Revised National

Tuberculosis Control
Program (RNTCP)
 Presenters

Masiya Debbarma
Naorem Kriyalaxmi Devi
N. Chingei Phem
Nevedita Das
 Introduction

 Tuberculosis is a chronic infectious disease

caused by Mycobacterium tuberculosis
which was discovered by Robert Koch

 Also known as “Koch’s Bacillus”

 The most common organ involved is

lung(>80%) but it can involve any organ of
the human body (except hair and nails) Robert Koch
 It usually affects human in the age group of
15 to 59 yrs
 Classification of TB
TB

Pulmonary (85-90%) Extra-pulmonary (10-15%)

Sputum Sputum Lymph Nodes

Positive TB Negative TB
Joints
(Those who (Those who
have do not have Genitourinary
bacteria in bacteria in tract
sputum) sputum)
Spinal tract
Intestines
 Symptoms of TB
Most common symptom of TB
• Cough for 2 weeks or more
Other symptoms of TB are:
• Fever, especially evening rise
• Pain in the chest
• Loss of weight
• Loss of appetite
• Coughing up blood-stained sputum
• Shortness of breath,
• Tiredness
 How TB Spreads ?
• Those who have Tuberculosis of the lungs are the ones
who can spread the disease to others
• When these infectious people cough, sneeze, talk or
spit, they can spread TB bacteria into the air in the form
of tiny droplets
• When these droplets are inhaled by a healthy person
he/she can get infected with tuberculosis

A sputum positive TB patient can infect 10-15 persons in a

year
 When to Suspect TB

TB should be suspected in anyone with cough for 2

weeks or more

These persons should have sputum examination in the

nearest Microscopy Centre at the earliest
 TB-HIV co-infection
TB is the most common opportunistic infection
amongst HIV infected individuals
An HIV infected person newly infected with TB has
10-30 times higher chances of developing TB than
those without HIV
In India, 55-60% of AIDS cases reported had TB and
TB is one of the leading causes of death in “People
Living with HIV AIDS” (PLHA)

Every TB patient should be referred to ICTC for HIV

status and vice versa
 Risk of infection
 About two persons infected in every 3 seconds

 About 50% are sputum smear positive and are infectious

 TB infected person will have a 10% lifetime risk of

developing tuberculosis

 Infection of TB is 60 times more common in HIV +ve

people than Non-HIV +ve

 Diabetes, malignancy, smoking tobacco, malnutrition and

alcohol abuse also increase the risk of progression from
infection to disease

 2 out of every 5 Indians are infected with TB bacillus

 BURDEN OF DISEASE
WORLD:
TB continues to be one of the most important public
health problems worldwide
 In 2014, an estimated 9.6 million people developed TB
and 1.5 million died from the disease, 400,000 of whom
were HIV positive
 Worldwide the proportion of new cases with MDR-TB
was 3.3% in 2014, whereas those for previously treated
cases was 20.0%
Of the estimated 9.6 million people who developed
TB in 2014, more than half (58%) were in South-East
Asia and Western Pacific regions and a further one
quarter (28%) were in African region
India, China and Indonesia alone accounted for 23%,
10% and 10% of total cases respectively
In 2014, an estimated 3.2 million cases were women
An estimated 510,000 women died as a result of TB,
more than 1/3rd of whom were HIV positive
Globally, about 1.1 million new cases and 130,000
deaths occur annually due to TB among children
(Global TB report 2015)
 INDIA
 Accounts for nearly 1/4th of the global burden of TB
 Around 2.2 million develop TB in 2013-14. During the
same period, 0.27 million people died due to TB
 Everyday about 20,000 people become infected, 5000
develop TB and more than 1000 die due to the disease
 In simple terms, 2 persons become sputum +ve for TB and
almost 1 person is killed every minute due to the disease (
WHO 2007)
 The proportion of new cases with MDR-TB was 2.2% in
2014, whereas those for previously treated cases was 15.0%
 Brief History of Tuberculosis (TB)
- 1865 Jean-Antoine Villemin:
confirmed that TB is contagious
- Robert Koch:
- 1882: Isolated and cultured M.
Tuberculosis(24th March)
- 1890: Announced the discovery of
tuberculin
- Developed staining methods used to
Visualization of M. tuberculosis
identify the bacteria using the Ziehl-Neelsen stain

- 1905: Received Nobel Prize

• Bacteriologist Paul Ehrlich developed Ziehl-Neelsen
staining

• Before 1940
– Sanatorium approach, good food, rest & fresh air

• 1948
– Introduction of BCG vaccination

• 1950s-60s:
– Antibiotics available
 Background History of RNTCP
– 1906- First open air TB sanatorium founded in
India
– 1939- TB association of India
- expert advice on the development of
standard methods to deal with the disease;
- setting up model institutions for training TB
workers;
- education of the public regarding preventive
measures;
- conceived the idea of domiciliary Rx of TB
in 1940
• 1946- Bhore Committee recommended to the GOI, setting
up TB clinics in the districts and mobile TB clinics in rural
areas.
• 1947- GOI established a TB division under DGHS in the
MoH, Planning and execution of anti-TB activities were
greatly facilitated by this Division.
• 1951- Mass BCG vaccination campaign covering 65 million
children in collaboration with IUAT
• 165 million tuberculin tests were administered to find the
prevalence of TB in India
• 1955-58 - National Sample Survey conducted under
ICMR to find the magnitude of TB problem in India

• 1956- TRC established in Chennai

- Proved the efficacy of domiciliary Rx for
TB with chemotherapy

• 1959- National TB Institute (NTI) established in

Bangalore by GoI, with the active cooperation of the
WHO, to develop a TB control programme
• 1962- National TB Control Program(NTCP) started
Managerial weakness, lack of supervision
Poor quality of sputum microscopy
Multiplicity of treatment regimens
Poor organizational set-up
Inadequate funding
Over dependence on X-ray for diagnosis
Frequent interrupted supplies of drugs
Low rate of treatment completion (30% only)
• 1992- Programme Review showed - only 30% of patients
diagnosed and only 30% of them treated successfully
• 1993- WHO Declared TB as a global emergency, RNTCP
was initiated applying the principles of DOTS as a pilot
project
• 1997- RNTCP started as a national programme
• 1998- Massive RNTCP expansion began, RNTCP Ist phase
(1998-2005)
• 1998 September- RNTCP Implemented in Imphal District,
Manipur RNTCP programme covered the State from 21st Jan
2002
Early 2000 - 135 million population covered;
Monitoring Mission conducted
Sept 2003 - 741 million population covered; Monitoring
Mission appreciates rapid expansion and overall quality
End 2005- 97% population covered; next 5-year plan
approved with additional activities, such as DOTS-
Plus
March 2006- The entire country covered by DOTS
 Oct 2006 - RNTCP phase II started for 5 years ( to Sep’11)

 2007 - New sputum + case detection was 70% and

 2007 - DOTS plus services for management of MDR-TB
patients have been rolled out in the states of Gujarat and
Maharashtra
 2009: Prevalence of all forms of TB ↓ from 338 per 100,000
population (1990) to 249 per 100,000 population and TB
mortality in the country ↓ from over 42 per 100,000
population in 1990 to 23 per 100,000 population (WHO
global TB report 2010)
 May 2012- Notification of TB is made mandatory by GOI
 Revised National Tuberculosis Control
Programme
o The National TB Programme (NTP) was started in 1962
for TB control in India. This programme was not able to
give expected results in India

o The NTP was reviewed in 1992

o As a result of the review and pilot studies in 1993, the

DOTS strategy was adopted in India under the Revised
National TB control Programme - RNTCP

o The programme was implemented in a phase manner

and by 24th March 2006, the entire country was covered
under the programme
Goal
The goal of RNTCP is to decrease the mortality and
morbidity due to tuberculosis and cut down the chain of
transmission of infection until TB ceases to be a public health
problem

Objectives
To achieve and maintain:
o Cure rate of at least 90% among newly detected smear
positive (infectious) pulmonary TB cases and
o Case detection of at least 85% of the expected new smear
positive PTB cases in the community
 Organisational structure of RNTCP
Central TB Division, DGHS, Deputy Director General-TB
MoH&FW
National Lab Committee, National TWG for
National Institutes TB-HIV, National DOTS Plus Committee,
(NTI, TRC, LRS, JALMA) NTF for medical colleges, National OR
Committee
State TB Training and STO, MO, Epidemiologist,
Demonstration State TB Cell DEO etc
Centre/SDS/IRL
Nodal centre for TB control District TB Centre DTO, MO-DTC, Support staff etc
in the district

1 per 5 lakh population, 1 per Tuberculosis Unit MO-TC, STS, STLS

2.5 lakh in tribal, hilly and
difficult areas

1 per 1 lakh population, 1 per DMC MO, LT

0.5 lakh in tribal, hilly and
difficult areas
DOTS Centre HW, ASHA, AWW, PPs,
NGO, Comm vol etc
 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
 FUNDING
• 100 % central government sponsored
• The program is assisted by World bank and The
Department for International Development (DFID)
• Other supporting agencies are
o Global TB Drug Facility(GDF)
o Global Fund to Fight AIDS, TB, Malaria(GFATM)
o United States Agency for International Development(USAID)
o Danish International Development Agency (DANIDA)
 Strategies
o Case finding and Diagnostics- Use of sputum testing
as the primary method of diagnosis
o Patient friendly treatment services and ensuring a
regular, uninterrupted supply of drugs up to the most
peripheral level-DOTS
o Scale-up of Programmatic Management of Drug
Resistance –TB (PMDT)
o Scale -up of Joint TB-HIV Collaborative Activities
o Integration with Health Systems
 Strategies

Engagement of Private Sector

 Human Resource Development
 Advocacy, Communication and Social Mobilization
(ACSM)
Monitoring and Evaluation, Surveillance and Impact
Assessment
Operational research to inform TB Control policy and
practice
 Strategies

1. Case finding and Diagnostics:

 Early identification of all infectious TB cases
 Improved integration with the general health system and
leverage field staff for home-based case finding
 Improve communication and outreach
 Screening clinically & socially vulnerable risk groups for
TB
 Develop improved sputum collection and transportation
systems
 Strategies

Deployment of higher-sensitivity diagnostic tests for

TB suspects (and incorporate new tests) &
decentralized DST services
 Catch patients already diagnosed through notification
from all sources
Improved referral for treatment mechanisms, and
deployment of Laboratory & Private Provider
notification
 Strategies
2. Patient friendly treatment services: DOTS strategy
 Promptly and appropriately treating TB, increasingly
guided by DST
Making DOTS more patient friendly through ↑
communitization of DOT
pilot incentives/offsets for patient costs to help patients
complete treatment and better monitoring through IT
 Improving partnerships between public and private
sector
 Strategies

3. Scale-up of Programmatic Management of Drug

Resistance –TB (PMDT):
Developing network of C&DST Laboratories &
Strengthening of Reference Laboratories
Decentralized DST at district level for early MDR
detection
 Improved information system for PMDT
 Implementation
• Case finding- by passive surveillance on patient with
symptoms of
i) Persistent cough for 2weeks or more.
ii) Haemoptysis
iii) Night sweats
iv) Evening rise of temperature
v) Chest pain
In lab.-
i) Sputum collection for diagnosis
ii) Radiography
iii) Tuberculin test
• Diagnosis of TB
Sputum examination is the best method to diagnose TB

• Pulmonary TB diagnosis can be confirmed by sputum

examination. Two sputum samples are collected over
one/two consecutive days
• If the health facility is a DMC, spot sample is collected
immediately and the patient is given a sputum container
to collect early morning sample & brought to the lab
• Alternatively the patient can be asked to collect a
morning sample and go to a DMC where a spot sample
can be taken
• In case the patient is not able to reach a DMC, both
samples - morning and spot, can be collected and
transported
• The sputum samples are subjected to microscopy
examination as early as possible

• A patient is diagnosed positive if one or both the

samples is positive for bacteria

• If the bacteria are not visible in any sputum

sample, the patient is negative and should be
referred to a medical officer for further evaluation

• TB of other organs is diagnosed by a medical

officer
RNTCP revised diagnostic algorithm (2009)

Note: RNTCP has

separate diagnostic
algorithm for
pediatric pulmonary
TB and common
forms of extra-
pulmonary TB
 DOTS
Directly Observed Treatment Short Course
 Directly Observed Treatment

Directly An observer Direct observation

ensures treatment
observed watches and
for the entire
treatment helps the course
(DOT) is one patient
• with the right
element of swallow the drugs
the DOTS tablets • in the right doses
strategy • at the right
 Components of DOTS

DOTS is a systemic strategy to control TB diseases. It has

the following 5 components -
1. Political and administrative commitment
2. Good quality diagnosis, primarily by sputum smear
microscopy
3. Uninterrupted supply of quality drugs
4. Directly observed treatment (DOT)
5. Systemic monitoring and accountability
 DOTS
Directly Observed Treatment Short Course
There are two phases in DOTS treatment
1- Intensive Phase(IP):-
 Intensive phase is of 2 to 3 months duration
 Patient swallow medicine under the observation of
a health worker during IP
 Medicines are taken 3 times a week on alternate
days
 If the sputum is negative for bacteria after IP,
continuation phase is started
 DOTS
Directly Observed Treatment Short Course
2. Continuation Phase
• This phase is of 4 or 5 months duration
• The patient is provided with a weekly blister pack to take
home
• The medicines from the blister pack are taken on
alternate days, three times a week and in the remaining
days, Vitamin tablets are taken
• The first dose of the weekly blister pack is taken under
direct observation of the health worker
• Empty blister packs are collected to ensure that the
medicines are taken at home by the patient
 Treatment Regimens

Category of
Type of Patient Regimen
Treatment

Category I All new pulmonary (smear-positive 2H3R3Z3E3+

and 4H3R3
negative), extra pulmonary and
‘others’ TB patients.
Category II TB patients who have had more than 2H3R3Z3E3S3
one month anti-tuberculosis treatment + 1H3R3Z3E3
previously + 5H3R3E3

Relapse , Failure, Treatment After

Default ,Others
 Towards A World Free From TB…
NEW CATEGORY
Treatment
 1st dose of this combipack should be swallowed
All medicines of the by patient under direct observation
blister pack have to be
taken under  The remaining medicines are taken home by
observation, thrice patient & taken thrice weekly on alternate days
weekly on alternate
 Vitamin tablets in the combipack are taken on
days
remaining days

It contains 24 blister It contains 18 weekly

doses for 2 months IP combipack doses for 4
months CP
The medicine box of this category-Red
Box contains 2 packets of IP & CP
 NEW CATEGORY
• Patient is sent for follow up sputum examination after
22 blister in the IP. The 23rd and 24th blisters should be
taken as per the scheduled time

• If the follow up examination is negative after the IP,

the patient is put on Continuous phase as per the
schedule

• After 2 months in the CP (8 weekly strips) and at the

end of the treatment (17th weekly strip), follow up
sputum examination is done
 NEW CATEGORY
• If the follow up sputum examination after the IP is
positive, the IP is extended for 1 month(12 blisters
strip). Sputum examinations is done again at the end of
this phase (11th blister strip)

• If the follow up sputum examination is positive after

the extended phase, CP is started irrespective of the
sputum result
 Previously Treated Category
Treatment
 1st dose of the weekly combipack should
All medicines of the
be swallowed by patient under direct
blister to be taken
observation
thrice weekly on
 Remaining part of combipack is taken
alternate days under
home by the patients and taken on
direct observation
alternate days
and Injection also on
 Vitamin tablets are taken in the
the same days
remaining days

Contains 36 blisters Contains 22 weekly

for 3 months & 24 combipacks for 5 month CP
injection
Medicine box of this category - Blue
Box contains 2 packets of IP & CP
 Previously Treated

• Patient is sent for follow up sputum examination after

34 blister strips in the IP. The 35th and 36th blisters
strips should be taken as per the scheduled time

• If the follow up examination is negative after the IP, the

patient is put on Continuous phase as per the schedule

• After 2 months in the CP (8 weekly strips) and at the

end of the treatment (21st weekly strip), follow up
sputum examination is done
 Previously Treated

• If the follow up sputum examination after the IP is

positive, the IP is extended for 1 month(12 blisters
strip). Sputum examinations is done again at the end of
this phase (11th blister strip)

• If the follow up sputum examination is positive after

the extended phase, CP is started irrespective of the
sputum result
 ANTI-TUBERCULAR DRUGS

Medication Drug action Dose(Thrice a Dose in

week)*** children(mg/kg)
Isoniazid Bactericidal 600 mg 10-15
Rifampicin Bactericidal 450 mg* 10
Pyrazinamide Bactericidal 1500 mg 30-35
Ethambutol Bacteriostatic 1200 mg 20-25
Streptomycin Bactericidal 0.75 g** 15

* Patients who weigh 60 kg or more at the start of treatment

are given an extra 150mg dose of Rifampicin
** Patients over 50 years of age are given 0.5g of streptomycin
*** Adult patients weighing <30kg receive drugs in patients-
wise from the weight band suggested for pediatric patients
 Treatment Outcomes
CURED
• Initially sputum smear-positive patient who has completed
treatment and had negative sputum smears, on two occasions,
one of which was at the end of treatment
TREATMENT COMPLETED
• Sputum smear-positive patient who has completed
treatment, with negative smears at the end of the intensive
phase but none at the end of treatment.
• Sputum smear-negative TB patient who has received a full
course of treatment and has not become smear-positive
during or at the end of treatment.
• Extra-pulmonary TB patient who has received a full course
of treatment and has not become smear-positive during or at
the end of treatment
• DIED
– Patient who died during the course of treatment
regardless of cause
• FAILURE
– Any TB patient who is smear positive at 5 months or
more after starting treatment.
• Default
– A patient who has not taken anti-TB drugs for 2 months
or more consecutively after starting treatment.
• Transferred out
– A patient who has been transferred to another
Tuberculosis Unit/ District and his/ her treatment result
(outcome) is not known.
 WHO definitions of TB cases recommended
for use since March 2013

• Bacteriologically confirmed case of TB: A patient from

whom a biological specimen is positive by smear
microscopy, culture or WHO-approved rapid diagnostic test
(such as Xpert MTB/RIF)
• Clinically diagnosed case of TB: A patient who does not
fulfil the criteria for bacteriologically confirmed TB but has
been diagnosed with active TB by a clinician or other
medical practitioner who has decided to give the patient a
full course of TB treatment
• Case of pulmonary TB: Any bacteriologically confirmed
or clinically diagnosed case of TB involving the lung
parenchyma or the tracheobronchial tree. Miliary TB is
classified as pulmonary TB because there are lesions in the
lungs. Tuberculous intra-thoracic lymphadenopathy
(mediastinal and/or hilar) or tuberculous pleural effusion,
without radiographic abnormalities in the lungs, constitute a
case of extrapulmonary TB. A patient with both pulmonary
and extrapulmonary TB should be classified as a case of
pulmonary TB.
• Case of extrapulmonary TB: Any bacteriologically
confirmed or clinically diagnosed case of TB involving
organs other than the lungs, e.g. abdomen, genitourinary
tract, joints and bones, lymph nodes, meninges, pleura,
skin
• New case of TB: A patient who has never been treated for
TB or has taken anti-TB drugs for less than one month
• Retreatment case of TB: A patient who has been treated
for one month or more with anti-TB drugs in the past.
Retreatment cases are further classified by the outcome of
their most recent course of treatment into four categories.
1. Relapse patients have previously been treated for
TB, were declared cured or treatment completed at
the end of their most recent course of treatment, and
are now diagnosed with a recurrent episode of TB
(either a true relapse or a new episode of TB caused
by reinfection)
2. Treatment after failure patients have previously
been treated for TB and their most recent course of
treatment failed i.e. they had a positive sputum smear
or culture result at month 5 or later during treatment
3. Treatment after loss to follow-up patients have
previously been treated for TB and were declared
‘lost to follow-up’ at the end of their most recent
course of treatment

4. Other previously treated patients are those who

have previously been treated for TB but whose
outcome after their most recent course of treatment is
unknown or undocumented
 DOTS Plus ?

• DOTS programme that add components for MDR-TB

diagnosis, management and treatment
Drug resistant TB
 Causes of drug resistance

 Programme related -Poor treatment

 Drug related - Poor drugs

 Patient related - Poor drug intake by the patient

Scientific basis of drug resistance

Genetic Mutation in bacteria due to continuous exposure to low
concentration of drugs
 Methods of Sputum C&DST
• Solid Culture – ( LJ Method)
-2-3 months
– Used both for diagnosis & follow up
• Liquid Culture:
- 2-4 weeks for diagnosis
- only used for diagnosis
• LPA – Line Probe Assay (Molecular test)
– 3 days for diagnosis
– Only used for diagnosis
• CBNAAT (Cartridge Based Nucleic Acid Amplification
Test)- can diagnose TB and Rifampicin resistance within
2 hours
 CAT IV – MDR TB
INITIAL INTENSIVE PHASE :6- 9 months
• Tab. Pyrazinamide
• Tab Ethionamide DOT – 6 days a Week

• Tab. Ethambutol
Sunday –
• Cap Cycloserine Unsupervised Oral Medicines
Inj Kanamycin OMITTED
• Tab Ofloxacin
• Inj. Kanamycin
CONTINUATION PHASE :18 months
• Tab Ethionamide
• Tab Ofloxacin
• Tab Ethambutol
• Cap Cycloserine
 CAT V- XDR TB
XDR TB- MDR TB+ Resistant to Second line injectable Anti
TB drug & Fluroquinolone
The Intensive Phase (6-12 months) will consist of 7 drugs
Capreomycin (Cm), PAS, Moxifloxacin (Mfx), High dose-
INH, Clofazimine, Linezolid, and Amoxyclav
The Continuation Phase (18 months) will consist of 6 drugs
PAS, Moxifloxacin (Mfx), High dose-INH, Clofazimine,
Linezolid, and Amoxyclav
 PROPHYLAXIS

• Preventive chemotherapy with isoniazid (H)

10mg/kg body weight daily for 6 months is
administered to all the children aged 6 years and
below who are in contact with smear positive
pulmonary TB case
 TB-HIV collaborative activities
Specific TB-HIV collaborative activities undertaken are:
 Establishment/Strengthening NACP-RNTCP co-
ordination mechanisms at national, state and district level
 Scaling up of intensified TB/HIV package of services
across the country
 Joint M&E including standardized reporting shared
between the two programmes
 Training of the programme and field staff on HIV/TB
 TB and HIV service delivery co-ordination
 Offer of HIV testing to TB patients
 Intensified TB case finding at ICTCs & ART
 Linking of HIV-infected TB patients to NACP for HIV care
and support and to RNTCP for TB treatment
 Provision of Co-trimoxazole Prophylactic Treatment (CPT)
for HIV infected TB patients
 Involvement of NGOs/CBOs and affected communities
working with NACP and RNTCP for all activities on
TB/HIV collaboration
 Operational research to improve the implementation and
impact of TB/HIV collaborative activities
 Public Private Partnership
 Intensified Public Private Mix Project is being undertaken with
IMA in 16 states and with CBCI-CARD(catholic bishop
conference of india-coalition for AIDS & related disease)
 Several organizations and Projects like Programme for
Appropriate Technology in Health (PATH), The Union,
Foundation for Innovative New Diagnostics (FIND),
Improving Health Behavior Project (IHBP), World Vision
India etc are actively involved in the programme
 At present 2,708 NGOs collaborations and 13,311 private
practitioners are involved in the programmes in different
schemes
Monitoring and Evaluation
Structure of RNTCP laboratory network

• 3 tier system
 National Reference Labs (NRL): 6 NRLs at present
1. Tuberculosis Research Centre (TRC), Chennai
2. National TB Institute, Bangalore
3. LRS Institute of TB and Respiratory Diseases, New
Delhi and
4. JALMA Institute, Agra
5. Regional Medical Research Centre, Bhubaneswar and
6. Bhopal Memorial Hospital and Research Centre, Bhopal
 Intermediate Reference Labs: At State TB Training
and Demonstration Centres (STDCs)
 Designated Microscopy Centres (DMCs): At the
periphery
 Each NRL will supervise sputum microscopy EQA of
states designated under them
 The NRL will ensure proficiency of RNTCP staff for
carrying out good quality diagnosis by providing
technical training to the STOs, STDC Directors,
Microbiologists and Lab Technicians of States
 The states will designate 1 IRLs in the STDC or
Medical Colleges or in any Public Health Laboratory
of the State
 The designated IRL will conduct sputum microscopy
EQA for the state and occasionally for a neighbouring
state or union territory
 The IRL will provide technical training to district and
sub-district technicians and STLS
 Sputum microscopy diagnostic services under
RNTCP are provided by DMCs established for every
1 lakh population (50,000 population in tribal, hilly
and remote areas)
 In addition, the DMCs are also established at Medical
Colleges, Corporate hospitals, ESI, Railways, NGOs,
large private hospitals and other major hospitals
Quality Assurance (QA) for smear microscopy: It includes
1. Internal Quality Control (IQC)
2. External Quality Assessment ((EQA)
3. Quality Improvement (QI)

Internal Quality Control (IQC):

 It’s a systematic internal monitoring of working practices
 It includes technical procedures, checking instruments,
quality of new batches of staining solution, smear
preparation, grading etc
External Quality Assessment (EQA): A process to assess
laboratory performance. It includes
1 On-Site Evaluation (OSE):
 Conducted at least once a month by STLS to the DMCs
 Once a year by STDC/IRL lab supervisors to DTCs and TUs
 Once a year by lab supervisors of NRLs to STDCs/IRLs
2 Panel testing:
 This determine whether a lab technician can adequately
perform AFB smear microscopy
 This method evaluate individual performance in staining and
reading
 Panel testing is not performed as a routine in the DMCs
3 Random Blinded Re-Checking (RBRC) of routine
slides:
 It’s a process of re-reading a statistically valid sample of
slides from a laboratory to assess whether that laboratory
has an acceptable level of performance
 Performed once a month for every DMCs
Quality Improvement (QI):
 A process by which all components of smear microscopy
diagnostic services are carefully analyzed with the aim of
looking for ways to permanently remove obstacles to
success
 Technical and managerial indicators for case
finding and management
Indicator Norm
Proportion of symptomatic patients who are smear 8-12%
positive
Two smears taken from suspect cases 100%

Percent of smear positive among new TB cases >50%

Proportion of new smear positive patients found in the >95%

lab register being on treatment
Proportion of new smear positive cases placed on DOTS >90%
(within seven days of diagnosis)
Sputum conversion for new smear positive cases at three >90%
months
Percent of new smear positive patients who are cured >85%
Improving TB surveillance by transitioning to
case based web based recording and reporting
(Nikshay)
• This ICT(information communication technology)
application (Nikshay) was launced on 15th May 2012 by
NIC(national informatics centre) (HQ) and Central TB
Division
• The data entry of the individual TB cases is being done at
the block level DEOs(data entry operator) of NHM
• The system has been extended to include drug resistant
TB cases, online referral and transfer of patients
 Achievements
 RNTCP has been recognized for the fastest expansion
of DOTS in the world
 During the year 2009 DOTS treatment success Rate
was 87%
 Diagnostic facilities have been established in >13000
labs/ DMC throughout the country
 RNTCP has successfully involved 297 medical colleges
,over 1971 NGOs,10,984 private practitioners and over
150 corporate private sector health units
 Quality Assurance protocol for smear microscopy has
been implemented in all the states
 662 DTC, 2,698 TB units, >13000 DMC are functioning
 About 140 internal evaluations conducted in 2007
 > 60,0000 Dots Provider
 38287 MDR TB suspects examined till the end of 2011,
 and 10267 MDR-TB patients diagnosed in 2011
 6994 have been put on treatment
 Programme performance
Indicator Norm Achievement
Annual case detection rate 135/lakh 176/lakh pop.
pop.
Annual new sputum positive case detection 70% 72%
rate
% of smear positives among total new 50% 62%
pulmonary TB cases
Proportion of new smear positive cases placed >90% 88%
on DOTS within 7 days of diagnosis
New sputum positive conversion rate at 3 >90% 90%
months
Cure rate >85% 87%
Default rate <5% 6%
Death rate <5% 4%
Source: MOHFW. RNTCP. Annual report 2013-14. Central TB Division, MOHFW, GOI, TB
India 2012 status report. Central TB Division, TB India 2014, RNTCP Annual Status Report.
 MANIPUR
 TB case detected 30,895 (1998-2008)
 Treated successfully – 28,072 (1998-2008)
 No. of patients put on DOTS - 2061( 2008 )
 (2011 )Manipur 27-lakhs, suspects examined- 13083 ;
No of Smear positive patients Diagnosed – 1360;
Total patients registered for treatment- 3080;
Annual total case notification rate- 113;
Annual new smear positive case notification rate -39 ;
Annual new smear negative case notification Rate 30; Annual
new extra pulmonary case notification rate -25
 Recommendations
• Strengthening and improving the quality of basic DOTS
services
• Further strengthening and alignment with health system
under NRHM
• Deploying improved rapid diagnosis at the field level
• Expand efforts to engage all care providers
• Strengthen urban TB Control
• Expand diagnosis and treatment of drug resistant TB
• Improve communication and outreach
• Promote research for development an implementation of
improved tools and strategies
• Govt of India had declared Tuberculosis as a
notifiable disease on 7th May 2012. All public and
private health providers shall notify TB cases
diagnosed and/or treated by them to the nodal officers
for TB notification
Thank you