Indian pharmaceutical manufacturing sites exporting to the US saw improved regulatory inspection outcomes in 2023 compared to the global average. A report by the Indian Pharmaceutical Alliance and McKinsey & Company revealed that 13% of Indian facilities inspected by the USFDA were categorized as ‘Official Action Indication’ (OAI), lower than the global average of 15%.
The USFDA conducted inspections at 906 facilities worldwide, resulting in 133 facilities receiving OAI classifications. An OAI status indicates that regulatory or administrative actions will be recommended. The report, titled ‘Quality & Manufacturing Excellence Charting the Next Decade of Indian Pharma,’ noted a significant improvement from 26% OAI classifications in 2014 to 13% in 2023.
OAI classifications by the USFDA indicate non-compliance with current good manufacturing practices (CGMP). Although it doesn’t immediately impact production or revenue, it can hinder new product approvals and lead to further regulatory actions like warning letters or import bans if issues aren’t resolved. The report highlighted increased remediation costs post-OAI classification.
Over a five-year span, there was a notable decrease in USFDA observations related to essential CGMP training and laboratory controls in 2023 compared to 2018, signaling improvements in manufacturing practices. Companies receiving Form 483 observations must respond with corrective action plans promptly to address FDA concerns.
