As US FDA inspections rise in India, drug majors worry about compliance costs

Indian pharmaceutical companies are concerned about the increase in warning letters and OAIs (official action indicated) from the US Food and Drug Administration, which could potentially delay product launches and can push up regulatory uncertainty and compliance costs. As the number of US FDA inspections increases, so does the number of good manufacturing practices (GMP) warning letters, reports The Pharma Letter’s India correspondent.

With around $9 billion in pharma exports to the USA in the calendar year 2021, India is one of the largest suppliers of generic drugs to the US market. In fiscal year 2020, the country has also been the subject of the highest number of FDA inspections outside of the USA with 177 inspections, accounting for 14% of the total number of FDA inspections.

China, on the other hand, had 18 inspections the same year, with the USA bagging the highest at 770 inspections.