Substandard Generic Drugs — Threats to Patient Safety and National Security

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Source: NEJM

Original: https://www.nejm.org/doi/full/10.1056/NEJMp2518256?af=R&rss=currentIssue...

Published: 2026-03-18T09:00:00Z

Substandard generic drugs pose a threat to patient safety and national security because they do not meet established quality specifications.[1] According to the 2009 WHO definition, these are genuine medicines from authorized manufacturers, but they do not meet national quality standards.[1] Examples include streptokinase, where 13 of 16 products had only 20.8–86.6% of the declared activity, and carvedilol, where 48.6% (n=35) of generic samples from 19 countries did not meet content specifications (95–105%).[1] These drugs can lead to treatment failure, such as increased antibiotic resistance or failure to respond to less active antimalarials.[1][2] Postoperative infections have occurred in Greece following the use of generic cefuroxime with an inadequate formulation.[1] Substandard antimicrobial drugs, especially antibiotics and antimalarials (36% of reported cases), threaten public health in endemic areas.[2] The problem occurs in supply chains with limited control of good manufacturing and distribution practices.[2]