2. The new National Tuberculosis
Elimination Program (NTEP)
launched with its new logo in early
2020. Logo have been launched is
circular with yellow and red colour.
Name of program is in circular and
with caption “TB Harega Desh
Jeetega”. There is red colour joyful
person surrounded by National Flag
with image of lung in the logo.
3. • India has the highest estimated burden of tuberculosis
infection (TBI) globally, with nearly 35-40 crores Indian
population having TBI, of which 26 lakhs people (18-36
lakh) are estimated to develop tuberculosis (TB) disease
annually.
•
4. • The India’s Tuberculosis (TB) control programme
got rechristened to National Tuberculosis
Elimination Programme (NTEP) from Revised
National Tuberculosis Control Programme
(RNTCP) on January 1st, 2020.
5. • The longest battle against this disease in India
started as National TB Control Programme (NTCP)
in 1962 and continued with two phases of RNTCP
from 1997 through 2019.
6. • As a first step in the country for TB control, TB Association
of India (TAI) was established in 1939 to develop standard
methods for managing TB and to develop model training
institutions.
• In 1959 the Government of India, with the help of World
Health Organization (WHO), established the National TB
Institute (NTI) in Bangalore to develop a National TB
Control Programme (NTP).
7. • NTCP initiated in 1962 was originally designed for domiciliary
treatment, using self-administered standard drug regimens. Short
course chemotherapy was introduced from 1983 in the programme but
compliance improved only marginally.
• The review of NTCP in 1992 highlighted managerial weaknesses, the
over-emphasis on X-rays for diagnosis, underutilization of laboratory
services, frequent drug shortages, and low rates of treatment
completion. Hence Government of India decided to revitalize NTCP
with the assistance of international agencies.
8. • In 1997, the RNTCP was launched as a national programme
and scaled it up in a phased manner.
• The RNTCP was designed to deliver TB services through the
general health service infrastructure, building on the network
developed by the NTCP. The programme was based on DOTS
(Directly Observed Treatment Short course) .
10. • History of RNTCP: – RNTCP (based on DOTS strategy), began
as a pilot in 1993 and was launched as a national program in
1997 Rapid RNTCP expansion began in late 1998
• By 24th March 2006, the entire country was covered under
DOTS, covering 1114 million people
• Infrastructure: – The RNTCP designated ‘Microscopy Centre’ is
established for approx. 100,000 population (50,000 in hilly and
mountainous areas)
• Senior TB Laboratory Supervisor (STLS) is one for every 5
microscopy centres
11. • Diagnosis in RNTCP: – In RNTCP, mainstay of diagnosis is
Sputum microscopy; the sputum smears are stained for acid
fast Bacilli (AFB) with ‘Zeihl Neelson (ZN) Stain’
• Minimum bacillary load for a positive result: >10,000 bacilli
per ml sputum
14. • Tuberculosis suspect: A person with productive cough > 2
weeks with or without hemoptysis, fever for > 2 weeks,
chest pain, weight loss, night sweats, and loss of appetite
15. DIRECTLY OBSERVED TREATMENT SHORT
COURSE (DOTS)
• Is a community based Tuberculosis treatment and care strategy which
combines the benefit of supervised treatment with community based care
and support
• Success of DOTS depend upon 5 components
Political commitment
Good quality sputum microscopy
Directly observed treatment
Uninterrupted supply of good quality drugs
Accountability
16. • DOTS is directly observed treatment short course chemotherapy
• – In DOTS during the intensive phase of treatment a health worker
are other trained person watches as the patients swallows the drugs
in his presence
• – During continuation phase the patient is issued medicine for one
week in multiblister combipack of which the first dose is swallowed by
the patient in the presence of health worker or trained person
17. • Consumption of medicine in the continuation phase is also
checked by return of empty multiblister combipack when patient
come to collect medicine for the next week
• Drugs are given category wise, same regimen is not given to all
patient
• Streptomycin is given in category II only
• In category-1 new sputum smear, positive cases sputum
examination is done in 2, 4 and 6 months
18. AFB SPUTUM SMEARS (SS) FOR DIAGNOSIS
OF A CASE OF TB
• Number of specimen(s) required for diagnosis of smear
positive pulmonary Tuberculosis: TWO
• 2 sputum smears’ over 2 days period:
• Spot Sample (Day 1) Morning Sample (Day 2)
• Chances of detecting smear positive cases:
• – With 1 sample: 80%
• – With 2 samples: 93%
19. • Interpretation of results of 2 sputum smear examinations: – None
sputum positive Give antibiotics for 10 – 14 days ,Cough relieved:
Non- tuberculosis person
• Cough persists: REPEAT two sputum smear examinations
• None sputum positive: X-ray chest Findings suggestive of TB:
Sputum negative tuberculosis; Start ATT
• No findings suggestive of TB: Non- tuberculosis person
• One sputum positive: Sputum positive pulmonary tuberculosis; Start
ATT
• Two sputum positive: Sputum positive pulmonary tuberculosis; Start
ATT
20. New Case: A person suffering from TB who has ‘never taken treatment or
took
treatment for <4weeks (1 month)’
Cured: Sputum smear positive (SS +ve) who has completed treatment, and
had
‘sputum smear negative (SS –ve) on atleast 2 separate occasions with one at
the end’
(completion of treatment)
• Relapse: A person ‘declared cured returns back as SS +ve’
•Failure: A person on treatment who is SS +ve at or after 5 months of
treatment
• Defaulter: A person who, at any time after registration, ‘has not taken anti-
TB drugs for 2 months or more consecutively’
21. CATEGORIZATION AND TREATMENT
REGIMENS IN RNTCP
Letters: R – Rifampicin, E –
Ethambutol, H – Isoniazid, S
– Streptomycin, Z –
Pyrizinamide, K –
Kanamycin, O – Ofloxacin, Et
– Ethionamide, C –
Cycloserine.
• Numbers: The numbers
before letters refer to months
of treatment (2 imply two
months of treatment). The
numbers after letters refer to
frequency of administration
per week (3 imply thrice per
week).
*Category IV - Dots Plus; Category III has been merged in
Category I
22. • Daily Self-administered Non-DOTS Regimes
• Indication: ONLY if there are adverse reactions to drugs or patients
compliance is not possible
23. • Follow-up smears examination timings:
Category If SS –ve at end of IP If SS +ve at end of IP
24. NATIONAL TUBERCULOSIS ELIMINATION
PROGRAMME
• The global public health and TB community is shifting its focus from
control of the TB epidemic towards elimination. It is India’s success that
will determine the global progress towards ending TB and subsequently
elimination.
• The National Strategic Plan (NSP) 2017-2025 was set up under the
Revised National Tuberculosis Control Program (RNTCP).
• The stated aim is complete elimination of the disease by 2025. The
requirements for moving towards TB elimination have been integrated
into the four strategic pillars of “Detect – Treat – Prevent – Build” (DTPB).
26. DETECT
• The first objective of NSP is to find all drug sensitive TB cases (DS-
TB) and drug resistant TB cases (DRTB) with an emphasis on
reaching TB patients seeking care from private providers and
undiagnosed TB cases in high-risk populations (such as prisoners,
migrant workers, people living with HIV/AIDS, etc.).
• Early diagnosis and treatment of TB cases in the community is an
important step in TB elimination, which will help in decreasing the
risk of transmission of disease to others, poor health outcomes, and
social and economic hardships of the patient and their family.
27. • Notification of TB cases: Notification of all TB patients from all health
care providers is made mandatory by Ministry of Health and Family
Welfare, Government of India since 2012.
• NIKSHAY: To facilitate TB notification, RNTCP has developed a case-
based web-based TB surveillance system called “NIKSHAY”
(https://nikshay.gov.in ) for both government and private health care
facilities.
28. • Public private partnership: For promotion of public-private
mix (PPM) in TB prevention and care, private providers are
provided incentives for TB case notification, and for
ensuring treatment adherence and treatment completion.
The incentives are provided through direct beneficiary
transfer.
29. TREAT
• Next step under the programme is initiation and sustaining
all TB patients on appropriate anti-TB treatment wherever
they seek care, with patient friendly system and social
support.
• Provision of free TB drugs in the form of daily fixed dose
combinations (FDCs) for all TB cases is advised with the
support of directly observed treatment (DOT).
30. • Nikshya poshak yozana: It is centrally sponsored scheme
under National Health Mission (NHM), financial incentive
of Rs.500/- per month is provided for nutritional support to
each notified TB patient for duration for which the patient
is on anti-TB treatment. Incentives are delivered through
Direct benefit transfer (DBT) scheme to bank accounts of
beneficiary
31. • Nikshay Aushadhi, is a web-based TB drug supply
management system. It is a major step towards adapting
technology to improve supply chain management of TB
drugs in State level and district stores, TB unit (TU),
Health facilities (HFs), DR-TBC and treatment supporter
centres. These applications deal with demand and
distribution of all essential anti-TB drugs and consumables
required at State, district, TU, TB detection centre and HF
level
32. PREVENT
• Air borne infection control measures-TB infection control is a combination of
measures aimed at minimizing the risk of TB transmission within population and
hospital and other settings. The foundation of such infection control is:
• Early diagnosis, and proper management of TB patients.
• Health education about cough etiquettes and proper disposal of sputum by patient.
• Cough etiquette means covering nose and mouth when coughing or sneezing. This
can be done with a tissue, or if the person doesn’t have a tissue they can cough or
sneeze into their upper sleeve or elbow, but they should not cough or sneeze into
their hands.
• Houses should be adequately ventilated.
• Proper use of air borne infection control measures in health care facilities and other
settings
33. • Contact tracing-Since transmission can occur from index
case to the contact any time (before diagnosis or during
treatment) all contacts of TB patients must be evaluated.
Tuberculosis Preventive Therapy(TPT)
34. BUILD
• Health system strengthening for TB control under
the National Strategic Plan 2017-2025 is
recommended in the form of building and
strengthening enabling policies, empowering
institutions and human resources with enhanced
capacities.
35. NEWER ANTI-TUBERCULAR DRUGS
• Newer Anti-tubercular Drugs Bedaquiline and delamanid
are only two drugs developed specifically for the treatment
of TB in the last 40 years.
36. • Bedaquiline is a new second line ATD of diarylquinoline class, approved for
use as second line ATD since 2015. It is considered as miracle drug for the
treatment of XDR-TB. It acts by inhibiting mycobacterial ATP synthase
• It is strongly mycobactericidal; has no cross resistance with other ATDs
• Showed significant benefit in improving the time to culture conversion in
MDR-TB patients
• Indication: It is recommended MDR-TB or XDR-TB cases which are
resistant to fluoroquinolones and/or second-line injectable drugs
37. • It is contraindicated in pregnancy and age <18 years
• Delamanid- Delamanid is a new ATD introduced in 2018; derived from
nitroimidazole class.
• Indication: It is approved for use in the treatment of DR-TB (MDR,
XDR or mixed pattern DR-TB) in a combination regimen
46. TYPES OF DRUG RESISTANT
• Monodrug-resistant TB: TB caused by organisms that show resistance to a single anti-TB
drug (eg, isoniazid, rifampin, ethambutol, or pyrazinamide).
• Isoniazid-resistant TB: TB caused by organisms that show resistance to isoniazid (rifampin
susceptible).
• Rifampin-resistant TB (RR-TB): TB caused by organisms that show resistance to rifampin,
but may be susceptible to isoniazid, or resistant to isoniazid (ie, MDR-TB), or resistant to
other first-line TB medicines (polydrug resistant) or second-line TB medicines (eg,
extensively drug-resistant TB [XDR-TB]).
• Polydrug-resistant TB (PDR-TB): TB caused by organisms that show resistance to more
than 1 anti-TB drug, but not including both isoniazid and rifampin.
•
47. • MDR-TB: TB caused by organisms that show resistance to at least isoniazid and
rifampin.
• Extensively DR TB (XDR-TB): TB caused by or ganisms that show multidrug
resistance, and resistance to any fluoroquinolone and at least 1 of the SLI agents.
• Primary or newly diagnosed DR-TB: DR-TB in a person who has previously received
no or less than 1 month of anti-TB treatment (ATT).
• Acquired or previously treated DR-TB: TB in a person who has previously received
at least 1 month of ATT.
48. TREATMENT OF DRUG-RESISTANT TB
• NTEP provides simplified regimen for various types
of DR-TB including (Based on DST/DRT results )
• Shorter oral Bedaquiline-containing MDR/RR-TB
regimen and
• Longer oral M/XDR-TB regimen
53. SHORTER ORAL BEDAQUILINE-CONTAINING
MDR/RR-TB REGIMEN
• Shorter oral Bedaquiline-containing MDR/RR-TB regimen
Total duration of shorter oral Bedaquiline-containing MDR/RR-TB regimen is for 9-11
months, depending on IP duration.
• IP should be given for at least 4 months. After 4th month of treatment, if the result of
sputum microscopy is negative then CP should be initiated with Bdq continued for another
2 months.
• If sputum smear microscopy does not become negative by the 4th month of treatment,
subject the patient to FL-LPA and SL-LPA and culture & DST and the IP should be
extended.
54. . LONGER ORAL M/XDR-TB REGIMEN
• Eligibility criteria
• Longer oral M/XDR-TB regimen is recommended for
MDR/RR-TB patients who are excluded from shorter
oral Bedaquiline-containing MDR/RR-TB regimen
including for the XDRTB patients.
55. LONGER ORAL M/XDR-TB REGIMEN
• In MDR/RR-TB patients on longer oral M/XDR-TB regimen, all three
Group A agents and at least one Group B agent should be included to
ensure that treatment starts with at least four TB agents likely to be
effective and that at least three agents are included for rest of the
treatment if Bdq is stopped.
• If only one or two Group A agents are used, both Group B agents are to be
included. If the regimen cannot be composed with agents from Groups A
and B alone, Group C agents are added to complete it as recommended by
WHO.
56.
57. • Other drugs that are not included in Groups A–C are: • Kanamycin
and capreomycin, which were associated with poorer outcomes when
used and are therefore no longer recommended for use in MDR-TB
regimens.
• Gatifloxacin and high-dose Isoniazid (Hh ) were used in very few
patients and thioacetazone was not used at all.
58. LONGER ORAL M/XDR-TB REGIMEN
• Injectables are no longer considered priority medicines when designing longer MDR-TB
regimens. Kanamycin and capreomycin are no longer recommended.
• Oral regimens are preferred for most patients.
• Fluoroquinolones (levofloxacin or moxifloxacin), bedaquiline, and linezolid are strongly
recommended for all longer regimens (unless contraindicated), with other medicines ranked
by a relative balance of benefits to harms.
• Most regimens should include at least 4 drugs that are likely to be effective in the first 6
months, and 3 drugs thereafter.
• The total duration of longer MDR-TB regimens should be 18 to 20 months, modified
depending on patient response.
59. BEDAQUILINE, PRETOMANID, LINEZOLID
(BPAL) REGIMEN
• BPaL regimen for MDR-TB with additional FQ resistance
• 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
operational research conditions, and thus does not apply to routine programmatic
use.
• BPaL showed 90% favourable outcomes among XDR (89%), MDR with FQ
resistance, treatment intolerant /non responders (92%); and
60. H MONO/POLY DR-TB REGIMEN (R RESISTANCE
NOT DETECTED & H RESISTANCE DETECTED)
UNDER NTEP
• (6 or 9) Lfx R E Z
• 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.
61.
62. • The social stigma, lack of medication, lack of awareness,
and unaffordable medical care are the major hindrances in
decreasing the burden of Tuberculosis in India. These are
the major determinants of large gap in ambition and reality.
The policy makers and the researchers have to understand
that the social determinants along with diagnostic and
treatment play a major role in achieving the elimination
goal.
63. • World TB Day: 24th March
• National Tuberculosis Institute (NTI) – Bangalore
• Tuberculosis Research Centre – Chennai
• Institute of TB and Respiratory Diseases – New Delhi