Time to prioritise drug discovery, innovative medical devices

Union Minister for Health and Family Welfare Dr Mansukh Mandaviya , while addressing a roundtable discussion on 'Opportunities in R&D and Innovation in Life Sciences' at the World Economic Forum in Davos had said that India is taking concerted and coordinated efforts on research and development (R&D) and innovation in pharma and medical technology sectors. The thrust was on indigenously developed cutting-edge products and technologies and promoting an enabling ecosystem for innovation in this sector to become a leader in drug discovery and innovative medical devices.

Dr Mandaviya said that the Union Government is focusing on three major areas in order to achieve this, including strengthening the regulatory framework to facilitate innovation and research in product development; incentivising investments in innovation through a mix of fiscal and non-fiscal measures, thereby matching risks with remunerative financing options; and creating a facilitatory ecosystem to support innovation and cross-sectoral research as a strong institutional mechanism for sustainable growth in the research and development and innovation sector.

Stating that the Indian regulators were presently working towards establishing global harmonisation in this regard, with modifications in the regulatory provisions, the Minister said that the country is looking 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 designing appropriate fiscal incentives to promote R&D.

He further said that the government is committed to promoting Indian life sciences as a globally competitive sector to ensure availability, accessibility and affordability of drugs and medical devices in both domestic and global markets.

According to industry estimates, a large share of global value capture (nearly 40 per cent of a market of $ 6.65 trillion) in life sciences sector lies in innovation-based products. Promoting drug discovery and innovation will unlock this value and will also enhance the industry's contribution to Indian economy (additional $10-12 billion in exports every year) and create a large pool of jobs to enhance India's differentiation vis-à-vis developing economies. The increased spending on healthcare globally, the increase in the size of the Indian middle class, the commitment to 'universal healthcare' and the attention to central government schemes like Ayushman Bharat – Pradhan Mantri Jan Arogya Yojana (PM-JAY) and Pradhan Mantri Bhartiya Jan Aushadhi Pariyojana (PMBJP) have created a sustained demand trajectory for pharma and medtech sectors.

The demand for better therapeutic outcomes, trends in personalized diagnostics, in-home treatment, wearables and telemedicine has created scope for differentiated products and service offerings. To grab the opportunities, pharma and medical technology sectors should move out of their comfort zone and adopt innovation as a driving feature of their business strategies.

Obviously, the Union Government is seized of the importance of the issue. It is clear from the fact that the Department of Pharmaceuticals (DoP) had come out with draft policy on catalyzing R&D and innovation in pharma-medtech ecosystem in India. The policy aims to encourage R&D in pharma-medtech sector, and promoting innovation to help India emerge a leader in drug discovery and innovative medical devices through incubating an entrepreneurial environment. 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 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. The government will undertake a review of the multiple legislations impacting R&D in pharma and medical devices sectors with a view to remove inconsistencies and redundancies.

This could include measures such as exemption of products that are cultured and cultivated artificially under controlled conditions and not impacting natural resources from the Biological Diversity Act and review Drug Price Control Order 2013 to enable differential pricing for innovation with therapeutic benefits, among others.

(The author is a freelance journalist with varied experience in different fields)