Indian pharma sites outpace global standards in USFDA inspections for 2023

The USFDA categorised 13 per cent (19 out of 145 inspections) of Indian facilities as 'Official Action Indication'(OAI), which is lower than the global average of 15 per cent OAIs

Indian pharmaceutical manufacturing sites exporting to the US showed better regulatory inspection outcomes in 2023, 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) categorised 13 per cent (19 out of 145 inspections) of Indian facilities as ‘Official Action Indication’ (OAI), which is lower than the global average of 15 per cent OAIs, as reported by The Economic Times.

The USFDA conducted inspections of 906 facilities worldwide, resulting in 133 facilities being classified as OAIs.

‘Official Action Indicated’ status implies that regulatory and/ or administrative actions will be recommended.

 

According to the report titled ‘Quality & Manufacturing Excellence Charting the Next Decade of Indian Pharma’, there has been a significant improvement in inspection outcomes. Specifically, the percentage of Official Action Indicated (OAI) classifications decreased from 26 per cent in 2014 to 13 per cent in 2023.

Comparatively, the global average for OAIs in 2014 was 7 per cent out of 1839 inspections, highlighting a higher incidence in India during the same period, the report said.

What is an OAI classification?

The USFDA classifies inspections as OAI when it finds manufacturing plants to be non-compliant with current good manufacturing practices (CGMP). Following an inspection, the FDA informs the company of this classification within 90 days.

While an OAI classification does not immediately affect existing production or revenue, it can block new product approvals from the site and potentially lead to further regulatory actions such as warning letters or import bans if issues are not adequately addressed. Remediation costs also typically increase following an OAI classification, the report stated.

A five-year analysis of USFDA inspection data indicates a 20 per cent decrease in observations related to essential CGMP training and capabilities, and a 45 per cent decrease in observations concerning laboratory controls and core manufacturing processes in 2023 compared to 2018.

Assessment of manufacturing practices

The USFDA conveys its concerns regarding manufacturing practices by issuing Form 483 observations following facility inspections. Companies that receive these observations are required to submit a written response outlining a corrective action plan and promptly execute it.

The report quoted Sathya Prathipati, senior partner, McKinsey & Company, as saying, “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.”

He further said, there has been a 35 per cent increase in observations around 'Facilities and Ancillary infrastructure' in 2023 as compared to 2018, 25 per cent increase in observations around "Investigations and Root Cause Analysis" during the same period.

Manufacturing plants in India

In India, around 650 plants, constituting a quarter of all USFDA-approved facilities outside the United States, highlight its significant role in pharmaceutical production. Following the United States, India boasts the second-highest number of USFDA-approved plants.

Before the Covid-19 pandemic, India underwent around 200 inspections each year. However, in 2020, this figure decreased to 80, dropping down further to only five in 2021 due to disruptions caused by the pandemic. Despite these challenges, India managed to export pharmaceuticals valued at $27.9 billion in the financial year 2023-24, with the United States accounting for 31 per cent of these exports.