Indian drug manufacturing sites exporting to the US have fared better on regulatory inspection outcomes compared to global average in 2023. The drug regulator United States Food and Drug Administration ( ) has classified 13%, or 19 out of 145 inspections it carried out against Indian facilities, as Official Action Indication (OAI) in 2023, which is lower than the global average of 15% OAIs, according to a report by Indian Pharmaceutical Alliance and McKinsey & Company said. USFDA inspected 906 facilities globally, out of which it classified 133 facilities as OAIs.
Official Action Indicated (OAI) means regulatory and/or administrative actions will be recommended. The report titled 'Quality & Manufacturing Excellence Charting the Next Decade of ' said inspection outcomes also improved significantly from 26% OAIs in 2014 to 13% in 2023. In 2014, the global average for OAIs was 7% out of 1839 inspections, while everyone out of four inspections in India was OAI in the same year.
USFDA classifies its inspection as OAI for plants found in an unacceptable state of compliance with current good manufacturing practices (CGMP). The agency will intimate the company about the classification within 90 days of the inspection. While an OAI classification doesn’t impact existing supplies and revenues from operations of the facilities, it blocks new product approvals filed from the site.
In addition, it may even trigger a warning letter or import ban, if companies fail to satisfactorily addre.
