The Government of India’s Amrit Kaal blueprint -Vision Pharma 2047 – which envisages India as ‘Vishwaguru’ (global leader) in innovation & research underscores the Government's commitment to nurture an innovation-driven ecosystem. There seems to be recognition on the part of the Government of India that research and innovation are critical means for enabling India to pivot from the volume based to value based pharmaceutical industry poised to deliver high-quality, innovative healthcare solutions that meet the evolving needs of patients and healthcare providers.
Pharmaceutical R&D is an evolving process and is fuelled by the quest for innovative resolutions to address global health challenges. The process of bringing new drugs to the market is lengthy, complex, and costly. As per the recent study cohort, it takes around 10 to 15 years to develop a new medicine and that the average cost to research and develop a pharmaceutical compound from discovery to launch from 2010 to 2020 was 2.5 billion U.S. dollars[1]. The commitment of the research-based industry to achieve improved patient outcomes motivates it to navigate the complexities involved in the drug development process. The R&D response of pharmaceutical industry to fight COVID-19 pandemic that resulted in the development of effective vaccines, diagnostics, and therapeutics highlighted its commitment to address unmet medical needs.
The discovery of new medicines and the improvement of existing ones is vital for the continued growth of the industry. As of January 2024, Pharmaprojects, a drug development database for monitoring and analysing global pharma R&D activity and trends across diseases, drugs and companies recorded 22,825 drugs in development. However, it also recorded that even with such an R&D pipeline, the number of drugs advancing to Phase III clinical trials appears to be slowing down. Furthermore, it recorded that China-based firms involved in pharma R&D rose to 16% in 2024 from 13% in 2023[2].
By embracing innovation, quality, patient-centricity, and affordability, India too is poised to make significant strides in improving healthcare outcomes and driving sustainable growth in the pharmaceutical sector.
Many policies and schemes like Scheme for Promotion of Research and Innovation in Pharma MedTech Sector (PRIP), 2023[3] and the National Policy on Research & Development and Innovation in the Pharma-Med Tech Sector in India, 2023[4] are indeed steps in the right direction. However, for incentivising research and innovation, it is critical that an effective IP regime provided along with a streamlined, fair and transparent regulatory mechanism.
It is also an opportune time to reflect on India's recent strides in the realm of intellectual property, particularly in the fields of patent law and international trade agreements. Recently, India has amended the Patents Rules, 2003 by notifying the Patents (Amendment) Rules, 2024. While the extent of effectiveness can only be assessed through empirical data, the amendments to the Patent Rules 2024 are certainly a welcome step, and it is sincerely hoped that the intent behind the amendments is achieved i.e., streamlining patent processes, improving efficiency of the IPO and enabling ease of doing business in India.
In addition to domestic reforms, India has also been actively engaging in shaping its trade and economic landscape through international agreements. One such much awaited agreement that India signed recently was the Trade and Economic Partnership Agreement (TEPA) with European Free Trade Association (EFTA) states comprising of Iceland, Liechtenstein, Norway, and Switzerland.
The India-EFTA TEPA, signed on March 10, 2024, encompasses various aspects of trade and economic cooperation between India and the member countries with an aim to create a conducive environment for innovation and trade by including provisions related to IP rights, promoting investments, relaxing tariff barriers relaxation, stimulating services exports, technology collaboration etc.
India has the potential to be a global leader in research and development in the pharmaceutical sector. Indian scientists have demonstrated their critical research talent in the biotech and pharmaceutical spheres, and with the right commercial incentives, it can help bring R&D to India. The research-based bio-pharma industry looks forward to India unlocking its full potential by transforming into a global innovation hub and emerging as a leader in the knowledge economy of the 21st century.
The author is Director General, OPPI
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