Independent Evaluation Group (IEG) Implementation Completion Report (ICR) Review Accelerating Universal Access to TB Care (P148604) Report Number : ICRR0021434 1. Project Data Project ID Project Name P148604 Accelerating Universal Access to TB Care Country Practice Area(Lead) India Health, Nutrition & Population L/C/TF Number(s) Closing Date (Original) Total Project Cost (USD) IDA-53760 31-Mar-2017 89,809,972.90 Bank Approval Date Closing Date (Actual) 08-Apr-2014 31-Mar-2018 IBRD/IDA (USD) Grants (USD) Original Commitment 100,000,000.00 0.00 Revised Commitment 100,000,000.00 0.00 Actual 89,809,972.90 0.00 Prepared by Reviewed by ICR Review Coordinator Group Salim J. Habayeb Judyth L. Twigg Joy Behrens IEGHC (Unit 2) 2. Project Objectives and Components a. Objectives According to the Financing Agreement dated 5/30/14, the objective of the Project was to support the aims of the Program to expand the provision and utilization of quality diagnosis and treatment services for people suffering from tuberculosis (TB). The statement of objectives in the Project Appraisal Document (PAD, p. 4) and the ICR (p. 10) were identical. Page 1 of 17 Independent Evaluation Group (IEG) Implementation Completion Report (ICR) Review Accelerating Universal Access to TB Care (P148604) Revision of key associated outcome targets. Key outcome targets were revised upwards during a project restructuring on 4/8/16, raising the project ambition, and the national scope of the project was maintained. A split evaluation methodology is therefore not warranted. b. Were the project objectives/key associated outcome targets revised during implementation? Yes Did the Board approve the revised objectives/key associated outcome targets? Yes Date of Board Approval 08-Apr-2016 PHEVALUNDERTAKENLBL c. Will a split evaluation be undertaken? No d. Components Original Components: Based on the original financing agreement dated 5/30/14, project components included the following: 1. New strategies to reach more TB patients with earlier and more effective care in the public and private sectors (Appraisal US$5 million; Actual US$41.7 million). The component was to support activities at the national level through, inter alia, provision of technical assistance, diagnostics and anti-tuberculosis medicines, all contributing to strategies aimed at increasing the number of TB patients receiving timely and effective care, including: - reaching patients seeking care through public-private mix schemes; - expanding urban TB services through city-specific strategies emphasizing active case finding in urban slums; - improving ease of access to diagnosis of drug-sensitive and drug-resistant TB through collection and transport systems; - leveraging information technology for the development of individual patient record systems; and - improving knowledge base and dissemination: learning from initial implementation of new strategies and inform further scale-up. 2. Scale-up and improve diagnosis and treatment of drug-resistant TB (Approval US$73 million; Actual US$37 million). The component was to support activities at the national level through, inter alia, provision of technical assistance, diagnostics and anti-tuberculosis medicines, all contributing to expanding the reach and effectiveness of drug-resistant TB services, including: Page 2 of 17 Independent Evaluation Group (IEG) Implementation Completion Report (ICR) Review Accelerating Universal Access to TB Care (P148604) - expanding access to drug-resistant TB diagnosis services through newer and quicker diagnostic equipment and laboratory capacity; - increasing capacity to manage and deliver drug-resistant TB services through human resources and training; and - expanding drug-resistant TB treatment services through expansion of the network and capacities of tertiary hospitals to handle drug-resistant TB patients. 3. Expand public TB services integrated with the primary health care system (Appraisal US$22 million; Actual US$11 million). The component was to support activities at the national level through, inter alia, provision of technical assistance, diagnostics and anti-tuberculosis medicines, all contributing to expanding and improving public sector TB services closely integrated with the primary health care system, including: - developing TB program management capacity at the central, state, and district levels; - integrating TB program management with the primary health care system; - strengthening TB services for vulnerable groups, including people living with HIV/AIDS, access-difficult areas, and children; and - improving communication, social mobilization and advocacy. Revised component activities: Based on the Amended and Restated Financing Agreement dated 4/21/16, the project introduced Disbursement-linked Indicators (DLIs) and revised component activities as follows: 1. New strategies to reach more TB patients with earlier and more effective treatment in the public sector. Supporting activities at the national level through, inter alia, provision of technical assistance and anti- tuberculosis medicines, all contributing to strategies aimed at increasing the number of TB patients receiving timely and effective treatment, including: - supporting existing strategies for treatment of drug-sensitive and drug-resistant TB in the public sector; and - rolling out daily regimen therapy for drug-sensitive TB patients in selected States. Note: The following activities were dropped from project financing, as the Revised National TB Control Program (RNTCP) implemented them with the support of States, municipalities, and other program donors (ICR, p. 14): - expanding urban TB services; - improving ease of access to diagnosis of drug sensitive and drug resistant TB; - leveraging information technology; and for the development of individual patient record systems; - improving knowledge base and dissemination; and - extending the program's reach to TB patients who seek care in the private sector. According to the ICR (p. 24), by the time of restructuring, the government had set a foundation for expanded engagement with the private sector, including (i) early adoption and implementation of the Page 3 of 17 Independent Evaluation Group (IEG) Implementation Completion Report (ICR) Review Accelerating Universal Access to TB Care (P148604) Standards for TB Care in India; (ii) implementation of the Nikshay online information system, which also covers cases managed by the private sector; and (iii) development of terms of reference for the Public- Private Interface Agency model, which evolved into a flagship initiative following support from the Bill and Melinda Gates Foundation. 2. Scale-up and improve diagnosis of TB. Supporting activities at the national level through, inter alia, provision of technical assistance and diagnostics, all contributing to expanding the reach and effectiveness of TB diagnosis services, including: - improving diagnosis of drug-sensitive TB; - expanding access to drug sensitivity testing; and - intensifying support to vulnerable and targeted groups. Note: The following activities were dropped, as RNTCP implemented them with the support of States, municipalities, and other program donors (ICR, p. 14). - increasing capacity to manage and deliver drug-resistant TB services through human resources and training; and - expanding drug-resistant TB treatment services through expansion of the network and capacities of tertiary hospitals to handle drug-resistant TB patients. 3. Improve Program management capacity. Supporting activities at the national level through, inter alia, provision of technical assistance and consulting services, all contributing to improving the management of public sector TB services and program management capacity. Note: Activities related to strengthening services to vulnerable groups were moved to component 2, and activities related to integration with the primary health care system were dropped from the project as they were pursued by RNTCP in collaboration with the National Health Mission (ICR, p. 15). e. Comments on Project Cost, Financing, Borrower Contribution, and Dates Cost and financing. The project was part of a larger program funded by the Borrower (Government of India or GOI); the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM); and the Bank. The original total cost of the program was estimated at US$532 million, including an International Development Association (IDA) Credit of US$100 million, a Borrower contribution of US$ 335 million, and a grant of US$97 million from GFATM. The total actual cost at closing amounted to US$1 billion due to increased financing from the Borrower (actual US$704 million) and GFATM (actual US$229 million). The actual cost under the IDA Credit amounted to US$89.8 million, but the TTL clarified on 11/29/18 that Credit allocations were fully disbursed and that the difference was due to fluctuations in SDR exchange rates. Page 4 of 17 Independent Evaluation Group (IEG) Implementation Completion Report (ICR) Review Accelerating Universal Access to TB Care (P148604) Dates. The project was approved on 4/8/14 and became effective on 6/26/14. A Mid-Term Review was carried out on 4/10/15. The project was restructured on 4/6/16 to revise components, allocations, results framework, and closing date. The project closed on 3/31/18, one year after the original closing date of 3/31/17. 3. Relevance of Objectives Rationale At appraisal, India was known to have a persisting communicable disease burden combined with a growing burden of non-communicable disease. TB was recognized as one of India’s most critical public health problems contributing to 25% of the global TB burden, including the highest number of multi-drug resistant (MDR) TB cases (ICR, p. 7). TB was an important cause of mortality among adults, contributing to more than 4% of all deaths (PAD, p. 3) or an estimated 480,000 deaths annually. TB cases and TB deaths were higher than the reported ones, as it was estimated that about one million patients remained undiagnosed every year (PAD, p. 7). TB-related deaths and disability affect adults at the economic prime of their lives and disproportionately affect poor households and communities, including the burden of stigma related to the disease. In the context of the Bank’s long-standing engagement in India’s human development sector in India, the project constituted a third Bank-assisted operation in TB control. The first project (1998-2006) contributed to scaling up Directly Observed Treatment (DOTS) nationwide (DOTS is recommended by the World Health Organization (WHO) and recognized to be cost-effective). The second project (2006-2012) initiated MDR- TB services and expanded services to the poor and to risk groups. Bank engagement complemented GOI efforts to progressively build up the national TB program, the RNTCP. The objectives were relevant to the GOI 12th National Five-Year Development plan and to the National Strategic Plan for TB, 2012-2017, which included a commitment to achieve universal access to quality diagnostics and treatment for TB. The objectives were also aligned to the Country Partnership Strategy (CPS, 2013-2017), which focused on reducing poverty and promoting shared prosperity. At project closing, the objectives remained fully consistent with the Country Partnership Framework (CPF, 2018-2022), which noted that more investment in India’s human capital -- in health, education, and skills -- is urgent and integral to sustaining high growth over time. The objectives remained in line with the CPF’s Focus Area 3, Investing in Human Capital, and to the CPF's Objective 3.4 on improving the quality of health service delivery and financing as well as access to quality healthcare. TB Case Notification Rate is one of the CPF indicators (Indicator 3.4.4). Rating Page 5 of 17 Independent Evaluation Group (IEG) Implementation Completion Report (ICR) Review Accelerating Universal Access to TB Care (P148604) High 4. Achievement of Objectives (Efficacy) PHEFFICACYTBL Objective 1 Objective Expand the provision of quality diagnostics and TB treatment services. Rationale Improving access to TB diagnosis and treatment, including for drug-resistant TB, reaching and supporting vulnerable groups, developing program capacities, providing health information and communication, and leveraging information technology could reasonably be expected to expand the provision and utilization of quality diagnostic services and TB treatment services. Outputs • The project provided diagnostics, anti-tuberculosis medicines, and technical assistance. • The project expanded the provision of a new technology, the Cartridge Based Nucleic Acid Amplification Test (CBNAAT), which was more accurate in assessing drug susceptibility, and it provided same day results in contrast with conventional smear microscopy which requires patients to wait for several days to obtain results, thus reducing the waiting time to initiate TB treatment. • Second line drug sensitivity testing was expanded to 35 laboratories out of 72 laboratories for culture and drug sensitivity testing. • 45 mobile vans with CBNAAT machines, with at least one in each State, were deployed to serve hard-to- reach areas and tribal populations. • 35 mobile TB diagnostic vans, equipped with digital X-ray and sputum microscopy capability, were deployed in 17 tribal districts. Note on favorable government policies: The ICR (p. 27) stated that government policies enacted in 2013 provided an enabling legal framework that was instrumental in facilitating the progress made under the project, such as making TB a notifiable disease, and mandating private sector providers to notify all TB cases to the national program. Outcomes Page 6 of 17 Independent Evaluation Group (IEG) Implementation Completion Report (ICR) Review Accelerating Universal Access to TB Care (P148604) • The provision of CBNAAT diagnostic technology increased from a baseline of 70 districts in 2012 to 594 districts in 2017, exceeding the target of 350 districts. • The project expanded the provision of drug sensitivity testing, as the number of suspected or diagnosed TB patients who received drug-sensitivity testing increased from a baseline of 130,244 in 2012 to 711,125 in 2017, exceeding both the original target of 175,000 and the revised target of 246,000. • The number of direct project beneficiaries who received TB treatment (under both DOTS and fixed combination regimens) reached 6.43 million in 2017, exceeding both the original target of 3.1 million and the revised target of 6.2 million. •The number of female beneficiaries reached 2.2 million in 2017, exceeding the original target of 1.1 million, but slightly short of the revised target of 2.3 million. Rating High PHREVDELTBL PHEFFICACYTBL Objective 2 Objective Expand utilization of quality diagnostic services and TB treatment services. Rationale The theory of change was the same as above under Objective 1. Outputs • The project provided diagnostics, anti-tuberculosis medicines, and technical assistance. • To improve utilization, the project introduced shorter TB treatment regimens, which would be expected to enhance patient compliance and retention, and to contribute to better management of drug-resistant TB. The daily regimen of fixed drug combination (in lieu of three times per week single-drug formulation) had the advantage of minimizing drug resistance while reducing the number of pills that patients had to take, thus reducing patient default. By introducing these regimens, India joined other middle-income countries in implementing a best practice intervention in its national TB program. The project also rolled out bedaquiline therapy for MDR-TB. Page 7 of 17 Independent Evaluation Group (IEG) Implementation Completion Report (ICR) Review Accelerating Universal Access to TB Care (P148604) • The project strengthened HIV-TB program collaboration and rolled out Isoniazid preventive therapy for people living with HIV in all Anti-Retroviral Therapy Centers in line with global best practices for HIV-TB co-management. •71 laboratories utilized the e-Nikshay system (web-based system for monitoring and tracking TB patients) that was developed jointly by the Central TB Division of the Ministry of Health & Family Welfare and the National Informatics Centre for surveillance of drug resistant TB patients, exceeding the target of 30 laboratories. Outcomes • The number of TB patients who utilized the daily regimen of fixed drug combination in the public sector reached 239,816 in 2017, exceeding the original target of 100,000 but short of the revised target of 300,000. (The ICR explained that the 2017 national roll-out of daily fixed drug combination for drug- resistant TB was originally planned for only five pilot states, but, in consideration of the scientific evidence in favor of the treatment regimen, it was decided to roll it out nationally). According to follow-on clarifications provided by the TTL (12/14/18), based on data from the Central TB Division, the target of 300,000 was achieved shortly after project closure, attaining 367,344 in the second quarter of 2018. • Patients with drug-resistant TB who had treatment increased from a baseline of 25,000 in 2012 to 38,363 in 2017, short of both the original target of 40,000 and the revised target of 50,000; and the number of females among such patients increased from a baseline of 6,000 to 12,851 in 2017, exceeding the original target of 11,000, but short of the revised target of 14,000. (The ICR, p. 20, stated that the overachievement in drug-sensitivity testing and its universal introduction by the end of the project has contributed to a substantial increase in enrollment of drug-resistant TB patients during the first six months of 2018, but no additional information was provided by the ICR. However, according to follow-on clarifications provided by the TTL (12/14/18), based on data from the Central TB Division, patient enrollment increased by 55% during the first two quarters of 2018 when compared with CY17). • The percentage of patients with drug-sensitive TB who successfully completed treatment with a daily regimen of fixed drug combination reached 81%, moderately short of the target of 85%. • The percentage of patients with drug-resistant TB who completed treatment declined from the baseline of 48% in 2012 to 47% in 2017, short of both the original target of 56% and the revised target of 57%. • The number of TB-HIV patients utilizing Isoniazid therapy in the public sector reached 265,256 in 2017, exceeding the target of 151,000. Page 8 of 17 Independent Evaluation Group (IEG) Implementation Completion Report (ICR) Review Accelerating Universal Access to TB Care (P148604) •The number of pediatric TB cases treated in the public sector increased from a baseline of 81,000 in 2012 to 92,308 in 2017, exceeding the original target of 90,000, but short of the revised target of 100,000. Rating Substantial PHREVDELTBL PHOVRLEFFRATTBL Rationale The project fully achieved its first objective for expanding the provision of quality diagnostics and TB treatment services, and almost fully achieved its second objective for expanding the utilization of such services. The aggregation of both indicates a Substantial rating for overall efficacy. Overall Efficacy Rating Substantial 5. Efficiency The PAD’s economic analysis used existing studies to offer arguments about high cost-effectiveness. It quoted a study by Laxminarayan R et al. (2009) "Global Investments in TB Control: Economic Benefits," Health Affairs 28(4): w730-w742, based on modeled projections for 2006-15, which estimated that the provision of DOTS in India would avert 3.2 million deaths during that period, with an economic benefit exceeding US$350 billion, or a benefit of US$191 per dollar spent on TB control (PAD, p. 11). TB was considered to be a disease of poverty, associated with crowding and poor living conditions, as indicated by the 2005-06 Third National Family Health Survey. The PAD (p. 48) referred to Jamison DT et al. (eds.) (2006) Disease Control Priorities in Developing Countries, Second Edition, Oxford University Press and the World Bank, New York and Washington, where available information on the cost-effectiveness was analyzed for a range of health interventions, including TB. The study estimated that the cost per death averted under a 10-year program providing TB diagnosis and treatment services like RNTCP was between US$150-750, while the cost per disability-adjusted life year (DALY) gained was between US$5 and US$35. The cost of MDR-TB diagnosis and treatment was estimated at over US$2,000 per death averted and between US$70-450 per DALY gained. It concluded that “the treatment of all forms of active TB using directly observed treatment strategy based on short-course chemotherapy is among the most cost-effective of all interventions available to improve health in low- and middle-income countries." The PAD (p. 49) also argued that reducing the burden of TB in India had positive global externalities as it would decrease the risk of disease transmission across borders. Page 9 of 17 Independent Evaluation Group (IEG) Implementation Completion Report (ICR) Review Accelerating Universal Access to TB Care (P148604) The ICR also examined cost-effectiveness. Data from the 2016 Global Burden of Disease for India were used to estimate baseline deaths and DALYs related to TB. International literature data on the effectiveness of interventions were used to estimate averted deaths and DALYs. In the context of a larger program funding, the analysis pragmatically and pertinently assumed that impact was proportional to funding, with the project accounting for only 11.5% of total RNTCP expenditures (ICR, p. 49). Accordingly, the ICR analysis estimated that 151,788 deaths were prevented and 2,919,000 DALYs were averted under the project. It estimated a cost-effectiveness ratio of US$415 per death averted, and US$16 per DALY averted. Using the WHO standard of 1x GDP per capita for India (US$1,752 in 2017) to assess cost-effectiveness, the ICR concluded that the project was highly cost-effective. The return was estimated at US$107 for each dollar invested in the project. There were implementation aspects that contributed to efficiency. The project adequately coordinated financing with GFATM to avoid duplication of investments, and shifted part of its allocations from drug procurement to new priorities such as HIV-TB coinfection. The project achieved cost savings in the procurement of microscopes and consulting services (ICR, p. 23). And, according to the ICR, the introduction of DLIs under the 2016 restructuring was a favorable factor in accelerating implementation. However, there were some shortcomings in the efficiency of implementation. The first two years of the project were characterized by slow decision-making, in an environment of overall fiscal restraint adopted by GOI, limiting RNTCP budget allocations. The pace of implementation accelerated in the third year, including when personnel changes were made (ICR, p. 27) and after expanding the e-Nikshay information system to encompass procurement, supply chain, financial management, and laboratory-based surveillance for drug- resistant TB. The Central Tuberculosis Division routed funds through state treasuries instead of making direct transfers to Health Societies in the States, and this contributed to slow disbursements and fund flows to front- line service delivery. Credit disbursements attained only 15% by the end of 2015. The shifting of substantial drug procurement to GFATM (see Section 10b), with subsequent reprogramming of Credit allocations, was another factor contributing to the initial low disbursement, but disbursements accelerated in the third year, and full disbursement of allocations was reached at closing. The project was implemented in a relatively short period of four years, as compared with an average exceeding five years for human development projects. Efficiency Rating Substantial a. If available, enter the Economic Rate of Return (ERR) and/or Financial Rate of Return (FRR) at appraisal and the re-estimated value at evaluation: Rate Point value (%) *Coverage/Scope (%) Available? 0 Appraisal 0 Not Applicable Page 10 of 17 Independent Evaluation Group (IEG) Implementation Completion Report (ICR) Review Accelerating Universal Access to TB Care (P148604) 0 ICR Estimate 0 Not Applicable * Refers to percent of total project cost for which ERR/FRR was calculated. 6. Outcome Relevance of objectives is rated High as the objectives remain fully consistent with the Bank’s Country Partnership Framework FY18-22. Efficacy is rated Substantial, as the project almost fully achieved its objectives. Efficiency is also rated Substantial with favorable cost-effectiveness, but with shortcomings in the efficiency of implementation during the first two years. Therefore, the overall Outcome is rated Satisfactory, indicative of essentially minor shortcomings in the project’s overall preparation, implementation, and achievement. a. Outcome Rating Satisfactory 7. Risk to Development Outcome According to the ICR, India is poised to play an increasingly global leadership role in responding to TB as highlighted during a summit hosted by the Prime Minister in March 2018 to galvanize national and global efforts to tackle the burden of TB in line with WHO's End TB strategy. India set its targets for "2025 End TB" five years ahead of the global TB targets, and matched its commitment with financial resources by doubling its 2016 budget envelope for TB to US$525 million in 2017. GOI continued to build upon the innovations supported by the project such as CBNAAT technology (see Section 4) for drug susceptibility and to expand the use of the e- Nikshay system for monitoring. In addition, GOI is extending the use of diagnostic technology to private providers to improve access and timely diagnostics in both public and private sectors. According to the TTL (11/29/18), GOI requested a follow-on project to support further scale-up of project innovations and to accelerate overall progress towards national TB targets for 2025. The institutional strengthening generated by the project, including the use of DLIs, program and financial management, drug and supplies chain management, and engaging the private sector, would be expected to facilitate these endeavors. 8. Assessment of Bank Performance a. Quality-at-Entry The focus on scaling up quality diagnostic services and TB treatment was appropriate and in line with the National Strategic Plan 2012-2017. The project considered lessons learned from national and international Page 11 of 17 Independent Evaluation Group (IEG) Implementation Completion Report (ICR) Review Accelerating Universal Access to TB Care (P148604) experience and pilots, notably for using information technology, importance of a robust response to the growing threat of MDR-TB, and private sector engagement (PAD, pp. 8-9). The successful experience under the two previous projects for a broad engagement, involving key partners and stakeholders, was planned to be continued. Bank collaboration in technical aspects was extended to all partners, regardless of the source of financing, notably to the network of WHO consultants working in the field. Risks were adequately identified, including for drug supply and quality, and for potential capacity constraints specific to the new strategies introduced by the project (PAD, p. 10). Mitigation measures were adequate, but the risk of overall macro-fiscal context was overlooked, as GOI fiscal restraint during the first three years of the National Strategic Plan contributed to slowing the originally anticipated increases in government investments and resources for TB (ICR, p. 27). Institutional arrangements for implementation, including financial management, were in place, as the infrastructure and processes of the existing program were well established in the country. The three-year implementation timeline was ambitious, including because heavy supply-side interventions require sufficient processing time. The Bank team made significant progress in front-loading the preparation of procurement packages by the time the proposed project was submitted to the Board. However, the contract of the procurement agency expired after Board approval, and this issue could have been anticipated by the Bank team (ICR, p. 31). The results framework was sound, but it mirrored the indicators of the National Strategic Plan, beyond the project, thus reducing attribution. The large multiplicity of sub- components reflected a lack of selectivity rather than focusing on a few key activity areas (ICR, p. 32). Quality-at-Entry Rating Moderately Satisfactory b. Quality of supervision Implementation support and supervision were reportedly adequately maintained by the Bank team. Reporting was clear with objectivity and candor, as evidenced by the Implementation Status Reports and Aides-memoire (ICR, p. 32). The team pro-actively used the findings of the joint monitoring mission of 2015 to obtain the Central TB Division’s buy-in to restructure the project in order to: (a) respond to a change in the original need for high value procurements of goods; (b) shift to a more focused approach; (c) support RNTCP to achieve reform priorities of the National Strategic Plan as opposed to the initial tendency to focus on supply-side inputs (ICR, p. 17); and (d) to revise the results framework. The introduction of DLIs in 2016 was a motivator for the national program to accelerate disbursements and to improve implementation towards the attainment of project objectives. The ICR (p. 28) stated that the team maintained flexibility with a strong engagement and collaboration with key partners, such as GFATM and WHO. According to the ICR (p. 32), the Central TB Division expressed its high appreciation during the ICR interviews of the way in which the Bank team was responsive to its requests and in its pro-active provision of implementation support. Page 12 of 17 Independent Evaluation Group (IEG) Implementation Completion Report (ICR) Review Accelerating Universal Access to TB Care (P148604) Quality of Supervision Rating Satisfactory Overall Bank Performance Rating Moderately Satisfactory 9. M&E Design, Implementation, & Utilization a. M&E Design The objectives were clear and measurable. Baselines were available as shown in the PAD, pp. 15-16. The results frameworks of both the original and restructured project were aligned with the objectives and with RNTCP’s monitoring framework, which maintained patient data that were updated by service providers during the course of diagnosis and treatment. However, as stated in Section 8a, the original framework had an overall program focus and replicated the indicators of the National Strategic Plan 2012-2017. b. M&E Implementation According to the ICR, M&E implementation was carried out in a satisfactory manner, and was embedded within the e-Nikshay information system that was initiated with project start-up to facilitate case notifications, patient management, referrals, reporting, and laboratory-based surveillance for drug resistance. Joint monitoring missions with key stakeholders were undertaken every two years. Following project restructuring, the results framework was revised and verification of DLIs was undertaken by WHO to validate results. The ICR (p. 29) stated that WHO validation on the ground brought added credibility and technical depth to the monitoring mechanism that was already in place under RNTCP. However, the ICR (p. 26) noted that the project could have provided more support to operational research in view of the introduction of new strategies such as the fixed daily treatment regimen. c. M&E Utilization M&E data were used for day-to-day management. Laboratory data for surveillance were used for mentoring staff in lower-level laboratories. Project data were used to improve the supply chain for drugs and to provide additional support to some states where M&E findings suggested lagging performance. Page 13 of 17 Independent Evaluation Group (IEG) Implementation Completion Report (ICR) Review Accelerating Universal Access to TB Care (P148604) M&E Quality Rating Substantial 10. Other Issues a. Safeguards E nvironmental safeguards. The project triggered safeguard policy OP 4.01 on Environmental Assessment and was classified as a Category B project in view of infectious waste and the risk of airborne infection. The government updated the Environment Assessment and Biomedical Waste Management Plan that was used under previous projects. The updated plan was disclosed by the Bank and in the country. The revised action plan included enhanced training, personal protection of health service providers, monitoring and surveillance, and infection control measures. A project legal covenant was maintained throughout the project period, whereby the government committed to carry out the project in accordance and consistent with provisions of the Environmental and Bio-Medical Waste Management Plan (ICR, p. 29). According to the ICR (p. 30), the plan was effectively implemented by the Central TB Division and the States. Social safeguards. The project triggered OP/BP 4.10 on Indigenous Peoples. The project updated a Social Action Plan that dealt with barriers affecting utilization of TB services. It included a Tribal Action Plan that identified women, children, HIV/AIDS patients and tribal people as groups vulnerable to TB, and the plan focused on increasing access to and utilization of TB services. Equipped mobile vans were deployed to serve hard-to-reach populations, bringing services to the doorstep of patients (ICR, p. 30). In addition, RNCTP provided financial and nutritional support to TB patients from vulnerable groups during the course of the project. b. Fiduciary Compliance Financial Management. Financial management built on the strength of existing arrangements under the Finance Cell of the Central TB Division. Accounting, internal controls, financial reporting, and auditing arrangements were in place at all levels of the program. However, delayed releases of funds from the central level to the States were noted by the ICR (p. 30). The ICR did not offer information about fiduciary compliance and audits, but the TTL clarified (12/14/18) that there were delays in the state audits and audit observations in three states (Tamil Nadu, Maharashtra, an Kerala). No cases of misprocurement were reported. The funds were utilized for their intended purpose, and no unutilized funds remained at the end of the project. The difference between the original and actual costs were due to US$ exchange rate fluctuations against the SDR. Page 14 of 17 Independent Evaluation Group (IEG) Implementation Completion Report (ICR) Review Accelerating Universal Access to TB Care (P148604) Procurement. At entry, 93% of the Credit was planned for the procurement of drugs, diagnostic equipment and consulting services. Early implementation lagged notably because of the government’s macro-level fiscal restraint that affected RNTCP budget allocations, and contributed a slow decision-making environment. US$52.3 million originally allocated to drug procurement was shifted to GFATM, and the equivalent Credit amount was reprogrammed for other priorities under the project, as illustrated in the revised component activities (see Section 2d). c. Unintended impacts (Positive or Negative) The ICR (p. 49) suggested that an important value-added generated by the project was global public good since India accounts for 25% of the global TB disease burden, and that improved TB control in India would contribute to global control. The ICR highlighted positive global externalities resulting from reduced transmission across borders, including for drug-resistant TB, and where the benefits may also accrue to populations of other countries. d. Other -- 11. Ratings Reason for Ratings ICR IEG Disagreements/Comment Outcome Satisfactory Satisfactory --- There is no disagreement on the sub-ratings, as both the ICR and this ICR Review rated quality at entry as Moderately Satisfactory, and the quality of supervision as Satisfactory. According to the Moderately harmonized guidelines, the Bank Performance Satisfactory Satisfactory appropriate rating for overall Bank performance in this case is Moderately Satisfactory. If the ICR had correctly applied the guidelines, Bank performance rating in the ICR would also have been Moderately Satisfactory. Quality of M&E Substantial Substantial --- Page 15 of 17 Independent Evaluation Group (IEG) Implementation Completion Report (ICR) Review Accelerating Universal Access to TB Care (P148604) Quality of ICR High --- 12. Lessons The ICR (pp. 33-34) offered several lessons and recommendations, including the following lessons restated by IEG: Joint monitoring missions with key stakeholders provide an opportunity for the government and development partners to identify implementation challenges and corrective directions in a harmonized manner. The joint monitoring missions provided a platform for partners and the RNTCP to be further aligned with the National Strategic Plan, and the recommendations of the joint missions provided the basis for restructuring the project. Focusing on results through the use of disbursement-linked indicators provides an incentive to augment implementation performance. The project benefited from a clear set of targets that triggered disbursements. Verification of results can be effectively performed by UN agencies’ presence on the ground. Rather than facing delays in identifying and contracting a third-party agency, WHO stepped in to fulfil the verification role at no extra cost to the project, while concurrently bringing added credibility and technical depth to the monitoring process. 13. Assessment Recommended? No 14. Comments on Quality of ICR The ICR was clear and candid, and provided a thorough analysis. It illustrated the theory of change in a lucid manner. The ICR was aligned to development objectives. The quality of the evidence was high. The narrative and evidence supported the ICR's conclusions on the project's overall outcome. Lessons and recommendations were generated by project experience and should prove useful to future TB control projects. The ICR's discussion on partnership with WHO and its role in validating results and in providing technical depth to monitoring was noteworthy. The ICR was consistent with the guidelines, except for insufficient information on fiduciary compliance and audits, which was subsequently provided by the TTL. Within the broader aspects of the quality spectrum, this shortcoming is considered to be relatively minor in view of the high quality of all other criteria. Page 16 of 17 Independent Evaluation Group (IEG) Implementation Completion Report (ICR) Review Accelerating Universal Access to TB Care (P148604) a. Quality of ICR Rating High Page 17 of 17