India's Gujarat state moves closer to country's first medical device testing lab

A lab dedicated to biocompatibility and medical device testing to be based in India's western Gujarat state, a manufacturing hub, would mark a first and has received backing from the federal government with hopes of getting state officials to offer funds as well.

This week, experts from India's National Institute of Health reviewed plans for the lab with the Gujarat Food and Drug Control Administration, Pharmabiz reported.

Companies that manufacture in the state see the lab as a crucial component for quality checks that would aid business with the Commerce Ministry based Engineering Export Promotion Council urging state officials to allocate funds for the project, Pharmabiz said.

H.G. Koshia

The plan has been pushed by H.G. Koshia, commissioner of the Gujarat FDCA, Pharmabiz said, and hopes are high for approval.

"They (NIH) were impressed by our vision to establish this testing lab dedicated for the medical device sector, a much needed factor for the growth of the industry," Koshia told Pharmabiz.

Last month, a key devices industry group, AdvaMed, or the Advanced Medical Technology Association, hailed legislation pending in India's parliament that would draw a sharp line between medical devices and drugs.

The Drug and Cosmetics Bill is "historic because it creates a distinction between drugs and medical devices for the first time in India's legislative history," Sanjay Banerjee, chair of AdvaMed India, told the Economic Times.

The group claims it produces nearly 90% of the healthcare technology purchased annually in the United States and more than 40% purchased annually around the world.

For India however, Pharmabiz said, domestic device manufacturers are forced to send products to countries like Singapore for tests before they can get international marketing nods, a process the publication said was time consuming and costly.

- here's the story from Pharmabiz