Exposure to US market causing constant FDA scrutiny for big drug firms

Dr Reddy's was in the news for falling short of expectations during routine audits conducted by the US drug regulator

Exposure to the US market and constant product filings are among the reasons why bigger Indian pharma players are more in regulatory glare than their smaller peers, according to analysts.

The shortfalls or deviations being noted by the US Food and Drug Administration (US FDA) inspectors during the inspection of manufacturing facilities are often causing a slowing down in terms of new filings or new launches impacting the revenues of these companies.

Dr Reddy's Laboratories Limited was the first Indian pharma player to secure the FDA approval for a manufacturing plant in the late eighties when the company set out