Identifying that the Promotion of Research and Innovation in Pharma Med-Tech (PRIP) Scheme to support industry-academia linkage in pharma and med-tech research and development (R&D) has been facing challenges in initiation, a Parliamentary Panel has sought the Department of Pharmaceuticals (DoP) to fix all the issues related to the scheme at the earliest.
The Scheme, approved by the Union Cabinet almost 18 months back, in July, 2023, with a budget outlay of Rs. 5,000 crore, is aimed at promoting industry-academia linkage for R&D in priority areas and to inculcate the culture of quality research and nurture the nation's pool of scientists. The scheme was notified on August 17, 2023 and was launched by the ministry of chemicals and fertilisers the next month itself.
The Parliamentary Standing Committee on Chemicals and Fertilisers, in its fifth report on the Demands for Grants of the DoP for the fiscal year 2024-25 submitted in the Lok Sabha recently, observed that for the year 2023-24, the Department sought no funds in the Budget Estimate stage, but in the revised estimate stage for the year, an amount of Rs. 1 crore was allocated. However, the actual expenditure during the year was zero.
The Department informed the panel that the scheme was approved by the Cabinet in July, 2023 and as such funds under the Scheme in the fiscal years prior to that were not sought. In the year 2023-24, engaging a Project Management Agency (PMA) as per scheme guidelines was planned and finally a tender in this regard was floated but due to non-receipt of any valid response, the tender could not be utilized.
"Under these circumstances the Committee recommend that all the issues involved in the Scheme may be fixed at the earliest," said the Panel headed by Lok Sabha member Kirti Azad Jha.
In the same report, the panel also raised concerns over the decline in fund allocations for various schemes run by the DoP as against the considerable increase in the Budget Estimates (BE) in the Union Budget 2024-25.
"The Committee are perturbed to note that for the Promotion of Research and Innovation in Pharma Med-Tech (PRIP), the allocation sought by the Department has been reduced by 50 per cent. In this case, the allocation has been reduced to Rs. 75 crore from Rs. 150 crore sought by the Department," said the report.
The scheme has two components comprising strengthening of research infrastructure through establishment of seven National Institutes of Pharmaceutical Education & Research (NIPERs) as Centres of Excellence (CoEs) in specific specialisations, and promotion of research in Pharma-MedTech sector by providing financial assistance for research in six priority areas - new chemical and biological entities, and natural products; complex generics and biosimilars; precision medicines; medical devices; orphan drugs; and drug development for antimicrobial resistance (AMR).
In terms of financial assistance from the total outlay of Rs. 5,000 crore, the establishment of CoEs in NIPERs will have an outlay of Rs. 700 crore, nine projects in the BI category will be eligible for R&D fund of around Rs. 1,125 crore, 30 projects in the BII will be eligible for Rs. 3,000 crore and 125 projects in BIII will have an outlay of Rs. 125 crore, over a period of five years. The total fund per year is estimated at Rs. 850 crore and the total administrative cost is estimated at Rs. 50 crore.
"The objective of the scheme is to transform the 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," said the Department of Pharmaceuticals (DoP) in an earlier notification.
"The Indian pharma industry has largely remained confined to generic drugs where they are holding global leadership. The total amount spent on pharma R&D in terms of USD billion in the US is 50-60, China is 15-20 and in India it is around 3," it added.
"In the financial year 2021, the investments in R&D by the top ten Indian pharma companies amounted to around 7.2% of their sales. There is a need to increase the R&D expenditure in the country by further promoting research and innovation. There is an urgent need to shift the focus to new areas where the future trajectory of the pharma industry lies. Accordingly, six moon-shot (priority) areas have been identified which hold potential for the future and will help industry to leapfrog in these areas," it added.
The Scheme proposes establishment of CoEs in the seven existing NIPERs at Mohali, Ahmedabad, Hyderabad, Guwahati, Kolkata, Hajipur and Raebareli at a tentative cost of Rs. 700 crore over a period of five years. As per this plan, NIPER Mohali will be a CoE for antiviral and anti- bacterial drug discovery and development, NIPER Ahmedabad for Medical Devices, NIPER Hyderabad for Bulk Drugs, NIPER Kolkata for flow chemistry and continuous manufacturing, NIPER Raebareli for novel drug delivery system, NIPER Guwahati for phyto-pharmaceuticals and NIPER Hajipur for 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 CoEs will strengthen the research infrastructure in Pharma-MedTech sectors in the country by providing advanced facilities to conduct research and will also help in nurturing talent pool by promoting industry academia linkage, said the Scheme.
Under the second component of promotion of research in pharma and MedTech sector, the financial assistance will be provided in three categories. In the first category (BI), nine established pharma companies may be selected to carry out research in six priority areas with academic collaboration in government institute of national repute and these companies can avail the facilities of the research infrastructure available at national institutes, while these companies need to provide training to selected number of students and scientists of the institutes.
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