USFDA assures of assistance on training for medical devices

US Food and Drug Administration (USFDA) has assured of assisting Gujarat medical devices' industry for training and knowledge sharing aspects, a top state official said here today.

"US health regulator USFDA, country director (India) Bruce Ross has assured us to provide assistance on training and knowledge sharing for medical devices in Gujarat," Commissioner Food and Drugs Control Administration H G Khosia told PTI.

Ross, who recently visited Gujarat and was amongst the speakers at the Drug Information Association seminar on Chemistry Manufacturing and Changed Control Compliance, for quality by design.

"There are close to 150 medical device manufacturing facilities, of which around 30 have the prestigious European Union CE Certification. There are also 31 USFDA approved drug making facility in Gujarat," he said.

"Gujarat is emerging as a major manufacturing hub for niche medical devices such as Orthopaedic implants, cardiac stents and intraocular lens implant's (IOL's) and this has lot of scope for expansion too," Koshia said.

Gujarat's contribution to minuscule exports of medical devices from the country in product categories like orthopaedic implants is (50 per cent), cadiac stents(50-60 per cent) and IOL's (30 per cent), FDCA official said.

A medical device cluster spread over 110 acres of land is proposed to come here adjacent to Tata Nano plant site at Sanand in Gujarat, having common facilities for product research and development for the industry.

The common facilities for research and product development shall be set up as part of joint venture between government of India, Department of Pharmaceuticals, NIPER and government of Gujarat with an investment of Rs 60 crore.

"Of which, GoG has approved an amount of Rs 30 crore and also released an amount of Rs 10 crore for it," sources close to development said.

"The cluster is expected to house close to 20-25 units, which shall exclusively be into the manufacturing of high-end medical devices like Orthopaedic implants, cardiac stents, IOL's," they said.

Such high-end medical products require lot of physical, biological and chemical testing facilities before they can be rolled out, they said.