Gujarat FDCA is planning to collaborate with National Institute for Pharmaceutical Education and Research (NIPER) Ahmedabad to equip officers on detection of serious adverse events (SAE) caused by the use of medical devices to ensure patient safety.
This will be a major boost to the government’s materiovigilance programme of India launched two years ago. Materiovigilance Programme of India was launched by the Union Health Ministry on July 6, 2015 at Indian Pharmacopoeia Commission (IPC), Ghaziabad.
The government of India has also mandated National Institute for Pharmaceutical Education and Research (NIPER) Ahmedabad to initiate a National Centre for Medical Devices (NCMD) for development of skilled manpower in the medical device industry. This would involve collaborative inputs from the industry to help build innovation ecosystem and develop human resources for the industry along with a testing infrastructure at NIPER.
This would also complement the first upcoming medical device testing lab of the country at Vadodara in Gujarat.Union Health Ministry has already sanctioned an amount of Rs. 15 crore towards setting up a dedicated medical device testing lab at Vadodara some time back.
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.
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 medical device testing lab based on an Engineering Export Promotion Council (EEPC) Meet at Ahmedabad one and a half years ago which raised the demand for setting up a dedicated medical device testing lab to ensure quality assurance of medical devices manufactured in the country.