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White Paper on Strategic Framework towards National TB Elimination Programme (2025-2035): India

Background:  As per WHO data published in 2024, India has registered 18% reduction in TB incidence and 24% reduction in TB related deaths in 2023 when compared with base year of 2015.[1] Still India is one of the high burden countries that accounts for 26% of TB disease burden, 27% of mortality due to TB globally. More than one fourth of TB cases are estimated to be in India. To reduce the disease burden and mortality, the ongoing National Tuberculosis Control Programme has been restructured to include newer diagnostic algorithm, addressing the gaps and delays across TB care cascade.  To accelerate the activities and give momentum multi-pronged strategies have been adopted. To ensure notification from private health sector, patient provider support agency (PPSA) was entrusted to promote private sector TB notification in Nikshay. The purpose was to decentralise the services to private healthcare services and to trace the missing cases and provide timely public health actions like drug susceptibility test (DST), drug adherence, comorbidity testing and contact tracing.  PPSAs have been instrumental in increasing notification in Nikshay. This was possible due to synergistic effect of State Technical Support Units (STSU) and PPSAs working together for improving quality of services accessible and available to TB patients notified in private sector. Similarly, campaigns like “TB Mukt Gram Panchayat Initiatives” and “100 days intensified campaign for TB elimination” aimed at reaching to the helmets and Panchayat in line of the strategic pillars of detect, treat, prevent and build. The Strategic document 2017-2025 has been a guiding document to guide the implementers and decision makers to take necessary changes in the approach.

Inspite of various efforts and commendable work done during this period, the programme has missed the target as it failed to reach even closer to the optimistic incidence rate of 44/lakh by 2025. The TB incidence rates of preceding three years have shown that disease is in its uphill of epidemiological curve especially high populated states like U.P and Bihar. This calls for reviewing the approach and develop strategic framework approach that more realistic in terms of milestone indicators, takes into consideration various factors that have direct or indirect impact and to be honest and fair in estimating the time frame by when TB can be actually eliminated from India.

1. Reviewing the shortcomings and learnings of the previous years
2. Ambiguity in TB Notification Policy: In 2012, by Gazette Notification** India made TB notification mandatory. However, paradoxically, incentives were later introduced for notifying TB cases. This creates ambiguity because If notification is mandatory, then everyone especially medical practitioner is obligated to notify TB cases. Failure to do so shall result in filing of FIR against such practitioners. At the same time introduction of incentive to private providers for TB notification is an appeasement policy and two extreme ends do not go well in theory and are neither legally or morally correct. This calls for clear policy guidelines and strict legal enforcement and compliance. Incentives should be given only for active case finding only.
3. Duplicacy in Payments: For same notification and treatment outcome private providers are paid incentives and the patient provider support agencies are also paid for notification. It is duplicacy and blatant misuse of Public Money. This leads to redundant spending and inefficient utilization of public funds. If both are being paid for the same patient, it results in double counting and inflated expenditure. Payment mechanism should be streamlined by linking payments to verified patient follow-up and treatment completion by augmenting use of AI in patient tracking. 
4. Cost-Benefit Analysis & exploring engaging Health Insurance The cost of treating a drug-sensitive TB (DSTB) patient under NTEP is approximately Rs. 15,000 per patient. With 2.5 million patients notified annually, the total cost incurred upon treatment would be approximately Rs. 3,750 crore per year. If TB treatment is included in PM-JAY and all the treatments are done through empanelled health care facilities, it will ease of the load on overburdened health system. The Govt. health system would look into adherence, follow-up and management of DRTB cases. If TB treatment is included in PM-JAY, insurance companies would regulate costs and improve efficiency. In such scenario, the Government should act as a regulator. Health insurance integration would bring transparency and financial sustainability to TB care.
5. Supply Chain Failures: Drug and Diagnostic Shortages Despite significant budget allocation, NTEP struggles to ensure continuity of drugs, cartridges for GeneXpert, chips for Truenat and other consumables. Supply disruptions lead to interruptions in treatment resulting in adverse treatment outcome. Once this cycle is broken, its impact will result in delay in achieving the elimination targets by couple of years. This necessitates Implementation of  real-time digital supply chain system with automated alerts to prevent shortages on pilot basis which may be scaled up in phase wise to cover whole country.
6. Delays in DBT Payments: The Direct Benefit Transfer (DBT) scheme under Nikshay Poshan Yojana provides 1000/month to TB patients during the course of treatment. However, delays in payments often lead to financial distress and unfavourable treatment outcomes. This mandates transparency in fund disbursement. Article 21 (Right to Life) and Article 47 (Duty of the State to Improve Public Health and nutrition) makes State duty bound for timely DBT as part of constitutional obligation. Delayed payments violate the right to dignified treatment and basic nutrition. The current phase of programme requires legal accountability measures for delayed payments.
7. Lack of Supply-Side Readiness:  NTEP has introduced multiple approaches (e.g., active case finding, community engagement, PPSAs, TB free Gram panchayat certification) without ensuring adequate supply-side readiness. At the same time increasing demand due to escalated demand-side strategies (creating awareness, engaging private providers) are increasing patient load but supply-side constraints (limited diagnostic centers, shortage of drugs, and lack of trained staff, lack of funds for DBT payments) create bottlenecks. A phased implementation and staggered approach ensuring supply-side strengthening before expanding services to hamlets.
8. Contradiction in output of TB Mukt Gram Panchayat and 100-Day Campaign:  The TB Mukt Gram Panchayat initiative and 100-day intensified campaign have contradictory implications. Former suggests TB elimination is achievable while later assumes high undiagnosed prevalence, indicating ongoing transmission. TB is still at the uphill phase of its curve in States like U.P and Bihar, making elimination unrealistic at this stage. Therefore, it is recommended to focus on long-term structural improvements rather than short-term symbolic campaigns which will actually derail the programme.
9. Underpaying Grassroots Workers: Communist economic theory states that profit is the unpaid share of workers’ contribution. The same applies to NTEP. High expectations from grassroots workers (NTEP staff like STS/STLS/DEO/LT/DPS, ASHA, ANM) and inadequate salaries and incentives lead to dissatisfaction and the staff are not motivated enough to pull through the indicator driven programme. This results in reduced program effectiveness and increased attrition among frontline workers. There is a need to have comparative realistic “wage structure” and “performance-based incentives” for field staff.
10. Engaging PPSAs in more efficient manner: The current contractual arrangement for private patients is very loosely managed. There is duplicacy in payment to private providers and PPSAs for notification and treatment outcome of same patient but they do not have control over quality services as the services like NAAT testing, DBT payment, Govt. FDC drugs availability is govt. driven. There is a need to review and adapt the learnings from PPIA Model which was more efficient and had control over the quality-of-care cascade both financially and technically. It fully integrated all private TB care into a single system. – It provided dedicated support for private TB patients. Therefore, all private TB care should be handled by PPSAs, ensuring a “single-window approach” for private sector engagement with financial power to procure drugs, logistics and DBT payments.
11. Exaggerated appreciation of achievements: In 2023, Districts were selected and recognised for reduced TB notification from 2015 during World TB Day celebration. Many of these districts have shown increasing trends in TB notification in subsequent years. Similar is the scenario with TB Free Gram Panchayat Certification. The programme has not matured enough at this stage. This actually makes a dent in the spirit and approach.
12. Reliance on flawed estimate data: One such flawed estimate is calculation based on drug sales. As per economic consumption pattern, for each unit of consumption at least 10 units readily available in shelf. This becomes even more complicated when there is no drug sales data below capital city due to grey market. Such kind of estimates and reliance often confuse the scientific temperament.

• Suggestive Framework
• Defining TB notification indicators as per elimination strategy:  National Strategic Plan 2017-2025 has set milestone TB notification target of 44 per lakh population which does not sync well with epidemiological definition of elimination.  As in disease like Leprosy elimination level is fixed as occurrence of annual new case of less than equal to one case per 10 lakh population. Similarly, it is suggested to have a global universal indicator for TB elimination which is realistic and achievable.
• Estimating the time-line with current trend of decline rate: The TB notification rate in 2022 and 2023 are 242 and 179 cases per lakh. With this trend of decrease, India may take another 75 years to reach to a level of <1 case per lakh per year. To accelerate the pace of decline there is a need to stagger current approach to aim at annual reduction rate of cases by 25% so that TB can be eliminated by 2047. The antagonism in the approach is that two of the highly populated states like U.P and Bihar are still in the uphill of the epidemiological work with less presumptive TB examination rate. These two states have the potential to change the trajectory as more missing cases are there in these two states with migrant population and skewed socio-economic indicators.
• Setting the realistic time bound indicators: Amidst all this fact premise, it is evident that strategic framework should be developed for at least 10 years in mind. Shorter duration itself will put undue pressure and overburden the struggling infrastructure. Even aiming to reach notification of 44/lakh will require optimum resource escalation, one window fund allocation, minimizing the bureaucratic barriers, empowerment of development partners and support agencies.
• Legal Framework Approach for TB Elimination: TB is a disease that requires early detection and treatment else it may cause death due to disease. For a republic and socialistic country, Article 21 read with Article 47 gives every person right to free and quality health care services for TB diagnostics, treatment and nutritional support. The magnitude and suffering due to disease are of such magnitude that it requires framing of “TB Elimination Act”. TB is covered under Entry 29 of the Union List (Schedule 7 of the Indian Constitution), allowing the central government to enact national laws superseding state provisions.  The Act shall advocate for making District level committees having power to adjudicate matters related to TB notification, non-availability of drugs, grievance redressal mechanisms for delayed or non-payment of Direct Benefit Transfer for nutritional support. The Committee shall ensure compliance to Mandatory TB notification as per the official gazette issued in 7^th May 2012.

The Act shall specifically have provisions for data privacy and security in conformation with Section 72A of the IT Act, 2000 that warns against unauthorised use of data and may invoke criminal liability. The Act shall incorporate and adapt the provisions of the Epidemic Diseases Act, 1897 to ensure legal accountability for non-reporting and Implement penalties for non-compliance while ensuring legal protection for whistleblower doctors. Ensure anonymized patient identifiers in Nikshay to protect patient confidentiality.

• Strengthening and expanding the role of State Technical Support Unit (STSU): STSU have been started to support PPSA agencies in nine states through funding from World Bank.STSUs have been instrumental in increasing private notification through regular monitoring and supportive supervision while working as catalyst. The joint effort of STSU-PPSA have resulted in increase private sector notification. The results have been phenomenal in States of Bihar where incremental growth in private notification has been 19% and 11% in year 2023 and 2024 respectively. The current strategic framework suggests for a more empowered and strengthened STSUs where the members should be placed regionally rather than at State head quarters for better day to day inputs and hand holding support at the districts and sub districts. All the STSU team should look into all domains rather than domain specific consultants. STSU shall be engaged in data quality assurance, demand forecasting, development of PIP, training and capacity building. A dedicated fund should be allocated for training and capacity building of STSU team as per programmatic needs.
• Models for Implementation: This paper advocates for three models of implementation. Each model has its own strength and limitations.
• Traditional System: Heavily dependent upon govt. healthcare system. Strength: strong healthcare system upto last mile. Weakness: slow in response time. The budget needed is Rs. 30000 crore/year.
• Health Insurance Model: Include TB treatment AB-PMJAY. Estimated cost of TB treatment for 25lakh TB cases per year will amount to Rs. 50000 crores. The Govt’s role will be of regulator.
• PPM model: where PPM/PPSA agency will establish one stop diagnostic centres in District HQ of identified 347 districts under 100 days intensified campaign for TB elimination. PPSA will do away with current contract-based notification tracking and would dedicate in establishing diagnostic centres. Private sector notification per se will be managed by DTC for which NTEP staff shall be incentivized nominally upto Rs. 50 for tracking whole care cascade from notification to treatment success. The budgetary allocation under this model shall be Rs. 35000 crores annually.

For meeting the budgetary requirements, it is suggested to have committed proportion of MPLAD, Prime Minister Relief Fund and to introduce TB cess as an interim measures. Resource allocation from CSR fund can be introduced in finance commission report.

[1]https://worldhealthorg.shinyapps.io/TBrief/?_inputs_&sidebarItemExpanded=null&sidebarCollapsed=true&iso2=%22IN%22&entity_type=%22country%22

1. Lack of proof of valid informed consent : Failure to communicate the possible outcomes of FESS surgery and post surgical complications, like fluid leakage, fracture of bone, injury to nerves that may even lead to blindness are often the main concerns of the affected patients that often holds attending surgeon guilty in the court of law.
2. Failure to meet standards of care: While ascertaining the onus, it is evaluated whether the surgeon has taken care of standard of practice prevalent in FESS. For this, Bolam principle is applied that there was deficiency of service and that resulted in the injury to the plaintiff causing irreparable loss.
3. Injury to Surrounding Structures: FESS involves working anatomical structures with thin bony walls surrounding the orbit, optic nerve, and internal carotid artery. Accidental injury to these structures can lead to serious complications like blindness, or even death. Such situation can result in medical negligence cases if not done with due care.

Cadavers are used by Medical Colleges for academic and research purposes for imparting education, demonstration and hands on practice to the medical students. Besides this, cadaveric organs like Kidneys, heart and liver can be transplanted. Skin, cornea and bones are also used for grafting and reconstructive surgery.

All this involve use of human body therefore, it requires stringent compliance and protocols that are governed under various statutory laws. In India, competent authority can permit to use cadaver for above mentioned purposes subject to valid consent and approval in accordance with the applicable laws. The law takes care of irrational and illegal use of cadaver that are in contravention to the provisions and has penal action.

The cadavers can be acquired through voluntary donation, unclaimed body duly handed over in compliance to statutory and legal norms and may be procured through licensed cadaver supply agencies that are legally compliant.

For cadaver obtained through voluntary donation or unclaimed body does not incur fee except that it should be legally obtained whereas procuring through agencies incur cost that may vary. However, it must be noted that the cadaver body given for the purpose of cremation or interment cannot be used for any other purpose other than the purpose of performing the last rights.

In Parmanand Katar Case (1989) and Ashray Adhikar Abhiyan Case (2002), the Supreme Court reiterated that the right of deceased must be ensured and it encompasses the right to life with dignity and honour as enshrined in Article 21 of Indian Constitution. The handing over of cadaver is governed by state specific laws. In Independent India, The Anatomy Act of 1949 was framed based on Coroners Act. But every State has its own ACT that governs the manner in which cadaver can be acquired.  Therefore, there is various in ‘aims and objects and definitions across states. For the purpose of donation of Human organs, specific law has been framed and amended. Human Organ Transplantation Act. Disposal of cadaver after use should be done in accordance with Biomedical Waste (Management and Handling) Rules, 2016.

Tuberculosis is one of the most dreaded disease due to it’s nature of spread, morbidity and mortality. It attacks the host body wherever immune system is weak be it HIV infection, age specific vulnerability, comorbidity or history of tobacco consumption or alcohol.  India accounts for more than one fourth TB disease burden and mortality. This necessitated to accelerate the revised national tuberculosis control programme to reframed to national tuberculosis elimination programme.

To assess the progress made and take corrective measures 2015 has been taken as a base year to track the progress. Central TB Division developed National Strategic Plan that gives a roadmap for the period of 2017-2025. The four broader pillars of strategy are detect, treat, prevent and build. Under these broader themes, Govt. affirms its commitment to provide free diagnostic services and ATT drugs for treatment to reduce morbidity and mortality with aim to reduce catastrophic cost due to tuberculosis.

In addition to this, Govt. extended direct benefit transfer of Rs. 500 per month to all notified TB patients during the course of treatment which has been further increased to Rs. 1000 per month from 1^st November 2024. The years bygone has marked expansion of diagnostic services especially molecular testing and extending the programme upto Panchayat level with commitment to make TB Mukt Panchayat.

However, there are various shortcomings that need to be addressed before generating demand for services as it will lead to make the vulnerable more miserable and helpless. The current programme has limited supply of ATT drugs, consumables and often delay in release DBT payment for nutritional support.

This paper will evaluate the legal dimensions and framework to understand the ambit and scope of Article 21 and Article 47 to understand Govt. liability for non-supply of ATT drugs, delay or non-payment of DBT. Failure to provide anti-TB services to the citizens attracts Article 21 harmoniously read with Article 47 that mandates Govt. to provide timely drugs, DBT under nutritional support because in absence of treatment there are chances of affected person to have severity of disease that may lead to death. The failure to commitment to provide services for TB is tortuous in nature and covers law of tort. Failure owing to negligent and callous behaviour of the TB Officials draws both criminal (IPC 304 A, 166 & 269) and civil liability and hence makes both Central and State Govt. accountable. TB patients who suffer due to shortages of ATT drugs or delays in DBT payments can file claims for damages against the state. Under IPC Section 304A, death of a person caused due to negligent act is punishable under Indian Criminal law. The Govt. authority having the knowledge of TB burden in their respective jurisdiction and not taking any corrective action to provide timely treatment to TB patients may be brought before Court of law if the death occurs due to non-availability of ATT drugs. At the same time, due to shortage of drugs and non-compliance to treatment due to shortage of drugs shall invoke section IPC 269 causing spread of infectious diseases due to negligent act of not providing committed ATT drugs. Criminal action against officials who knowingly allow shortages, PILs under Article 32/226, and right to compensation for affected patients.

Proper assessment, forecasting and allocation of budget for programme under DBT and judicial oversight are essential to preserve the fundamental right to health. The delay in taking corrective measures shall make the plight more worrisome and prolong TB crisis and erode away the right guaranteed under Constitution. It is suggested to create of fast-track health rights tribunals and judicial monitoring of TB control programs through Supreme Court directives.

Right to Die is a plea sought by terminally ill patients and their relatives who have no hope of recovery but in a rational society, it is the duty of executive and judiciary to preserve the health and life of it’s citizens as enshrined in Article 21 of Indian Constitution. In many European Countries and USA such provisions are there. In India, both legislature and Judiciary have cautiously observed for years before giving limited right of passive euthanasia under strict medical conditions. There are instances like the one in the matter of Aruna Ramchandra Shanubaug where patient has been in vegetative state for almost four decades with irreversible hope of recovery following assault in early 70’s. The matter came before the honourable Supreme Court where court rejected the plea for right to die but laid down framework for passive euthanasia depending upon severity and may be decided on case to case basis. Under passive euthanasia the life supports are withdrawn following the decision of medical board formed by competent authority.

This got further strong support in the matter of Common Cause v. Union of India in 2018 where it was held to create secondary medical board to decide the grant of passive euthanasia if it is done as living will in advance and has to be certified by the magistrate. It also directed legislature to frame laws rather than depending upon judicial precedents.

The directives laid down by the Supreme Court has paved way for recent judgement of Karnataka High court that further simplified the procedure for granting permission for passive euthanasia based on living wills of the patient based on advance medical directives.

Though,it is a progressive judgement but still caution has to be taken as people may give free living will in case of terminal illness owing to exuberant medical cost and at the same time there is every possibility of it being abused by the service providers also.