Need to integrate various regulatory agencies with single-window system for medical devices: DoP Secy S Aparna
Aparna said there is a need to put in place a transparent, stable, predictable and easy-to-navigate interface between investors, manufacturers, exporters and the regulatory ecosystem.
New Delhi: There is a need for integration of various regulatory agencies with a single-window system for the medical devices industry, other than incentives for domestic production, a senior government official said on Thursday.
The medical devices industry, which is growing at a compound annual growth rate (CAGR) of about 15 per cent, holds the highest growth potential among all the constituents of the healthcare sector such as pharma and hospital services, an official statement said quoting S Aparna, secretary of Department of Pharmaceuticals, under the Ministry of Chemicals and Fertilisers.
Speaking at the inaugural session of Medical Devices Expo 2021, she said, "It is important to remember that this is an inter-disciplinary sector with a huge range of products covering re-agents, diagnostic kits, and high-end imaging equipment."
She said that therefore, it is a sector that requires a nuanced approach.
Beside incentives for domestic production of medical devices, she also highlighted the need for integration of various regulatory agencies with a single-window system.
Aparna also said there is a need to put in place a transparent, stable, predictable and easy-to-navigate interface between investors, manufactures, exporters and the regulatory ecosystem.
She also emphasised that innovation, adoption and adaptation of new technologies would be key to tap the huge opportunities in both domestic and export markets.
The medical devices sector has been growing at an accelerated pace in pandemic times and is projected to become USD 65 billion industry by 2024, the statement said.
It offers a big opportunity for domestic players, especially engineering MSMEs, to make deep inroads into global markets, the statement added.
The Indian medical device market is the fourth largest in Asia after Japan, China and South Korea. It has, however, potential to overtake some of its peers in size and scale given the government support it has been receiving over the past few years.
The government initiatives to boost the sector include 100 per cent FDI, setting up of medtech parks and the production-linked incentive (PLI) scheme. The recent Medical Devices Amendment Rule 2020 is aimed at making the sector more regularised, the statement said.
"The Covid-19 pandemic has pushed us further on the track of strengthening our medical devices industry and India has appropriately risen up to the cause," EEPC India Vice-Chairman, Arun Kumar Garodia said.
Read also: Medical sector incentive rate under PLI scheme should be revised to 10 percent: Transasia
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