NTEP (National TB Elimination Programme) — Latest Guidelines

1. Case Definitions

2. Diagnostic Algorithm

2.1 Initial Diagnosis

• All presumptive TB cases → CBNAAT (Xpert MTB/RIF) or TrueNat MTB as the first-line diagnostic test (replaced sputum smear microscopy as the primary tool)
• Smear microscopy retained where molecular tests unavailable
• Chest X-ray as adjunct; AI-based X-ray screening (CAD4TB) at sub-centre level
• LF-LPA (Line Probe Assay) for rapid detection of isoniazid and rifampicin resistance in smear-positive specimens

2.2 Drug Resistance Testing

• All bacteriologically confirmed TB cases → DST cascade:
  • Xpert MTB/RIF Ultra → detects RIF resistance
  • LF-LPA (FL-LPA + SL-LPA) → detects resistance to FQ, second-line injectables, isoniazid (inhA/katG)
  • Liquid culture + phenotypic DST (MGIT) for confirmation and individualised regimen
• Whole Genome Sequencing (WGS) — being scaled at National Reference Laboratories

2.3 Extrapulmonary TB

• CBNAAT on relevant specimen (CSF, pleural fluid, lymph node aspirate, etc.)
• Histopathology + AFB culture on tissues

3. Treatment Regimens

3.1 Drug-Susceptible TB (DS-TB)

• Daily therapy under 99-DOTS (differentiated treatment delivery); no more thrice-weekly regimens
• Fixed-dose combinations (FDC) used throughout
• Pyridoxine (B6) co-administered with H to prevent peripheral neuropathy

• TB meningitis / spinal TB with neurological involvement: extension to 9–12 months (2HRZE / 7–10HR)
• Isoniazid-resistant TB (HR-TB): 6RZELfx (6 months — Rifampicin + Pyrazinamide + Ethambutol + Levofloxacin)

3.2 Drug-Resistant TB (DR-TB)

MDR/RR-TB — BPaL-M Regimen (Preferred, 2023 update)

• Bedaquiline: extended to 24 months if needed; QTc monitoring mandatory
• Linezolid: 600 mg/day; monitor for myelosuppression, peripheral neuropathy, optic neuritis
• Injectables (amikacin, kanamycin, capreomycin) largely phased out

Key NTEP DR-TB Programme Points

• All MDR-TB patients enrolled on NIKSHAY (web-based case management)
• PMDT (Programmatic Management of Drug-Resistant TB) at designated DR-TB centres
• C-DST (Comprehensive DST) before regimen initiation

4. Preventive Therapy (TB Preventive Treatment — TPT)

• Tuberculin Skin Test (TST) ≥5 mm or IGRA positive used to guide TPT in HIV-negative contacts
• TST/IGRA not mandatory before TPT in high-burden settings; ruled-out active TB is sufficient

5. Monitoring & Follow-up

DS-TB

• Sputum smear/CBNAAT at end of intensive phase (month 2)
• If positive at month 2 → extend IP by 1 month; re-test
• Sputum smear at month 5 and month 6 (end of treatment)
• Treatment outcomes: Cured / Treatment completed / Failed / Died / Lost to follow-up / Not evaluated

DR-TB

• Monthly sputum smear + culture during treatment
• Culture conversion (two consecutive negatives ≥30 days apart) = key milestone
• DST at treatment failure
• ECG (QTc) monitoring: baseline, week 2, 4, 8, 12, then monthly (for Bdq, Dlm, Cfz)

6. Special Populations

TB-HIV Co-infection

• ART started within 2 weeks of TB treatment initiation (regardless of CD4 count)
• Exception: TB meningitis — ART deferred to 4–8 weeks
• Preferred ART: Dolutegravir-based regimen (dose adjustment not required with Rifampicin in adults >30 kg)
• Cotrimoxazole prophylaxis for all TB-HIV patients

Paediatric TB

• Child-friendly FDCs (dispersible tablets) per weight-band dosing
• NTEP 2023 recommends CBNAAT on all paediatric presumptive TB samples
• Shorter 4-month regimen (2HRZE/2HR) under trial for non-severe TB in children (WHO 2022); NTEP evaluating adoption
• MDR-TB in children: BPaL/BPaLM with paediatric dosing guidance

Pregnancy

• DS-TB: Standard 2HRZE/4HR — safe; avoid streptomycin
• DR-TB: Bedaquiline and linezolid used with caution; pretomanid safety data limited
• Breastfeeding: not contraindicated; infant should receive INH prophylaxis

Diabetes mellitus

• Screen all TB patients for DM (FBS/HbA1c)
• Screen all DM patients for TB
• Bidirectional screening mandated under NTEP

7. Nikshay & Programmatic Components

8. Key Updates (2022–2023)

1. BPaLM/BPaL adoption for MDR/XDR-TB — aligned with WHO 2022 consolidated guidelines
2. Xpert MTB/RIF Ultra replacing standard Xpert for higher sensitivity (especially paucibacillary/EPTB)
3. TPT expansion to all household contacts (not just <5 years or HIV-positive)
4. WGS scale-up at NRLs for comprehensive resistance profiling
5. AI-based chest X-ray screening (CAD software) integrated at peripheral levels
6. Decentralised DR-TB treatment — MDR-TB patients no longer require hospitalisation for initiation
7. Delamanid available for children with MDR-TB where BPaL not feasible

Sources: NTEP Technical & Operational Guidelines for TB Control in India (MoHFW, 2016 updated 2022–23); NTEP DR-TB Guidelines (2022); WHO Consolidated Guidelines on TB (2022); WHO TB/HIV Guidelines (2023); Central TB Division, Ministry of Health & Family Welfare, Government of India.