Centre finalising policy to catalyse RnD and innovation in pharma and med-tech sectors

New Delhi, February 8, 2023:

The Central government is in the process of finalising the cabinet note on its Policy to catalyse R&D and innovation in the pharma med-tech sector in line with the budget announcement for the year 2022-23.

The Union Budget for the year 2022-23 has announced that supportive policies, light-touch regulations, facilitative actions to build domestic capacities, and promotion of research & development will guide the government’s approach.

“For R&D in these sunrise opportunities, in addition to efforts of collaboration among academia, industry and public institutions, government contribution will be provided,” said the Budget.

“Finalisation of the Cabinet note on Policy to catalyse R&D and innovation in the pharma med-tech sector is under process,” said the Union finance ministry earlier this month, updating the progress of its announcements made in the Union Budget 2022-23.

The Department of Pharmaceuticals (DoP) had constituted a high level Inter Departmental Committee, including academia and industry doyens to draft and finalize policy on R&D and innovation including academia-industry linkage in pharmaceuticals & medical devices. Based on the Report of the Committee submitted in September, 2020, the draft policy has been prepared.

The Department last year said that after detailed inter-departmental and stakeholders consultation with industry, the policy was finalised and the Fair Cabinet Note has since been sent for consideration for the cabinet.

The policy is built upon three focus areas, - streamlining the regulatory framework, incentivising investments and creating a facilitator ecosystem for Innovation.

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

The policy focuses 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.

A Common Specific Procedure Pathway (CSPP) will be provided for each class of product, including checklists, prescribed timelines, parallel processing, joint inspections, automatic and deemed approvals and sharing of data across regulators. The aim is to bring down the time taken for regulator approvals for innovative products by at least 50 per cent within two years.

Besides, in line with the budget announcement for the year 2022-23, on development of sunrise opportunities including pharma, along with artificial intelligence, geospatial systems and drones, semiconductor ecosystem, six major sectors have been identified by the government’s think tank NITI Aayog.

Following this, an approach paper on digital health has been prepared based on detailed deliberations with various ministries with a designated nodal officer appointed for the further processes. As the next step, the nodal officers are in the process of indicating timelines and proposed course of action, which will be presented in a workshop for the sector-specific vision documents, said the Ministry of Finance. Pharmabiz