National Tuberculosis Elimination Program

(NTEP)

National NTEP Update

Dr. Ashok Bhardwaj

NTF Chair
Outline

• Epidemiology: Global and India

• Diagnosis of drug-susceptible TB
• Management of TB including comorbidities
• Drug-resistant TB
• TB preventive therapy
• Other developments
 EVOLUTION OF NTEP

2020
In January 2020, GoI revised RNTCP to
National TB Elimination Program (NTEP)
2017 – 25
NSP (2017 – 25) – patient centric care 2012 -17
for TB elimination National Strategic Plan (2012 -17) -
mandatory notification of TB, rapid molecular
testing, active case finding and integration of
the program with National Health Mission
2005 – 11
Second phase of RNTCP – Pan India
coverage and improved quality and scale 1997
up of services GoI revised NTP to RNTCP – introduction of
DOTS (Directly Observed Treatment Short
1993 course)
WHO declares TB as a global 1962
emergency Govt. of India launched the National TB
Program and set up District TB Centres
 TB Burden: Global versus India

Global and National Magnitude of TB and DR-TB

4
TB Incidence-Notification Gap in India

•Estimated TB Burden: 2.8 million cases

TB Notification: 2.3 million
•Estimated TB Incidence rate : 195/100,000
TB Notification rate: 159/100,000
Reduction in Reduction in Catastrophic
mortality, incidence, health
compared to compared to expenditure SDG and NTEP
2015, by 2015, by Targets
 TB epidemiology in India: snapshot
• Estimated incidence rate of TB for 2023*  195 cases / 100,000 population
• Reported TB cases 2023  25.52 lakh (2.55 million)
• Reported in 2024  26.2 lakhs

1.4% HIV-Positive Men Women Children 33% Urban

58% 36% 6%

2.8% Drug Resistant 58% Rural

65% 15-45 years (Age) 9% Tribal

7% TB - Diabetes 46% BMI <18.5

 Profile of TB patients in India
National TB Prevalence Survey: 2019-21

• Estimated incidence rate of TB  195 / lakh population in 2022 (27.6 lakh cases)
 National TB Prevalence Survey - Summary

How many TB cases

are there for every TB Screening Tests Past H/O TB
patient notified
Prevalence : Notification ratio Chest X-ray – Additional yield Patients with past H/o TB
2.84 42.6% 23.4%
481 cases out of 981 Among those diagnosed
diagnosed cases had X-ray 981 in the survey
abnormality only

Interpretation:
•For every 2.8 TB cases prevalent in the community, 1 case gets notified and 1.8 cases get missed.
•Mere symptomatic screening may lead to missed cases
•Addition of diagnostic tests like Chest X ray adds to the yield
•Patients with past H/O TB contribute significantly to the total cases
 National TB Prevalence Survey - Summary

LTBI More in persons with comorbidities

Prevalence of latent TB infection Malnourished Diabetics Smokers Alcohol users

31.4% 930 511 853 726
Among total surveyed Per Lakh pop Per Lakh pop Per Lakh pop Per Lakh pop

Interpretation:
•Prevalence of latent TB infection is around 1/3 rd of the population
•31% of the survey participants have TB infection. There is a 10% lifetime chance of this infection converting into disease, with 60% of the probability being in first year
•Presence of co-morbidities has an impact of disease progression, severity, and treatment outcomes
 National TB Prevalence Survey - Summary

Health care seeking behaviour

Public and private facility Did not seek care Costs incurred Costs incurred
preferences 63.6% – Govt. facility – Private facility
49% - 49% Among those found to be Rs. 7500 Rs. 20000
Among the 5156 sought health symptomatic during the
Max: 39000 Min:1500
care survey Median costs among those currently on
ATT

Interpretation:
•Patient seek treatment equally from both public and private sector
•Health in terms of chest symptoms is not a felt need
•Patients prefer to get self treated rather than seeking formal health care
•Costs for TB care is present in TB patients seeking care both in the public and private sector.
Intensified TB Case Finding in Vulnerable Patients

Most important risk factors* contributing to TB incidence in India are -

Risk Factor Estimated Attributable Cases (L) (2022)

Undernourishment 7.44 L (6.3 L – 8.6 L)
Alcohol Use Disorders 2.48 L (0.9 L – 4.9 L)
Smoking 1.06 L (0.25 L – 2.46 L)
Diabetes 1.02 L (0.37 L – 1.99 L)
HIV Infection 0.94 L (0.29 L – 1.97 L)

Collaborative activities for bidirectional screening and referral

13
 TB Burden in India Vs target: SDG
END TB Targets
Incidence
(per lakh population)
Mortality
(per lakh population)

Target Target
 NATIONAL STRATEGIC PLAN (2017-25)
DETECT
TREAT
•TB screening
•Daily regimen –Fixed Dose Combination
•Scale up Molecular Diagnostics, telemedicine (e-
•Chlid Friendly medications
sanjeevani), MMUs with portable HH Xrays
•ICF-NACP, NCD, MH, RBSK, RKSK, NTCP, MHP, •Injection free treatment regimens
Alcohol/ drug abuse •Scale up of Newer drugs/regimens
•Active case finding ACF, Sample collection and •Treatment adherence
transportation mechanism – Hub & Spoke model, Early •Active drug safety monitoring and
Detection of DRTB, IPD screening. management (aDSM)
•Private Sector Engagement, Mandatory notification; •Treatment Success Rate of > 90%
DBT Incentives Schedule H1, Patient Provider Support
Agency PPSA, STSUs, professional bodies like IMA & NSP
IAP (2017-
2025) BUILD
•STDC, iGot, eGurukul
PREVENT
•Community Mobilization & People’s
•Contact Tracing & TB Preventive Treatment
Movement
•Airborne Infection Control AIC in community
•IEC
& Health Facilities, Sustaining COVID
appropriate behavior •Multisectoral Collaboration
•Adult BCG •Digital Interventions
•Research & Surveillance
 NTEP Diagnostic Network
TESTING MODALITIES

NATIONAL LEVEL 6 NRL NAAT

LPA

Liquid
STATE LEVEL 37 IRL Culture

LCDST
C&DST LABORATORY
(IN MEDICAL COLLEGES & 98 45 Microscopy
C&DST
PRIVATE SECTOR LABS
Rapid molecular test
(NAAT)
• CBNAAT
DISTRICT & SUB- DISTRICT 8293 NAAT 651 • TrueNat
LEVEL

PERIPHERAL LEVEL 25530 Microscopy 16000

Microscopy
Data as on 2Q 2024

NAAT- Nucleic Acid Amplification Test; LPA- Line Probe Assay; LC DST- Liquid Culture Drug
 INR. 1000/- per month for the entire duration of treatment
1 NI-KSHAY POSHAN YOJANA to every TB patient. Nutrition Kits for two months

Drug sensitive TB: INR. 1000/- at completion of treatment

2 INCENTIVE FOR TREATMENT SUPPORTER Drug Resistant TB: INR. 5000/- at completion of treatment
TPT Patient: INR. 250/- at completion of treatment

INCENTIVE FOR Incentive of INR. 500/- for reporting a confirmed TB case

3 NOTIFICATION AND OUCTOME and INR. 500/- on reporting of outcome

INR 750/- is provided to all TB patients notified from

4 TRAVEL SUPPORT tribal/hilly/difficult areas

INR 50/- Incentive to ASHAs or community volunteers for facilitating PwTB bank account within 15 days from
date of treatment initiation. However, It's not a DBT scheme under NTEP.
TB preventive strategy
Strategies for eliminating TB (<1 case/million per year)

TB elimination is not possible

without addressing Latent TB
treatment

Dye C et al. Prospects for tuberculosis elimination. Annu Rev Public Health.
2013;34:271-86.
 Burden of TB infection: National TB Prevalence Survey 2019-21

• India has the highest estimated

burden of tuberculosis infection
(TBI) globally,
o with nearly 35-40 crore
Indian population having
TBI, of which 26 lakh (18-36
lakh) are estimated to
develop TB disease annually
o Crude prevalence of TB
infection among population
age ≥15years is 31.3%
 Cascade of TB case finding and TPT
Target Population

Rule out active TB

No signs/
Presumptive TB
symptoms of TB

Test for TB infection

TB confirmed Active TB ruled out (as per policy)

Evaluate for TPT

Start TB treatment

Start TPT
Systematic follow-up
Systematic follow-up

© WHO India
Test for TB infection: TST and IGRA

© WHO India
 Cy-TB
Cy-TB is the next-generation skin test for detection of Tuberculosis.
 Easy-to-use (Simple)
 Point-of-care (On field)
 Specific test (based on ESAT-6 and CFP-10 antigens of M.tb)
 Unaffected by BCG vaccination status
 Easy Replacement for PPD (TST) test

© WHO India
 Target population and
strategies
Target Group Strategy
People living with HIV (+ ART)
Adults and children >12 months Screen and Treat
Infants <12 months with HIV in contact with active TB Screen and Treat
HHC of Pulmonary MC index patients
HHC below 5 years of pulmonary TB patients Screen and Treat
HHC 5 years and above of pulmonary TB patients Test and Treat
Individuals who are on immunosuppressive therapy, having Test and Treat
silicosis, on anti-TNF treatment, on dialysis,preparing for
organ or hematologic transplantation

© WHO India
 Target population and strategy
Target population
 People living with HIV (+ ART)
o Adults and children >12 months
o Infants <12 months with HIV in contact with active TB
 HHC below 5 years of pulmonary* TB patients
HHC 5 years and above of pulmonary* TB patients # TEST & TREAT policy:
policy

#
Chest X Ray (CXR) and TBI testing would be offered wherever available, but TPT must not be deferred in their
absence

Target population
Individuals who are: TEST & TREAT policy:
policy
•on immunosuppressive therapy (e.g. Prednisone or equivalent ≥15 mg/day for ≥1 month)
•having silicosis
• on anti-TNF treatment (Infliximab, Etanercept and others)
•on dialysis
•preparing for organ or hematologic transplantation

*bacteriologically confirmed pulmonary TB patients

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Group 02: Household contacts of MICROBIOLOGICALLY CONFIRMED
PULMONARY TB
IGRA/
No TB
>5 years Cy-TB
disease
Positive

<5 years No TB
disease Give TPT

DSTB
Type of Index case
6H Pre XDR or
3 HP H and R
H Resistant XDR
1 HP Resistant

4R 6 Lfx No TPT
TB diagnosis
 Definitions… 1
• Presumptive TB.
• This refers to a person with any of the symptoms or signs suggestive of TB. [Diagnosis of TB is
difficult in certain key groups of the presumptive TB patients like extra-pulmonary, PLHIV,
children, smear -ve /NA with x-ray suggestive of TB, other vulnerable groups as defined in TOG-
2016 and DR-TB contacts, hence, NAAT is offered upfront for diagnosis of TB among these
presumptive TB patients.]
• Presumptive DR-TB.
• It refers to the patient who is eligible for rifampicin-resistant screening at the time of diagnosis
OR/and during the course of treatment for DS TB or H mono/poly DR-TB. [This includes all notified TB
patients (Public and private), follow-up positive on microscopy including treatment failures on standard
first-line treatment and H mono/poly DR-TB regimen and any clinical non-responder including
paediatric].
• Universal DST.
• Refers to universal access to rapid DST for at least rifampicin, and further DST for at least
fluoroquinolones among all TB patients with rifampicin resistance (preferably before 29
 Definitions… 2
• A second-line TB drug:
• This is an agent reserved for the treatment of drug-resistant TB. First-line TB drugs used to treat
drug-susceptible TB – ethambutol, isoniazid and pyrazinamide – may also be used in MDR-TB
regimens (streptomycin is now considered a second-line TB drug and used only as a substitute for
amikacin when amikacin is not available or there is confirmed resistance to it).
• Bacteriologically confirmed TB:
• TB diagnosed in a biological specimen by smear microscopy, culture or a WHO-endorsed rapid
molecular test and adopted by NTEP such as Xpert MTB/RIF®/Truenat®.
• Drug-susceptibility testing:
• DST refers to in-vitro testing using either of the phenotypic methods to determine
susceptibility.
• Drug resistance testing:
• DRT refers to in-vitro testing using genotypic methods (molecular techniques) to determine
30
 Definitions… 3
• Active case finding (ACF)
• It is defined programmatically as systematic screening for TB disease through outreach activities outside
health facility settings.

• At-risk group:
• Is any group of people in whom the prevalence or incidence of TB is significantly higher than in the
general population.

• High TB transmission setting:

• This is a setting with a high frequency of individuals with undetected or undiagnosed TB disease, or
where infectious TB patients are present and there is a high risk of TB transmission. [TB patients are
most infectious when they are untreated or inadequately treated. Transmission will be increased by
aerosol-generating procedures and by the presence of susceptible individuals.
• These settings with health-care workers, prisoners, miners, slum dwellers, tribals, migrant labourers
etc. could be mapped out as part of the vulnerability mapping exercise done for and prioritized by
states for specific TPT interventions guided by differential TB epidemiology in the respective state].
31
 Definitions… 4
• Systematic screening for TB disease:
• Is a systematic identification of people with presumed TB disease, in a predetermined
target population, using tests, examinations or other procedures that can be applied
rapidly. [Among those screened positive, the diagnosis needs to be established by one or
several diagnostic tests and additional clinical assessments, which together have high
accuracy.]
• Adult:
• For programmatic purpose in India, an adult is a person over 19 years of age.
• Child:
• For programmatic purpose in India, a child is a person up to and including 18 years of
age. [This includes adolescents aged 10–18 years].
• Infant: Is a child under one year (12 months) of age. 32
 CASE DEFINITIONS-
• TB diagnosed in a biological specimen by smear microscopy, culture or a
Bacteriologically
WHO-endorsed rapid molecular test and adopted by NTEP such as Xpert
confirmed TB
MTB/RIF®/Truenat®
• A presumptive TB patient who is not Bacteriologically confirmed but
diagnosed with active TB by a clinician on the basis of X-ray, histopathology
or clinical signs with a decision to treat the patient with a full course of Anti-
Clinically diagnosed TB treatment.
TB • In children, this is based on the presence of abnormalities consistent with TB
on radiography, history of exposure to an infectious case, evidence of TB
infection (positive TST) & clinical findings suggestive of TB in the event of
negative or unavailable microbiological results

Bacteriologically confirmed or clinically diagnosed cases of TB are also classified according to:
– anatomical site of disease
– history of previous treatment
– drug resistance
Classification based on Anatomical site of Disease
Any bacteriologically confirmed or clinically diagnosed case of TB can be
classified as either
 Diagnosing TB Disease

A. Smear Microscopy C. Rapid molecular tests:

•Zeihl-Neelsen Staining •Line Probe Assay for MTB
•Fluorescence staining complex and detection of drug
resistance (FL& SL LPA)
B. Culture:
•Nucleic Acid Amplification
•Solid (Lowenstein Jensen) media Test(CBNAAT/Truenat)
•Automated Liquid culture Supportive tools: Chest X-ray and
systems e.g. BACTEC MGIT 960, radiological tests, TST, IGRA, other
BacT Alert or Versatrek etc. blood tests, Histopathology, etc..
 Sensitivity of diagnostic test

Light FM-LED Solid culture Liquid LPA CBNAAT

microscopy culture
10,000/ml 10,000/ml 100/ml 10/ml >10/ml 1-10/ml
10%
sensitivity
increases

• This means that, molecular tests such as CBNAAT has best sensitivity, as
compared to other tests.
• Molecular tests should not be used for follow up examination

36
 Comparison of NAAT with Microscopy

Technology Sensitivity Specificity

Microscopy 50-60% 98%
NAAT 73-96% 98%

• NAAT has higher sensitivity.

• Microscopy has lower capital cost and lower recurring expenditure.
• Requires skilled technicians, stringent protocols for quality assurance
 LPA
• First Line LPA detects resistance to Rifampicin (rpoB) and Isoniazid
(katG , inhA)
• Second Line LPA detects Fluoroquinolone class resistance
(gyrA,gyrB) and Second line injectable class resistance (rrs ,eis)

3 steps:
1. Sample preparation:
Decontamination
DNA extraction
2. Amplification: PCR
3. Hybridization: reverse hybridization on nitrocellulose strips
containing probes specific for MTb and mutations
• Results: within 48 hrs 38
© WHO India
Turn Around Time

39
© WHO India
 Patient Turn-Around-Time (Patient TAT)

• Patient identification • Specimen receipt at the • Receipt of laboratory

• Referral for testing laboratory results
• Specimen collection, • Testing • Pretreatment evaluation
packaging and transport • Reporting results • Treatment initiation/
modification
40
Operational aspects in Case finding & Diagnosis

41
100 Days Campaign
 Intensified campaign: Rationale

Key Challenges
Intensified
campaign in • Low TB testing rate - High dependance on
347 Microscopy
High Focus
Districts • 60% of the symptomatic did not seek care

• 46% TB patients undernourished

• Factors contributing to High Mortality: Drug

Resistance, Low BMI & Comorbidities
• More than 40% Pulmonary TB pts are
asymptomatic
 Intensified campaign: Goals and Objectives

Intensified campaign to accelerate TB case

detection, reduce mortality, and prevent new cases
through focused interventions in districts with the
highest TB burden in a stratified approach.

Accelerate Reduce Prevent New

Case Mortality cases
Detection
 Criterion for prioritization of Districts

1. Death rate >=3.6% & testing rate <1700/lakh

population (195 districts)
2. Death rate >=3.6% & testing rate >=1700 (119
districts)
3. Incidence rate >=200/lakh population (21
districts)
4. TB Prevalence > 400/lakh population (12
districts)
Key Strategies – Reduce TB Incidence

TB

No
T B

46
 Key Strategies – Reduce TB Mortality

• Risk assessment for Diabetes,

HIV, Cancer, Heart, Kidney, Liver
• Priority care for high-risk cases
Differentiated
• Admission in hospital, if
TB Care
Approach required

Early Detection Death Audit of all

and right Follow up and
Follow up and reported Deaths
treatment monitoringF
monitoring
drug sensitive /
drug-resistant TB

Nutrition • Rs 1000 / month Ni-kshay Poshan Yojana

Interventions • Ni-kshay Mitra – cover household contacts
• EDNS (nutritional suppl) with treatment
for TB patients with <18 BMI for 2 months
47
 Expected outputs – National Level
The campaign will impact positively towards the overall goal of reducing mortality and
morbidity due to TB.

Specific Output of the Campaign will be as follows:

Increase
90% screening Upfront NAAT 100% coverage Panchayats
Additional
(X-Ray & NAAT) for diagnosis of prepared for
Ni-kshay Poshan
of line-listed TB/MDR-TB from
cases Yojana & TB free
vulnerable
Ni-kshay Mitra certification
individuals
30% to 70%

48
Activities under 100 days campaign
Activity flow
 Algorithm

• In children <5 years- additionally failure to gain

weight or decreased activity or playfulness
 Screening at Health Facility
● At AAMs and CHCs → 5% of OPD tested for TB
● At SDH, DH, Medical College → 10% of OPD
● In priority settings → 100% of OPD visitors
should be screened for TB symptoms
○ HIV, Diabetes, Tobacco cessation, Cancer,
dialysis units, indoor admitted patients, and
other immunocompromised settings

Screening Methods:
●Symptomatic screening for both pulmonary and extra pulmonary TB.

●X-Ray for both symptomatic and asymptomatic (especially vulnerable individuals)

Linkages for X-Ray and testing (when not available in facility)

●Ensure smooth referral processes to access X-Ray

●Specimen collection and transportation to laboratory for NAAT and extra pulmonary testing
 Testing

Test For whom Where How

X-Ray All vulnerable @Camp site in MMU • Route map with schedule

individuals @Health facility nearest to village • Schedule the shifts of LT and

(Symptomatic & radiographers as per workload

asymptomatic) @Private health facility • Purchase of X-Ray services

NAAT Individuals with from private sector (based
symptoms of TB on requirement)
Individuals with X-Ray
suggestive of TB

Extra Persons with extra @Health facilities where extra • Assign CHC, District Hospital and
pulmonary pulmonary pulmonary specimens collected & Medical Colleges for
tests symptoms / signs tested extrapulmonary testing
 Health Facility Notification from private sector

Issue advisory from district magistrate TB referral and specimen transport

to private health facilities • Clinics
Issue letter from IMA and Chemist TB notification
association to private doctors • Hospitals
DST specimen transport
Issue letter from chief medical officer • Chemists
with performance and feedback to
private facilities Dispensation of free drugs
• Laboratories
Visit of health functionaries to private
health facilities for notification and • AYUSH Linkages for DBT, PMTBMBA, nutrition
supply of containers/drugs supplements
 Differentiated TB Care for reducing Mortality

Goal
Identify TB patients who are at risk of mortality, provide timely
care to prevent death
 Differentiated TB Care – Risk Assessment Parameters

11 CLINICAL PARAMETERS INVESTIGATIONS

(To be recorded every month)
12.HIV testing
These tests may
1. General Condition 13.Random Blood Glucose NOT be repeated
2. BMI* – Height & Weight 14.Haemoglobin during follow up
3. Middle Upper Arm Circumference 15.Total count of White Blood Cellsassessments if they
(MUAC)* 16.Chest X-Ray – are normal at
4. Hemoptysis (Blood in cough) At baseline, at the end of intensivebaseline
phase (2
5. Icterus (Jaundice) months), and thereafter at the end of
treatment, if symptoms persist and as and
6. Pedal Edema
when clinically indicated.
7. Pulse Rate NOTE:
8. Blood Pressure If indicated, additional laboratory investigations
9. Respiratory Rate like Sr. Creatinine, AST, ALT, Bilirubin, Alkaline
*Nutritional phosphatase may be carried out at the discretion
10.Oxygen Saturation Tests
of the Medical Officer. 56
Risk Stratification after Comprehensive Assessment
• Individual score is given for each of the 16 parameters based on the measured value.
• Based on the score, actions are initiated as follows:

Total score Actions

Score 0-1 Providing intermediate care and observing for symptoms to subside
Score 2-3 Manage/Refer to an appropriate health facility with the availability
of an MBBS doctor for consultation
(After correlating clinical condition)
Score >3 Referring to secondary or tertiary care with the
availability of indoor and/or intensive care facility
(After correlating clinical condition)

• Support for Referral

▪ TB champion, Health System mobile vans or vehicles for referral, financial
support for referral
57
 Referral Care

• For patients with deranged clinical parameters, but who do not require in-patient
care will be managed by qualified practitioners at outpatient basis
Outpatient • Care includes largely comorbidity management
care • Telemedicine can be used for outpatient consultation
• Document additional care provided at the referral centre

• The referral facility should have the essential and desirable therapeutic package of
services to manage in-patients care (as per NTEP guidelines)
• Arrange mobility of patients to referral facilities
In-patient • Identify list of referral facilities, along with details of therapeutic services, nodal
person and map them with all AAMs
care
• Issue advisory to district authority to make indoor facilities available for TB patients
• Document all treatment provided at referral centre

58
 TB Preventive Treatment

Target
groups for
TPT

Strategy Rule out active TB  TPT Rule out active TB  TBI test  TPT

Regimen 1HP 3HP, 3RH

options
6H

TPT in contacts of DR-TB (6Lfx and 4R)

 The motive

If we really want to have a lasting and sustainable

response that will end TB, we need to shift the dynamics
so that the people, communities and grass root
organizations are at the heart of the response.
This shift ensure that the needs of the people affected by
TB are understood, represented, prioritized and
responded to.

#TB Harega Desh Jeetega

 Yes! We can end
TB!'
#TB Harega Desh
Jeetega
Pradhan Mantry TB Mukt Bharat
Abhiyan

A step moving towards