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India Launches New Pharma-MedTech Research, Innovation Policies

The Ministry of Chemicals and Fertilizers in India recently initiated programs to encourage innovation, research, and development in the Medical and Pharmaceutical sectors. These initiatives include the National Policy on Research and Development and Innovation in Pharma-MedTech Sector in India and the Scheme for Promotion of Research and Innovation in Pharma MedTech Sector (PRIP).

Overview of the Indian Pharmaceutical Industry

The Indian pharmaceutical industry ranks as the third largest globally by volume and currently boasts a market size of approximately USD 50 billion.

National Policy on Research and Development and Innovation in Pharma-MedTech Sector Initiative

This policy is designed to stimulate R&D in pharmaceuticals, incorporating traditional medicines, phytopharmaceuticals, and medical devices. The scheme holds the potential to expand the sector to USD 120-130 billion over the subsequent decade, thereby increasing its contribution to the GDP by approximately 100 basis points.

Primary Objectives

The prime objective of this policy is to develop a regulatory environment that facilitates innovation and product development research, extending beyond the traditional regulatory objectives of safety and quality. It aims to incentivize private and public investments in innovation via fiscal and non-fiscal measures. Moreover, it seeks to construct an enabling ecosystem designed to facilitate innovation and cross-sectorial research, thereby laying a strong institutional foundation for sustainable growth in the sector.

Scheme for Promotion of Research and Innovation in Pharma MedTech Sector (PRIP) Initiative

The PRIP scheme concentrates on fostering innovation and transitioning the MedTech sector into an innovation-driven powerhouse. It prioritizes high-quality research and innovation with the aim of steering the sector towards value and innovation-based approaches.

Key Components of The PRIP Scheme

Component A of the PRIP initiative focuses on bolstering the research infrastructure through the establishment of seven ‘Centres of Excellence’ at National Institutes of Pharmaceutical Education and Research (NIPER).

Meanwhile, Component B is centred on promoting research in the pharmaceutical sector by encouraging research in six priority areas comprising New Chemical Entities, Complex generics including biosimilars, medical devices, stem cell therapy, orphan drugs, Anti-microbial resistance, etc. Financial aid will be provided for industries, MSME, SME, startups in collaboration with government institutes for both in-house and academic research.

Additional Initiatives Related to the Pharmaceutical Sector

In addition to the aforementioned initiatives, the ministry has announced the Production Linked Incentive (PLI) Scheme for Pharmaceuticals, the Bulk Drug Parks Scheme, and the Strengthening Pharmaceuticals Industry Scheme.

Preserving Traditional Knowledge of Medicine

Following an examination question posed in 2019 about how the Government of India safeguards traditional medicinal knowledge from patenting by pharmaceutical companies, it is clear that these new initiatives continue to underscore the importance of incorporating traditional medicines and phytopharmaceuticals into innovation and research efforts.

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