Unsafe Cancer Drugs

How Unsafe Cancer Drugs Reach Patients

Context : A major investigation has revealed that contaminated and poor-quality cancer drugs have been distributed to over 100 countries, highlighting severe gaps in global pharmaceutical safety, especially in low- and middle-income countries.

Risks in Drug Manufacturing:

• Contamination is a primary concern.

• The responsibility for ensuring sterility lies with manufacturers.

• Even minor lapses (e.g., unclean water, improperly sterilised rooms or equipment) can make life-saving cancer drugs toxic or ineffective.

Drug Safety Systems:

In the U.K. (a gold-standard model):

• Two rounds of quality testing (at source and upon entry).

• Checks for 20+ quality markers per batch.

• MHRA inspections of domestic and foreign manufacturing units.

In Low- and Middle-Income Countries (e.g., Nepal):

• No effective drug testing facilities.

• Lack of regulatory expertise, tracking systems, and verified experts.

• Vulnerable to fake and substandard drug imports due to corruption and porous borders.

Consequences of Contaminated Cancer Drugs:

Specific Cases:

• Methotrexate (a critical chemotherapy drug for leukemia):

  • Yemen (2022): At least 10 children died after receiving methotrexate contaminated with deadly bacteria.

• Vincristine (used in chemotherapy):

  • Saudi Arabia (2019): One child died, four others developed fever after receiving Indian-made vincristine alongside other chemo drugs.

• Unspecified substandard brands of childhood cancer drugs:

  • Colombia (2019): Four child deaths, over 100 fell ill after receiving poor-quality drugs.

  • Brazil (2023): The Bureau of Investigative Journalism identified a dozen poor-quality brands used in pediatric cancer treatment.

WHO’s Response and Interventions:

1. Rapid Alert System – flags harmful drugs but only after incidents occur.

2. Global Benchmarking Tool – rates national regulatory systems (70% of countries rated Level 1 or 2, meaning low capability).

3. Essential Medicines List – helps countries prioritize and focus on safe, essential drugs.

4. Prequalification Programmes – WHO-certified lists of safe drugs, APIs, and labs.

5. GMP Certification – ensures drugs are made under globally accepted Good Manufacturing Practices.

6. Certificate of Pharmaceutical Product (CoPP) – functions like a "passport" for drugs, validating them for export.

Despite WHO systems and model regulations in countries like the U.K., methotrexate, vincristine, and various childhood cancer drugs have caused harm and deaths due to substandard manufacturing and weak global oversight. Until low-income nations are equipped with proper regulatory systems, unsafe cancer drugs will continue to endanger lives globally.