ENVIRONMENTAL AND SOCIAL SYSTEMS ASSESSMENT (ESSA) FOR THE India: Program Towards Elimination of Tuberculosis (P167523) DECEMBER 18, 2018 This document is being made publicly available so that views of interested members of the broader public may also be considered before all Program decisions are made final. TABLE OF CONTENTS EXECUTIVE SUMMARY.................................................................................................................... VII I. INTRODUCTION ..................................................................................................................... 1 A. ENVIRONMENTAL AND SOCIAL SYSTEMS ASSESSMENT: PURPOSE AND OBJECTIVES ........................................................ 1 B. ESSA METHODOLOGY ....................................................................................................................................... 2 II. PROGRAM DESCRIPTION AND POTENTIAL ENVIRONMENTAL AND SOCIAL EFFECTS ................. 5 A. PROGRAM CONTEXT .......................................................................................................................................... 5 B. THE GOVERNMENT OF INDIA’S PROGRAM.............................................................................................................. 6 C. BANK FINANCED PFORR SCOPE, OBJECTIVES, AND KEY RESULTS AREAS....................................................................... 6 D. PROGRAM IMPLEMENTATION ARRANGEMENTS ..................................................................................................... 10 E. DESCRIPTION OF PROGRAM ACTIVITIES AND IDENTIFICATION OF ENVIRONMENTAL AND SOCIAL EFFECTS .......................... 12 III. ASSESSMENT OF ENVIRONMENTAL AND SOCIAL MANAGEMENT SYSTEMS AND IMPLEMENTATION CAPACITY ....................................................................................................................................... 26 A. INTRODUCTION............................................................................................................................................... 26 B. CORE PRINCIPLE 1 - ENVIRONMENTAL AND SOCIAL MANAGEMENT .......................................................................... 27 C. CORE PRINCIPLE 2 – NATURAL HABITATS AND PHYSICAL CULTURAL RESOURCES ......................................................... 28 D. CORE PRINCIPLE 3 – PUBLIC AND WORKER SAFETY................................................................................................ 28 E. CORE PRINCIPLE 4 – LAND ACQUISITION ............................................................................................................. 29 F. CORE PRINCIPLE 5 – INDIGENOUS PEOPLES AND VULNERABLE GROUPS ..................................................................... 29 G. CORE PRINCIPLE 6 - SOCIAL CONFLICT................................................................................................................. 32 H. GENDER ........................................................................................................................................................ 32 I. CITIZEN ENGAGEMENT ..................................................................................................................................... 33 J. GRIEVANCE REDRESS MECHANISM ..................................................................................................................... 33 IV. DISCLOSURE AND CONSULTATION ....................................................................................... 35 A. DISCLOSURE ................................................................................................................................................... 35 B. STAKEHOLDER CONSULTATIONS ......................................................................................................................... 35 C. SUMMARY OF MULTI-STAKEHOLDER WORKSHOP.................................................................................................. 37 V. INPUTS TO THE PROGRAM ACTION PLAN ............................................................................. 38 A. INTRODUCTION............................................................................................................................................... 38 B. RECOMMENDATIONS TO BE INCLUDED IN THE PAP. ............................................................................................... 38 C. RECOMMENDATIONS TO ENVIRONMENTAL AND SOCIAL ACTION PLAN AS PART OF PIP ................................................. 40 ANNEX 1: LIST OF DOCUMENT REVIEWED ....................................................................................... 42 ii ANNEX 2: DESCRIPTION OF ENVIRONMENTAL AND SOCIAL MANAGEMENT SYSTEM AND CAPACITY AND PERFORMANCE ASSESSMENT ......................................................................................................... 44 A. INTRODUCTION............................................................................................................................................... 44 B. ENVIRONMENTAL AND SOCIAL MANAGEMENT SYSTEMS ......................................................................................... 44 C. ENVIRONMENTAL AND SOCIAL LAWS, REGULATIONS AND POLICIES ........................................................................... 45 D. INSTITUTIONAL FRAMEWORK............................................................................................................................. 53 E. BORROWER’S PAST EXPERIENCE IN MANAGING ENVIRONMENTAL AND SOCIAL RISKS ................................................... 53 ANNEX-3 STAKEHOLDER CONSULTATIONS - KEY COMMENTS RECEIVED THROUGH CONSULTATIONS67 ANNEX-4 SUPPLEMENTAL ENVIRONMENTAL AND SOCIAL RISK SCREENING WORKSHEET ................. 75 ANNEX-5 SUGGESTIVE TOPICS FOR CAPACITY BUILDING ON ENVIRONMENTAL HEALTH AND SAFETY ASPECTS ......................................................................................................................................... 80 ANNEX – 6 SAFEGUARD SCREENING CHECKLIST ............................................................................... 81 ANNEX -7 MULTI-STAKEHOLDER CONSULTATION WORKSHOP ......................................................... 84 iii List of Acronyms ACSM Advocacy, Communication and Social Mobilization AIDS Acquired Immuno- Deficiency Syndrome BMGF Bill and Melinda Gates Foundation BMW Bio Medical Waste BMWM Bio medical Waste Management C&DST Culture and Drug Susceptibility Testing CAAA Controller of Aid, Accounts, and Audit. CAG Comptroller and Auditor General CBMWTF Central Biomedical Waste Treatment Facility CIEs Central Level Internal Evaluations CMSS Central Medical Services Society CPF Country Partnership Framework CPCB Central Pollution Control Board CPP Central Procurement Portal CTD Central TB Division CTF Common Treatment Facility CVC Central Vigilance Commission DALY Disability-Adjusted Life Year DBT Direct Benefit Transfer DDG Deputy Director-General DLI Disbursement-Linked Indicator DMC Designated Microscopy Centres DLR Disbursement-Linked Result DOHFW Departments of Health and Family Welfare DOTS Directly Observed Treatment Therapy DR-TB Drug-Resistant TB EMP Environment Management Plan ESSA Environmental and Social Systems Assessment FM Financial Management FMR Financial Monitoring Report FPIC Free and Prior Informed Consultation FSA Fiduciary System Assessment GDP Gross Domestic Product GFATM Global Fund to Fight AIDS, Tuberculosis and Malaria GFR General Financial Rules GoI Government of India GOI Government of India GPS Global Positioning System GST Goods and Services Tax HDI Human Development Index HIV Human Immune- Deficiency Virus iv IBRD International Bank of Reconstruction and Development IC Infection Control ICT Information and Communications Technology IDA International Development Association IEC Information, Education, and Communication IFSA Integrated Fiduciary System Assessment IMEP Infection Management and Environmental Plan Framework IPHS Indian Public Health Standards INR Indian National Rupee INT Institutional Integrity IRL Intermediate Reference Laboratory IRR Internal Rate of Return ISM Implementation Support Mission IT Information Technology IVA Independent Verification Agency JEET Journey of Enhancing Targeted Interventions JICA Japan International Cooperation Agency JMM Joint Monitoring Mission MDR-TB Multidrug Resistant Tb MoHFW Ministry of Health and Family Welfare MoEFCC Ministry of Environment and Climate Change NCD Noncommunicable Diseases NGO Non-Governmental Organization NHM National Health Mission NPV Net Present Value NPY Nikshay Poshan Yojana NRL National Reference Laboratory NSP National Strategic Plan OPRC Operational Procurement Review Committee PAD Project Appraisal Document PAP Program Action Plan PDO Program Development Objective PFMS Public Financial Management System PforR Program for Results PIP Program Implementation Plan PP Public Private PPE Private Provider Engagement PPM Public-Private Mix PTETB Program Towards Elimination of TB PWD Public Works Department RNTCP Revised National TB Control Program RoP Record of Proceedings SC Scheduled Castes SPCB State Pollution Control Boards ST Scheduled Tribes TA Technical Assistance v TB Tuberculosis TSU Technical Support Unit WHO World Health Organization XDR-TB Extensively drug-resistant TB vi EXECUTIVE SUMMARY Environmental and Social Systems Assessment (ESSA) 1. As per World Bank policy and the directive on Program for Results (PforR) financing, an ESSA was carried out to assess the adequacy of environmental and social systems at the national and focused state level in the context of the Program boundary; promote environmental and social sustainability in the Program design; avoid, minimize, or mitigate adverse impacts; and promote informed decision-making related to the PforR’s environmental and social impacts. The specific objectives of the ESSA included the following: (a) identify potential environmental and social benefits, risks, and impacts applicable to the Program interventions; (b) review the policy and legal framework related to management of environmental and social impacts of the Program interventions; (c) assess institutional capacity for environmental and social management systems within the Program system; (d) assess Program system performance with respect to the core principles of the PforR instrument and identify gaps, if any; and (e) describe actions to be taken to fill the gaps that will be used as inputs to the Program Action Plan (PAP). ESSA Methodology 2. The ESSA primarily relied on desk reviews of existing information and data sources, complemented by primary data collection, assessment through consultations, interviews, discussions with key stakeholders and select field visits to high risk settings such as drug resistant TB (DR-TB); anti-retroviral centres (ART centres), central bio medical waste treatment facilities (CBMWTFs), and TB containment laboratories including private laboratories currently engaged under the RNTCP. Additionally, the ESSA included consultations with experts, government officials and community groups (including tribal population) to observe and capture opinions, anecdotal evidences, functional knowledge and concerns. The discussions and visits that were conducted by staff who were managing and working within these facilities created the basis for the development of this ESSA. The desk review included all available guidance documents provided by CTD, and past reports from bank funded engagements. The primary data collection and assessment involves consultations, discussions and interviews with CTD officials in charge of environment and social aspects and consultations with various sector experts, State TB officers, and development partners during the Program preparation workshop in Delhi, Lucknow, Mumbai, Pune, Hyderabad, and Udaipur, and NGOs/academia currently engaged in the RNTCP Program. A free and prior informed consultation (FPIC) with tribal communities was also conducted in tribal blocks of Pune and Udaipur districts belonging to Schedule-V areas under the constitution of India. Applicability of the ESSA Core Principles Core Principle 1: Applicable Environmental and social management procedures and processes are designed to: (a) promote environmental and social sustainability in the Program design; (b) avoid, minimize, or mitigate against adverse impacts; and (c) promote informed decision-making related to a Program’s environmental and social effects Summary Findings: This is determined as relevant and applicable. India has an adequate legal framework for environmental, health and safety, and waste management (including hospital, general, plastics and liquid wastes) backed vii by a set of comprehensive laws, regulations, technical guidelines and standards, which apply nationwide. Over the decades, it has gradually evolved into a comprehensive system that is generally consistent with the PforR. However, capacity needs to be strengthened in order to implement these guidelines/ regulations effectively. Certain interventions under the Program would require mitigation actions and sustainable approaches to better manage Program’s environmental effects. These include, among others: (i) Strengthen environment health and safety monitoring capacity in CTD and States on BMW, IC, and AIC; (ii) Support accreditation criteria for C&DST labs to include enhanced EHS and biosafety criteria; (iii) Update BMW trainings to include management of all wastes including e-waste and hazardous wastes, to all staff engaged under RNTCP; (iv) Ensure emergency response mechanisms such as fire detection, and accident reporting and response mechanisms are functional at all HCFs and Labs; (v) Strengthen AIC and IC capacity at facility level through the public health system; (vi) develop guidance for State and District TB officers to understand and implement EHS aspects as part of national guidelines/ regulations. Adverse impacts associated with limited physical works/renovations supported under the PforR include dust, noise, and solid waste generation, however, these are expected to be minor in nature and limited to the healthcare facility, and easily mitigated. The PforR will ensure the environmental and social sustainability under the context of the government’s investment in the NSP, which is aligned with the global End TB Strategy and Sustainable Development Goal targets. Core Principle 2: Not Applicable Environmental and social management procedures and processes are designed to avoid, minimize, or mitigate adverse impacts on natural habitats and physical cultural resources resulting from the Program. Summary Findings: This is determined as not applicable. Interventions proposed under the Program would largely take place within existing facilities and not impact natural habitats and physical cultural resources. Core Principle 3: Applicable Environmental and social management procedures and processes are designed to protect public and worker safety against the potential risks associated with: (i) construction and/or operations of facilities or other operational practices under the Program; (ii) exposure to toxic chemicals, hazardous wastes, and other dangerous materials under the Program; and, (iii) reconstruction or rehabilitation of infrastructure located in areas prone to natural hazard. Summary Findings: TB diagnosis and treatment exposes healthcare and lab workers to risks associated with exposure to TB, hazardous materials, infections, as well biosafety, and would require mitigations These include, among others: (i) Improving occupational health and safety practices at healthcare facilities through infrastructure design, AIC, infection control, protocols for addressing accidental spills; (ii) Providing protective clothing and personal safety equipment, as required; (iii) Ensuring safe storage, segregation, transport and disposal of biomedical and hazardous wastes; (iv) Implementing good practices with regards to cleanliness, hygiene and general waste management; (v) Encouraging worker and public health and safety focusing on emergency response as well as fire safety; (vi) Maintaining critical lab safety equipment; (vii) Training for workers in sputum collection transport on biosafety and use of spill kits; and (viii) Employing qualified biomedical engineers and technical staff available to service, maintain and conduct safety testing on critical lab equipment in the IRLs. Core Principle 4: Not Applicable viii Land acquisition and loss of access to natural resources are managed in a way that avoids or minimizes displacement, and affected people are assisted in improving, or at least restoring, their livelihoods and living standards. Summary Findings: The Program does not intend to do any land acquisition or resettlement, as it does not support any major construction and is limited to minor renovation and repairs within the existing footprint of the health facilities and laboratories. However, in order to rule out any adverse social effects and exclude activities/ sub-activities leading to land acquisition and/ or resettlement, screening will be conducted in facilities where any repair, renovation and/or expansion is proposed under the Program by the healthcare facility in charge, under the guidance from DTO. The resettlement which is to be avoided, includes involuntary displacement of people who are illegally occupying areas within the grounds of the health facilities. Core Principle 5: Applicable Due consideration is given to cultural appropriateness of, and equitable access to, Program benefits giving special attention to rights and interests of Indigenous Peoples and to the needs or concerns of vulnerable groups. Summary Findings: The Program provides for special incentives in the tribal and difficult to reach areas for transportation to patients and sputum sample transportation to enhance access. However, in recent years some of these areas have been reporting a high incidence of not only drug sensitive, but also drug resistant, TB cases. The NSP 2017-25 also recognizes that there has been limited progress in the form of a special action plan for tribal populations and requires enhancing access and coverage not only through screening and treatment mechanisms, but also by adopting culturally appropriate ACSM and communication activities. The RNTCP tribal action plan should be updated to address NSP concerns and the changing context. Core Principle 6: Not Applicable Avoid exacerbating social conflict, especially in fragile states, post-conflict areas, or areas subject to territorial disputes. Summary Findings: While there are some conflict-affected areas including the presence of left wing extremist (LWE) areas in the nine Program focus states, it is important to note that Program interventions do not exacerbate any social conflicts, as it attempts to improve upon the overall health of the residents and reach out to all vulnerable pockets for TB case finding and linking them to treatment. Exclusion of any groups in terms of caste, religion, and/ or geography from Program activities, is not expected. Key Findings of Institutional Assessment on Environment and Social Aspects 3. CTD has already implemented three Bank funded projects for Tuberculosis control and management. While these projects are now closed, the institutional setup is still functional and active, and the environment management framework for bio medical waste management and capacity building remains relevant. Over the years, BMW has seen considerable improvement at all levels of healthcare facilities. This is indicative of good borrower capacity to deal with the environmental and social aspects of the proposed Program. The RNTCP has guidelines for most of its activities including: (i) engagement of the private sector, (ii) SOP for labs and biosafety guidelines (iii) Treatment of DR-TB, and (iv) AIC guidelines, (v) reaching out to tribal and difficult areas, (vi) Advocacy communication and social mobilization (ACSM), and (vii) social and behavior change communication (SBCC). However, they should be updated with the current context and the agenda set forth in the NSP 2017-25. This includes institutional reorganizing, building capacity at all levels, and updating ix ‘Partnership guidelines’ and ‘Technical and Operational Guidelines for TB Control in India’. It also includes monitoring mechanisms and tools such as Central Level Internal Evaluation (CIE) and State Level Internal Evaluation (SIE) specific to the areas mentioned above to address the issues raised in the NSP 2017-25 and the guidance suggested therein. In addition, the key institutional gaps in CTD, and the State TB Cell, is the lack of dedicated and skilled manpower to plan and implement partnerships, advocacy, communication and social mobilization (ACSM) and psycho social support (PSS) activities in a coherent manner. There is also a lack of biomedical engineers which is critical to sustaining C/DST laboratory services, and uninterrupted service. According to national guidelines, Airborne Infection Control (AIC) Committees are proposed to be formed at State, District and Health care facility level, committees to plan and manage this aspect were not always fully operational, and capacity needs to be institutionalized in the RNTCP structure. This will need strengthening through the PforR Program. Biomedical waste management is being addressed through collection transport and disposal with a private agency and is adequately managed. There are however, opportunities for continuous training of staff on management of BMW and all other types of wastes. Legal and Regulatory Framework 4. The existing legislative framework is adequate to ensure social sustainability and the interest of marginalized and vulnerable populations including the SC and ST population, but require strengthening institutional capacity to comply. It ensures: (a) protection of the interest of SC and ST population, (b) non- discrimination based on religion, race, caste, and gender, (c) transparency with the right to information, and (d) the right to fair compensation in case of land acquisition. 5. The provisions of the existing environmental legal and regulatory framework are adequate but require enabling institutional and technical capacity for compliance. While the provisions of the Biomedical Waste Management & Handling) Rules, (as amended on March 2018), are being implemented, provisions of other relevant environmental acts such as, hazardous, solid, plastic and e-waste Rules applicable to RNTCP require additional capacity building efforts. Efforts are also required to improve the monitoring of the management of different kinds of wastes, including liquid waste and effluents. The existing National and RNTCP Program guidelines are adequate for addressing the following: (i) patient and worker safety, (ii) ensuring biosafety, (iii) air borne infection control, (iv) packaging and transport of infectious samples for DST, and (v) screening of TB workers. Assessment of Environmental and Social Management Systems 6. Consistent with the requirements of the Bank PforR Policy, the proposed PforR operation does not support activities that pose high social or environmental risks such as large civil works, effluent treatment plants or disposal facilities. The activities to be supported by the Program are likely to provide significant environment and social benefits, such as improved waste management and handling, health and safety provisions for workers engaged in the RNTCP and higher standards for infection control. The applicable environmental and social management systems are generally adequate to address underlying environmental and social risks, with noteworthy strengths of having regulations and guidelines in place for bio-medical and other waste management, and guidelines for worker safety, biosafety and infection control. The ESSA did uncover gaps in implementation, monitoring and supervision in some areas, as summarized below. x (i) No dedicated capacity to manage EHS issues within the Program. At central level EHS capacity has been imbedded within the CTD, but at state level BMW, IC, AIC is being managed by different committees, technical specialists, and coordination needs to be strengthened at the healthcare facility level (ii) Evaluation and accreditation criteria for private sector C&DST labs (under NGO-PP scheme) could be strengthened further to emphasize EHS and biosafety criteria consistent with national regulations (iii) Need for a health advisory, biosafety training for workers involved in sputum collection and transport (iv) Update BMW trainings to include the most relevant rules and regulations, e-waste and hazardous wastes, liquid waste and implement a Program training for all staff engaged under RNTCP. (v) Ensure that emergency response mechanisms such as fire detection, and accident reporting and response mechanisms are functional at all IRLs (vi) Provide technical expertise (biomedical engineers) for maintenance and safety testing of lab equipment such as biosafety cabinets, centrifuge and air handling units (vii) Servicing and decommissioning of critical lab safety equipment needs standardization to ensure lab workers always have access to all necessary equipment in good operational condition (viii) AIC capacity needs to be strengthened at the facility level, and plans should be prepared and approved according to the National Guidelines. Need for better institutional coordination with the public works department that usually undertakes construction work. 7. The Program does not intend to do any land acquisition or resettlement, as it does not support any major construction and is limited to minor renovation and repairs within the existing footprint of the health facilities and laboratories. Screening will be conducted to rule out any adverse environmental and social impacts where any renovations and/ or expansion is planned under the Program in the health facility/ laboratory or associated infrastructure. The resettlement, which is to be avoided includes involuntary displacement of people who are illegally occupying areas within the grounds of the health facilities. Both health facility in-charges as well as DTOs, will be trained by the social safeguard officer at the State TB Cell. The focus states account for 51.5 million people from the tribal population (49 percent of India’s tribal population) and are both scheduled V and Scheduled VI areas, as defined under the Constitution of India with special legislative and judicial provision including customary rights in scheduled-VI areas. The NSP 2017-25 also recognizes that there has been limited progress in the form of a special action plan for tribal populations. It is even more important to strengthen the TB control activities in these difficult areas, given that some of these areas have been reporting a high incidence of not only drug sensitive, but also drug resistant, TB cases. In order to extend the incentives designed for tribal population and for tribal areas, CTD recommends following designated tribal areas (tribal districts and blocks and scheduled areas) as per the Ministry of Tribal Affairs. However, field visits in tribal districts suggests gaps in understanding and extending the incentives in tribal areas. It requires CTD to clearly spell out the mechanism for identifying the tribal areas as part of the Program guidelines and strengthens data collection and monitoring of tribal population transport xi reimbursement and other incentives. In addition, the following related social issues were identified: (a) access to TB services in hilly and remote areas, and to some of the key population, (b) knowledge and awareness about TB especially among poor and marginalized population, (c) stigma reduction, (d) weak community support system, and (e) lack of nutritional care and support for TB patients. While the NSP 2017- 2025 also highlights most of these issues and provides overall policy guidance, the issue remains in translating them into effective implementation. And hence, the Program has moderate social risk. 8. Over the last three years the central level internal evaluations (CIEs) and Joint Monitoring Mission (JMM) in 2015, has observed weak engagement with NGOs to carry out various social mobilization activities in many states and lack of ACSM activities. The ACSM implementation require further analysis and introspection and updating the RNTCP partnership guidelines to this effect, and further monitoring and follow up. Additionally, a more coherent Social and Behavior Change Communication (SBCC) strategy required to be prepared, updated and adopted as the earlier communication strategy is outdated and currently not being followed. In order to strengthen the activities for tribal people, CTD need to update the RNTCP tribal action plan with changing context. As the Program plans to engage with private providers for TB notifications and link the patients to nutritional support, it will require additional focus on communication and mobilization of people to learn about the provisions under the Program. 9. Gender: Women and girls make up nearly one million of the estimated 2.8 million TB cases in India each year; it is the fifth leading cause of death among women in the country, accounting for nearly 5 percent of fatalities in women aged 30–69. Although more men are affected by TB, women experience the disease differently and also experience the impact of stigma disproportionately. The rapid assessment of gender and TB in India reveals the differential aspects of TB among women including the fact that women may be diagnosed late or not diagnosed at all due to added risk of socio-cultural barriers. This includes women delaying seeking care for TB ailments because of the high burden of household work combined with the deprivation of health awareness, mobility, access to resources and decision-making powers. These factors considerably influence TB case detection and adherence to treatment. In addition, with more than half of all women in the India being anemic and one in five underweight, risks for contracting TB increase. To address this, a technical expert group is being constituted by CTD to develop and finalize the collaborative framework for TB and Women in India, including the development of Programmatic interventions to address the socio- cultural barriers. The key Program action required is the development and adoption of framework for TB among women and is further detailed under the proposed PAP actions. 10. Citizen Engagement: The CTD aims to enhance Community Engagement for a people centered and community led TB Response under the RNTCP. This is proposed to be achieved by creating TB Forums at State and District level for working collaboratively with and through communities to address issues affecting their well-being, including influencing systems and serving as catalysts for changing polices, Programs and practices that are more patient sensitive. The scope of community engagement is envisaged as: (a) providing patient support services through community participation - including awareness creation and stigma reduction, screening for TB and TB-related morbidity, referring for diagnosis of TB and related diseases, providing treatment adherence support, linking social support to patients, and helping address equity and non-discrimination issues; and (b) implementing community Empowerment activities for sustainable community engagement by informing, empowering and institutionalizing, and building an accountability platform by creating a mechanism of feedback on TB care services to the providers at all levels, using xii community monitoring tools. The scope defined for community engagement is much wider than the terms of reference developed for the TB forums at State and District level, which lacks in community empowerment and accountability aspect. The key Program actions required are as follows: (a) building an accountability mechanism by modifying and adding to their composition, roles and responsibilities, and terms of reference of the Central, State and District Forums; (b) creating TB forums at the State and district level, as per the expanded scope with an improved accountability mechanism that is also embedded as the Intermediate Result indicator under the Intermediate Results Area #4 of the Program on Strengthening RNTCP Institutional Capacity and Information Systems. This will be measured through the following: (a) Government approval to the revised Terms of Reference of State and District TB Forum with expanded scope with respect to an accountability mechanism, and (b) the number of state and districts conducting Annual TB Forum meetings and submitting minutes to STC (by districts) and CTD (by states). The Program also will also introduce an incentive mechanism through small disbursements every year for incremental increases in a number of states and districts conducting the Annual TB Forum meeting. Conclusion and Recommendations 11. The ESSA concludes that the Program has a moderate environmental and social risk. There is no land acquisition and/ or resettlement anticipated under the Program. Based on the assessment of the environmental and social management system applicable to the proposed PforR, it is concluded that the Government of India (GoI) has established a comprehensive set of environmental and social management systems. Such systems are in line with the core principles and key planning elements as defined in the Bank Policy for PforR. The overall potential environmental and social risks for this PforR, is rated as moderate and can be effectively mitigated within the existing environmental and social management systems. 12. The key social risk emerges from capacity gaps to manage tribal issues, develop and implement ACSM activities, communication, and ensuring that the Program is gender responsive. In addition, the key environmental and social risk emerges from the Program not having adequate and dedicated human resources for addressing environment and social risks. The key environmental risks also emerge from the following: (i) lack of dedicated capacity at State level to plan and monitor BMW, IC and AIC activities; (ii) shortage of dedicated biomedical engineers to support lab safety, (iii) management of infection control associated with TB related diagnostic and treatment services, and (iv) management of the incremental increase in biomedical and other wastes generated through Program supported activities. There are no high impact activities associated with the PforR boundaries such construction of large buildings, central bio- medical waste treatment facilities, and effluent treatment plants (these activities are not eligible for including under the Program). Recommendations for Program Action 13. The ESSA proposes the following recommendations, which are Inputs to the PAP: Action 1: Develop Protocols/SOP for servicing and decommissioning key lab safety equipment. Action 2: Update RNTCP tribal action plan to strengthen outreach in tribal and hilly areas, ACSM and Social Behavior Change Communication (SBCC). Action 3: Central, State and District TB Forum strengthened for improving the accountability mechanism xiii i. Building accountability mechanism by modifying/ adding to their composition, roles and responsibilities, and terms of reference of the Central, State and District Forums. ii. State and district creating TB forums as per the expanded scope with improving accountability. Action 4: CTD Strengthens Data Collection and Monitoring of Tribal Population Transport Reimbursement, and strengthen DBT mechanism. Annual CTD report to capture coverage and trends in DBT for tribal populations. Action 5: Development and adoption of framework for TB among women. This will include: i. Analysis of context specific, socio-cultural norms and overlapping health concerns that are likely to amplify the incidence of TB amongst women in participating states ii. Specific Programmatic interventions towards addressing socio-cultural barriers iii. Include gender specific data for TB monitoring. Disclosure and Consultations 14. This ESSA is being disclosed in-country and on the World Bank’s external website. A multi- stakeholder workshop on this ESSA and the PforR was held in Delhi on 26th November 2018. Following incorporation of the feedback received from the other sources, the ESSA was finalized and will be re-disclosed in-country and on the World Bank’s external website, prior to Board consideration. 15. The ESSA preparation process involved extensive stakeholder consultations. During ESSA preparation, World Bank environmental and social specialists undertook recurrent meetings and consultations with different stakeholders, experts, technical specialists including relevant government institutions at the national level in CTD, State, District TB officers in Mumbai, Pune, Udaipur, Lucknow and Hyderabad. Also, a free and prior informed consultation (FPIC) was conducted in tribal areas of Pune and Udaipur districts. 16. Section V provides more detailed descriptions of the scope of these recommendations and provides indicative costs and timetables for implementation. If these inputs to the PAP are successfully implemented, the overall environmental and social management system for the Program will have been considerably strengthened and set on a more sustainable path. This is also true for RNTCP Program to be implemented throughout India, since the improvements in environmental and social management systems and capacity are likely to extend beyond the life of the Program. xiv I. INTRODUCTION A. Environmental and Social Systems Assessment: Purpose and Objectives 1. This Environmental and Social Systems Assessment (ESSA) has been prepared by a World Bank ESSA Team for the proposed Program Towards Elimination of Tuberculosis, which will be supported by the World Bank’s Program for Results (PforR) financing instrument. In accordance with the requirements of the World Bank Policy Program-for-Results (PforR) Financing Policy, PforRs rely on country-level systems for the management of environmental and social effects. The PforR Policy requires that the Bank conduct a comprehensive ESSA to assess the degree to which the relevant PforR Program’s systems promote environmental and social sustainability. Additionally, the ESSA is in place to ensure that there are effective measures to identify, avoid, minimize, or mitigate adverse environmental, health, safety, and social impacts. Through the ESSA process, the Bank ESSA Team develops recommendations to enhance environmental and social management within the Program, which are both included in the overall management action plan. 2. The main purposes of this ESSA is to: (i) identify the Program’s environmental, health, safety, and social effects; (ii) assess the legal and policy framework for environmental and social management, including a review of relevant legislation, rules, procedures, and institutional responsibilities that are being used by the Program; (iii) assess the implementing institutional capacity and performance to date, to manage potential adverse environmental and social issues; and (iv) recommend specific actions to address gaps in the Program’s environmental and social management system, including with regard to the policy and le gal framework and implementation capacity. 3. This ESSA assesses or considers the extent to which the Program’s environmental and social management systems are adequate for and consistent with six core environmental and social principles (hereafter, Core Principles), as may be applicable or relevant under PforR circumstances. The Core Principles are listed below and further defined through corresponding Key Planning Elements that are included under each Core Principle in Section III. (a) Core Principle 1: Environmental and Social Management: Environmental and social management procedures and processes are designed to: (a) promote environmental and social sustainability in Program design; (b) avoid, minimize, or mitigate against adverse impacts; and (c) promote informed decision making related to a Program’s environmental and social effects. (b) Core Principle 2: Natural Habitats and Physical Cultural Resources: Environmental and social management procedures and processes are designed to avoid, minimize, and mitigate any adverse effects (on natural habitats and physical and cultural resources) resulting from the Program. (c) Core Principle 3: Public and Worker Safety: Program procedures ensure adequate measures to protect public and worker safety against the potential risks associated with: (a) construction and/or operations of facilities or other operational practices developed or promoted under the Program; and (b) exposure to toxic chemicals, hazardous wastes, and otherwise dangerous materials. (d) Core Principle 4: Land Acquisition: Land acquisition and loss of access to natural resources are managed in a way that avoids or minimizes displacement, and affected people are assisted in improving, or at least restoring, their livelihoods and living standards. 1 (e) Core Principle 5: Indigenous Peoples and Vulnerable Groups: Due consideration is given to cultural appropriateness of, and equitable access to, Program benefits, giving special attention to the rights and interests of indigenous peoples and to the needs or concerns of vulnerable groups. (f) Core Principle 6: Social Conflict: Avoid exacerbating social conflict, especially in fragile states, post- conflict areas, or areas subject to territorial disputes. 4. An additional purpose of this ESSA is to inform decision making by the relevant authorities in the borrower country and to aid the Bank’s internal review and decision process associated with the Program Towards Elimination of TB (PTETB). The findings, conclusions and opinions expressed in this document are those of the World Bank and the recommended actions that flow from this analysis will be discussed and agreed with counterparts in CTD and States and will become legally binding agreements under the conditions of the new loan. B. ESSA Methodology 5. The proposed Program Towards Elimination of TB (PTETB) is a well-defined subset of the Government of India’s (GOI) National Strategic Plan (2017-2015) of the Revised National Tuberculosis Control program. The PTETB focuses on the following: (i) scaling up private sector engagement, (ii) rolling out TB patient management and support interventions, (iii) strengthening diagnostics and management of DR-TB, and (iv) strengthening program management capacity and information systems. The interventions planned are expected to result in environmental and social benefits. Adverse effects that are sensitive, diverse and unprecedented on the environment and people are not anticipated. However, planned efforts are essential to ensure that the Program interventions will result in sustainable social and environmental benefits. As required by the Bank Policy on Program-for Results Financing, this ESSA was conducted during Program preparation to assess the adequacy of the environmental and social systems of the GOI, and the Revised National Tuberculosis Control Program, and to identify specific strengthening measures. 6. The focus of this assessment has been on understanding the social and environmental risks, benefits, impacts and opportunities of the NSP 2017-2025. The study looks at the social and environmental checks and balances that exist in the country and institutional level rules, policies and guidelines, map the risks and gaps, and suggest the possibilities for implementation, and institutional strengthening. It reviews the appropriateness of existing and planned infrastructure, equipment, technologies and institutional mechanisms for planning and monitoring for environment health and safety, and compliance to existing rules and regulations. 7. The following actions were undertaken as part of the assessment from 14 October to 5 November, 2018: (a) a comprehensive review of government policies, legal frameworks, Program documents, national guidelines for RNTCP and other assessments of India’s environmental and social management systems (See Annex 2); (b) interviews and consultations were conducted with relevant experts and officials from CTD, State and District TB officers, Technical staff in IRLs, DR-TB centres, DMCs and District Hospitals (Annex 3),, and the task team had detailed questionnaire-based discussions with officials who manage the programs in the States.); (c) district level consultations with tribal populations, NGOs, and District TB officers, community members and beneficiaries from Pune and Udaipur. 8. The task team also conducted on-ground reconnaissance of various healthcare facilities, designated microscopy centres, intermediate reference laboratories, ART centres, DR-TB centres in Pune, Mumbai, Udaipur and Hyderabad to understand the activities involved, institutional mechanisms, and on-site risks 2 related to implementation and operations in TB diagnostics and treatment. Central Bio-Medical Waste Treatment Facilities were also visited in Lucknow and in Virudhanagar, Tamil Nadu. Site Visits Undertaken Officials Met 1 Hyderabad – STDC, State Reference Lab, EQA Lab, and ▪ Dr. Sumalatha (State Epidemiologist) BPHRC (Private C&DST Lab under NGO PP Scheme) ▪ Mr. Srikant (IRL, Microbiologist) ▪ Mr. Anil Kumar (Technical Officer) ▪ Dr. Sneha Shukla (WHO- Consultant), IRL Lab staffs 2. Lucknow, UP (Discussion with State TB officer and Visit to ▪ Dr. Santosh Gupta, State TB officer SMS Watergrace, Mediwaste management CBWTF) 3. Udaipur (Rajasthan): ▪ Dr. Dinesh Kothari (DTO) ▪ Dr. D. S. Rao (S.M.O) i. DMC lab, CBNAAT lab in District TB Clinic ▪ Dr. Sanjay Sinha (WHO- consultant) (inside Maharana Bhupal Hospital campus) ▪ Mr. B.K. Gupta(NGO – ALERT, and member Child Haathipole, Udaipur Welfare Committee) ii. RNT- Medical college- DMC Lab, MDRTB ward, ▪ Mr. Naresh Paneri and Mr. Tyag Narayan (NGO – iii. BMWM, BADI, Udaipur SWACH) iv. RNTCP-laboratory, Gitanjali Medical College & ▪ Dr. Manoj Arya (RNT medical college) Hospital, Udaipur ▪ Laboratory technicians v. Jhadol PHC in tribal area, SWACH NGO training ▪ Dr.S.K. Lohadiya, Head, Dept. of TB & respiratory centre at Jhadol block disease, Geetanjali Medical College & Hospital ▪ All STS and STLS of the district ▪ Free and prior informed consultation (FPIC) with tribal community in Jhadol block, including discussion with MO, ANM and other outreach staffs of Jhadol PHC and tribal TB patients; discussion with NGO (SWACH) extension workers placed in each trbal village/ panchayat of the block working as TB extension worker (called Swach Mitra). 4. Pune: ▪ Dr. Padmaja Jogeshwar, STO i. IRL lab ▪ Dr. P.L. Mane, AD HS; Dr. Sanjay Darade DTO ii. DMC lab ▪ Dr. Sandeep Bharaswadkar WHO consultant, iii. TB ward and Rural health centre ▪ Dr. Vaibhav Saha WHO consultant iv. Dimphe Khurd Tribal PHC, Awegaon ▪ Ms. Shilpa Balyam C&DST STDC (IRL- microbiologist) ▪ Dr. Balaji Lakade Medical Officer PHC ▪ Dr. Udawant & Dr. Sayali ▪ TB ward and other lab staff ▪ MO, ANM, STS, STLS, other PHC staffs including four ASHAs associated with PHC and working in tribal villages; ▪ FPIC with tribal community and patients 5. Mumbai: ▪ Dr. Shalini Bhagat Dy Director TISS; ▪ Ms. Shweta Bajaj Sr Program Manager, Saksham i. Pt. MM Shatabdi Hospital, Govandi TISS ii. CBNAAT lab ▪ Dr. Narender G. Sutar DTO, CBNAAT lab iii. TB diagnostic centre (DR TB centre) ▪ Dr. Dhayagude BMW in charge iv. Microbiology Lab, Sir JJ hospital ▪ Dr. Shubhangi Mankar SMO DRTB v. 2nd October Health post- Bhoiwada, Parel ▪ Dr. Ameeta A. Joshi, MD (Microbiologoy) SJJ hospital vi. TB Hospital- SEWRI, (CBNAAT and ▪ Dr. Ajay Dhawale, DTO Biochemistry Lab) ▪ Dr. Lalitkumar D Anande, Medical Superitendent GTB hospital, Sewree, Mumbai ▪ Dr. Amit Karad, WHO consultant 3 9. The ESSA review process seeks to describe and assess the systems for managing environmental and social effects of a proposed Program. The World Bank drew on a wide range of data, sources, and inputs during the ESSA review process, including the following actions: (a) Assessment of the environmental and social effects of the Program: The ESSA Team assessed the potential for the Program to cause adverse environmental and social effects, either due to its design and Program components or due to gaps in Program systems. Such risks were assessed at various levels to be moderate. (b) Comprehensive desk review of policies, legal framework, Program documents, and other assessments of environmental and social management systems: The review examined the set of national policy and legal requirements related to environment and social management, waste management, infection control, biosafety, occupational health and safety management, and construction of small civil works. The review also examined technical and safeguards documents from previous World Bank projects and Programs including the Second National Tuberculosis Control Project (2006-11), and The Accelerating Universal Access to Early and Effective Tuberculosis Care Project, which ran from (2014-2018) including Safeguard Diagnostic Reviews. The ESSA Team also reviewed assessments of relevant environmental and social management systems for the Tamil Nadu Health System Reform Program (P166373). (c) Institutional analysis: An institutional analysis was carried out to identify the roles, responsibilities, and structure of the relevant institutions responsible for implementing the PTETB funded activities, including coordination between different entities at the National, State and District levels. The assessment of capacity of key institutions to plan, monitor and implement, required environmental and social management actions which need strengthening and better coordination with other departments and medical directorates. An important input for this assessment was an evaluation of the previous track record of these institutions in management and such risks in the context of previous projects and Programs. 10. Findings of the assessment have been used in the formulation of an overall Program Action Plan (PAP) with key measures to improve environmental and social management outcomes of the Program. The findings, conclusions, and opinions expressed in the ESSA document are those of the World Bank. Recommendations which are included in the analysis and have been discussed and agreed upon with the Central TB Division, State TB officers, and IRLs (of the PTETB Focus States). 11. This ESSA is updated based on the feedback received from stakeholders and experts prior to finalization of the Program, and the updated document is being made publicly available in accordance with the Bank’s policy on Access to Information. 4 II. PROGRAM DESCRIPTION AND POTENTIAL ENVIRONMENTAL AND SOCIAL EFFECTS A. Program Context 12. With the world’s second largest population, India has made substantial contributions to global economic and human development and overall poverty reduction over the last three decades. Achievements include India’s increased share of the global gross domestic product (GDP) from 1.8% in 2005 to 2.7% in 2010. India’s own GDP has grown steadily and become more diversified and resilient; growth is expected to continue at around 7% per annum. While robust economic growth has availed resources to address critical development challenges across various sectors, stark inequalities remain. Notably, India reduced the population living in extreme poverty from 45% in 1994 to 22% in 2012; life expectancy rose from 58 years in 1990 to 69 years in 2016, and several health outcomes have improved. However, sustaining India’s economic growth depends on the government’s ability to reach all segments of society with critical services and resources. India is still marked by disparities between urban and rural areas, as well as structural inequalities by gender, tribe and caste. Addressing these inequalities will require increasing access, quality, and utilization of human development services, including health. 13. Despite substantial achievements in improving health outcomes since 1990, India still faces tremendous challenges in health care access, quality, and utilization. Quality of care is a significant and complex challenge. India’s demographic and epidemiological transition calls for an aggressive response to persisting communicable diseases and a burgeoning burden of non-communicable diseases (NCDs). India’s health expenditures are relatively low; National Health Accounts 2014-2015 indicate that India spends I(INR) 3,800 (US$56) per person, while other lower middle-income countries spend around US$233 per person on health. In addition, there is a weak correlation between per capita health expenditures and outcomes across states. TB is a prime example of a persisting communicable disease challenge for India. TB kills around 480,000 people every year in India. Over the last 20 years, India has contributed to almost 25% of the global TB burden, where an estimated 480,000 people die from the disease annually. 14. TB outcomes have stagnated over the past five years. Particularly, drug-resistant TB is a major public health threat to India. TB is one of the world's top anti-microbial resistant pathogens, mostly due to inadequate treatment. Resistance to first-line drugs is known as Multidrug Resistant TB (MDR-TB). In appropriate management of MDR-TB can then lead to a highly lethal form of extensively drug-resistant TB (XDR-TB). Resistant forms of TB require more expensive drugs with higher levels of toxicity, case fatality, and treatment failure rates. Unfortunately, India has the world’s highest number of multi-drug resistant TB (MDR- TB) cases and the health systems are ill-equipped to adequately respond to drug-resistant TB (DR-TB), with DR-TB outcomes lagging global and regional trends. These resistant forms of TB threaten to erode India's health and developmental gains. Many TB cases remain undiagnosed and/or inadequately treated. Despite increases in total new TB cases reported by providers to the RNTCP, India still accounts for approximately one third of the world’s three million people with TB each year who are not diagnosed, treated, or officially registered by a national TB Program. There are a combination of gaps and challenges that contribute to India’s persistently high levels of TB, which include: (i) fragmented health care provision through diverse providers, including the unregulated private sector that accounts for over half of TB cases treated in India; (ii) quality gaps in diagnosing and managing TB in both public and private sector; (iii) lack of adherence to treatment resulting from various behavioral and socio-economic factors; and (iv) significant limitations in the diagnostic laboratory network. 5 B. The Government of India’s Program 15. It was in this context that the Government of India (GoI) launched the new National Strategic Plan (NSP 2017-2025) for the Revised National Tuberculosis Control Program. As articulated in the NSP, the GoI aims to support high impact interventions and implementation reforms to accelerate the country’s progress toward elimination of TB. These include switching to a more effective treatment regimen for drug-susceptible TB and introducing shorter regimens for drug resistant TB. The overall objectives are to: (i) improve TB outcomes and diagnosis and treatment of the millions of private sector patients, (ii) provide incentives to private providers to follow standard protocols for diagnosis and treatment, and (iii) notify cases to the government. The government has supported its Program through an investment of US$535 million in 2017. The RNTCP’s implementation has been supported in the past by the World Bank, WHO, Gates Foundation, Global Fund and other bilateral donors. C. Bank Financed PforR Scope, Objectives, and Key Results Areas 16. In response to the government’s request for support, the World Bank has prepared PTETB to support and enhance the aims of the RNTCP NSP 2017. The Bank and the GoI agreed to develop and support RNTCP using the World Bank’s PforR instrument. The PTETB is a subset of a well-defined subset government program. The Program was carved out of the NSP by results area, geographical area with the selection of priority states, and timeframe. Of several NSP result areas, the Program focuses on four: (i) scaling up private sector engagement, (ii) rolling out TB patient management and support interventions, (iii) strengthening diagnostics and management of DR-TB, and (iv) strengthening Program management capacity and information systems. These results areas are inter-linked and mutually reinforcing. In terms of geographical area, considering both the estimated TB burden and the gap between private notification and the estimated TB burden, the GOI selected nine states for the Program: Uttar Pradesh, Maharashtra, Bihar, Rajasthan, Madhya Pradesh, Karnataka, West Bengal, Assam, and Tamil Nadu. 17. The PforR will also focus on the institutional capacity of RNTCP at the National, State and District levels in select states which will include staff vacancies. This is also considered as a disbursement linked indicator which is an essential pre-condition for success of the activities under RNTCP. The PforR Program expenditure boundary, would include procurement of first-line and second-line anti-TB drugs, equipment, and laboratory materials by the Central TB Division (CTD). At the state level, relevant expenditure categories include: private sector support (PPM, NGO, PP support), salaries and benefits, honorarium, patient support and transportation, and supervision and monitoring. All the remaining States will still benefit from cross- cutting, systems interventions under the Program. In terms of timeframe, the Program is a fraction of the NSP (five years out of seven remaining years of the NSP). 18. The Program Development Objective (PDO) of the proposed PTETB is to improve the coverage and quality of TB control interventions in the private and public sector in targeted states of India . The Program includes four result areas as specified below, which are inter-linked and mutually reinforcing areas, which are summarized below with their relevant PDO indictors. 19. The PforR focuses on four key result areas, summarized as follows: Result Area 1: Scaling-up Private Provider Engagement: The aim of the GOI’s efforts to scale up private sector engagement is to ensure timely diagnosis and notification, and effective management of TB among patients, in line with Standards of TB Care in India. The NSP envisages an initial doubling of the number of patients detected and treated, with most of the increase coming from engagement of private healthcare providers. The array of private sector providers includes: Rural Health 6 Practitioners chemists and pharmacies, laboratories, qualified AYUSH providers, qualified allopathic Bachelor of Medicine General Practitioners, and specialists, including pulmonologists or chest physicians. Until recently, their engagement has been sporadic and small-scale. The new GOI approach to scaling up private provider engagement includes: (i) direct engagement by RNTCP staff, (ii) contracting of intermediary agencies and (iii) a hybrid model in which the roles are shared. All models are increasingly powered by digital systems for large-scale monitoring and strategic purchasing, built around version 2.0 of the Nikshay case-based registration information system, including direct electronic payments and new adherence support technologies. These approaches rest on a foundation of regulations that would otherwise be difficult to enforce. The transformative nature of India’s NSP and the scale of its ambition are unprecedented among TB High- Burden Countries. The PTETB PforR will help the GOI build the many institutional capacities on both the public and the private sides of the partnership – all of which will be critical to the success of the Program. Result Area 2: Rolling out TB Patient Management and Support Interventions: TB control outcomes depend on the extent to which patients seek early care, and on treatment adherence and completion. It is for this purpose that the GOI is rolling out TB patient support as one of its strategic interventions to eliminate TB. Providing treatment enablers in the form of financial incentives and nutritional support can provide for increased adherence and treatment success rates and is one of the recommended interventions under the WHO End TB Strategy. To meet these twin objectives of adherence and treatment support, the GOI is rolling out a scheme for incentives for nutritional support to TB patients called Nikshay Poshan Yojana (NPY). This Program will adopt a DBT mechanism for transfer of monetary support and incentives to patients. To support NPY, RNTCP will use Nikshay, a web-based case monitoring application already utilized by health employees at various levels across India. The support to tribal patients will be part of the Program Action Plan as the GOI is still strengthening data management and recording systems for this scheme. Result Area 3: Strengthening Diagnostics and Treatment of Drug-Resistant TB: The aim is to scale- up DR-TB interventions in India to aggressively respond to the continued complex and costly DR-TB challenge. The proposed PTETB PforR, directs efforts at the key bottlenecks for DR-TB control. Proposed activities under the Program involve incentivizing achievement of universal DST. Testing is the most essential activity for DR-TB control to succeed. The RNTCP’s policy to offer free diagnostics services for drug-resistant TB increases the value proposition that the RNTCP can offer to private providers for complying with TB notification. The PTETB PforR will support airborne infection control and increase advocacy and attention to a neglected but important area of epidemic control and in retaining human resources for health to address DR-TB. Facility-by-facility infection control assessments and plans are the globally-recommended best practice. Result Area 4: Strengthening RNTCP Institutional Capacity and Information Systems: The management of the TB Program is well embedded within the MOHFW and the National Health Mission (NHM), as well as the general health system at the State and District levels. The CTD is the nodal agency for the TB Program nationally. The RNTCP institutional staffing structure and information systems have been evolving with the expanding TB Program. However, substantial gaps remain in human resource staffing and skills mix to match the goals of the NSP at Central and State 7 levels, particularly in the nine states supported by the PTETB PforR. In addition, while improvements in information systems through the Nikshay system since its launch in 2012 are encouraging, it continues to lag behind the needs of a fast expanding Program. PTETB will support the MOHFW to develop and implement a human resource plan to enable the TB Program to adequately staff to match the scope and implementation needs of the NSP and roll out a performance-based mechanism between the CTD and states. 20. The results chain (see Table 1 below) includes a description of activities within each of the results areas, which collectively aim to achieve the PDO. Indicators and outcomes within each of the Results Areas have been defined to monitor the progress of the Program. A set of these indicators will be used as the Program’s DLIs, which are bolded in Table 1. The remainder will be monitored through the Program Results Framework. More detailed descriptions of the activities under each results area are included in Section II. 8 Table 1: PTETB Program Results Chain Results Area Activities Intermediate Indicators/Outputs `Outcomes / PDO Results Result Area 1: Scaling-up Private (i) Increased number of TB cases diagnosed and put on treatment (i) Number of TB notifications from private providers (i) Identify and support TB patients in the private sector Provider Engagement: (ii) Increased number of public-private agencies contracted in targeted states (ii) Provide incentives to private providers (iii) Increased proportion of TB patients and private providers (ii) The increase in private notifications, net of any (iii) Improve quality of treatment in private sector receiving incentives decrease in public notifications (iv) Strengthen central and state institutional capacity to engage private (iv) Technical Support Unit (TSU) integrated at state level and CTD (iii) Treatment success rate of private sector-notified providers and provider – patient engagement system level to support activities related to Private Sector TB patients (v) Strategically purchase TB services from private providers Engagement (vi) Develop and roll-out national tools and guidelines for private sector (v) Proportion of privately notified TB patients that have engagement microbiological confirmation in targeted states (vii) Improve enforcement of India TB standards of care (viii) Scale up of RNTCP Call Centre from 50 Seater to 100 Seater Result Area 2: Rolling out TB Patient (i) Develop Nikshay information system (i) Nikshay information system enhanced and supporting DBT& Proportion of beneficiaries receiving financial Management and Support (ii) Support Nikshay Poshan Yojna private sector support through DBT (Annually, by category of DBT Interventions (iii) Support to tribal patients (ii) Development of modules for all 4 DBT schemes (Nikshay scheme) (iv) Integration of Nikshay with PFMS Poshan Yojana, Tribal TB Patients, Private Providers and (i) Notified Public TB patients (v) Financial Support through DBT Treatment Supporters) in Nikshay 2.0 (prior result) (ii) Notified Private TB patients (iii) Proportion of districts implementing digital signature (iii) Private sector providers certificate (DSC) based approval process for DBT payment Result Area 3: Strengthening (i) Increased TB surveillance capacity in RNTCP (i) Proportion of notified pulmonary TB patients with (i) Expanding and incentivizing drug-susceptibility testing and monitoring Diagnostics and Treatment of Drug- (ii) Proportion of RR-TB patients with follow-up culture results known Rifampicin-susceptibility status (ii) For achievement of universal DST. (with a focus on private sector Resistant TB: documented by nine months of treatment (ii) Proportion of privately notified pulmonary TB engagement) (iii) Strengthened sputum transportation systems in priority patients that have microbiological confirmation (iii) improving airborne infection control in high-risk settings, by increasing (iv) Facilities having AIC plans prepared according to National advocacy and attention to this area Guidelines (iv) Strengthen Airborne infection control assessments and plans (v) Strengthen diagnostic services in public sector – include TB sample transportation (vi) Strengthen notification of all TB patients with known Rifampicin susceptibility status Result Area 4: Strengthening RNTCP (i) Develop human resources plan to match scope and ambition of NSP (i) Improved staffing at CTD and state level RNTCP institutional capacity to achieve select NSP Institutional Capacity and Information (ii) Better performance-based management contract between CTD and states (ii) Better informed & empowered communities in priority states objectives strengthened (private sector, DR-TB and Systems: (iii) Implement HR Plan to improve CTD and state capacity (iii) Completion of annual institutional (CTD, NIRT, NTI, BMHRC, patient support) (iv) Update supervision and monitoring guidelines to include integration of routine NRLs, STDCs) strengthening activities compared to agreed assessment and improvement of data completeness and quality annual plans (v) Building in the mechanism of data deduplication (of patients and providers) (iv) Development and implementation of a performance-based and reconciliation of different provider types. management mechanism between CTD and states (v) Conduct TB Forums at State and National Levels 9 D. Program Implementation Arrangements 21. The MoHFW will implement the PTETB and will be responsible for overall oversight and implementation of the Program activities. The CTD provides national leadership, financing, regulatory oversight, and capacity building support - responsibility for translating the NSP into implementation plans rests with the states. 22. Under the direction of the MoHFW, CTD will be the main implementing agency of the Program, with responsibility to prepare the annual work plan and budget and carrying out Program activities. RNTCP management is well embedded within the MOHFW and the national health mission (NHM) and within the general health system at the state and district levels. The institutional structure of the RNTCP Program is outlined in Table 2 below: Table 2: Institutional Structure of RNTCP Level Administrative Head Technical Head General Health System Central Secretary – Health & Family Welfare, Deputy Director Additional Secretary (Health), Joint General-TB Secretary in charge of TB State Principal Secretary- Health and Family State TB Officer Director- Health Services Welfare and Mission Director- NHM District District Collector/Deputy District TB Officer District Health Commissioner Officer/Chief Medical Officer/Civil Surgeon (a) At National Level: The Deputy Director General (TB) reports to the Director General of Health Services. A Joint Secretary (Public Health) is responsible for the Program, reporting to the Additional Secretary and Director of the NHM (formerly the National Rural Health Mission). The Additional Secretary and NHM Director will in turn report to the Secretary of Health and Family Welfare. CTD focuses on policy development, technical oversight, monitoring and evaluation and capacity- building. Several committees and research institutes provide technical guidance to CTD. All Laboratory related planning, monitoring and infrastructure support is managed by full time Deputy Additional Director General, Labs. (b) At State level: Administrative and financial management structures of RNTCP are merged with those of the NHM. The MOHFW and each state and union territory have entered into a memorandum of understanding for implementation of the NHM, which includes the RNTCP. The State TB Officer in the State TB Cell is part of the NHM State Program Management Unit, reporting to the Director of Health Services and the Director of the NHM in the state. The State TB officer—with team support— oversees district level Program implementation, reviews staff training, undertakes minor procurement, prepares technical and financial reports, ensures quality control, and monitors Program indicators. (c) At District (or municipal corporation) level: The Chief District Health Officer/Chief District Medical Officer or an equivalent functionary in the district is responsible for all medical and public health activities, including TB control. The District TB Officer at the District TB Centre manages the RNTCP and coordinates with other Programs and departments. The District TB Officer is assisted by a Medical Officer and supervisors of TB/HIV coordination, public-private mix (PPM), and advocacy, communication and social mobilization (ACSM), as well as other staff. 10 (d) At Sub-district level: The TB Unit manages day-to-day RNTCP services. Planned alignment of TB Units with the block-level administrative structures of the NHM (Block Program Management Units) will mean that the responsibilities of the Block Medical Officer will include the RNTCP (along with other health Programs and services), with a Medical Officer (TB Control) or Program Officer focusing on TB services and a Senior Treatment Supervisor, and a Senior TB Laboratory Supervisor providing support. There are currently 2,700 TB Units, for average coverage of one TB Unit per 500,000 population. As there are about 5,900 sub-district administrative units in the country, alignment with NHM’s sub-district structures will mean more than a doubling of the number of TB Units to increase coverage to one TB Unit per 200,000 population—100,000 in tribal, desert, remote and hilly regions. The subsequent increase in Senior Treatment Supervisors will provide additional supervisory and management capacity, notably to handle MDR-TB services and expanded public-private engagement. 23. The Program Key Results, DLIs, and intermediate indicators will be regularly measured and reported. CTD will have overall responsibility for coordinating, monitoring, and reporting on the Program’s progress according to agreed results indicators. The CTD has over twenty years of experience with implementing World Bank supported Programs, including successful implementation of a TB project which had DLIs. The CTD will report on DLI achievement and provide evidence to the World Bank in line with the agreed verification protocol. In addition, the CTD working with the WHO as the IVA will commission surveys (telephone and in person) and assessments of relevant DLIs, PDO indicators and intermediate results indicators. 11 E. Description of Program Activities and Identification of Environmental and Social Effects 24. This sub-section describes the activities to be implemented under each of the Results Areas followed by a discussion of the potential environmental and social effects that could arise from each activity. The sections below summarize the environment and social risks of the whole PTETB program, followed by the environmental and social effects grouped under each Results Area. Results Area 3 accounts for a preponderance of environmental effects, followed by Results Area 1. Results area 2 and 4 have minimal environmental effects, and do not raise any notable concerns. Overall, the proposed Program is expected to a moderate level of environmental and social risks. 25. Environmental and Social Screening As required by the Bank PforR Policy, and Directive, the Bank team carried out screening exercise for the PforR to identify and exclude potential investment areas or activities that may have high risk environmental and social issues, as well as opportunities, or warrant further analysis through the ESSA. The purpose of the screening was to: (i) identify program activities likely to have significant adverse impacts on the environment and/or affected people (those activities are not eligible for the PforR and should not be included under the Program); and (ii) determine the priority areas for further attention during the environmental and social system assessment. The completed screening checklist is provided in Annex 4. 26. Environmental Benefits: PTETB Activities are likely to introduce positive environmental, health, and safety provisions for healthcare and lab workers in high-risk settings (DR-TB Centres, ART Facilities and Tb Containment Labs) by (i) reducing the risk of contracting TB and preventing other potential infections and diseases, (ii) providing training and awareness to healthcare works and staff on the use of PPE, (iii) introducing regimented health check-up and screenings for all workers. At the same time, the Program will strengthen environmental systems for better management and monitoring for medical waste, infection control, and accident management at facility level. Under Results Area 3, the PTETB will also have a dedicated focus on implementation of airborne infection control (AIC) measures as an integral component of Environment Health and Safety. 27. Environmental Opportunities: Based on the assessments of environmental benefits, possible opportunities to improve environmental performance include: (i) upgrading existing RNTCP technical and operational guidelines to avoid, mitigate, and manage environmental health and safety risks; (ii) enhancing safety provisions and cleanliness in healthcare facilities and labs, which is important not only for better management of environmental aspects, but also for direct impact on health outcomes; (iii) introducing changes in health and safety conditions of informal and formal workers linked to the handling and transportation of infectious substances; and (iv) generating training and capacity building activities for HCFs to maintain appropriate logs of all categories of wastes, immunization of workers involved in;, and accidents/spills; and (v) Introducing better coordination with the State pollution control boards, and public works department for implementation of civil works that will support the outcomes of the Program (i.e. ventilation systems) This will ultimately strengthen linkages with reporting under the BMWM Rules, 2018, as mandated by the CPCB/SPCB. 28. Environmental Risks: These are likely to be associated with the following: (i) infection control associated with TB services, including safe handling of clinical and infectious waste, sputum, sharps (slides) generated from diagnosis and treatment services; (ii) adequate disposal of all waste streams including bio- medical waste, solid wastes, e-waste, plastics, pharmaceuticals, hazardous waste (x-ray developer) and liquid waste streams (chemical reagents, wastewater effluents) so that there is no contamination of surrounding environments and impacts on nearby communities; (iv) ensuring all lab safety equipment (Bio safety cabinets, 12 fire detection systems, air handling units and centrifuges to be kept in good working condition; and (v) public and worker exposure to infectious diseases. 29. These risks are well defined, site-specific and easily managed within the current system and technical guidance available. However, inadequate attention and poor management, can pose greater risks to worker and public health and safety. There are no high impact activities associated with the PforR boundaries such as construction of large buildings, central bio-medical waste treatment facilities, and effluent treatment plants (these activities are not eligible for inclusion under the Program). 30. Adverse impacts associated with limited physical works/renovations supported under the PforR include dust, noise, and solid waste generation, but these are expected to be minor in nature. These would include renovation works for laboratory upgrading, and implementation of AIC measures, all works will be carried out within existing facilities, and there will be no expansion of facilities. There is also a minimal risk of construction safety concerns. There are no anticipated adverse impacts to natural habitats, physical cultural property, or natural resources. Overall, there is a moderate risk that undertaking the activities described above, would result in impacts to surrounding environments (water, soil and air quality) and on worker and public health and safety. Table 3 Institutional Responsibilities for Environmental Risks Risks Institutional responsibility Documents 1 Generation of Bio medical HCFs are responsible for management of all Bio-medical Waste waste management the EHS issues related to the medical waste Management Rules (applicable to all facilities management within the HCF. This includes where biomedical waste RNTCP Environmental segregation, bar coding, storage of BMW, is generated) Assessment and Bio immunization of workers, trainings, Medical Waste treatment of liquid wastes and monitoring Management Plan reporting. Collection and Disposal of BMWM is conducted by the Private sector that operates Central Bio-medical waste treatment facilities. State health departments provide support in the form of training, waste management auditing, preparation of hospital-specific BMWM plans, procurement of materials and supplies, and construction of on-site disposal facilities. Funds for BMWM are provided by NHM, but provisions for State TB officers for consumables are included in annual planning. State Pollution Control Boards are designated to organize training programmes to staff of healthcare facilities and municipal workers on bio-medical waste. 2 Incremental increases in Manufacturers, producers, consumers, bulk Environment (Protection) generation of E-Waste consumers, collection centres, dealers, e- Act, 1986 Protection Act retailers, dismantlers and recyclers involved in 13 Risks Institutional responsibility Documents (applicable to all facilities manufacture, sale, transfer, purchase, E-waste (Management) where e-Waste is collection, storage and processing of e-waste Rules, 2018 generated) or electrical and electronic equipment listed in Schedule I, including their components, consumables, parts and spares which make the product operational. Responsibilities of GoI for environmentally sound management of E-waste include: (i) ensuring allocation of space for e-waste dismantling and recycling, (ii) ensuring recognition and registration of workers involved in dismantling and recycling; and (iii) undertaking annual monitoring to ensure safety and health of workers involved in dismantling and recycling CPCB Grants Authorization and Renewal of Extended Producer Responsibility - and monitoring of its compliance to manufacturers, bulk consumers, collection centres, dealers, e-retailers, dismantlers and recyclers. Incremental increase in All institutional generators of plastic waste, Plastic Waste generation of Plastic shall segregate and store the waste generated Management Rules 2016 waste by them in accordance with the Solid Waste Management Rules, and handover segregated (applicable to storage, wastes to authorized waste processing or transport, handling, disposal facilities or deposition centers, either recycling / reuse disposal on its own or through the authorized waste of plastic wastes) collection agency. Key plastic wastes generated include sputum cups and Cartridges. 3 Infection control and MoHFW is responsible for supervising and IMEP comprises of a worker safety controlling the infectious diseases within the Policy Framework HCFs in accordance with the Indian Public document which gives a Health and Health Standards and the Infection broad overview and environmental risks arise management and Environmental Plan Policy contains generic guidance out of poor infection Framework. It is monitored as part of the to central and state level control practices and NHM. institutions on the type of unsound systems and processes to environment HCF level BMW and IC committees are also be established for management systems responsible for establishing and operating the infection control and bio- such as: (i) inappropriate system of occupational health and safety medical waste disinfection, (ii) poor protection, including training, monitoring and management and a set of sterilization provision of protective gear. operational 14 Risks Institutional responsibility Documents techniques, (iii) guidelines/manuals for inadequate use of healthcare protective gears, (iv) poor workers at primary level bio-medical waste healthcare level. handling, treatment and disposal Healthcare Worker practices, (v) unhygienic Surveillance for and unsanitary conditions Tuberculosis in India- and inadequate Handbook (Screening and potable water within the diagnosis of workers) healthcare facilities. Hospital Waste Management Guidelines. (BMWM good practices, training requirements, management and administration requirements and co- ordination between hospital and other agencies) 4 Bio-safety CTD ensures that all IRL and C&DST WHO Guidelines for Bio- laboratories implement appropriate biosafety safety norms according to BSL 3 standards. RNTCP Technical NRLs conduct an external equality assurance Guidelines for process of all labs every two years for re- Infrastructure, Equipment accreditation. NRL also provides training to all and Consumables for TB STDC and IRL staff on lab safety and biosafety containment Lab 5 Airborne Infection The RNTCP integrates AIC and general health National Airborne Control (AIC) system guidelines prepared by the National Infection Control Airborne Infection Control Committee, Guideline’s, 2010 Applicable to all high-risk MoHFW, GoI and Central TB Division (CTD). settings DR-TB centres, ART centres, and C&DST National and State AIC committees promotes Laboratories the incorporation of infection control considerations into health facility design, construction, renovation, and use, and conducts surveillance and assessment at all levels of the health system. The AIC activities at the district level are coordinated and undertaken by the Sub- Committee on Biomedical Waste Management / Infection Control (SCBMW/IC) under the District Health Society (DHS). They should function under guidance and close coordination with the SAICC, State Health Society and with the TB Sub-Committee under DHS (NRHM). 15 Risks Institutional responsibility Documents 6 Civil works Civil works pertaining to new healthcare National Building codes facility is carried out by Public works National Policy department. Relevant State PWD specifications The National Policy on Safety, Health and Environment at workplace Institutional and Capacity Risk: Within the RNTCP environment, health and safety aspects such as BMWM, IC, and AIC are being managed at different levels and by different technical specialists and committees. There is no standardized state level approach to plan and roll out activities pertaining to EHS. Further, necessary budgets for PPE, consumables and disinfectants, are provided under the general health system and not separately for RNTCP. The treatment of TB requires higher adherence and vigilance in the use of PPE. There is a shortage of dedicated biomedical engineers to support lab safety, and there needs to be a stronger connect with the NHM to utilize support in terms of manpower, technical capacity, and budget for their maintenance. There is scope for strengthening the existing technical and operational guidelines to include EHS aspects and ensure full coverage of activities under the NSP, through careful program planning, capacity building and monitoring. There is a risk that given the high Program targets in the NSP, CTD may inadvertently overlook the environmental aspects, which would decrease the overall effectiveness of the interventions. Lack of appropriate monitoring and supervision may lead to improper management of waste and lack of attention to worker safety and site maintenance. While CTD has prepared and implemented training programs for the staff on environment or social related aspects under previously supported Bank projects, there are potential risks that can emerge due to improper planning, execution and management of various activities. While the proposed operations would not lead to significant risks, the specific actions which need to be addressed to prevent any risks include arrangements for safe disposal of all waste as part of various operations, and occupational and public safety risks for workers and the communities. It is recommended that the modification and updating of the existing guidance documents to ensure that full coverage of EHS aspects is undertaken in Program implementation and operations. The activities supporting the results areas broken out by relevant environmental sphere or issue area, are described in detail below: Table 4 Key Environment Risks and Gaps and Potential Measures to Align with ESSA Core Principles Sl. Cross-Cutting Areas of Key Risk and Gaps Potential Measures to align with ESSA Core No. Risks/ Impacts Principles 1 Incremental increase in Incremental increase in BMW Risk- Moderate the generation of Bio generated such as (i) sharp waste Currently the BMWM Rules, 2016 and Medical Waste (slides); (ii) chemical waste (e.g., amended 2018 confirm with the same Management reagents, solvents, etc.); (iii) requirements of WBG EHS guidelines. Waste infectious waste (sputum etc.); (iii) is being segregated at facility level, Colour general waste (plastics, cartridges, coded bins and bags are being utilized. packaging) and (v) e- waste (e.g., Collection, transport and final disposal is 16 Sl. Cross-Cutting Areas of Key Risk and Gaps Potential Measures to align with ESSA Core No. Risks/ Impacts Principles batteries, older medical managed through private operators who also equipment, There are health risks manage CBMWTFs. Pollution monitoring (air from exposure to poorly managed emissions, treated effluents) from CBMWTF medical waste and through contact are monitored by the CPCB. All States under with infected sharps, skin the PTETB Program have access to CBMWTF. infections through poor disposal Overall, while the infrastructure and practices. equipment for safe biomedical waste Risks arise in decentralized disposal is available, there is a need to facilities, wastes are not collected strengthen BMWM systems, including an on time (they can become breeding overall waste management plan (include e- grounds for vector- borne wastes, chemicals, pharmaceuticals) infections) and lack of adequate including trainings and reporting. investment in continuous/rigorous training to staff on safe handling There is a need for dedicated capacity to help and management of biomedical states plan and implement activities relating waste. to BMWM. 2 Small civil works/ Given that works will take place Risk- Minimal renovations work within existing facilities, the visitors Such impacts are site-specific and can be required for (CBNAAT and patients, particularly the effectively mitigated by measures such as Lab, x-ray facilities, TB inpatients, may be exposed to screens, water spray, dust-net, use of low- containment labs, and noise and dust. Solid wastes noise equipment, following The National for AIC controls generated would have to be Building Codes will effectively alleviate any collected and disposed of risks and aligns with Core Principle 1 and 2. appropriately in municipal landfill. Capacity should be built for health specialists to understand engineering interventions Current construction management important for health outcomes (for example practices are carried out as per the ventilation systems). National Building Codes which contain the general building requirements, fire safety requirements, structural design and construction (including safety), and sustainability. These are adequate in addressing infrastructure integrity, health and safety aspects. and management of negative environmental impacts related to construction activities. No prior permission is required from Pollution Control Board, and no EA/ EIA is required by the country system due to small nature of civil works. 3 Disposal of Hazardous Due to expansion in diagnostics, in Risk – Minimal. The incremental increase in x Wastes particular x ray facilities, there will ray waste will be negligible. For x ray be an Incremental increase in x-ray equipment, the licensing, safe use, and waste such as fixer and rinse proper decommissioning are regulated to solutions, films and discarded lead avoid potential impacts. Wastes from x-ray 17 Sl. Cross-Cutting Areas of Key Risk and Gaps Potential Measures to align with ESSA Core No. Risks/ Impacts Principles aprons. This waste should not be film processing are regulated by the CPCB burned, incinerated, or landfilled. under the Hazardous Waste Rules. Instead, they must be given or sold Implementation is adequate. to the authorized recyclers of the Pollution control boards for metal recovery 4 Disposal of Liquid With expansion in diagnostics and Risk- Moderate Wastes (Chemicals and lab capacity, there will be an As per the BMWM Rules 2016, and Technical wastewater) incremental increase in chemical Guidelines for Infrastructure in TB reagents (disinfectants, dyes, Containment Labs, the chemical liquid waste reagents) and wastewater being from HCFs/Labs must be collected through a disposed. The BMWM rules 2016 separate drainage system leading to the provide the guidelines for disposal Effluent Treatment Plant (ETP). HCFs with of all HCF related waste and are large standalone labs such as NRLs and IRLs adequate in addressing all install ETP for separate collection and risks/impacts that may arise. If disinfection of infectious waste from the wastewater is not adequately laboratory. The combined discharge shall disposed of as per the rules, it may conform to the discharge norms given in pollute water sources with Schedule II. microbiological pathogens and hazardous chemicals. For middle and small healthcare facilities and labs such as DMCs/ rural locations having no There are no records to document system of separate ETP, the liquid waste is whether treated effluent quality needed to be onsite chemically disinfected from HCFs/Labs meets the with chlorine solution in a tank before mixing required standards BMWM Rules with other wastewater and ultimately 2016. Moreover, decentralized discharged in sanitary sewer system or septic labs (DMCs) do not always have tank/soak pit system. connections to sewer systems, and disinfected effluent/chemicals are Treated water should conform to the disposed into a soak pit. standards of liquid waste as listed in Schedule II of BMW Rules; 2016 Chemical disinfection is to be performed by Hypochlorite Solution or equivalent disinfectants. (following IMEP and WHO guidelines for Infection Control in Healthcare Facilities). Chemical disinfection performed must meet the standard of chemical disinfection as listed in Schedule II of BMW Rules, 2016. Any risk of untreated wastewater being disposed in water bodies is significantly averted if ETPs are installed. In smaller establishments, appropriate mechanisms of disinfection, pre-treatment and final disposal to septic tank and soak pit system should be adopted. As good practice, the effluent quality from HCFs/Labs having ETPs, needs to be 18 Sl. Cross-Cutting Areas of Key Risk and Gaps Potential Measures to align with ESSA Core No. Risks/ Impacts Principles monitored regularly to ensure that treated effluent meets the required standards BMWM Rules 2016 Schedule II. 5 Disposal of Expired TB drugs need to be Risk- Minimal Pharmaceutical Waste/ suitably disposed according to the According to BMW Management rules, HCFs expired drugs BMW handling Rules. Lack of are required to send expired medicines sent adequate implementation may back to the manufacturer or crushed and result in expired drugs being disposed of, to secure land fill or they should diverted to the market or be handed to CBMWTF to be disposed of inappropriately disposed in water through incineration. This adequately bodies/dumpsites. addresses any adverse impacts that may arise from inappropriate disposal of pharmaceutical waste, for HCFs with or without linkages with CBMWTFs. This aligns with Core Principle 1. 6 Accidents and Fire The risk of fire in TB containment Risk- Moderate Safety labs is a concern due to electrical Infrastructure guidelines for TB containment fire, the storage, handling, and labs require appropriate fire safety systems, presence of chemicals, and other and accident remediation (water supply for flammable substrates. All labs do emergency shower and eyewash). The risk not have fully functional fire arises when these systems are not detection systems/alarms. maintained appropriately and not in working Currently Reporting on condition. To align with ESSA core principles, Accidents/spills and other hazards it is proposed as a supplementary action that is mandated under the BMWM these systems are reviewed in the next Rules, 2016, but implementation External quality assurance (EQA) process of remains weak, particularly for the IRLs - where deficits exist these should be decentralized facilities. mitigated. 7 Worker Health and Healthcare and lab workers are Risk- Moderate Safety exposed to general infections, and The BMWM Rules also specify use of PPE, other potential infectious materials healthcare worker immunization, use of during TB care and treatment, as autoclave machines, and health and safety well as during collection, handling, trainings. Each facility is required to have a treatment, and disposal of waste. working infection control plan according to The Program will not result in the requirements under IMEP standards increased exposure to general These requirements are aligned with core infections or in handling of wastes. principle 3. There are other provisions where Given that the activities under the PforR will lack of adequate attention could enhance treatment of DR-TB- healthcare result in worker health and safety facilities and TB containment labs, capacity to being compromised, this is manage infection control and airborne particularly relevant to high risk infection control needs to be built in order to settings such as (TB containment increase the effectiveness of the Program labs, DR-TB and ART centres. These interventions. areas include: (a) regular health The Program will include a results indicator screening and checkup of workers, on Airborne infection control, so that (b) Unhygienic and unsanitary facilities can be audited, and remedial conditions at healthcare facilities measures can be implemented to conform to can increase the risk to workers to national guidelines. 19 Sl. Cross-Cutting Areas of Key Risk and Gaps Potential Measures to align with ESSA Core No. Risks/ Impacts Principles contract hospital acquired infections; (c) Inpatient treatment of DR-TB carries the risk of airborne infection and requires substantial investment in advocacy, communications (signage, campaigns) behavior change (cough etiquette, use of PPE), and implementation of AIC infrastructure (segregation, ventilation systems). Sl. Activity Cluster Key Risk and Gaps Potential Measures to align with ESSA Core No. Principles Result Area-1: Scaling-up Private Provider Engagement 2 Identify and support TB No adverse environmental impacts Risk- Moderate patients in the private - the activities will be beneficial to Private sector compliance with biomedical sector, provide the Program. However, private waste, lab safety and EHS criteria: As incentives to private sector services need to be partnership guidelines will be revised and providers, improve monitored to ensure they meet purchasing of services from private sector quality of treatment in national standards on will be increased, there is a risk that private private sector, environment health and safety. Labs (C &DST) will not meet essential criteria strengthen central and for EHS and BMW management. This will state institutional need to be strengthened under the capacity to engage Program. private providers and provider – patient Strengthening of sputum/TB sample engagement system collection, transportation and linkages with Strengthen diagnostic NGO partnership would require protecting services in public sector shipping personnel/ postal workers, – include TB sample laboratory staff, and the public from inadvertent exposure to infectious agents transportation, during transport and receipt of specimens. strategically purchase Though guidelines exist for packing of TB services from sputum sample, transport is not always private provider, done according to recommended protocols, Develop and roll-out and workers are not provided with adequate national tools and biosafety training, spill kits and awareness. guidelines for private This will need to be strengthened under the Program. sector engagement, improve enforcement of India TB standards of care, and scale up of RNTCP Call Centre from 50-Seater to 100 Seater. 20 Sl. Activity Cluster Key Risk and Gaps Potential Measures to align with ESSA Core No. Principles Result Area 2: Rolling out TB Patient Management and Support Interventions 1 Develop Nikshay There are no risks or impacts information system, associated with this activity support Nikshay cluster. Poshan Yojna, support to tribal patients, integration of Nikshay with PFMS, and financial Support through DBT Result Area 3: Strengthening Diagnostics and Treatment of Drug-Resistant TB 1 Expanding and All IRL and C &DST labs/ TB Risk- Moderate incentivizing drug- containment labs need to meet the Maintaining Biosafety in TB containment susceptibility testing requisite biosafety standards to be labs: and monitoring for fully operational. Gaps have been Assessments revealed that there are gaps in achievement of observed in infrastructure and C&DST labs conforming to the WHO universal DST (with a staffing capacity, which can impact standards for Biosafety. These gaps are focus on private sector service delivery and continuity. present in laboratory design and facilities, engagement) (age and servicing of critical equipment, and Protection of workers and ensuring health surveillance of workers. The Program their health and safety is essential proposes specialized units to ensure in preventing any lab acquired availability of biomedical engineers and infections. provisions for annual maintenance of equipment to ensure it is always in working condition. Occupational risks to acquire TB Inpatient treatment of DR-TB carries the risk of airborne infection and requires substantial investment in advocacy, communications (signage, campaigns) behavior change (cough etiquette, use of PPE), and implementation of AIC design and infrastructure (segregation, ventilation systems). Capacity to plan and implement at the HCF level would also require strengthening if DR-TB treatment is to be scaled up all levels – national, state, and local/health care facility levels. AIC capacity will be strengthened at District level for IC committee and IC officers in medical colleges. Annual maintenance of lab equipment such as biosafety cabinets, centrifuge and AHU needs is an issue, as well as needs standardization in servicing. Lab workers should be provided this equipment in good operational condition so that there are no adverse impacts on their health. This was also outlined in the NSP as a challenge for the diagnostics. Older equipment would also 21 Sl. Activity Cluster Key Risk and Gaps Potential Measures to align with ESSA Core No. Principles require decommissioning and appropriate disposal according to the e-waste handling rules. The Program will develop an SOP on servicing and AMC for all critical lab equipment and will standardize the practice throughout the country. Poor or nonexistent disaster/fire safety and emergency response arrangements. For DST services, it is critical that TB containment labs bought under the RNTCP, conform to the standards and have regulated access control, fire detection and safety mechanisms, and accident reporting mechanisms. These provisions are critical to ensuring safety within the premises due to the storage, handling, and presence of chemicals, pressurized gases, and other flammable substrates. The Program will support IRLs will all key safety infrastructure needed to meet EHS standards. 2 Improving AIC in high- Implementation of AIC plans Risk- Minimal risk settings by (administrative and environmental Covered in risks associated with minor civil increasing advocacy controls) will be overall beneficial works. and attention to this from an environment and health area standpoint. Any impacts associated Facility-by-facility with upgrading of ventilation infection control systems are covered in minor civil assessments and plans works mentioned above. 3 Strengthen notification No impacts/ Risks of all TB patients with known Rifampicin susceptibility status Result Area 4: Strengthening RNTCP Institutional Capacity and Information Systems 1 Develop human There are no direct environmental Risk- Moderate resources plan to impacts associated with this With the hiring of key laboratory staff and match the scope and activity cluster. biomedical engineers, any risks arising from ambition of NSP, better low staffing and technical capacity in the performance-based All staffing vacancies associated laboratory network will be adequately management contract with RNTCP network and the NSP addressed. The States and the Centre need a between CTD and will be filled through the Program. nodal officer on environmental monitoring states, implement HR A standalone DLI has been included to address all activities (BMWM, IC and AIC) Plan to improve CTD to incentivize this. that have been identified to have potentially and state capacity, significant impacts on the environment and conduct TB Forums at There is no dedicated capacity on worker health and safety. State and National environmental management in Levels, update CTD or the states. Hence, record supervision and keeping on trainings, occupational monitoring guidelines health and safety, accidents etc. is to include integration not always updated and well of routine assessment maintained. 22 Sl. Activity Cluster Key Risk and Gaps Potential Measures to align with ESSA Core No. Principles and improvement of data completeness and quality, building in the mechanism of deduplication (of patients and providers) and reconciliation of different provider types (a) Social Effects 31. The key risks and gaps to the activities supporting the result areas and potential measures to align with ESSA core principles, are presented in Table 4 below. Table 5. Key Social Risks and Gaps and Potential Measures to Align with ESSA Core Principles Sl. Activity Cluster Key Risk and Gaps Potential Measures to align No. with ESSA Core Principles Result Area-1: Scaling-up Private Provider Engagement 1 Identify and support TB patients Low likelihood of any negative Given that approximately 80 in the private sector, provide social effects. This in fact percent of TB patient makes incentives to private providers, provides further opportunity first contact at a private improve quality of treatment in for better social outcome. provider, scaling up private sector, strengthen However, the key area that engagement with the private central and state institutional requires strengthening is the sector provides an capacity to engage private IEC/ SBCC to inform patients in opportunity to not only have providers and provider – patient the private sector on linkages better adherence to engagement system and benefits provided to TB recommend a treatment patients by Government. regiment, but also build linkages to Nikshay Poshan Yojna for nutritional support - especially to the poor. A comprehensive IEC/ SBCC will further help in this and raise demand side awareness on TB, apart from helping in stigma reduction. 2 Strengthen diagnostic services The incentive for sample The Program action is in public sector – include TB transportation in tribal and informed by the RNTCP sample transportation, difficult to reach areas require operational guidelines to be strategically purchase TB streamlining and monitoring. updated including a services from private provider, Also, the call centre is mechanism for develop and roll-out national expected to act as a grievance strengthening data collection tools and guidelines for private registration system and hence and monitoring of Tribal sector engagement, improve requires a proper mechanism Population Transport enforcement of India TB for escalation of grievances. Reimbursement. 23 Sl. Activity Cluster Key Risk and Gaps Potential Measures to align No. with ESSA Core Principles standards of care, and scale up Additionally, developing a of RNTCP Call Centre from 50- Grievance Redress policy, Seater to 100 Seater. which should be like a Standard Operating Procedure with defined escalation matrix, etc. Result Area 2: Rolling out TB Patient Management and Support Interventions 3 Develop Nikshay information While the GoI claims that Already aligned with core system, support Nikshay Poshan more than 91.7 percent of the principle #5. The Program Yojna, support to tribal patients, population (as per Census further intends to address integration of Nikshay with 2011) have Aadhaar card, and this issue for seamless PFMS, and financial Support over 99 percent of the adult transfer of incentives through DBT population above the age of through DBT mechanism. 18 years have been assigned Aadhaar number, support to tribal patients using DBT is still being considered a difficult area by CTD and being prioritized under the Program. Result Area 3: Strengthening Diagnostics and Treatment of Drug-Resistant TB 4 Expanding and incentivizing Strengthening diagnostic Already aligned with core drug-susceptibility testing and services and linkage with principle #5. However, monitoring for achievement of treatment provides screening will be conducted universal DST (with a focus on opportunity for better social to rule out any adverse private sector engagement), outcome given in many areas - social impact where any improving airborne infection especially the tribal and renovations and/ or control in high-risk settings by difficult to reach areas, expansion is planned under increasing advocacy and travelling for diagnostic the program in the health attention to this area, facility- services not only poses facility/ laboratory or by-facility infection control financial burden but also associated infrastructure. A assessments and plans, cause in delay in initiating screening checklist is strengthen notification of all TB treatment. presented in Annex-6. patients with known Rifampicin The strengthening of susceptibility status. diagnostic services and treatment of DR-TB does not require any major construction and is limited to minor renovation and repairs within the existing footprint of the health facilities and laboratories. Result Area 4: Strengthening RNTCP Institutional Capacity and Information Systems 7 Develop human resources plan The key risks emerge from the The Program plan to to match the scope and gaps in human resources to at reorganize the CTD and STCs ambition of NSP, better CTD as well as at State TB cell into four sectoral divisions performance-based to plan and implement with dedicated staffs 24 Sl. Activity Cluster Key Risk and Gaps Potential Measures to align No. with ESSA Core Principles management contract between partnerships, ACSM and including for partnerships, CTD and states, implement HR psycho social support (PSS) ACSM and psycho social Plan to improve CTD and state activities in a coherent support (PSS) activities, and capacity, conduct TB Forums at manner, adequate capacity of plans to build capacity of State and National Levels, the existing human resources staff at all levels for different update supervision and at district and sub-district level Program components monitoring guidelines to include on ACSM, SBCC activities, and including procurement. In integration of routine proper procurement capacity addition, the Technical assessment and improvement to source in services from Support Unit (TSU) is of data completeness and NGOs and other partners. planned to be placed at CTD quality, building in the and STCs for further support. mechanism of deduplication (of patients and providers) and reconciliation of different provider types. 25 III. ASSESSMENT OF ENVIRONMENTAL AND SOCIAL MANAGEMENT SYSTEMS AND IMPLEMENTATION CAPACITY A. Introduction 32. This section provides a summary assessment of whether the Program’s environmental and social management systems are adequate for and consistent with the core principles and key planning elements contained in the PforR Policy. It also assesses whether the involved institutions have the requisite capacity to implement these systems’ requirements. An in-depth description and analysis of the Program’s systems and implementation capacity are found in Annex 2. 33. As noted earlier, the PforR Policy requires the proposed Program to operate within an adequate environmental and social management system that can manage environmental and social effects (particularly adverse impacts and risks) identified during the ESSA process. This includes (a) an adequate legal and regulatory framework and institutional setting to guide environmental and social impact assessment and the management of environmental and social effects; and (b) adequate institutional capacity to effectively implement the requirements of the system. 34. This section assesses whether the Program’s environmental and social management systems are consistent with the core principles and key planning elements contained in the PforR Policy and whether the involved institutions have the requisite capacity to implement these systems’ requirements. Both elements (e.g. Program systems and capacity) are necessary in order to ensure that the environmental and social effects identified in Section II are effectively managed. Through both analyses, the ESSA team has identified gaps in both areas, which are addressed in the Inputs to the Program Action Plan and Supplemental actions. 35. A Program system constituted by the rules and “arrangements within a Program for managing environmental and social effects,�1 including “institutional, organizational, and procedural considerations that are relevant to environmental and social management�2. Additionally, it includes those that provide “authority� to those institutions involved in the Program “to achieve to achieve environmental and social objectives against the range of environmental and social impacts that may be associated with the Program.�3 This includes existing laws, policies, rules, regulations, procedures, and implementing guidelines, etc., that are applicable to the Program or the management of its environmental and social effects. It also includes inter-agency coordination arrangements if there are shared implementation responsibilities in practice.4 36. Program capacity is the “organizational capacity� the institutions are authorized to undertake environmental and social management actions to achieve effectively “environmental and social objectives against the range of environmental and social impacts that may be associated with the Program.�5 This ESSA has examined the adequacy of such capacity by considering, among other things, the following factors: (a) adequacy of human resources (including in terms of training and experience), budget, and other implementation resources allocated to the institutions; 1 Drawn from Program-for-Results Financing: Interim Guidance Notes on Staff Assessments, “Chapter Four: Environmental and Social Systems Assessment Interim Guidance Note,� Page 77, paragraph 1. 2 Ibid, page 82, paragraph 12. 3Ibid., Page 77, paragraph 2, and page 82 paragraph 12. 4Based “Chapter Four: Environmental and Social Systems Assessment Interim Guidance Note,�Program-for-Results Financing: Interim Guidance Notes on Staff Assessments. 5Ibid., Page 77, paragraph 2, and page 82 paragraph 12. 26 (b) adequacy of institutional organization and the division of labor among institutions; (c) effectiveness of interagency coordination arrangements where multiple agencies or jurisdictions are involved; and (d) the degree to which the institutions can demonstrate prior experience in effectively managing environmental and social effects in the context in projects or Programs of similar type and magnitude. 37. This ESSA examines and discusses only those aspects of the proposed Program’s environmental and social management systems and related capacity that the ESSA Team found to be relevant considering its identified environmental and social effects. This section provides a summary assessment of the Program’s systems and capacity as they relate to each of the core principles and key planning elements. The text and tables below clarify the instances in which one or more of the Core Principles or Key Planning Elements are not relevant to the Program and are thus inapplicable. More in depth discussion and analysis of the Program’s systems and capacity are found in Annex 2 and 3. 38. Overall, the applicable environmental management systems are generally adequate to address underlying environmental and social risks; noteworthy strengths are strong regulations and guidelines on biomedical waste management, general waste management, and infection control. The provisions of the existing environmental legal and regulatory framework are adequate but require enabling institutional and technical capacity for compliance. While the provisions of the Biomedical Waste Management & Handling) Rules, (as amended on March 2018), Infection Management and Environment Policy Framework (IMPS) are being implemented, provisions of other relevant environmental acts such as, hazardous, solid, plastic and e- waste Rules applicable to RNTCP require additional capacity building efforts. 39. There are National and RNTCP Program guidelines for addressing the following risks: patient and worker safety, biosafety, air borne infection control, packaging and transport of infectious sputum samples, and surveillance and screening of TB workers. There is scope for strengthening the existing technical and operational guidelines to include EHS aspects and ensuring full coverage of activities under the NSP, through careful program planning, capacity building and monitoring. 40. Although there are comprehensive national guidelines covering institutional, administrative and infrastructure needs for airborne infection control (AIC), implementation has been limited to a few pilot centers, and each health facility is responsible for how they implement the provisions in guidelines, with different capacity resulting in varied practice. AIC is critical to ensuring worker safety in high risk settings. The program results framework includes an audit of healthcare facilities in the select states, to support implementation of AIC measures in high risk settings. 41. The ESSA did uncover gaps in some areas, as summarized below, which will need to be addressed through the Program Action Plan (PAP) and supplemental actions. B. Core Principle 1 - Environmental and Social Management 42. Core Principle 1: Assessment of the degree to which the Program Systems promote environmental sustainability in the Program design; avoid, minimize or mitigate against adverse impacts; and promote informed decision-making relating to a Program’s environmental effects. This is determined as relevant and applicable. India has an adequate legal framework for environmental, health and safety, and waste management (including hospital, general, plastics and liquid wastes) backed by 27 a set of comprehensive laws, regulations, technical guidelines and standards, which apply nationwide. Over the decades, it has gradually evolved into a comprehensive system that is generally consistent with the PforR. Certain interventions under the Program would require mitigation actions and sustainable approaches to better manage Program’s environmental effects. These include, among others (i) strengthening environment health and safety monitoring capacity in CTD and States on BMW, IC, and AIC ,(ii) supporting accreditation criteria for C&DST labs to include enhanced EHS and biosafety criteria, (iii) updating BMW trainings to include management of all wastes including e-waste and hazardous wastes, to all staff engaged under RNTCP, (iv) ensuring emergency response mechanisms such as fire detection, and accident reporting and response mechanisms are functional at all HCFs and Labs, (v) strengthening AIC and IC capacity at facility level through the public health system, and (vi) develop guidance for State and District TB officers to understand and implement EHS aspects as part of national guidelines/ regulations. Adverse impacts associated limited physical works/renovations supported under the PforR include dust, noise, and solid waste generation, but these are expected to be minor in nature and limited to the healthcare facility. A screening checklist is attached in Annex 6 to screen all EHS, BMWM and IC measures at the HCF level, and also for any adverse impacts that may arise through renovation works, so that the requisite mitigation can be implemented. The screening will be conducted by the healthcare facility in charge, with guidance from DTO. C. Core Principle 2 – Natural Habitats and Physical Cultural Resources 43. Core Principle 2: Assessment of the degree to which the Program systems avoid, minimize, and mitigate against adverse impacts on natural habitats and physical cultural resources resulting from the Program This is determined as not applicable. The analysis confirmed that Program investments would neither impact nor convert critical natural habitats or impacts physical and cultural resources. This Core Principle will not be applicable to the Program and the PforR, as there will be no new construction or expansion of facilities and all renovation works will be undertaken in existing facilities within Program States. D. Core Principle 3 – Public and Worker Safety 44. Core Principle 3: Assessment of the degree to which the Program Systems protect public and worker safety against the potential risks associated with (a) construction and / or operation of facilities or other operational practices developed or promoted under the Program; (b) exposure to toxic chemicals, hazardous wastes, and otherwise dangerous materials; and (c) reconstruction or rehabilitation of infrastructure located in areas prone to natural hazards. This is determined as highly applicable. The government systems have management and supervision systems for work safety and ensures the screening of safety issues and occupation hazards, construction work safety. Overall, the legal framework of environmental management in India, and RNTCP guidelines in this regard is consistent with the Bank PforR Policy and Directive, but requires capacity strengthening to implement. 28 This is determined as applicable. TB diagnosis and treatment exposes healthcare and lab workers to risks associated with exposure to TB, hazardous materials, infections, as well biosafety, and would require mitigations These include, among others: (i) Improving occupational health and safety practices at healthcare facilities through infrastructure design, AIC, infection control, protocols for addressing accidental spills; (ii) Providing protective clothing and personal safety equipment, as required; (iii) Ensuring safe storage, segregation, transport and disposal of biomedical and hazardous wastes; (iv) good practices with regards to cleanliness, hygiene and general waste management; (v) worker and public health and safety focusing on emergency response and fire safety; (vi) maintenance of critical lab safety equipment (vii) training for workers in sputum collection transport on biosafety and use of spill kits; and (viii) having qualified biomedical engineers and technical staff available to service, maintain and conduct safety testing on critical lab equipment in the IRLs. E. Core Principle 4 – Land Acquisition 45. The Program does not intend to do any land acquisition or resettlement, as it does not support any major construction and it is limited to minor renovation and repairs within the existing footprint of the health facilities and laboratories. Hence, this principle is not applicable. However, screening will be conducted to rule out any adverse social impact where any renovations and/ or expansion is planned under the program in the health facility/ laboratory or associated infrastructure. A screening checklist with this effect is presented as Annex-6 of the report. The screening for all civil works will be conducted by the healthcare facility in charge with guidance from DTO. The resettlement which is to be avoided includes involuntary displacement of people who are illegally occupying areas within the grounds of the health facilities. Both health facility in-charges as well as DTOs will be training by the social safeguard officer at the State TB Cell. F. Core Principle 5 – Indigenous Peoples and Vulnerable Groups 46. The focus State under the Program accounts for 49 percent of the total tribal population in India. The key social concern relevant to indigenous people and vulnerable group emerges from the access, knowledge and outreach, and addressing stigma and discrimination. Hence, the core principle is applicable. Access to TB Services in Tribal and Difficult to Reach Areas 47. According to Census 2011, the tribal population accounted for 8.6 percent of the country’s population with over 104 million people across 750 different tribes living in different parts of India. The nine focus states i.e. Assam, Bihar, Karnataka, Maharashtra, Madhya Pradesh, Rajasthan, Tamil Nadu, West Bengal and Uttar Pradesh, account for 51.5 million (49 percent of tribal population) of the 104 million tribal population in India and includes good number of districts under Schedule -V and Schedule -VI areas as per constitution. Of the 177 high priority tribal districts and 672 high priority tribal sub-district having more than 10,000 tribal population and more than 50% population belonging to tribal community in the country, the nine focus states have 50 high priority tribal districts and 115 high priority tribal sub-districts6. While the lack of access to health services, poor health literacy and high level of malnourishment in the remote tribal7 and hilly areas has been a known factor influencing health seeking behavior, the NSP 2017-25 further informs that some of the states with tribal and hilly terrains in India have been reporting a high incidence of not only drug sensitive but also drug resistant TB cases. Hence it becomes even more important to strengthen the TB 6https://tribal.nic.in/writereaddata/AnnualReport/AR2017-18.pdf 7http://nhm.gov.in/nhm_components/tribal_report/Executive_Summary.pdf 29 control activities in these difficult areas. The Tribal Action Plan followed by RNTCP in the earlier World Bank project identified poor physical access of tribal population to diagnosis and treatment under the RNTCP due to difficult terrain and sparsely distributed tribal population in forest and hilly regions. The key actions identified in the tribal action plan of the earlier project included the following: (a) Promote closer supervision of tribal areas by RNTCP staff, (b) Encourage tribal populations to report early in the course of illness for diagnosis and among other activities provide travel reimbursements of Rs. 750 to patient and one attendant for travel for follow-up and treatment, and (c) Enhance treatment outcomes amongst tribal populations by enhance culturally appropriate outreach and ACSM activities along with IEC in local language. While the action identified under the tribal action plan is still valid, it required updating to the current context and CTD to closely monitor the RNTCP activities in tribal areas including streamlining the incentives and support mechanisms through DBT to tribal patients such as tribal patients transport reimbursement. Discussion with members of tribal communities, local NGOs, and healthcare facility staff during field visit to tribal areas of Pune district in Maharashtra and Udaipur district in Rajasthan, further elaborates on these issues and stresses upon strengthening service provision and outreach using ACSM activities to address the same. Also, RNTCP shall follow the list of tribal districts and sub districts as per the Ministry of Tribal Affairs list articulating them and also presented in the Annual Report 2017-18 describing the State/ UT and District wise list of ST Priority Sub-Districts. The RNTCP tribal action plan is to be updated with the changing context and with focus on filling gaps and strengthening measure for implementation. ACSM Activities Including Social and Behavior Change Communication (SBCC) 48. Since the inception of the RNTCP Program, ACSM is seen as a cross cutting, supportive strategy that focuses on all aspects of TB care for diagnosis and treatment interventions, strengthening social support systems for TB care and community interventions to reduce stigma. The NSP 2017-25 further focuses on ACSM for improvement in early identification of symptoms of TB and referrals from communities aiding in early case detection, support for treatment adherence, combating stigma and discrimination, people’s empowerment, and mobilizing political commitment and capacity building for decentralized planning. However, the JMM 2015 observed that ACSM activities were accorded low priorities with very small budget and have impacted the forging of partnerships with various stakeholders including private sector, NGOs, CBOs, community groups, and local self-governments etc., in improving provision of care for TB patients. The already overburdened staff at STC and DTC tend to do things that are budgeted and monitored, and whereas community engagement falls in either with very low on the priority list. This is further echoed in various evaluation documents including the Central level internal evaluation (CIE) reports of 2017. The need for a revised communication strategy is further enhanced given that the Program now plans to engage with a range of private sector stakeholders including communities that have been mainly resorting to the private sector for TB treatment. 49. Analysis of the budget provision under the RNTCP Partnership Guidelines for community level partnership suggests INR 250,000 per annum, for one million population on pro-rata basis for population covered. This includes staff salaries for NGOs, cost of activities and transportation, and mobility to undertake activities in the area of coverage. The NGO partner is expected to undertake a certain minimum number of activities every month as per the agreed plan within the assigned geographical area/population within the district. An analysis of Census 2011 data of districts suggests that about 195 (i.e. 30 percent of the districts) of the then 640 districts in the country, are below one million in population, and are mostly in tribal and remote districts with a spread out geographic landscape and difficult to commute areas as presented in Table 5 below. With low population base, the pro rate budget will also be lower, while to cover these districts by any means, will require more budgetary allocation including for transport etc. 30 Table 5. Population Ranges for Districts in India (As per Census 2011) Population Size Class No. of Districts % Districts Remarks (out of 640 as per Census 2011) < 0.2 million 51 8% Most of the districts from North East India 0.2 - 0.5 million 45 7% Large proportion of North-east districts, some from Uttarakhand and some tribal districts 0.5 - 1 million 99 15% Remaining North-east districts, large proportion from HP, J&K, Assam, and some from Jharkhand, Odisha, Chhattisgarh, and Madhya Pradesh < 1 million 195 30% Mostly Schedule-V and VI districts and other tribal and remote districts > 1 million 445 70% Total Districts 640 As per Census 2011 50. Providing inadequate budget for ACSM, not only results in exclusion of these areas for ACSM activities, but it also presents difficulties in districts that have a population of more than one million but are geographically spread-out and have forested and difficult to reach pockets. To address this, the National Partnership Guidelines must be updated with revised financial norms and mechanisms for strengthening ACSM activities for community engagement and social mobilization across all districts especially for the poorer, hilly and remote districts including the tribal districts. Discussion with CTD recommended moving away from the prescribed rigid financial guidance for ACSM, and instead providing a lump sum budget to the state so they can plan their ACS activities accordingly, including in tribal and difficult to reach areas. Issues Related to TB Associated Stigma Reduction and Addressing Discrimination 51. Stigma has an adverse impact on the health and health seeking behavior of people with TB. In India, stigma related to TB is rampant and many people refrain from telling anyone, even family members, that they have or suspect that they have TB. In some cases, persons with TB have lost their jobs after disclosing this at their work place. Some patients travel to distant clinics to avoid being seen taking treatment by their neighbors, or go to private clinics, which are perceived to offer more privacy, both of which increase the likelihood that treatment will be discontinued for financial reasons8. TB-related stigma is a well-recognized barrier to timely screening, diagnosis, care seeking, and adherence to treatment. Further, TB patients experience discrimination at work, in healthcare contexts, within families, and in communities; their families, people they associate with or those at higher risk of infection due to social determinants of health also 8See Tanu Anand et al., Perception of Stigma Towards TB Patients on DOTS and Patients Attending General OPD in Delhi, 61 INDIAN J. TUBERCULOSIS 35, 35 (2014); D. Somma et al., Gender and Socio-Cultural Determinants of TB-Related Stigma in Bangladesh, India, Malawi and Colombia, 12 INT’L J. TUBERCULOSIS & LUNG DISEASE 856, 858-60 (2008) (“India had the highest item-adjusted stigma index (1.17) . . . .�) 31 encounter discrimination. The NSP 2017-25 also acknowledges the intangible costs related to social stigma associated with their illness by the TB patients and their family and requires among other activities, a sustained campaign to combat stigma. The strategic intervention to address this has been through the ACSM activities along with Social and Behavior Change Communication (SBCC). 52. While the national level media campaign has helped and made a good impact on conveying the threat of TB to the public at large, at the local field level, it remains limited as observed by JMM 2015 and various CIE reports. Discussions at CTD level suggests that the current communication strategy is outdated and requires updating or preparing a coherent social and behavior change communication (SBCC) strategy and action plan and adopting the same for addressing the communication requirement of the Program. G. Core Principle 6 - Social Conflict 53. While there are some areas affected by social conflict, including the presence of left wing extremist (LWE) areas in the nine Program focus states, it is important to note that the Program interventions do not exacerbate any social conflicts as it is trying to improve upon the overall health of the residents and attempting to reach out to all vulnerable pockets for TB case finding and linking them to treatment. Exclusion of any groups in terms of caste, religion, and/ or geography by the program activities is not expected. 54. Considering the nature of the PforR activities, OP 7.50 International Waterways or OP 7.60 Disputed Territories are not applicable to the PforR. All risks/ effects analyzed, and mitigation suggested would be applicable to public and private sector facilities and workers. The revised monitoring system should also be expanded to all entities under the Bank funded PforR. H. Gender 55. While TB is seen as a men’s disease9, the number of women with TB globally as well as in India, is very high. Twenty-seven percent of the world’s 10.4 million new TB cases, and 29 percent of the 1.8 million annual deaths are from India. Women and girls make up nearly 1 million of the estimated 2.8 million TB cases in India each year; it is the fifth leading cause of death among women in the country, accounting for nearly 5 percent of fatalities in women aged 30–6910. Although more men are affected by TB, women experience the disease differently, and gender disparities play a significant role in how men and women access healthcare in the public and private sectors. Women also experience the impact of stigma disproportionately. The rapid assessment of gender and TB in India11 reveals the differential aspects of TB among women including that women may be diagnosed late or not diagnosed at all due to added risk of socio-cultural barriers. This includes women delay seeking care for TB ailments because of high burden of household work combined with the deprivation of health awareness, mobility, access to resources and decision-making powers. The rapid assessment found that a high level of stigma associated with TB diagnosis exists among both unmarried and married women. The unmarried women were anxious that they might not get married if they had TB and as a consequence, families hide TB diagnosis status, marrying off the women and later sending them to a 9 Globally more men are seen to be diagnosed with TB than women and the ratio is approximately 60:40 between men and women. More men die of TB globally, both as a proportion of total cases and in absolute numbers. This has given TB the image of being a ‘men’s disease’. The Global TB Report 2018 mentioned in 2017, 64% of cases were among men and boys, and 36% were among women and girls. 10 https://www.newsdeeply.com/womenandgirls/community/2017/03/24/time-address-devastating-impact-tb- indias-women 11 http://www.reachtbnetwork.org/wp-content/uploads/2018/09/REACH-CRG-Gender-Assessment-2018.pdf 32 relative’s home to begin treatment which may cause delay in treatment and/or non-adherence to the treatment regime. For already married women, the fear of being divorced or being sent back to their natal family is an obstacle to accepting TB diagnosis and treatment. The constant struggle and priority for women and their families is to get married and stay married rather than get diagnosed, start TB treatment and adhere to it until cured. These factors considerably influence TB case detection and adherence to treatment. In addition, malnutrition substantially increases the risk of TB among women with more than half of all women in the India being anemic and one in five underweight. To address this, a technical expert group is being constituted by CTD to develop and finalize the collaborative framework for TB and Women in India, including developing Programmatic interventions to address the socio-cultural barriers. 56. The key Program action required is the development and adoption of a framework for TB among women. This will include: ▪ Analysis of context specific, socio-cultural norms and overlapping health concerns that are likely to amplify the incidence of TB amongst women in participating states. ▪ Specific Programmatic interventions towards addressing socio-cultural barriers. ▪ Gender specific data for TB monitoring I. Citizen Engagement 57. The CTD aims to enhance Community Engagement for a people centered and community led TB Response under the RNTCP by creating TB Forums at State and District level for working collaboratively with and through communities to address issues affecting their well-being, including influencing systems and serving as catalysts for changing polices, Programs and practices to be more patient sensitive. The scope of community engagement is envisaged as follows: (a) Providing patient support services through community participation - including awareness creation and stigma reduction, screening for TB and TB-related morbidity, referring for diagnosis of TB and related diseases, providing treatment adherence support, linking social support to patients, and helping address equity and non-discrimination issues; and (b) Community Empowerment activities for sustainable community engagement – by informing, empowering and institutionalizing, and building accountability platform by creating mechanism of feedback on TB care services to the providers at all levels using community monitoring tools. The scope defined for community engagement is wider than the terms of reference developed for the TB forums at the State and District level, which lacks in community empowerment and accountability aspect. The key Program actions required are: to build an accountability mechanism by modifying and adding to their composition, roles and responsibilities, and terms of reference of the Central, State and District Forums; and create TB forums at the State and district level per the expanded scope with an improved accountability mechanism that is embedded as the Intermediate Result indicator under Intermediate Results Area #4 of the Program on Strengthening RNTCP Institutional Capacity and Information Systems. This will be measured by government approval of the revised Terms of Reference of State and District TB Forum with expanded scope with respect to accountability mechanism, and the number of states and districts conducting Annual TB Forum meetings and submitting minutes to STC (by districts) and CTD (by states). The Program also introduces an incentive mechanism through small disbursements every year for an incremental increase in the number of states and districts conducting Annual TB Forum meeting. J. Grievance Redress Mechanism 58. The RNTCP National Call centre "Nikshay Sampark� has a mechanism to receive inbound calls and make outbound calls. The calls include queries regarding services available under the Program, as well as grievances related to various aspects of Program implementation. All grievances registered by the Call Centre 33 Executives is escalated to the Centre In-charge and Team Lead for further processing. The team lead is identified as a nodal point at call centre. All grievances reported by the nodal person using a standardized format from the official email id of Nikshay Sampark i.e. nikshay.sampark@rntcp.org. All emails from the nodal point will be marked to the respective District TB Officer (DTO) and State TB Officer (STO) where the patient/caller is residing currently/registered. The prime responsibility of resolution of grievances is with the DTO. All grievances should be followed up for initiating action within seven days of reporting and should be resolved maximum within one month. Once the response has been received from STO/ DTO, the call centre then makes a call to the patient/ person and records whether the grievance has been resolved and whether the patient/ person is satisfied with the response. A separate cumulative line list of all grievances in excel format will be maintained and shared with CTD on a weekly basis along with an updated (final) resolution status. 59. To strengthen further, the RNTCP should have a proper Grievance Redress Policy. While the Program envisages increasing the capacity of the call centre from 50-100 seats, it would be beneficial to develop a well-defined policy similar to a Standard Operating Procedure with defined escalation matrix, etc. 34 IV. DISCLOSURE AND CONSULTATION A. Disclosure 60. This draft ESSA was disclosed in-country and on the World Bank’s external website, prior to formal appraisal of the relevant PforR, to serve as the basis for discussion and receipt of formal comments and finalized after incorporating them. A public multi-stakeholder workshop on this ESSA and the PforR was conducted in Delhi, on 26th November 2018. Following incorporation of the feedback received from the workshop and other sources, the ESSA was finalized and will be disclosed in-country and on the World Bank’s external website. B. Stakeholder Consultations 61. Consultations with relevant institutions, Program affected peoples, experts, and beneficiaries are essential in the proper planning and preparation of development projects and Programs, to ensure effective identification and assessment of environmental and social effects, and to recommend measures to improve environmental and social management capacity. Stakeholder consultations are an integral part of the ESSA process and will be carried out consistent with applicable World Bank principles. The Bank has and will continue to engage in other formal and informal consultations as needed prior to finalization of this ESSA and the PforR. The points of discussions were to collect information as an input for the followings activities: i. Assessment of relevant environmental and social management systems related to the PforR principles ii. Assessment of the capacity and performance related to the environmental and social management procedures and processes relevant to the Program, and past performance on previous Bank Funded operations iii. Development of an action plan to enhance environmental and social management capacity and performance of the PforR Program; and iv. Development of performance monitoring and implementation support to the Program. 62. Table 6 below outlines a summary of the formal and informal consultations that contributed directly to important parts of the ESSA and the major findings and recommendations received. Table 6. Formal and Informal Consultations Sl. Location Sites Visited Officials/ People Met No. 1 Hyderabad, Telangana Dr. Sumalatha (State ▪ STDC Epidemiologist), Dr. Sneha Shukla ▪ State Reference Lab (WHO Consultant), Mr. Srikant ▪ EQA Lab, (IRL, Microbiologist), Mr. Anil ▪ BPHRC (Private C&DST Lab Kumar (Technical Officer) under NGO PP Scheme) IRL Lab staffs 2. Lucknow, UP Dr. Santosh Gupta, State TB ▪ District TB Hospital officer ▪ Central Biomedical Waste Treatment Plant by M/s Watergate 35 Sl. Location Sites Visited Officials/ People Met No. 3. Udaipur, Rajasthan Dr. Dinesh Kothari (DTO), ▪ DMC lab, Dr. D. S. Rao (S.M.O), Dr. Sanjay ▪ CBNAAT lab in District TB Clinic Sinha (WHO- consultant), Mr B.K. (inside Maharana Bhupal Gupta(NGO – ALERT, and member Hospital campus) Haathipole, Child Welfare Committee); Mr. Udaipur Naresh Paneri and Mr. Tyag ▪ RNT- Medical college- DMC Lab Narayan (NGO – SWACH); Dr. ▪ DR-TB ward, BADI, Udaipur Manoj Arya (RNT medical college); ▪ RNTCP-laboratory, Geetanjali Laboratory technicians; Dr.S.K. Medical College & Hospital, Lohadiya, Head, Dept. of TB & Udaipur respiratory disease, Geetanjali Medical College & Hospital; All STS and STLS of the district 4. Udaipur, Rajasthan Free and prior informed ▪ Jhadol PHC in tribal area, consultation (FPIC) with tribal ▪ SWACH NGO training centre at community in Jhadol block, Jhadol block including discussion with MO, ANM and other outreach staffs of Jhadol PHC and tribal TB patients (men and women); discussion with NGO (SWACH) extension workers placed in each tribal village/ panchayat of the block working as TB extension worker (called Swach Mitra). 5. Pune, Maharashtra ▪ IRL lab, Dr. Padmaja Jogeshwar, STO ▪ DMC lab Dr. P.L. Mane, AD HS; ▪ TB ward Dr. Sanjay Darade DTO; Dr. ▪ Rural health centre Sandeep Bharaswadkar WHO consultant, Dr. Vaibhav Saha WHO consultant; Ms. Shilpa Balyam C&DST STDC (IRL- microbiologist); Dr. Balaji Lakade Medical Officer PHC; Dr. Udawant & Dr. Sayali ,TB ward and other lab staff. 6. Pune, Maharashtra MO, ANM, STS, STLS, other PHC ▪ Dimphe Khurd Tribal PHC, staffs including four ASHAs Awegaon associated with PHC and working in tribal villages; FPIC with tribal community and patients including men and women 7. Mumbai, Maharashtra Dr. Shalini Bhagat Dy Director ▪ Pt. MM Shatabdi Hospital, TISS; ▪ Govandi, CBNAAT lab, Ms. Shweta Bajaj Sr Program ▪ TB diagnostic centre (DR TB Manager, Saksham TISS; Dr. centre); Microbiology Lab, Sir JJ Narender G. Sutar DTO, CBNAAT hospital and BMWM; 36 Sl. Location Sites Visited Officials/ People Met No. ▪ 2nd October Health post- lab; Dr. Dhayagude BMW Bhoiwada, Parel; and Group of incharge; Dr. Shubhangi Mankar TB Hospital- SEWRI, CBNAAT SMO DRTB; and Biochemistry Lab Dr. Ameeta A. Joshi, MD (Microbiologoy) SJJ hospital; Dr. Ajay Dhawale, DTO; Dr. Lalitkumar D Anande, Medical Superitendent GTB hospital, Sewree, Mumbai and Dr. Amit Karad, WHO consultant C. Summary of Multi-Stakeholder Workshop The Bank-sponsored multi-stakeholder workshop in New Delhi held on 26 November 2018, was attended by CTD, State TB officers from Karnataka, Assam, Maharashtra, and civil society members from Uttar Pradesh. Major points raised by the participants are summarized below and provided in detail in Annex 7. The participants concurred with the ESSA findings, the issues raised, and subsequent mitigations. In addition, the participants offered the following suggestions to strengthen environment and social performance under the Program: (a) States should be required to have flexibility for planning and implementing the Tribal Strategy. The State incentive grants can be utilized for showcasing innovations in this area. (b) In order to operationalize TB forums at the State and district level, and support State TB cell, it would be useful to engage a professional agency or institution. (c) Creation of specialized units in NTI Bangalore that can cater to servicing and maintenance of key lab equipment (bio-safety cabinets, AHUs, and centrifuge). This would cater to the 64 IRLs in India. This would effectively transition this responsibility from FIND, the NGO that was providing technical support to RNTCP laboratory network, which was created under another externally supported project to RNTCP. (d) Hiring of State officers/experts to supervise, monitor and strengthen BMW, IC and AIC. (e) Hiring of State social experts to supervise and monitor the implementation of social safeguards activities, including citizen engagement, ACSM, gender, tribal health issues. (f) Mainstream AIC capacity and responsibilities to plan and implement with IC officers of medical colleges and district IC committees so that capacity and knowledge built remains institutionalized. (g) Creation of easy to understand guidance handbook for environment health and safety management for STOs and DTOs to include key aspects of BMWM, IC and AIC. (h) Develop abbreviated guidelines for planning and retrofitting DR-TB centers to conform with national guidelines on AIC, IC and BMWM. This includes guidance on consumables (PPE, chemicals, vendors, suppliers). (i) Bio-medical engineers at the district level posted under NHM can be engaged to provide support for RNTCP lab network (DMC and TU). 37 V. INPUTS TO THE PROGRAM ACTION PLAN A. Introduction 63. This section summarizes the measures that the ESSA Team recommends be taken during Program implementation to address important gaps identified above between the Program system and the PforR core principles and key elements. It will also address any capacity shortcomings. 64. The ESSA recommends the following actions for inclusion in the Program Action Plan: (a) hiring of environment and social experts at state level (providing full-fledged program planning and management with due considerations on environmental and social Aspects), and (b) strengthening of RNTCP Technical and Operational Guidance. At CTD level; institutional guidelines and the capacity to align the Programs towards better environmental and socially sustainable operations, need improvement. There is scope for improving the existing technical guidelines and documents through careful program planning, capacity building and monitoring. 65. During implementation, the World Bank will continue to consult with Program counterparts and provide support to help resolve implementation issues. The Bank will also monitor PAP implementation as part of Program Performance. The recommendations and proposed actions are described in detail below. B. Recommendations to be Included in the PAP. Table 7 below presents the actions that the ESSA Team recommends be included in the Program Action Plan (PAP). 38 Action Description Responsibility Recurrent Frequency Due Completion Date Measurement 1. Update RNTCP tribal CTD No Once March Approved Updated action plan to strengthen 31, RNTCP Tribal Action outreach in tribal and 2019 Plan hilly areas, ACSM and SBCC. 2. Develop SOP for CTD No Once Dec SOP published on CTD servicing and 2019 webpage and shared decommissioning key lab with IRLs safety equipment. 3. Central, State and CTD Yes Annual; Dec 31, Government approval District TB Forum Incremental 2019 to revised Terms of strengthened for increase in Reference of State improving the number of and District TB Forum accountability states and with expanded scope mechanism by: districts with respect to i. Building accountability conducting accountability mechanism by Annual TB mechanism. Set-up modifying/ adding to Forum procurement their composition, roles meeting. monitoring and responsibilities, and committee. terms of reference of the Central, State and Measured by number District Forums. of state and districts ii. State and district conducting Annual TB creating TB forums as per Forum meeting and the expanded scope with submitting minutes to improving accountability STC (by districts) and mechanism. CTD (by states) 4. CTD Strengthens Data CTD Yes Continuous Dec 31, Data Collection and Collection and 2019 Monitoring Plan for Monitoring of Tribal Tribal Populations Population Transport Reimbursement, and Annual TB Report strengthen DBT with data on DBT for mechanism for the Tribal Populations same. Annual CTD report to capture coverage and trends in DBT for tribal populations 39 5. Development and adoption CTD No Once Dec 31, Framework for TB of framework for TB among 2019 Among Women women. This will include: Adopted by CTD for i. Analysis of context Program specific, socio-cultural Management norms and overlapping Purposes health concerns that are likely to amplify the incidence of TB amongst women in participating states ii. Specific Programmatic interventions towards addressing socio-cultural barriers iii. Include gender specific data for TB monitor C. Recommendations to Environmental and Social Action Plan as part of PIP There are opportunities for improving and strengthening the way in which CTD manages environmental and social impacts and risks associated with its activities, particularly in relation to capacity building for waste management, accidents/ biosafety and infection control measures. Discussed below are actions required for appropriate management of identified environmental and social concerns. 66. It was also recommended to include an intermediate results indicator on airborne infection control. The CTD will conduct an annual audit of AIC measures in select states, accordingly, recommendations will be made to strengthen implementation, capacity and address gaps. The costs relating to the external annual audit will be included. Action Description Respons Timeframe Indicators ibility Strengthening environmental, health and safety management capacity 1. Hiring of Environment and Social Experts in CTD As per RNTCP E & S experts in place in all 9 Program selected states (as part of HR plan) staffing plan focus states and at CTD 2. Training and capacity building of medical CTD Preparation Detailed training calendar and lab workers on key environment health of Training prepared and safety issues. (key training areas are calendar by provided in Annex 5) August, 2019 3. The CTD formulates and adopts health and CTD August 2019 Health and Safety Advisory for safety advisory for staff/workers involved inconsul Sputum Transportation in the transport of sputum. tation Published and disseminated to All persons transporting specimens should with State TB Units for follow the new advisory issued under the NRLs implementation RNTCP and be provided with training on biosafety and spill kits in case of accidents. 4. Review and Strengthen EHS and biosafety CTD June 2019 Updated documents notified criteria in selection and evaluation of and under implementation private sector laboratory for C&DST under PP scheme 40 Action Description Respons Timeframe Indicators ibility CTD March 31, Approved Grievance 5. Grievance Redressal Policy. While the Program envisages increasing the capacity 2019 RedressPolicy of call centre from 50-100 seats, it would be beneficial to have well defined policy which should be like a Standard Operating Procedure with defined escalation matrix, etc. CTD Dec 31, 2019 Approved revised SBCC 6. Updating/ preparing a coherent social and strategy behavior change communication (SBCC) strategy and action plan and adopting the same 7. Strengthen coordination with PWD engineers on healthcare facility CTD and June 2020 Workshop held with CTD, infrastructure needs (ventilation systems, State TB States, Experts and PWD ETPs, BMW management) officers. representaitves. Workshop proceedings will be used to furthur strenghten planning in new healthcare facilities. 8. Creation of specialized unit in NTI Bangalore (with bio-medical engineers, CTD and Dec 2020 Specialist unit notified and microbiologists) that can cater to servicing NRL operational under RNTCP and maintenance of key lab equipment in IRLs Monitoring of Environmental and Social management 9. Supervising AIC measures in high risk State TB Annual Implementation of AIC settings communication tools and behavior officers measures according to trainings conducted. national guidelines. CTD and August 2019; Annual report of CIE and SIE 10. Updating Central Level Internal Evaluation State TB Annual submitted to CTD (CIE) and State Level Internal Evaluation (SIE) for specific areas such as outreach in Officer Monitoring tribal and hilly areas, ACSM, SBCC, State and districts TB Forum meeting, and gender responsiveness. 41 ANNEX 1: List of Document Reviewed National Guidelines Relevant to the Project 1. RNTCP Environment Assessment and Biomedical waste management report (2013) https://tbcindia.gov.in/WriteReadData/l892s/1185049634Environment%20Management%20Plan%2020 13%20Final.pdf 2. Government of India, National Health Mission: Infection Control and Environmental Plan http://nrhm.gov.in/about-nrhm/guidelines/nrhm-guidelines/infection-management-and-environment- plan-imep.html 3. The Indian Public Health Standards http://nrhm.gov.in/about-nrhm/guidelines/indian-public-health- standards.html 4. National Guidelines for Airborne Infection Control (2010) https://tbcindia.gov.in/showfile.php?lid=2858 Bio-Medical and other Waste Management 5. CPCB Biomedical Waste Management Rules (2016) and Amendments issued (2018) http://cpcb.nic.in/uploads/Projects/Bio-Medical-Waste/Amendment_BMWM_Rules2018.pdf 6. Technical guidelines issued by CPCB http://cpcb.nic.in/technical-guidelines-2/ i. Guidelines for Management of Healthcare Waste in Health Care Facilities as per Bio Medical Waste Management Rules (2016) ii. Guidelines for CBWTFs (2003). iii. Guidelines for BMW Incinerators (2003). Draft Guidelines for Bio-medical Waste Incinerator (2017) iv. Guidelines for Bar Code System for Effective Management of Bio-Medical Waste v. Standards for treatment and disposal of Bio medical waste by Incineration vi. Environmentally Sound Management of Mercury Waste Generated from Health Care Facilities. Revised National Tuberculosis Control Program 7. RNTCP partnership Guidelines (2014) 8. Standards for TB care in India 9. National Strategic Plan (2017-22) for Tuberculosis 10. Guideline for PMDT India (2017) 11. AIC Risk Assessment for 35 HCF (2015) 12. Technical and Operational Guidelines for Tuberculosis Control in India, 2016 13. TB India Report 2017 14. TB India Report 2018 15. Supervision and Monitoring Strategy in RNTCP, March 2012 16. Joint Monitoring Mission, 2012 17. Joint Monitoring Mission, 2015 RNTCP Laboratory Network 18. WHO Manual for Biosafety 19. RNTCP laboratory Network: Guidelines for Quality Assurance of smear microscopy for diagnosing tuberculosis https://tbcindia.gov.in/showfile.php?lid=2987 20. Guidance for accreditation of laboratories under RNTCP for Culture & DST https://tbcindia.gov.in/showfile.php?lid=2986 21. NTI Bangalore Laboratory Training Manual (2014) 22. WHO Guidance on regulations for the Transport of Infectious Substances 2017–2018 23. Final Report Joint Assessment of the Tuberculosis Diagnostic Network of India,2017 24. Technical Specifications and Quantity of Equipment for Culture Sensitivity for IRLs 25. Technical Specifications of Equipment in the TB Culture and DST Laboratories under RNTCP (2017) 42 26. Technical Specifications for Construction, testing, commissions and validation of TB containment Laboratory 27. Technical Specifications of Laboratory Consumables required for DMCs 28. Technical Specifications of Laboratory Consumables required for IRLs Tribal Population 29. Statistical Profile of Scheduled Tribes, 2013 30. Report of the Expert Committee on Tribal Health, Ministry of Health and Ministry Tribal Affairs, Government of India. 2018. Available at http://www.nhm.gov.in/nrhm-updates/598-report-of-the- expert-committee-on-tribal-health.html 31. Annual Report 2016-17, Ministry of Tribal Affairs, Government of India. 32. Annual Report 2017-18, Ministry of Tribal Affairs, Government of India. 33. Census of India, 2011 Other Research Studies 34. India: Health of the Nation’s States. Disease Burden Trends in the States of India 1990 to 2016. ICMR, Ministry of Health and Family welfare, Government of India, 2017 35. Global Tuberculosis Report 2017, World Health Organization 36. A Rapid Assessment of Gender and Tuberculosis in India, 2018. Resource Group for Education and Advocacy for Community Health (REACH). Chennai, India. 37. Rapid Assessment Report on Data for Action for Tuberculosis Key and Vulnerable Populations in India, 2018. Resource Group for Education and Advocacy for Community Health (REACH). Chennai, India. 38. Rapid Assessment Report on Legal Environment Assessment for TB in India, 2018. Resource Group for Education and Advocacy for Community Health (REACH). Chennai, India. 39. Tanu Anand et al., Perception of Stigma Towards TB Patients on DOTS and Patients Attending General OPD in Delhi, 61 INDIAN J. TUBERCULOSIS 35, 35 (2014) 40. D. Somma et al., Gender and Socio-Cultural Determinants of TB-Related Stigma in Bangladesh, India, Malawi and Colombia, 12 INT’L J. TUBERCULOSIS & LUNG DISEASE 856, 858-60 (2008) (“India had the highest item-adjusted stigma index (1.17)�) 43 ANNEX 2: Description of Environmental and Social Management System and Capacity and Performance Assessment A. Introduction 1. This section describes the existing environmental and social management system of the institutions applicable in the implementation of the proposed Program. It provides an overview of the policy and legal framework and a profile of the roles and responsibilities of institutions involved in the environmental and social assessment and management. 2. The Government of India has enacted a range of laws, regulations, and procedures relevant to managing the environmental and social effects of the proposed Program. The following criteria were used to select the relevant legislation that best describes the country’s system for managing the Program’s effects: i. environmental and social policies, ii. environmental and social protection laws, and iii. laws, regulations, or guidelines in the relevant sectors and subsectors that provide relevant rules or norms for environmental and social management. B. Environmental and Social Management Systems The provisions of the existing environmental legal and regulatory framework are adequate but require enabling institutional and technical capacity for compliance. While the provisions of the Biomedical Waste Management & Handling) Rules, 1998 – (amended on March 2018) are being implemented, provisions of other relevant environmental Acts, such as, hazardous, solid, plastic and E-waste Rules (2016) require additional capacity building efforts. Efforts are required to improve the monitoring of the management of different kinds of these wastes. The existing policy framework has a clear emphasis on BMWM, infection control and occupation health and safety at the workplace. The existing national and state laws and regulations provide a strong framework for environmental management in the Program. They cover a wide range of aspects relevant to the Program including management of different types of wastes (plastics, e-waste and hazardous wastes). There are also guidelines/SOPs on lab operations which include National guidelines of Airborne Infection Control, Infection Management and Environment Plan (IMEP) guidelines, standards for TB care in India, Biosafety manuals for DST labs, RNTCP technical specifications on TB lab consumables, equipment and infrastructure. CPCB also has published guidelines/ toolkits on implementation of the BMW rules. Thus, the existing policy, legal and regulatory framework is adequate in its coverage of environmental aspects pertaining to the relevant Program activities. However, application of the legal and regulatory provisions is not consistent in the selected states due to lack of capacity and monitoring. 44 C. Environmental and Social Laws, Regulations and Policies Several relevant national and state level laws, regulations and policies were analyzed for the proposed Program. The analysis examined whether or not there are significant gaps that prevent the realization of e the environmental and social objectives as included in the ESSA core principles. Table 8, provides a detailed analysis of the legal and regulatory framework applicable to the Program. Adequacy of legislative framework on environmental aspects. The provisions of the existing environmental legal and regulatory framework are adequate but require enabling institutional and technical capacity for compliance. While the provisions of the Biomedical Waste Management & Handling) Rules, 1998 – as amended up to March 2018 are being implemented, provisions of other relevant environmental Acts, such as, hazardous, solid, plastic and E-waste Rules 2016 require additional capacity building efforts. Efforts are required to improve the monitoring of the management of different kinds of wastes. The ambit of the rules has been expanded to include: (a) Camps for vaccination, blood donation, surgical or any other healthcare activity; (b) Phasing out chlorinated plastic bags, gloves and blood bags within two years; (d) Training and immunization for all health care workers regularly; (e) Bar-Coding for bags or containers containing bio-medical waste for disposal; (f) Reporting major accidents; (g) More stringent standards for incinerator to reduce emission of pollutants; and (h) Existing incinerators to achieve the standards for retention time in secondary chamber and Dioxin and Furans within two years. Adequacy of legislative framework on social aspects. The existing legislative framework is adequate to ensure social sustainability and the interest of marginalized and vulnerable population including the SC and ST population, but require strengthening institutional capacity to comply. It ensures the following: (a) protection of the interest of SC and ST population, (b) non-discrimination based on religion, race, caste, and gender, (c) transparency with the right to information, (d) the right to fair compensation in case of land acquisition. However, it requires strengthening rights-based approach for TB, to help empower affected communities seek health services and commodities as part of their right to health, and listen to their voices while tailoring the response, and involve them as partners and participants in the development of the most socially appropriate rights-based strategies to address TB effectively12. The focus states account for 51.5 million of the tribal population (49 percent of the India’s tribal population) and have both scheduled V and Scheduled VI areas as defined under the Constitution of India with special legislative and judicial provision including customary rights in scheduled-VI areas. While the legislative framework is adequate, institutional capacities requires strengthening both at CTD level as well as state level to incorporate culturally appropriate outreach mechanisms in these areas. 12 http://www.reachtbnetwork.org/wp-content/uploads/2018/09/REACH-CRG-LEA-2018-Full-Version.pdf 45 Table 9 Environmental and Social Laws, Regulations and Policies that are relevant to the Proposed Program Sl. Applicable Act/ Regulation/ Objective and Provisions Relevance to the Program and No. Policy key Findings 1 The Constitution of India The Indian Constitution entitles individuals Relevant to the overall Program (especially, Articles 15,16 and with TB to certain rights. The Constitution 46) protects the rights to life, health, non- discrimination, privacy, informed consent, housing and food. These rights are safeguarded either explicitly or implicitly under the “Fundamental Rights� part of the Constitution (Articles 13 to 35) and are enforceable in courts. Fundamental rights are interpreted in light of the “Directive Principles of State Policy� part of the Constitution (Articles 36 to 51). While Directive Principles are not themselves directly enforceable in courts as legal rights, they do establish specific duties that the government must strive to fulfill when making laws. 2 Bio-medical Waste Schedule 1: Categorization and Highly relevant to the entire Management(Amendment) Management Program (cover labs, healthcare Rules,2018 Schedule 2: Standards for treatment and facilities/hospitals and clinics) disposal of BMW Rules are adequate, however it Schedule 3: Prescribed Authority and is the enforcement of rules that duties remains weak. The BMWM Schedule 4: Label of containers, bags and Rules are equivalent to the transportation of Bio-Medical waste WBG EHS Guidelines for Healthcare Facilities as they The provisions under the rules provide for cover good practices such as both solid and liquid medical wastes labelling, colour bins/ bags and Liquid waste should be treated with 1% symbols for hazardous hypochlorite solution before discharge into materials and waste. They sewers. emphasize waste reduction, Hospitals not connected to municipal segregation, storage, WWTPs should install compact on-site transportation (manifest), sewage treatments (i.e. primary and treatment and handling (with secondary treatment, disinfection) to autoclave, incineration), health ensure that wastewater discharges meet workers’ occupational health applicable thresholds. and safety and public health and safety. On solid BMW there is good overall capacity and compliance. On liquid BMW, there are significant gaps in treatment and disposal of wastewater from hospitals. 46 Sl. Applicable Act/ Regulation/ Objective and Provisions Relevance to the Program and No. Policy key Findings Other provisions of the rules that are directly relevant to the Program: All the HCFs irrespective of The type of treatment and quantity of bio-medical waste generated need to obtain authorization under BMWM Rules, 2016 State and District advisory committees on BMW should be established and advise SPCBs etc. in the handling of medical solid and liquid wastes. All states covered under the Program have access to central biomedical waste treatment facilities. Private hospitals in India have had to comply with the requirements of the Biomedical Waste Rules using their own resources. Public hospitals are provided budget to implement BMW management. The Private sector partnership scheme under RNTCP requires all private labs for C&DST testing to submit information on how BMW is managed at the lab, but more emphasis should be provided on trainings, and immunization of health workers who are in contact with such wastes. 3 E-Waste (Management and There are policies governing the Relevant as it is applicable for Handling) Rules 2011 as responsible disposal of e-waste generated all HCFs and Labs under RNTCP, Amendment up to 2018 by bulk Consumers to address leakage of e- including private sector. The waste to informal sector at all the stages of disposal of E-wastes to be done channelization. at the specified collection centres and reported annually. 47 Sl. Applicable Act/ Regulation/ Objective and Provisions Relevance to the Program and No. Policy key Findings The 2016 Amendment brought healthcare facilities (with turnover over INR 20 crore or more than 20 employees). 4 Plastic Waste Management All institutional generators of plastic waste, Relevant as hospitals and labs Rules 2016 shall segregate and store the waste are generators of large quantity generated by them in accordance with the of plastics, including non- Solid Waste Management Rules, and reusable types. handover segregated wastes to authorized waste processing or disposal facilities or deposition centres, either on its own or through the authorized waste collection agency 5 Hazardous Waste Rules, 2016 To address the appropriate management Relevant to all HCFs and Labs of all x ray wastes developer so that they as management of x-ray wastes are safely handled and disposed. and by products. Expansion of diagnostic services will require check x-ray service to be provided at district and block levels. Equipment would be upgraded, and new equipment would be installed. At the same time medical staff managing developer and fixers would need to be trained in their safe handling. 5 National Building Codes of The Code provides regulations for building Relevant to any India 2016. construction by departments, and public renovation/upgrading work for bodies. It lays down a set of minimum expansion of diagnostic provisions to protect the safety of the services and DR-TB centres/ public with regard to structural sufficiency, wards. fire hazards and health aspects. The Code mainly contains administrative regulations, development control rules and general building requirements; fire safety requirements; stipulations regarding materials, structural design and construction (including safety); building and plumbing services; signs and outdoor display structures; guidelines for sustainability, asset and facility management, etc. 6 The Building and Other There are guidelines/policies concerning Relevant- To address Construction Workers public safety and worker safety integrated employment and conditions of (Regulation of Employment into infrastructure and public amenities service of building and other and Conditions of Service) Act, These acts aim to improve health, safety, construction workers and to 1996 (27 of 1996) 48 Sl. Applicable Act/ Regulation/ Objective and Provisions Relevance to the Program and No. Policy key Findings and general wellbeing of workers and provide for their safety, health The Workmen’s Compensation workplaces by promoting occupational and welfare measures. Act health and safe practices in order to eliminate occupational accidents and National Policy of Safety, diseases, hence achieve better health and productivity in the workplaces. Environment at Work Place, 2009 5 Water (Prevention and Control Provisions are largely to prevent air and Relevant to all HCFs, Labs and of Pollution) Act 1974 water pollution by not releasing untreated Central Biomedical Waste effluents and harmful emissions from Treatment Facilities- largely Air (Prevention and Control of Generator sets and incinerators. complied with Pollution) Act 1981 Most provisions are already discussed under the Bio-Medical Waste Rules. Environment Protection Act (nd Rules), 1986 and 1996 6 Indian Penal Code (IPC) Section 278 (making atmosphere noxious Relevant to health) and Section 269 (negligent act Although individuals would likely to spread infection or disease require providing evidence dangerous to life, unlawfully or negligently 7 The Indian Medical Council Act Provisions are applicable to practicing Relevant to entire Program 1956 doctors and medical professionals to The Indian Medical Council provide quality service to the patients or (Professional Conduct, healthcare seekers. Etiquette and Ethics Regulations 2002) 8 Basel and Stockholm As a signatory, India is committed to meet Relevant to all health Programs Convention its obligations related to the transportation of clinical wastes and emissions of dioxins and furans which result from incineration of hospital waste, as well as that of ensuring safe use and disposal of pesticides in vector control activities. 9 Infection Management and IMEP has been mainstreamed within the Relevant- However, compliance Environment Policy NHM for infection control and worker and implementation on the Framework, 2007: safety- emphasis on capacity building and ground has been disjointed, training, applicable to all healthcare driven by different centres. implementing agencies and multiple stand-alone training modules. Since RNTCTP is part of a general health system, conforming to IPHS and implementation of IMEP is the responsibility of each health 49 Sl. Applicable Act/ Regulation/ Objective and Provisions Relevance to the Program and No. Policy key Findings facility under the public health system. With the enhancement in capacities of health managers/administrators, health facilities will be better positioned to develop and articulate plans and budgetary requirements in their annual plans for robust implementation of IMEP. The Central TB Division will allocate sufficient budget to support monitoring and review of airborne infection control measures for DR-TB inpatient wards under RNTCP’s Programmatic Management of Drug-Resistant TB (PMDT) activities. 10 CPCB has brought out Any activities from BMW temporary Relevant- BMW is listed as Guidelines that are relevant for storage, transportation, and hazardous waste due to its the health sector Disposal/treatment requires valid license. infectious characteristics. CPCB has also notified Revised Guidelines CPCB Guidelines for CBWTFs for Common Bio-medical Waste Treatment (2003). and Disposal Facilities which covers the location setting of the incinerator, CPCB Guidelines for BMW operational and maintenance performance Incinerators (2003). Draft standards and monitoring. The State Guidelines for Bio-medical Pollution Control Board plays an important Waste Incinerator, 2017 role in granting consent to establish and operate license to the CTF operators, which are largely private sector players. Guidelines for Management of Healthcare Waste in Health Care Facilities as per Bio Medical Waste Management Rules, 2016 Guidelines for Bar Code System for Effective Management of Bio-Medical Waste Standards for treatment and disposal of Bio medical waste by Incineration 50 Sl. Applicable Act/ Regulation/ Objective and Provisions Relevance to the Program and No. Policy key Findings Environmentally Sound Management of Mercury Waste Generated from Health Care Facilities. CPCB Manual on Hospital Waste Management 11 Right to Information Act, 2005 Provides a practical regime of right to Relevant as all documents information for citizens to secure access pertaining to the Program to information under the control of Public requires be disclosed to public. Authorities. The act sets out (a) obligations of public authorities with respect to provision of information; (b) requires designating of a Public Information Officer; (c) process for any citizen to obtain information/disposal of request, etc.; and (d) provides for institutions such as Central Information Commission/State Information Commission 12 The Right to Fair Aims to ensure, a humane, participative, Not applicable as no land Compensation and informed and transparent process for land acquisition or resettlement is Transparency in Land acquisition with least disturbance to the anticipated. Acquisition, Rehabilitation and owners of the land and other affected Resettlement Act, 2013 families and provide just and fair compensation to the affected families whose land has been acquired or proposed to be acquired or those that are affected by such acquisition and make adequate provisions for their rehabilitation and resettlement and for ensuring that the cumulative outcome of compulsory acquisition should be that affected persons become partners in development leading to an improvement in their post-acquisition social and economic status. 13 The Sexual Harassment of An act that aims at providing a sense of Relevant and applicable to all Women at Workplace security at the workplace that improves health care facilities and (Prevention, Prohibition and women’s participation in work and results directorates Redressal) Act, 2013 in their economic empowerment. It requires an employer to set up an “Internal Complaints Committee� (ICC) and the Government to set up a ‘Local Complaints Committee’ (LCC) at the district level to investigate complaints regarding sexual harassment at workplace 51 Sl. Applicable Act/ Regulation/ Objective and Provisions Relevance to the Program and No. Policy key Findings and for inquiring into the complaint in a time bound manner. The ICC need to set up by ever organization and its branches with more than 10 employees. 14 Fifth and Sixth Schedule Areas In the Sixth scheduled area, the Relevant to the overall in the Constitution of India Constitution of India makes special Program – Among the focus provisions for the administration of the states, Assam comes under tribal dominated areas in four states viz. sixth schedule while Assam, Meghalaya, Tripura. The Sixth Maharashtra, Rajasthan, scheduled areas have autonomous Madhya Pradesh has districts and autonomous regions with scheduled-V areas and districts certain legislative and judicial powers. where Panchayat (Extension to the Scheduled Areas) Act - In the Scheduled Areas, involvement of PESA is applicable. tribal councils and communities, incorporating their views and culture specific needs will enhance their participation in the Program. Under the provisions of Fifth Scheduled Areas, the State should set up a Tribes Advisory Council (TAC) to advise the State Government on matters of welfare and development of the Scheduled Tribes in the State. 15 The Panchayat (Extension to The Ministry of Panchayati Raj, GoI, under Relevant to the Program – All the Scheduled Areas) Act, 1996 this Act mandates for the Fifth Schedule Tribal Sub Plan (TSP) districts as areas to make legislative provisions in 'High Priority Districts' under order to give wide-ranging powers to the National Rural Health Mission. tribes on matters relating to decision- Also, the Gram Sabha have making and development of their control over local institutions communities. The PESA Act empowers the and functionaries including the Gram Sabha (the council of village adults) Health Sub-centres and and the Gram Panchayat to take charge of Anganwadi centres. village administration. Under the Act, Government of India stipulates to conduct consultations and obtain consent for the development Program from the tribal advisory council (TAC), Gram Sabha and the Gram Panchayat under the Fifth Schedule Areas. 52 D. Institutional Framework The implementing agency of the proposed PTETB PforR is the MOHFW. At the central level, the MOHFW’s CTD is the primary responsible agency for the day-to-day implementation of the NSP 2017- 25 and will provide Program leadership, management, and regulatory oversight to ensure adherence to technical standards. At state and district levels, a multi-stakeholder health society is responsible for Program planning budgeting and administration. State government health services under the NHM, including state and district TB officers within state Departments of Health and Family Welfare (DOHFW), will be responsible for implementation of TB services. RNTCP services and systems are highly-standardized, and anti-TB medicines are procured centrally by MOHFW to ensure quality and uniformity of treatment. E. Borrower’s Past Experience in Managing Environmental and Social Risks MOHFW has had more than twenty years of experience in working with World Bank and with more than three projects over this period clearly shows their prior experience in implementation of Bank safeguard policies. MOHFW has a continuous and long engagement with the Bank on health and nutrition projects. The proposed Program is a continuation to the three earlier projects supported by World Bank to RNTCP since 1997. As part of second phase of the Bank supported RNTCP, the Central TB Division (CTD) of the MOHFW, developed an Environmental and Bio-medical Waste Management (BMWM) Plan. This plan was in line with the IMEP operational guidelines and policy framework and included specific activities such as: (i) Training modules for Medical Officers and Laboratory Technicians; (ii) vaccinations for all health staff as a preventative measure; (iii) dissemination of guidelines, standards, protocols to health facilities to enhance knowledge of health workers and support implementation of IMEP; and( iv) systems for recording and monitoring of waste disposal. The third project, the AUAEETC is also closed, the institutional setup is still functional and active in CTD, and the environment management framework for bio medical waste management and capacity building remains relevant. Over the years, BMW has seen considerable improvement at all levels of healthcare facilities. This is indicative of good borrower capacity to deal with the environmental and social aspects of the proposed Program. Since RNTCTP is a part of general health system, conforming to Indian Public Health Standards (IPHS)and implementation of IMEP is the responsibility of each health facility under the public health system. It is also important to note that while health-care waste management is implemented by the Department of Health, with support from municipal bodies and private service providers for disposal, environment management issues including water, sanitation-related diseases, and solid waste management are state subjects and the responsibility is also shared by various municipal bodies. Implementation and execution is carried out through state departments (Public Health Engineering or Rural Development Engineering) or State Water Boards along with the urban local bodies. Engagement under previous projects has helped CTD in developing guidelines for most of its activities including those associated with reaching out to tribal and difficult areas, ACSM, and communication, they should be updated with the current context and the agenda set forth in the NSP 2017-25. This includes institutional reorganizing, building capacity at all levels, updating ‘Partnership guidelines’, ‘Technical and Operational Guidelines for TB Control in India’ and monitoring mechanisms and tools such as Central Level Internal Evaluation (CIE) and State Level Internal Evaluation (SIE), specific to the areas mentioned above to address the issues raised in the NSP 2017-25 and the guidance suggested therein. In addition, there is need to build capacity to address gender concerns of the RNTCP Program 53 and the citizen engagement that are being foreseen through TB Forum mechanism at National, State and District levels. Table 9 Institutional Set up under RNTCP Level Technical Head RNTCP positions Capacity to be reviewed for environmental management Central Deputy Director DDG (TB) and consists of 4-5 full NRLs General-TB time staff from the central health service of the rank of ADDG/DD (this includes dedicated staff for labs) State State TB Officer ▪ Director (STDC) IRL and C&DST labs ▪ Epidemiologist (APO) State TB Cell ▪ MO – STC ▪ TB-HIV Coordinator ▪ PPM Coordinator ▪ DR -TB Coordinator ▪ State IEC Officer ▪ State Accountant ▪ Technical Officer- ▪ Proc. and Logistics ▪ DEO-STC ▪ Pharmacist - SDS ▪ Store Assistant - SDS District District TB ▪ Senior MO – DR TB Centre District Hospitals, which include Officer ▪ Counsellor – DR TB Centre ART centres ▪ SA – DR TB Centre DR TB centres ▪ MO – DTC District TB centres ▪ MO-TC ▪ Senior DR TB –TB HIV supervisor ▪ District PPM Coordinator ▪ Accountant ▪ Senior Treatment Supervisor (STS) ▪ Senior TB Lab Supervisor (STLS) ▪ Lab. Techs. (LT) – RNTCP Contractual ▪ Tuberculosis Health Visitor (TBHV) Sub Block Medical ▪ Medical Officer (TB TB Unit + BPMU (NHM) district Officer Control)/ Program Officer BMW and AIC committees focusing on TB services DMCs Senior Treatment Supervisor ▪ Senior TB Laboratory Supervisor Notwithstanding the already built capacity within the borrower’s institutions, a detailed assessment of all the relevant institutional stakeholders was undertaken to identify any critical and/or significant 54 gaps, as well as smaller shortcomings for effectively managing the environmental and social issues of the RNTCP. In addition to assessing the institutions at the national and state level, the ESSA also reviewed some of the ongoing national health programs. The institutional assessment has contributed to the resulting recommendations and Program actions that will support the further building of borrower capacity. 55 Table 10: Capacity Gap Analysis of Relevant Institutions Related to the Proposed Program Institution Roles and Responsibilities Capacity Gap Analysis National Level Institutions Ministry of Health and • Deals with health care, including • No significant gaps identified, MOHFW is well equipped to Family Welfare awareness campaigns, immunization handle their current Programs and have well laid out (MoHFW) and campaigns, preventive medicine, and guidelines and processes for implementation within the Department of Health public health services applicable legal and regulatory framework. Health schemes (state level) • Heads many statutory bodies, such as, are quite inclusive and well implemented. Medical Council of India (MCI), Indian • RNTCP management is well embedded within the MOHFW Nursing Council, Dental Council of India, and the national health mission (NHM) and within the and Pharmacy Council of India (PCI) general health system at the state and district levels. The • Provides funds under NHM for BMWM. RNTCP, as an integral part of the NHM is implemented State health departments also have through India’s public health system. All disease specific provided assistance to government Programs integrated under the NHM are committed to hospitals for HCW management in the adoption of the IPHS and implementation of the Biomedical form of personnel training, waste Waste Management Rules and the Infection Management management auditing, preparation of and Environment Plan (IMEP). hospital-specific plans, procurement of • The role of Departments of Health in monitoring the materials and supplies, and construction operations of CBMWTFs is typically unclear, though as the of on-site disposal facilities. generator of waste and purchaser of its services, they should • Publication of list of registered health have the right to review and supervise the facility and its care facilities with regard to bio-medical operations. This responsibility is limited to the CPCB and waste generation, treatment and SPCBs. disposal. • The responsibility for ensuring the implementation of the • Coordinates with State Pollution Control IMEP lies with the MoHFW, which is the implementing Boards for organizing training agency for the NRHM. The overall responsibilities will be programmes to staff of health care with the Secretary (MoHFW). The specific responsibility will facilities and municipal workers on bio- be with the Infrastructure Division for Infection medical waste. Management & Environment Plan (IMEP) and with Immunization Division for issues pertaining to AD syringes 56 Central Tuberculosis • The central TB division (CTD) is the • While CTD is headed by the DDG (TB) and consists of 4-5 full Division (CTD) nodal agency for the TB Program time staff and also has contractual staff such as national nationally. consultants and experts in procurement and finance who are • Responsible for policy and Program either supported from the domestic budget or through formulation and implementation of the donor agencies, they are not adequate and need Revised National TB Control Program reorganizing as well as adding specific skills as suggested (RNTCP), and preparation of Technical under the NSP. and Operational Guidelines for the • There no dedicated full-time staff looking at Environment same. Health and safety aspects of the Program (which includes • The NSP 2017-25 made several general IC measures, and airborne infection control recommendations to improve the measures for the protection of health care staff and other institutional structure of the TB patients, lab construction, and disposal of bio medical and e Program. One of them was to set up the -wastes) Currently, DCDG Labs within CTD is currently national TB elimination board, a policy looking at all aspects of labs including biosafety, and making body at the highest level chaired sufficient knowledge and capacity has been built to oversee by the Prime Minister and a similar this aspect. board at the state level. It also • Lack of bio-medical engineers at state/regional level that can recommended implementing TB support lab equipment testing, service and maintenance. elimination efforts in a ‘mission mode’. • Through consultations with CTD, it was revealed that staff are aware of environmental, health and safety management, and aware of their responsibilities and duties designated by the laws and regulations. • With respect to implementation on environmental and social safeguard activities, the key gaps in CTD includes dedicated and skilled manpower to plan and implement partnerships, advocacy, communication and social mobilization (ACSM) and psycho social support (PSS) activities in a coherent manner. • Capacity related to M&E and citizen engagement also needs strengthening. Ministry of Tribal Affairs • No significant gaps identified, as the mandate and functions • Nodal Ministry for overall policy, (MoTA) of the ministry support welfare of indigenous people. The planning and coordination of Programs Ministry lists out the ST priority areas and the Scheduled for development of STs Areas as per constitution and present them regularly in their 57 Annual Report for easy reference and to be followed by CTD for RNTCP. Ministry of Social Justice • No significant gaps identified • Responsible for bringing marginalized and Empowerment • Support for marginalized section is well mainstreamed in sections of the society viz. Scheduled (MoSJ&E) sector Programs Castes, Backward Classes, Persons with Disabilities, Aged persons etc. into the • While interventions under the RNTCP/ NSP 2017-25 do not mainstream of development by making result in any adverse impacts and/or risks. However, most of the SC community are poor and marginalized and forms them self-reliant. part of the lower socio-economic category of population • Through the Scheduled Castes along with STs and hence given poor living conditions Development Bureau, implements vulnerable to TB. The Active case finding (ACF) should also Scheduled Caste Sub-Plan (SCSP) which prioritize SC dominant areas for TB case findings. is an umbrella strategy to ensure flow of targeted financial and physical benefits from all the general sectors of development for the benefit of SCs. MoEF&CC • Although the MoEFCC/ CPCB has notified the BMWM Rules, • The MoEFCC is the nodal agency for Central Pollution Control 2016 and 2018 (draft) implementing agencies specified in planning, promoting, coordinating and Board the rules (such as municipalities, hospitals and district overseeing the implementation of State Pollution Control authorities) do not fall under its administrative control. environmental Programs. The Boards (SPCB) and Attempts at enforcement therefore need to be Hazardous Substances Management Pollution Control strengthened, especially within the public health-care Division in the MoEF is responsible for Committees (PCC) sector. Better institutional coordination could help the overall implementation of the rules strengthen BMW management related to waste management (solid and • Collection, Transport and final disposal of BMW is in most health-care). cases done by certified agencies in the private sector that • The Central Pollution Control Board provide the colour coded bags and bar codes, CPCB monitors (CPCB) establishes standards, compiles this aspect through annual reports from SPCBs and data and plays an advisory role to the CBMWTFs along with online monitoring. MoEF on technical matters. It Prepares • There is little involvement of the Central Pollution Control Guidelines on bio-medical waste Board (CPCB) in identification of training development Management for the Ministry. needs, development of SOPs on environmental health and • The CPCB is the key authority at safety management, and biomedical waste management. national level for regulation of air • Collection of other solid waste (other than the biomedical pollution, water pollution with regards waste) from the health care facilities is carried out per the to construction activities and disposal of construction wastes. 58 • CPCB, the State Pollution Control Boards Municipal Solid Waste (Management and handling) Rules, (SPCB) and Pollution Control 2000 by the municipality. Committees (PCC) enforce environmental legislations in the states and in union territories, respectively. Both CPCB and SPCBs/PCCs are scientific/technical organization which are also responsible for setting the technology standards of equipment, issuance of authorizations and licenses for operations of health-care facilities and their waste treatment equipment (incinerators, autoclaves etc.) National Reference • No significant gaps identified. Visits to IRLs revealed that • Provide Training to all IRLs and C&DST Laboratory, (NIRT) trainings (biosafety, infection control and BMWM) are being facilities on Safety in the laboratory: Chennai and (NTI) routinely provided by the NRLs to the IRLs Disinfectants and Coping with Lab Bangalore • EQA is being conducted as per the RNTCP guidelines accidents National Reference • Reference and guidance documents issued by the NRLs is • Provide external quality assurance for Laboratory Coordination adequate for environment health and safety and biosafety private sector labs Committee management. • The laboratory network and diagnostic services are guided by the National Expert Committee on Diagnosis and Management of Tuberculosis the apex committee which provide the technical advice to the Program for the laboratory policy. National Reference Laboratory Coordination Committee reviews the progress and facilitates newer initiatives. • NRLs develop SOPs for the technical procedures, equipment maintenance, infection control, and recording and reporting • Under NSP, National TB Institute Bangalore will be the nodal institute for 59 building capacity of sentinel surveillance sites at labs in public and private sector. National, State, and • Multiple levels of AIC coordinating bodies have not • National AIC Guidelines require a District Airborne streamlined the process in implementing recommended National, State and District Airborne Infection Control infection control activities. Though ToRs are provided by the Infection Control Committee to be Committees national guidelines, institutional mechanisms need more established to provide coordination, clarity, for example districts are also under administrative and provide technical guidance for their arena of the District Health Societies. implementation, evaluation, and revisions. • The airborne infection control activities at the district are undertaken by the Sub-Committee on Biomedical Waste Management / Infection Control (SCBMW/ IC) under the District Health Society (DHS). Their primary role is sensitization of stakeholders to AIC. State Level Institutions IRLs and C&DST facilities • There are HR issues critical for sustaining C/DST laboratory • There is at least one IRL per state, services which require urgent attention. Vacant positions situated in the STDC campus or an and lack of qualified manpower, including dedicated identified location in a state biomedical engineers. government hospital. • Technical Specifications provided for C&DST lab • The IRL provides culture and DST for the infrastructure, consumables and equipment is adequate category IV services in the State and its • Biosafety Guidance manual is comprehensive and adequate capacity has been built with support to maintain environment health and safety standards and in from central level by additional training. line with the WBG WHS guidelines for healthcare facilities • The IRL conducts on-site evaluation • EHS criteria for Accreditation private sector / medical college visits to districts for sputum microscopy mycobacteriology laboratory for culture and DST under at least once a year. RNTCP can be strengthened further to build in (i) repotting • The IRL undertakes panel testing of STLS mechanisms for accidents/ spills (ii) trainings and (iii) at each DTC. The IRL ensures the servicing of key safety equipment. proficiency of staff performing RNTCP smear microscopy activities by 60 providing training to laboratory technicians and STLS. • In additional to IRLs, RNTCP also involves the microbiology department of Medical colleges for providing diagnostic services for drug resistance Tuberculosis, Extra-pulmonary Tuberculosis (EP-TB) and research. The RNTCP provides additional human resources, equipment’s and training to C & DST laboratories. State TB Cells • While the NSP envisages further strengthening of the State • State TB Cells oversee the work at state TB Cell, the key gaps in planning and implementation of and district levels towards planning and environmental and social safeguard activities require implementation of RNTCP Program dedicated and skilled manpower to plan and implement the activities and works under the Principal following: (a) Partnerships, advocacy, communication and Secretary- Health and Family Welfare social mobilization (ACSM) and psycho social support (PSS) and Mission Director- NHM. activities in a coherent manner; (b) Air-borne infection • Given that health is under state control measures and bio-medical waste management. mandate, STO is administratively • It also requires strengthening in the inter-institutional accountable to the State Government coordination mechanism with NHM and other health and technically coordinate with CTD for directorates, as well as with other departments such as implementation of RNTCP Program. Women and Child Development (WCD) and Department of • The State TB Cell is headed by State TB Tribal Affairs for effective implementation of environmental officer (STO) and supported by Director and social safeguard activities. State TB Training and Demonstration Centre (STDC), Deputy STO and contractual staff like TB-HIV coordinator, PPM coordinator, DRTB coordinator, State Accountant, Procurement Officer etc. National Health Mission • No significant gaps identified on the social side except a • Works to pool all resources available in (NHM) better coordination will help bring synergy implementation of the Programs • While adequate funding is provided, need to improve • All National Health Programs at the monitoring of BMWM. State and District level are brought • Infection control and environmental guidelines for HCFs under one umbrella of NHM have been prepared, though dissemination of guidelines to 61 • Provides funding support for BMWM health facilities to enhance knowledge of health workers through CTFs needs to be enhanced. • Has six financing components i.e. (1) NRHM-RCH Flexi pool, (2) NUHM Flexi pool, (3) Communicable disease Flexi pool, (4) Flexible pool for Non- communicable disease (NCD) including Injury and Trauma, (5) Infrastructure and Maintenance, and (6) Family Welfare Central Sector components • Funding for TB Program is through NHM Communicable disease Flexi-pool under two separate budget lines for (a) General Component, and (b) Externally Aided component. Public Works • Coordination between PWD (engineers and architects) and • Constructs and maintains buildings of Department (PWD) State committees on AIC would facilitate better various Government Departments implementation of AIC plans- Health facility design should • Will construct or rehabilitate and repair consider TB infection control as integral part of building healthcare facilities and laboratories plans. including for TB unit Tribal Welfare • No significant gaps identified • Implements the Programs related to the Department • TSP planning and implementation with detailed guidelines welfare of Scheduled Tribe population and budgetary process being done well in the state for their socio-economic advancement. In some states also implement the Program related to welfare of Scheduled Caste population. • Nodal department for the formulation and implementation of TSP at State Level Women and Child • No significant gaps identified • The Women and Child Department and Department and Social Social Welfare Department in some Welfare Department states are a separate department, while in others they are a merged department 62 following similar mandate to their target population. • Entrusted with ensuring the welfare of the poor, the down-trodden, Women, Children, Senior Citizens and trans- genders • Promotes empowerment and improvement of social status of women • Plans and implement nutritional support Program under the National Nutrition Mission/ ICDS Program. State Pollution Control • SPCBs are generally under staffed for adequate monitoring • The 'prescribed authority' for Board but have adequate technical capacity and role clarity. enforcement of the provisions of BMW rules in respect of all the health care facilities is the respective State Pollution Control Board (SPCB)/ Pollution Control Committee (PCC). • State pollution Control Board is entrusted with monitoring and ensuring compliance to environmental regulations including Biomedical Waste Management Rules, 2016 • Grant of authorization to Common Biomedical Waste Treatment Facilities. • Action against health care facilities or common bio-medical waste treatment facilities for violation of these rules. • Monitoring CBWTFs and Healthcare Facilities to ensure compliance to BMW Rules, 2016, and issue of notices, orders and penalties etc. for non-conformance as per Environment Protection Act, 1986. • Organize training Programs for staff of health care facilities and common bio- 63 medical treatment facilities and State Pollution Control Boards or Pollution Control Committees Staff on segregation, collection, storage, transportation, treatment and disposal of bio-medical wastes. • Inventory of occupiers and data on bio- medical waste generation, treatment & disposal. • Grant consent to and publish the list of registered or authorized Recyclers. (E - Waste) • Undertake and support third party audits of the common bio-medical waste treatment facilities in their State State Bio Medical Waste • Each state needs to constitute a • Coordination and participation among different Committee committee to advise the state stakeholders—in particular, state environmental and health government and the SPCBs about agencies, local authorities, health care facility implementation of the BMW rules. The representatives, academia, and NGOs are also needed. committee is under the chairmanship of the health secretary include representatives from the departments of Health, Environment, Urban Development, State Pollution Control Board or Pollution Control Committee and urban local bodies. District and Sub-District Level Institutions District TB Centre • Field visits to Pune and Udaipur districts, and analysis of • The Chief District Health Officer sanctioned positions and vacancy suggests gaps with (CDHO)/ Chief District Medical Officer number of positions vacant at all levels especially at DR-TB (CMHO)/ Chief Medical Officer (CMO)/ counselors, Medical officers and the lab assistants. Civil Surgeon is responsible for all • Discussion with STS and STLS suggests very low salary and medical and public health activities in absence of benefits being one of the main reasons for the district including the TB Program. vacancy. 64 • The District Tuberculosis Officer (DTO) is • Apart from adequacy of human resources at district and responsible for planning, implementing, block level, a key gap exists in DTCs coordination with training, supervision and monitoring of CMHO/CMO managing NHM Program with separate budget the TB Program at the district level. and with other district level agencies/ institutions. Have separate budget allocated for the • Discussion with DTOs suggests gap in procurement of TB Program by the State NHM. services related capacity leading to gap in ACSM and • At the district level DTO manages the partnership activities. Program and is supported by DR- • Implementation of AIC measures in DR-TB and ART centres TB/HIV-TB coordinator, PPM needs strengthening. coordinator and accountant as well as the MO-TC, Senior Treatment Supervisor (STS) and Senior Treatment Laboratory Supervisors (STLS) at the sub-district level. Tuberculosis Unit (TU) at • Mentioned as above. • TU is the nodal point for TB control sub-district level Program at the sub-district level and aligned at the NHM block Program unit. The Block Medical Officer also functions as the MO-TC and is trained under RNTCP Program. • The TU has the microscopy centre and also referred as Designated Microscopy centre (DMC) under the Program. 65 Relevant National Programs 3. National Health Mission (NHM): The National Health Mission (NHM) is an overarching mission within the National Rural Health Mission (NRHM). It was launched in 2005 and the National Urban Health Mission (NUHM) in 2013 - the other Sub-mission of NHM. The vision of the NHM is the “Attainment of Universal Access to Equitable, Affordable and Quality Health Care Services�, accountable and responsive to people’s needs, with effective inter-sectoral convergent action to address the wider social determinants of health. The State Health Society under the Department of Health and Family Welfare (DoHFW) is responsible for implementation of NHM. NHM has six financing components i.e. (i) NRHM-RCH Flexi pool, (ii) NUHM Flexi pool, (iii) Flexible pool for Communicable disease, (iv) Flexible pool for Non-communicable disease including Injury and Trauma, (v) Infrastructure Maintenance, and (vi) Family Welfare Central Sector component. The TB Program is funded through the flexible pool for communicable diseases and implemented through the State TB Cell administratively reporting to State NHM and technically reporting to CTD at the national level. 4. Tribal sub plan (TSP) and Scheduled Caste sub plan (SCSP) : The strategy of Tribal Sub Plan (TSP) has been in force since 1974, to ensure adequate flow of plan resources for the development of Scheduled Tribes. The strategy of Scheduled Castes Sub Plan (SCSP) (earlier known as the Special Component Plan for Scheduled Castes) has been in force since 1979-80, to ensure a proportionate flow of plan resources for the development of Scheduled Castes. As per the revised 2014 guideline for implementation of TSP and SCSP, funds are placed under a separate Minor Head ‘789’ and ‘796’ to ensure their non-diversion to any other schemes. TSP funds are earmarked by the state through their annual budget under each of the department’s budget including the budget of DoHFW also earmarked in proportion to the tribal population living in the state. Many states and districts use this fund to extend their Program activities, especially the ACSM activities in tribal areas. 66 ANNEX-3 Stakeholder Consultations - Key Comments Received through Consultations Sl. Consultations Key Issues Noted Officials/ People Met No. Undertaken 1 Hyderabad – STDC, Dr. Sumalatha (State i. Fire detection and alarm systems at IRLs not in working condition State Reference Lab, Epidemiologist), Dr. Sneha Shukla i. Health insurance not provided to contract staff at IRL EQA Lab, and BPHRC (WHO Consultant), Mr. Srikant (IRL, ii. Health checkup before enrolment in the TB laboratory, at regular (Private C&DST Lab Microbiologist), Mr. Anil Kumar intervals thereafter, annually or bi-annually, and any biohazard under NGO PP Scheme) (Technical Officer) incident needs stronger adherence. Dr. Sumalatha (State iii. AMCs for critical equipment is an issue and needs to be addressed. Epidemiologist), Dr. Sneha Shukla Similarly, BSCs are over 10 years old and need replacement (causing (WHO- Consultant), IRL Lab staffs negative pressure issues) iv. Need for dedicated bio-medical engineer in labs, overall staffing capacity is weak) v. Access control systems were lacking at IRL but were in place at BPHRC vi. Accident reporting can be strengthened, and remedial measures vii. Disposal of used chemical reagents is done through disinfection and disposal in sewer (IRL) and soak pit (BPHRC) viii. Biomedical waste from labs was being segregated and disposed in correct bins. Collection system is done through private sector. ix. BPHRC is following good protocols for biosafety, health, cleanliness and safety of workers. 2. Lucknow, UP i. Training for Infection control for the staff is provided for time to Dr. Santosh Gupta, State TB officer (Discussion with State time. However, the training needs to be strengthened for the staff TB officer) which is risk-prone and works in poor environmental conditions. ii. Some of the larger HCFs have proper water and sanitation facilities but generally these need to be improved. The problem is far more acute in the Urban Areas where there is a lack of proper hygiene, water and Sanitation facilities. iii. More emphasis needs to be placed on formulation and functioning of HCF level BMW and IC Committees. iv. Implementation of AIC plans has been weak, though there have been guidelines provided for sharp waste disposal and Airborne Infection Control Trainings. 67 Sl. Consultations Key Issues Noted Officials/ People Met No. Undertaken v. Delays of several days has been reported in many such cases of BMW collection from lab facilities. Fresh directives, however, have been issued to alleviate this problem. vi. There is no special provision for PPE for this purpose. Health check- ups etc. are also not regularly done. vii. Reporting issue with respect to female patients. Social mobilization and IEC with respect to reducing stigma associated with TB among women and addressing social determinants are generally missing and need be brought under the Program. 3. UDAIPUR (Rajasthan) i. Detection and alarm Systems at DMC, CBNAAT labs and TB ward Dr. Dinesh Kothari (DTO), DMC lab, CBNAAT lab needs Fire augmentation. Currently not installed. Dr. D. S. Rao (S.M.O), Dr. Sanjay in District TB Clinic ii. AIC/IC committee not formed Sinha (WHO- consultant), Mr B.K. (inside Maharana iii. Due to heavy load of samples of CBNAAT/GeneXpert analysis process Gupta(NGO - – ALERT, and member Bhupal Hospital always delayed. Require more CBNAAT machine. Child Welfare Committee); Mr. campus) Haathipole, iv. HR issue: shortage of staff- Laboratory technician Naresh Paneri and Mr. Tyag Narayan Udaipur; v. Printer is requiring for report printing in CBNAAT laboratory (NGO – SWACH); Dr. Manoj Arya RNT- Medical college- vi. Requirement of N-95 mask (PPE) for the safety of staff working in (RNT medical college); Laboratory DMC Lab, MDRTB ward, lab/TB ward in HCFs. technicians; Dr.S.K. Lohadiya, Head, BMWM, BADI, Udaipur; vii. Health insurance not provided to contract staffs at DMC, CBNAAT, Dept. of TB & respiratory disease, And RNTCP- laboratory and other staff of the HCFs. Geetanjali Medical College & RNTCP-laboratory, viii. Health checkup record is not maintained (a) before enrolment in the Hospital; All STS and STLS of the Geetanjali Medical TB laboratory (b) No health checkup at regular intervals thereafter district College & Hospital, ix. AMC for critical equipment is an issue and needs to be addressed. Udaipur x. Accident reporting can be strengthened and remedial measures. xi. E- waste and spill management is require in HCF. xii. Disposal of used chemical reagents is done through disinfection and disposal in municipal sewage system. xiii. Biomedical waste from labs and HCF was being segregated and disposed in correct bins. Collection system is done through private sector. xiv. CTF facilitator is collecting BMW on alternative/2nd day (within 48 hours). Need strengthen for daily/regular collection of BMW. xv. Private hospital is following good protocols for biosafety, health, fire, cleanliness and safety of workers. xvi. BMWM, Safety, PPE and IC training is requiring for the staff. Bar coding on waste disposal bags are not being done. 68 Sl. Consultations Key Issues Noted Officials/ People Met No. Undertaken xvii. Shortage of Slide boxes (as sputum analyses for microscopic investigation and the glass slides are retained for up to 2 months) as per the guidelines (preserve glass slides up to 3 months in slide boxes). xviii. Proper/adequate ventilation, maintenance and exhaust fans require in the TB ward/DMC lab (as per guidelines of ACH flow). xix. While general health system through NHM has good IEC budget and activities, integrating TB in that will enhance reach. xx. CMHO generally not aware of TB Program as all financial powers are vested with DTO and TB is exclusively under DTO, ensuring mechanism for CMHO to review TB Program in the district and advise and involve will help in addressing some of the gaps. TB forum could be a mechanism to do that. xxi. No State and District TB forums are being initiated as the directive from Chief Secretary suggests no new forum to be created. This require resolution by CTD. xxii. Remuneration of STS and STLS are much lower and require a relook in commensurate to their work as similar positions under NHM and other departments. xxiii. Financial guideline with 10 percent additional fund for tribal areas is not sufficient. Also, the financial norm for engaging NGOs for community mobilization is quite less and NGOs have to depend on other sources of fund to work as required. This should be revisited by CTD for revision. xxiv. One of the major challenges at DTO level is to do proper procurement of services by NGOs and other agencies and require capacity building in this procurement of services. 4. Jhadol PHC in tribal Free and prior informed i. Overall the community support the Program and see the benefit area, SWACH NGO consultation (FPIC) with tribal from it. training centre at Jhadol community in Jhadol block, ii. No tribal patients receiving the transport reimbursement as the block including discussion with MO, ANM district and the block is not notified by STC as tribal area – which is and other outreach staffs of Jhadol non-adherence to following Ministry of Tribal Affairs designated PHC and tribal TB patients (men tribal areas. and women); discussion with NGO iii. The SWACH Mitras – trained volunteers by the NGO working in (SWACH) extension workers placed each of the tribal village of the block helped tremendously in case in each tribal village/ panchayat of finding and linking with treatment. However, the NGO could 69 Sl. Consultations Key Issues Noted Officials/ People Met No. Undertaken support them through trying to source fund from NHM under the the block working as TB extension Tribal Sub Plan head for doing other activities. worker (called Swach Mitra). 5. Pune: IRL lab, DMC lab, i. AIC committee not formed Dr. Padmaja Jogeshwar, STO; TB ward and Rural ii. Sample for GeneXpert analysis always collected from other districts Dr. P.L. Mane, AD HS; Dr. Sanjay health centre within 2-3 days by courier Darade DTO; Dr. Sandeep iii. HR issue: shortage of staff- Laboratory technician Bharaswadkar WHO consultant, Dr. iv. Space between bed to bed is not followed as per rules in TB wards Vaibhav Saha WHO consultant; Ms. v. BMWM training requires to the staff and bar coding on waste Shilpa Balyam C&DST STDC (IRL- disposal bags are not being done. microbiologist); Dr. Balaji Lakade vi. Stock shortage of BMW collecting color polybags Medical Officer PHC; vii. Health insurance not provided to contract staffs at DMC, RNTCP, IRL Dr. Udawant & Dr. Sayali, TB ward laboratory and RHC. and other lab staff. viii. AMC for critical equipment is an issue and needs to be addressed. ix. Accident reporting can be strengthened and remedial measures. x. E- waste and spill management is require in HCF. xi. Disposal of used chemical reagents is done through disinfection and disposal in municipal sewage system. xii. Biomedical waste from labs and HCF was being segregated and disposed in correct bins. Collection system is done through private sector. xiii. Ventilation, repairing and maintenance require in DMC lab. 6. Dimphe Khurd Tribal MO, ANM, STS, STLS, other PHC i. Overall the community support the Program and see the benefit PHC, Awegaon, Pune staffs including four ASHAs from it. associated with PHC and working in ii. ASHAs and ANMs linked to PHC doing active case finding and are tribal villages; able to link TB patients to treatment. FPIC with tribal community and iii. One of the challenge faced is for x-ray facility not being nearby and patients including men and women no transportation assistance from the Program for the same being received. 7. Mumbai: Pt. MM i. AIC committee formed. Need strengthened. Dr. Shalini Bhagat Dy Director TISS; Shatabdi Hospital, ii. Behavior changes of staff towards the adopting safety and BMWM, Ms. Shweta Bajaj Sr Program Govandi, CBNAAT lab, Awareness for Air borne disease control/ / health safety and Manager, Saksham TISS; Dr. TB diagnostic centre general cleaning of the hospital. Narender G. Sutar DTO, CBNAAT (DR TB centre); iii. Shortage of PPE/masks/gloves for Laboratory staffs lab; Dr. Dhayagude BMW incharge; Microbiology Lab, Sir JJ Dr. Shubhangi Mankar SMO DRTB; 70 Sl. Consultations Key Issues Noted Officials/ People Met No. Undertaken hospital and BMWM; iv. HR issue: shortage of staff- Laboratory technician, Doctors and Dr. Ameeta A. Joshi, MD 2nd October Health Counselors (Microbiologoy) SJJ hospital; Dr. post- Bhoiwada, Parel; v. Health insurance is not provided to contract staffs at CBNAAT, Ajay Dhawale, DTO; Dr. Lalitkumar and Microbiology laboratory, DRTB centre and other staff of the HCFs. D Anande, Medical Superitendent Group of TB Hospital- vi. Health checkup record is not maintained in CBNAAT laboratory and GTB hospital, Sewree, Mumbai and SEWRI, CBNAAT and health checkup is not being at regular intervals. Dr. Amit Karad, WHO consultant Biochemistry Lab vii. Shortage of BMW collecting color polybags supply viii. Hub cutter/ needle cutter is not available ix. E- waste and spill management is require in HCF. x. Dispose of chemical reagents through disinfection and disposal in municipal sewage system. xi. Biomedical waste from laboratory and HCF being segregated and disposed in correct bins. Collection system is done through private sector. xii. Microbiology lab of Sir JJ hospital is following good protocols for biosafety, health, fire, cleanliness and safety of workers. xiii. BMWM, Safety, PPE and IC training is requiring for the staff. Bar coding on waste disposal bags are not being done. xiv. DRTB centre require MRT, CT scan, and Sonography machine. 71 Photographs of Consultations and Site Visits Undertaken Discussion with Dr Sanjay Darade DTO, Lab technician Mr. Patole and other Lab staff DMC lab, District TB Hospital, Pune Patient Help desk, Geetanjali Medical college and Hospital, Udaipur PHC lab, Mann, Pune with Dr. Sanjay Darade DTO and Dr. Balaji Lakade Medical Officer and staff of Rural Health Centre, Mann Pune Discussion with District hospital TB wards on- duty Medical Officer Dr. Udawant, Dr. Sayali and Dr Sanjay Darade, DTO, Pune 72 Discussion with Dr. Rokade, Medical Officer, PHC Mann, Dr. Sanjay Darade DTO and PHC Staffs World Bank Consultant Mr. Ranjan Verma discussion with DTO Dr. Dinesh Kothari, Dr. Sanjay Sinha (WHO Consultant), Mr. B.K. Gupta(NGO-ALERT) and Mr Naresh Paneri, Mr Tyag Narayan (NGO-SWACH) and other staffs of District TB Clinic, Udaipur. Facility exclusively for TB patients in Department of TB and Respiratory Disease, Geetanjali Medical College and Hospital, Udaipur FPIC with tribal TB patients and village level volunteers (SWACH Mitra) working on TB in tribal areas of Jhadol Block, Udaipur 73 Discussion with STS and STLS from different TUs of Udaipur along with DTO National Consultation in New Delhi 74 ANNEX-4 Supplemental Environmental and Social Risk Screening Worksheet This section provides a program definition and describes the scope of the proposed Program, including its major investments, activities, and geographic coverage. Risk Assessment Associated or Likely Social and Environmental There will be no loss or conversion of forests Effects and natural habitats, as all Program activities (This section describes the potential benefits, impacts will take place within existing facilities in rural and risks that are likely to be associated with the and urban areas. GoI has rigorous regulations Program.) and policies for the protection and Environmental effects: conservation of forest and wildlife areas hence • Potential loss or conversion of natural any potential loss or conversion of natural habitats? habitats would not be permitted under the • Potential pollution or another project context of the Program activities. externalities? • Changes in land or resource use? The key sources of pollution under the project Social effects: will be the incremental increase in bio-medical • Nature/scale of involuntary resettlement or and liquid waste generated through the land acquisition required? expansion in diagnostics and treatment, this is • Potential impacts on vulnerable of moderate or minimal risk. This ca be communities? effectively mitigated by the existing waste • Changes in resource access? management rules and regulations for medical, • Are Indigenous Peoples affected? liquid and solid wastes. There is no major construction activity supported under the PETB, only minor renovation works will be supported for improvement in lab equipment, safety, and implementation of airborne infection control measures. There will be no adverse impacts on land or resource use. The Program does not intend to do any land acquisition or resettlement as it does not support any major construction and is limited to minor renovation and repairs within the existing footprint of the health facilities and laboratories. However, in order to rule out any adverse social effects and exclude activities/ sub-activities leading to land acquisition and/ or resettlement, screening will be conducted in facilities where any repair, renovation and/or expansion is proposed under the program. There will be no change I resource access and/or affect tribal population habitats. Environmental and Social Context The PTETB PforR will focused in 9 states Uttar (This section describes the geographical coverage Pradesh, Bihar, Maharashtra, Rajasthan, and scope of the Program and environmental and Madhya Pradesh, Tamil Nadu, Karnataka, West Bengal and Assam. Interventions will take 75 social conditions in the Program area that may have place within existing health care facilities and significance for Program design and RNTCP laboratory network in urban and rural implementation.) environmental settings. There will be no new Environment: construction activity/healthcare facilities, the o Does the environmental setting of PTETB will support renovation works, and Program pose any special challenges that installation of new equipment in existing need to be taken into account? laboratories and TB facilities. The o Program activities in or near sensitive environmental footprint will be limited to habitat areas? existing facilities and will not impact natural o Potential cumulative or induced effects? habitats and physical cultural resources. The Social: PforR will not involve any investment in or near o Area of social sensitivity such as sensitive natural habitats. Indigenous Peoples; vulnerable groups; conflict zones? Any new labs which come on board through PP o Potential cumulative or induced effects? scheme will comply with stringent accreditation criteria for private sector labs to comply with good biomedical waste and worker health and safety management. The key effects screened include the incremental increase in biomedical waste, and other general waste generated through the implementation of the PTETB Program, worker and public health and safety, biosafety in TB containment laboratories. Through screening, site visits and consultations, it was found that the potential risks and impacts can be avoided or minimized or mitigated. The program provides for special incentives in the tribal and difficult to reach areas for transportation to patients and sputum sample transportation to enhance access. However, in recent years some of these areas have been reporting a high incidence of not only drug sensitive but also drug resistant TB cases. The NSP 2017-25 also recognizes that there has been limited progress in the form of a special action plan for tribal populations and requires enhancing access and coverage not only through screening and treatment mechanisms, but also by adopting culturally appropriate ACSM and communication activities. With program intending to engage with private sector this is even more important, and RBTCP plans to position a dedicated staff at national as well as state level to coordinate these activities. The program does not anticipate or promote and exclusion of any groups in terms of caste, religion, and/ or geography by the program activities is not expected. 76 Program Strategy and Sustainability This PforR is a well-defined subset of GoI’s new (This section situates the Program, and its National Strategic Plan (NSP) for 2017-2025, environmental and social management systems, which encompasses several high impact within the country’s broader development strategy, interventions and implementation reforms to with particular emphasis on identification of factors accelerate the country’s progress and priority that may impede successful Program management interventions toward elimination of TB which is over time.) aligned with the global End TB Strategy and o Strategic context: What is the long-term Sustainable Development Goal targets. The vision of this Program in relation to the PforR will ensure the environmental and social country’s development strategy? sustainability under the context of o Does it include explicit environmental and governments’ continuous investment on the TB social management objectives? detection and treatment. through previously o Do Program activities commit, constrain or supported bank and other donor funded alter decisions of future generations? projects, there has been substantial capacity o Are there any potential roadblocks to building in CTD. ensuring the environmental and social sustainability of the Program after There are few bottlenecks in ensuring the implementation? environmental and social sustainability of the PforR after implementation. The Government of India is placing more emphasis on Biomedical waste management rules, 2018, have been updated to include more stringent provisions. CTD through RNTCP is improving institutional arrangements and providing more resources to enhance institutional capacity on infection control and AIC measures. There is also increased emphasis on worker health and safety, the Ministry of labour has prepared a preliminary draft on Code on Occupational Safety, Health and Working Conditions, 2018, by amalgamating 13 labour laws relating to safety and health standards, health and working conditions, welfare provisions for the workers. The focus on prioritizing and inclusion of tribal community, people living in difficult areas, migrants, slum dwellers, people with HIV, and other vulnerable communities, women and children are already identified as part of the key population that the NSP has prioritized for achieving its goal. The proposed program aims to develop strategy in reaching out to key population and address their access to TB screening and treatment related issues. Institutional Complexity and Capacity CTD has already implemented three Bank (This section describes organizational, funded projects for Tuberculosis care and administrative and regulatory structures and management. While these projects are now practices, as they relate to environmental and social closed, the institutional setup is still functional assessment, planning and management.) and active, and the environment management o Does the Program involve multiple framework for bio medical waste management jurisdictions? or implementing partners? and capacity building remains relevant. Over 77 o Capacity or commitment of counterpart to the years, BMW has seen considerable implement regulations and procedures? improvement at all levels of healthcare o Is there a track record of commitment and facilities. This is indicative of good borrower implementation experience on environment capacity to deal with the environmental and social aspects? aspects of the proposed program. RNTCP is a o Are there any known institutional barriers part of the National Health Mission (NHM), and that would prevent the implementation of TB diagnostic and treatment services are this Program? integrated in the government health system o Is there sufficient institutional capacity to nationwide. State level BMW and AIC address the environmental and social impacts committees are responsible for providing of this Program? technical guidance to the facilities. The collection, transport and disposal of medical wastes are carried out by specialized agencies in the private sector that also operate the treatment and disposal facilities. The stigma reduction and discrimination issues associated with TB requires a sustained advocacy and social mobilization (ACSM) activities and Social and Behavior Change Communication (SBCC). The mechanism for implementation of ACSM and SBCC have been well thought out and evolved over the last three projects, though requires updating with changing context and strengthening implementation. This PforR will involve national, state and district level institutions for environmental, social, and health and safety management, and their roles are clearly defined. environmental and social concerns will be effectively addressed by monitoring and quality assurance through the RNTCP institutional network. The institutional capacities will be adequate to manage the environmental and social risk associated with the PforR. Reputational and Political Risk Context There are no potential governance issues, and (This section describes environmental and social the sector is not controversial. issues, trends or other factors that may cause the program, the country, or the Bank to be exposed to significant reputational or political risk.) o Potential governance or corruption issues Are there any political risks associated with this sector or proposed Program? o Is the sector or Program known to be controversial? Overall Assessment: The proposed activities under this PforR, are (This section describes the overall risk profile for the suitable to be supported according to the Program, based on the team’s subjective weighting World Bank PforR Policy, and Directive. There and aggregation of all factors identified above. are no large infrastructure investments/ 78 Environmental and social risk factors should be activities that pose a risk of potentially summarized separately). significant and irreversible adverse impacts on Is the proposed Program suitable for PforR or would the environment and health that would it be better suited to a specific investment loan? normally be considered Category A-type investments under investment lending policies. The environmental and social risk is moderate and can be effectively managed under the current EHS and environment and social system. 79 ANNEX-5 Suggestive Topics for Capacity Building on Environmental Health and Safety Aspects Area Topics Stakeholders 1 Awareness on national CTD, State and District TB ▪ Government of India and guidelines and legislation officers state environmental including development of And TSUs /implementing guidelines, legislation, and required guidance material agencies project guidelines on BMWM and infection control. 2 Occupational Health and safety All HCF workers, and lab ▪ Safety concerns, staff under the Program operationalization of safety procedures, PPE and their use, safety equipment. 3 Safety in Laboratories Laboratory Staff ▪ Safe Disposal of Hazardous and Chemical wastes ▪ Prevention of laboratory- acquired infections ▪ Accidents and Spills 4 Sputum Collection and Laboratory and Sputum ▪ Practices for Safe Collection Transport Transport Workers of Sputum ▪ Biosafety and use of Spill Kits 5 Development of Facility Level State and District TB ▪ All high-risk areas for TB Airborne Infection Control plans officers transmission should have an airborne infection control plan and a facility person or team responsible for AIC. ▪ Plans should be formulated as per national guidelines and provide area-specific AIC and IC recommendations for the facility including the laboratory which should have its own specialized standard safety procedures. 80 ANNEX – 6 Safeguard Screening Checklist FOR PRELIMINARY ASSESSMENT OF HEALTH CARE FACILITIES (This screening format needs to be filled under the guidance of health care facility/ Laboratory in-charge to rule out any adverse environment and social impacts due to program intervention.) 1 Name of the District 2 Name of the Block 3 Name of the Health Facility/ Laboratory 4 Category of health facility/ Laboratory 5 Requirement of Land for any renovation Yes/ No and expansion beyond exiting land (If Yes, give details below; In case No – Q.6 to available with the health facility Q.11 are not applicable) 6 Is the site identified for the proposed Yes/ No (If Yes, give details below) activities under the program 7 Is there a need to acquire the land for If Yes- Activity not eligible proposed activities No 8 Any other specific information related to Give details land 9 Are there any squatters living on the Yes / No (If Yes, give details below) proposed land 10 Are there any commercial structures on the Yes/ No (If Yes, give details below) land proposed 11 Is the land proposed is being used for Yes/ No common property resources - such as water (If Yes, please write details about the structure supply structure; sanitation structures; and its use by local residential/ commercial/ power supply infrastructure etc. or institutions) approach way Is there any encroachment or any claim on Yes/ No 12 the proposed land (If yes, give details of from when and what kind) If Yes, report to STO/ CTD for necessary action 13 Are there photographs of the construction Yes/ No site/ land enclosed 14 Yes/ No 81 Has there been any ‘Yes’ answer to any of If Yes, Report to STO/ CTD for necessary action the screening point # 9,10, 11 and 12 above 15 Does this facility contain high risk setting? Yes/ No (DR-TB Centre, ART Centre, TB Containment Lab) If Yes Yes/ No • Are the requisite systems of AIC being followed? Yes/ No • Health Checkup of Workers being conducted? Yes/ No • Immunization of Health workers Yes/ No being conducted? Yes/ No • Is PPE readily available? Yes/ No • Are healthcare and sanitary workers trained on IC and BMW management? 16 Has the state/district AIC officer/ Yes/ No committee approved the required renovations? 17 If facility is a Lab • Is all Lab Safety Equipment in Yes/ No Working Condition? (BSC, AHU, Centrifuge) Yes/ No • Is there fire detection system operational • Is there a biomedical engineer to oversee engineering protocols of equipment and conduct safety tests? 18 Is BMW being suitably segregated, Yes/ No collected and disposed? 21 Is there a dedicated officer/ committee on Yes/ No BMW, IC, AIC at facility level? 26 Is liquid waste and wastewater being Yes/ No generated from the facility suitably disposed? Is an ETP required for the facility? Yes/ No 27 Will renovation activities have an impact on Yes/ No air quality, noise and impact patient health or treatment within the HCF? 28 If Yes to #28 have the requisite mitigations Yes/ No been incorporated into the construction contract? 82 29 Does the renovation work involve removal Yes/ No of asbestos sheeting/pipes? If yes, then is will be required to be dealt with as per the national guidelines on hazardous waste management rules. In-charge of Health care facility/ Laboratory District TB Cell/ DTO Name……………………………. Name: ……………………………………………… Designation: ……………………. Designation: ……………………………………………. Phone No. …………………….. Phone No. ……………………………….. Signature ……………………… Signature…………………………………… Date: ……………………………. Date: ……………………………………. 83 ANNEX -7 Multi-stakeholder Consultation workshop 1. A multi-stakeholder consultation workshop was held in New Delhi on 26 November 2018 on the draft ESSA. The Purpose of the consultation was (a) to gather to share ESSA findings and seek views from a wider range of stakeholders connected to the programme (b) establish consensus on environmental and social effects of the programme, and proposed PAP actions and (c) agree on measures for monitoring environmental and social management performance 2. The participants agreed with the key ESSA findings and recommendations and provided additional actions for environment and social system strengthening. During the preparation and appraisal process for the PforR, the actions recommended below will be clarified through consultations with program counterparts and specific agreements will be made to address recommendations by including them in the Program Action Plan (PAP) and/ or Program Implementation Plan. Implementation of these actions will result in the environmental and social management system for the Program considerably strengthened and set on a more sustainable path which will likely extend beyond the life of the Program. 3. The participants and CTD were informed about disclosure process for the ESSA, and period for public comment prior to ESSA finalization. Table 9: Key Comments Received Through Consultations and Responses S. Comments/Suggestions from Participating How the Program Design Addresses These No. Stakeholders 1 • Biomedical waste management requires significant • Dedicated capacity at State level- expert/ capacity strengthening at all levels to be specialist who can support BMW, IC and AIC implemented successfully. planning and implementation with the STO 2 • Biosafety, BMWM and equipment with respect to • A guideline specific to different types of IRL, DMC and TU level labs requires standard facilities for BMW management to be operating procedure. prepared by CTD. • Maintenance and repair of IRL equipments • Develop a specialized unit in NTI for supporting IRLs across states 3 • Airborne infection control is poorly understood and • Requires CME with AIC as a topic poorly implemented. • Infection control committee should have the • AIC and waste management committee/ Officer is AIC as part of it. mandatory and shall be implemented • Make designated person for AIC at district • DTOs capacity building required on AIC level • AMC for all Equipments to be ensured • Allocate funds for AMC and phasing/ • Engineer’s at NHM and PWD requires capacity replacement of equipment building on methods • Update and develop fact sheet for BMW and AIC including PPEs 4 • Biosafety guidelines of procurement and • Potential vender list to be prepared and maintenance of Equipments from IRL lab should be circulated/ published by NRL/ CTD. made available 5 • Tribal health action plan for TB is the requirement of • Program should give flexibility to state for the day and should be prepared in culturally planning and implementing tribal action plan appropriate manner. for TB. 84 S. Comments/Suggestions from Participating How the Program Design Addresses These No. Stakeholders • Given the heterogeneous nature of tribal population • State incentive money can be used for across state and district, there should be flexibility at showcasing innovations in tribal health. state and district level to plan based on local context and implement. 6 • Stigma and discrimination being one of the • SBCC to incorporate the communication important areas in dealing with TB, focused and strategy for stigma reduction. continued communication with target community is important. 7 • Monitoring for incidence of TB cases and treatment • The framework for development and outcome for women and children should be adaptation streamlined. 8 • Currently there is a shortage of biomedical • Need to utilized bio medical engineers under engineers, and microbiologists are conducting the NHM to support RNTCP lab network. tasks of engineering controls • Creation of specialized unit in NTI Bangalore for this purpose, that can travel to all 64 IRLs and provide technical support. 9 • Additional capacity needed at State level to support • Environment expert at State level environment and social aspects- BMW, IC, and AIC • AIC to be mainstreamed with IC officer in medical college and IC committee and district level. • State officer on social safeguards to be hired 10 • State and district level capacity to roll out citizen • State level expert institution to be hired to engagement and accountability mechanisms is very support roll out of TB forums at state and weak and needs strengthening district level 11 • No guidance to health professionals/ health system • Develop abbreviated guidelines for planning on implementation of engineering measures such as and retrofitting DR-TB centres to conform with ventilation systems, effluent treatment plants etc. national guidelines on AIC, IC and BMWM. This • Civil engineers/PWD supporting health centre includes guidance on consumables (PPE, construction are not sensitized to the needs of chemicals, vendors, suppliers) health care facilities and specific requirements of DR_TB centres. 12 • No clarity on budget head for consumables • State Environment expert to support (chemicals, disinfectants, and PPE) for RNTCP STOs on better planning of PPEs in annual specifically- as budget is part of NHM and health planning/ PIP, and facilitate better facility as a whole. Though TB care requires higher coordination with NHM adherence to use of PPE to protect worker health and safety • IRLs are not covered under NHM and hence budget is dependent on the medical college. 13 • No guidance on use of plastics, Styrofoam (sputum • State TB cell to further discuss with CTD transport) in Maharashtra due to plastic ban as part on alternative mechanisms of Government program. 14 • Need up to date guidance on Environmental • Preparation of guidance tools for STOs practices and norms (given many updates in policies, and DTOs under institutional capacity regulations and guidelines) for RNTCP building. environmental management systems to conform to national systems. 85 86