The World Bank Implementation Status & Results Report Innovate in India for Inclusiveness (P156241) Innovate in India for Inclusiveness (P156241) SOUTH ASIA | India | Finance, Competitiveness and Innovation Global Practice | IBRD/IDA | Investment Project Financing | FY 2017 | Seq No: 8 | ARCHIVED on 27-Aug-2021 | ISR47943 | Implementing Agencies: India, Biotechnology Industry Research Assistance Council Key Dates Key Project Dates Bank Approval Date: 31-May-2017 Effectiveness Date: 23-May-2018 Planned Mid Term Review Date: 07-Oct-2020 Actual Mid-Term Review Date: 26-Oct-2020 Original Closing Date: 30-Jun-2023 Revised Closing Date: 30-Jun-2023 pdoTable Project Development Objectives Project Development Objective (from Project Appraisal Document) The proposed project development objective (PDO) is to facilitate innovation in biopharmaceutical products and medical devices that address public health priorities in India Has the Project Development Objective been changed since Board Approval of the Project Objective? No Components Table Name Strengthening the pilot-to market innovation ecosystem:(Cost $125.00 M) Accelerating the pilot-to-market process for specific products:(Cost $120.00 M) Project management:(Cost $5.00 M) Overall Ratings Name Previous Rating Current Rating Progress towards achievement of PDO Satisfactory Satisfactory Overall Implementation Progress (IP) Moderately Satisfactory Moderately Satisfactory Overall Risk Rating Substantial Substantial Implementation Status and Key Decisions The project is making satisfactory progress in achieving its project development objective (PDO). All five PDO indicators have achieved end of project targets: 32 intellectual property (IP) registrations or product prototypes, 13 technologies licensed for manufacturing or commercialization, 50 products that address public health priorities advancing at least one step on the product development pathway, 7 technology transfer offices established, and 108 companies using the shared facilities supported by the project. Project support in response to COVID-19 is advancing. The project is supporting the development of six novel COVID vaccine candidates (e.g., DNA, Adenovirus, Virosome, Subunit). A vaccine supported during Phase I/II trials, Zydus Cadila, received emergency approval on August 20, becoming the world's first approved DNA vaccines. The Biological E vaccine recently completed Phase II for all 360 subjects. In addition, two vaccine candidates have moved to Phase III clinical trials. In addition, the cGMP manufacturing facility at Shilpa Biologicals is now manufacturing the drug substance for the Sputnik-V vaccine. Similarly, manufacturing facilities have developed RT-PCR Diagnostic Kits for detection of COVID-19 infection, Ventilators, Nucleic Extraction Kits, Material and Viral Transfer Medium, and Pulse Oximeters. 8/27/2021 Page 1 of 5 The World Bank Implementation Status & Results Report Innovate in India for Inclusiveness (P156241) Project implementation is also making progress with over 92 percent of project funds committed in INR. Disbursement, currently at 32 percent, is below the agreed targets. The COVID-19 pandemic has affected the ability of beneficiaries to implement their projects, especially as most of the work requires physical presence (e.g. laboratories). Risks Systematic Operations Risk-rating Tool Risk Category Rating at Approval Previous Rating Current Rating Political and Governance Low Low Low Macroeconomic Low Moderate Moderate Sector Strategies and Policies Moderate Moderate Moderate Technical Design of Project or Program Substantial Substantial Moderate Institutional Capacity for Implementation and Moderate Substantial Substantial Sustainability Fiduciary Moderate Moderate Moderate Environment and Social Low Low Low Stakeholders Low Low Low Other -- Moderate Moderate Overall Substantial Substantial Substantial Results PDO Indicators by Objectives / Outcomes To facilitate innovation in biopharma & medical devices addressing public health priorities in India IN01030424 ►Number of products addressing public health priorities advanced at least one step on the product development pathway (Number, Custom) Baseline Actual (Previous) Actual (Current) End Target Value 0.00 19.00 50.00 6.00 Date 14-Nov-2016 04-Nov-2020 30-Apr-2021 01-May-2023 IN01030425 ►Number of new IP registrations or product prototypes (Number, Custom) Baseline Actual (Previous) Actual (Current) End Target Value 0.00 32.00 39.00 15.00 8/27/2021 Page 2 of 5 The World Bank Implementation Status & Results Report Innovate in India for Inclusiveness (P156241) Date 14-Nov-2016 04-Nov-2020 30-Apr-2021 01-May-2023 IN01030426 ►Number of technologies licensed for manufacturing or commercialization (Number, Custom) Baseline Actual (Previous) Actual (Current) End Target Value 0.00 13.00 23.00 2.00 Date 14-Nov-2016 04-Nov-2020 30-Apr-2021 01-May-2023 IN01030427 ►Number of TTOs established (Number, Custom) Baseline Actual (Previous) Actual (Current) End Target Value 0.00 5.00 7.00 6.00 Date 14-Nov-2017 04-Nov-2020 30-Apr-2021 01-May-2023 IN01030428 ►Number of companies using shared facilities supported by the project (Number, Custom) Baseline Actual (Previous) Actual (Current) End Target Value 0.00 57.00 108.00 60.00 Date 14-Nov-2017 04-Nov-2020 30-Apr-2021 01-May-2023 Intermediate Results Indicators by Components Strengthening the pilot-to market innovation ecosystem IN01030429 ►Number of clinical trial sites that are GCP compliant (Number, Custom) Baseline Actual (Previous) Actual (Current) End Target Value 0.00 11.00 11.00 5.00 Date 14-Nov-2016 04-Nov-2020 30-Apr-2021 01-May-2023 IN01030431 ►Number of registered technology transfer professionals qualified (Number, Custom) Baseline Actual (Previous) Actual (Current) End Target Value 0.00 15.00 25.00 12.00 Date 14-Nov-2016 04-Nov-2020 30-Apr-2021 01-May-2023 IN01030433 ►Number of people trained (Number, Custom) 8/27/2021 Page 3 of 5 The World Bank Implementation Status & Results Report Innovate in India for Inclusiveness (P156241) Baseline Actual (Previous) Actual (Current) End Target Value 0.00 1,406.00 6,295.00 1,775.00 Date 14-Nov-2017 04-Nov-2020 30-Apr-2021 01-May-2023 IN01030435 Number of people trained who are women (Percentage, Custom Supplement) Baseline Actual (Previous) Actual (Current) End Target Value 0.00 37.00 44.00 50.00 Accelerating the pilot-to-market process for specific products IN01030430 ►Number of product development agreements in place (Number, Custom) Baseline Actual (Previous) Actual (Current) End Target Value 0.00 104.00 116.00 9.00 Date 14-Nov-2016 04-Nov-2020 30-Apr-2021 01-May-2023 IN01030432 ►Number of international publications (Number, Custom) Baseline Actual (Previous) Actual (Current) End Target Value 0.00 11.00 14.00 10.00 Date 14-Nov-2016 04-Nov-2020 30-Apr-2021 01-May-2023 IN01030434 ►Proportion of grievances responded to and/or resolved within the stipulated service standards for response times (Percentage, Custom) Baseline Actual (Previous) Actual (Current) End Target Value 0.00 100.00 100.00 90.00 Date 14-Nov-2016 04-Nov-2020 30-Apr-2021 01-May-2023 The PIU received five queries from respondents to issued RFPs seeking further detailed clarifications on Comments: the reasons of proposal rejections or further representations. All five were adequately responded to. Performance-Based Conditions Data on Financial Performance Disbursements (by loan) Project Loan/Credit/TF Status Currency Original Revised Cancelled Disbursed Undisbursed % Disbursed 8/27/2021 Page 4 of 5 The World Bank Implementation Status & Results Report Innovate in India for Inclusiveness (P156241) P156241 IBRD-87510 Effective USD 125.00 125.00 0.00 39.91 85.09 32% Key Dates (by loan) Project Loan/Credit/TF Status Approval Date Signing Date Effectiveness Date Orig. Closing Date Rev. Closing Date P156241 IBRD-87510 Effective 31-May-2017 24-Apr-2018 23-May-2018 30-Jun-2023 30-Jun-2023 Cumulative Disbursements PBC Disbursement Achievement Disbursed amount in Disbursement % PBC ID PBC Type Description Coc PBC Amount Status Coc for PBC Restructuring History There has been no restructuring to date. Related Project(s) There are no related projects. 8/27/2021 Page 5 of 5