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Revised National Tuberculosis Control
Programme (RNTCP)
Introduction of Daily Regimen for

1st line TB Treatment
Central TB Division
Directorate General of Health Services
Ministry of Health & Family Welfare
Government of India
Regime for new cases of TB in India
National Guidance on Regimen

• Daily treatment
• 2 HREZ -------4HRE (continuation phase includes
Ethambutol)
• Weight Band wise drug dosage (4 weight bands in
adults)
• FDC
• Comprehensive approach (including ADR Mx,
improved recording reporting, ICT enabled treatment
adherence)
Outline
• Concept of FDCs
• Daily dose
• Dosage
• Weight Bands
• Packaging
• Concept of FDCs
• Daily dose
• Dosage
• Weight Bands
• Packaging
FDCs - Background
• Fixed Dose Combinations (FDCs) refer to
products containing two or more active
ingredients used for a particular indication(s)
• FDCs are already in use by National AIDS
control programme and National Vector Borne
Disease Control Programme
• STCI/WHO has advocated replacing single-
drug regimens for treatment of primary TB
with fixed-dose combinations
FDCs – Potential Advantages
• Simplicity of treatment
• Increased patient acceptance
– Fewer tablets to swallow
– Prevents ‘concealed’ irregularity
• Increased health worker compliance
– Fewer tablets to handle, hence quicker supervision of DOT
• Easier drug management
• 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
4FDC
3FDC
Single-Dose Blister Pack FDC Monthly Blister Pack
• Concept of FDCs
• Daily dose
• Dosage
• Weight Bands
• Packaging
Recommended Daily Dose of essential
first-line anti-TB drugs
Name of Drug Daily Dose (mg/kg body wt.)
Isoniazid 5 mg/kg (4–6 mg/kg) daily
Rifampicin 10 mg/kg (8–12 mg/kg) daily
Pyrazinamide 25 mg/kg (20–30 mg/kg) daily
Streptomycin 15 mg/kg (12–18 mg/kg) daily
Ethambutol 15 mg/kg (15–20 mg/kg) daily

Inj. Streptomycin
• 15 mg/kg (12–18 mg/kg) daily
• Maximum daily dose 1000 mg
• Patients aged over 50 years may not be
able to tolerate more than 750 mg daily
• Similarly, patients weighing less than 50
kg may not tolerate doses above 500-750
mg daily
• Concept of FDCs
• Daily dose
• Dosage
• Weight Bands
• Packaging
Dosage
• Frequency of Dosage : DAILY (7 day/week)
• Single daily dosage
• 4 weeks per month, i.e. 28 doses
• No extension of Intensive Phase
• For the time being, paediatric patients would
continue to be treated with the currently
available drugs/regimen
Doses in RNTCP Daily Regimen
Type of TB Case Doses in IP Doses in CP
New 56 doses (8 weeks x 112 doses(16 weeks

7 days/week) or x 7 days/week) or
28*2 28*4
Previously treated 84 doses (12 weeks x 140 doses(20 weeks

7 days/week) or x 7 days/week) or
28*3 28*5
• Concept of FDCs
• Daily dose
• Dosage
• Weight Bands
• Packaging
Daily Dose Schedule for Adults
(as per weight bands)
Weight band Number of tablets Inj.
Streptomycin
Intensive phase Continuation
phase
HRZE HRE
75/150/400/275 75/150/275 gm
mg mg
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
Tab Pyridoxine
• Tab pyridoxine not required for all TB patients
• To be supplied separately for specified

patients
• Concept of FDCs
• Daily dose
• Dosage
• Weight Bands
• Packaging
Schedule 9 : IP Inside the box
Schedule 10: CP
Product Details
Product Product Description No. of No. of Unit
Code strips strips
in IP in CP
PC-1D-1 Daily regimen treatment Box for New Cases 4 8 PWB
weight Band (25-39kg)
PC-1D-II Daily regimen treatment Box for New Cases 6 12 PWB
PC-1D-III Daily regimen treatment Box for New Cases 8 16 PWB
PC-1D-IV Daily regimen treatment Box for New Cases 10 20 PWB
weight Band (≥70 Kg)
PC-2D-1 Daily regimen treatment Box for Re-Treatment 6 10 PWB
Cases weight Band (25-39kg)
PC-2D-II Daily regimen treatment Box for Re-Treatment 9 15 PWB
PC-2D-III Daily regimen treatment Box for Re-Treatment 12 20 PWB
PC-2D-IV Daily regimen treatment Box for Re-Treatment 15 25 PWB
Cases weight Band (≥70 Kg)
PC-5D-I Inj Streptomycin 500 mg Vial 56 Vials/Kit
-
doses
PC-5D-II Inj Streptomycin 750 mg Vial 56 Vials/Kit
-
doses
PC-5D-III Inj Streptomycin 1gm Vial 56 Vials/Kit
-
doses
Illustration of consumption of tablets
(PC1DII – wt band 40-54, 3 tabs/day)
Day 1
Day 2
Day 4
Day 10
Day 11
Day 19
Day 19
Day 28
Intermittent to Daily
M T W T F S S M T W T F S S
O U E H R A U O U E H R A U
N E D U I T N N E D U I T N
   
   
Operational steps for transition

Identified States
Himachal Pradesh
Sikkim
Bihar
Maharashtra
Kerala
Total population -
2690 Lakh
Patient criteria
 ×
• Adult (till the time • Non-resident of State
paediatric formulations are • Currently on existing RNTCP
made available) intermittent regimen
• Resident of State/willing to • Diagnosed as DR-TB
stay for the entire course of beforehand
Tt.
• Not currently on any RNTCP
regimen
Pre-treatment counselling
• About the disease, it’s mode of spread and it’s
treatment (dosage schedule, duration, common
side-effects, etc.).
• Methods to prevent transmission of disease
(cough etiquettes, proper disposal of sputum)
• Contact screening(especially household contacts)
• Look for co-morbidities (diabetes, liver or renal
diseases, neurological disorders, substance
abuse, especially tobacco (in any form) &
alcoholism)
Initiation of treatment
• Treatment to be prescribed by a Medical
Practitioner
• TB Treatment Card(s)/Identity card made
prior to initiation of treatment by the
concerned
• Suitable treatment supporter identified
• PWB
• Nikshay entry
Process of initiation of treatment
Successful treatment
outcome
Monthly clinical
follow-up
Weekly supervisory
visits and support by
health worker
PWB handed over to

treatment supporter
Suitable treatment
supporter identified
TB Treatment
Card(s)/Identity card
made prior to
initiation of
treatment
Treatment to be
prescribed by a
Medical Officer
TREATMENT ADHERENCE
“To ensure that patients benefit
from TB control efforts, it is clear
that good health services are
necessary but not sufficient.
Patients still need to choose to
take the drugs”

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Revised National Tuberculosis Control

Introduction of Daily Regimen for

National Guidance on Regimen

Isoniazid 5 mg/kg (4–6 mg/kg) daily

Rifampicin 10 mg/kg (8–12 mg/kg) daily

Pyrazinamide 25 mg/kg (20–30 mg/kg) daily

Streptomycin 15 mg/kg (12–18 mg/kg) daily

Ethambutol 15 mg/kg (15–20 mg/kg) daily

New 56 doses (8 weeks x 112 doses(16 weeks

Previously treated 84 doses (12 weeks x 140 doses(20 weeks

• To be supplied separately for specified

Operational steps for transition

PWB handed over to

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