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Govt to explore possibility of integrating India’s first medical device testing lab with NCMD
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Shardul Nautiyal, Mumbai
June 01 , 2017
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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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