Critical review of rntcp

1. Critical Review of Revised National
Tuberculosis Control
Programme(RNTCP)
Presenter -Dr Har Ashish Jindal
JR

2. Contents
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Introduction
Burden of disease
Timeline of TB Control
National Tuberculosis Programme
Revised National Tuberculosis Control Programme(RNTCP)
Directly Observed Treatment Short Course(DOTS)
STOP TB Strategy
RNTCP Funding
Diagnosis
Treatment
Multi Drug Resistant TB
TB-HIV Collaboration
Recent Advances
Conclusion

3. Introduction
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Tuberculosis is one of the leading causes of mortality
in India- killing -2 persons every three minute, nearly
1,000 every day.
Tuberculosis (TB) is a contagious disease caused by
Mycobacterium tuberculosis
Left untreated, each person with infectious
pulmonary TB will infect an average of between 10
and 15 people every year.
With emergence of Multi Drug Resistance and coinfection with HIV has weakened our battle against
the disease.

4. Burden of Disease

Globally, in 2011, there were an estimated 8.7 million
new cases of TB (13% co-infected with HIV) and 1.4
million people died from TB.
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New cases of TB have been falling for several years
and fell at a rate of 2.2% between 2010 and 2011.

The TB mortality rate has decreased 41% since 1990
and the world is on track to achieve the global target
of a 50% reduction by 2015.(MDG Target)

5. Global
India
Prevalence(million
)
12
3.1
Incidence rate(per
100 000
population)
125
181
Mortality rate(per
100 000
population)
14
24
HIV prevalence
rate in incident TB
cases (%)(per 100
000 population)
13%
4.2%
26%

6. TB in INDIA
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Incidence rate(2011): 181 per lakh population
Prevalence : 3.8million (2000) to 3.1million(2011)
The Annual Risk of TB Infection (ARTI) has
decreased from 1.5% in 2002-03 to 1.1% nationally
in 2008-10 with the estimated decline of 3.7% per
year (95% confidence interval, 2.4-5.1% per year).
New Smear Positive(NSP) PTB cases in the country
is estimated as 55 per 100,000 population.
WHO estimated TB mortality in India as 280,000
(24/100,000 population) in 2011
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Source: Global TB Report 2012

7. Achievements of RNTCP

9. Evolving Treatments of TB in India
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1962 - National Tuberculosis Programme (NTP)
started
1992- NTP Reviewed and concluded its failure
1993: RNTCP formulated, adopted Directly
Observed Treatment Short-course (DOTS) strategy.
1997-Large-scale implementation of the RNTCP with
DOTS
RNTCP I: 1997-2006
RNTCP II: 2006-11
National Strategic Policy: 2012-17

10. National Tuberculosis Programme (1962)
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Based on strategic principles of domiciliary
treatment
Use of a self-administered standard drug
regimen of initially 12-18 months duration
Treatment free of cost
Priority to newly diagnosed patients over
previously treated patient
Treatment organization decentralized to district
level.
The NTP created an extensive infrastructure for
TB control, with a network of 446 district TB

11. FAILURE OF NTP

Results:
Low rates of case detection and treatment completion (30%),
 Continuing high mortality (50 per 100,000)
 High rates of default (40–60%),
REASONS:
 More emphasis on case detection rather than cure
 Inadequate budget and insufficient managerial capacity
 Shortage of drugs
 Emphasis on x-ray diagnosis resulting in inaccurate
diagnosis
 Poor quality sputum microscopy
 Multiplicity of treatment regimens.


12. DELAYED POLICY REVISION in RNTCP and DOTS
INITIATION
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30 years had lapsed before RNTCP is implemented in
1993. why? why the policy not revised much earlier
knowing that results are not good with NTP? why
wasted 30 years?
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HZES-1962 R -1982(leprosy).
Led to accumulation of too many old and retreatment
cases.
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13. Revised National Tuberculosis Control
Programme(1993)
Goals
- To reduce mortality and morbidity from tuberculosis
- To interrupt chain of transmission.
Objectives
- To cure at least 85% of all newly detected
infectious(NSP) cases of Pulmonary tuberculosis
- To detect at least 70% of estimated new smear
positive pulmonary tuberculosis

14. Are the targets adequate?
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Total net missed cases for treatment will be almost
40%.
Is this ethical to leave the patients untreated when we
have detected them with disease??
Have we done like this for any infectious disease with
high
communicability
and
longer
period
of
communicability in the past?
Why should we take a risk in leaving the known
infected cases?
What is the rationale behind leaving the detected
infectious cases without treatment?
Is it cost-effective to leave the detected cases?
We have wasted our valuable resources also to detect
those 15%.

15. RNTCP(1993)
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The RNTCP was built on the infrastructure and
systems built through the NTP.
Major additions to the RNTCP:
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a sub-district supervisory unit, known as a TB Unit
decentralization of both diagnostic and treatment
services
with treatment given under DOTS (directly observed
treatment).
highest priority to the provision of quality assured sputum
smear microscopy services.
Patient-Wise Boxes, which contain the full course of
treatment for one individual patient, ensuring that
treatment of that patient cannot be interrupted due to a
lack of drugs.

16. RNTCP Organization structure:
State level

17. DOTS(1997)
DOTS is a systematic strategy which emphasizes on:
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Political and administrative commitment.
Good quality diagnosis.
 Good quality microscopy is essential to identify the infectious patients
who need treatment the most.
Good quality drugs.
 An uninterrupted supply of good quality anti-TB drugs must be available.
Directly observed treatment short-course chemotherapy
 The DOTS strategy along with the other components of the Stop TB
strategy, implemented under the Revised National Tuberculosis Control
Programme (RNTCP) in India, is a comprehensive package for TB
control.
Systematic monitoring and accountability.

18. Weak Political Approach

Political commitment, the first requisite of dots
management is only on paper.

Politicians were not serious and not actively involved in
the crusade against tuberculosis.
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Example TB was made Notifiable(May 7,2012)
Other countries e.g China (2000)


19. WHERE PATIENT OF TUBERCULOSIS
GO FOR TREATMENT ?
Private Sector
Government Sector

20. Quality diagnosis? Quacks and Private
Practioners
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Tb is still a poor man's disease in India

Quacks And Private Practitioners :
The First point of contact for a majority of patients
 In India, 75% of doctors (6 million) are based in private
practice and only 0.31% are implementing RNTCP.
 In June 2012, the government banned serological tests for TB. based on
Treatment in the private sector is often started
serology results leading to wrong and/or delayed
diagnosis.
 inflate costs of care.
 Thus, undiagnosed TB, delayed diagnosis and
mismanaged TB continues to fuel the TB epidemic.


21. Improvements
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In 2009, WHO recommended that conventional
Fluorescence Microscopy be replaced by LED
microscopy in all settings and that LED microscopy be
phased in as an alternative for conventional ZN
microscopy in both high volume and low-volume
laboratories.
Success: Central TB Division is planning to replace the
Binocular Microscopes with LED Microscopes in a
phased manner over the next 5 years especially in the
high work load settings.
200 LED Microscopes have already been procured by
UNION for use in Projects in Medical Colleges

22. STOP TB Strategy(2006)
■ In DOTS collaboration ,STOP TB strategy was started
with additional six components1. Pursue high-quality DOTS expansion and enhancement
2. Address TB/HIV, MDR-TB, and the needs of poor and
vulnerable populations
3. Contribute to health system strengthening based on
primary health care
4. Engage all care providers
5. Empower people with TB, and communities through
partnership
6. Enable and promote research

23. RNTCP FUNDING
Actual allocation as per planning commission
450
582
Rupees in crore
400
350
300
267
275
285
300
320
250
200
actual allocattion as per
planning commision
150
100
50
0
1.8

24. World Bank Funding
175
170
170
165
$ in millions
160
155
150
145
World Bank Funding
142
140
135
130
125
1997-2005
2006-2012
Additional funding of $ 100 million for 2 years up to 2014 for Universal
Access goals addressing MDR TB , Scaling up approach and New
approaches

26. Category
Type of Patient
Regimen
Duration in
months
Category I
New Sputum Positive ,
sputum negative,
extra pulmonary
2 (HRZE)3,
4 (HR)3
6
Sputum Positive relapse
Sputum Positive failure
Sputum Positive treatment after
default
2 (HRZES)3,
1 (HRZE)3
5 (HRE)3
8
Color of box:
RED
Category II
Color of box:
BLUE

27. DOTS Treatment
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Lengthy treatment: chemotherapy for six months
duration is still a problem for the patient to comply.
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Need to reduce the duration of treatment in view of
patient’s compliance and side effects of drugs.
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Ultra- short treatment regimens for three months
duration using quinolones with rifampicin are on the
anvil.

28. DOTS Treatment
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Inadequate information and poor management of
adverse events and toxicity continue to result in
patients defaulting on treatment .
Controversy regarding the efficacy of the 6-month
regimen that is recommended under RNTCP in TB
meningitis and TB of bones and joints cases
compared with the 9–12 month regimen
recommended by some experts.

29. DOTS Implementation Status
31st March 2006
Nationwide DOTS
coverage -632 districts
and 1164 million people
covered under RNTCP

30. LARGE POPULATION
The provision of quality TB services to a
population of over 1 billion is a difficult task.
 Providing an uninterrupted supply of Anti-TB
drugs to more than 1.3 billion cases each year.
 Quality????
 Requires a large amount of resources to be
mobilized ????
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Human resource management ???

31. DOTS in India
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TB as a disease and its treatment may be viewed
differently in the various socio-cultural-economic
conditions prevailing in India today. E.g. Muslims during
Roza
Socioeconomic factors that have been identified in
studies done among patients on DOTS in India include
smoking, alcoholism, old age, poverty with default and
malnutrition etc. It is unclear to what extent these factors
affect the functioning of DOTS treatment.
Poverty, social upheaval and crowded living conditions
Inadequate health coverage and poor access to health
services
Reluctance to report TB suspects leading to poorly
administered programmes

32. POOR PATRONAGE OF DOTS
REGIMENS
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Most Indian doctors/health workers are not aware of
DOTS, its success in TB control in other countries and
how it is being implemented in the country.
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All doctors, some knowingly and some unknowingly
are prescribing anti-tuberculosis drugs as they like.
Even pulmonologists are not sticking on to dots
regimens as recommended in the national program.
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The knowledge regarding the treatment guidelines
among the residents and consultants is low, points to
the fact that re-education of faculty members regarding
recent trends or guidelines is essential if we want this
knowledge to percolate to the periphery.

33. RNTCP has consistently shown treatment success rates of around
87%, whilst case detection rates have generally risen to now stand
at around 72%.

34. Progress towards MDG indicator 23
Prevalence rate of TB
Cases per 1,00,000 population
Prevalence rate of TB
500
450
400
350
300
250
200
150
100
50
0
459
249
1990
2011
230
2015

35. Progress towards MDG indicator 23
Mortality rate of TB
Cases per 1,00,000 population
Mortality rate of TB
45
40
42
41%
35
30
24
25
19.5
20
15
10
5
0
1990
2011
2015

36. Programme Performance
Indicator
Norm
Achievement
Annual case detection rate
135/lakh population
129/lakh (145/lakh)
Case detection rate
70%
71%(Haryana-71.4%)
% of smear positive among
total new pulmonary TB cases
50%
62%(Haryana-51.9%)
Proportion of new smear
positive cases on DOTS
within 7 days of diagnosis
>90%
86%(Haryana-89%)
New sputum positive
conversion rate at three
months
> 90%
90%(Haryana-90%)
Cure rate
>85%
86% (Haryana-84.6%)
Default rate
<5%
6% Haryana (6.4%)
Death rate
<5%
4%(Haryana -4.4%)

37. Reasons for Unachieved targets
•Migratory population???
• Poor commitment of DOTS providers and
supervisory staff
•Defaulter correction activities need to be
more effective

38. Patients with TB
symptoms
Patients investigated
Patients with
appropriate TB test is
ordered
Patients qualityWhy is TB a big problem in India, despite
assured results
the success of the DOTS program?
Patients width
diagnoses
Patients who get correct TB therapy
Patients who get therapy and
cured
Misdiagnosis and management can result in only fraction of TB patients getting correct
diagnosis, appropriate therapy and positive outcomes

39. High Relapse Rate
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Irregularity in treatment and presence of initial drug
resistance.
There is a choice of providers for the patient and he
is free to discontinue and start treatment from
whichever provider he likes, based on his perception
of getting benefit for treatment.
Thus, patients can be over treated or started with
intensive phase again when they switch providers.
This previous treatment history is poorly
documented.
Retreatment cases not followed up after treatment
for any length of time, there is very less information
about relapse

40. Why intermittent regimen was opted?
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In a high-burden country as India intermittent
regimen was never critically reviewed.
The current WHO guidelines, based on "strong/high
grade evidence" recommends "wherever feasible,
the optimal dosing frequency for new patients with
pulmonary TB is daily throughout the course of
therapy";
Studies have been documented rates of acquired
drug resistance were higher among patients
receiving three times weekly dosing throughout
therapy than among patients who received daily drug
administration throughout treatment.
Missed dose in Intermittent Regimen leads to no
medicine for 3 or 4 straight days ?????

41. Recommendations
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The model of DOT being implemented in India needs
to be reconsidered ,which enable access to treatment
and maximize adherence.
There is a need for operational research into
alternative models of DOT, especially in urban areas,
which do not impede access to care under the
RNTCP, and which minimize the indirect costs of
DOT based treatment.

42. Challenges Ahead!!!!!
“If detecting and treating all TB patients
who are not drug resistant is
challenging enough, detecting and
treating drug-resistant TB is riddled with
problems.”

43. MDR-TB & XDR-TB
MDR-TB is defined as resistance to isoniazid and
India, China, the Russian or without resistance to other60% of the
rifampicin, with Federation and South Africa have almost anti-TB
world’s cases of MDR-TB.
drugs.
 XDR-TB is defined as resistance to at least Isoniazid
and Rifampicin (i.e. MDR-TB) plus resistance to any
of the fluoro-quinolones and any one of the second
line injectable drugs (amikacin, kanamycin or
capreomycin).


44. Burden of MDR TB
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Globally, 3.7% (2.1–5.2%) of new cases and 20% (13–
26%) of previously treated cases are estimated to have
MDR-TB in 2011
In India, 2.1% have been estimated to be MDR in New
TB cases , and 15% in Retreatment cases.
respectively(2011)
Extensively drug-resistant TB (XDR-TB) has been
identified in 84 countries globally.
Combining data from 65 countries and 3 union territories,
the proportion of MDR-TB cases with XDR-TB was 9.0%
(95% confidence interval, 6.7%–11.2%).

46. Drug Resistant TB
• In December 2011 , 4 patients from Mumbai, “totally drug
resistant” tuberculosis i.e. resistant to all first -line and
second-line drugs tested.
• Media reports have added reports of further cases in
Mumbai and in Bangalore.
• Such cases have been reported sporadically in Europe
and 15 cases in Iran in 2009.
Audit Reveals: Unsupervised second line drugs
Incorrect doses
Multiple private practitioners (on average from
4
physicians during a 18-month period)
(an attempt to cure their (MDR)tuberculosis.)

47. Treatment Of MDR-TB Cases
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RNTCP will be using a Standardised Treatment
Regimen (Cat IV) for the treatment of MDR-TB
cases (and those with rifampicin resistance) under
the programme.
Category
Intensive Phase
IV
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Category of
Patients
Continuation
phase
MDR TB Cases
6-9(kmOfxEtoCsZE) 18(OfxEtoCsE
)
Km – Kanamycin ;Ofx- Ofloxacin; Eto-Ethionamide ;
Cs- Cycloserin; Z- Pyrazinamide ; E- Ethambutol

48. Gaps in the MDR TB management
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Diagnosed with TB and MDR TB in the private sector
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No notification done to public health authorities, who would be
able to take actions to confirm diagnoses, offer supportive
services, and offer free treatment to patients from public
sources or at least supervise the quality of care in the private
sector.
Inadequate or inefficient administration of effective treatment.
Poor case holding .
Frequent use of Second line drugs in treatment common
ailments.
inadequate or irregular drug supply.
Ignorance of health care workers in the treatment and control
of TB.
Interruption of chemotherapy due to side effects.
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49. Gaps in the MDR TB management
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Anti-TB drugs available without prescription and
subsequent widespread irrational and irresponsible use
Insufficient public sector MDR and XDR TB diagnosis
and treatment services
Only in recent years has a public sector option for free
diagnosis and treatment of MDR TB become available;

50. Success
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In 2008 were only 17 accredited facilities for doing culture
and DST (which works out to 0.1 facility per 10 million
residents, against a minimum of 1 per 10
million), although efforts are underway to increases the
number to 43 laboratories with DST capacity. Indeed, by
2011, 27 accredited laboratories are
operational, including 8 private/NGO sector laboratories.
Expansion of laboratory capacity is critical to ensure that
patients with suspected drug resistant TB can be
diagnosed early and.
The RNTCP has begun to incorporate recent, more rapid
methods of performing culture and DST (e.g. liquid
culture and molecular assays) and this is important to
avoid unnecessary delays in the management of patients
with MDR–TB

51. New lines of diagnosis
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Xpert MTB/RIF has 72 per cent sensitivity with one
test, and 90 per cent with three tests in the case of
smear-negative patients. The sensitivity goes up to 98
per cent in the case of smear-positive and culturepositive patients. Xpert MTB/RIF has 99 per cent
specificity.
It can turn in results in less than two hours compared
with four to six weeks in the case of the culture
process.
But the most important advantage is its ability to
diagnose rifampicin drug resistance.

52. Recommendation

Need for continuous surveying of drug resistance by
a network of investigators in different regions of the
country, by employing a common protocol, with an
emphasis on quality control, which will serve as a
useful parameter in the evaluation of current and
past chemotherapy programs

53. TB-HIV collaboration

In comparison to 19 states in 2010, in 2011 23 states
are implementing the intensified TBHIV package for at
least 2 quarters with close to 6 lakh TB patients were
ascertained for their HIV status (67% of TB patients
registered) and about 44,000 HIV-infected TB patients
In 2011, 1.1 million (13%)
were diagnosed. of the 8.7 million people who developed TB
worldwide were HIV-positive ; 79% of these HIV-positive TB cases were in the
African Region. Globally, there were an estimated 0.4 million HIV-associated
TB deaths in 2011, with
 Till December 2011, more thanand women centres were
approximately equal numbers among men 300 ART
operating in the country, and 550 link- ART centres.

54. TB HIV Collaboration
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In 2007, the first National Framework for joint TB-HIV
collaborative activities was developed which endorsed a
differential strategy reflective of the heterogeneity of TBHIV epidemic.
Coordinated TB-HIV interventions were implemented
including establishment of a coordinating body at national
and state level, dedicated human resources, integration of
surveillance, joint monitoring and evaluation, capacity
building and operational research.
Interventions have focused on improving services for HIVinfected patients, with intensified TB case finding at HIV
care settings and linking with TB treatment; and for TB
patients with provider initiated HIV testing and counseling,
provision of ART and decentralized CPT.

55. Challenges

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Treatment outcomes among HIV-infected TB
patients: low failure rates but high case-fatality;
death has been associated with lack of ART. .
Only about 50% of TB patients know their HIV status
and of those identified as HIV positive, only about
60% are linked to ART as the majority are poor and
unable to reach centralized ART centres.
Thus, gap between RNTCP and NACP
infrastructure results in suboptimal linkages.

56. POOR DIAGNOSIS and POOR POLICY
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Sputum smear microscopy is not a sensitive tool to
diagnose TB among PLHIV, and access to a culture
based diagnosis (or equivalent technology) is lacking.
Implementation of airborne infection control measures in
health care settings is also limited.
Revised National TB Control Programme (RNTCP) in
India uses a fully intermittent thrice-weekly rifampicin
containing regimen for all TB patients including those
who are HIV-infected; whereas, WHO recommends daily
TB treatment at least during the intensive phase.
The WHO recommendation was based on the results of a
meta-analysis demonstrating increased risk of recurrence
and failure among HIV-infected TB patients receiving
intermittent TB treatment, compared to a daily regimen.

57. Human Resource


Vision
A world where every person, everywhere has access
to a motivated and supported health worker, who is
skilled in TB control.
Goal
Health workers at different levels of the health
system have the skills, knowledge, and attitudes
(professional competence) necessary to successfully
implement and sustain comprehensive TB control
services based on the Stop TB Strategy.

58. NEED FOR HUMAN RESOURCE
PLANNING

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Unprecedented programme expansion in the last five
years has outpaced capacity at central, state and district
level to ensure quality of services.
Members of the staff at state and district levels : perform
multiple functions , being overburdened.
New Recruits necessitates frequent trainings, which is
neglected at times.
Hence, there is an urgent need for national HRD
planning that strategically and comprehensively
addresses the overall staffing issues related to
recruitment, capacity development, performance .

59. NEED FOR HUMAN RESOURCE
PLANNING



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Advanced training on management aspects such as health
financing, leadership/governance, business
planning, organizational development
Engage in strategic partnerships for health workforce
development with other Training divisions/ institutions, inservice training for programmes, Ministry of Education and
other relevant ministries, Professional
associations, Private sector including NGOs and bilateral
and international organizations
Monitor and supervise health worker performance to
detect performance deficiencies; identify new staff in need
of training; identify additional staff needs for current
interventions and for new interventions/strategies.
Quality assessment of Training.

60. National Strategic Plan (NSP)(2012-17)
Vision
TB-free India
RNTCP defined newer objectives of 'Universal Access to TB Care' for TB control in
Goal
 Decrease the morbidity and mortality by
early diagnosis and treatment to all TB
cases thereby cutting the chain of
transmission.
India in 2010.

61. Objectives
Case detection
NSP objective:
RNTCP Objective :
To 70% of estimated New Smear for all cases cases
Achieve 90% Notification rate Positive TB
Treatment
RNTCP Objective: success
NSP Objective:
85% of all New amongst New TB cases
90% success rateSmear positive & 85% amongst retreatment TB
cases registered under RNTCP
Drug resistant
NSP Objective: TB
Improve the successful outcome of treatment of MDR
cases

62. Objectives
TB-HIV
Collaboration
NSP Objective:
Decrease Mortality and morbidity of HIV associated
TB
Private
Sector
NSP Objective:
Improve the outcome of TB care in Private
sector

63. Targets planned for 2012 to2017

64. TB Made Notifiable (May 7,2012)




Mandatory for laboratories, hospitals, nursing homes and
doctors, both in the public and private sector, to report
every TB case detected.
Once a case is notified govt. will ensure correct diagnosis
and complete adherence to treatment during the entire
duration of treatment.
This is where the approaches that India and China
adopted to fighting TB diverged.
Of the 37 notifiable diseases in China, TB ranks No. 1. It
pulled out all the stops by 2000. “The concept of
acceptance of the problem, identifying its requirement and
the political will of TB eradication has set China on a
progressive path,” notes a paper published in the journal
Interdisciplinary Perspectives on Infectious Diseases.

65. Conclusion

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Join Hands
Strong Commitment from TB control Staff
Human Resource Management
Strong Political Commitment
Proper IEC Activities
Decentralization of the resources
Research
HELP US COMBAT TUBERCULOSIS

66. Thank you