The Gujarat State Food and Drug Control Administration (FDCA), which has initiated efforts to achieve expertise and facilities to effectively monitor and regulate the medical devices industry, is expected to receive tips from the US Food and Drug Administration (US FDA) on the latest technology developments in the segment, it is learnt.

Senior officials from the Indian office of the US FDA, during their visit to the Gujarat FDCA in the end of July, has agreed to work in collaboration with the state drug regulator to share their expertise for the effective regulation of medical devices industry in the state, said H G Koshia, commissioner, FDCA.

“Gujarat is the hub of medical devices industry in the country and is expected to grow in higher pace with the central government’s proposed medical devices cluster project. In our discussion with the US FDA officials, they assured their support to improve our knowledge and manpower skills on the segment,” said Koshia.

He added that the collaboration would be mutually beneficial, since the state drug regulator would be able to ensure quality of medical devices on the one hand and the US drug regulator could expect enhanced quality of medical devices exported to its territory from Gujarat.

The medical devices segment is comparatively a new arena for the Indian drug regulators, hence calling for more attention in training the existing regulatory officials, who have worked more on pharmaceuticals, in areas like metallurgy and related subjects for better monitoring.

The FDCA claims that the state is the largest manufacturer of medical devices with more than 100 manufacturing licenses issued for the segment. The administration has issued 11 licenses for units manufacturing orthopedic implants, 25 for IV and BT set manufacturing units, nearly 50 for cotton benders and gauze manufacturers, six for intraocular lenses, four for cardiac stents and another four for catheter manufacturing, said Koshia.

The state accounts for 50 per cent of the orthopedic implants, 35 per cent intraocular lens and more than 30 per cent of the cardiac stents produced in the country, he informed. Further, the state is expected to increase its performance in the segment, as the central government, through the Department of Pharmaceuticals, is working on a cluster project to set up common facilities for medical devices industry near Ahmedabad with the support of the state government.

Anticipating a huge upsurge in medical devices production in the state, the FDCA has also initiated a project to set up a laboratory for testing quality of devices in the premises of its existing food and drug testing laboratory at Baroda.