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Study Clears Confusions Linked to US Drug Shortages and API Manufacturers During COVID pandemic

Visual Representation

United States: The COVID-19 pandemic has been always linked to the shortage of vaccines, which has always been a concern for the health experts, recently a study has revealed shortages of approximately 11 percent of the generic active pharmaceutical ingredients (APIs) made by global manufacturers. 

Out of the total, 35 percent of them were from larger facilities in India which were tied to generic-drug unavailability in the US. The conclusions have been made by a research letter posted in JAMA, this week, as outlined by cidrap.umn.edu.

APIs key to drug quality

Analysts from Johns Hopkins University scrutinized the FDA’s drug scarcity data spanning January 2020 to December 2021. They correlated each scarcity with the Clarivate Analytics Cortellis Generics Intelligence (CGI) repository, which catalogs global generic Active Pharmaceutical Ingredient (API) manufacturers. Details concerning all generic APIs destined for the United States were extracted.

Visual Representation for API Manufacturers

The dataset encompassed the quantity, whereabouts, and attributes of API production facilities; debut year of US abbreviated new drug applications; US-licensed generic drug fabricators utilizing the API; administration routes; and therapeutic classifications.

APIs are pivotal for prescription drug caliber, constituting approximately 90% of US prescriptions in 2022, as remarked by the researchers. They stated, “In 2014, 9% of drug scarcities were ascribed to API unavailability.” Moreover, APIs could potentially be associated with the 40% of scarcities linked to quality issues and the 30% induced by manufacturing delays and capacity constraints, cidrap.umn.edu outlined.

Scarcities endured for an average of 2.3 years

The FDA documented 194 drug scarcities, persisting for an average of 844.6 days and encompassing 162 distinct generic APIs, where 91% were likewise present in the CGI repository. Among the 1,379 US-bound generic APIs in the CGI database, 565 firms manufactured them, with each API originating from an average of 3.7 facilities.

Relative to APIs not connected to scarcities, the 147 scarcity-affiliated APIs (10.7% of 1,379 APIs) were predominantly older products (average year of new-drug endorsement, 1993 vs 2004), affiliated with more approval holders (average, 7.2 vs 4.1), more inclined to be injectable or possessed multiple administration routes, and more likely to be neuromuscular or anti-infective.

Identifying API fabricators associated with scarcities could inform FDA inspections and aid in prioritizing approvals for new participants in susceptible markets.

The quantity of manufacturing facilities did not differ by scarcity affiliation (average, 3.6 vs 3.7). However, establishments connected to at least one API in scarcity (48.1%) produced more APIs (average, 13.7 vs 4.5), showed no distinction by year of last FDA inspection (average, 2017 vs 2018) or reception of an FDA cautionary communication (33 vs 35 facilities), and hosted more non-US assessors (average, 2.1 vs 1.5) compared to those producing APIs not tied to scarcities, as per cidrap.umn.edu.

Visual Representation for Vaccine Administration | Credits: Shutterstock

Altogether, 35.3% of facilities manufacturing APIs in scarcity were situated in India, 12.1% in Italy, 10.7% in China, and 9.6% in the United States.

“Identifying API fabricators associated with scarcities could inform FDA inspections and aid in prioritizing approvals for new participants in susceptible markets,” the authors of the study conveyed and they further mentioned, “Although the pandemic exerted additional strain on global supply chains, underscoring the significance of robust generic drug supply chains for national security, drug scarcities have continued to escalate since then.”

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