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The Department of Pharmaceuticals (DoP) has invited Request for Proposal (RFP) from central public sector enterprises (CPSEs) and Public Financial Institutions (PFIs) to operate as Project Management Agency (PMA) for the Promotion of Research and Innovation in Pharma and MedTech Sector (PRIP), the scheme notified by the government in August this year.
The PRIP scheme was announced by the government to support Research and Development (R&D) and innovation in pharma, medical devices and animal health segments. The scheme, with two components, has a total financial outlay of Rs. 5,000 crore for the period 2023-24 to 2027-2028 with financial outlay of Rs. 4,300 crore for Component B.
The bid is to select a PMA for the Component B of the scheme, which emphasizes six ‘Priority areas’ and provides financial assistance to companies and projects engaged in in-house and academic research and development (R&D). Through the process, a Project Management Agency (PMA) shall be selected by the DoP for providing secretarial, supervisory, technical, managerial and implementation support and to carry out other responsibilities as assigned by DoP within the framework of scheme and guidelines, said the Department. Proposals must be received at the assigned official in the DoP latest by 5 pm on October 13, 2023, by hand or by speed post. The bids submitted by telex, telegram, fax or e-mail etc. shall not be considered, it added.
The PMA shall be responsible for Component B of the scheme including receipt of applications, examination and processing of applications and issuing acknowledgements; weekly submission to DoP the status of applications received and processed under the Scheme; making appropriate recommendations to the PAAC for approval of applications under the Scheme; examination of claims for disbursement of incentive and making appropriate recommendations to the PAAC; verification of the reconciliation of disbursement claims with prescribed documents; compilation of data regarding progress and performance of the scheme through Quarterly Review and other information or documents; carry out inspections or visit of selected projects as when required by DoP/PAAC, among other activities.
The Component A aims to enhance the research infrastructure by establishing Centers of Excellence (CoEs) at the National Institutes of Pharmaceutical Education & Research (NIPERs) in core areas of Pharma MedTech research with a total budget of Rs. 700 crore. The Component B aims 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).
Component B is divided into three, with Category B I focusing on companies that are willing to conduct research in the six priority areas through collaboration with reputed government institutes. Under this category, up to about 9 established companies would be selected for this category with a funding allocation of Rs. 1,125 crore over a period of 5 years. 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. Investments made by the companies on the projects at the institutes would be supported with financial support at the rate of 35 per cent of the total cost incurred or Rs. 125 crore, whichever is less on milestone basis (from Technology Readiness Level [TRL] 1 to reach TRL 9) over a period of five years under benefit sharing principle.
The Category B II offers funding to research projects in the six priority areas that have reached the successfully validated level of Technology Readiness Level (TRL) 5, with an aim to expedite the market launching and large-scale commercialisation process of products/ technologies in priority areas having high commercial potential or societal impact financial assistance. A total of about 30 projects will be selected under this category, with a funding allocation of Rs. 3,000 crore over a period of five years.
Funding would be provided to these 30 research projects in six priority areas which are at successfully validated level (TRL 5) to reach TRL 9 at 35% of the cost or Rs. 100 crore whichever is less over a period of five years on the principle of benefit sharing. The projects would be selected on the basis of TRL 5, commercial potential, national/social impact of the product, affordability, revenue model and past performance of the company, said the notification. The funding disbursed for the projects will be recovered through benefit sharing (excluding refunded funding, if any) either through royalty or equity through 10% royalty on net sale of the product/technology till the patent is effective; or equity (not less than 100% of the DoP support provided). Beneficiaries will have to opt either of the models at the time of signing the agreement. In case, the project is declared unsuccessful/commercially unviable, the remaining assistance would not be released and any un-utilised amount as on date would be refunded to the Department of Expenditure within 30 days of the declaration.
The Category B III provides funding to research projects in the six priority areas, specifically designed to support Indian startups and Micro, Small and Medium Enterprises (MSMEs) in reaching TRL 4. About 125 projects would be provided funding under this category, with a total funding of Rs. 125 crore over a duration of five years, said the Department. Under this category, DoP will provide financial support for projects in six priority areas which have clear potential to translate into commercial product/technology. Around 125 research projects from startups/ SMEs/ MSMEs having potential or having made sufficient headway in the research of priority areas will be selected and funding up to Rs. 1 crore per projects over a period of five years in milestone manner which would be provided from ideation to proof of concept on royalty sharing basis.
The six priority areas include development of New Chemical Entity (NCE) or New Biological Entity (NBE) or Phyto-pharmaceuticals (natural products); Complex generics such as products with a complex active ingredient, complex formulation such as liposomes, colloids etc., novel route of drug delivery or dosage form among others and biosimilars; Precision medicines which are targeted innovative therapeutics including stem cell therapy, gene therapy and biomarkers; Medical devices including AI/ML based medical devices with software development, Software as Medical Device (SaMD) and software in Medical Device (SiMD), medical diagnostics and screening devices with genetic technology and others; Orphan Drugs which are medicinal products intended for diagnosis, prevention or treatment of life threatening or very serious diseases or disorders that are rare- about 450 rare diseases recorded in India (in tertiary care hospitals); and Drug development for AMR.
"The aim of the scheme is to encourage industry for R&D in priority areas and to inculcate the culture of quality research and nurture our pool of scientists by promoting industry-academia linkage. This will lead to sustained global competitive advantage and contribute to quality employment generation in the country," said the Department.
In its notification on the Scheme on August 17, 2023, the Department said, "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."
"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 Component A of the scheme proposes establishment of CoEs in the seven existing NIPERs at Mohali, Ahmedabad, Hyderabad, Guwahati, Kolkata, Hajipur and Raebareli. 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.
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