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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 (USFDA) 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 Indian Pharma' 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 address the concerns raised by the USFDA. The OAI also increases the spend on remediation.

A five-year analysis of USFDA inspection data pointed to 20% reduction in observations around essential CGMP training and capabilities and around 45% reduction in observations around lab controls and core manufacturing processes in 2023, versus 2018.

USFDA conveys its concerns on manufacturing practices through Form 483 observations at the end of a facility inspection. Companies that receive its observations must respond in writing with a corrective action plan and implement it quickly.

"While the industry has addressed several critical areas over the last few years, quality expectations continue to evolve where some areas remain to be addressed," said Sathya Prathipati, senior partner, McKinsey & Company

Prathipati pointed to some areas where there has been an increase in observations in recent years.

"There is 35% increase in observations around ‘Facilities and Ancillary infrastructure’ in 2023, versus 2018, 25% increase in observations around ‘Investigations and Root Cause Analysis’ (same period)," Prathipati said

India is home to about 650, or 25% of USFDA approved plants outside the US. India also has the highest number of USFDA plants after the US.

During the pre-pandemic period, on an average India used to see about 200 inspections annually. This number dropped to 80 in 2020, and to just 5 in 2021 due to Covid related disruptions. India exported pharmaceuticals worth $27.9 billion in 2023-24, of which the US accounted for 31%