What are the key components of an effective tuberculosis (TB) program in India?

Tuberculosis Program in India

India's TB control program should be built on the DOTS strategy foundation with five core elements: government commitment, bacteriological diagnosis, standardized and supervised treatment, uninterrupted drug supply, and regular program monitoring, while simultaneously engaging private healthcare providers and addressing MDR-TB challenges. 1

Core Program Components

DOTS Strategy Implementation

The Revised National TB Control Programme (RNTCP) in India has achieved remarkable scale, becoming the fastest-expanding and largest DOTS program globally in terms of patients initiated on treatment. 2, 3 The program has demonstrated substantial impact:

• Coverage: Over 83% of India's population has access to DOTS services, with more than 200,000 health workers trained 4, 3
• Treatment outcomes: Success rates exceeding 80-86%, surpassing the international target of 85% 4, 3
• Lives saved: Approximately 600,000 additional lives saved during the first 8 years of DOTS implementation 1, 4
• Case detection: Achievement of 69% new sputum-positive case detection rate by 2003, approaching the 70% target 3

Diagnostic Standards

All persons with productive cough lasting 2-3 weeks must be evaluated for TB, with at least two (preferably three) sputum specimens obtained for microscopic examination, including at least one early morning specimen. 1

For suspected pulmonary TB:

• Sputum microscopy remains the cornerstone diagnostic tool 1
• Chest radiography for smear-negative cases with findings consistent with TB 1
• Laboratory confirmation should be pursued whenever possible to maintain quality standards 3

Treatment Protocols

The standard first-line regimen consists of 2 months of isoniazid, rifampin, pyrazinamide, and ethambutol, followed by 4 months of isoniazid and rifampin. 1, 5

Specific dosing:

• Adults: 5 mg/kg isoniazid (up to 300 mg daily) with rifampin and pyrazinamide 5
• Children: 10-15 mg/kg isoniazid (up to 300 mg daily) 5
• Alternative regimens: Twice or thrice weekly administration under directly observed therapy 5

Directly Observed Treatment (DOT)

All patients should receive DOT, where a healthcare provider or responsible person directly observes medication ingestion, as patient non-compliance is a major cause of drug-resistant TB. 5 This can be implemented with daily, twice-weekly, or thrice-weekly regimens. 5

Critical Program Challenges in India

Private Sector Engagement

The unregulated private healthcare sector represents a major challenge, with widespread irrational use of first-line and second-line anti-TB drugs leading to treatment failures and drug resistance. 2 The WHO Stop TB Strategy explicitly addresses this by mandating engagement of all care providers, as many patients initially seek care in the private sector. 1

MDR-TB Management

Multidrug-resistant TB (resistance to at least isoniazid and rifampin) requires individualized treatment based on drug susceptibility testing, with consultation from TB experts. 5 India faces an emerging MDR-TB threat resulting from deficient TB control in certain areas. 2

The program should:

• Implement rapid molecular diagnostics (such as GeneXpert MTB/RIF) for early detection of rifampin resistance 6
• Ensure universal access to second-line TB drugs for diagnosed drug-resistant cases 6
• Establish drug susceptibility testing for all newly diagnosed TB patients 5

Infrastructure Requirements

National TB programs must establish functional monitoring and evaluation systems with standardized indicators including: LTBI testing coverage, treatment initiation and completion rates, development of active TB during treatment, and drug resistance monitoring. 1

Essential infrastructure elements:

• Robust laboratory network for bacteriological diagnosis 1
• Uninterrupted drug supply chain 1
• Electronic data capture systems for real-time monitoring 1
• Multi-sectoral engagement with universal health coverage 1

HIV-TB Co-infection

The Stop TB Strategy must specifically address TB/HIV co-infection, as TB is a leading cause of death among HIV-infected people. 1 HIV-infected patients may require:

• Expedited diagnostic evaluation 1
• Screening of antimycobacterial drug levels due to malabsorption risk 5
• Careful management of drug-to-drug interactions with antiretroviral therapy 1

Monitoring and Quality Assurance

Follow-up sputum microscopy (two specimens) should be performed at completion of the initial 2-month phase, at 5 months, and at end of treatment, with patients showing positive smears at 5 months considered treatment failures. 1

Key performance indicators:

• Case detection rate (target: ≥70%) 3
• Treatment success rate (target: ≥85%) 3
• Laboratory confirmation rates 3
• Proportion of patients completing treatment 1

Financial Protection

Integration of TB services with universal health coverage schemes (such as Ayushman Bharat) is essential to prevent catastrophic costs and ensure free access to diagnosis and treatment. 7 This integration provides:

• Elimination of treatment delays 7
• Prevention of patient dropout 7
• Coverage across primary, secondary, and tertiary healthcare facilities 7

Common Pitfalls to Avoid

• Relying solely on governmental services: This greatly limits TB control efforts, as many patients seek initial care in the private sector 1
• Inadequate supervision during rapid expansion: Quality of services must be maintained during scale-up 3
• Premature cessation of treatment: Continuous administration for sufficient duration is essential, as relapse rates increase with premature stopping 5
• Using fluoroquinolones in diagnostic trials: These drugs are active against M. tuberculosis and may cause transient improvement, delaying proper diagnosis 1