US drug regulator to build capacity of Indian exporters

With instances of import alerts on the rise, the US drug regulator is now working on capacity building of Indian exporters.

The local drug regulator in Gujarat, the Food and Drug Control Administration (FDCA) pointed out that the US Food and Drug Administration (USFDA) is sending at least three senior drug inspectors from the country to Ahmedabad for a training session on quality assurance with local drug exporters. The session would also have representation from the academia.

H G Koshia, commissioner, Gujarat FDCA said that in the last meeting with USFDA's new director in India, Altaf Ahmed Lal in March, the issue of capacity building and training of exporters was discussed. "He was on a visit to Gujarat, and we had discussed about the training issue, as it would significantly help exporters." He added that the issue is not so much of quality of the drugs, but more related to documentation etc.

Taking cue from the need to train local industry, USFDA is organising a training session in Ahmedabad this week. The domestic industry had already initiated talks with the US regulator in the wake of frequent import alerts on Indian manufacturing facilities.

A Gujarat-based pharma exporter too confirmed the same, adding that, "Local exporters need to have a better idea about the law of the land in the US, and this would go a long way to reduce compliance related issues."

The Indian Pharmaceutical Alliance (IPA) had approached the US FDA in this regard. The IPA has 19 members, including multinational companies such as Ranbaxy, Wockhardt, Sun Pharma and Lupin.