Finally, India to get labs to test medical devices

India does not have a single nationally recognized medical device testing laboratory. That is set to change. 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), a technical support institution under the health ministry.

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 setting up the laboratory.

Two reports released on Friday outlined the basic requirements, work flow, infrastructure and human resources required for establishing medical testing laboratories for testing of biomaterials and implants and for testing electrical and electronic medical devices. Released at a conference on patient safety and medical devices, the reports were prepared by the NHSRC in collaboration with the World Health Organization (WHO) country organization with inputs from Underwriter Laboratories (UL), a US-based international safety science company and technical support on implants from the Sri Chitra Tirunal Institute of Medical Sciences and Technology, Trivandrum.

Speaking at the conference, Rajiv Capoor, joint secretary in the ministry, said that though medical devices have a huge potential in India, 70-75% 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.