US FDA to Increase Inspections in India

The US FDA will increase inspections of Indian drug and medical device manufacturing facilities in response to growing concerns about the quality of Indian medical device and pharmaceutical products. In mid-September, the agency issued the latest of many import alerts against Indian generics manufacturers — this time Ranbaxy — for problems ranging from contaminated drug products to falsified documentation.

According to an FDA spokesperson, the agency will increase its India based staff by more than 60 percent by year’s end. Currently, there are just 12 inspectors in the FDA Delhi and Mumbai offices. By 2014, the FDA said it hopes to have a total of 19 inspectors and possibly a new office in Hyderabad. Ten of the FDA inspectors will be dedicated to pharmaceutical products oversight, and the remaining nine will work on medical devices and food.

Expansion of the FDA’s India offices has been funded by generic drug user fees authorized by the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA). Under FDASIA, the FDA must achieve the same inspection schedule for foreign facilities as domestic manufacturers. In 2012, the FDA increased its total overseas inspections by 10 percent from 2011.

India is one of the largest providers of finished dose products to the US, constituting 10 percent of the market. Fixing quality problems there will be as difficult as “scaling Mount Everest,” according to the FDA’s new India head, Dr. Altaf Ahmed Lal. But in a blog post on the FDA website, he says that it can be done through “collaboration, coordination and commitment.”