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Nearly One in Five India-Made Chemotherapy Drugs Fall Short in Global Tests

Regulatory holes in India’s drug approval system allow substandard cancer treatments to reach patients in more than 100 countries

**HANDOUT**SINGLE USE** July 3, 2024; Professor Marya Lieberman prepares a fentanyl solution in her lab. ( Marya Lieberman, professor in the Department of Chemistry and Biochemistry at Notre Dame and corresponding author of the study, works in her research lab. Photo by Barbara Johnston/University of Notre Dame)
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Overview

  • An investigation of 189 samples across four African countries found that 20 percent of essential chemotherapy batches failed to meet international potency standards
  • Some batches contained as little as 26 percent of the declared active ingredient while others exceeded the safe concentration by up to 12 percent
  • Venus Remedies saw its cyclophosphamide fail in all eight tested samples and Zee Laboratories has faced 46 substandard drug flags since 2018 yet continues exporting
  • India’s drug regulator admits it lacks the laboratory capacity to test oncology drugs and has never exercised its legal authority to recall unsafe chemotherapy batches
  • Experts warn that weak oversight in generic drug production puts critical cancer medications at risk for millions of patients in low- and middle-income countries