Set up regulators at different levels for medical devices industry, recommends Parliamentary panel

The commission should study the aspect of centralising 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 on Thursday.

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, 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 centre for the manufacture and service of such devices, and also a leader in medical tourism, it said.

It further recommended that to realise the goal of making India a USD 50 billion market 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 the manufacturing capacity by having a simplified yet effective regulatory regime and liberal taxation system, the panel said.

The government must also focus and invest in research and development in 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 local availability of raw materials and critical components, and that 80 percent 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 incentivise such institutes, start-ups, manufacturing units which are engaged in 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 should be expanded to cover raw materials and component manufacturing as well so that India can become a hub for raw material for the world," the panel said in its report.

"The committee recommends that the new legislation should set up a new set of regulator at different levels for regulating the medical devices industry. Unlike the present structure, the proposed regulator should license the manufacturing of all classes of medical devices... This would help harmonise 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 also recommended that to undertake the regulation for all classes of medical devices throughout the country, the proposed regulator should be adequately staffed with a workforce which is technically skilled and well-versed with the functioning of the medical devices industry.

The devices which are required for critical care to the patients should ideally be categorised under "Scheduled Medical Devices" and listed under the National List of Essential Medicines, the panel said.