NTEP - National Tuberculosis Elimination Programme

Background and Evolution

Vision and Targets

• Goal: Eliminate TB in India by 2025 (SDG 3)
• Compared to 2015 baseline, by 2025:
  • 80% reduction in TB incidence
  • 90% reduction in TB mortality
  • 0% patients facing catastrophic expenditure due to TB

National Strategic Plan (NSP) 2017-2025 / 2020-2025

1. DETECT

• Active Case Finding (ACF): TB Mukt Bharat campaign for awareness and early case finding
• Community screening
• Institutional screening
• Engagement of private sector providers
• Upfront NAAT (Nucleic Acid Amplification Testing) for diagnosis
• X-ray-based mass screening in high-burden districts

2. TREAT

• Daily fixed-dose combination (FDC) regimens replacing thrice-weekly regimens
• Nikshay Poshan Yojana (NPY): Direct benefit transfer of Rs. 500/month for nutritional support
• Private sector engagement under PMTBMBA (Pradhan Mantri TB Mukt Bharat Abhiyan)
• Drug-resistant TB management (MDR-TB, XDR-TB)
• DR-TB Centres: 20-30 bedded tertiary care facilities (147 established by 2017), one per ~10 million population

3. PREVENT

• TB Preventive Therapy (TPT): For household contacts and vulnerable groups (HIV patients, malnourished individuals, etc.)
• Contact tracing in high-risk areas
• Addressing social determinants through multi-sectoral approach
• Airborne infection control measures

4. BUILD

• Strengthening health systems
• Engaging private providers
• Community involvement
• Data systems (Nikshay - national TB notification system)
• Financial support via World Bank, GFATM, DFID

Diagnostic Framework under NTEP

• Sputum smear microscopy (still backbone in peripheral centres)
• CBNAAT/Xpert MTB-RIF: Upfront molecular testing for rapid diagnosis and rifampicin resistance detection
• Culture and Drug Sensitivity Testing (DST)
• TrueNat machines at district level
• TRUNAT / LPA (Line Probe Assay): For detecting MDR-TB

Treatment Regimens

• New cases (Cat I): 2HRZE / 4HRE (Intensive phase 2 months + Continuation phase 4 months)
• Previously treated (Cat II): 2HRZES / 1HRZE / 5HRE (now being phased out in favor of individualized regimens)
• FDC tablets color-coded: Red for Category I, Blue for Category II

• Services initiated in 2007 (Gujarat & Maharashtra), scaled nationally by March 2013
• MDR-TB prevalence (DRS 2014-2016): 2.84% in new cases, 11.60% in retreatment cases
• Managed by state PMDT (Programmatic Management of Drug-resistant TB) Committees

Programme Structure

Key Initiatives Under NTEP

India's TB Burden

• India accounts for approximately 26% of global TB cases (highest burden country)
• TB is predominantly a disease of the poor - affecting migrant labourers, slum dwellers, marginalized populations
• A significant proportion of the economic burden is due to loss of life rather than morbidity
• 32% increase in drug-resistant TB cases has been a major challenge

Financial Support

• World Bank
• DFID (Department for International Development)
• WHO
• Global TB Drug Facility (GDF)
• Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM)

NTEP - Latest Clinical Guidelines & Protocols (2024-2026)

Key Source Documents

• India TB Report 2024/2025 - Central TB Division, MoHFW, GoI
• Technical & Operational Guidelines for Management of Drug-Resistant TB in India (CTD, 2024)
• National Guidelines for Management of Drug Resistant TB (2024)
• NTI Annual Report 2024-25 - National Tuberculosis Institute, Bengaluru
• WHO Global TB Report 2025 (referenced for India data)

1. Drug-Sensitive TB (DS-TB) Treatment

Current NTEP Standard Regimen (Official National Guideline)

• Intensive phase (2 months): Isoniazid (H) + Rifampicin (R) + Pyrazinamide (Z) + Ethambutol (E)
• Continuation phase (4 months): Isoniazid (H) + Rifampicin (R) [+/- Ethambutol]
• Administered as daily fixed-dose combinations (FDC) - color coded (red for new, blue for retreatment)

Important note: The WHO-recommended 4-month regimen (2HPMZ / 2HPM - incorporating Moxifloxacin + Rifapentine) has been evaluated through the SHINE and TB-PRACTECAL trials and shown non-inferiority. However, as of 2026, NTEP has NOT yet formally adopted the 4-month regimen - it remains under evaluation in India. The 6-month 2HRZE/4HRE remains the official NTEP guideline. (source)

2. Drug-Resistant TB (DR-TB) - Major 2024 Protocol Update

NEW: BPaLM Regimen (Bedaquiline + Pretomanid + Linezolid + Moxifloxacin)

3. TB Preventive Therapy (TPT) - Expanded Protocol

• All household contacts (any age) of pulmonary TB patients - eligible for screening and TPT
• Vulnerable groups: malnourished, diabetics, immunocompromised
• Regimens used:
  • 6H (6 months of daily Isoniazid) - standard
  • 3HP (3 months of weekly Isoniazid + Rifapentine) - shorter alternative

4. Diagnostic Protocols - Current Standards

5. Special Populations Protocols

HIV-TB Co-infection

• Early ART initiation (within 2 weeks of TB treatment start in most cases)
• TPT with 6H for PLHIV who are TB-negative
• Cotrimoxazole preventive therapy continued

Pediatric TB

• Dedicated pediatric FDC formulations (weight-based dosing)
• SHINE trial data (shorter regimens for non-severe TB in children being evaluated)
• Contact tracing and TPT for child contacts <5 years - gaps identified in a 2026 study showing 65.5% of eligible pediatric contacts received no contact tracing (Cureus 2026, PMID study)

Diabetes + TB

• All TB patients screened for diabetes (bidirectional screening)
• Separate monitoring for blood glucose during anti-TB treatment
• Nutritional support under Nikshay Poshan Yojana

6. BCG Vaccination - New 2024 Initiative

7. 100 Days Campaign (Dec 7, 2024 - Mar 24, 2025)

• Upfront X-ray + NAAT for all screened individuals

• 20 crore (200 million) vulnerable persons screened

• 28 lakh (2.8 million) TB patients diagnosed (including 9 lakh asymptomatic)

• TB death audits conducted
• TPT for household contacts and vulnerable groups
• Bank seeding + NPY payment saturation

8. Programme Performance - WHO Global TB Report 2025

• New TB cases in India reduced by 21% from 2015-2024 - one of the fastest declines globally
• TB deaths reduced by 28% over the same period
• 46,118 Gram Panchayats certified TB-free for 2024
• India remains the highest-burden country but is on track toward targets

9. Identified Programmatic Gaps (2025 Evidence)

• Only 69% of confirmed TB patients were tested for drug sensitivity
• Only 16% of staff were trained in recent DR-TB guidelines
• Only 30% of DR-TB patients received psychological assessment
• Contextual barriers: human resources, transport, financial gaps despite NPY support
• Recommendation: Establish dedicated district DR-TB treatment centres, dedicated clinical psychologists, and train all staff categories on 2024 guidelines

Official Reference Documents

1. BPaLM is now the standard regimen for MDR/RR-TB under NTEP (6 months, injectable-free)
2. TPT expanded to all household contacts using 6H or 3HP
3. Adult BCG booster piloted in 40 high-burden districts (2024)
4. Upfront NAAT (TrueNat/CBNAAT) mandated across public sector
5. EPTB guidelines being newly developed (workshop completed 2024-25)
6. WHO 4-month DS-TB regimen not yet adopted by NTEP - 2HRZE/4HRE remains official

Medical Record Department (MRD) - Structure & Functions

Definition

"A medical record is a clinical, administrative, scientific, and legal document that justifies a diagnosis and treatment plan." - McGibbon

"Memories fade, people lie, witnesses die - but medical records live forever." - PMC 2020

Purpose of a Medical Record

Organisational Structure of MRD

Medical Superintendent
        |
Faculty In-Charge MRD (Hospital Administration)
        |
Chief Medical Record Officer (MRO) - Officer In-Charge
        |
   ┌────┴─────┐
   |          |
Medical    Jr. Medical
Record     Record Officer
Officer    (Receptionist)
   |
Medical Record Technician
   |
Coding Clerk / Statistical Assistant

Staffing Pattern (as per MoHFW/CBHI guidelines)

Staffing pattern must be standardised based on bed strength and inpatient/outpatient load. Pay scales of MRD personnel must be at par with equivalent hospital positions. - MoHFW/CBHI Guidelines

Location of MRD

• Admitting/Registration area
• OPD (Out-Patient Department)
• Emergency/Casualty
• Hospital administration office

Sections & Sub-Sections of MRD

1. Registration / Admitting Section

• OPD Registration (new and revisit)
• Emergency Registration
• IPD (Inpatient) Admission - generates unique CR (Case Record) Number
• Central Admitting Office / Inquiry Desk

2. Incomplete Record (Peripheral) Section

• Receives records directly from wards after patient discharge
• Record Assembling: MRTs assemble records in Source Oriented Medical Records (SOMR) format
• Checks for completeness - marks deficiencies
• Sends incomplete records back to clinical departments for completion
• Weekly completion visits by clinical department teams

3. Complete Section (Central Unit)

• Coding: ICD-10 (International Classification of Diseases, 10th revision) diagnosis and procedure coding; speciality-wise 3-digit ICD code lists circulated to departments
• Indexing: Disease index, operation index, physician index
• Statistics: Midnight census collected daily from HMIS; monthly and annual statistical bulletins
• Digitization: All records digitized before final physical filing (mandatory under Digital India initiative)
• Filing and Storage: Secured filing with color-coded folders; durable materials recommended

4. Medico-Legal Section

• Handles Medico-Legal Cases (MLC) documentation
• Responds to court summons and subpoenas
• Provides records to law enforcement, insurance, legal authorities with appropriate authorisation

5. Medical Library / Reference Section

• Maintains reference resources for clinical and research use

Flow of Medical Records

PERIPHERAL UNIT                    CENTRAL UNIT
─────────────────                  ─────────────────────────
OPD Registration     →
Emergency Registration →  ──────►  Assembly & Deficiency Check
Inquiry & Central    →             ↓
  Admitting Office                 Incomplete Record Desk
Admission Check Desk →             ↓
Ward                 →             Admission/Discharge Analysis
Ward Census Desk     →             ↓
                                   Coding & Indexing
                                   ↓
                                   Filing & MR Library

Key Functions of MRD

MRD and NABH Accreditation

• Patient records must be available at the point of care at all times
• Confidentiality, security and integrity of records must be maintained
• Defined retention periods for all record types
• Continual training and quality initiatives for MRD staff
• Transition to Electronic Medical Records (EMR) / Hospital Information System (HIS)

• Data governance
• Clinical documentation improvement
• Interoperability
• Confidentiality and information security
• KPI-based performance monitoring

Medical Record Retention Policy (India)

Coding System Used

• Diagnosis coding (morbidity)
• Cause of death coding (mortality)
• Procedure coding

Hospitals must circulate speciality-wise 3-digit ICD-10 code lists to all departments for easy reference by doctors. MRD staff must be trained in ICD-10 coding through CBHI (Central Bureau of Health Intelligence) training programmes. - CBHI/MoHFW

MRD in the Digital Era - Transition to EMR

• EMR / HIS implementation and data governance
• Clinical Documentation Improvement (CDI) - ensuring records accurately reflect clinical complexity
• Digitization of paper records for long-term preservation
• HMIS data collection - daily census, OPD counts, bed occupancy
• WGS / molecular data management (in reference centres)
• Performance monitoring through KPIs (key performance indicators)

Common MRD Challenges in India (Evidence)

• MRD located far from OPD and emergency - reducing efficiency
• No separate inactive records storage room
• OPD records not linked with MRD
• No dictation and transcription system
• Metal fasteners causing staff injury (recommended replacement with plastic)
• Inadequate periodic staff training
• Need for color-coded durable folders

• Many hospitals still use ICD-9 instead of ICD-10
• MRD staff undertrained in coding
• Staffing not standardized with bed strength
• Pay scales of MRD staff not at par with equivalent hospital positions
• OPD and IPD records not linked electronically in most institutions

Summary