Published on LMS

There are certain inclusion and exclusion criteria for the use of Bedaquiline (Bdq) in TB treatment.

Inclusion Criteria

• Adults and children aged 5 years to less than 18 years of age and weighing at least 15 kg, given their special needs, in consultation with a paediatrician.
• Patients with controlled stable arrhythmia can be considered after obtaining cardiac consultation.
• Pregnant & lactating women (with necessary precautions). ​

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Exclusion Criteria​

To expand access to the Programmatic Management of Drug-resistant TB (PMDT) services, including new regimens and new drugs like Bedaquiline, Delamanid for patients seeking care in the private sector, the following mechanisms are applicable:

Programmatic Management of Drug-resistant TB (PMDT) services for patients seeking care in the private/ other sectors can be accessed from the National TB Elimination Programme (NTEP) at all levels of the health system. 

• This includes care offered from the field level, through the network of Health and Wellness Centres (HWCs) under Ayushman Bharat, to tertiary care available in medical colleges/ nodal DR-TB centres and national-level institutions.

The Difficult-to-treat TB clinic (DT3C) is an initiative to support Drug-resistant TB Centres (DR-TBCs) for better patient management. 

The DT3C structure is intended to handhold and mentor District DR-TB centres (DDR-TBCs) for the effective management of Drug-resistant TB (DR-TB) cases.

Figure: Difficult-to-treat TB Clinic: Three-tier Structure

The Nodal Drug-resistant Tuberculosis Centre (NDR-TBC) committee is a clinical committee that is responsible for taking decisions regarding the management of DR-TB patients at the NDR-TBC.

The composition of the NDR-TBC committee is provided in the table below.

District Drug-resistant TB Centres (DDR-TBCs) are dedicated centres for providing DR-TB services for patients and can be established at the district or sub-district level. ​

Nodal Drug-resistant Tuberculosis Centres (NDR-TBCs) are established to manage all forms of DR-TB, including complicated cases. ​Therefore, the centre should have:

• Advanced general laboratory
• Allied investigation facilities for Pre-treatment Evaluation (PTE)
• Intensive Care Unit (ICU)
• Ventilator backup
• In-house lab/ linkages for PTE laboratory tests

The NDR-TBC is established as per the need and is generally in a tertiary care setting where expertise and facilities for the management of DR-TB are available. ​

Some Culture and Drug Susceptibility Test (C&DST) laboratories host an Intermediate Reference Laboratory (IRL) under the National TB Elimination Programme (NTEP). 

There is at least one IRL per state at an identified location, usually in a secondary or tertiary level public health facility. There are 34 IRLs in India.

The IRLs are responsible for:

Reliability is a measure of a test’s performance. The reliability of a diagnostic test depends on theaccuracy and reproducibility of the test results.

In the context of Drug Resistant (DR) TB, the reliable test  should accurately be able to detect the DR-TB and provide important information that assists in the diagnosis, treatment, or monitoring of a patient with DR-TB, i.e., it should provide accurate Drug Susceptibility pattern of TB.