1. National Tuberculosis Control Program
DR. KANUPRIYA CHATURVEDI

2. Dr. KANUPRIYA CHATURVEDI
Lesson Objectives
To know about the magnitude of TB problem
To know about the evolution of TB control in India
To learn about the goals, objectives and strategies
To know about the achievements and progress
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Dr. KANUPRIYA CHATURVEDI

3. Magnitude of the Problem
Global annual incidence = 9.1 million
India annual incidence = 1.9 million
India is 17th among 22 High Burden Countries (in terms of TB incidence rate)
In 2008, there were estimated 9.4 million new cases equivalents to 139 cases per 100,000 population of TB globally. In 2008, out of the estimated global
annual incidence of 9.4 million TB cases, 1.98 million were estimated to have occurred in India, of whom 0.87 million were infectious cases, thus catering to a fifth of the global burden of TB. About 40% of Indian population is infected with TB bacillus. The incidence of TB in India is estimated based on findings of the nationwide annual risk of tuberculosis infection (ARTI) study conducted in
The national ARTI being 1.5%, the incidence on smear positive TB cases in the country is estimated as 75 new smear positive cases per 100,000 population
Source: WHO Geneva; WHO Report 2008: Global Tuberculosis Control; Surveillance, Planning and Financing
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Dr. KANUPRIYA CHATURVEDI

4. Global Burden of Tuberculosis
TB is one of the leading causes of death due to infectious disease in the world
Almost 2 billion people are infected with M. tuberculosis
Each year about:
9 million people develop TB disease
2 million people die of TB
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Dr. KANUPRIYA CHATURVEDI

5. Contribution of India to Global TB Control*
5.28 m
4.92 m ? ?
On a national scale, the high burden of TB in India is illustrated by the estimate that TB accounts for 17.6% of deaths from communicable disease and for 3.5% of all causes of mortality (WHO, 2004). More than 80% of the burden of tuberculosis is due to premature death, as measured in terms of disability-adjusted life years (DALYs) lost . WHO estimated TB mortality in India as
276,000 (24/100,000 population) in With RNTCP implementation, there is 43% decline in death due to TB in India by 2008 is compared to 1990.
It was estimated that the TB mortality was over 500,000 annually at the beginning of the revised national TB control program (RNTCP). Data from specific surveys, however, suggest that case fatality rates prior to RNTCP were generally greater than 25%. In RNTCP era, case fatality has remained less than 5% for new cases registered under the program
23%
23%
*WHO Global TB Report 2007 & 2008
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Dr. KANUPRIYA CHATURVEDI

6. The Beginning :National Tuberculosis Control Program
Before the Revised National Tuberculosis Program (NTCP) came into force the existing Tuberculosis program had the following objectives:
To identify and treat as large a number of TB patients as possible so that infectious cases are rendered non- infectious.
To reduce the magnitude of TB problem in the country to a level where it ceases to be a public health problem.
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Dr. KANUPRIYA CHATURVEDI

7. Organization and administration
Central level
Besides the Tuberculosis Division in the Directorate General Health services, National Tuberculosis Institute, Bangalore and Tuberculosis Research centre at Chennai
District level
A district constitutes a functional unit of the NTCP and is called District Tuberculosis Control Program
Peripheral level
Comprises of chest clinics and Primary Health Centers (PHC)
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Dr. KANUPRIYA CHATURVEDI

8. Program Implementation( prior to RNTCP)
Program activities were:
Case detection
Case treatment
Health education
BCG vaccination
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Dr. KANUPRIYA CHATURVEDI

9. Program performance and evolution of RNTCP
Despite a nationwide network of facilities , NTCP failed to yield satisfactory results. The situation did not change much.
The case finding efficiency was only 30 of the expected level although the mortality rate decreased to 53/100,00 population
Government of India launched the Revised National Tuberculosis Control Program(RNTCP) in 1997 encouraged by the results of Pilot studies were tested in
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Dr. KANUPRIYA CHATURVEDI

10. Evolution of TB Control in India
1950s-60s Important TB research at TRC and NTI
National TB Programme (NTP)
Programme Review
only 30% of patients diagnosed;
of these, only 30% treated successfully
RNTCP pilot began
RNTCP scale-up
million population covered
>80% of country covered
2006 Entire country covered by RNTCP
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Dr. KANUPRIYA CHATURVEDI

11. Revised National TB Control Program (RNTCP)
Launched in 1997 based on WHO DOTS Strategy
Entire country covered in March’06 through an unprecedented rapid expansion of DOTS
Implemented as 100% centrally sponsored program
Govt. of India is committed to continue the support till TB ceases to be a public health problem in the country
All components of the STOP TB Strategy-2006 are being implemented
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Dr. KANUPRIYA CHATURVEDI

12. Dr. KANUPRIYA CHATURVEDI
Objectives of RNTCP
To achieve and maintain a cure rate of at least 85% among newly detected infectious (new sputum smear positive) cases
To achieve and maintain detection of at least 70% of such cases in the population
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Dr. KANUPRIYA CHATURVEDI

13. Dr. KANUPRIYA CHATURVEDI
Strategy
Augmentation of organizational support at the central and state level for meaningful coordination
Increase in budgetary outlay
Use of Sputum microscopy as a primary method of diagnosis among self reporting patients
Standardized treatment regimens.
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Dr. KANUPRIYA CHATURVEDI

14. Dr. KANUPRIYA CHATURVEDI
contd.
7 Augmentation of the peripheral level supervision through the creation of a sub district supervisory unit
8. Ensuring a regular uninterrupted supply of drugs up to the most peripheral level
9. Emphasis on training, IEC, operational research and NGO involvement in the program
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Dr. KANUPRIYA CHATURVEDI

15. Core elements of Phase I
The core element of RNTCP in Phase I ( )was to ensure high quality DOTS expansion in the country, addressing the five primary components of the DOTS strategy
Political and administrative commitment
Good Quality Diagnosis through sputum Microscopy
Directly observed treatment
Systematic Monitoring and Accountability
Addressing stop TB strategy under RNTCP
Sputum microscopy continues to be the primary tool for detection of infectious cases. Apart from sputum microscopy, RNTCP also uses standardized diagnostic algorithms to diagnose and treat all forms of TB wherein X-ray plays a supporting role. However in line with the stop TB strategy the program is exploring all possible avenues with newer and innovative technologies for early detection of TB including use of LED fluorescent microscopes, liquid culture and line probe assay for diagnosis drug resistant TB etc.
Sufficient anti-TB drugs in patient wise boxes are made available at all the appropriate levels (Peripheral Health Institution/TB unit/District/State/National). The uninterrupted supply of drugs to teach patient is made possible through the “patient wise box.” Patient-wise drug boxes (both adult and pediatric) are an innovation of RNTCP wherein a box of medications for the entire duration of the treatment is earmarked for every patient registered.
Directly observed treatment (DOT) is one of the key elements of the DOTS strategy. In DOT, an observer (health worker or trained community volunteer who is not a family member) watches and supports the patient in taking drugs. The DOT provider ensures that the patient takes the right drugs, in the right doses, at the right intervals, for the right duration.
RNTCP has a systematic monitoring mechanism which accounts for/tracks the outcome of every patient put-on treatment. There is a standardized recording and reporting structure in place. The cure rate and other key
indicators are monitored regularly at every level of the health system and regular supervision ensures quality of the program. RNTCP shifts the responsibility for cure from the patient to the health system.
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Dr. KANUPRIYA CHATURVEDI

16. Dr. KANUPRIYA CHATURVEDI
RNTCP Phase II( )
The RNTCP phase II is envisaged to:
Consolidate the achievements of phase I
Maintain its progressive trend and effect further improvement in its functioning
Achieve TB related MDG goals while retaining DOTS as its core strategy
The RNTCP Phase II of the World Bank project has been approved by the CCEA for the period Oct 2006 to Sep 2011 for a total outlay of USD million which includes credit from World Bank of USD 170 million and commodity assistance of anti-TB drugs from DFID through WHO for
USD 62.5 million, and the balance by GoI. New financial norms in respect of certain expenditure heads have been approved by Cabinet Committee on
Economic Affairs which have been implemented with effect from April 01, 2009.
Global Fund Support: The Global Fund has supported by grants) DOTS expansion in India under different rounds. DOTS expansion in the 3 States of Chhattisgarh,
Jharkhand, and Uttarakhand (56 million populations) was supported by grants for USD 8.78 million under Round 1 of GFATM from April 2003-September 2006.
In addition, the Round 2 of GFATM supported DOTS expansion in 56 districts of Bihar and Uttar Pradesh with a population of 110 million for USD million (April 2004 to March 2009). Round 4 of GFATM is supporting
strengthening of RNTCP implementation in the states of Andhra Pradesh and Orissa w.e.f November 05 and January 2006 respectively for USD million till March 2010.
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Dr. KANUPRIYA CHATURVEDI

17. Diagnosis of TB in RNTCP: Smear examination
Cough for 3 weeks or More
3 sputum smears
3 Negative
3 or 2 positives
1 positive smear
Antibiotics
1-2 weeks
X- ray
Symptoms
persist
positive smear
negative
The revised definition of a new sputum smear positive pulmonary TB case is based on the presence of at least one acid-fast bacillus (AFB) in at least one sputum sample in countries with a well functioning EQA system The number of specimens required for diagnosis of smear positive pulmonary TB is two, with one of them being a morning sputum specimen. Two sputum specimens are collected over one, or two consecutive days. Of the two sputum specimens, one is collected on the spot and the other is an early morning specimen collected at home by the patient
RNTCP has established a nation wide laboratory network, encompassing over 12,500 designated sputum Microscopy Centers (DMCs), which are being supervised by Intermediate reference laboratories (IRL) at state level, and National Reference laboratories (NRL) & Central TB division at the national level. Efforts have been made to consolidate the laboratory network into a well organized one, with a defined hierarchy for carrying out sputum microscopy with external quality assessment (EQA), Drug resistance Surveillance (DRS), mycobacterium culture and Drug susceptibility testing (DST) and DOTS-Plus related activities.
The four NRLs under the program are Tuberculosis Research Centre (TRC), Chennai, National Tuberculosis Institute (NTI), Bangalore, Lala Ram Swarup Institute of Tuberculosis and Respiratory diseases (LRS), Delhi and JALMA Institute, Agra. The NRLs work closely with the IRLs, monitor and supervise the IRL’s activities and also undertake periodic training for the IRL staff in EQA, culture & DST activities. .
Smear-Positive TB
X-ray
Negative
For TB
Positive
Anti-TB Treatment
Smear-Negative TB
Non-TB
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Dr. KANUPRIYA CHATURVEDI
Anti-TB Treatment

18. Dr. KANUPRIYA CHATURVEDI
Classification of Patients in Categories for Standardized Treatment Regimen
Category
Type of Patient
Regimen
Duration in months
Category I
Color of box: RED
New Sputum Positive Seriously ill sputum negative, Seriously ill extra pulmonary,
2 (HRZE)3,
4 (HR)3 6
Category II
Color of box: BLUE
Sputum Positive relapse Sputum Positive failure
Sputum Positive treatment after default
2 HRZES)3,
1 (HRZE)3
5 (HRE)3 8
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19. Dr. KANUPRIYA CHATURVEDI
Contd.
Category
Type of Patient
Regimen
Duration in months
Category III
Color of box: GREEN
Sputum Negative,
extra pulmonary not Seriously ill
2 (HRZ)3,
4 (HR)3 6
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Dr. KANUPRIYA CHATURVEDI

20. Types of Drug-Resistant TB
Mono-resistant Resistant to any one TB treatment drug
Poly-resistant Resistant to at least any two TB drugs (but not both isoniazid and rifampicin)
Multidrug- resistant
(MDR TB) Resistant to at least isoniazid and rifampicin, the two best first-line TB treatment drugs
Extensively drug-resistant
(XDR TB)
Resistant to isoniazid and rifampicin, PLUS resistant to any fluoroquinolone AND at least 1 of the 3 injectable second-line drugs (e.g., amikacin, kanamycin, or capreomycin)
The emergence of drug resistant TB, and particularly MDR-TB, has become a significant public health problem in a number of countries and an obstacle to
effective TB control.16 A large scale population based survey in the state of Gujarat and Maharashtra has indicated multi drug resistance levels of <3% among new TB cases and 14-17% among previously treated TB patients. Though the rate of MDR-TB is relatively low in India, this translates into a large absolute number of cases, with an estimated annual incidence of 131,000
cases of MDR TB in the country.
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Dr. KANUPRIYA CHATURVEDI

21. RNTCP Organization structure: State level
Health Minister
Health Secretary
MD NRHM
Director Health Services
Additional / Deputy / Joint Director
(State TB Officer)
State TB Cell
Deputy STO, MO, Accountant,
IEC Officer, SA,
DEO, TB HIV Coordinator etc.,
State Training and Demonstration
Center (TB)
Director, IRL Microbiologist, MO,
Epidemiologist/statistician, IRL LTs etc.,
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Dr. KANUPRIYA CHATURVEDI

22. Dr. KANUPRIYA CHATURVEDI
Program innovations
Creation of sub district level supervisory and monitoring unit “TB Unit”
Patient-wise individual drug boxes for entire course of treatment
Community involvement in DOTs – shopkeepers, teachers, postmen, cured patients, etc
Continuous Internal Evaluation of districts
Monitoring strategy document with checklists
NGO & PP (Private Provider) schemes
Task Force mechanism for involvement of Medical colleges
Web based IEC/ ACSM resource centre
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Dr. KANUPRIYA CHATURVEDI

23. Dr. KANUPRIYA CHATURVEDI
Contd.
District TB Control Society
Modular training
Patient wise boxes
Sub-district level supervisory staff (STS, STLS) for
Treatment & microscopy
Robust reporting and recording system
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Dr. KANUPRIYA CHATURVEDI

24. Quality Diagnostic and Treatment Services
~12,500 decentralized designated microscopy centers established
External Quality Assurance (EQA) system for sputum microscopy as per international guidelines
Quality assured anti-TB drugs
Patient friendly DOT services
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Dr. KANUPRIYA CHATURVEDI

25. Data Management System: RNTCP
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Dr. KANUPRIYA CHATURVEDI

26. Dr. KANUPRIYA CHATURVEDI
Public Private Mix (PPM) Activities for Involvement of All Health Care Providers
Involvement of NGOs and Private Practitioners
Schemes revised in 2008
Presently > 2500 NGOs, 17,000 PPs involved
Involvement of professional bodies like IMA, IAP
Other Central government departments/PSUs
CGHS, Railways, ESI, Mining, Shipping
Corporate sector
~150 Corporate Houses participating
Involvement of FBOs like CBCI
Involvement of Medical Colleges
Task Forces and Core Committees formed
260 Medical colleges involved
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Dr. KANUPRIYA CHATURVEDI

27. Well Defined IEC Strategy
Web based resource centre
Communication facilitators provided to support IEC at district level
Ongoing capacity building of program managers for planning and implementing need based IEC activities
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Dr. KANUPRIYA CHATURVEDI

28. RNTCP: Assessment of Impact
Nation wide ARTI Survey –
Coordinated by NTI, Bangalore in association with
New Delhi TB Centre (North Zone)
MGIMS, Wardha (West Zone)
LRS Institute, New Delhi (East Zone)
CMC, Vellore (South Zone)
Symptomatic screening + CXR + Sputum Smear + Culture
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Dr. KANUPRIYA CHATURVEDI

29. External Evaluations Undertaken
Joint Monitoring Mission (JMM) by WHO and other development partners in 2000, 2003 and 2006
Conclusions
JMM 2000
RNTCP is succeeding and its results have been excellent
JMM 2003
Extra-ordinarily rapid expansion of the programme & highly economical
JMM 2006
Excellent system of recording & reporting with indicators for monitoring & evaluation; well integrated into general health system
Future plan
JMMs planned in 2009 and 2012
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Dr. KANUPRIYA CHATURVEDI

30. Dr. KANUPRIYA CHATURVEDI
Contd.
Disease prevalence Surveys –
TRC Chennai – MDP project
NTI, Bangalore
MGIMS, Wardha
PGI, Chandigarh
AIIMS, New Delhi
JALMA, Agra
RMRCT, Jabalpur
Repeat ARTI and Disease prevalence surveys planned in 2015
Symptomatic screening + Sputum Smear + Culture
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Dr. KANUPRIYA CHATURVEDI

31. Dr. KANUPRIYA CHATURVEDI
Impact of RNTCP
Trends in prevalence of culture-positive and smear-positive tuberculosis in south India(5 Blocks),
RNTCP era
Pre-SCC treatment era
SCC treatment era
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Dr. KANUPRIYA CHATURVEDI

32. Achievements Under RNTCP
412766
Since implementation
> 40 million TB suspects examined
> 9 million patients placed on treatment
> 1.6 million lives saved (deaths averted)
Achievements in line with the global targets
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Dr. KANUPRIYA CHATURVEDI 32 32

33. Progress Towards Millennium Development Goals
Indicator 23: between 1990 and 2015 to halve prevalence of TB disease and deaths due to TB
Indicator 24: to detect 70% of new infectious cases and to successfully treat 85% of detected sputum positive patients
The global NSP case detection rate is 61% (2006) and treatment success rate is 85%
RNTCP consistently achieving global bench mark of 85% treatment success rate for NSP; and case detection rate 70% (2007)
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34. Cost Effectiveness of Program in India*
Total costs of TB control per capita is US $ 0.1 (2007)
Cost of first line drugs per patient treated in India is US $ 14 compared to US $ 30 (median) for HBCs
India remains the country with the lowest cost per patient treated (US $ 84) compared to US $ 274 (median) for HBCs
*Source: WHO Report 2008, Global Tuberculosis Control; pg 71 &112; HBCs= High Burden Countries
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Dr. KANUPRIYA CHATURVEDI

35. TB-HIV: Accomplishments
Developed and implemented mechanism for TB & HIV program collaboration at all levels (National, State, District)
Conducted surveillance and determined national burden of HIV in TB patients
Mainstreamed TB-HIV activities as core responsibility of both programs (training & monitoring)
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Dr. KANUPRIYA CHATURVEDI

36. TB-HIV: Current Policies (2008)
TB/HIV activities in all States
Coordination & Training on TB/HIV
Intensified Case Finding (ICF)
Referral of all HIV- TB patients for HIV care and support (CPT & ART)
Involve NGOs
Activities in high-HIV states
Provider-initiated HIV counseling and testing for all TB patients
Decentralized provision of Co-trimoxazole
Expanded TB-HIV monitoring
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Dr. KANUPRIYA CHATURVEDI

37. RNTCP- DOTS-Plus Vision
By 2010 DOTS-Plus services available in all states
By 2012, universal access under RNTCP to laboratory based quality assured MDR-TB diagnosis for all retreatment TB cases and new cases who have failed treatment
By 2012, free and quality assured treatment to all MDR-TB cases diagnosed under RNTCP (~30,000 annually)
By 2015, universal access to MDR diagnosis and treatment for all smear positive TB cases under RNTCP
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Dr. KANUPRIYA CHATURVEDI