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The Department of Pharmaceuticals (DoP) is expecting its work towards a policy to catalyse research and development in the pharmaceutical and medical devices sector and its similar measures to strengthen innovation to strengthen the industry in the country. Setting up a Centre for Marine Therapeutics is another initiative the department is looking at to strengthen the research works.
The DoP had last year released a draft policy on catalyzing R&D and innovation in pharma-medtech ecosystem in the country, following constitution of 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.
The policy is built upon three focus areas, - streamlining the regulatory framework, incentivising investments and creating a facilitator ecosystem for innovation.
"After detailed inter-departmental and stakeholders consultations with industry, the policy has been finalized and the Fair Cabinet Note has since been sent for consideration for the Cabinet," according to a report of the Department Related Parliamentary Standing Committee on Commerce, earlier this month. The DoP submitted its response to the recommendations of the Committee in its previous report, in July, this year, elaborating its efforts to strengthen the sectors to win the global market.
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 percent within two years.
The DoP also informed the Parliamentary Committee that an Inter-Departmental Committee (IDC) set up by the Department in January, 2019 based on the recommendation by the Parliamentary panel so as to coordinate research work in the area of pharmaceuticals undertaken by organization and institutes under the Central Government, has made a proposal to set up Centre for Marine Therapeutics and referred to DST for seeking funds.
The Terms of Reference (ToR) of the IDC include - to periodically review and coordinate the research work undertaken by various government organisations under different Central Ministries and Departments in a collaborative, synchronized and synergized way for optimum utilization of funds; and to ensure that research is conducted in such a way so as to avoid duplication of efforts and resources.
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