Indian pharmaceutical companies spread business to avoid regulatory ire

Increased USFDA import alerts could be reason for finding alternative sites

In 2019 so far, Indian drug makers (including active pharmaceutical ingredient makers) got 11 warning letters from the US drug regulator —much more than the seven which came in all of 2018. Major companies say to de-risk their business; they have developed alternative sites for their key products. 

The aim being to reduce dependence on a single site, in case they get an import alert that would stop export to the US from the particular site. 

Once the US regulator, the Food and Drug Administration (FDA), inspects a particular site, it may classify under Official Action Indicated (OAI) or Voluntary