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RNTCP Programme of India - 12 Mark LAQ Answer
(Park's Textbook of Preventive and Social Medicine)
Introduction
The National Tuberculosis Programme (NTP) was launched in India in 1962 but suffered from poor treatment success rates, high death rates, and the threat of multidrug-resistant TB (MDR-TB). In 1993, the Government of India revitalized the programme as the Revised National TB Control Programme (RNTCP), adopting the internationally recommended Directly Observed Treatment Short-course (DOTS) strategy. In view of the End TB targets (World Health Assembly, 2014), the programme was renamed the National Tuberculosis Elimination Programme (NTEP).
A. Salient Features of RNTCP
1. Objectives of RNTCP
- Achieve at least 85% cure rate of infectious TB cases through DOTS involving peripheral health functionaries.
- Augmentation of case finding through quality sputum microscopy to detect at least 70% of estimated cases.
2. Key Structural Features
- Built on the infrastructure of the previous NTP while incorporating DOTS elements.
- Covers the entire country since March 2006; programme entered Phase II focusing on consolidation.
- Decentralized smear microscopy at designated RNTCP Microscopy Centres (at CHCs, PHCs, Taluka Hospitals, TB Dispensaries).
- Each centre has a skilled technician; a Senior TB Laboratory Supervisor (STLS) is appointed for every 5 microscopy centres to recheck all positive slides and 10% of negative slides.
3. Drug Supply System
- Drugs are supplied in patient-wise boxes (PWBs) containing the full course of treatment, packaged in blister packs.
- Intensive phase: each blister pack contains one day's medication.
- Continuation phase: each blister pack contains one week's supply.
- Boxes are colour-coded: Red for Category I, Blue for Category II patients.
4. New Initiatives under NTEP
- NIKSHAY - A case-based web-based IT system launched in May 2012, with modules for patient registration, diagnosis, DOT provider details, HIV status, outcome, SMS alerts, and automated periodic reports.
- TB Notification (mandatory since 7th May 2012) - All healthcare providers must notify every TB case to local authorities monthly.
- Ban on TB Serology - Due to poor specificity, the Government of India banned import, manufacture, sale, distribution, and use of serological tests for TB.
- Direct Benefit Transfer (DBT) - Linking TB patients in NIKSHAY with AADHAR and PEMS to deliver direct benefits.
- Universal DST - Expanded rapid molecular diagnostics (CBNAAT) covering all districts; ~55% of all notified TB cases offered DST in Q3 2019.
- Shorter regimen and Bedaquiline (from 2018) for drug-resistant TB.
- Campaign mode - Active Case Finding - Systematic TB screening in high-risk populations (tribal areas, slums, prisons, old age homes, orphanages).
B. Three Regimens of Treatment under RNTCP
RNTCP uses Short-Course Chemotherapy (SCC) under direct observation. The standard regimens use abbreviated drug notation:
- H = Isoniazid, R = Rifampicin, Z = Pyrazinamide, E = Ethambutol, S = Streptomycin
- Number before letters = duration in months; subscript number = doses per week
Category I Regimen (New patients - smear positive, severely ill smear negative, new EPTB)
- Intensive Phase: 2 months - HRZE (2HRZE) given thrice weekly (2 months × 3/week)
- Continuation Phase: 4 months - HRE (4HRE) given thrice weekly
- Total duration: 6 months
- Red patient-wise boxes used.
Category II Regimen (Previously treated - relapse, failure, default, others)
- Intensive Phase: 3 months - HRZES for 2 months + HRZE for 1 month (2HRZES + 1HRZE)
- Continuation Phase: 5 months - HRE (5HRE) given thrice weekly
- Total duration: 8 months
- Blue patient-wise boxes used.
Category III / Paediatric / Daily Regimen (Non-severe new cases)
- Under NTEP update, a daily regimen was introduced:
- 2HRZE/4HR (daily dosing replacing the thrice-weekly DOT)
- Drug doses adjusted by weight bands.
- This is now the preferred regimen under National Strategic Plan 2017-2025 for all new TB patients.
C. Changes in RNTCP as Compared to NTP
| Feature | NTP (Old) | RNTCP (New) |
|---|
| Treatment strategy | Self-administered domiciliary treatment | Directly Observed Treatment Short-course (DOTS) |
| Treatment duration | 12-18 months (long course) | 6-8 months (short course) |
| Drugs used | Mainly H + T (Thiacetazone) + S | HRZE + S (4-drug combination, no Thiacetazone) |
| Drug supply | Central hospital-based supply | Decentralized patient-wise boxes (PWBs) at peripheral level |
| Diagnosis | Clinical and radiology-based | Quality sputum smear microscopy (bacteriological confirmation priority) |
| Case categorization | No formal categorization | Formal Category I, II, III |
| Monitoring | Inadequate monitoring | Systematic recording, reporting, and accountability |
| DOT provider | No systematic DOT | Trained peripheral DOT providers at every level |
| Lab network | Centralized | Decentralized microscopy centres (DMCs) at PHC/CHC level |
| Treatment success | ~30% cure rate | Target >85% cure rate |
| Financial support | Mainly GoI | GoI + World Bank + GFATM + USAID + GDF |
| Notification | Not mandatory | Mandatory notification of all TB cases (2012) |
| IT system | None | NIKSHAY web-based system |
D. DOTS Strategy - Five Principles
DOTS (Directly Observed Treatment Short-course) is the internationally recommended strategy adopted by RNTCP. It has five main components:
1. Political Will and Administrative Commitment
- Sustained political and administrative commitment at all levels (national, state, district, peripheral).
- Ensures provision of organized and comprehensive TB control services.
- Allocation of adequate financial resources and infrastructure.
2. Diagnosis by Quality-Assured Sputum Smear Microscopy
- Bacteriological confirmation through sputum smear examination (Ziehl-Neelsen or fluorescence staining).
- Decentralized diagnostic services at DMCs.
- External quality assurance through Senior TB Lab Supervisors.
- Identifies the most infectious cases (smear-positive) who are the priority for treatment.
3. Adequate Supply of Quality-Assured Short-Course Chemotherapy (SCC) Drugs
- Uninterrupted supply of standardized, quality-assured anti-TB drugs.
- Drugs supplied in patient-wise boxes (colour-coded).
- Buffer stock maintained at all levels to prevent drug shortage and incomplete treatment.
- Prevention of drug resistance through uninterrupted supply.
4. Directly Observed Treatment (DOT)
- Every dose of treatment is administered in the presence of and observed by a DOT provider.
- DOT providers include health workers, ASHA workers, community volunteers, or any person trusted by the patient and acceptable to the health system.
- Ensures treatment compliance and prevents default and drug resistance.
- Removes the burden of compliance from the patient alone.
5. Systematic Recording, Monitoring, and Accountability
- Standardized registers: TB Register, Laboratory Register, Treatment Card.
- Cohort analysis of treatment outcomes (cured, treatment completed, died, failed, defaulted, transferred out).
- Regular supervision and monitoring at all levels.
- Quarterly reports sent from peripheral to district, state, and national levels.
- Basis for programme evaluation and corrective action.
Additional Note: STOP TB Strategy (2006) and End TB Strategy (2014)
In 2006, WHO announced the STOP TB Strategy, adopted by RNTCP with six components:
- Pursuing quality DOTS expansion and enhancement
- Addressing TB/HIV and MDR-TB
- Contributing to health system strengthening
- Engaging all care providers
- Empowering patients and communities
- Enabling and promoting research (diagnosis, treatment, vaccine)
In 2014, the End TB Strategy was approved with the vision of zero deaths, disease, and suffering due to TB, leading to renaming of RNTCP to NTEP (National TB Elimination Programme).
Source: Park's Textbook of Preventive and Social Medicine (PSM), Chapter on National TB Elimination Programme
Key Points to Remember for Exams:
- DOTS = 5 principles (remember: P-D-D-D-S: Political commitment, Diagnosis, Drug supply, DOT, Systematic monitoring)
- NTP started 1962; RNTCP launched 1993; NTEP (renamed) 2014
- Cat I = 2HRZE + 4HRE (6 months); Cat II = 2HRZES + 1HRZE + 5HRE (8 months)
- Red box = Cat I; Blue box = Cat II
- Objectives: 85% cure rate + 70% case detection