al FOR OFFICIAL USE ONLY Report No: PPHI00674 INTERNATIONAL DEVELOPMENT ASSOCIATION PROJECT PAPER ON A PROPOSED GRANT IN THE AMOUNT OF US$1 MILLION TO THE MINISTRY OF HEALTH AND FAMILY WELFARE FOR A INDIA - ENHANCING INNOVATION AMONG ICMR INSTITUTIONS {January 27, 2025 } Health, Nutrition & Population South Asia CURRENCY EQUIVALENTS (Exchange Rate Effective January 27, 2025) Currency Unit= INDIAN RUPEES (INR) INR 84.11 = US$1 US$0.01 = INR 1 FISCAL YEAR April 1 – March 31 Regional Vice President: Martin Raiser Acting Regional Director: Stefano Paternostro Country Director: Auguste Tano Kouame Practice Manager: Aparnaa Somanathan Task Team Leaders: Lung Duy Vu, Dinesh M. Nair ABBREVIATIONS AND ACRONYMS BSL-3 Biosafety Level 3 CDSCO Central Drug Standard Control Organization CPF Country Partnership Framework DHR Department of Health Research ESCP Environmental and Social Commitment Plan E&S Environmental and Social FY Financial Year GCP Global Challenge Program GDP Gross Domestic Product GRS Grievance Redress Service HEPPR Health Emergency Prevention, Preparedness, and Response ICMR Indian Council of Medical Research (ICMR) CLiMB Catalysing and Leveraging Innovation in Medtech Biodesign (ICMR) mPRiDE Product Ignition and Development Enabler (ICMR) CoE Centre of Excellence (ICMR) INTENT Indian Clinical Trial and Education Network INR Indian Rupees IP Intellectual Property IPR Intellectual Property Rights M&E Monitoring and Evaluation MCM Medical Counter Measures MDMS Medical Device & Diagnostics Mission Secretariat MoHFW Ministry of Health and Family Welfare NCD Non-communicable diseases NITI National Institution for Transforming India PDO Project Development Objectives PSU Project Support Unit SME Small and Medium Enterprises TR Translational Research The World Bank India - Enhancing Innovation among ICMR Institutions (P505177) @#&OPS~Doctype~OPS^dynamics@padsgbasicinformation#doctemplate BASIC INFORMATION Project Beneficiary(ies) Operation Name India India - Enhancing Innovation among ICMR Institutions Financing Instrument Classification Investment Project Financing (IPF) Small Grants Approval Date Closing Date Environmental and Social Risk Classification 14-Mar-2025 30-Jun-2027 Moderate Approval Authority Bank/IFC Collaboration CD Decision No Proposed Development Objective(s) To strengthen the ecosystem for successful commercialization of medical technologies among the Indian Council of Medical Research (ICMR) institutions and ICMR-supported institutions. Components Component Name Cost (US$) Deployment of bio-property sharing platform 150,000.00 Ecosystem development for technological advancement 100,000.00 Capacity building of ICMR faculty and program management support 750,000.00 @#&OPS~Doctype~OPS^dynamics@padborrower#doctemplate Organizations Borrower: Ministry of Health and Family Welfare Contact Title Telephone No. Email Nidhi Kesarwani Director (Mission 01123062434 nidhikesarwani@nic.in Karmayogi NIHFW, NIPHTR, NIRHFWT/Naco) Implementing Agency: Department of Health Research, Ministry of Health and Family Welfare Contact Title Telephone No. Email Anu Nagar Joint Secretary 01123736222 anu.nagar1@gov.in i The World Bank India - Enhancing Innovation among ICMR Institutions (P505177) @#&OPS~Doctype~OPS^dynamics@padfinancingsummary#doctemplate PROJECT FINANCING DATA (US$, Millions) Maximizing Finance for Development Is this an MFD-Enabling Project (MFD-EP)? No Is this project Private Capital Enabling (PCE)? No SUMMARY Total Operation Cost 1.00 Total Financing 1.00 Financing Gap 0.00 DETAILS Non-World Bank Group Financing Trust Funds 1.00 Health Emergency Preparedness and Response Multi-Donor Trust 1.00 @#&OPS~Doctype~OPS^dynamics@paddisbursementprojection#doctemplate Expected Disbursements (US$, Millions) WB Fiscal Year 2025 2026 2027 Annual 0.35 0.50 0.15 Cumulative 0.35 0.85 1.00 @#&OPS~Doctype~OPS^dynamics@padsgprocessing#doctemplate FINANCING & IMPLEMENTATION MODALITIES Situations of Urgent Need of Assistance or Capacity Constraints [ ] Fragile State(s) [ ] Fragile within a non-fragile Country [ ] Small State(s) [ ] Conflict [ ] Responding to Natural or Man-made Disaster Other Situations [ ] Financial Intermediaries (FI) [ ] Series of Projects (SOP) [ ] Performance-Based Conditions (PBCs) [ ] Contingent Emergency Response Component (CERC) [ ] Alternative Procurement Arrangements (APA) [ ] Hands-on Expanded Implementation Support (HEIS) Practice Area (Lead) ii The World Bank India - Enhancing Innovation among ICMR Institutions (P505177) Health, Nutrition & Population Contributing Practice Areas @#&OPS~Doctype~OPS^dynamics@padrisk#doctemplate OVERALL RISK RATING Risk Category Rating Overall ⚫ Moderate @#&OPS~Doctype~OPS^dynamics@padcompliance#doctemplate POLICY COMPLIANCE Policy Does the project depart from the CPF in content or in other significant respects? [ ] Yes [✓] No Does the project require any waivers of Bank policies? [ ] Yes [✓] No ENVIRONMENTAL AND SOCIAL Environmental and Social Standards Relevance Given its Context at the Time of Appraisal E & S Standards Relevance ESS 1: Assessment and Management of Environmental and Social Risks and Relevant Impacts ESS 10: Stakeholder Engagement and Information Disclosure Relevant ESS 2: Labor and Working Conditions Relevant ESS 3: Resource Efficiency and Pollution Prevention and Management Relevant iii The World Bank India - Enhancing Innovation among ICMR Institutions (P505177) ESS 4: Community Health and Safety Relevant ESS 5: Land Acquisition, Restrictions on Land Use and Involuntary Resettlement Not Currently Relevant ESS 6: Biodiversity Conservation and Sustainable Management of Living Natural Relevant Resources ESS 7: Indigenous Peoples/Sub-Saharan African Historically Underserved Not Currently Relevant Traditional Local Communities ESS 8: Cultural Heritage Not Currently Relevant ESS 9: Financial Intermediaries Not Currently Relevant NOTE: For further information regarding the World Bank’s due diligence assessment of the Project’s potential environmental and social risks and impacts, please refer to the Project’s Appraisal Environmental and Social Review Summary (ESRS). @#&OPS~Doctype~OPS^dynamics@padlegalcovenants#doctemplate LEGAL Legal Covenants Sections and Description @#&OPS~Doctype~OPS^dynamics@padconditions#doctemplate Conditions Type Citation Description Financing Source @#&OPS~Doctype~OPS^dynamics@padteam#doctemplate PROJECT TEAM Bank Staff Name Role Specialization Unit Lung Duy Vu Team Leader(ADM Responsible) Public Health HSAHN Dinesh M. Nair Team Leader HSAHN Financial Management Specialist(ADM Tanya Gupta ESAG1 Responsible) Geeta Shivdasani Chawla Procurement Specialist(ADM Responsible) Procurement Specialist ESARU Anupam Joshi Environmental Specialist(ADM Responsible) SSAE1 Venkata Rao Bayana Social Specialist(ADM Responsible) SSAS2 Mohammad Nadeem Counsel LEGAS Payal Malik Madan Procurement Team Program Assistant SACIN Anuradha Gollur Procurement Team Procurement Analyst BPSSM Seshachari Ramprasad iv The World Bank India - Enhancing Innovation among ICMR Institutions (P505177) Radha Narayan Procurement Team ESARU Amit Chander Team Member Private Sector Specialist CM4UA Om Prakash Kansal Team Member HSAHN Monitoring and Anagha Vasudeo Khot Team Member HSAHN Evaluation Shilpa John Team Member HSAHN Suresh Kunhi Mohammed Team Member HHNGE Tanvi Mundra Team Member WFACS Guru Rajesh Jammy Team Member HSAHN v The World Bank India - Enhancing Innovation among ICMR Institutions (P505177) TABLE OF CONTENTS I. STRATEGIC CONTEXT .................................................................................................................. 1 A. Country Context ................................................................................................................................ 1 B. Sectoral and Institutional Context .................................................................................................... 1 C. Higher Level Objectives to which the Project Contributes ............................................................... 4 II. PROJECT DEVELOPMENT OBJECTIVES ......................................................................................... 4 A. Project Development Objectives (PDO)............................................................................................ 4 B. Project Beneficiaries ......................................................................................................................... 5 C. PDO-Level Results Indicators ............................................................................................................ 5 III. PROJECT DESCRIPTION ............................................................................................................... 6 A. Project Components ........................................................................................................................ 6 B. Project Cost and Financing................................................................................................................ 8 IV. IMPLEMENTATION ..................................................................................................................... 8 A. Institutional and Implementation Arrangements............................................................................. 8 B. Results Monitoring and Evaluation ................................................................................................... 9 C. Sustainability ..................................................................................................................................... 9 D. Fiduciary ........................................................................................................................................... 9 V. KEY RISKS ................................................................................................................................ 10 A. Overall Risk Rating and Explanation of Key Risks ........................................................................... 10 VI. APPRAISAL SUMMARY ............................................................................................................. 10 A. Legal Operational Policies ............................................................................................................... 11 B. Environmental and Social ............................................................................................................... 11 VII. WORLD BANK GRIEVANCE REDRESS ......................................................................................... 12 III. RESULTS FRAMEWORK AND MONITORING ................................................................................. 13 The World Bank India - Enhancing Innovation among ICMR Institutions (P505177) I. STRATEGIC CONTEXT A. Country Context 1. Growth is estimated to have risen to 8.2 percent in fiscal year (FY) 23-24, and it is expected to remain robust in the medium term. In FY23-24, India remained the fastest-growing large economy. While consumption growth is estimated to have softened and export demand moderated due to a weak global environment, strong public investment and a nascent private capex upcycle kept economic growth elevated. Going forward, consumption demand will recover gradually, thanks to declining inflation and higher rural incomes, and private capex is expected to accelerate, facilitated by healthy corporate balance sheets and strong macroeconomic fundamentals. The government’s efforts to contain current spending and strong revenue performance helped reduce the general government fiscal deficit to 8.5 percent of Gross Domestic Product (GDP) in FY23-24. They should contribute to narrowing the deficit further over the medium term, with the debt-to-GDP ratio stabilizing at around 82 percent of GDP. India’s external position remains favorable, with growing services exports, a narrowing merchandise trade deficit, healthy foreign portfolio inflows, and large foreign exchange reserves of more than US$684 billion (as of October 25, 2024). 2. India has made remarkable progress in reducing extreme poverty over the past two decades. Extreme poverty is estimated to have declined significantly between 2011 and 2019, from 22.5 to 13.2 percent. In line with global trends, extreme poverty increased by two percentage points in 2020 due to the COVID-19 pandemic. However, broad access to vaccines and government mitigation measures contributed to the return to pre-pandemic poverty levels. The extreme poverty rate is estimated to have declined to 12.9 percent in FY21-22, while the moderate poverty (US$3.65 per person per day) rate is estimated at 44.1 percent in FY21-22. India's long-term progress in reducing extreme poverty was accompanied by a sharp decline in multidimensional poverty, from 27.7 percent in 2015-16 to 16.4 percent in 2019-21. Inequality in consumption has remained stable over the past two decades, with a Gini index of 32-35. Child stunting (under age 5) has steadily declined since 2005-06, reaching 35.5 percent in 2019-21. Headline employment indicators have consistently improved since 2020, and unemployment rates have recovered in urban and rural areas, but concerns about job quality, youth unemployment, and female labor force participation remain. B. Sectoral and Institutional Context 3. India’s performance in health has improved over time, yet wide variation exists across states and indicators. India’s under-five mortality rate (36 per 1,000 live births), infant mortality rate (30 per 1,000 live births), and maternal mortality ratio (103 per 100,000 live births) are closer to the average for India’s income level, reflecting significant achievements in improving access to skilled birth attendance, immunization, and other priority services. However, India lags behind global trends on some key indicators, including stunting (35.5 percent). The country faces a double burden of disease with an unfinished agenda of reproductive, maternal, newborn, child, and adolescent health, undernutrition, and communicable diseases, while the prevalence of chronic non- communicable diseases (NCDs) and obesity is rapidly increasing. 4. The COVID-19 pandemic also underscored the need for strong foundational bio-medical research ability to identify biosecurity risks from emerging and reemerging pathogens. Keeping track of pathogens, especially those of zoonotic origin, and maintaining maps with hot spots of vulnerable areas has become a critical national function for ensuring biosecurity. During the pandemic, the Indian Council of Medical Research (ICMR) played a vital role in indigenous vaccine development and established validation platforms for assessing COVID-19 diagnostic kits. Page 1 The World Bank India - Enhancing Innovation among ICMR Institutions (P505177) This helped in domestic industry growth, improved access, and reduced prices of testing kits ten-fold. There is a need to sustain these efforts and further enhance engagement with the private sector to scale up new technology platforms to prevent, detect and treat infectious diseases. 5. India's pharmaceutical industry, known as the 'pharmacy of the world,' is projected to reach US$64 billion by 2024 and US$130 billion by 2030. India supplies over 80 percent of antiretroviral drugs for AIDS, 50 percent of global vaccine demand, 40 percent of generic drugs for the US, and 25 percent of all medicines in the UK1. The key competitive advantages of India’s pharmaceutical industry include low cost and having strong government support such as research linked incentive schemes to foster research and development aimed to transform India into a hub for developing and producing medical countermeasures, especially vaccines and diagnostics. 6. India needs to promote translational research (TR) to develop new products and strategies to improve healthcare services and better prepare the country for future pandemics. The TR involves a multidisciplinary approach to expedite the development and availability of clinically relevant, affordable products and strategies for improving the existing healthcare system. The TR, which turns scientific discoveries into practical applications, faced challenges such as limited access to technology, biomaterials, testing facilities, and obtaining regulatory approvals by small and medium enterprises (SMEs), impacting their ability to develop new products needed by Indian citizens. The ICMR initiated a TR program in 2008 and constituted an expert committee to screen the intramural completed project reports to identify potential leads for further research. Later, in 2017, a similar screening was initiated for extramural projects to identify translational potential. These initiatives need further acceleration and capacity building among ICMR institutions. 7. The Transforming India’s Public Health Systems for Pandemic Preparedness Program (PHSPP , P175676) was approved by the World Bank’s Board on June 28, 2022, aiming to strengthen pandemic preparedness and response systems and institutions in India. Result Area 2 (RA2) of this project focuses on bio-medical research to enhance capacity for detecting emerging and reemerging pathogens to guide India’s bio-security response including the development of public-private partnerships to develop and manufacture medical counter measures for priority infectious diseases. To date, moderate progress has been made, including creating a public-private forum and launching the Medtech Mitra initiative to foster the development of affordable and accessible indigenous medical devices. However, this effort needs to be accelerated to accommodate an increasing number of innovators and the private sector participation. ICMR has requested the World Bank to support this effort with an additional US$1 million through a Recipient Executed Trust Fund. 8. There is an urgent need to strengthen eco-systems for accelerating market readiness of promising research by ICMR’s network to enhance India’s health security. Ecosystems involve a set of capabilities and services that integrate partners in the value chain (researchers, regulators, entrepreneurs and users) to create improved and efficient consumer and stakeholder experiences by solving significant pain points or inefficiencies2. While ICMR and its network of institutions undertake high-quality research and develop pathbreaking technologies, the commercialization of successful technologies remains a challenge due to inadequate development of ecosystems. Some of the key ecosystem challenges in India include the lack of a uniform and effective mechanism for sustained 1 Pharmaceutical Industry Report; India Brand Equity Foundation November 2024. 2 Adapted from Shuban Singhal, Basel Kayyali, Rob Levin and Zachary Greenberg, The next wave of healthcare innovation: The evolution of ecosystem. McKinsey Company Healthcare June 23, 2020 Page 2 The World Bank India - Enhancing Innovation among ICMR Institutions (P505177) public-private engagement in many of the institutions, limited understanding of regulatory framework by the private sector and ICMR researchers, the need for enhanced awareness and appropriate protocols for technology transfer of co-created assets and sharing royalties, among other things. De-risking investments by entrepreneurs, especially in the case of medical countermeasures for endemic and neglected tropical diseases, is also a priority. 9. To address some of these ecosystem challenges, the ICMR, as the apex body in India for the formulation, coordination, and promotion of biomedical research, has always been at the forefront of developing biomedical interventions for wider societal benefit. Various initiatives have been taken by the ICMR-Department of Health Research (DHR), Government of India, including the following: a) Establishing the Medical Device and Diagnostics Mission Secretariat (MDMS) at ICMR. MDMS aims to support and catalyze research, development, and manufacturing of cost-effective medical devices in the country to strengthen India's healthcare sector and reduce its import dependency. b) The Indian Clinical Trial and Education Network (ICMR-INTENT), which plays a vital role in determining the safety and effectiveness of innovative medical technologies through its pan-India network of 47 sites for conducting large multi-centric regulatory clinical trials. c) “MedTech Mitra�: A joint initiative recently launched under the guidance of NITI (the National Institute for Transforming India) Aayog by the ICMR and the Central Drug Standard Control Organization (CDSCO) as a highway to foster the development of indigenous medical technologies, including novel vaccines, drugs, medical devices, and in-vitro diagnostics by bridging the gap between MedTech entrepreneurs/innovators and key MedTech knowledge providers. Specifically, support under MedTech Mitra includes clinical evaluation, regulatory facilitation, and support for the uptake of new products. The MDMS Unit is the key coordinator for MedTech Mitra. So far, more than 250 applications have been received, and initial engagement, including formal meetings, has been held with 190 innovators. ICMR has invested INR 95 Crore for these initiatives including INR 90 Crore support to INTENT and INR 5 Crore for hiring eight regular staff for working under the MedTech Mitra initiative. This important initiative requires further acceleration. d) Policy on Biomedical Innovation & Entrepreneurship for Medical Professionals, Scientists and Technologists at Medical, Dental and Para Medical training Institutes. This policy aims to ensure multi-disciplinary collaboration, promote start-up culture and develop an innovation-led ecosystem at medical institutes across the country. This policy will support the Make-in-India, Start-Up-India, and Atmanirbhar Bharat initiatives. 10. The ICMR institutions, over the years, have generated considerable bio-properties. Access to such bio-property is vital for public and private entities to develop preventive, diagnostics, and therapeutic products. For effective management of these bio-resources for the public good, an appropriate and transparent system to create access is required for catalyzing material transfer processes and its monitoring for rapid product development including validation of products specifically aligned with the national health priority. Importantly, the capacities of ICMR’s staff need to be further strengthened in the translation of innovative research to benefit the neediest people through commercialization, including innovations vital for detecting infectious disease pathogens in the context Page 3 The World Bank India - Enhancing Innovation among ICMR Institutions (P505177) of a pandemic (e.g. the COVID-19 pandemic). This requires a sustained effort toward relevant training, appropriate exposure programs, and engagement with the private sector. C. Higher Level Objectives to which the Project Contributes 11. The proposed project aligns with the India Country Partnership Framework (CPF) FY18–22; Report No. 126667- IN, discussed by the World Bank Board of Executive Directors on September 20, 2018, and extended to FY25 by PLR dated October 23, 2023. 12. The proposed project contributes to CPF Focus Area 1: Promoting Resource Efficient Growth and is directly linked to key objective 1.5: strengthening disaster resilience by augmenting the development of medical countermeasures relevant to the country. The project also contributes to Focus Area 3: Investing in Human Capital and its key objective 3.4 of improving the quality of health service delivery and financing and access to quality health care by fostering innovation in the development of affordable medical devices and in-vitro diagnostics. 13. The project will contribute to the World Bank's Global Challenge Program (GCP) on Health Emergency Prevention, Preparedness, and Response (HEPPR). The long-term goal of the GCP on HEPPR is to support countries, regions, and the global community in developing the capacities to prevent, prepare for, and respond to health emergencies. Specifically, this project aids in industrial growth and improving market readiness, and is also important for pathogen identification and disease detection. Additionally, focusing on indigenous technologies, this project will ultimately enable equitable and timely access to health services and medical countermeasures in the context of a pandemic or other health emergency. 14. This project further strengthens the catalytic funding supported by the overall HEPR TF grant. For example, under the PHSPP project, the capacity for pathogen detection is further being expanded through the creation of three new national institutes of virology and the existing Viral Disease Research and Diagnostic Laboratory Network. In addition, advanced public health laboratories are being established in states to ensure prompt access to diagnosis novel pathogens. Furthermore, ICMR is developing algorithms for etiological diagnosis for six common syndromes which helps to develop appropriate point of care tests. II. PROJECT DEVELOPMENT OBJECTIVES A. Project Development Objectives (PDO) To strengthen the ecosystem for successful commercialization of medical technologies among the Indian Council of Medical Research (ICMR) institutions and ICMR-supported institutions. 15. The PDO will be achieved through three mutually complementary components (a) supporting ecosystem development to promote translation of promising research done by ICMR institutions to products and services accessible to vulnerable populations, building on the MedTech Mitra initiative; (b) supporting the creation of repositories of bio- materials generated through ICMR research and making them available to the industry Page 4 The World Bank India - Enhancing Innovation among ICMR Institutions (P505177) following a public-private partnership approach to develop products and technologies aligned to national health priorities and enhance India’s emergency preparedness and response; and (c) capacity building of ICMR faculty and program management support. 16. The project's design is informed by lessons learned within India and globally. The Department of Biotechnology, Government of India, started a similar initiative under the National Bio-pharma Mission. The mission aimed to address some of the long-standing challenges of the Indian Bio-pharmaceutical industry, including insufficient investment in public goods, low spending on research and development, and reluctance of the industry in diseases affecting the poor due to expected low returns. In India, the Government spends over 60 percent of the research and development expenditure, in contrast to the US, China, South Korea, and Australia, where the private sector contributes more than 70 percent of research and development spending. In this context, the initial challenge for India is to translate the promising bio-medical research done by public sector institutions such as the ICMR to commercial products that improve the health of citizens. 17. The World Bank supported the National Bio-Pharma Mission through the Innovate in India for Inclusiveness Project (P156241) to facilitate innovation in biopharmaceutical products and medical devices that address public health priorities in India. The project used a strategic “rails and trains� approach to promote innovation in the bio- pharma sector. The rails symbolize the ecosystem creation consisting of clinical trial networks to assess the safety and validity of new products, familiarization of regulatory systems, protocols for technology transfer, and capacity building. The trains include specific products such as vaccines, biosimilars and medical devices. The project contributed fifty-three intellectual property (IP) registrations or product prototypes, eighteen technologies licensed for manufacturing, and over two hundred facilities used the shared facilities. Over 6,700 researchers, scientists, and staff were trained through the project, enhancing India’s human capital and fostering a vibrant innovation ecosystem. The proposed project incorporates lessons learned from this operation giving priority focus on capacity building and eco-system development for promising medical countermeasures developed by the ICMR institutions to optimize future commercialization potential. B. Project Beneficiaries 18. The primary beneficiaries are scientists working in the ICMR institutions, ICMR-supported institutions and the innovators under the MedTech Mitra Initiative. The MedTech Mitra Initiative has received over 250 applications in the last six months. The biorepository portal, which facilitates access of ICMR bio-property to industry to develop technologies and products aligned with national health priorities, will benefit Indian citizens as well as citizens of other countries to which Indian manufacturers export the new medical countermeasures developed through improved ecosystems and enhanced capacities. C. PDO-Level Results Indicators 19. The project will be monitored through three PDO-level indicators: MedTech Mitra Innovators sensitized about ecosystems for the commercialization of medical countermeasures Stakeholders supported with ICMR generated bio-properties through the bio-repository sharing platform for developing technologies and products addressing national health priorities. Page 5 The World Bank India - Enhancing Innovation among ICMR Institutions (P505177) ICMR staff received competency-based training in patent laws, technology transfers, and business development disaggregated by gender. III. PROJECT DESCRIPTION A. Project Components 20. Component 1: Supporting ecosystem development for technological advancement (US$150,000). This component supports the creation and nurturing of an eco-system to promote technology advancement partnerships. 21. Subcomponent 1.1: This subcomponent builds on the initiatives started by the MDMS of ICMR including the recently adapted policy on the biomedical innovation and entrepreneurship for medical and allied professionals and Intellectual Property Rights (IPR) guidelines to facilitate transfer of ICMR developed/supported technologies for commercialization. To strengthen the IP Management system of ICMR, the grant will facilitate a consultative process involving ICMR scientists, industry representatives and independent technical experts to develop standard operating procedures including ownership of co-created assets, norms for technology licensing transfers and formulas for revenue sharing. Specific activities supported by the project include meetings, workshops and consultant support. The grant will also support capacity building of ICMR in strengthening its IP management systems. Since intellectual property /technology transfer pertains to confidential and proprietary information of ICMR, data related to this will not be shared under this project without prior consent from the competent authority, ICMR. 22. Subcomponent 1.2. This subcomponent will support the ongoing efforts to provide strategic handholding support to innovators enrolled with ICMR under the MedTech Mitra Initiative. Specific areas of support will include one- on-one and group meetings, as well as online forums to provide guidance on safety and clinical evaluations, sensitization regarding regulatory requirements, including facilitation of interactions with CDSCO, and sharing information and strategies for enhancing commercial uptake of new products. This subcomponent will strengthen the existing investments made by ICMR in terms of human resources to generate regulatory-compliant clinical evidence for MedTech. 23. Component 2: Creating repositories of ICMR research to develop technologies aligned with national health priorities through public-private partnerships (US$100,000). This component will support the currently operating as well as establishment of a bio-repository network of ICMR bio-materials generated through research which will be made available to the interested industry for developing products and technologies addressing national health priorities, especially products vital in the context of pandemic or health emergency. The grant will support the creation of mechanisms for managing appropriate and transparent access, catalyzing material transfer processes, and its monitoring for rapid product development and validation. Additionally, the technical know-how and capacity for developing medical countermeasures for emergencies will be identified and further developed through effective public-private partnerships. To provide equal opportunity, collaborative proposals will be invited from the industry by publishing an Expression of Interest. Page 6 The World Bank India - Enhancing Innovation among ICMR Institutions (P505177) 24. Component 3: Capacity building of ICMR faculty and program management support (US$750,000). This component will support the capacity building of the research fraternity within ICMR and its partner institutions, including the establishment of a project support unit (PSU) with specialized skills currently not available at ICMR. 25. Subcomponent 3.1. The capacity building of the ICMR staff will focus on identifying innovations while balancing equity and commercialization potential, managing research results, protecting technology, and advancing to commercialization. Training will be based on live case studies and practicum to ensure competencies. Additionally, targeted training programs will be offered by organizing study tours and interactions with regulators and industry experts. 26. Subcomponent 3.2. A PSU will be established under the leadership of senior ICMR staff member and supported by up to four technical experts with specialization in intellectual property protection, technology transfer, business development and patent laws. Specifically, the subcomponent will include consultant support, travel, meetings, workshops and communication costs. 27. Theory of change Figure 1: Project Theory of Change Number of standard opera ng evelop standard opera ng procures protocols developed to cosystem procedures for Technology transfer support commerciali a on of bio of I M research withcommercial medical innova ons of ICMR development for poten al ins tu ons technological Strategic handholding support to advancement umber of MedTech Mitra innovators enrolled under the sensi ed about ecosystems for MedTech Mitra Ini a ve commerciali a on of medical countermeasures(P Data base of ICMR bio proper es established Iden fy of bio proper es in A framework for sharing ICMR I M network and partner eployment of bio ins tu ons bio proper es is created. property sharing reate a comprehensive umber of stakeholders pla orm database of I M bio proper es supported withI M generated Train I M sta in maintaining bio proper es to develop the data base and track technologies products commercial applica on addressing na onal health priori es (P apacity building of Train I M sta in iden ca on of I M faculty and innova ons with program umber of I M sta received commerciali a on poten al, management technology protec on and competency based trainingin technology support advancement to commerciali a on patent laws, technology transfers transfer, business development and stablish a PS with speciali a on and business development patent laws in IP , technology transfer, disaggregatedby gender (P business development and patent laws Page 7 The World Bank India - Enhancing Innovation among ICMR Institutions (P505177) B. Project Cost and Financing Table 1: Project cost by component Project Components Project cost Trust Funds Counterpart Funding Ecosystem development for 150,000 150,000 00.0 technological advancement Deployment of bio-property 100,000 100,000 00.0 sharing platform Capacity building of ICMR faculty and program 750,000 750,000 00.0 management support Total Costs 1,000,000 1,000,000 00.0 Total Project Costs Total Financing Required 1,000,000 1,000,000 00.0 IV. IMPLEMENTATION A. Institutional and Implementation Arrangements 28. The ICMR will be responsible for implementation of the project. ICMR is an autonomous society under Ministry of Health and Family Warfare (MoHFW). It is the apex body for formulation, coordination, and promotion of biomedical research and is headed by the Director General. The Secretary of the DHR is the administrative head of the DHR. At present, the ICMR has 26 Institutes/ Regional Research Centers spread across various parts of the country and each of these are headed by a director. Administratively, the DHR is under the purview of the Joint Secretary. All project activities under the ICMR will be implemented through Divisions/Cells of ICMR. Decentralized operations will be undertaken by the ICMR headquarters and its two branches. 29. The primary responsibility for the technical aspects of project implementation rests with the MDMS Unit of the Division of Development Research at the ICMR headquarters. The MDMS Unit will be supported by the PSU in day-to-day operations and organizing interactions with entrepreneurs enrolled under the MedTech Mitra program and sensitization sessions for the staff from ICMR and partner institutions. MDMS Unit has significant experience working with the World Bank projects, including the India COVID-19 Emergency Response and Health Systems Preparedness Project - (P173836) and the Transforming India's Public Health Systems for Pandemic Preparedness Program - (P175676). The PSU will also provide specialized technical consultants on either a short- or long-term basis to address critical capacity gaps within ICMR. The Joint Secretary, DHR will provide administrative support while the Director General, ICMR and Secretary DHR will approve annual work plans and budgets while providing border oversight to the project by undertaking quarterly reviews. Page 8 The World Bank India - Enhancing Innovation among ICMR Institutions (P505177) B. Results Monitoring and Evaluation 30. The MDMS Unit of the ICMR will develop a comprehensive monitoring and evaluation (M&E) system for the project to generate high-quality data on identified project results. The database of ICMR bio-properties will be updated every year. To ensure equity focus, the project M&E system will prioritize tracking technology transfers for endemic and neglected tropical diseases affecting the poor. 31. A key component of the M&E system will be detailed process documentation of the process to facilitate wider knowledge sharing. A six-monthly results report will be prepared and shared with the ICMR senior management led by the Director General. An early mid-term review of the project will be undertaken in June 2026 to identify and promptly address implementation bottlenecks for the project activities. An endline review will be done at project closure to assess project achievements and document key lessons learned. C. Sustainability 32. Improving citi en’s access to indigenous, accessible and affordable technologies developed by its network of institutions and partner agencies is an identified priority of the ICMR under the Viksit Bharat Initiative of the Government of India. Towards this, the ICMR has created a Medical Device and Diagnostics Mission Secretariat which is closely collaborating with various stakeholders and research institutions such as the Indian Institutes of Technology to develop eco-systems for transfer of promising technology to the industry. The new MedTech Mitra initiative has already created a sensitize large network of entrepreneurs. In addition, the ICMR is in the process establishing a Section 8 company to facilitate technology transfers. 33. The ICMR currently has an annual budget (FY24-25) of Rs. 2732.13 Crore (US$320 million) and the incremental resource needs for activities supported by the project will be around US$3,400,000 per annum. The project activities can, therefore, easily be absorbed by the ICMR within the current budget. In addition, the ICMR is also expecting an increase in its budget allocations under the Viksit Bhart Initiative. D. Fiduciary 34. Financial management (FM) arrangements for the project are fully reliant on the ‘use of country systems’, i.e., predicated on Government of India (GOI)’s own systems, including accounting and reporting arrangements, internal control procedures, planning and budgeting, external audits, funds flow, organization and staffing arrangements, all of which the Bank has assessed as Satisfactory. The project has acceptable FM arrangements to account for and report on project expenditures. 35. The financial management function is the responsibility of a finance team headed by Senior Financial Advisor at ICMR. ICMR is familiar with the World Bank’s financial management system, and their capacity has been strengthened by the India COVID-19 Emergency Response and Health Systems Preparedness Project - (P173836) and continues to be strengthened by the PHSPP-Transforming India's Public Health Systems for Pandemic Preparedness Program - (P175676). The FM staff of the PHSPP (P175676) project will be tasked to carry out the day-to-day FM work under this proposed project. FM staffing is currently adequate and has experience handling Page 9 The World Bank India - Enhancing Innovation among ICMR Institutions (P505177) World Bank financial documents. The FM manual prepared for the two above mentioned projects will also apply to this project. 36. The World Bank funds will be provided to the GOI and will remain within the existing financial management systems of the MOHFW. All guidelines followed for financial management are as per the General Financial Rules (GFR), 2017. ICMR, an autonomous society, was part of a GOI pilot for Treasury Single Account (TSA) consolidation – which allows the transfer of allocations and not actual funds to the autonomous agencies. The World Bank funds will be disbursed against eligible expenditures or statements of expenses. No retroactive financing is envisaged under this project. V. KEY RISKS A. Overall Risk Rating and Explanation of Key Risks 37. The overall risk for the project is Moderate. The focus of the project is primarily on strengthening ecosystems for technology transfer and creation of a database of biorepositories of ICMR and its partner institutions with capacity building of ICMR staff and entrepreneurs enrolled under the MedTech Mitra initiative. It does not support direct bio-medical research nor commercialization. No physical handling or movement of bio-properties is envisaged under the project. In addition, the implementing agency, ICMR, has strong experience in implementing World Bank-funded projects and has technical expertise in implementing the proposed activities. In addition, the PSU is being setup and strengthened with experienced staff and consultants who have been part of the parent project PHSPP. Lastly, the World Bank team would work closely with ICMR and PMU to provide technical support during project implementation. VI. APPRAISAL SUMMARY 38. To minimize the risk of the next pandemic, more equitable global access is required for diverse manufacturing platforms of medical countermeasures linking researchers and industry along with capacity building and creation of appropriate ecosystems for translational research. Estimates by Nobel laureate Michael Kremer suggests that investing US$60 billion upfront to expand production capacity for vaccines and supply chain inputs and US$2.2 billion thereafter to maintain capacity would be worthwhile for a future coronavirus-type risk3. In the event of a pandemic, this investment could generate expected benefits of US$1.6 trillion, relative to a scenario where countries made no advance investments. Recent modeling estimates that the probability of a future zoonotic spillover event resulting in a pandemic of COVID-19 magnitude or larger is between 2.5–3.3 percent annually. This translates to a 22–28 percent chance within the next 10 years and a 47–57 percent chance within the next 25 years. Assuming a conservative two percent annual risk of a pandemic, the expected net benefits would be US$780 billion over the next 25 years4. 3 https: www.acceleratinght.org academic papers 4 Rapid and Equitable Access to Medical Countermeasures: Lessons, Landscape, and Near Term Recommendations Amanda Glassman, Javier Gu man, Julia Kaufman, Prashant Yadav. Center for Global Development Note May 2022. Page 10 The World Bank India - Enhancing Innovation among ICMR Institutions (P505177) 39. The project is consistent with the adaptation and mitigation goals of the Paris Agreement and the updated India’s ationally etermined ontribution ( 0 India has committed to reduce the emissions intensity of its GDP by 45 percent by 2030 relative to 2005 levels. India’s National Action Plan on Climate Change (2008) outlines a strategy to strengthen climate mitigation and adaptation efforts. The proposed project activities (mainly training, study tours, and policy dialogues) are limited and face extremely low levels of inherent risk from India’s climate hazards, such as extreme heat, floods, and zoonotic/climate-related diseases. In addition, the project will build future pandemic preparedness capacity for India, eventually increasing vulnerable populations' adaptive capacity to deal with climate-related shocks and diseases. All project components are on the Universally Aligned List for Mitigation� thus exempting them from a full mitigation assessment. A. Legal Operational Policies @#&OPS~Doctype~OPS^dynamics@padlegalpolicy#doctemplate Legal Operational Policies Triggered? Projects on International Waterways OP 7.50 No Projects in Disputed Area OP 7.60 No B. Environmental and Social 40. The environmental and social (E&S) risks associated with the project are moderate. The overall impacts of the project are likely to be positive, owing to benefits such as enhanced preparedness of the health sector towards any future pandemic or disease outbreaks. The project will not finance any activities that would cause high E&S risks and impacts such as land acquisition and/or involuntary resettlement, and construction of BSL3 (Biosafety Level 3) laboratories. 41. The proposed grant will support the commercialization of research on biological materials and properties for developing innovative products for the medical and health sectors. No adverse impacts are expected on key social issues of inclusion and equity. The ICMR and its network institutions have good capacity and years of experience in conducting research on biological materials and properties, occupational health and safety and on storing of biological materials. The grant will focus on strengthening biosecurity and biosafety measures. ESS1, ESS2, ESS4, ESS6, and ESS10 are considered relevant at this stage. The grant will support the development of screening checklists for ascertaining the capacity of private and public entities as they express interest in accessing biological materials and properties for further research. 42. The environmental and social compliance requirements have been included as a commitment in the project's Environmental and Social Commitment Plan (ESCP). The ESCP also includes requirements and commitments for stakeholder engagement and labor management. Page 11 The World Bank India - Enhancing Innovation among ICMR Institutions (P505177) VII. WORLD BANK GRIEVANCE REDRESS 43. Grievance Redress. Communities and individuals who believe that they are adversely affected by a project supported by the World Bank may submit complaints to existing project-level grievance mechanisms or the Bank’s Grievance Redress Service (GRS). The GRS ensures that complaints received are promptly reviewed in order to address project-related concerns. Project affected communities and individuals may submit their complaint to the Bank’s independent Accountability Mechanism (AM). The AM houses the Inspection Panel, which determines whether harm occurred, or could occur, as a result of Bank non-compliance with its policies and procedures, and the Dispute Resolution Service, which provides communities and borrowers with the opportunity to address complaints through dispute resolution. Complaints may be submitted to the AM at any time after concerns have been brought directly to the attention of Bank Management and after Management has been given an opportunity to respond. For information on how to submit complaints to the Bank’s Grievance Redress Service (GRS), visit http://www.worldbank.org/GRS. For information on how to submit complaints to the Bank’s Accountability Mechanism, visit https://accountability.worldbank.org. Page 12 The World Bank India - Enhancing Innovation among ICMR Institutions (P505177) III. RESULTS FRAMEWORK AND MONITORING @#&OPS~Doctype~OPS^dynamics@padsgannexresultframework#doctemplate Project Development Objective Indicators Project Development Objective(s) To strengthen the ecosystem for successful commercialization of medical technologies among the Indian Council of Medical Research (ICMR) institutions and ICMR- supported institutions. Baseline Closing Period MedTech Mitra Innovators sensitized about eco-systems for commercialization of medical countermeasures (Number) Mar/2025 Jun/2027 190 210 Stakeholders supported with the ICMR generated bio-properties through the bio-repository sharing platform for developing technologies/products addressing National health priorities. (Number) Mar/2025 Jun/2027 0 10 ICMR staff received competency-based training in patent laws, technology transfers, and business development disaggregated by gender. (Number) Mar/2025 Jun/2027 0 52 Intermediate Indicators Baseline Closing Period SOPs developed covering critical aspects of technology transfer (Number) Page 13 The World Bank India - Enhancing Innovation among ICMR Institutions (P505177) Mar/2025 Jun/2027 0 3 Establishment of a transparent system of seeking collaborative proposals from Industry (Number) Mar/2025 Jun/2027 0 2 Case studies (vaccines, diagnostics and therapeutics) developed for capacity building of ICMR staff (Number) Mar/2025 Jun/2027 2 6 Page 14