In 2023, Indian pharmaceutical manufacturing facilities exporting to the US showed notable improvement in regulatory inspections compared to the global average, according to a report by the Indian Pharmaceutical Alliance and McKinsey & Company.
The United States Food and Drug Administration (USFDA) classified 13% (19 out of 145 inspections) of these facilities as Official Action Indications (OAI), a decrease from the global average of 15% OAIs.
This marks a significant improvement from the 26% OAIs reported in 2014, indicating enhanced adherence to current good manufacturing practices (CGMP) and regulatory standards.
An OAI classification by the USFDA points out areas of non-compliance that could result in regulatory actions such as warning letters or import bans if corrective actions are not promptly taken.
Although OAIs do not directly impact ongoing operations, they can delay new product approvals and necessitate increased spending on remedial measures. As reported by ibef.org, the inspections also highlighted areas needing improvement in essential CGMP training, laboratory controls, and core manufacturing processes.
