Last Updated on December 31, 2023 by The Health Master
Pune: NITI Aayog member VK Paul said that despite India’s advances in the production of medical devices, there is still some time to go before large-scale trials of the same can be carried out on Indian patients and in the country’s medical establishments owing to regulatory and ethical restrictions.
“We are still figuring out the trials and testing mechanisms for medical devices in India as there are some regulatory issues as well as a relative lack of experience in this regard.”
There are also issues regarding the methodology, ethical framework, the effects, as well as the comfort of the medical staff, patients and their families.
We are still working to establish the standard operating procedure regarding these issues,” Paul said.
He was speaking at the launch of the second research and development facility of the American medical devices firm Boston Scientific here, eight years after the launch of its first such facility in India, in Gurgaon.
The Pune R&D centre will have an initial strength of 170 engineers at the 45,000 square feet facility in Balewadi and will provide more R&D capacity in its core focus areas, such as interventional cardiology, urology, endoscopy, among others.
Boston Scientific’s executive vice-president Art Butcher added that the addition of the Pune facility makes India their largest R&D hub globally, outside the United States.
The medical devices can grow from the current US$ 11 billion industry to a US$ 65 billion industry with the Union government having announced a US$ 500 million product-linked incentive scheme for manufacturing of medical devices.
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