DoP Launches New Portal to Implement R&D Policy in Pharma-Medtech Sector

The ICPMR is set to lead the Drug Discovery Mission, a multi-institutional initiative that pools the strengths of various research institutions.

The Department of Pharmaceuticals (DoP) has launched a new portal to monitor the implementation of the National Policy on Research and Development and Innovation in the Pharma-Medtech Sector.

Additionally, the Indian Council for Pharmaceuticals and Medtech Research and Development (ICPMR) has been constituted, as outlined in the R&D Policy.

In its April 2024 monthly summary report, the DoP detailed the progress of its operations. The R&D Policy, approved by the Cabinet on July 25, 2023, and notified on August 18, 2023, proposes several measures to boost R&D.

These include the establishment of the ICPMR, aimed at facilitating collaboration across industry, academia, and research institutions.

Digital Portal for R&D Monitoring

Operational since April 2, 2024, the newly developed portal will serve as an end-to-end digital interface for different departments and regulators, aligning with the Ease of Doing Business initiative and reducing compliance burdens.

This single digital portal is designed to facilitate the interaction between innovators and regulators, streamlining processes and reducing approval timelines.

ICPMR’s Key Functions

The ICPMR, constituted on March 5, 2024, with the approval of the Minister of Chemicals and Fertilizers, focuses on prioritizing national healthcare research, strengthening outreach mechanisms, and promoting resource optimization through information sharing among research bodies.

The ICPMR is set to lead the Drug Discovery Mission, a multi-institutional initiative pooling strengths from various research institutions, including the Department of Health Research, Department of Biotechnology, and Council of Scientific & Industrial Research.

Educational institutions such as the Indian Institute of Technology and the Indian Institute of Science, alongside Public-Private Partnerships (PPPs), are also part of this initiative.

The council aims to prioritize research areas, build synergies, and ensure the convergence of various government schemes to optimize resources.

About the R&D Policy

The DoP envisions the R&D Policy to reform the regulatory framework and streamline processes, reducing approval timelines and incentivizing innovation investment.

Currently, the regulatory landscape presents challenges, such as multiple agencies with varying mandates and expertise and a lack of regulatory capacity aligned with the latest advances in science and technology.

The policy proposes a mechanism to mandate collaborative efforts among regulators, reduce process overlapping, and establish approval timelines. Emphasizing data protection and time-bound regulatory approvals, the policy aims to cut the current approval times for innovative products by at least 50% within the next two years.

To enhance institutional capacity, the DoP plans to build in-house expertise in new biological entities, new chemical entities, biologics, imaging medical technologies, and AI/ML-based innovations.

The National Pharmaceutical Pricing Authority (NPPA) will also develop greater expertise in pricing new innovative products while ensuring affordability.

Collaborating with international regulatory agencies and building regulatory capacity will enable the adoption of best practices and support the expansion of the Pharma-MedTech sectors.

The policy also includes reviewing multiple legislations impacting R&D in pharmaceuticals and medical devices to identify areas of friction and design viable solutions.

This involves differentiated research handling in artificially cultured products, increasing the number of bodies that can approve pre-clinical trials, and enabling joint inspections and licensing for traditional medicinal products.

Moreover, the policy focuses on providing fiscal and non-fiscal incentives for pharmaceutical and medtech innovations through direct and indirect funding support.

Interventions will comply with international treaties, ensuring non-discriminatory treatment of foreign investments.

Innovation funding support will be sought from existing and future government programs such as the National Research Foundation (NRF) and the Biotech Innovation Fund. The policy aims to establish a compelling "Discover in India" vision that will be actively promoted among stakeholders.

A ten-year strategy and action plan outlining the necessary policy and programmatic interventions supports the policy.

The DoP aims to create an enabling ecosystem for innovation and research, reduce regulatory approval times, and promote investment in innovation. This comprehensive approach is designed to transform India into a global hub for pharmaceutical and medical device innovation.