The document provides an overview of updates to India's National Tuberculosis Elimination Programme (NTEP) guidelines in 2020. It summarizes the history of tuberculosis programs in India since 1997 and key changes introduced in 2020, including renaming the program from the Revised National Tuberculosis Control Programme to NTEP. It outlines case definitions, diagnostic algorithms, treatment guidelines for drug-sensitive and drug-resistant tuberculosis, and definitions of treatment outcomes. The guidelines emphasize making every attempt to microbiologically confirm TB diagnoses and introduce changes like daily drug dosing and expanding the use of molecular diagnostic tests like CBNAAT.
1. Updated NTEP Guidelines
(2020)
Presented By: Dr. Sonali Paradhi Mhatre
Source – Central Tuberculosis Department, Government of India.
(Ministry of Health and Family Welfare)
https://tbcindia.gov.in/index1.php?lang=1&level=1&sublinkid=4571&lid=3176
2. History of RNTCP
• Introduced in 1997. (Initially it was NTP)
• Objective: To achieve atleast 85% cure among new cases and 70% case detection rate.
• RNTCP 1 - At introduction and was then expanded across India until the entire nation was
covered by the RNTCP in March 2006.
• RNTCP 2 - RNTCP II was designed to consolidate the gains achieved in RNTCP I, and to
initiate services to address TB/HIV, MDR-TB and to extend RNTCP to the private sector.
• Based on the concept of DOTS (Direct Observed Treatment Shortcourse)
• With the RNTCP both diagnosis and treatment of TB are free.
• There is also, at least in theory, no waiting period for patients seeking treatment and TB
drugs.
3. History of TB Programmes in India
1997 RNTCP introduced.
2006 – ‘STOP TB’ by WHO – Adapted
by India
2012- 2017 National Strategic Plan
(NSP)
2014 – WHO+RNTCP prepared
Standards of TB Care in India (STCI)
2020 – RNTCP renamed as NTEP
(National TB Elimination Programme)
4. Present Nomenclature
• At the start of 2020 the central government has renamed the RNTCP the
National Tuberculosis Elimination Program (NTEP).
• In a lettter to all the State Chief Secretaries of states and UTs, the
commitment is emphasised of the Union government achieving the
sustainable development goal of ending TB by 2025, five years ahead of
the global targets.
5. CASE Definitions
1. Presumptive TB refers to a patient who presents with symptoms or
signs suggestive of TB (previously known as a TB suspect).
2. Presumptive pulmonary TB – Any person with signs of pulmonary TB
(including cough, fever>2wks, significant weight loss, hemoptysis,
CXRay abnormality) OR TB contact, PLHIV, DM, SAM, cancer,
immunosuppression with any sign.
3. Presumptive Extrapulmonary TB – Any person with organ specific signs
(Eg. LN swelling, joint pain/swelling, neck stiffness + constitutional
symptoms like fever>2 wks, wt loss, night sweats.
4. Presumptive Pediatric TB – Children with cough, fever >2 wks,
significant wt. loss(>5% in last 3 months or no weight gain) or contact
with infectious TB case)
6. Diagnostic Modalities under NTEP
TB Diagnostic
Modalities
Microbiological
Confirmation
Phenotypic
tests
Sputum Smear for
AFB
(Limited sensitivity in
PLHIV and Pediatric)
TB Culture
Solid Culture
(LJ Media)
Reports in 84 days
Liquid culture
(Bactec MGIT)
Reports in 42 days
Genotypic tests
(Rapid molecular
testing)
CBNAAT
Brand- Gene Xpert
Reports in 2 hrs
LPA
Reports in 72
hours
Other
Diagnostic
modalities
CXRAY
HRCT Chest
Tuberculin Skin test
OR
Interferon gamma
assay (Not in India)
Serological Tests
Not Recommended
and banned in India
since 2012
7. CBNAAT
Cartridge Based Nucleic Acid Amplification test.
Rapid Molecular testing for TB.
(Brand available – Gene Xpert)
Detects TB and Rifampicin Sensitivity.
Needs – Single sputum sample. Gives results in 2 hours.
Recommendation: To be done upfront in EPTB + Pediatric TB + TB-HIV.
High Sensitivity – FNAC/ Biopsy samples, Specimen from LN, CSF, other biopsies.
Low Sensitivity – Pericardial fluid, Ascitic fluid, Synovial fluid, *Lowest in pleural fluid.
Tissue for CBNAAT – collect without Formalin.
Cannot be performed on ‘bloody samples’.
8. EVERY ATTEMPT MUST BE
MADE TO
MICROBIOLOGICALLY
PROVE THE DIAGNOSIS OF
TB.
BASIC DICTUM
11. Definitions in TB treatment
Category 1 (New case) – TB diagnosed patient who has never taken
treatment OR taken treatment <1 month.
Category 2 (Previously treated case)- TB diagnosed patient who has
received >1 month of AKT previously and includes:
1. Recurrent TB – previously declared cure and now has microbiologically
confirmed TB.
2. Treatment after failure TB – previously treated TB and treatment failed
after the most recent course.
3. Treatment after loss to followup TB – previously treated for >1 month
and then declared lost to followup and now microbiologically
confirmed TB.
4. Other previously treated TB – previously treated >1 month but
outcomes unknown or undocumented.
12. Newer changes in NTEP treatment
guidelines
1. Daily dosing.
2. DOTS provider – family member.
3. Ethambutol added to CP.
4. No continuation of IP. CP can be extended by 12-24 months (depending on the
site)
5. Tracking – 99 DOTS
6. Followup : IP- 14 days, CP – 30 days.
7. F/u sputum after 1 month by Gene Xpert.
14. Indications for INH Prophylaxis
(10mkd * 6 months)
1. Child born to mother with TB in pregnancy (after r/o Cong.
TB)
2. Children <6 yrs with TB contact.
3. All HIV infected children with TST positive and no active
disease.
4. All TST positive children with immunosuppression.
15. Indications for Steroids in TB
1. TB Meningitis (2mkd prednisolone OR 0.4mkd Dexa *4 wks
and taper over next 4 weeks).
2. Pericardial TB.
3. Miliary TB.
4. Tuberculoma with increased ICT.
5. Massive and bilateral TB Pleural effusion with respiratory
compromise.
17. Case Definition of
Presumptive DR- TB
Patients with TB who:
1. Have failed treatment with 1st line ATT.
2. Pediatric TB non-responders.
3. Have DR- TB contacts.
4. Have been found positive on any followup sputum
examination during 1st line ATT.
5. TB patients with co-existent HIV infection
18. Drug Resistant TB definitions
1. Mono Drug resistant TB – Biological sample resistant to 1st line ATT drug (other
than H/R)
2. Polydrug resistant TB – Biological sample resistant to >1 first line drugs (except
H/R)
3. Multidrug resistant TB (MDR-TB) – Biological sample resistant to both INH and
Rifa ± other first line drugs.
4. Rifampicin resistant TB – Biological sample resistant to ONLY RIFA (not INH).
Treated as MDR-TB.
5. Extensive drug resistant TB (XDR-TB) – An MDR-TB case whose biological
sample is additionally resistant to:
Flouroquinolones (Moxi/Levo/ Oflox)
&
Second line injectable drugs (Kan/Amika/Capreo)
22. Outcomes in Drug Resistant TB
1. Treatment completed – ATT received as per the national policy, but no records of
cultures.
2. Cure – ≥ 3 consequetive cultures negative (30 days apart), post IP.
3. Treatment Success – 1 + 2
4. Treatment failed – Treatment terminated OR Need for change in treatment
regimen of atleast ≥ 2 ATT drugs in CP due to :
No microbial conversion at the end of IP.
Microbial Reversion during CP.
Adverse drug reaction.
Evidence of additional resistance to other 2nd line ATT drugs.
5. Conversion – Atleast 2 consequetive cultures, 30 days apart are negative.
6. Reversion – After initial conversion, if 2 consequetive cultures 30 days apart are
positive.
23. TB & HIV
8 times higher Risk of TB than the non-HIV population.
If both treatments need to be started : Start Anti-tubercular treatment
first followed by Anti-Retroviral treatment after 2 weeks.
Upfront CBNAAT indicated on Sputum or EPTB samples.
Treatment same as per NTEP guidelines.
All HIV infected TB patients need to be tested for Drug susceptibility
before initiating treatment.
Concurrent Cotrimoxazole can be continued.
