Gujarat Food and Drug Control Administration (FDCA) has written to the Commerce Ministry to expedite the process of setting up India’s first medical device testing lab at Vadodara in Gujarat.

Recommended and promoted by the Union commerce ministry, the country’s flagship project will be developed in partnership with Union health ministry with technical support from Healthcare Technology Division of National Health Systems Resource Centre (NHSRC), a technical support institution under the Union health ministry.

The site for country’s first medical device testing lab at Vadodara was approved 8 months ago based on an audit. Following which, the union health ministry in consultation with Government of Gujarat also sanctioned Rs. 15 crore towards setting up a dedicated medical device testing lab at Vadodara.

The testing lab will allow manufacturers to overcome deficiencies in their products and hence ensure safety and efficacy of medical devices marketed in the country.

NHSRC, which surveyed 16 testing labs in the country and nine medical device testing labs across the globe had submitted a report to the government specifying the need for setting up the testing lab. It had also suggested in its report the modalities required for setting up such a dedicated medical device testing lab based on the standards existing globally.

Gujarat Food and Drug Control Administration had earlier sent a proposal to HLL for procurement of testing equipment through a global tendering process towards setting up the testing lab.

Setting up of a dedicated medical device testing lab in the country would be a boon for the Indian manufacturers to help adhere to compliance towards patient safety as the country today lacks in registering and thereby reporting adverse events due to faulty medical devices at the point of care.

Gujarat FDCA pursued the matter of setting up the testing lab based on an Engineering Export Promotion Council (EEPC) Meet at Ahmedabad one and a half years ago which raised the need for setting up a dedicated medical device testing lab to ensure quality assurance of medical devices manufactured in the country.

Till date, products are usually sent to foreign countries for testing due to lack of a reliable and advanced medical device testing facility in the country. Though the government plans to set up two medical device testing labs in the country at Vadodara in Gujarat and another at Noida subject to getting approvals, medical device testing lab in Gujarat would be the first and the only dedicated biomaterials and implants testing lab in the country. The lab at Noida will be set up primarily to test electrical and electronic medical devices in the country.