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: 7 | ARCHIVED on 27-Nov-2020 | ISR44119 | 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 Moderately 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 outcome indicators. Three out of the five outcome indicators have achieved end of project targets, including: 32 intellectual property (IP) registrations or product prototypes, 13 technologies licensed for manufacturing or commercialization, and 19 products that address public health priorities advancing at least one step on the product development pathway. The remaining two indicators have achieved their FY21 targets, with the establishment of 5 technology transfer offices and 57 companies using the shared facilities supported by the project. Over 90 percent of project funds have been committed in INR. Nearly 80 percent of commitments have already been signed through Grant-in-Aid Letter Agreements (GLAs), with the remaining 20 percent expected by the end of 2020. The project’s ecosystem (Component 1) includes support for 21 shared facilities (average INR 192m/U$2.6m), 29 scientific research (average INR 34.8m/US$0.5m), 16 clinical trial networks (average INR 87.8m / US$1.2), and 7 technology transfer offices (average INR 97.7m/US$1.3m). The project’s product portfolio includes support for the 11/27/2020 Page 1 of 6 The World Bank Implementation Status & Results Report Innovate in India for Inclusiveness (P156241) development of 22 vaccines (average INR 103.3m/US$1.4m), 27 biosimilars (average INR 111.9m/US$1.5m), and 33 medical devices and diagnostics (average INR 23.6m/US$0.3m). The project’s success in identifying and funding the biotech ecosystem together with a large product portfolio will need a redefinition of project's progress toward its development objective. The reach of many Project Development Objective indicator targets at mid-term review means that new measures of project success are needed for actionability during the second half of the project. This is especially important as the product portfolio is about 10 times larger than originally envisioned. This will require BIRAC's close monitoring and facilitation support to maximize the chances of products reaching the market to address India's public health priorities. 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 Substantial 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 IN00913575 ►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 7.00 19.00 6.00 Date 14-Nov-2016 16-Apr-2020 04-Nov-2020 01-May-2023 IN00913576 ►Number of new IP registrations or product prototypes (Number, Custom) 11/27/2020 Page 2 of 6 The World Bank Implementation Status & Results Report Innovate in India for Inclusiveness (P156241) Baseline Actual (Previous) Actual (Current) End Target Value 0.00 13.00 32.00 15.00 Date 14-Nov-2016 16-Apr-2020 04-Nov-2020 01-May-2023 IN00913577 ►Number of technologies licensed for manufacturing or commercialization (Number, Custom) Baseline Actual (Previous) Actual (Current) End Target Value 0.00 0.00 13.00 2.00 Date 14-Nov-2016 16-Apr-2020 04-Nov-2020 01-May-2023 IN00913578 ►Number of TTOs established (Number, Custom) Baseline Actual (Previous) Actual (Current) End Target Value 0.00 5.00 5.00 6.00 Date 14-Nov-2017 16-Apr-2020 04-Nov-2020 01-May-2023 IN00913579 ►Number of companies using shared facilities supported by the project (Number, Custom) Baseline Actual (Previous) Actual (Current) End Target Value 0.00 14.00 57.00 60.00 Date 14-Nov-2017 16-Apr-2020 04-Nov-2020 01-May-2023 Intermediate Results Indicators by Components Strengthening the pilot-to market innovation ecosystem IN00913580 ►Number of clinical trial sites that are GCP compliant (Number, Custom) Baseline Actual (Previous) Actual (Current) End Target Value 0.00 0.00 11.00 5.00 Date 14-Nov-2016 16-Apr-2020 04-Nov-2020 01-May-2023 IN00913582 ►Number of registered technology transfer professionals qualified (Number, Custom) Baseline Actual (Previous) Actual (Current) End Target Value 0.00 11.00 15.00 12.00 Date 14-Nov-2016 16-Apr-2020 04-Nov-2020 01-May-2023 11/27/2020 Page 3 of 6 The World Bank Implementation Status & Results Report Innovate in India for Inclusiveness (P156241) IN00913584 ►Number of people trained (Number, Custom) Baseline Actual (Previous) Actual (Current) End Target Value 0.00 1,183.00 1,406.00 1,775.00 Date 14-Nov-2017 16-Apr-2020 04-Nov-2020 01-May-2023 IN00913586 Number of people trained who are women (Percentage, Custom Supplement) Baseline Actual (Previous) Actual (Current) End Target Value 0.00 31.00 37.00 50.00 Accelerating the pilot-to-market process for specific products IN00913581 ►Number of product development agreements in place (Number, Custom) Baseline Actual (Previous) Actual (Current) End Target Value 0.00 61.00 104.00 9.00 Date 14-Nov-2016 16-Apr-2020 04-Nov-2020 01-May-2023 IN00913583 ►Number of international publications (Number, Custom) Baseline Actual (Previous) Actual (Current) End Target Value 0.00 2.00 11.00 10.00 Date 14-Nov-2016 16-Apr-2020 04-Nov-2020 01-May-2023 IN00913585 ►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 16-Apr-2020 04-Nov-2020 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) 11/27/2020 Page 4 of 6 The World Bank Implementation Status & Results Report Innovate in India for Inclusiveness (P156241) Project Loan/Credit/TF Status Currency Original Revised Cancelled Disbursed Undisbursed % Disbursed P156241 IBRD-87510 Effective USD 125.00 125.00 0.00 28.01 96.99 22% 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) 11/27/2020 Page 5 of 6 The World Bank Implementation Status & Results Report Innovate in India for Inclusiveness (P156241) There are no related projects. 11/27/2020 Page 6 of 6