Finally, India to get labs to test medical devices

In a first step towards recognizing medical devices as an industry separate from the pharmaceuticals industry and requiring different regulatory standards, the commerce ministry has decided to fund the setting up of three medical device testing laboratories in Noida (UP), Haryana and Gujarat, which already have device manufacturing clusters.

These laboratories are being set up to provide a boost to the domestic manufacturing sector by providing adequate infrastructure for device testing based on project proposals and technical support given by the National Health Systems Resource Centre (NHSRC).

While the Haryana and Gujarat governments have promised to allot land for the labs, in Noida, HLL Lifecare Ltd, a PSU, will be providing its campus for set ting up the laboratory.

Speaking at the conference on patient safety and medical devices on Friday, Rajiv Capoor, joint secretary in the ministry, said that though medical devices have a huge potential in India, 7075% of the market continued to be import based.

“To grow the industry and achieve the $25 billion target, we need to lay greater emphasis on developing standards and making regulatory amendments to the existing Drugs and Cosmetics Act,” said Capoor.

He added that in keeping with government encouraging the medical devices sector in India and its ‘Make in India’ drive, the detailed report on setting up of these laboratories would be timely.