INTEGRATED SAFEGUARDS DATA SHEET APPRAISAL STAGE

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Public Disclosure Authorized Public Disclosure Authorized Public Disclosure Authorized Public Disclosure Authorized Public Disclosure Copy Public Disclosure Copy Date ISDS Prepared/Updated: 02-Jan-2014 INTEGRATED SAFEGUARDS DATA SHEET APPRAISAL STAGE Date ISDS Approved/Disclosed: 02-Jan-2014 I. BASIC INFORMATION 1. Basic Project Data Report No.: ISDSA6883 Country: India Project ID: P148604 Project Name: Accelerating Universal Access to Early and Effective Tuberculosis Care (P148604) Task Team Patrick M. Mullen Leader: Estimated Estimated 14-Mar-2014 Appraisal Date: Board Date: Managing Unit: SASHN Lending Instrument: Investment Project Financing Sector(s): Health (100%) Theme(s): Health system performance (30%), Tuberculosis (70%) Is this project processed under OP 8.50 (Emergency Recovery) or OP No 8.00 (Rapid Response to Crises and Emergencies)? Financing (In USD Million) Total Project Cost: 532.00 Total Bank Financing: 100.00 Financing Gap: 0.00 Financing Source Amount BORROWER/RECIPIENT 335.00 International Development Association (IDA) 100.00 The Global Fund to Fight AIDS, Tuberculosis & Malaria 97.00 Total 532.00 Environmental B - Partial Assessment Category: Is this a Yes Repeater project? 2. Project Development Objective(s) To support implementation of India's National Strategic Plan for Tuberculosis Control that aims to expand utilization of quality diagnosis and treatment services for people suffering from tuberculosis. 3. Project Description Page 1 of 8

The project will support India s National Strategic Plan for TB Control, comprising three components: Public Disclosure Copy Public Disclosure Copy Component 1. (New strategies to reach more tuberculosis patients with earlier and more effective care in the public and private sectors). This component will support new strategies designed to boost the number of TB patients who receive timely and effective care, including: (i) supporting patients who seek care in the private sector; (ii) expanding urban TB services; (iii) improving ease of access to diagnosis; (iv) leveraging information technology; and (v) improving knowledge of the epidemic to find more cases. Component 2. (Scale-up and improve diagnosis and treatment of drug-resistant tuberculosis). This component will support expansion of multi-drug resistant TB (MDR-TB) diagnosis and treatment services, including: (i) increasing capacity to manage and deliver MDR-TB services; (ii) expanding MDR-TB diagnostic capacity; (iii) improving the quality of MDR-TB care through better diagnosis; and (iv) developing MDR-TB treatment services. Component 3. (Expand public tuberculosis services integrated with the primary health care system). This component will focus on expanding and improving public sector TB services closely integrated with the government primary health care system. The national TB program will become fully aligned with the National Health Mission s implementation structure within state health systems. This will involve: (i) development of program management capacity; (ii) alignment with primary health care system and expansion of TB service delivery capacity; and (iii) intensification of support to vulnerable and targeted groups, including people infected with HIV, children with TB, tribal and poor populations, and urban poor populations. 4. Project location and salient physical characteristics relevant to the safeguard analysis (if known) The project will be implemented country-wide, in the 28 states and 7 union territories of India. Because socially vulnerable, poor and tribal populations, migrants and those living in urban slums are more at risk of TB, the TB program will target these vulnerablegroups with suitable outreach strategies. The TB program has taken special measures to support TB services in districts with large tribal and poor populations and plans to expand TB services for the urban poor during the project period. TB diagnostic and treatment services are integrated in the primary health care system and follow medical waste management policies and procedures of the general health system. Treatment of multi-drug resistant TB (MDR-TB) includes inpatient care. This requires airborne infection control measures for the protection of health care staff and other patients. The program will continue to implement its tribal action plan in compliance with OP 4.10. 5. Environmental and Social Safeguards Specialists Ruma Tavorath (SASDI) Satya N. Mishra (SASDS) 6. Safeguard Policies Triggered? Explanation (Optional) Environmental Assessment OP/ BP 4.01 Yes Environmental and infection control issues associated with tuberculosis stem from clinical and infectious waste materials (primarily sharps including needles and slides and sputum cups) generated from diagnosis and treatment services. Page 2 of 8

Natural Habitats OP/BP 4.04 No Forests OP/BP 4.36 No Pest Management OP 4.09 No Inpatient treatment of MDR-TB requires airborne infection control measures. These issues are well defined, site-specific and easily mitigated if implemented in a systematic and sustained manner during service delivery activities. However, with inadequate attention and poor management, these issues can pose as a severe public health risk. Physical Cultural Resources OP/ No BP 4.11 Indigenous Peoples OP/BP 4.10 Yes The project aims to support equitable provision of diagnosis and treatment services to all sections of the society while reaching out to marginalized and vulnerable groups, who are more vulnerable to the disease due to their health and socioeconomic conditions and suffer maximum adverse consequences due to high costs of disease treatment and productivity loss. It is essential to address socio-economic, cultural and health system barriers that affect utilization of diagnostic and treatment services by these populations, including in poor/backward/tribal districts and urban slum dwellers. OP 4.10 is triggered in view of the impact on tribal populations and accordingly a Tribal Action Plan is prepared and implemented with supplementary social inclusion measures for other vulnerable groups such as those affected by HIV/AIDS, urban slum dwellers, and others. Involuntary Resettlement OP/BP No 4.12 Safety of Dams OP/BP 4.37 No Projects on International Waterways OP/BP 7.50 Projects in Disputed Areas OP/BP 7.60 No No II. Key Safeguard Policy Issues and Their Management A. Summary of Key Safeguard Issues Page 3 of 8

1. Describe any safeguard issues and impacts associated with the proposed project. Identify and describe any potential large scale, significant and/or irreversible impacts: Social: the link between TB and poverty is well known and the highest burden of TB is borne by the poor and disadvantaged groups of the society characterized as "hard to reach populations" and include the poor - both urban and rural, tribal communities and specifically women. The program is socially inclusive and aims at providing universal access to all those affected in the community with quality diagnosis and treatment. The TB program will aim at positively benefitting tribal groups (equivalent of indigenous people in India) by (i) bridging gaps related to information, access and providers, and (ii) facilitating the tribal community in overcoming socio-economic and cultural barriers to access to and utilization of diagnostic and treatment services. The Operational Policy on Indigenous People (OP/BP 4.10) has been triggered in order to ensure continued special attention to their needs. Environmental Impacts: Environmental and infection control issues associated with TB are related to poor management of clinical and infectious waste [including human/biological waste (sputum), sharps (needles, glass slides etc.) and laboratory waste] generated from service delivery and treatment centers. Inpatient treatment of MDR-TB cases also carries the risk of airborne infection. The issues are well defined, site-specific and easily mitigated if implemented in a systematic and sustained manner during service delivery activities. However, inadequate attention and poor management of infectious waste can pose a severe public health risk due to the infectious nature of the disease. The project has been classified as Category C in accordance with the World Bank Group s Operational Policy OP 4.01. This implies that the environmental impacts are seen to be negligible and/or effective systems are in place for their sound management. The institutional structures of the Central TB Division and the Government of India are well established for management of safeguards, with improvement in implementation as defined in the revised Biomedical Waste Management (BMWM) Plan. Bank supervision will include review and guidance of implementation of the BMWM Plan. 2. Describe any potential indirect and/or long term impacts due to anticipated future activities in the project area: Social: The key long term impacts expected with regard to the tribal populations are positive in terms of reducing TB incidence amongst these poor and vulnerable communities. No long term adverse impacts are foreseen. 3. Describe any project alternatives (if relevant) considered to help avoid or minimize adverse impacts. N. A. 4. Describe measures taken by the borrower to address safeguard policy issues. Provide an assessment of borrower capacity to plan and implement the measures described. (a) Borrower s Measures to address environmental safeguard issues Social: A Social Assessment undertaken in 2011 identified various socio-cultural, economic and health system barriers affecting full utilization of RNTCP services by special populations such as migrants and tribal groups. The SA recommended measures such as strengthening societal and family support systems, improving community awareness to reduce stigma, reducing the economic burden on patients and their families, influencing provider behavior to minimize social distance Page 4 of 8

and improving organization of health care services to make biomedical interventions more patientfriendly. Drawing on this, the National Strategic Plan (2012-2017) was prepared, emphasizing universal access to quality diagnosis and treatment for all TB patients in the community. The NSP identifies migrants and tribal groups as special groups and prescribes gender sensitive approaches to provide them with appropriate, accessible, acceptable and affordable RNTCP services. Social Action Plan and Tribal Action Plan: The borrower has prepared a Social Action Plan which outlines measures to ensure universal access to and utilization of TB services in alignment with the National Strategic Plan (2012-2017). The strategy will involve strengthening of referral linkages for provision of services, especially for migrant populations; use of communication approaches specific to geographic areas and social/cultural contexts; modification of service delivery and budgetary norms to make services more affordable and accessible to special groups; sensitization of providers to the needs of special groups through training and retraining; and involvement of local practitioners/ngos for provision of care, awareness generation etc. The Social Action Plan (including the Tribal Action Plan) is an outcome of free, prior and informed consultations carried out with key stakeholders including the tribal communities during the course of Social Assessment in 2011, national consultation at Delhi on July 23, 2012 to finalize the National Strategic Plan, and follow up consultations held at Delhi on October 24, 2013 and at Phulbani, Odisha (tribal area) on November 4, 2013.. The Social Action Plan prepared by the Borrower provides for continued implementation of the Tribal Action Plan (2005) with necessary improvements as per the National Strategic Plan, and in compliance with the Bank Operational Policy 4.10. The Tribal Action Plan emphasizes: (a) strengthening early reporting, (b) enhancing treatment outcomes, and (iii) closer supervision of tribal areas. Specific measures include: increasing case detection and treatment success trends in a sample of pre-defined districts with higher proportion of tribal population; reducing default rates of female patients compared to male patients; promoting locally adapted IEC messages and patient education material in place; and having operational research results to assist in planning and implementation of RNTCP in the tribal pockets. The Social Action Plan will be carried out by the implementation mechanisms established for RNTCP at national, state, and district levels as a part of the National Health Mission. 13,000 Designated Microscopy Centers (DMCs) and 2,600 TB Units are operating across rural and urban areas. A cadre of community health workers, including Accredited Social Health Activists (ASHAs), Community Volunteers, incentivized DOT providers and NGOs link the program with TB patients. The Central TB Division (CTD) of the Ministry of Health and Family Welfare leads the program, providing resources, drugs, capacity building support, technical guidance, policy formation, less on sharing and monitoring and evaluation for the program. At the state level, the State TB Cell set up in state health societies monitors the program at the district level. The District TB Center (DTC) operates under the District Health Societies that manage the National Health Mission. DTCs monitor the DMCs and Tuberculosis Us, and supervise TB control activities in designated areas. The Project will address any capacity building requirements at any level as a part of implementation strategy. Grievance Redress: The grievance handling systems established for National Rural Health Mission will address grievances, including any instance of stigma or discrimination in RNTCP. The program has a Patients Charter for TB Care, which defines patients rights in terms of care, dignity, information, choice, confidence, justice, organization and security provided. The National Page 5 of 8

Health Mission has designated Central Public Information Officers and Appellate Authorities to address queries under the Right to Information Act, 2005. The National Health Mission has also prescribed a framework for grievance redress that entails establishment of mechanisms at facility level, district level and state level to accept, record, respond to and resolve grievances in a structured manner with the support of an unbiased third party preferably an NGO. RNTCP is working towards establishing helplines at state and national levels. Monitoring and Evaluation: The implementation of the Social Action Plan will be monitored with the help of the monitoring and evaluation system established for RNTCP, which enables collection of implementation data segregated by areas and population groups with performance indicators. Mid-term and end-term evaluations will be carried out to document the more specific social outcomes and lessons learnt for the future. Joint Review Missions of RNTCP will assess performance of the Social Action Plan as a part of overall program monitoring. Environment: The Revised National Tuberculosis Program (RNTCP) is a part of the National Health Mission (NHM), previously known as the National Rural Health Mission (NRHM), and TB diagnostic and treatment services are integrated in the government health system nationwide. As such, TB services subscribe to the Indian Public Health Standards (IPHS) (1) and Infection Management and Environment Plan (IMEP) (2) prescribed by the NHM for all its disease control programs implemented in public health facilities. The RNTCP continues to implement an environmental and biomedical waste management plan adopted in 2005 as part of the previous IDA-financed project. (3) RNTCP is also applying guidelines on airborne infection control in inpatient settings. (4) The TB program is committed to building capacity of providers in environmentally-responsible service delivery. Monitoring mechanisms to review implementation of the IPHS and IMEP are institutionalized by way of ongoing review missions and periodic third party assessments including annual joint missions involving international partners. In 2012, the program did an assessment of biomedical waste management implementation in a sample of states and TB services. The program is committed to revising its policies and plans as required. The CTD has an existing Environmental and Bio-medical Waste Management (BMWM) Plan which was prepared under the earlier Bank supported projects. This Plan is aligned with the Government of India s Biomedical Waste Management Rules, the Infection Management and Environment Plan (IMEP) and the Indian Public Health Standards (IPHS). Based on an assessment of sample health facilities undertaken in late 2012, the CTD has further revised the BMWM Plan and updated the Action Plan, in line with the activities being undertaken under this project. The revised Action Plan includes strengthening training of health service providers, improved monitoring systems, improved airborne infection control and standardization of health surveillance and procurement of personal protective equipment. Any construction activities of new MDR TB labs and wards will be as per the guidelines for airborne infection control and clearances and quality control measures will be well documented. The proposed IDA financing will not support any construction activities, which will be financed from other sources. The assessment findings and the revised Action Plan were discussed and agreed during a stakeholder consultation held in Delhi on October 24, 2013. 1 http://nrhm.gov.in/about-nrhm/guidelines/indian-public-health-standards.html 2 http://nrhm.gov.in/about-nrhm/guidelines/nrhm-guidelines/infection-management-andenvironment-plan-imep.html 3 http://www.tbcindia.nic.in/pdfs/rntcp%20ii%20env%20plan%2010%20may%202005.pdf Page 6 of 8

4 http://www.tbcindia.nic.in/pdfs/ Guidelines_on_Airborne_Infection_Control_April2010Provisional.pdf 5. Identify the key stakeholders and describe the mechanisms for consultation and disclosure on safeguard policies, with an emphasis on potentially affected people. The key stakeholders for the project include: the central government and state government health institutions, district level health service providers, private sector health care providers, local bodies, village level CBOs and NGOs, WHO, and other international agencies, and research institutions. Stakeholder consultations were carried out in multiple phases for designing the Program. Consultations were held with affected and served people in four tribal districts of Kandhamal (Odisha), Karbi Anglong (Assam), Adilabad (Andhra Pradesh), and Banswara (Rajasthan); and in four districts with slums at Hyderabad (AP), Bhubaneswar (Odisha) Jaipur (Rajasthan), and Lucknow (UP) during the Social Assessment (2011). A national consultation was held in Delhi on July 23, 2012, to finalize the National Strategic Plan (2012-2017). Two follow up consultations were held to discuss the Social Action Plan: at Delhi on October 24, 2013, and at Phulbani (tribal area), Odisha on November 4, 2013. Disclosure: RNTCP discloses relevant policy guidelines, plans, and status reports on its website http://tbcindia.nic.in/. In addition to this, it implements an Advocacy Communication and Social Mobilization (ACSM) strategy to inform and communicate with the patients and other stakeholders regarding the program, Many of the educative and informative materials are prepared and disseminated in local languages in the implementing states. B. Disclosure Requirements Environmental Assessment/Audit/Management Plan/Other Date of receipt by the Bank 29-Nov-2013 Date of submission to InfoShop 05-Dec-2013 For category A projects, date of distributing the Executive Summary of the EA to the Executive Directors "In country" Disclosure India 06-Jan-2014 Comments: The Environment Management Plan will be disclosed by the Central TB Division on their website www.tbcindia.org Indigenous Peoples Development Plan/Framework Date of receipt by the Bank 31-Dec-2013 Date of submission to InfoShop 02-Jan-2014 "In country" Disclosure India 06-Jan-2014 Comments: The Social Action Plan (including Tribal Action Plan) will be disclosed by the Central TB Division on their website www.tbcindia.org If the project triggers the Pest Management and/or Physical Cultural Resources policies, the respective issues are to be addressed and disclosed as part of the Environmental Assessment/ Audit/or EMP. If in-country disclosure of any of the above documents is not expected, please explain why: Page 7 of 8

C. Compliance Monitoring Indicators at the Corporate Level Public Disclosure Copy Public Disclosure Copy OP/BP/GP 4.01 - Environment Assessment Does the project require a stand-alone EA (including EMP) report? If yes, then did the Regional Environment Unit or Sector Manager (SM) review and approve the EA report? Are the cost and the accountabilities for the EMP incorporated in the credit/loan? OP/BP 4.10 - Indigenous Peoples Has a separate Indigenous Peoples Plan/Planning Framework (as appropriate) been prepared in consultation with affected Indigenous Peoples? If yes, then did the Regional unit responsible for safeguards or Sector Manager review the plan? If the whole project is designed to benefit IP, has the design been reviewed and approved by the Regional Social Development Unit or Sector Manager? The World Bank Policy on Disclosure of Information Have relevant safeguard policies documents been sent to the World Bank's Infoshop? Have relevant documents been disclosed in-country in a public place in a form and language that are understandable and accessible to project-affected groups and local NGOs? All Safeguard Policies Have satisfactory calendar, budget and clear institutional responsibilities been prepared for the implementation of measures related to safeguard policies? Have costs related to safeguard policy measures been included in the project cost? Does the Monitoring and Evaluation system of the project include the monitoring of safeguard impacts and measures related to safeguard policies? Have satisfactory implementation arrangements been agreed with the borrower and the same been adequately reflected in the project legal documents? III. APPROVALS Task Team Leader: Name: Patrick M. Mullen Approved By Sector Manager: Name: Julie McLaughlin (SM) Date: 02-Jan-2014 Page 8 of 8