Substandard Indian Chemotherapy Drugs Raise Global Health Alarm

A recent landmark study by researchers at the University of Notre Dame (USA) and partners in four African countries (Cameroon, Ethiopia, Kenya, Malawi) revealed that nearly 1 in 5 chemotherapy drug samples failed quality standards. Of the 17 implicated manufacturers, 16 are Indian.

Key-findings of the Study

• 189 drug samples of 7 essential cancer drugs were tested (including cisplatin, cyclophosphamide, methotrexate, etc.).
• 20% samples failed quality tests:
• Some had too little active ingredient (as low as 25%).
• Others had too much, risking overdose and organ toxicity.
• Several samples from the same blister pack showed inconsistent dosage, indicating poor manufacturing quality.

Why this is alarming?

• The chemotherapy drugs are used to treat common cancers: breast cancer, leukaemia, ovarian cancer, etc.
• Generic chemotherapy drugs are lifelines in low- and middle-income countries, where alternatives are unaffordable.
  • Patients in LMICs (low- and middle-income countries) pay up to 58% of cancer drug costs out-of-pocket (vs. <2% in high-income countries).
  • The poorest patients suffer most when drugs fail or run out due to faulty batches.
  • Indian pharma firms, though critical to global health access, face growing scrutiny for quality concerns.
• Poor-quality drugs can lead to:
  • Treatment failure (if under-dosed).
  • Severe side effects or death (if overdosed).
  • Loss of trust in healthcare systems.

Key Countries and Companies Involved

• India: World's largest generic drug producer; major source of the failed drugs.
• Ethiopia and Malawi: Countries where doctors reported unexpected treatment failures and toxicity symptoms in patients.
  • Venus Remedies, Zuvius Lifesciences, United Biotech, among others, were named in the report.
  • Intas Pharmaceuticals, previously found falsifying records, had gained dominant market share in the U.S.

Systemic Issues Highlighted

• Weak Global Regulatory Oversight: 70% of countries lack capacity to test drug quality. Even U.S. FDA admitted its overseas inspections are inadequate.
• Lax Domestic Monitoring (India): Companies with repeated quality violations (e.g., Zee Laboratories) face few consequences: India’s drug regulator rarely discloses timelines or penalties for substandard production.
• WHO Limitations: WHO’s essential medicines list only recently expanded to cancer drugs (post-2019). WHO quality certification is reportedly misused or manipulated by some companies.
• Economic Pressure: Price-cutting incentives often push manufacturers to cut corners in manufacturing or ingredient sourcing.

Required Measures:

• Tighter international regulation and mandatory random testing of generic drugs, especially cancer medicines.
• Stronger domestic oversight in India, including public disclosure of penalties, blacklisting, and reforms in CDSCO functioning.
• Expand the WHO essential medicines list to include more critical cancer drugs.
• Push for greater transparency and accountability in global drug procurement chains (especially via UN agencies).