New scheme for R&D in pharma, medtech

The Scheme for Promotion of Research and Innovation in Pharma MedTech Sector (PRIP) would have a financial outlay of ₹5,000 crore, over a period of five years from 2023-24 to 2027-28.

The six priority areas identified under the scheme are new drugs (new chemical entities, new biological entities and phyto-pharmaceuticals), complex generics and biosimilars, precision medicines (targeted innovative therapeutics), medical devices, orphan drugs and drugs meant to tackle the problem anti microbial resistance (AMR).

In a notification on August 16, the Ministry of Chemicals and Fertilizers said the objective of the scheme is to transform Indian Pharma MedTech sector from cost based to innovation-based growth by strengthening the research infrastructure in the country. "The aim of the scheme is to promote industry-academia linkage for R&D in priority areas and to inculcate the culture of quality research and nurture our pool of scientists. This will lead to sustained global competitive advantage and contribute to quality employment generation in the country," it said.

As part of the scheme, nine established pharma companies will be selected on the basis of their willingness to carry out research in six priority areas with academic collaboration in government research institutions. The selected companies will be allowed to avail the facilities of the research infrastructure (lab, equipment, and support staff) available at national institutes. Investments made by the companies on the projects at the institutes would be supported with financial support at the rate of 35% of the total cost incurred or ₹125 crore whichever is less on milestone basis over a period of 5 years under the benefit sharing principle.

Funding (35% of the cost or ₹100 crore, whichever is less) would also be provided to 30 successfully validated research projects in six priority areas for further development and commercialization.

The scheme also offers financial support for 125 research projects from startups/ SMEs/ MSMEs having potential or having made sufficient headway in the research of priority areas. Under this category, the funding will be up to ₹1 crore per project over a period of five years in milestone manner which would be provided from ideation to proof of concept on royalty sharing basis.

The scheme also proposes to establish centres of excellence in the seven existing National Institutes of Pharmaceutical Education and Research (NIPERs) at Mohali, Ahmedabad, Hyderabad, Guwahati, Kolkata, Hajipur and Raebareli at a tentative cost of ₹700 crore over a period of five years. While the centre in NIPER Mohali will specialize in anti-viral and anti- bacterial drug discovery and development, the focus areas of other centres are  NIPER Ahmedabad (Medical Devices), NIPER Hyderabad (Bulk Drugs), NIPER Kolkata (Flow Chemistry and Continuous Manufacturing), NIPER Raebareli (Novel Drug Delivery System), NIPER Guwahati (Phyto-pharmaceuticals) and NIPER  Hajipur (Biological Therapeutics).  This will help in building specific research capacities in the identified priority areas in a focused time bound programme, tapping industry-academia linkage, the notification says.