US FDA raps Indian drugmakers over manufacturing facility failures

American regulator the US Food and Drug Administration has issued warning letters to India’s top drug firms such as Dr Reddy’s, Sun Pharma, Lupin, Glenmark Pharmaceuticals, Biocon, Torrent Pharma, Aurobindo and Cadila, among others. Facing the heat, drug majors appear to be cleaning up their act, reports The Pharma Letter’s India correspondent.

In the last year, the US FDA has increased its scrutiny of the Indian pharmaceutical sector. India accounted for nearly one-third of total foreign inspections by the agency between October 2018 and June 2019, according to data collated by Jefferies India.

In a report, the research firm said FDA inspections on Indian pharma plants exporting to the USA have increased lately and that the increased scrutiny is expected to result in higher costs in quality enhancement for Indian drug makers. In the past four years, India’s share in the total number of foreign inspections by the US FDA was about one-fifth of the total.