India's Drug Approvals Surge Despite FDA Scrutiny

Aug. 17, 2016

Despite the U.S. FDA's inspection blitz on Indian drug manufacturing facilities, the agency has been approving generic drug applications from the country’s drugmakers at a record pace, reports Bloomberg.

Smaller companies like Aurobindo Pharma and Glenmark Pharmaceuticals are leading the way, as the FDA approved a record 83 new generic drug applications from India in the last six months of 2015.

With a number of larger drugmakers, including Sun Pharma and Dr. Reddy's, receiving FDA warning letters, the perception is that India is plagued with quality issues, but this, according to analysts, is not the case.

Surya Patra, an analyst at PhillipCapital India in Mumbai, told Bloomberg that smaller Indian companies are getting more approvals as they take over production of the low-margin generic pills, while larger companies are graduating into more complex, higher-margin medicines.

Read the Bloomberg analysis