Last Updated on December 11, 2022 by The Health Master
New Delhi: A parliamentary panel has recommended setting up a new set of regulators at different levels for the medical devices industry and establishing a ‘National Commission on Medical Devices.’
The commission should study the aspect of centralizing medical device licensing with the central regulator so as to make the approval process easy, the Parliamentary Standing Committee on Health said in its 138th report tabled in Rajya Sabha.
The Union Health Ministry should also focus on guaranteeing transparency by designing this legislation so that citizens and experts get a right to participate in the decision-making process, it added.
The blueprint for the new legislation must also include a 10-15 year roadmap with a clear policy plan and targets, the panel stated.
The committee strongly believes that with a 15-year roadmap with annual targets for the medical devices industry, India would emerge as the world’s biggest center for the manufacture and service of such devices, and also a leader in medical tourism, it said.
It further recommended that to realize the goal of making India a USD 50 billion markets by 2025, all three pillars of the medical devices sector, government, industry, and academia—should work in synergy.
With the ultimate goal of becoming “self-reliant,” the focus should be on increasing manufacturing capacity through a simplified yet effective regulatory regime and a liberal tax system, the panel said.
The government must also focus on and invest in research and development at premier technological institutions like the IITs.
Stress must also be laid on skill development to have a trained and qualified workforce for the sector, it added.
The committee said it believes that indigenous manufacturing can only be fostered if there is the local availability of raw materials and critical components and that 80 percent of the country’s dependency on imported products is primarily due to the lack of high-end technology and poor availability of raw materials.
“The committee, therefore, recommends that the government must incentivize such institutes, start-ups, and manufacturing units that are engaged in the manufacturing of raw materials and spare parts locally.
Academic institutions like IITs, AIIMS and IISCs and research bodies like CSIR, who have the technical know-how and the technology required, should be allowed and encouraged to produce certain raw materials like antibodies, synthetic antigens, proteins, etc,” it said.
“Additionally, the committee recommends that the PLI scheme be expanded to cover raw materials and component manufacturing as well so that India can become a hub for raw materials for the world,” the panel said in its report.
“The committee recommends that the new legislation should set up a new set of regulators at different levels for regulating the medical device industry.” Unlike the present structure, the proposed regulator should license the manufacturing of all classes of medical devices.
This would help harmonize the regulation process throughout the country as it would do away with different regulating procedures employed by different states,” the report said.
This step would greatly help the manufacturers and reduce the time required to start a manufacturing unit, thereby facilitating ease of doing business, it said.
It was also recommended that to undertake the regulation of all classes of medical devices throughout the country, the proposed regulator should be adequately staffed with a workforce that is technically skilled and well-versed in the functioning of the medical devices industry.
The devices that are required for critical care for the patients should ideally be categorized as “scheduled medical devices” and listed under the National List of Essential Medicines, the panel said.
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