India's PRIP scheme targets robust R&D and innovation in pharma and MedTech. It seeks to support major firms, startups, and MedTech projects, fostering industry-academia partnerships for global competitiveness.
The Promotion of Research and Innovation in Pharma and MedTech Sector (PRIP) scheme to support 26 major Indian firms, 13 foreign multinationals, a minimum of 50 startups, and 20 MedTech projects over five years. This move is to bolster research and development (R&D) and innovation in the pharmaceutical, medical devices, and animal health sectors.
Operational guidelines issued by the Department of Pharmaceuticals (DoP) elaborate on the selection criteria for institutions and private sector companies participating in this INR 5,000 Cr project. The guidelines also outline the support for the scheme's duration and detail the expected outcomes and benefit-sharing arrangements.
The Indian government introduced the PRIP scheme in August 2023. The primary objective of the PRIP scheme is to encourage industry investment in R&D in "Priority areas" and promote a culture of quality research while nurturing a pool of scientists in India. This initiative aims to strengthen industry-academia linkages, ensuring a sustained global competitive advantage and contributing to quality employment generation in the country, according to the DoP.
The PRIP scheme consists of two components
1. Strengthening research infrastructure by establishing seven National Institutes of Pharmaceutical Education & Research (NIPERs) as Centres of Excellence (CoEs) in specific specialisations at an estimated INR 700 Cr.
2. Promoting research in the Pharma-MedTech sector by providing financial assistance for research in six priority areas: new chemical and biological entities, natural products, complex generics and biosimilars, precision medicines, medical devices, orphan drugs, and drug development for antimicrobial resistance (AMR).
The guidelines specify that companies with annual revenues of more than or equal to INR 1,000 Cr in the pharmaceutical sector, with an average R&D expenditure of 3-5% over the last five years, and companies with annual revenues of not less than INR 250 Cr in the medical devices sector, with R&D expenditure of at least 1-3% of total annual revenue, can apply for Category B1 of Component B.
Category B-II is reserved for R&D projects in priority areas at higher Technology Readiness Level (TRL) levels, ranging from TRL 5/6 to TRL 9. Category B-III encompasses research projects in priority areas at TRL 1 to 4, with a preference for startups, micro, small, and medium enterprises (MSMEs) and small and medium-sized enterprises (SMEs).
For Category B-I, a maximum of three out of the nine participants will be foreign multinational corporations (MNCs). In Category B-II, out of 30 participants or projects, a maximum of 10 will be foreign MNCs. In Category B-III, the 125 participants may include a minimum of 50 startups and a minimum of 20 MedTech projects, subject to sufficient eligible applicants. Any company or group of companies can be selected for a maximum of three projects overall.
The PRIP scheme's tenure is set for five years, from FY 2023-24 to FY 2027-28. The fund allocation for the categories is INR 1,125 Cr for Category B-I, INR 3,000 Cr for Category B-II, and INR 125 Cr for Category B-III.
The first instalment of 10% will be issued at the signing of the agreement, with the second and third instalments of 30% each upon completing the first and second milestones. The fourth instalment of 30% will be issued upon the completion of the approved project and submission of the final report.
Budget planning for selected applicants includes allocating 20% for Category B-I, 30% for Category B-II, and 70% for Category B-III to upgrade equipment and infrastructure. The remaining funds will cover recurring costs, including staffing, consumables, approvals, clinical trials, travel, and contingencies, among other expenses.
The guidelines also outline the benefit-sharing model for each of these categories.
Under Component A, which focuses on establishing CoEs at the seven NIPERs, institutions must submit their proposals within 30 days of the guidelines' issuance for setting up the CoEs.
NIPERs must provide an undertaking that no regular staffing posts will be created from the financial assistance provided under the scheme. They will also be responsible for bearing the expenditure on salaries of contractual workers employed for the CoE after five years. NIPERs must ensure that CoEs achieve self-sufficiency within five years of their establishment.
The progress of the CoEs will be monitored by an in-house CoE Committee chaired by the director of the respective NIPER. Research programs and time-bound deliverables of CoEs will be set in consultation with the Boards of Governors of the respective institutes.
A Steering Committee (SC) will be established, chaired by the Secretary (DoP), to review the progress of CoEs and adjust ceilings under non-recurring and recurring heads as necessary during the scheme's tenure.
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