Finally, Indian pharmaceutical industry scores on compliance with USFDA

2018 saw remedial work finally bearing fruit

After years of struggle, the Indian pharmaceutical industry finally got many things right in 2018 with the American government’s drugs regulator.

Not only did inspection outcomes improve, far more in line with global outcomes. The number of cases where the Food and Drug Administration (FDA) there chose to classify a production unit here under the 'Official Action Indicated' (OAI) category fell sharply. 

From 27 cases of OAI in 2014 and 22 in 2017, the number shrank significantly to seven. After an inspection, the FDA classifies a plant as either OAI, VAI (Voluntary Action Needed) or NAI (No Action Needed). 

This change came even