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Gujarat govt approves setting up India’s first medical device testing lab
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Shardul Nautiyal, Mumbai
August 29 , 2016
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Gujarat government has finally approved setting up of country’s first
medical device testing lab to be housed at Gujarat Food and Drug Control
Administration (FDCA) office at Vadodara. The lab 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.
Recommended and promoted by the Union commerce ministry
to help Indian manufacturers gain self-reliance in medical device
testing in the country, an amount of Rs.15 crore has also been earmarked for the country’s flagship project.
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. Only a few testing labs in the country which claim to offer
testing have been found to be redundant and obsolete.
The Union commerce ministry is currently vetting the proposal to fund the project and sanction an amount of Rs.15 crore for the same, according to an official associated with the development.
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.
Work for the lab at
Vadodara, Gujarat will start soon as funds are to be released by the
central government for which building is already available. The testing
lab will be housed at Gujarat Food and Drug Control Administration
office located strategically in the middle of a thriving industrial belt
and is likely to materialise in the coming two months time.
Setting
up of the dedicated medical device testing labs 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.
In order to comply with all safety requirements,
sets of universal standards and norms have been prescribed, compliance
to which ensures delivery of right technology in the right way. A means
to verify the devices against this desired compliance is testing.
Thus,
product testing brings into existence the first level of assessment of
appropriateness and safety of a device. This would complement the
government's Make in India’ drive pushing industrial growth and
encouraging medical devices sector in the country.
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