WHO-UNODC Report: Contaminated Medicines Linked to 1,300 Deaths Over 90 Years

Quick Summary

• Over the past 90 years, at least 25 incidents of excipient contamination globally resulted in over 1,300 deaths, many of them children.
• Excipients are inactive substances used to deliver active drug components to patients. Contaminations mainly involved diethylene glycol (DEG) and ethylene glycol (EG), industrial chemicals that can be fatal even in small amounts.
• Major cases concerned inexpensive paediatric oral liquid medicines sold without prescriptions in pharmacies and informal markets.
• incidents stem from vulnerabilities in the global supply chain predominantly affecting low- and middle-income countries with limited regulatory oversight.
• Since October 2022, WHO issued seven ‘medical Product Alerts’ about contaminated medicines marketed for children; two alerts addressed falsified bulk chemicals used as pharmaceutical-quality excipients.
• The report titled “Contaminated Medicines and Integrity of the Pharmaceutical Excipients Supply Chain” highlights a lack of regulatory control on excipient manufacturers and issues with recycling packaging materials meant for pharmaceutical use.
• Recommendations include enhanced regulatory frameworks, better traceability systems for high-risk excipients, and stronger collaboration between health authorities, law enforcement agencies, and private sector stakeholders.

Indian Opinion analysis

The findings from this report underscore critical gaps in international pharmaceutical safety standards that could have serious implications for India’s healthcare ecosystem given its position as one of the largest producers of generic drugs globally. With export markets focusing on affordable medicines aimed at low-income populations internationally-including many paediatric products-it becomes imperative for India to prioritize rigorous oversight mechanisms along its supply chain.

Systemic flaws like insufficient regulation or traceability pose risks not just abroad but domestically too if unchecked contaminants enter local medicine stocks meant for underserved communities. Strengthening legal frameworks governing excipient suppliers-while improving collaboration across industry sectors-may mitigate these risks while fostering confidence among global buyers regarding Indian pharmaceuticals.

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