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The Central government will soon give its approval for setting up of India’s first dedicated medical device testing lab in the country based on the recent MoU signed between the Central government and Gujarat government. An amount of Rs. 15 crore has already been earmarked for the same, according to an official associated with the development.
National Health Systems Resource Centre (NHSRC), a technical support institution under the Union health ministry which had surveyed 16 testing labs in the country and 9 medical device testing labs across the globe submitted a report to the government specifying the need and also the modalities required for setting up such a dedicated medical device testing lab based on the standards existing globally.
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 from the department of commerce, 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.
Such type of testing labs will allow manufacturers to overcome deficiencies in their products and enhance product value in the market which has been a hitherto neglected aspect until now. It will also ensure safety and efficacy of medical devices marketed in the country.
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.
Work for the lab at Vadodara, Gujarat will start as soon as the funds are released by the Central Government which is likely to materialise in the coming two months time for which building is available. The testing lab will be housed at Gujarat Food and Drug Control Administration (FDCA) office located strategically in the middle of a thriving industrial belt.
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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