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REVISED NATIONAL TUBERCULOSIS CONTROL PROGRAMME (RNTCP)

Introduction

Tuberculosis (TB)

Burden of TB

In India everydayMore than 6000 people develop TB diseasesMore than 600 people die of TB ( i.e. 2 deaths in every 5 mins )

NATIONAL TUBERCULOSIS PROGRAM (NTP)

Operational since 1962.

Unacceptably low success rate.

Spread of multidrug resistant TB.

Managerial weakness

Inadequate funding.

Over-reliance of X-ray for diagnosis.

Frequent interrupted supplies of drugs.

Low rate of treatment completion.

Evolution of TB Control in India 1950s-60s Important TB research at TRC and NTI 1962 National TB Programme (NTP) 1992 Programme Review

◦ only 30% of patients diagnosed; ◦ of these, only 30% treated successfully

1993 RNTCP pilot began 1998 RNTCP scale-up 2001 450 million population covered 2004 >80% of country covered 2006 Entire country covered by RNTCP

Revised national tuberculosis control programme (RNTCP)

Launched in 1997 based on WHO DOTS Strategy◦ Entire country covered in March’06 through an unprecedented rapid expansion of DOTS

Implemented as 100% centrally sponsored program◦ Govt. of India is committed to continue the support till TB ceases to be a public health

problem in the country

All components of the STOP TB Strategy-2006 are being implemented

Objectives

Objectives Achievement of at least 85% cure rate of infectious cases; through

DOTS involving peripheral health functionaries.

Augmentation of case finding activities through quality sputum

microscopy to detect at least 70% of estimated cases.

Directly Observed Treatment, Short Course, comprises five components

1. Sustained political and financial commitment. TB can be cured & the epidemic reversed if adequate resources and administrative support for control are provided

2. Diagnosis by quality ensured sputum-smear microscopy.

3. Standardized short-course anti-TB treatment (SCC) given under direct and supportive observation (DOT).Helps to ensure the right drugs are taken at the right time for the full duration of treatment.

4. A regular, uninterrupted supply of high quality anti-TB drugs. Ensures that a credible national TB programme does not have to turn anyone away.

5. Standardized recording and reporting. Helps to keep track of each individual patient and to monitor overall programme performance

Five Components of the Stop TB strategy

by World Health Organisation

1. Pursue high-quality DOTS expansion and enhancement.

a. Secure political commitment, with adequate and sustained financing.

b. Ensure early case detection, and diagnosis through quality-assured bacteriology.

c. Provide standardized treatment with supervision, and patient support.

d. Ensure effective drug supply and management.

e. Monitor and evaluate performance and impact.

2. Address TB-HIV, MDR-TB, and the needs of poor and vulnerable populations

a. Scale-up collaborative TB/HIV activities.

b. Scale-up prevention and management of multidrug-resistant TB (MDR-TB).

c. Address the needs of TB contacts, and of poor and vulnerable populations.

3. Contribute to health system strengthening based on primary health care

a. Help improve health policies, human resource development, financing, supplies, service delivery and information.

b. Strengthen infection control in health services, other congregate settings and households.

c. Upgrade laboratory networks, and implement the Practical Approach to Lung Health (PAL).

d. Adapt successful approaches from other fields and sectors, and foster action on the social determinants of health.

4. Engage all care providersa. Involve all public, voluntary, corporate and private providers through

Public-Private Mix (PPM) approaches.

b. Promote use of the International Standards for Tuberculosis Care (ISTC).

5. Empower people with TB, and communities through partnership.

a. Pursue advocacy, communication and social mobilization.

b. Foster community participation in TB care, prevention and health promotion.

c. Promote use of the Patients' Charter for Tuberculosis Care.

6. Enable and promote researcha. Conduct programme-based operational research.

b. Advocate for and participate in research to develop new diagnostics, drugs and vaccines.

RNTCP laboratory network

Introduction RNTCP has quality assured laboratory network for bacteriological examination of sputum in a three tier system consisting of

◦ Designated Microscopy Centre (DMC), ◦ Intermediate Reference laboratory (IRL),◦ National Reference laboratory (NRL).

One of its National Reference laboratories (National Institute for Research in Tuberculosis – formerly TRC), Chennai is also one of the WHO designated supra-national reference laboratory (SNRL) for the South East Asia Region since 1997 and another the National Institute of TB and Respiratory Diseases (NITRD) New Delhi has been designated as a centre of excellence for TB mycobacteriology by WHO in the recent past.

Structure and functions of RNTCP Laboratory network

National Reference Laboratory (NRL)NRL conducts annual On-site evaluation/supervisory visits to laboratories for assessing quality of microscopy, Culture and DST, and for improvement of overall laboratory quality .The programme has provided HR support by way of three microbiologists and four senior laboratory technicians to each NRL for these activities under the head of NRL strengthening.The functions of the NRLs include conduct of Culture and DST trainings to the IRLs, develop SOPs for the technical procedures, equipment maintenance, infection control, and recording and reporting.

Intermediate Reference Laboratory (IRL)There is at least one IRL per state.Its functions is to provide culture and DST for the category IV services in the State .The IRL conducts on-site evaluation visits to districts for sputum microscopy at least once a year. The IRL undertakes panel testing of STLS at each DTC. The IRL ensures the proficiency of staff performing RNTCP smear microscopy activities by providing training to laboratory technicians and STLS.

Designated Microscopy Centre (DMC)The most peripheral laboratory under the RNTCP network is the designated microscopy centre (DMC) which serves a population of around 100,000 (50,000 in tribal and hilly areas).RNTCP has provided financial assistance for upgrading existing health facilities, supplied a binocular microscope for each DMC and ensured adequate supply of staining reagent and consumables at the DMCs.DMCs are manned by a trained laboratory technician (LT) of the state health system.

RNTCP External Quality Assessmento Panel testing

o On site evaluation‐

o Random blinded rechecking of routine slides

RNTCP endorsed diagnostic

technologies for TB & DR-TB

1. Smear Microscopy (for AFB) – Sputum smear stained with

Zeil-Nelson Staining or

– Fluorescence stains and

examined under direct or

indirect microscopy with or

without LED.

2. Culture – Solid (Lowenstein Jansen) media or Liquid media (Middle Brook) using manual, semiautomatic or automatic machines e.g. Bactec , MGIT etc.

3. Rapid diagnostic molecular test

– Conventional PCR based Line Probe Assay for MTB complex or Real-time PCR based Nucleic Acid Amplification Test (NAAT) for MTB complex e.g. GeneXpert

Note: Diagnosis of TB basedon radiology (e.g. X-ray) will be termed as clinical TB.

The RNTCP endorsed technologies for DR-TB

Multi Drug Resistance Tuberculosis (MDR-TB)/ Rifampicin Resistance

Patient with a drug susceptibility test result from a RNTCP-certified laboratory or WRD (WHO-endorsed Rapid Diagnostics) drug susceptibility test report showing resistance to rifampicin.

o Rapid Molecular Test ( LPA/ CB-NAAT) o Liquid Culture & DST o Solid Culture & DST

XDR TB case An MDR TB case whose recovered M. tuberculosis isolate is resistant to at least isoniazid, rifampicin, a fluoroquinolone (ofloxacin, levofloxacin, or moxifloxacin) and a second-line injectable antiTB drug (kanamycin, amikacin, or capreomycin) at a RNTCP-certified Culture & DST Laboratory.

o Liquid Culture & DST o Solid Culture & DST

New Initiatives

1.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), offer early diagnosis of TB and DR-TB) in the programmatic settings amongst adult and children as well.Currently 80 such CBNAAT machines deployed across the country

2.Case-based web-based reporting system (NIKSHAY)

The database of RNTCP was conventionally on Epiinfo based software for reporting with electronic data transmission from district level upwards.

CTD in collaboration with National Informatics Centre (NIC) developed a case based web-based online (Cloud) application - ‘Nikshay’, launched in May 2012, which has been now scaled up nationally.

NIKSHAY It has following components –

• Master management

• User details

• TB patient registration & detail of diagnosis, DOT

provider, HIV status, follow up, contact tracing,

outcome

• Details of Solid and liquid culture & Drug Sensitivity

Testing (DST), Luciferin Probe Assay (LPA), CBNAAT

• DRTB patient registration with details

• Referral & transfer of patients

• Private health facility registration and notification

• Mobile application for TB notification

• SMS alert to patients on registration and to programme

officer

• Automated periodic report (case finding, sputum

conversion and outcome).

3.TB notificationIn order to ensure proper TB diagnosis and case management, reduce TB transmission and address the problems of emergence and spread of DRTB, it is essential to have complete information of all TB cases.

To curb this situation, Government of India declared Tuberculosis a notifiable disease on 7th May 2012 mandating all the healthcare providers to notify every TB case diagnosed and/or treated to local authorities .

A total of >57,000 private health facilities are registered till now.

Till now >41,000 TB cases have been notified by private sector in addition to ~5,000 cases notified by public sector being treated outside .

4.Ban on commercial serology tests for TB diagnosisMinistry of Health and Family Welfare had prohibiting the import of the commercial sero-diagnostic test kits for tuberculosis and the manufacture, sale, distribution and use of the serodiagnostic test kits for tuberculosis on 7th June,2012.

The serological tests are based on antibody response, which is highly variable in TB and may reflect remote infection rather than active disease.

The WHO experts Group and Strategic and Technical Advisory Group for Tuberculosis (STAG-TB) which reviewed the data and concluded that currently available commercial serological tests provide inconsistent and imprecise results and put patients lives in danger, therefore WHO strongly recommended that these tests should not be used for the diagnosis of pulmonary and extra-pulmonary TB.

This historic ban has had a big impact in reducing the use of inaccurate serological tests in India.

Programmatic management of drug resistant TB (PMDT) servicesThe term “Programmatic Management of Drug Resistant TB” (PMDT) (erstwhile DOTS Plus), refers to programme based MDR TB diagnosis, management and treatment.

RNTCP introduced the PMDT services since 2007 to address the MDR TB issue in the country.

MDR TB suspect criteria as per current programme guidelines.‑Criteria A: All failures of new TB cases, Smear +ve previously treated cases who remain

smear +ve at 4th month onwards, All pulmonary TB cases who are contacts with known MDR TB case

Criteria B – in addition to Criteria A, All smear +ve previously treated pulmonary TB cases at diagnosis, Any smear +ve follow up result in new or previously treated cases

Criteria C – in addition to Criteria B, All smear −ve previously treated pulmonary TB cases at diagnosis HIV TB co infected cases at diagnosis‑

Policy changes related to the DOTS plus•The definition of the MDR suspects has been revised to include ‘contacts of MDR cases who are found to be smear positive; besides Category I failures and Category II patients who are smear positive at 4 months or later.

•The existing exclusion criteria for MDR suspects i.e. Age < 15 years and history of intake of second line drugs for more than 1 month in the past has been withdrawn. A new weight band (16-25 Kgs) has been added for the treatment of the paediatric MDR patients.

•In order to make Category IV regimen more effective it has been decided to replace Ofloxacin with Levofloxacin.

•Guidelines for the management of MDR patients with pregnancy have been finalized.

•Guidelines for the management of Extensively Drug Resistant TB (XDR TB) patients with Category V regimen have been formulated.

TWELFTH FIVE YEAR PLAN – KEY ACTIVITIESPROPOSED (2012-2017)

Ensuring early and improved diagnosis of all TB patients, through improving outreach, vigorously expanding case-finding efforts among vulnerable populations, deploying better diagnostics, and by extending services to patients diagnosed and treated in the private sector.Improving patient-friendly access to high-quality treatment for all diagnosed cases of TB, including scaling up treatment for MDR TB nationwide.Re-engineering programme systems for optimal alignment with National Rural Health Mission (NRHM) at block level and human resource development for all health staff.Enhancing supervision, monitoring, surveillance, and programme operations for continuous quality improvement and accountability for each TB case, with programme based research for development and incorporation of innovations into effective programme practice.

Strategic vision to move towards universal access.

Objectives of programme proposed are

To achieve 90%notification rate for all cases.

90% success rate for all new and 85% for retreated cases.

Improve the successful outcomes of treatment of MDR cases.

Decrease mortality and morbidity of HIV associated TB.

Improve out come of TB care in private sector.

Notification of TB cases

According to govt of India it is mandatory for all healthcare providers to notify every TB case to local authorities.

Achievements of rntcpCovers whole country since march 2006.Phase II has been launched from 1st October 2006.Increased treatment success rate from 25% in 1988 to 88% in 2010.Reduced death rate from 29% to 4%.More than 15million patients have been treated saving almost 2.5million lives.Four urban DOTS project have also been launched.

Financial resources India receives assistance from:

1.World Bank, in first phase.

2.DFID & World Bank in second phase.

3.DANIDA , GDF & USAID