Study Flags Quality Failures in Indian-Made Chemotherapy Drugs

A new study has shown that many widely used generic chemotherapy medicines around the world have failed quality testing. This raises serious doubts about the safety and efficacy of cancer therapy in more than 100 countries. The affected drugs are important to treat some common cancers, including breast and ovarian cancers, and leukaemia.

The research study, co-led by University of Notre Dame, with researchers in Cameroon, Ethiopia, Kenya and Malawi, tested 189 medicines of seven commonly prescribed chemotherapy medicines—cisplatin, cyclophosphamide, doxorubicin, ifosfamide, leucovorin, methotrexate and oxaliplatin. Approximately 20% of drugs failed the quality checks, some contained almost negligible amounts of active ingredients, or too high amounts.

Medicines that have too little of an active ingredient can be ineffective; medicines that have too much active ingredient can cause extreme toxicity and sometimes even fatal side effects. There were also instances of tablets from the same pack which had different doses. This question's the safety of the patient and consistency with treatment.

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All of the medicines that failed were generics. These are commonly prescribed medicines because generics are cheap. This is especially true for low- and middle-income countries.  The findings of the study expose significant breakdowns in global regulatory systems that are supposed to ensure drugs are of acceptable quality for medication and protect patient safety.

As cancer rates continue to rise, particularly in resource-constrained regions, the reliability of life-saving medicines remains a pressing global health issue.