WHO-UNODC report on Contaminated Medicines

Prelims: Current events of national and international importance| General science

Why in News?

Recently, the WHO-UNODC released a report revealing that Contaminated medicines killed 1,300 people in last 90 years.

• Critical findings - This report provides for persistent and preventable threat of excipients contamination worldwide.

• WHO Alerts - Since October 2022, it has issued seven ‘Medical Product Alerts’ concerning multiple batches of contaminated liquid oral medicines.
  • Marketed for paediatric use and exported widely to low- and middle-income countries.
  • Two alerts concerning falsified bulk chemicals masquerading as pharmaceutical-quality excipients.
• Issue - Most of the recent cases involve inexpensive oral liquid medicines that can be bought without a prescription.
• In most cases these are marketed specifically for children and are registered medicines available in pharmacies.

• Impact
  • Children are mostly affected by these contaminated drugs.
  • Disproportionately affected people in low and middle-income countries.
• Contamination aiding factors

• Unregulated production - Manufacturers of high-risk pharmaceutical grade excipients are not currently subject to regulatory oversight
• Unsafe reuse & poor oversight - Lack of control on recycling or reuse of empty drums of pharmaceutical excipients, resulting in the packaging being passed on to third parties for reuse.
• Absence of tracking system - Lack of traceability systems used in relation to high-risk excipients.

• Recommendation
  • Addressing systematic weakness - Strengthening of systemic vulnerabilities in the global supply chain of pharmaceutical excipients.
  • Regulatory reform - Need for improved regulatory frameworks and enforcement mechanisms.
  • Improving visibility - Greater transparency and traceability in the excipient supply chain.
  • Collaborative mechanism - Stronger association between the health and law enforcement authorities, and the private sector.

Reference

The Hindu| WHO-UNODC report on Contaminated Medicines