By New Delhi Post
A recent study has revealed that many chemotherapy drugs, used for cancer treatment worldwide, have failed quality tests and identified as ‘poor quality’, endangering the lives of patients. The drugs include numerous common cancers such as breast, ovarian and leukemia. Many Indian companies have also found supplying ‘sub-standard’ drugs and are now under fresh scrutiny.
“Vital chemotherapy drugs used around the world have failed quality tests, leaving cancer patients in more than 100 countries at risk of ineffective treatments and potentially fatal side effects,” reveals the Bureau of Investigative Journalism (TBIJ), UK. “Sixteen of the 17 manufacturers of failed drugs in this investigation are based in India,” the probe reveals.
189 samples, including common cancer drugs such as cisplatin, cyclophosphamide, doxorubicin, ifosfamide, leucovorin, methotrexate and oxaliplatin have been tested, but about one-fifth of them failed the standards. This consists of 20 different brands of generic drugs made by 17 manufacturers, including India.
Doctors across the world told TBIJ these drugs are 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. “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.”
The study reveals that 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%).
“The worst-performing drug is made by an Indian manufacturer Venus Remedies,” says the study. It is a drug called cyclophosphamide, which is often used to treat cancers, including lymphoma and breast cancer. “All eight samples of the 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.” The drug has been shipped to 6 countries, the largest of them to Ethiopia.
When asked, Venus Remedies replied to TBIJ, countering that “the study results were not scientifically plausible given the company’s validated manufacturing systems and quality controls”. The company further 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.
Venus Remedies added that thestorage conditions in the supply chain, which can affect drug quality, might have affected the test results. The company said cyclophosphamide is highly temperature-sensitive.
Sixteen of the 17 manufacturers identified in the investigation are from India, and five of them were previously flagged by a regulator for producing substandard batches of drugs. One such manufacturer, Zee Laboratories, has been flagged 46 times since 2018. Other Indian companies in the list are Getwell Pharmaceuticals, United Biotech, VHB Medi Sciences, Zuvius Lifesciences and GLS Pharma.
The drug regulator in India defended its monitoring mechanism, saying that failing drugs are recalled and manufacturers face “either administrative penalties or legal prosecution in court”.
