Indian Pharma Sees Fewer USFDA Adverse Outcomes in 2024

Indian pharmaceutical firms have achieved significant progress in complying with rigorous US Food and Drug Administration (USFDA) standards in 2024, with evidence indicating a reduction in adverse outcomes from inspections involving biologics, pharmaceuticals, and medical devices.

In 2023, the USFDA performed 225 inspections, resulting in 18 instances of Official Action Indicated (OAI) and 117 instances of Voluntary Action Indicated (VAI). By 2024, even with stricter regulatory standards, inspections decreased to 206, while OAI cases declined to 14 and VAI cases lowered to 115. This emphasizes that the industry is progressively aligning with international standards to guarantee superior manufacturing practices.

Reflecting on the years before the pandemic, there was a 100 percent rise in OAI status between 2018 and 2019. Nonetheless, the beginning of the pandemic in 2020 resulted in a 75 percent decline, and the status decreased by 50 percent in 2021.

When the FDA evaluates a facility, it categorizes the outcomes according to the inspection results. If there are any deficiencies, the facility gets a VAI designation, indicating that unacceptable conditions or practices were noted, but the facility is allowed the chance to rectify them voluntarily without prompt regulatory measures from the FDA. The FDA could assist in this process via a regulatory meeting.