Revised national tuberculosis control programme

RAVI ROHILLA
DEPTT OF COMMUNITY MEDICINE
PGIMS Rohtak

CONTENTS
• Background Information
• World Scenario
• Indian Scenario
• TB control in India
• RNTCP
• STOP TB strategy
• RNTCP Funding
• Classification and diagnostic algorithm

CONTENTS
• Case registration
• Treatment
• Follow-up schedule for sputum examination
• Reports and feedback
• Achievements

Background Information
• 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.
• One in ten people infected with TB (but who are
not infected with HIV) become ill with TB at some
time during their life.
• People with both HIV and TB infection are much
more likely to become ill with TB.

• In 2009, there were an estimated 9.4 million incident
cases (range, 8.9 million–9.9 million) of TB globally
• There were an estimated 14 million prevalent
cases(range 12 million–16 million) of TB in 2009
• In 2009, an estimated 1.3 million deaths (range 1.2
million–1.5 million) occurred among HIV-negative cases
of TB
• There were an estimated 440 000 cases of multi-drug
resistant TB (MDR-TB) in 2008
• There were an estimated 0.4 million deaths (range,0.32
million–0.45 million) among incident TB cases that were
HIV-positive

Revised national tuberculosis control programme

INDIAN Scenario
• India is the highest TB burden country
accounting for more than one fifth of the
global incidence.
• Global annual incidence estimate is 9.4
million cases out of which it is estimated that
1.98 million cases are from India.
• India is 17th among 22 High Burden
Countries in terms of TB incidence rate
(Source: WHO global TB report 2009).

Other Countries
20%
Other HBCs
16%

TUBERCULOSIS CONTROL IN INDIA
• National TB Control Programme (NTP) 1962
• RNTCP – 1993 as pilot project
• RNTCP: 1997 expanded across the country in a
phased manner with support from the World
Bank and other development partners
• RNTCP I: 1997-2006
• RNTCP II: 2006-2011 (Sept.)

NTP
• Ground-breaking research in the 1950s and
early 1960s by the Tuberculosis Research
Centre at Chennai and the National TB
Institute at Bangalore, a National Tuberculosis
Programme (NTP) was implemented by
Government of India in 1962.
• The NTP was implemented on a 50:50 cost
sharing basis between Centre and State.

NTP
• 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 centres and
330 TB clinics.

FAILURE OF NTP
• Inadequate budget and insufficient managerial
capacity
• Shortage of drugs
• Less than 40% of patients completed the
treatment
• Emphasis on x-ray diagnosis resulting in
inaccurate diagnosis
• Poor quality sputum microscopy
• Multiplicity of treatment regimens.

Revised strategy
• Augmentation of organizational support
• Increased budgetary outlay
• Use of sputum as a primary method of diagnosis
• Standardize treatment regimens
• Augmentation of the peripheral level supervision
• Ensuring a regular, uninterrupted supply of drugs
up to the periphery health unit
• Emphasis on training, IEC, and Operational
research

RNTCP
• GOI –WHO revised strategy for control of
TB in India
• RNTCP application of WHO – DOTS
launched in 1993 as pilot project covering
2.35 – 20 million population (1993-1997)

STRATEGIES
• The Revised National TB Control Programme
(RNTCP), based on the internationally
recommended Directly Observed Treatment Short-course
(DOTS) strategy

OBJECTIVES
The objectives of the programme are to:
• To achieve and maintain cure rate of at least
85% among New Sputum Positive (NSP)
patients.
• To achieve and maintain case detection of at
least 70% of the estimated NSP cases in the
community.

UNIQUE FEATURES OF RNTCP
• District TB Control Society
• Modular training
• Patient wise boxes
• Sub-district level supervisory staff (STS, STLS)
for treatment & microscopy
• Robust reporting and recording system

RNTCP Organization structure:
State level

Designated Microscopy Centre
• Tertiary / Secondary level health care institutions
• Block PHCs / other equivalent institutions
• Caters to a population of 1 lakh (0.5 lakh in hilly,
tribal and difficult areas)
• 60 -100 new adult outpatient attendance per day
• The laboratory technician must be examining an
average of at least 3 – 5 smears and not more
than 20 – 25 smears per day.

Annual Risk of Tuberculosis Infection
• 1.5%
• Means out of 100000 people, 1500 people would be
infected of Tuberculosis.
• Out of these 1500 infected subjects, 10% would be the
number of people who will be developing the disease
• It means 150 people will be developing the TB. Out of
these, 50% of the cases will be new sputum positive
cases.
• This shows that for ARTI of 1.5%, there will be 75 new
sputum positive cases per year per lakh population

DOTS Strategy
DOTS is a systematic strategy which has five
components:
• Political and administrative commitment.
– TB is the leading infectious cause of death .
– Since TB can be cured and the epidemic reversed, it
warrants the topmost priority as given by GoI.
• 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.

DOTS Strategy
• 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.
– The programme is accountable for the outcome of every
patient treated. The RNTCP shifts the responsibility for cure
from the patient to the health system.

RNTCP
• In the first phase of RNTCP (1997-2006), the
programme’s focus was on ensuring expansion
of quality DOTS services to the entire country.
• The RNTCP has now entered its second phase
(2006-2011)in which the programme aims to
firstly consolidate the gains made to date, to
widen services both in terms of activities and
access, and to sustain the achievements for
decades to come in order to achieve ultimate
objective of TB control in the country.

RNTCP
• RNTCP Phase II (2006-11) is in line with the new
WHO Stop TB Strategy for TB control and covers all
the activities proposed under the strategy.
• RNTCP is committed to implementing the 2006
Global Strategy to Stop TB and reaching the TB
related targets of the Millennium Development Goals
by 2015.
• The RNTCP II aims to provide a road map for TB
control to achieve the long term goal, by 2015, of
reducing the prevalence of TB by 50%.

TB in MDGs
• Goal 6 – to combat HIV/AIDS, malaria and other diseases
• Target 8 – to have halted by 2015 and begun to reverse the
incidence of malaria and other major diseases, including
tuberculosis.
• Indicator 23: Between 1990 and 2015, to halve the
prevalence and death rates associated with tuberculosis;
and
• Indicator 24: by 2005, to detect 70% of new smear positive
TB cases arising annually, and to successfully treat 85% of
these cases

THE STOP TB STRATEGY
• The new WHO Stop TB Strategy, released in
2006, has identified six principal components
to realise the global TB related MDGs by 2015.
• These components were further revised in
2009:

All components of new Stop TB Strategy are
incorporated in the second phase of RNTCP. These
are:
1.Pursue quality DOTS expansion and enhancement, by
improving the case finding are cure through an
effective patient-centred approach to reach all patients,
especially the poor.
2. Address TB-HIV, MDR-TB and other challenges, by
scaling up TB-HIV joint activities, DOTS Plus, and other
relevant approaches.
3. Contribute to health system strengthening, by
collaborating with other health programmes and
general services.

4. Involve all health care providers, public, nongovernmental and
private, by scaling up approaches based on a public-private mix
(PPM), to ensure adherence to the International Standards of TB
care.
5. Engage people with TB, and affected communities to demand,
and contribute to effective care. This will involve scaling-up of
community TB care; creating demand through context-specific
advocacy, communication and social mobilization.
6.Enable and promote research for the development of new
drugs, diagnostic and vaccines. Operational Research will also be
needed to improve programme performance.

• “In recent years India has taken major
strides towards controlling TB. The Stop
TB Partnership is confident that India will
continue the momentum and contribute
significantly towards the implementation of
the Global Plan to Stop TB, 2006-2015.”
Dr. Marcos Espinal, Executive Secretary,
Stop TB Partnership Secretariat, Geneva

RNTCP FUNDING
• 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
256.9 million which includes credit from
World Bank of USD 170 million and
commodity assistance of anti-TB drugs from
DFID (Department For International
Development)through WHO for USD 62.5
million, and the balance by Government of
India.

CLASSIFICATION
• Tuberculosis cases are classified as either
pulmonary or extra pulmonary.
• Pulmonary tuberculosis is defined as having
lesions in lungs. It is divided into two types:
• Smear-positive pulmonary TB:
• A patient with one or two smears positive for AFB
out of the two sputum specimens subjected for
smear examination by direct microscopy is
classified as having smear positive pulmonary TB.

CLASSIFICATION
Smear-negative pulmonary TB:
• Patients with two initial negative smear
results, whose symptoms persist after two
weeks of broad spectrum antibiotics and
whose repeat sputum examination results are
also negative along with radiological
abnormalities suggestive of active TB is
classified as having smear negative pulmonary
tuberculosis.

CLASSIFICATION
Extra-pulmonary TB:
• Tuberculosis of organs other than the lungs
such as pleura, lymph nodes, intestine,
genitor-urinary tract, joint and bones,
meninges of the brain etc., is called as extra
pulmonary TB. Pleural tuberculosis is classified
as extra pulmonary.
• If a patient has both smear-positive
pulmonary TB and extra-pulmonary TB, the
patient is classified as having pulmonary TB
and the site of extra-pulmonary TB is recorded
as well.

Case registration
• Types of cases to be registered: All
tuberculosis patients put on DOTS or non
DOTS regimen under RNTCP are to be
registered. This includes new smear positive,
new smear negative, new extra pulmonary,
new others and re-treatment cases comprising
of relapses, treatment after defaults, failures
and others. Besides, transfer-in cases are also
to be registered.

Case registration
• Person responsible for registration: Senior
Treatment Supervisor (STS) is responsible for
registering all TB cases put on treatment
under the jurisdiction of TB Unit. He / She is
also responsible for updating and
maintenance of the TB register under the
overall supervision of the MOTC.

Case registration
• Tuberculosis number
• Each patient who is being registered is assigned a
new Tuberculosis Number and this number is
written in the Tuberculosis Register.
• The number should be started with number ‘1’
(e.g. -01 / 2010 at the beginning of every year
and patients are registered serially.
• After TB number is written in the TB register the
same is recorded in the treatment card also.

Case registration
• TB number facilitates identification of the patient
in the TB register and other details pertaining to
treatment.
• An individual TB patient may have more than one
TB number if he is reregistered (e.g. after
declaring him as ‘Defaulted’ and restarting on
treatment afresh or after declaring as failure and
initiating on regimen for previously treated cases,
details of which will be recorded in the remarks
column).

Case registration
The STS should write the TB number in the
following records:
• TB register
• TB treatment card
• TB laboratory register (Remarks column)

Case registration
• Timeline for registration: All tuberculosis
patients should be registered within a month
after the initiation of the treatment and after
patient’s home visit by the STS.
• Under no circumstances the treatment should
be delayed pending the registration of the
patient.

Types of cases
New
• A TB patient who has never had treatment for TB or
has taken anti-TB drugs for less than one month is
considered as a new case.
Transferred in
• A TB patient who has been received for treatment in
a Tuberculosis Unit, after starting treatment in
another TB unit where s/he has been registered is
considered as a case of transferred in.

Types of cases
• Treatment after default patient: who has received
treatment for TB for a month or more from any
source and returns for treatment after having
defaulted i.e., not taken anti-TB drugs consecutively
for two months or more and found to be smear-positive
is a case of treatment after default.
• Failure: Any TB patient who is smear-positive at 5
months or more after initiation of treatment is
considered as failure.

Types of cases
• Relapse: A TB patient who was declared cured or
treatment completed by a physician and who reports
back to the health facility and is now found to be
sputum smear positive is a relapse case.
• Others: A patient who does not fit into the any of the
types mentioned above. The reasons for labelling a
patient under this type must be specified in the
Treatment card and TB Register

Types of cases
Cured
• Initially sputum smear positive patient who has completed treatment
and had negative sputum smears on two occasions, one of which is at
the end of the treatment is declared as cured.
Treatment completed
– Initially sputum smear positive patient who has completed treatment with
negative smears at end of the intensive phase / two months in the
continuation phase, but none at the end of treatment the treatment is
declared as treatment completed , or
– Initially sputum smear negative patient who has received full course of
treatment and has not become smear positive at the end of the treatment, or
– Extra pulmonary TB patient who has received full course of treatment and
has not become smear positive during or at the end of treatment is also
declared as treatment completed.

Patient wise drug boxes
• Drugs are supplied in patient-wise boxes (PWB)
containing the full course of treatment, and packaged
in blister packs. The PWB have a color code indicating
the two regimen - Red for “New”, Blue for “Previously
Treated”. In each PWB, there are two pouches one for
intensive phase and one for continuous phase.
• In the intensive phase, each blister pack contains one
day’s medication. For the continuation phase, each
blister pack contains one week’s supply of medication.
The drugs for extension of the intensive phase
(prolongation pouches) are supplied separately.

• Regimen for New cases treatment consists of
total 78 doses and for previously treated cases
consists of 102 doses.

Drug dosages for adults in the blister
packs

MDR-TB & XDR-TB
• MDR-TB is defined as resistance to isoniazid
and rifampicin, with or without resistance to
other anti-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).
• Cure rate for MDR-TB is 20-30%.

Treatment Of MDR-TB Cases
• 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.
• Cat IV regimen comprises of 6 drugs- kanamycin,
ofloxacin (levofloxacin)†, ethionamide,
pyrazinamide, ethambutol and cycloserine during
6-9 months of the Intensive Phase and 4 drugs-ofloxacin
(levofloxacin), ethionamide, ethambutol
and cycloserine during the 18 months of the
Continuation Phase. p-aminosalicylic acid (PAS) is
included in the regimen as a substitute drug if any
bactericidal drug (K, Ofl, Z and Eto) or 2
bacteriostatic (E and Cs) drugs are not tolerated.

Monitoring the MDR-TB patient
• Close monitoring is essential during treatment of MDR-TB
patients.
• To assess treatment response, sputum smears and
cultures should be performed monthly until smear and
culture conversion. (Conversion is defined as two
consecutive negative smears and cultures taken 30
days apart.)
• After conversion, the minimum frequency
recommended for bacteriological monitoring is
monthly for smears and quarterly for cultures.
• Monitoring of MDR-TB patients by a clinician should be
at least monthly until sputum conversion, then every
2–3 months.
• Each patient’s weight should be monitored monthly.

Non-DOTS (ND) treatment regimen
• In rare and exceptional situations, non-DOTS
treatment (with a self-administered non-rifampicin
containing regimen) may be needed in
a few TB cases. Examples include:
1. Those with adverse reactions to rifampicin and /
or pyrazinamide
2. “New” patients who refuse DOT,S despite all
efforts
– To facilitate registration of patients started on non-
DOTS regimens, a Tuberculosis Treatment Card should
be filled.
– A maximum of 1% of patients may get non-DOTS
treatment in an RNTCP area.

NON DOTS
– The justification for initiating patient on non-DOTS
treatment should be specified in the “Remarks”
column of the treatment card and TB register.
– This is a treatment regimen of 12-month duration
comprising 2 months of SHE and 10 months of HE
(2SHE / 10HE).
Dosages administered per day in the regimen are:
– Isoniazid - 300 mg
– Ethambutol - 800 mg
– Streptomycin - 750 mg (500 mg for >50 years of age).
• Those who weigh less than 30 kgs receive
dosages calculated as per body-weight.

Follow up schedule for sputum
examination:
• Follow up sputum examination is recommended as
follows
For New Cases
1. At the end of Intensive Phase (2nd month)
2. Two months into the Continuation Phase (4th
month)
3. End of treatment (6th month)

examination:
• New smear positive patients remaining smear
positive at the end of 2 months of treatment and
new smear negative cases becoming smear positive
at the end of 2 months will have their intensive
phase extended by 4 weeks by administering 12
blisters from prolongation pouch. They would be
subjected for repeat follow up sputum examination
at the end of 3 months. Irrespective of the smear
results (whether positive or negative) at the end of
third month, continuation phase is started.

examination:
• Subsequently, the patient is subjected for sputum
examination at 2 months into the continuation phase
i.e. at the end of 5 months of treatment. The final
follow up sputum examination is done at the end of
the treatment.
• If patients are found to be positive either at the end
of 5 months or at the end of treatment they are
declared as failure and sputum is sent for culture and
drug sensitivity testing. Then, they are registered
afresh and put on treatment regimen for previously
treated.

examination:
For Previously treated cases
1. At the end of Intensive Phase (3rd month)
2. Two months into the Continuation Phase (5th
month)
3. End of treatment (8th month)

examination:
• In situations where sputum is positive at the end
of three months, intensive phase is extended by
four weeks by administering additional 12 blister
packs and a follow up sputum examination is
undertaken at the end of fourth month.
• Irrespective of the smear results (whether
positive or negative) at fourth month,
continuation phase is started.
• In case sputum is positive at the end of the fourth
month, sputum is sent for culture and drug
sensitivity testing.
• Subsequently, the patient is subjected for sputum
examination at the end of sixth and ninth month.

Points worth mentioned
• Smear conversion at the end of the intensive phase is an early
indication for achieving high cure rates. This has to be ensured by
regular monitoring of the treatment.
• Treatment of smear-negative and extra-pulmonary TB is
monitored by regularity of drug intake and clinical improvement.
• A patient initiated on treatment for tuberculosis will have only
one of the seven outcomes (cured, treatment completed, died,
failure, defaulted, transferred out or switched over to MDR-TB
treatment).
• While determining the date of outcome in cure and treatment
completed, the date on which the last dose of drug consumed is
considered and not the last date when drugs were collected.

Points worth mentioned
• During follow-up sputum smear examinations, if 2
specimens are examined and one of them is positive, the
patient is considered smear-positive.
• If both specimens are positive, the higher grade out of the
two results is written on the patient’s Tuberculosis
Treatment Card.
• If both specimens are negative, the patient is smear-negative
and ‘NEG’ is recorded in the appropriate space.
• The results of follow up sputum smear examination done at
the end of treatment should be available not later than two
week of completion of treatment, so that appropriate
outcome for the patient can be given in the TB Treatment
Card.

Flow of reports and feedback
• The monthly PHI level PMR is prepared by the
MO of the PHI and sent to the district and TU. At
the TU a quarterly PMR is prepared by the MOTC
with support of STS/STLS and despatched to the
DTO.
• Quarterly reports on case finding, sputum
conversion and treatment outcome are prepared
at the TU level from the TB register. The STS is
responsible for preparing the reports mentioned
above under the overall supervision of the MOTC
at TU level. The MOTC is responsible for
validating and signing the reports and
despatching it to DTO.

Flow of reports and feedback
• The quarterly reports received from all the TUs in the
district are consolidated at District TB Centre. District TB
Officers in turn are responsible for reporting the same to
the state level authorities [STC and STDC] and CTD.
• The reports are consolidated at STC and sent to CTD. The
reports are analysed at the STC/STDC and feedback given
to districts.
• The quarterly reports are also analysed by CTD and
feedback is provided to the state for corrective actions.
All the above reporting activities are undertaken on a
quarterly basis from TU to central level. A diagrammatic
flow chart is provided below depicting the monitoring
process.

Achievements
• With respect to the progress towards indicator 23, as
per the WHO estimates in the year 1990, the
prevalence of TB in India was 586 per 100,000
populations and the mortality due to TB was 42 per
100,000 population.
• In comparison, in the year 2008, the prevalence of
TB in India was estimated by WHO to be 185 per
100,000 populations, and the mortality due to TB is
24 per 100,000 populations. The estimates show that
India has progressed in reducing the prevalence rate
by 68% and mortality rate by 43%.

Progress towards MDG indicator 23

Revised national tuberculosis control programme

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