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Shardul Nautiyal, Mumbai June 01 , 2017
In order to effectively bring in testing and research competencies under one roof to better the prospects of medical device sector in the country, Department of Pharmaceuticals (DoP) is currently evaluating the possibility to integrate India’s first upcoming medical device testing lab with the National Centre of Medical Devices (NCMD), which is scheduled to be set up at National Institute of Pharmaceutical Education and Research (NIPER) Ahmedabad as per government mandate.

“DoP will have to talk to the Health Ministry to take a final call whether the medical device testing lab will be a part of NCMD or will be an independent entity under the Health Ministry. Since medical device is a fast growing sector, a medical device testing lab should be integrated with the NCMD for the holistic development of the medical device sector in the country because this would allow research and testing under one roof for the betterment of the sector,” according to an official associated with the development.

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 Union Health Ministry had recently 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 to help Indian manufacturers gain self-reliance in medical device testing in the country.

Meanwhile, NIPER Ahmedabad has also sent a fresh proposal to the DoP to sanction an amount of around Rs.150 crore for setting up a centre of excellence for strengthening academic research and development of skilled manpower for medical devices sector.

Gujarat Food and Drug Control Administration (FDCA) had also 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 medical testing lab at Vadodara.

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.

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