Revised National Tuberculosis Control Program

India has had an ongoing National TB Program (NTP) since 1962.[3] At that time, the Indian government lacked the financial backing to meet its public health goals. Therefore, external sources of funding and administration, often from the WHO and UN, became common in the realm of public health[4]. In 1992, the WHO and Swedish International Development Agency evaluated the NTP, finding that it lacked funding, information on health outcomes, consistency across management and treatment regimens, and efficient diagnostic techniques[5].

In order to overcome these lacunae, the Government decided to give a new thrust to TB control activities by revitalising the NTP, with assistance from international agencies, in 1993. Given TB's high curability rate 6-12 months after diagnosis, moving toward a clinical and treatment-based strategy was a sensible progression from the NTP[6].

The Revised National TB Control Programme (RNTCP) thus formulated, adopted the internationally recommended Directly Observed Treatment Short-course (DOTS) strategy, as the most systematic and cost-effective approach to revitalise the TB control programme in India. DOTS was adopted as a strategy for provision of treatment to increase the treatment completion rates. Political and administrative commitment were some of its core strategies, to ensure the provision of organised and comprehensive TB control services was obtained. Adoption of smear microscopy for reliable and early diagnosis was introduced in a decentralized manner in the general health services. Supply of drugs was also strengthened to provide assured supply of drugs to meet the requirements of the system.[7]

Large-scale implementation of the RNTCP began in late 1998.[8]

Expansion of the programme was undertaken in a phased manner with rigid appraisals of the districts prior to starting service delivery. The initial 5-year project plan was to implement the RNTCP in 102 districts of the country and strengthen another 203 Short Course Chemotherapy (SCC) districts for introduction of the revised strategy at a later stage.

The Government of India took up the massive challenge of nationwide expansion of the RNTCP and covering the whole country under RNTCP by the year 2005, and to reach the global targets for TB control on case detection and treatment success. The structural arrangements for funds transfer and to account for the resources deployed were developed and thus the formation of the State and District TB Control Societies was under- taken. The systems were further strengthened and the programme was scaled up for national coverage in 2005.

This was followed up with RNTCP Phase II, developed based on the lessons learnt from the implementation of the programme over a 12-year period. The design of the RNTCP II remained almost the same as that of RNTCP I but additional requirements of quality assured diagnosis and treatment were built in through schemes to increase the participation of private sector providers and also inclusion of DOTS+ for MDR TB and also offering treatment for XDR TB. Systematic research and evidence building to inform the programme for better de- sign was also included as an important component. The Advocacy, Communication and Social Mobilization were also addressed in the design. The challenges imposed by the structures under NRHM were also taken into account. India achieved country wide coverage under RNTCP in March 2006.

The RNTCP was built on the infrastructure and systems built through the NTP. Major additions to the RNTCP, over and above the structures established under the NTP, was the establishment of a sub-district supervisory unit, known as a TB Unit, with dedicated RNTCP supervisors posted, and decentralization of both diagnostic and treatment services, with treatment given under the support of DOT (directly observed treatment) providers.

NIKSHAY, the web based reporting for TB programme has been another notable achievement initiated in 2012 and has enabled capture and transfer of individual patient data from the remotest health institutions of the country.

The program initially adopted the Directly observed treatment, short-course strategy which consisted of the five components of strong political will and administrative commitment, diagnosis by quality assured sputum smear microscopy, uninterrupted supply of quality assured Short Course chemotherapy drugs, Directly Observed Treatment (DOT) and systematic monitoring and Accountability. The DOTS strategy achieved and sustained the target detection rate of 70% of all estimated cases and a cure rate of 85% in new cases. The strategy is estimated to have saved 1.3 million lives since its implementation, and has cut the disease duration by nearly 70% (by 1.6 years)[9]. Although incidence and mortality remain quite large in magnitude, with 2 million incident cases and over 250,000 deaths from TB in 2009 alone[7], the DOTS has also led to the decrease in incidence of TB in the country.

With progress in achieving objectives outlined in the DOTS Strategy of the 11th Five year Plan, the program defined the new targets of Universal Access to TB care. Under the 12th Five Year Plan of Government of India as the National Strategic Plan for 2012–17. The plan hopes to achieve detection of at-least 90% the total estimated cases and a cure rate of 90% in new and 85% in re-treatment cases.[1] Following are the key components:

Case finding and diagnostics:

• Early identification of all infectious TB cases. Improved integration with the general health system, and leverage field staff for home-based case finding.
• Improve communication and outreach
• Screening clinically and socially vulnerable risk groups for TB.
• Develop improved sputum collection and transportation systems.
• Deployment of higher-sensitivity diagnostic tests for TB suspects (and incorporate new tests) and decentralized DST services
• Catch patients already diagnosed through notification from all sources, improved referral for treatment mechanisms, and deployment of laboratory and private provider notification

Patient friendly treatment services:

• Promptly and appropriately treating TB, increasingly guided by DST.
• Making DOTS more patient friendly through increased communitization of DOT; pilot incentives/offsets for patient costs to help patients complete treatment and better monitoring through information technology.
• Improving partnerships between public and private sector—establish 'Indian Standards for TB Care' which can be used to engage providers using existing private treatment and improve care with some public sector support and supervision.
• Research will guide improvements in regimens and delivery systems.
• National Treatment Committee/TWG for regular review of regimens, all treatment related technical guidance

Scale-up of Programmatic Management of Drug Resistant TB:

• Developing network of C&DST laboratories and strengthening of reference laboratories
• Decentralized DST at district level for early MDR detection
• Improved information system for PMDT
• Manpower support for additional workload by aligning with NRHM health blocks and rationalization of number of patients per STS
• Improved drug management of second-line anti-TB drugs

Scale-up of joint TB-HIV collaborative activities:

• Activities will aim at early, rapid TB diagnosis with high sensitivity tests for HIV-infected TB suspects and ART for all HIV-infected TB patients, with transport support.

Integration with health systems:

• Integrating the RNTCP with the overall health system will increase effectiveness and efficiencies of TB care and control which has been depicted in the picture.
• In rural areas the RNTCP can focus integration through the National Rural Health Mission.
• In urban areas the RNTCP can integrate through the private sector and the evolving National Urban Health Mission.

Control TB: compared to today's activities, success will:

• Accelerate decline in incidence and prevent 22 lakh TB cases
• Reduce TB deaths by 75%, and save 17 lakh lives from TB
• Contain MDR TB: avert 1 lakh MDR cases and reduce incidence by 50%
• Quicker diagnosis of more TB patients, more effective treatment in future direct economic expenditure on TB cases prevented and
• Leadership for India: Sustain India's global leadership in TB treatment and control.

Diagnosis is made primarily based on sputum smear examination. X-rays play a secondary role in the standard diagnostic algorithm for pulmonary tuberculosis

Sputum smear microscopy, using the Ziehl-Neelsen staining technique, is employed as the standard case-finding tool. Two sputum samples are collected over two days (as spot-morning/morning-spot) from chest symptomatics (patients with presenting with a history of cough for two weeks or more) to arrive at a diagnosis. In addition to the test's high specificity, the use of two samples ensures that the diagnostic procedure has a high (>99%) test sensitivity as well.

As a national health program, RNTCP pays more attention to the sputum-positive pulmonary tuberculosis patients (who are likely to spread the disease in the community) than people with other, non-pulmonary forms of the disease.

Based on results from a recent study, RNTCP has issued guidelines to states on daily treatment for tuberculosis. The daily regimen will replace the existing alternate day (thrice weekly) regimen from January - February 2016 in selected states. The daily regimen has shown to be effective in reducing relapse rates and drug-resistance.

Standardized treatment regimens are one of the pillars of the DOTS strategy. Isoniazid, Rifampicin, Pyrazinamide, Ethambutol, and Streptomycin are the primary antitubercular drugs used. Most DOTS regimens have thrice-weekly schedules and typically last for six to nine months, with an initial intensive phase and a continuation phase.

Based on the nature/severity of the disease and the patient's exposure to previous anti-tubercular treatments, RNTCP classifies tuberculosis patients into two treatment categories.

H: Isoniazid (600 mg), R: Rifampicin (450 mg), Z: Pyrazinamide (1500 mg), E: Ethambutol (1200 mg), S: Streptomycin (750 mg)

1. Patients who weigh 60 kg or more receive additional Rifampicin 150 mg.
2. Patients who are more than 50 years old receive Streptomycin 500 mg. Patients who weigh less than 30 kg receive drugs as per Pediatric weight band boxes according to body weight.

Notes

*New categories includes former Categories I & III

**Previously treated is former Category II

# Others include patients who are Sputum Smear-Negative or who have Extra-pulmonary disease who can have recurrence or resonance.

In India a sizable proportion of the people with symptoms suggestive of pulmonary tuberculosis approach the private sector for their immediate health care needs. However, the private sector is overburdened, and lacks the capacity to treat such high volumes of patients. RNTCP-recommended Private-Provider Interface Agencies (PPIAs) help treat and track high volumes of patients through offering treatment vouchers, electronic case notification, and information systems for patient tracking[10].

Due to lacking training and coordination amongst private providers, adherence to the RNTCP protocol is quite variable amongst private providers[11], and less than 1% of private providers comply with all RNTCP recommendations[5]. There is need for regularizing the varied anti-tubercular treatment regimens used by general practitioners and other private sector players. The treatment carried out by the private practitioners vary from that of the RNTCP treatment. Once treatment is started in the usual way for the private sector, it is difficult for the patient to change to the RNTCP panel. Studies have shown that faulty anti-TB prescriptions in the private sector in India ranges from 50% to 100% and this is a matter of concern for the healthcare services in TB currently being provided by the largely unregulated private sector in India.

In the first phase of RNTCP (1998–2005), the programme’s focus was on ensuring expansion of quality DOTS services to the entire country. The future holds a different set of challenges including MDR TB and HIV/TB

The RNTCP has now entered its second phase, approved for a period of five years from October 2006 to September 2011, in which the programme aims to firstly consolidate the gains made to date, to widen services both in terms of activities and access, and to sustain the achievements. The second phase aims to maintain at least a 70% case detection rate of new smear positive cases as well as maintain a cure rate of at least 85%. This needs to be done in order to achieve the TB-related targets set by the Millennium Development Goals for 2015 and to achieve TB control in the longer term. Today India's TB control program needs to update itself with the international TB guidelines as well as provide an optimal anti TB treatment to the patients enrolled under it or it will land up being another factor in the genesis of drug resistant tuberculosis.[12]

• Public health system in India
• Epidemiology of tuberculosis
• Tuberculosis management
• Tuberculosis diagnosis
• DOTS (Directly Observed Treatment, Short-Course)
• Stop TB Partnership
• Multi-drug-resistant tuberculosis

• Nikshay, A web based solution for monitoring of TB patients to monitor RNTCP
• Tuberculosis Control India's Homepage on RNTCP
• TRC Chennai Tuberculosis Research Center, Chennai
• NTI Bangalore The National Tuberculosis Institute, Bangalore
• StopTB The Stop Tuberculosis Partnership Website
• History of TB Control in India
• WHO Page on TB WHO's Global TB Programme
• What is DOTS? A guide to Understanding the WHO-recommended TB Control Strategy -1999
• RNTCP at a Glance
• Tuberculosis Control in India
• RNTCP Annual Report, 2007 Status Reports 2007
• Anurag Bhargava; Lancelot Pinto; Madhukar Pai (2011). "Mismanagement of tuberculosis in India: Causes, consequences, and the way forward". Hypothesis. 9 (1): e7. doi:10.5779/hypothesis.v9i1.214.
• Gyanshankar Mishra; Jasmin Mulani (2013). "Tuberculosis Prescription Practices In Private And Public Sector In India". National Journal of Integrated Research in Medicine. 4 (4): 71–76.