To help Indian manufacturers gain self-reliance in medical device testing in the country, the Union Health Ministry has sanctioned an amount of Rs.15 crore towards setting up a dedicated medical device testing lab at Vadodara for the first time in the country.
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.
Gujarat Food and Drug Control Administration (FDCA) had earlier sent an MoU to HLL, a company under Union health ministry 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.
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.
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.