Despite the surge in USFDA scrutiny of Indian Pharma plants, on an average Indian sites have had only a nine per cent share of total global inspections, analysts point out. Moreover, while the pace of inspections has been on the rise since calendar year 2020, it is still significantly below pre-Covid-19 levels.
According to an analysis by India-Ratings, Indian Pharma is exposed to an average nine per cent of overall global inspections over CY09 to Q1FY23. “According to USFDA data, Indian pharma exposed to average nine per cent of inspections over CY09-Q1FY23 against US at 61 per cent. This is despite the fact that Indian companies have the second largest number of US Food and Drug Administration (USFDA) approved plants (both API and formulations), largest number of ANDA filings (required for formulation) market share (around 35 per cent), largest number of DMF filings (required for API; market share around 50 per cent), volume share of around 40
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