Standards of TB care in India

1. Standards for TB Care in India
Dr. Abhijit Dey, Senior Medical Consultant
TUBERCULOSIS HEALTH ACTION LEARNING INITIATIVE, THALI

2. WHO TB Report 2016 vs 2017
Indicator 2016 report (2015 data) 2017 report (2016 data)
TB Incidence 28.4 lacs 27.9 Lacs
MDR TB Incidence 1.30 lacs 1.47 Lacs
XDR-TB cases started
on second-line treatment
248 (2013 cohort) 1397 (2014 Cohort)
Incidence rate (per lac) 217 (112-355) 211 (109-345)
TB-HIV Incidence 113,000 87,000
Non HIV mortality 4.80 lacs 4.23 lacs
TB HIV Mortality 37,000 12,000
Male : Female Ratio 1.86 : 1 1.78:1
Total notified case 17.40 lacs 19.36 lacs
Percentage of case missing (not
notified)
38.7 % 30.6 %

3. NSP 2017-2025

4. Standards for TB Care in India
•Standard 1: Testing and Screening for Pulmonary TB
•1.1 Testing:
• Any person with cough >2 weeks, fever >2 weeks, significant
weight loss, haemoptysis etc. and any abnormality in chest
radiograph.
• Children with persistent fever and/or cough >2 weeks, loss of
weight or no weight gain, history of contact with infectious
TB cases

5. •Standard 2: Diagnostic Technology
•2.1 Microbiological Confirmation on Sputum:
•All patients with presumptive pulmonary TB should undergo
RNTCP approved sputum test for rapid diagnosis of TB under
quality assurance (with at least two samples, including one
early morning sample,) for microbiological confirmation.
•2.2 Chest X-Ray as Screening Tool:
•Where available, initial chest X-Ray can be used as a
screening tool to increase the sensitivity in sputum smear
negative patients
Standards for TB Care in India

6. GOI & WHO approved Diagnostic Tools
1. Smear Microscopy (for AFB)
2. Culture (Liquid & Solid)
3. Rapid diagnostic molecular test
(CBNAAT)
+
4. CXR
Microbiolo
gicaltest

7. WHO approved diagnostic tests: PTB
Microbiological confirmation
 Sputum smear microscopy for AFB (ZN Staining)
 Fluorescence Microscopy (AO Staining)
 GeneXpert (CBNAAT)
 LPA(Line probe assay)
 Liquid Culture/Solid Culture
+
 Chest X-ray
Additional tests for Pediatric:
 TST(Mantoux)
Procedures in case sputum is not expectorated:
 Induced sputum by steam/nebulization
 Broncheo-alveolar lavage
 Gastric lavage
Serological test (IgG, IgM,
ELISA etc) are Banned !!!
Mountoux Test / IGRA / TB
Gold etc also not
recommended as routine
diagnostic.
[cant differentiate between
Active TB, LTBI or already
cured]
Empirical ATD use is not
recommended

8. Standards for TB Care in India
•Standard 3: Testing for Extra-Pulmonary TB
• Appropriate testing with appropriate specimens for
microscopy, culture and drug sensitivity testing (DST),
molecular test and histo-pathological examination.
• Endometrial biopsy (not menstrual blood)
• Plural fluid ADA (not culture)
• Standard 4: Diagnosis of HIV co-infection
• 4.1 All diagnosed TB patients should be offered HIV
counselling and testing.

9. Standards for TB Care in India
•4.2 Diagnosis of Multi-Drug Resistant TB (MDR-TB):
• Prompt and appropriate evaluation for MDR-TB should be
undertaken for the patients suspected of MDR-TB or Rifampicin
(R) resistance.
• MDR Presumptive case- Those who are tested positive in any of
follow-up test or Primary contact of MDR TB converted to a case
• 4.3 Diagnosis of Extensively Drug Resistant TB (XDR-TB):
• On detection of R resistance, patient may be offered second line
DST on an appropriate specimen using RNTCP approved
phenotypic or genotypic method, wherever available.

10. Standards for TB Care in India
•Standard 5: Probable TB
• Those without microbiological confirmation but with
strong clinical and other investigative evidence may be
diagnosed as “Probable TB”. (Clinical TB)
• In case of Negative Report on Rapid Molecular Test do
microbiologic culture & rule out other diagnosis before
ATT (Empirical ATT is not recommended)
•Standard 6: Paediatric TB
• Microbiological confirmation in clinical specimen with
smear microscopy / Preferably by rapid molecular test-
CBNAAT or culture.

12. CBNAAT (Cartridge Based Nucleic Acid Amplification Test)
 CBNAAT is an automated Cartridge Based
Nucleic Acid Amplification Test that has
demonstrated its potential to detect
tuberculosis and Rifampicin resistance with
high accuracy.
 It is also called Gene Xpert MTB/RIF (Cepheid
Inc, USA) test, a highly sensitive and specific
tool with a quick turn-around time (TAT),
offers early diagnosis of TB and DR-TB) in the
programmatic settings amongst adult and
children as well.
 Wide range of specimen e.g. Sputum, Gastric
Lavage, Pus, CSF, FNAC , Tissue biopsy ( except
blood, urine & stool) can be tested
 Result within two hours.
 Best result – if sample sent before or within
7days of treatment initiation

13. Candidate for CBNAAT
• All HIV patients
• All under 14 years
• All EPTB
• All DR TB Contacts
• If sputum –ve but X-ray suggestive
• If sputum & x-ray are negative but clinical suspicion is high
• Sputum +ve in any of the follow-up testing
• All previously treated patient (Cat-II)

14. DR TB Management Centre (THALI districts)
SL.NO. Name of the Hospital Address of the Hospital Catchment Districts
1
Mother Teresa Memorial
TB Hospital
Boral Main Rd, Prantik Pally, Garia, Kolkata 700084
Phone:033 2435 1240
Kolkata
2 Dr K S Roy TB Hospital
Dr Kumud Shankar Ray TB Hospital, K P C Medical College and
Hospital Campus, Jadavpur, Kolkata 700032
Phone:033 2412 2202
South 24 Parganas & Purba
Medinipur
3
R G Kar Medical College &
Hospital
1, Kshudiram Bose Sarani, Kolkata, 700004
Phone:033 2555 7656
North 24 Parganas
4 TL Jaiswal Hospital
Tulsiram Lakshmi Devi Jaiswal Hospital
Surendranagar, Liluah, Howrah, 711204
Phone: 099525 84191,03326559215, 03326555453
Howrah & Hoogly
CBNAAT Location within THALI Districts
District Existing CBNNAT Location RNTCP accredited Pvt LAB with CBNNAT (IPAQT Network)
KOL
STDC office, Dr BC Roy Polio Clinic Hospital (2 machine) AMRI Hospitals (Saltlake)
Tangra Chest Clinic (2 Machine) Probe Diagnostics
R G Kar Medical College Scientific Clinical Research Laboratory (Dr Subir Dutta's Lab)
N R S Medical College DRS. Tribedi & Roy Diagnostic Laboratory
School of Tropical Medicine Ramkrishna Mission Seva Pratisthan (Sishu Mangal)
NPG
Barasat DH Dr Lal Path Labs & Collection centers
Barrackpur SDH TATA Memorial Center (New Town)
Basirhat SDH SRL Diagnostics & Collection center
Bangaon SDH
HRA
Howrah District Hospital
Uluberia SDH
SPG
Canning SDH
Kakdwip SDH
Amtala RH
HGL Chinsura District Hospital
TML Tamluk DH

16. Standards for TB Care in India
•Standard 7: Treatment with first-line regimen
•7.1 Treatment of New TB patients
• The initial phase - H, R, Z, E for two months
• The continuation phase - H, R and E for at least four months
• 7.2 Extension of Continuation Phase:
• Extend CP by 3 to 6 months in special situations like Bone &
Joint TB, Spinal TB with neurological involvement and neuro-
tuberculosis.
•7.3 Drug Dosages: As per body weight in weight bands

17. • Standard 7: Treatment with first-line regimen
New TB patient
IP CP
2
H
4
H
R R
Z E
E
Standards for TB Care in India

18. Previously treated* TB patient ( No MDR )
IP CP
2
H
+ 1
H
5
H
R R R
Z Z E
E E
S
Standards for TB Care in India

19. Daily dosage of ATT
First-line ATT Dosage per Kg body weight Maximum dosage per
day
Isoniazid
10 mg/kg 300 mg
Rifampicin
10-12 mg/kg 600 mg
Streptomycin
15 mg/kg 1 gram
Ethambutol
20-25 mg/kg 1500 mg
Pyrazinamide
30-35 mg/kg 2 grams
H , R ,S ,E, Z 10, 12 , 15, 25 , 35

20. Daily Dose – FDC Schedule for
Adults
(as per weight bands)
Weight
band
Number of tablets Inj.
Streptomy
cin
Intensive
phase
Continuatio
n phase
HRZE HRE
75/150/400/275
mg
75/150/275
mg
gm
25-39 kg 2 2 0.5 gm
40-54 kg 3 3 0.75 gm
55-69 kg 4 4 1 gm
≥70 5 5 1 gm

21. Drug Dosage for Paediatric TB
Weight
category
Number of tablets
(dispersible FDCs)
Inj.
Streptom
ycin
Intensive phase Continuation phase
HRZ E HR E
50/75/150 100 50/75/100 100 mg
4-7 kg 1 1 1 1 100
8-11 kg 2 2 2 2 150
12-15 kg 3 3 3 3 200
16-24 kg 4 4 4 4 300
25-29 kg 3 + 1A* 3 3 + 1A* 3 400
30-39 kg 2 + 2A* 2 2 + 2A* 2 500
*A=Adult FDC (HRZE = 75/150/400/275; HRE = 75/150/275)

22. 4FDC - Adult
Isoniazid, Rifampicin, Pyrazinamide and
Ethambutol
Note: Larger tablets compared to 3FDC

23. 3FDC - Adult
Isoniazid, Rifampicin and Ethambutol
Note: Smaller tablets compared to 4FDC

24. 3 FDC - Paediatric

25. Standards for TB Care in India
•Standard 8: Monitoring Treatment Response
• 8.1 Follow up sputum microscopy: End IP & End Treatment (
at least one sample)
• 8.2 Extension of Intensive Phase: Extension of IP Not
Recommended
• 8.3 Offer DST in follow up sputum positive cases: For positive
sputum in follow-up any time during treatment.
• 8.4 Response to treatment in Extra-pulmonary TB: Assessed
clinically with radiological & relevant investigations.
• 8.5 Response to treatment in Children: Clinically assessed if
no sputum & radiological & relevant investigations.
• 8.6 Long term follow up: Follow up clinically and/or sputum
examination at the end of 6 ,12 , 18 & 24 months.

26. Standards for TB Care in India
•Standard 9: Drug Resistant TB Management
• 9.1 Treatment of M/XDR-TB (or R resistant TB): Confirmed by
Accredited laboratory should be treated with specialized
regimen.
•
• 9.2 Model of Care for Drug Resistant TB cases: Ambulatory
treatment.
•9.3 Regimen for MDR-TB (or Rifampicin Resistant TB) patients
• At least Pyrazinamide, Ethambutol,Levofloxacin,
Kanamycin/ Amikacin, Ethionamide/Prothionamide, and
Cycloserine or PAS .

27. MDR-TB Treatment
Intensive Phase: 6-9 months Continuation Phase:18 months
Pyrazinamide Ethambutol
Ethambutol Ethionamide
Ethionamide Cycloserine
Cyloserine
Levofloxacin
Levofloxacin
Kanamycin
E-E-C-OP-E-E-C-O-K

28. XDR TB Mx
• Drugs given are –
• Capreomycin
• Moxifloxacin
• Linezolid
• PAS
• Clofazamine
• Amoxi/Clav
• High Dose INH

29. www.tbcindia.gov.in
Thematic area- Guideline- TOG 2016

30. Standards for TB Care in India
•Standard 10: Addressing TB with HIV Infection and other Co-
morbid Conditions
• 10.1 Treatment of HIV associated TB patients:
• Treatment with Daily regimen.
• 10.2 Anti-retroviral (ART) & Co-trimoxazole prophylactic
therapy (CPT) in TB HIV patients
•10.3 Isoniazid preventive therapy (6-9 month) in HIV patients
without active TB

31. TB and co-morbidities
•Considering closed association of TB and comorbidities it is
recommended that:
• All presumptive TB cases should be screened for HIV(substantiated by
research and recommended by WHO)
• All TB patients should be tested for Diabetes (random blood sugar)
• All HIV infected TB patients should be started on ART irrespective of CD
4 count.
• TB Patients with HIV, first starts with ATT, and then, after 2 weeks start
ART
• All HIV infected TB patients should be given (Co-trimoxazole Prophylactic
Treatment) CPT in order to prevent other opportunistic infection.

32. Standards for TB Care in India
•Standard 11: Treatment Adherence
•11.1 Patient centred approach for adherence
•11.2 Measures for treatment adherence
•11.3 Trained treatment supporter for treatment adherence
• 11.4 Information Communication Technology to promote
treatment literacy & adherence

33. Standards for TB Care in India
•Standard 12: Public Health Responsibility :
•Prescribe an appropriate regimen, ensure adherence
•Standard 13. Notification of TB cases:
•Report all TB cases and their treatment outcomes to public
health authorities. Any patient who is under ATT must be
notified to Govt
•Standard 14: Maintain Records for all TB patients
•.

34. Standards for TB Care in India
•Standard 15: Contact Investigation
• Standard 16: Isoniazid prophylactic therapy: Children <6
years of age who are close contacts of a TB patient, after
excluding active TB, should be treated with isoniazid for a
minimum period of 6 months and should be closely monitored
for TB symptoms

35. Standards for TB Care in India
• Standard 17: Airborne Infection Control:
• Airborne infection control should be an integral part of all
health care facility infection control strategy.
•Standard 18: Quality Assurance Systems
• 18a QA for diagnostic tests
• 18b QA for anti-TB drugs
•Standard 19: Panchayat Raj Institutions
•Standard 20: Health Education

36. Standards for TB Care in India
•Standard 21: Deaths audit among TB patients
•Standard 22: Information on TB Prevention and Care Seeking
•Standard 23: Free and Quality services
•Standard 24: Respect, Confidentiality and Sensitivity
•Standard 25: Care and support through social welfare
programmes
•Standard 26: Addressing counselling and other needs

37. THANK YOU