The NMJI
VOLUME 18, NUMBER 5

SEPTEMBER/OCTOBER 2005

Editorials

The Revised National Tuberculosis Control Programme: The gains and the future road map

As India has successfully completed the first phase of the World Bank-assisted Revised National Tuberculosis Control Programme (RNTCP) project in September 2005, it is time to reflect on the achievements and experience gained over the years, and plan for the challenges ahead so as to achieve the Millennium Development Goals of halving by 2015 the 1990 levels of mortality and prevalence of tuberculosis (TB) and effectively controlling TB to a level where it ceases to be a public health problem.
1
  Tuberculosis is one of the oldest diseases known to affect mankind. It has been reported in the Vedas and Ayurvedic Samhitas as the kshaya rog. Though an ancient disease, TB remains a major global public health problem in much of the developing world. Globally, it is estimated that 8–9 million people develop active disease every year, of whom nearly 4 million are sputum smear-positive; the majority live in developing countries.
2 Of an estimated 1.8 million new cases of TB every year in India, about 0.8 million are infectious new smear-positive pulmonary TB cases. More adults die from TB than from any other infectious disease in India—more than 1000 every day or 2 every 3 minutes. Deaths due to TB exceed the combined deaths from all other communicable diseases and account for 26% of all avoidable adult deaths. TB is also the leading killer of women, causing more orphans than those produced by all causes of maternal mortality combined. With nearly 40% of the Indian population already infected with the TB bacillus, constituting a large pool of infected people, TB will continue to be a major problem in the foreseeable future.3 Besides the disease burden, TB also causes an enormous socioeconomic burden on India. It is estimated that TB costs India more than US$ 300 million annually in direct costs alone.4 More than 300 000 children may have left school permanently because of their parents’ TB, and more than 100 000 women were rejected by their families because they had TB.4
  Globally, the HIV epidemic is worsening the TB situation, increasing the number of TB cases and accelerating the spread of the disease. One-third of the world’s AIDS patients are also suffering from TB. HIV infection increases a person’s susceptibility to TB and is now considered the most important risk factor for the progression of TB infection to disease. With nearly 5.1 million HIV-infected persons in India, the HIV epidemic has potential implications for the epidemiology of TB in India.
2,3
  Effective antituberculosis drugs have been available for over 50 years. Different treatment regimens and combinations have been practised over these years across the globe. Currently, the internationally recommended Directly Observed Treatment, Short-course (DOTS) strategy has been recognized as the most cost-effective approach for the treatment of TB, to reduce the disease burden and to control the spread of infection. Over 180 countries are implementing the DOTS programme and India’s DOTS programme is now the largest globally in terms of the number of patients being put on treatment—over 1.2 million cases in 2004 alone, i.e. over 100 000 every month.
3

Evolution of TB control activities in India
5
Pioneering research by the Tuberculosis Research Centre, Chennai and the National Tuberculosis Institute, Bangalore laid the foundation and principles of the TB control programme in India and the world. Research at these institutions in the 1950s and 1960s demonstrated the effectiveness of domiciliary chemotherapy given under supervision.
6,7 India started the National TB Control Programme (NTCP) in 1962, based on a District TB Centre Model. A review of the NTCP, after nearly three decades of implementation, demonstrated that it had failed to make any significant epidemiological impact. The review, conducted by the Government of India (GoI) and the Swedish International Development Agency (SIDA) in 1992 concluded that the NTCP suffered from managerial weaknesses, inadequate funding, over-reliance on X-ray for diagnosis, non-standard treatment regimens, low rates of treatment completion, and lack of systematic information on treatment outcomes. The programme review also showed that only 30% of patients were diagnosed and, of these, only 30% were successfully treated. Based on the findings and recommendations of the 1992 review, the GoI evolved a revised strategy and launched the Revised National TB Control Programme (RNTCP) in the country based on the internationally recommended DOTS strategy.
  From October 1993 to 1996, the RNTCP was pilot-tested in a population of nearly 20 million. Following the successful pilot implementation of the programme, which demonstrated both technical and operational feasibility, a credit agreement was signed with the World Bank in 1996 to expand the programme in a phased manner. Support from other international agencies such as the Department for International Development (DFID) of the United Kingdom, Danish International Development Agency (DANIDA), Global Fund for AIDS, TB and Malaria (GFATM), United States Agency for International Development (USAID) and Global Drug Facility (GDF) helped to expand and achieve universal coverage.
  A rapid scale-up of the programme began in late 1998, when another 100 million population was covered under the RNTCP. In the past few years, the RNTCP has been expanding rapidly. By the end of September 2005, over 1059 million people (95% of the population) in more than 604 districts/reporting units were covered under the programme and complete nationwide coverage is expected by the end of 2005.
Gains and future road map of the programme
  Over the past 8 years, the RNTCP has made rapid gains and, since 1999, progress in global TB control has been determined by India’s success, which is expected to continue over the coming years. Over 4.8 million patients have been put on treatment under the RNTCP. Treatment success rates have more than tripled from 26% in the earlier programme to 86% under the RNTCP. Death rates have decreased from 29% to 4%, thereby saving over 800 000 additional lives since the inception of the programme.
  Over 600 District TB centres, nearly 11 000 microscopy centres and 2150 Tuberculosis Units have been upgraded. The programme has made provisions for contractual staff to ensure effective programme implementation and monitoring. The establishment of a sub-district level ‘Tuberculosis Unit’ covering a population of 500 000 with provision for a dedicated contractual Senior Treatment Supervisor and Senior Tuberculosis Laboratory Supervisor has strengthened the programme at the field level. These provisions will be continued in the next phase of the programme to consolidate the gains achieved so far by the RNTCP.
  The quality of diagnosis of TB patients under the RNTCP has improved by giving the highest priority to the provision of quality assured sputum smear microscopy services with RNTCP-designated microscopy centres serving populations of 100 000. One of the unique innovations under the RNTCP has been the development of ‘patient-wise boxes’, which contain the full course of treatment for one individual patient, ensuring that the treatment of that patient cannot be interrupted due to a lack of drugs. The RNTCP has effectively decentralized supervision via the sub-district TB Units, with inbuilt systems for monitoring and evaluation.
  The quality of diagnostic and treatment services is of utmost priority under the programme. A quality assurance protocol was initiated towards the end of phase I of the RNTCP and will be further strengthened in the coming phase by building the capacity of state-level laboratories to the level of an accredited RNTCP Intermediate Reference Laboratory (IRL), capable of implementing quality assurance protocol, and also perform quality assured culture and drug sensitivity testing (DST). A new strategy document for Supervision and Monitoring has laid down detailed guidelines, checklists and indicators for monitoring the programme at the Peripheral Health Institution (PHI)/ Designated Microcopy Centre (DMC), TB Unit, District, State and National level. The quality of DOTS implementation is already being monitored through select indicators collected routinely.
  The RNTCP has been successful in mobilizing political and administrative commitment to ensure adequate funds, staff and other key inputs, and in encouraging community participation at the grassroots level. The RNTCP has forged participation with other stakeholders, such as NGOs, private practitioners, medical colleges and other ministries’ health facilities (Employees’ State Insurance [ESI], Railways, Ports and Mines, Army, etc.), and the corporate sector. Over 1600 NGOs, 9000 private practitioners and 100 corporate houses are now involved in the programme. Guidelines for the management of hospitalized TB patients have been developed, and over 200 medical colleges have been involved. Medical colleges have made an important contribution to case detection, 10%–15% in some areas. With the establishment of a task force mechanism for the involvement of medical colleges in the RNTCP and 5 zonal nodal medical college centres, there is an increased professional consensus, although still not universal, between public health and medical opinion leaders on the appropriateness and feasibility of the RNTCP for TB control in India. These partnerships are constantly being reviewed to strengthen collaboration.
  The RNTCP is a human resource-intensive programme. Human resource development being the core for any successful programme, the programme has developed standardized modular training material for all levels of health staff. To date, over 420 000 personnel have been trained. To build the capacity of the states, the State TB Training and Demonstration Centres (STDCs), one in each of the large states, have been strengthened. These centres have a training unit, supervision and monitoring unit, and a laboratory unit.
  A systematic programme evaluation mechanism is in place, with the responsibility of planning and implementation of such evaluations decentralized to the state level. In 2004, internal evaluations were planned and conducted in 47 selected districts to evaluate the actual status of the RNTCP, including both the negative and the positive aspects of programme implementation. Based on the observations and recom-mendations of such evaluations, the programme has taken steps to rectify any problems identified, so as to continuously improve the performance of the RNTCP. These are supplemented by Centrally-driven district-level evaluations, regular programme review in the states by representatives from the Centre and district reviews by state and district officials.
  Under a joint National AIDS Control Programme (NACP)/RNTCP Action Plan, since 2001, collaborative TB/HIV control activities and coordination have been implemented by the RNTCP and the NACP. As a result, coordination and service linkages have been established between 242 voluntary counselling and testing centres (VCTCs) and RNTCP diagnostic and treatment centres in the 6 high-prevalence states of Andhra Pradesh, Karnataka, Maharashtra, Manipur, Nagaland and Tamil Nadu.
  TB/HIV activities are being scaled-up in 8 more states. HIV seroprevalence surveys among TB patients are under way in selected sentinel sites (4 districts) of Andhra Pradesh, Karnataka, Maharashtra and Tamil Nadu.
The RNTCP with the Indian Academy of Pediatrics has developed guidelines for the management of paediatric cases. During phase II, it is planned to procure and supply paediatric drugs in patient-wise boxes based on specific weight bands. Currently, nearly 6% of new cases registered under the programme are in the paediatric age group.
  Today, with the greatly expanded efforts to strengthen TB prevention and control programmes worldwide, there is growing concern about the reported and potential future rates of multidrug-resistant (MDR) TB (resistance to at least isoniazid and rifampicin). Though the prevalence of MDR-TB in India is under 3% in new cases, when translated into numbers, these cannot be ignored. The RNTCP views the treatment of MDR-TB patients as a ‘standard of care’ issue. However, recognizing that the treatment of MDR-TB cases is very complex, an RNTCP standardized second-line drug regimen has been developed following the internationally recommended DOTS Plus guidelines and will be provided from designated RNTCP DOTS Plus sites. In the initial years, these sites will be located in a limited number of highly specialized centres, at least one in each large state, and will have ready access to a state-level accredited culture and DST laboratory, the IRL, under the RNTCP. By 2010, these sites would be capable of registering 5000 patients every year.
8
  Operational research is integral to the continued improvement of the programme. In 2003, the RNTCP, successfully completed a National Annual Risk of Tuberculosis Infection (ARTI) survey. From the survey, the national ARTI was estimated at 1.5%.
9 The TB burden in India was estimated at 8.5 million cases of which 3.8 million were bacillary pulmonary TB cases.10 These surveys have given, for the first time, true estimates of the disease burden in India and repeat surveys planned in the next phase of the programme will help to assess the impact of the RNTCP. A detailed RNTCP operational research agenda has been prepared and circulated for constant technical and operational inputs.11
   The RNTCP has developed its own website (www.tbcindia.org) where regularly updated information, RNTCP data, documents and training manuals are readily accessible in the public domain. An interactive bulletin board is operational on the website for the sharing of ideas and experiences, and to seek and receive information. State-wise and district-wise performance data are also posted on the site. Each district has been electronically connected, and quarterly programme reports are now routinely received electronically from over 90% of the districts. A web-based information, education and communication (IEC) resource centre has been developed and is accessible on the RNTCP website.

CONCLUSION
As the programme moves from the preparatory and expansion phase to the maintenance and consolidation phase, the RNTCP will endeavour to continue providing high quality and cost-effective TB diagnostic and treatment services. To further improve the quality of services, earlier strategies have been fine-tuned and strengthened, and several new initiatives have been taken.
  To achieve the ultimate goal of TB control in India, the programme will have to be sustained for many years to come. While implementing the RNTCP since 1997 to date, nearly Rs 8.45 billion has been spent and it has shown impressive gains. Further, planned investment of over Rs 14.6 billion over the next 5 years is expected to consolidate the gains achieved so far and yield better results, and have a major impact on reducing the TB burden in India. Continued decentralization of programme management and implementation, ensuring financial support for the RNTCP, and mobilizing community participation in TB control efforts will facilitate the process.

REFERENCES

  1. Human Development Report 2003. Millennium Development Goals—A compact among nations to end human poverty. http://hdr.undp.org/reports/global/2003/
  2. World Health Organization. Global tuberculosis control—Surveillance, planning, financing. WHO Report 2005. Geneva:WHO. WHO/HTM/TB/2005.349.
  3. TB India 2005: RNTCP Status Report. Central TB Division, Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India, New Delhi, 2005. http://www.tbcindia.org/documents.asp
  4. Rajeswari R, Balasubramanian R, Muniyandi M, Geetharamani S, Thresa X, Venkatesan P. Socio-economic impact of tuberculosis on patients and family in India. Int J Tuberc Lung Dis 1999;3:869–77.
  5. Agarwal SP, Chauhan LS. The Revised National Tuberculosis Control Programme. In: Tuberculosis control in India. New Delhi: Elsevier (India); 2005:23–4.
  6. Indian Council of Medical Research. Tuberculosis in India—A sample survey 1955–58, Special Report Series No. 34. New Delhi:Indian Council of Medical Research; 1959:1–21.
  7. Tuberculosis Chemotherapy Centre. A concurrent comparison of home and sanatorium treatment of pulmonary tuberculosis in south India. Bull World Health Organ 1959;21:51–144.
  8. Central TB Division. Managing the Revised National Tuberculosis Control Programme Phase II 2005. New Delhi:Directorate General of Health Services, Ministry of Health and Family Welfare; 2005.
  9. Directorate General of Health Services (DGHS), Government of India (GoI), the National Tuberculosis Institute (NTI), Bangalore and the Tuberculosis Research Centre, Chennai. Annual risk of tuberculosis infection in different zones of India: A national sample survey 2000-2003. Bangalore:National Tuberculosis Institute (NTI); 2004.
  10. Central TB Division. Meeting of the Expert Committee to estimate TB burden in India. 10-11 March 2005, New Delhi. Directorate of Health and Family Welfare, Government of India, 2005.
  11. Research in RNTCP. http://www.tbcindia.org/documents.asp# (accessed on 6 September 2005).

S. P. AGARWAL
Director General Health Services
Ministry of Health and Family Welfare
Nirman Bhavan
New Delhi

 

 

 

 

 

 

 

 

 

 

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