In 2023, Indian pharmaceutical manufacturing facilities exporting to the US demonstrated superior regulatory compliance 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), which is lower than the global average of 15% OAIs. This improvement marks a significant decline from the 26% OAI rate observed in 2014, indicating enhanced adherence to current good manufacturing practices (CGMP) and regulatory standards.
An OAI designation by the USFDA signals areas of non-compliance that could result in regulatory actions such as warning letters or import bans if corrective actions are not promptly undertaken. While OAIs do not directly affect ongoing operations, they can delay new product approvals and necessitate increased expenditure on remedial measures. The inspections also underscored the need for improvements in essential areas such as CGMP training, laboratory controls, and core manufacturing processes.
McKinsey & Company’s senior partner, Mr. Sathya Prathipati, highlighted ongoing industry initiatives aimed at meeting evolving quality expectations. He noted significant enhancements in facility infrastructure, root cause analysis, and overall compliance efforts in recent years, reflecting a proactive approach within the industry to address regulatory challenges.
