NTEP Review and Recent Updates

NTEP- REVIEW AND
RECENT UPDATES
Dr. Soujannya

INTRODUCTION- TB & NTEP
PROBLEM STATEMENT
STRATEGIES FOR TB CONTROL
NTEP: OBJECTIVES, ORGANIZATIONAL
STRUCTURE
 CASE DEFINITIONS
DIAGNOSTIC TOOLS
TREATMENT
NIKSHAY PORTAL AND INCENTIVES
TB PREVENTIVE TREATMENT

WHAT IS TUBERCULOSIS?
Tuberculosis (TB) is an infectious disease caused by the bacterium
Mycobacterium tuberculosis (MTB) which generally affects the lungs,
but can also affect other parts of the body
One patient with infectious
pulmonary TB if untreated
can infect 10-15 persons in
a year
o Malnutrition
o Diabetes
o HIV infection
o Poor immunity
o Severe kidney disease
o Other lung diseases
e.g. silicosis
o Substance abuse etc.
o Overcrowding
o Inadequate
ventilation
o Enclosed living/
working
conditions
o Occupational
risks
Risk factors:

NATIONAL TB ELIMINATION
PROGRAMME
 The National Tuberculosis Control Programme (NTP) of India
was initiated in 1962. A comprehensive review of the NTP in
1992 found that the NTP had not achieved its aims or targets.
 Based on the recommendations of the 1992 review, the
Revised National Tuberculosis Control Programme (RNTCP),
incorporating the components of the internationally
recommended Directly Observed Treatment Short-course
(DOTS) strategy for the control of TB
 In 2020 the RNTCP was renamed the National Tuberculosis
Elimination Program (NTEP) to emphasize the aim of the
Government of India to eliminate TB in India by 2025.

PROGRAMME

PROBLEM STATEMENT
 TB was on decline in HIC’s even before the advent of BCG and
effective chemotherapy.
 Attributed to ‘non-specific determinants of disease’
 Globally 1/3rd are infected of these 5-10% will have disease at
some point

PROBLEM STATEMENT CONT..
TB CASES 2019-2020
YEAR ESTIMATE
D CASES
NOTIFIED
CASES
DEATHS HIV
NEGATIVE
DEATHS
TB PLHIV
2019 10
MILLION
7.1
MILLION
1.2 MILLION 208,000
2020 10
MILLION
5.8
MILLION
1.5 MILLION 214,000

PROBLEM STATEMENT CONT..
 India 26% global cases– highest
 Indonesia 8.5%, China 8.4%
 Globally 73% of cases had HIV status known
 88% of TB patients known to be living with HIV were on
ART
 Preventive therapy is having low acceptability
 Paedicatric TB difficulties in diagnosis.

PROBLEM STATEMENT- INDIA
 Leading cause of death among Communicable
diseases.
 5th most common cause of death among all causes.
2000 RANK 2019 RANK
1. CARDIOVASUCAL DISEASES 1. CARDIOVASUCAL DISEASES
2. MATERNAL & NEONATAL 2. NEOPLASMS
3. RESPIRATORY INFECTIONS &
TB
3. MATERNAL & NEONATAL
4. NEOPLASMS 4. OTHER NON-
COMMUNICABLE
5. ENTERIC INFECTIONS 5. RESPIRATORY INFECTIONS &
TB
6. OTHER NON-
COMMUNICABLE
6. MUSCULOSKELETAL
DISORDERS
7. OTHER INFECTIONS 7. MENTAL DISORDERS

TB CASES 2019-2020
YEAR ESTIMATE
D CASES
NOTIFIED
CASES
DEATHS HIV
NEGATIVE
DEATHS
TB PLHIV
2019 2.6
MILLION
2.4
MILLION
436,000*
79,144#
9500*
2020 10
MILLION
1.8
MILLION
89823# -
* Estimated by WHO
# notified by MOHFW, India

 Highest burden of TB, MDR-TB in world Second
Highest in TB+HIV.

STOP TB STRATEGY-2006
 Vision: a world free of TB.
 Goal: to reduce dramatically the global burden of TB
by 2015 in line with the MDGs and the Stop TB
Partnership targets and to achieve major progress in
the research and development needed for TB
elimination.

STOP TB STRATEGY-2006
CONTD..
 Objectives:
1. To achieve universal access to high-quality diagnosis and treatment for
people with TB.
2. To reduce the suffering and socioeconomic burden associated with TB.
3. To protect poor and vulnerable populations from TB, TB/HIV and MDR-
TB.
4. To support the development of new tools and enable their timely and

END TB STRATEGY-2015
 Vision: A world free of tuberculosis - zero deaths,
disease and suffering due to tuberculosis
 Goal: End the global tuberculosis epidemic

END TB STRATEGY-2015
MILESTONES FOR 2025:
1. 75% reduction in tuberculosis deaths (compared with 2015)
2. 50% reduction in tuberculosis incidence rate (less than 55 tuberculosis cases per 100
000 population)
3. No affected families facing catastrophic costs due to tuberculosis
TARGETS FOR 2035:
1. 95% reduction in tuberculosis deaths (compared with 2015)
2. 90% reduction in tuberculosis incidence rate (less than 10 tuberculosis cases per 100
000 population)
3. No affected families facing catastrophic costs due to tuberculosis

THE NATIONAL STRATEGIC PLAN
2017-2025

21
Strategie
s
Private
sector
engageme
nt
Active
Case
Finding
TB
Co-
morbidities
Multi-
sectoral
respons
e
Drug
Resistan
t TB
ICT Tools
for
adherence
and
monitorin
g
Preventiv
e
Measures
Communit
y
Engageme
nt
THE NATIONAL STRATEGIC PLAN
2017-2025

PROGRAMME
OBJECTIVES:
1. To achieve 90% notification rates for all cases
2. To achieve 90% success rate for all new and 85% for all re-
treatment cases
3. To significantly improve the successful outcomes of
treatment of DR-TB cases
4. To achieve decreased morbidity & mortality of HIV-
associated TB
5. To improve outcomes of TB CARE in private sector

ORGANIZATIONAL STRUCTURE
Supporting Facilities
 National Reference
Laboratories (6)
 Intermediate Reference
Laboratories (31)
 Culture and DST Laboratories
(81 including IRL/NRL)
 CBNAAT Laboratories (1268)
 DRTB Centres- 703

KEY SERVICES
1. Free diagnosis and treatment for TB patient
2. Public health action- contact tracing, testing for co-morbidities etc.
3. Treatment adherence support
4. Nutrition assistance to TB patients (DBT-Nikshay Poshan Yojana)
5. Preventive measures

CASE DEFINITIONS
 Presumptive Pulmonary TB:
– a person with any of the symptoms and signs suggestive of
TB, including: cough for 2 weeks or more, fever for 2 weeks or
more, signi cant weight loss, haemoptysis, any abnormality in
chest radiograph.
Note: In addition, contacts of microbiologically-con rmed TB
Patients, PLHIV, diabetics, malnourished, cancer patients,
patients on immune-suppressants or steroid should be
regularly screened for sign and symptoms of TB.
 Presumptive Extra Pulmonary TB:
presence of organ-speci c symptoms and signs like swelling of
lymph node, pain and swelling in joints, neck stiffness,
disorientation, etc., and/or constitutional symptoms like

CASE DEFINITIONS
 Presumptive Paediatric TB:
-- Children with persistent fever and/ or cough for 2 weeks or
more, loss of weight*/ no weight gain and/ or history of contact
with infectious TB cases**.
*History of unexplained weight loss or no weight gain in past 3
months; loss of weight is de ned as loss of more than 5% body
weight as compared to highest weight recorded in last 3
months.
** In a symptomatic child, contact with a person with any form
of active TB within last 2 years may be signi cant

CASE DEFINITIONS
 Presumptive DR TB:
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.
This includes following patients:
- All Noti ed TB patients (Public and private)
- Follow-up positive on microscopy including treatment failures on
standard rst line treatment and all oral H mono/poly regimen;
- Any clinical non-responder including paediatric.

CASE DEFINITIONS
Microbiologically con rmed TB:
– presumptive TB patient with biological specimen positive for
AFB, or positive for MTB on culture, or positive for TB through
Quality Assured Rapid Diagnostic molecular test.
 Clinically diagnosed TB case:
– A presumptive TB patient who is not microbiologically
con rmed, 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-TB treatment.

CASE FINDING
 Passive Case Finding: When the Patient Voluntarily reports
symptoms to the Medical Of cer.
 Intensi ed Case Findings: When the Medical Of cer searches
for TB symptoms among the individual seeking care in the
health facility e.g., ART Centre, Diabetic Clinics, NCD Clinics.
 Active Case Finding: When the Community health workers
seeks for TB symptoms among the vulnerable key population.
The Programme encourages Active Case nding as an
intervention for Ending TB

DIAGNOSTIC TOOLS
A. Sputum Smear Microscopy (for AFB):
• Zeihl-Neelsen Staining
• Light Emitting Diode based Fluorescent Microscopy (LED FM).
B. Culture:
• Solid (Lowenstein Jensen) media
• Automated Liquid culture systems e.g. BACTEC MGIT 960, BacT
Alert or Versatrek etc

DIAGNOSTIC TOOLS CONT..
C. Drug Sensitivity Testing:
• Modi ed Proportionate Sensitivity Testing (PST) for MGIT 960
system
• Economic variant of Proportion sensitivity testing (1%) using LJ
medium
D. Rapid molecular diagnostic tests:
• Line Probe Assay (LPA) for MTB complex and detection of RIF & INH
resistance (FL LPA) and FQ and SLI resistance (SL LPA)
• Nucleic Acid Ampli cation Test (NAAT) (CBNAAT/Truenat)
Serological tests
The Government of India has banned the manufacture, importation,
distribution and use of currently available commercial serological
tests for diagnosing TB. These tests are not recommended for

IDEAL SPUTUM SAMPLE
COLLECTION
A good sputum sample consists of recently discharged material from
the bronchial tree with minimum amount of oral or nasopharyngeal
material, presence of mucoid or mucopurulent material and should be
2-5 ml in volume.
It should be collected in a sterile container after rinsing of the oral
cavity with clean water.
The collected specimens should be transported to the laboratory as
soon as possible after collection.
If delay is unavoidable, the specimens should be refrigerated
(maximum up to one
week) to inhibit the growth of unwanted micro-organisms

DIAGNOSTIC ALGORITHM FOR
PAEDS TB

CLASSIFICATION BY
ANATOMICAL SITE
 Pulmonary tuberculosis (PTB): any microbiologically
con rmed or clinically diagnosed case of TB involving
lung parenchyma or tracheo-bronchial tree.
Extra Pulmonary tuberculosis (EPTB): any
microbiologically con rmed or clinically diagnosed
case of TB involving organs other than lungs e.g.
pleura, lymph nodes, intestine, genitourinary tract,
joint and bones, meninges of the brain etc.
A patient with both pulmonary and extra-pulmonary TB should be classi ed as
a case of PTB.

CLASSIFICATION BY H/O PREVIOUS
TB Rx
 New case - A TB patient who has never had treatment for TB
or has taken anti-TB drugs for less than one month.
 Previously treated patients have received 1 month or more of
anti-TB drugs from any source in the past.
1. Recurrent TB case - A TB Patient previously declared as
successfully treated (cured/treatment completed) and is
subsequently found to be microbiologically con rmed TB
case.
2. Treatment After failure- those patients who have previously
been treated for TB and whose treatment failed at the end of
their most recent course of treatment.

CLASSIFICATION BY H/O PREVIOUS
TB Rx
3. Treatment after lost to follow-up A TB patient
previously treated for TB for 1 month or more and
was declared lost to follow-up in their most recent
course of treatment and subsequently found
microbiologically con rmed TB case.
4. Other previously treated patients are those who have
previously been treated for TB but who cannot be
classi ed into any of the above classi cation.

CLASSI CATION BASED ON DRUG
RESISTANCE
1. Mono-resistant (MR): A TB patient, whose biological specimen is resistant
to one rst-line anti-TB drug only.
2. Poly-Drug Resistant (PDR): A TB patient, whose biological specimen is
resistant to more than one rst-line anti-TB drug, other than both INH
and Rifampicin.
3. Multi Drug Resistant (MDR): A TB patient, whose biological specimen is
resistant to both isoniazid and rifampicin with or without resistance to
other rst line drugs, based on the results from a quality assured
laboratory.
4. Rifampicin Resistant (RR): resistance to rifampicin with or without
resistance to other anti-TB drugs excluding INH. Patients, who have any
Rifampicin resistance, should also be managed as if they are an MDR TB
case.
5. Extensively Drug Resistant (XDR): A MDR TB case additionally resistant to
a uoroquinolone (OFX, LFX, or MFX) and a second-line injectable anti TB

TREATMENT
Goal and Objectives of treatment :
1. • Render patient non-infectious, break the chain of
transmission and decrease pool of infection
2. • Decrease case fatality & morbidity by ensuring
relapse free cure
3. • Minimize & prevent development of drug
resistance.

TREATMENT
Anti-TB drugs have the following
three actions:
a. Early bactericidal activity
b. Sterilizing activity
c. Ability to prevent emergence of
drug resistance

TREATMENT.. FLD AKT
Isoniazid (H): Isoniazid is a potent drug exerting early
bactericidal activity, prevents emergence of drug resistant
mutants to any companion drug and has low rates of adverse
drug reactions.
Rifampicin ®: Rifampicin is a potent bactericidal and sterilizing
drug acting on semi- dormant bacilli which multiply
intermittently and causing relapse.
Pyrazinamide (Z): Pyrazinamide is a bactericidal and sterilizing
drug effective in eliminating the semi dormant bacilli
multiplying slowly in an acidic environment.
Ethambutol (E): Ethambutol is an effective bacteriostatic drug
helpful in preventing emergence of resistance to other
companion drugs.
Streptomycin (S): Streptomycin is a bactericidal drug known to

TREATMENT REGIMEN
Treatment is given in two phases:
1. Intensive phase (IP) consists of 8 weeks (56 doses) of
isoniazid (H), rifampicin (R), pyrazinamide (Z) and ethambutol
(E) given under direct observation in daily dosages asper
weight band categories.
2. Continuation phase (CP), consists of 16 weeks (112 doses) of
isoniazid, rifampicin and ethambutol in daily dosages. Only
pyrazinamide will be stopped in the continuation phase. The
CP may be extended by 12-24 weeks in certain forms of TB
like CNS TB, Skeletal TB, Disseminated TB etc. based on
clinical decision of the treating physician on case to case
basis. Extension beyond 12 weeks should only be on
recommendation of specialists.

TREATMENT REGIMEN
Type of TB case Treatment
Regimen in IP
Treatment
regimen in CP
New and previously treated
cases (H and R Sensitive /
unknown)
2 HRZE 4 HRE
Pre x to the drugs stands for number of
months

TREATMENT ALGORITHM FOR
(MDR/RR-TB)

TREATMENT ALGORITHM FOR H
MONO/POLY DRUG RESISTANT
TUBERCULOSIS

OTHER EXCLUSION CRITERIA FOR
SHORTER REGIMEN
• History of exposure for > 1 month to BDQ, Lfx, Eto or Cfz, if
result for DST (BDQ, FQ, Inh A mutation, Cfz & Z) is not
available
• Intolerance to any drug in the shorter MDR TB regimen or risk
of toxicity from a drug in the shorter regimen(e.g. drug–drug
interactions)
• Extensive TB disease – presence of bilateral cavitary disease
or extensive parenchymal damage on chest radiography. In
children aged under 15 years, presence of cavities or bilateral
disease on chest radiography.
• Severe EP-TB disease - presence of miliary TB or TB
meningitis or CNS TB. In children aged under 15 years,
extrapulmonary forms of disease other than lymphadenopathy
(peripheral nodes or isolated mediastinal mass without
compression)

PRE-TREATMENT EVALUATION
(PTE)

DOSAGE OF SHORTER ORAL BEDAQUILINE-
CONTAINING
MDR/RR-TB REGIMEN DRUGS FOR ADULTS

TREATMENT REGIMEN
Type of TB case Treatment
Regimen in IP
Treatment
regimen in CP
Shorter oral Bedaquiline-containing
MDR/RR-TB regimen
(4-6) Bdq (6 m), Lfx,
Cfz, Z, E, Hh, Eto
(5) Lfx, Cfz, Z, E,
Points to remember:
• From start to end of 4th month – Bdq, Lfx, Cfz, Z, E, Hh, Eto
• From start of 5th month to end of 6th month – (If IP not extended) – Bdq,
Lfx, Cfz, Z, E
• From start of 7th month to end of 9th month – Lfx, Cfz, Z, E
• If the IP is extended up to 6 months then all 3 drugs Bdq, Hh and Eto are

TREATMENT REGIMEN
Type of TB case Treatment Regimen
Longer oral M/XDR-TB
regimen
(18-20) Lfx Bdq (6 month or longer)
Lzd# Cfz Cs
Points to remember:
 #dose of Lzd will be tapered to 300 mg after the initial 6–8 months
of treatment
 Bdq will be given for 6 months & extended beyond 6 months as an
exception
 Pyridoxine to be given to all DR-TB patients as per weight band
 For Pre-XDR-TB and XDR-TB patients the duration of longer oral
XDR-TB regimen would be for 20 months with appropriate
modifications

TREATMENT REGIMEN
Type of TB case Treatment Regimen
H mono/poly DR-TB
regimen
(6 or 9) Lfx R E Z
Points to remember:
H mono/poly DR-TB regimen is of 6 or 9 months with no
separate IP/CP.
In exceptional situations of unavailability of loose drug R or E
or Z, the use of 4 FDC (HREZ) with Lfx loose tablets may be
considered as an option rather than not starting the H
mono/poly DR-TB patients on treatment.

BEDAQUILINE, PRETOMANID,
LINEZOLID (BPaL) REGIMEN
New WHO recommendations
• A treatment regimen lasting 6-9 months, composed of Bedaquiline,
pretomanid and
linezolid (BPaL) may be used under operational research conditions in MDR-
TB
patients with TB that is resistant to fluoroquinolones, who have either no
previous
exposure to Bedaquiline and linezolid or have been exposed for no more
than 2
weeks; and
• This is a new recommendation for a defined patient group; it is to be used
under

FIXED DOSE COMBINATIONS
(FDCS)
Fixed Dose Combinations (FDCs) refer to products containing two or more
active ingredients in xed doses, used for a particular indication(s).
• Simplicity of treatment
• Increased patient acceptance
– Fewer tablets to swallow
• Increased health worker compliance
– Fewer tablets to handle, hence quicker supervision of DOT
• Reduced use of monotherapy
– Lower risk of misuse of single drugs
• Lower risk of emergence of drug resistance
• Easier to adjust dosages by body weight

DRUG DOSAGES FOR RST LINE
ANTI-TB DRUGS
*Streptomycin is administered only in certain situations, like TB meningitis
or if any rst line drug need to be replaced due to ADR as per weight of the
patient
** Ethambutol is given separately for children to monitor ophthalmic ADR.

DAILY DOSE SCHEDULE FOR ADULTS
(AS PER WEIGHT BANDS)

CASCADE OF CARE APPROACH
--all target population who are at-risk of developing TB disease
are systematically reached out, screened for TB disease and
after ruling out TB disease provided TPT as a part of continuum
of care.

TESTS FOR TB INFECTION
Tuberculin Skin Test (TST)
Interferon-Gamma Release Assay (IGRA).

CONTRAINDICATIONS FOR TPT
• Active TB disease
• Acute or chronic hepatitis
• Concurrent use of other hepatotoxic medications (such as
nevirapine)
• Regular and heavy alcohol consumption
• Signs and symptoms of peripheral neuropathy like persistent
tingling, numbness and
burning sensation in the limbs
• Allergy or known hypersensitivity to any drugs being considered for
TPT

NIKSHAY
• Nikshay is a unified ICT system
for TB patient management and
care in India and allows both
public and private sector health
care providers to manage their
patients.

NIKSHAY AUSHADHI
Continuous and smooth supply of
good quality assured Anti TB Drugs
and all related commodities.
Central Level forecast the
requirement of Anti TB Drugs and
other required commodities on an
annual basis
Monitoring and Distribution of
drugs procured by Central TB
Division and supplied to
Government Medical Store Depots

CALL CENTRE- NIKSHAY
SAMPARK
 1800-11-6666
 Outbound & Inbound
 Time – 7 to 11
 Languages – 14
 100 call centre agents
 Pan-India coverage
 Citizen – Patient - Providers
Counsellin
g
Treatment
Adherence
Grievance
Redressal
Follow
Up
TB
Notification
Informatio
n
Niksha
y
Poshan
Yojana

NIKSHAY POSHAN YOJANA
 Under this scheme all noti ed TB patients are provided incentive of Rs 500
per month during anti-TB treatment for Nutritional support in cash or in-
kind support through Direct bene t transfer (DBT).
 Rs. 500 for a treatment month paid in installments of up to Rs. 1000 as an
advance
Private Practitioner, Hospital, Laboratory and Chemist)
 Rs. 500 as a one-time payment on notification
 Rs. 500 to Private Practitioner or Hospital for updating the patient’s
treatment Outcome

OTHER INCENTIVES UNDER
NIKSHAY
Transport support for TB patients in notified tribal areas
Rs. 750 as a one-time payment at the time of notification
Treatment Supporters’ honorarium
Rs. 1,000 as a one-time payment on the update of Outcome for Drug-sensitive
TB patients
Rs. 2,000 on completion of Intensive phase (IP) and Rs. 3,000 on completion of
continuation phase (CP) of treatment for Drug-resistant TB patients

Thank You
Bending the Curve
Accelerating towards a TB free India
Thank You

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