Key Findings from the Study
- A University of Notre Dame study tested 189 chemotherapy drug samples across countries.
- ~20% of samples failed quality checks — posing risks of ineffective treatment or toxic side effects.
- 16 of 17 failed drug manufacturers were India-based.
- Failed drugs were exported to over 100 countries, including Nepal, Ethiopia, U.S., U.K., and Saudi Arabia.
Relevance : GS 2(Health , Governance )
Drugs & Manufacturers Under Scrutiny
- Venus Remedies: All 8 samples of its cyclophosphamide failed.
- Claimed test results were not “scientifically plausible”.
- Blamed storage conditions, denied receiving complaints.
- Zuvius Lifesciences, GLS Pharma, and Zee Laboratories:
- Supplied poor-quality drugs to 40+ countries.
- Did not respond to repeated requests for comment.
- Deviation from international testing standards was alleged by manufacturers, but:
- Study leader Marya Lieberman defended the methodology.
- Testing was peer-reviewed and followed standard practices.
Types of Drug Failures
- Too little active ingredient: Rendered the medicine ineffective.
- Too much active ingredient: Posed risk of organ damage or death.
- Case evidence:
- Doctors noted patients becoming unresponsive to treatment or suffering extreme side effects.
- Some were forced to discontinue chemotherapy due to toxicity.
Global Regulatory Gaps
- More than two-thirds of countries cannot assure medicine quality.
- Nepal:
- One of the largest importers of the failed drugs.
- No capacity to test cancer drugs.
- Has never recalled any cancer drug despite external evidence.
- Patients have no visibility on drug quality; no accountability mechanisms in place.
India: Major Supplier, Questionable Oversight
- India is the world’s largest generic drug manufacturer.
- Activists like Dinesh Thakur allege:
- Indian drug regulation protects industry more than patients.
- Enforcement is inconsistent and weak.
- The Central Drugs Standard Control Organisation (CDSCO):
- Claims failing drugs are recalled, and legal action is taken.
- Lacks transparency on actual recall data or prosecutions.
High Stakes for Patients
- In low-income countries (e.g., Ethiopia), patients save for months or years to afford treatment.
- Receiving a faulty drug can be financially and emotionally devastating.
- Chemotherapy is already physically taxing; substandard drugs worsen outcomes.
Larger Implications
- Highlights failure of international drug surveillance systems, including the WHO.
- Raises concerns over reliance on generic exports from countries with poor regulatory capacity.
- Calls for:
- Stronger cross-border pharmacovigilance.
- International accountability mechanisms.
- Investment in regulatory infrastructure in importing countries.
