs. 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. India’s drug regulator told TBIJ that Zee Laboratories had been audited and given a “stop production order”, 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.
“India is a key player in the global supply of generic medicines. With that player status also comes responsibility. Steeper compliance with quality standards, transparency and global oversight should not be considered optional, but a necessity. Quality care in cancer medicine is inevitable. There has to be a safe batch; there has to be an effective dose,” Dr Ankit Sharma added.

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Conclusion

Drugs essential for various cancer treatments failing tests is a concerning development, not just for patients worldwide but for the global medical community as well. The report clearly indicates a huge disparity between those treated with original medicine and those who cannot afford it.