Cabinet approves National Policy on R&D and Innovation and PRIP Scheme

In a move to strengthen the research and development (R&D) and innovation efforts of Indian pharma industry and academia, the Cabinet has approved the National Policy on Research & Development and Innovation in the Pharma-MedTech Sector and the Scheme for Promotion of Research and Innovation in Pharma-MedTech (PRIP).

Apart from the policy and the scheme, the Department of Pharmaceuticals (DoP) is also coming up with a new scheme on Human Resource Development in the Medical Devices Sector, said a document from the Department.

According to the DoP’s monthly summary report for the month of July, 2023, the Cabinet has approved the National Policy on Research and Development and Innovation in the Pharma-MedTech sector in the country in its meeting held on July 25, 2023.

In the same meeting, the Cabinet approved the PRIP Scheme with an outlay of Rs. 5,000 crore for a period of five years from 2023-24 to 2027-28.

Besides, the Department said, “In pursuance of the budget announcement in FY 2023-24, the Department of Pharmaceuticals has come up with a new scheme on ‘Human Resource Development in Medical Devices Sector’. The scheme has been appraised by the Standing Finance Committee in its meeting held on July 14, 2023 under the chairmanship of Secretary, Department of Pharmaceuticals”.

As reported earlier, while the DoP has submitted a proposal for the PRIP Scheme with an outlay of Rs. 7,150 crore to the Economic Finance Committee (EFC), the Committee in its meeting held on March 15, 2023 recommended the scheme with an overall outlay of Rs. 5,000 crore.

Finance minister Nirmala Sitharaman, in the Union Budget 2023-24, had announced that a new programme will be launched to promote research and innovation in pharmaceuticals and to launch dedicated multidisciplinary courses for the medical devices sector for the development of skilled manpower.

In her Budget Speech in the Parliament on February 1, 2023, the Minister said, “A new programme to promote research and innovation in pharmaceuticals will be taken up through centers of excellence. We shall also encourage industry to invest in research and development in specific priority areas.” The allocation for development of pharmaceuticals is also expected to see a significant jump in the coming fiscal year, according to the budget estimates.

Following the Budget announcement, a proposal was submitted by the DoP to the EFC with the scheme, which has two components – one of strengthening the research infrastructure by establishment of seven Centres of Excellence (CoEs) at NIPERs and the second, of promoting research in pharmaceutical sector by encouraging research in six moonshot areas like new chemical entities, complex generics including biosimilars, medical devices, stem cell therapy, orphan drugs, Antimicrobial resistance etc., wherein financial assistance will be provided for the companies working with government institutes and for in-house R&D.

It may also be noted that the DoP has released a draft policy to catalyse R&D and innovation in the Pharma-MedTech Sector in India, in October, 2021, to encourage research and development (R&D) in pharmaceutical and medical devices sector, promoting innovation for India to become a leader in drug discovery and innovative medical devices through incubating an entrepreneurial environment.

The policy, with a ten-year perspective, was expected to be implemented through an Action plan defining roles, responsibilities, activities, targets and timelines. The Action Plan will be broken down to five year and annual activities for ease of implementation. A High-level Task Force will be set up in the DoP to guide and review the implementation of the policy.

According to the draft policy, the focus is on simplifying regulatory processes to enable rapid drug discovery and development and innovation in medical devices; exploring mechanisms to incentivise private sector investment in research and evaluate various funding mechanisms including budgetary support, venture capital, CSR funding etc., and fiscal incentives to support innovation; and strengthening the R&D ecosystem through increased collaboration between industry and academia in order to develop mechanisms to dovetail research as per requirement of the industry.

On the regulatory front, which is currently geared towards assuring safety and efficacy and not differentiate in favour of innovation, the policy contemplates to create a regulatory bias in favour of innovation and original research by mandating all regulators (as there are several regulators and agencies involved in the approval processes) to work together to reduce process overlapping and establish timelines for requisite approvals. It also elaborated on increasing the capacity of the Central Drugs Standard Control Organisation (CDSCO), among others

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