Indian pharmaceutical companies have made major strides in adhering to stringent US Food and Drug Administration (USFDA) norms in 2024, with data suggesting a decline in the number of adverse classification outcomes of inspections across biologics, drugs, and devices.
In 2023, the USFDA conducted 225 inspections, which led to 18 cases of Official Action Indicated (OAI) and 117 cases of Voluntary Action Indicated (VAI). By 2024, despite a tightening of regulatory standards, the number of inspections dropped to 206, while OAI cases fell to 14 and VAI cases reduced to 115. This highlights that the sector is increasingly aligning with global benchmarks to ensure high-quality manufacturing practices.
Looking back at the pre-pandemic years, there was a 100 percent increase in OAI status from 2018 to 2019. However, the onset of the pandemic in 2020 led to a 75 percent drop, and the status fell 50 percent in 2021.
Diese Geschichte stammt aus der December 30, 2024-Ausgabe von Business Standard.
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