‘Need to transform India into high-value player’ — Centre launches national pharma R&D policy
New Delhi: Union Health Minister Mansukh Mandaviya Tuesday formally launched the National Policy on Research & Development and Innovation, and the scheme for promotion of Research and Innovation in the Pharma MedTech Sector (PRIP).
The aim, Mandaviya noted, was to transform India into a high-volume and high-value player in the global pharmaceutical market.
“We need to transform Indian pharma and med-tech sectors from a cost-based to a value-based and innovation-based industry, meeting the quality, accessibility, and affordability goals,” the union minister said.
The national policy was first announced in the 2023 Budget by Finance Minister Nirmala Sitharaman. Both the policy and the scheme were published through a gazette notification last month.
The policy includes three main areas of focus, in order to achieve objectives such as creating a regulatory environment that facilitates innovation and research in product development, expanding the traditional regulatory objectives of safety and quality.
Other components of the policy include incentivising private and public investment in innovation through a mix of fiscal and non-fiscal measures; building an enabling ecosystem designed to support innovation; and cross-sectoral research as a strong institutional foundation for sustainable growth in the sector.
The department of pharmaceuticals, under the Union Ministry of Chemicals and Fertilizers, had proposed the PRIP scheme with a budget outlay of about Rs 5,000 crore.
Of this, Rs 750 crore is being planned for setting up seven centers of excellence at the National Institute of Pharmaceutical Education and Research, while Rs 4,250 crore has been earmarked for promoting research in the pharmaceutical sector — new chemical entities, complex generics, including biosimilars, medical devices, stem cell therapy, orphan drugs and antimicrobial resistance.
The Centre aims to provide financial assistance to industries, as well as small, medium and micro enterprises/startups working with government institutes for in-house and academic research.
‘Low value generic drugs a concern’
In a statement released by the Centre, it was also noted that a major component of Indian exports are low-value generic drugs. On the other hand, a large proportion of the demand for patented drugs is met through imports.
This situation mostly stems from the fact that the Indian pharmaceutical sector lacks in high-value production capacity, or world class pharma research and development.
“In order to incentivise the global and domestic players to enhance investment and production in these product categories, a well-designed and suitably targeted intervention is required to incentivise specific high value goods such as biopharmaceuticals, complex generic drugs, patented drugs or drugs nearing patent expiry, cell based or gene therapy drugs,” the statement said.
India has the third largest pharmaceutical industry in the world by volume, with a current market size of around $50 billion.
The government also said the industry could grow up to $120-130 billion over the next decade if one of its key drivers is in the space of innovation.
Also read: Reporting faulty manufacture to annual audits: How govt wants drugmakers to improve quality
