New Delhi: The Department of Pharmaceuticals (DoP) has said that it has developed a portal for monitoring the implementation of the research and development (R&D) policy and has constituted the Indian Council for Pharmaceuticals and Medtech Research and Development (ICPMR), as envisaged in the National Policy on Research and Development and Innovation in the Pharma-Medtech Sector in India.
The Department, while releasing its monthly summary report on its operations during the month of April, 2024, said, “R&D Policy envisages setting up of Indian Council for Pharmaceutical and Meditech Research and Development (ICPMR) which has been constituted vide DoP OM dated March 5, 2024 with the approval of the Hon’ble Minister of Chemicals and Fertilisers.”
“The Department has developed a portal for monitoring the implementation of the R&D Policy that is operational since April 2, 2024,” it added.
The Cabinet of Ministers has approved the National Policy in its meeting held on July 25, 2023 and it was notified on August 18, 2023.
The policy, as notified, proposes various measures including setting up of an Inter-Departmental Research Council namely the ICPMR to facilitate, strengthen outreach mechanisms, and promote collaboration across industry, academia and research institutions across Departments. It suggested that the Council will have an agile and slim structure with a focus on prioritizing areas for research based on national healthcare priorities, building synergies, strengthening outreach mechanisms, convergence with various schemes of the Government of India and promoting the sharing of information among these research bodies, for resource optimization.
The Council would also lead the Drug Discovery Mission as a multi- institutional initiative by pooling the strengths and talents of research institutions under DoP, Department of Health Research, Department of Biotechnology and Council of Scientific & Industrial Research, educational institutions such as Indian Institute of Technologies, Indian Institute of Science, Indian Institute of Science Education and Research, etc. and Public- Private Partnerships (PPPs).
At the time of notification, it announced that the government will create a single end-to-end digital portal to be used by different departments and regulators as a single interface between innovator and regulator aligning it with Ease of Doing Business and reduce compliance burden.
The DoP envisages the Policy to bring in reforms in terms of regulatory framework and streamlining processes reducing the approval timelines, incentivising investment in innovation and creation of an enabling ecosystem for innovation and research.
The Department identifies that in the regulatory framework, there are challenges including presence of multiple agencies with different mandates and expertise that an innovator firm has to navigate, and lack of regulatory capacity within the government in tandem with the latest advances in science and technology and dependence on ad-hoc external inputs.
“A mechanism will be explored by the government that will mandate all the regulators to work together to reduce process overlapping and establish timelines for requisite approvals. Data protection and time bound processing of regulatory approvals will be an important aspect to be followed by the regulators,” said the policy.
“It will aim to bring down the current time taken for regulatory approvals for innovative products by at least 50% within the next two years,” it added.
Various measures to strengthen the existing institutional capacity of the regulatory bodies, will be explored which would include building in-house expertise in respect of New Biological Entities and New Chemical Entities, Biologics, Imaging medical technologies, New Materials, tele-diagnostics, AI/ML based innovations, Sensors, etc.
National Pharmaceutical Pricing Authority (NPPA) would work to develop greater expertise in the pricing of new innovative products while pursuing affordability as an overall objective. Collaboration with relevant international regulatory agencies and capacity building of regulators will enable them to introduce benchmarked best practices, stay ahead of the curve and add value to the expansion of the Pharma-MedTech sectors through Innovation.
“A review of the multiple legislation impacting research and development in pharmaceuticals and medical devices could be undertaken to identify areas of friction and design tenable solutions. Some of the areas indicated for such effort include differentiated handling of research in products that are cultured and cultivated artificially, increasing the number of bodies that can approve pre-clinical trials, enabling joint inspections and licensing mechanisms for traditional medicinal products,” added the Policy notified by the Department.
The policy focuses on the provision of appropriate fiscal and non-fiscal incentives for pharmaceuticals/MedTech innovations by introduction of direct/ indirect funding support to promote India as an innovation hub. The interventions would be in compliance with multiple treaties with foreign countries wherein inter alia the Government of India has committed to non-discriminatory treatment of foreign investments in the country.
There is also a need to look at a range of interventions that would facilitate funding support for innovation such as schemes to support investments into R&D/innovation, reimbursement of R&D spending and appropriate fiscal incentives, review of scope of the patent box etc., it added.
Funding support can also be explored from the existing and future government programmes and schemes to aid R&D based innovation in the sector such as National Research Foundation (NRF) and Biotech Innovation Fund and leveraging the existing fund support available with various Ministries and departments for focused outcome-oriented Pharma and MedTech research. Thus, a compelling ‘Discover in India’ vision is to be created as a message to be actively disseminated across stakeholders.
The Policy will be supported by a ten-year Strategy and action plans that will spell out the policy and programmatic interventions required from time to time within the Policy, said the DoP during the time of notification.
