|Year : 2014 | Volume
| Issue : 1 | Page : 5-12
Revised National Tuberculosis Control Program: Evolution, Achievements, and Challenges
Devidas Trimbak Khedkar, Udaykumar Bhaskar Chitnis, Jitendra Shyamsundar Bhawalkar, Megha Sunil Mamulwar
Department of Community Medicine, Padmashree Dr. D. Y. Patil Medical College, Hospital and Research Center, Dr. D. Y. Patil Vidyapeeth, Pimpri, Pune, India
|Date of Web Publication||10-Dec-2013|
Devidas Trimbak Khedkar
C-11, Prem Angan Housing Society, Antariksha Road, Udyam Nagar, Pimpri, Pune - 411 018
Source of Support: None, Conflict of Interest: None
India initiated National Tuberculosis Control Program (NTCP) in 1962. After reviewing NTCP and realizing its shortcomings, the Government of India evolved and adopted a revised strategy - the directly observed treatment short course (DOTS) - under Revised National Tuberculosis Control Program (RNTCP) with the goal of reducing TB burden and the twin objective of 70% case detection and 85% cure rates. RNTCP was launched in 1993, in a phased manner to be evolved through pilot phase (1993-1996), DOTS intensification phase (1997-2006), Stop TB strategy (2007-2011), and currently the Universal Access or National Strategic Plan (2012-2017). RNTCP has been progressing successfully toward its goal and achieving its objectives since 2007. This addresses the Millennium Development Goal (MDG) and target to be achieved by 2015 and the Stop TB Partnership targets to be achieved by 2015 and by 2050. By 2011, the RNTCP has treated more than 14.2 million TB patients and saved 2.6 million additional lives using the DOTS strategy. The spread of human immunodeficiency virus and acquired immune deficiency syndrome (HIV/AIDS), emergence of multidrug resistant TB (MDR-TB) and the unregulated and underutilized vast private sector using anti-TB regimes different from those under RNTCP pose additional challenges in the control of tuberculosis.
For this review, information has been collected from official websites of World Health Organisation (WHO) Geneva, WHO South East Asia Regional Office (SEARO) New Delhi, Ministry of Health and Family Welfare; Government of India and published literature, through search engines like Google, Google Scholar and Pub Med using MeSH Terms "DOTS" and "Tuberculosis Control."
Keywords: Revised National Tuberculosis Control Program (RNTCP), Directly Observed Treatment Short course (DOTS) Strategy, Stop TB Strategy, Universal Access, National Strategic Plan (NSP), Multidrug Resistant Tuberculosis (MDR-TB)
|How to cite this article:|
Khedkar DT, Chitnis UB, Bhawalkar JS, Mamulwar MS. Revised National Tuberculosis Control Program: Evolution, Achievements, and Challenges. Med J DY Patil Univ 2014;7:5-12
|How to cite this URL:|
Khedkar DT, Chitnis UB, Bhawalkar JS, Mamulwar MS. Revised National Tuberculosis Control Program: Evolution, Achievements, and Challenges. Med J DY Patil Univ [serial online] 2014 [cited 2019 Oct 23];7:5-12. Available from: http://www.mjdrdypu.org/text.asp?2014/7/1/5/122753
| Introduction|| |
Tuberculosis (TB) is one of the biggest public health challenges confronting the world today  and a major social problem in the developing world. It is one of the most ancient diseases of mankind and has co-evolved with humans for thousands or perhaps for millions of years.  Mycobacterium tuberculosis, the causative agent of TB was discovered by Robert Koch in 1882; and for this discovery, he was awarded Nobel Prize in 1905. 
National TB Institute (NTI) Bangalore developed National TB Control Program (NTCP)  which was launched throughout the country, in a phased manner, in 1962. , Later, case-finding and case-holding were found to be the major problems in the fight against TB.  During NTCP era, TB mortality and severe forms of childhood TB were reduced to a certain extent, but the average case finding rates remained around 30% and the treatment completion rates between 30% and 40%. 
In 1992, the Government of India, together with the World Health Organization (WHO) and the Swedish International Development Agency (SIDA), reviewed the NTCP and concluded that the program suffered from: inadequate budget and insufficient managerial capacity, shortage of drugs, emphasis on X-ray resulting in inaccurate diagnosis, poor quality sputum microscopy, and multiplicity of treatment regimens. ,
Around the same time, in 1993, WHO declared TB to be a global emergency and devised the directly observed treatment short course (DOTS) and recommended that all countries adopt this strategy.  The Government of India adopted the DOTS under Revised National TB Control Program (RNTCP) which was launched in a phased manner in 1993 which covered the whole country by March 2006. ,,
RNTCP is progressing successfully toward its goal and achieving its objectives since 2007. The spread of human immunodeficiency virus (HIV), emergence of multi-drug resistant TB and extensively drug resistant TB (MDR-TB and XDR-TB) and unregulated and underutilized vast private sector using drug regimens different from those under the RNTCP pose additional challenges in effective TB control. 
For this review article, information available at the official websites of World Health Organization (WHO), Geneva; WHO South East Asia Regional Office (SEARO), New Delhi; the Ministry of Health and Family Welfare; Government of India and published literature was collected through search engines like Google, Google Scholar, and Pub Med, using MeSH terms "DOTS" and "TB Control."
About one-third of the world population is infected with M. tuberculosis. , Out of 8.8 million TB cases that occurred globally in 2010, 59% occurred in Asia (WHO South East Asia and Western Pacific Regions), 26% in the African Region, 7% in the Eastern Mediterranean Region, 5% in the European Region, and 3% in the American Region. Twenty-two high burden countries (HBCs) accounted for 81% of all estimated cases worldwide. The best estimates of five countries with the largest number of incident cases in 2010 were: India 2.3 million, China 1 million, South Africa 0.49 million, Indonesia 0.45 million, and Pakistan 0.40 million. China and India together accounted for 40% of the world total. , Around 95% cases and 99% deaths due to TB occur in the developing world. ,
The global HIV positive proportion in all incident TB cases in 2010 was 13% with highest proportion of about 60% in African countries like Mozambique and South Africa. The HIV epidemic worldwide is declining. , TB is one of the top three infectious killer diseases in the world: HIV/AIDS kills 3 million people, TB 2 million and malaria 1 million annually. 
India is the highest TB burden carrying country (26%) in the world.  It is estimated that the prevalence of TB infection (latent infection) in India is about 40%.  Currently, about one person dies of TB every 2 minutes. Approximately, 75 new sputum smear positive cases occur per 100,000 population per year in India. , A smear-positive pulmonary TB case in the general community may infect 10-15 other persons in a year, and remain infectious for 2-3 years if left untreated. ,, In 2010, the incidence, prevalence, and mortality rates per 100,000 population were 185, 256, and 26, respectively. ,
Annual Risk of Tuberculosis Infection
It is the proportion of individuals getting infected or re-infected with M. tuberculosis over a period of 1 year. This depends upon the burden of infectious cases in the community and the duration and frequency of exposure to the source of infection.  This is enhanced by risk factors like under-nutrition, co-morbidities like diabetes and HIV, habits like smoking, alcohol misuse, etc. ,
Annual risk of tuberculosis infection (ARTI) of 1% is presumed to reflect an incidence of 50 new sputum smear-positive cases occurring in 100,000 population in 1 year. A national survey conducted during 2000-2003 in India showed the average ARTI to be 1.5%, with variations between regions. Thus, 75 new sputum smear-positive cases per 100,000 population annually are expected to occur in India. ,
Progression of Latent Infection to Active TB
Co-morbidities and risk factors like HIV, under nutrition, diabetes mellitus, alcohol misuse, smoking, indoor air pollution, silicosis, malignancy, other chronic lung diseases etc strongly favor this progression. The population attributable fraction (PAF) for some of these modifiable factors in India is as follows: HIV 5%, under nutrition 31.6%, diabetes 9.1%, indoor air pollution 22.8% (all in total population) and alcohol misuse 9.9% and smoking 16% in populations >15 years. 
Socio-economically TB is more common in poor, in males, and in adults. ,,
Revised National Tuberculosis Control Program; evolution and implementation
Review of NTCP in 1992 resulted in the adoption of the RNTCP by Government of India in 1993 with the Goal of decreasing the burden of TB till it ceases to be a public health problem. It has the twin objective of achieving case detection rate of at least 70% of the expected new sputum smear-positive TB cases and cure rate of at least 85% in these newly detected cases. The current focus, however, is on ensuring "universal access" to quality assured TB diagnosis and treatment services for each patient in the community. ,,,
Pilot phase of RNTCP (1993-1996) was launched in a population of 2.4 million in 1993 in a phased manner. This was later expanded to cover 13 million people by 1995, 20 million by 1996, and the whole country by 2006.  The program is based on the internationally recommended WHO devised DOTS strategy for TB control.  The ambulatory, home-based, and intermittent nature of DOTS, which is as effective as hospitalized and daily treatment, is based on the successful results of various studies conducted at TB Research Center, Chennai. ,,,
With encouraging cure rates of 80-90% in pilot phase,  the actual implementation of RNTCP phase-I began in 1997 with about 12% of population coverage and by March 2006, the whole country was brought under the program.  The main focus since then is effective implementation of DOTS strategy, which improves success rates and prevents MDR-TB.
DOTS is a systematic strategy based on five principles or components: Political and administrative commitment, good-quality diagnosis; primarily by sputum smear microscopy, uninterrupted supply of quality drugs in patient-wise boxes (PWBs), directly observed treatment (DOT), and systematic monitoring and accountability. ,, RNTCP shifts accountability to cure on health care system and not the patient. ,
The thrust of RNTCP Phase-II (2007-2011) is on WHO Stop TB Strategy which is linked with TB related millennium development goal (combat HIV/AIDS, malaria and other major communicable diseases including TB) and MDG target (halt and begin to reverse the incidence of TB by 2015). It also addresses MDG targets endorsed by Stop TB Partnership i.e. to halve mortality and prevalence of TB by 2015 as compared to 1990 and to eliminate TB i.e. to reduce incidence to <1 per million population by 2050. ,, In line with this strategy, RNTCP India implements all its six principles: effectively pursuing DOTS, addressing TB-HIV enhanced package and MDR TB, strengthening general health care system by deploying contractual staff, involving private practitioners and NGOs, empowering TB patients and communities through advocacy, communication and social mobilization (ACSM) and promoting research. This has resulted in a downward trend of prevalence and mortality due to TB in the country. ,
With progress in achieving objectives of RNTCP, a newer strategy has been developed as a comprehensive National Strategic Plan (NSP) 2012-2017,  which coincides with RNTCP Phase-III. The Vision under this plan is a 'TB-free India'. The new objective is 'Universal Access' to quality diagnosis and treatment for all TB patients in the community. This entails sustaining the achievements of the program and extending the reach and quality of services to all patients of TB.  Six targets to be achieved under Universal Access by 2015 are: early detection and treatment of at least 90% of estimated TB cases in the community, including HIV-associated TB; reduction of default rate below 5% in new cases and below 10% in retreatment cases, initial screening of all re-treatment smear-positive TB patients for drug-resistant TB and their management; offer of HIV counseling and testing for all TB patients and linking HIV-infected TB patients to HIV care and support and screening all persons attending HIV care and support facilities for TB; successful treatment of at least 90% of all new TB patients, and at least 85% of all previously treated TB patients and extending RNTCP services to patients diagnosed and treated in the private sector. ,,,
Currently, in order to achieve Universal Access targets, the program is deploying rapid diagnostics like light-emitting diode (LED) microscopy, line probe assay (LPA), liquid culture, and GeneXpert for the rapid diagnosis of TB and drug-resistant TB. In addition to improving the quality of basic DOTS services and aligning with National Rural Health Mission (NRHM) supervisory structure, the program is also expanding services for management of HIV-TB and MDR TB, strengthening urban TB control, supporting public private mix (PPM) initiatives, addressing ACSM activities, building capacity of all care providers, promoting research, etc. ,
Achievements under RNTCP
As per WHO estimates, in the year 1990, the prevalence rate of TB in India was 338 per 100,000 population and the mortality rate was 42. , In comparison, in the year 2010, these were reduced to 256 and 26 per 100,000 population, respectively. ARTI decreased from 1.7% to 1.5% during 1999-2003 ,, and further to 1.1% in 2008-10 with an estimated declining rate of 3.7% per year, which, as an independent marker, definitely indicates possibility of decreasing TB incidence in the country.  This is in tune with the MDG goal and targets for TB. The collaborative Tuberculosis Research Centre (TRC)/ WHO Model DOTS Project (MDP) in Thiruvullar district, Tamil Nadu, gives ample evidence of the effectiveness of DOTS in significantly decreasing the burden of TB in the community. The project area showed an annual decline of 12.3% in prevalence , and of 5.3% in ARTI since the implementation of RNTCP in 1999.  Also, the country is achieving the targets on case detection and treatment success rates (70% and 85%, respectively), since 2007, with the 2011's achievements being 71% and 88%, respectively. , While doing so till 2011, the RNTCP India has treated more than 14.2 million TB patients and saved 2.6 million additional lives using the DOTS strategy, in comparison to earlier program.  The death rate among TB patients in non-RNTCP areas was 29% which is reduced seven-folds to about 4% in RNTCP areas in smear-positive cases. 
The impact of DOTS, in India, in contrast to previous program is mainly attributed to following inputs: strong financial and administrative support, diagnosis of pulmonary TB mainly by sputum microscopy and judicious use of X-ray, provision of drugs in patient-wise boxes (PWBs) containing the drugs for a full course category wise and the assignment of the box to a patient at the initiation of treatment, direct supervision of all doses in intensive phase and about one-third doses in continuation phase which helps maintaining the adherence and regularity of treatment and effective supervision and monitoring of the DOTS by exhaustive record keeping and regular review meetings, follow-up sputum examinations, field visits, etc. ,,
Global and Indian Trends
Globally, the incidence, mortality, and prevalence trends are declining and the MDG target (halt and begin to reverse the incidence by 2015) will be achieved in all WHO regions. Also, the MDG targets endorsed by Stop TB Partnership (halve mortality and prevalence by 2015 as compared to 1990 baseline) will be achieved in all WHO regions except the prevalence in African and Eastern Mediterranean Regions.  In India, the prevalence and incidence rates have been falling since 2002 and mortality rate since 2005.  WHO estimated prevalence, incidence, and mortality trends from 1990 to 2010 are plotted in [Figure 1], with associated uncertainty. First, as described earlier, the incidence of TB is falling. Second, the prevalence of TB has reduced by an estimated 44% from 1990 to 2010. Third, TB mortality has fallen by an estimated 32% from 1990 to 2010. If current trends remain sustained, then India stands a strong likelihood of achieving the TB-related MDG and associated Stop TB Partnership Targets. 
|Figure 1: Trends in WHO-estimated prevalence, incidence, and mortality; India 1990-2010. |
Source, WHO Global TB Control Report, 2011.
This figure shows that the prevalence of TB is rapidly declining since 2000, but it is modest and slow in mortality and incidence.
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RNTCP Case Finding and Treatment Outcome Performance, 1999-2011
RNTCP follows the global method of cohort analysis for describing case finding and treatment outcomes. The data from the quarterly reports are analyzed and disseminated in the public domain as quarterly performance reports and as an annual report. The annual performances of RNTCP in India, from 1999 to 2011, pertaining to case finding, case notification, and treatment outcomes are presented graphically in [Figure 2], [Figure 3], [Figure 4], [Figure 5]. These graphs are constructed from the tabular information available in TB India 2012, RNTCP, Annual Status Report, published by Government of India.  The rates mentioned in this section are per 100,000 population.
|Figure 2: TB case finding and notification rates per 100,000 population (2000-2011), India |
This bar-diagram depicts that, over the years from 2000 to 2011, the rate of TB suspect examination has increased by 50%, from 421 to 651 per 100,000 population. Similarly, the rate of sputum smear positive cases diagnosed by microscopy has increased by 20%, from 62 to 79 per 100,000 population. An average difference of 11.3% [Range 8-15%] was observed between the rates of sputum-positive cases diagnosed and the sputum-positive cases notified.
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|Figure 3: Notification rates per 100000 population for different types TB under RNTCP (1999- 2011), India |
This figure reveals that, overall case notification has increased over the analysis period, in most types of TB cases, with the exceptions of new smear-negative and "treatment after default." Some of the arguments for non-increase in new smear-negative type are increased efforts to get the sputum examined and bacilli demonstrated with increasing availability and application of quality sputum smear microscopy services expanded under the program.The notification rate of re-treatment cases has increased by 40% over the past 12 years. The notification rate of failure-type re-treatment cases has remained almost stable and the "Treatment after default" notification rates have declined.
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|Figure 4: Treatment outcomes among notified new TB cases (2000- 2010), India |
Note - SP+ Sputum Positive, SP- Sputum Negative, EP Extra Pulmonary
Treatment outcome of Notified TB cases:
Among New Sputum Positive (NSP) cases, during 2010, the treatment success rate, death rate and failure rate has been 88%, about 5% and 2% respectively and over the period, the default rate has decreased from 9% to 6%.
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|Figure 5: Treatment outcomes among notified re-treatment TB cases (2000-2010), India |
Note: 1- Relapse cases put on re-treatment
2- Failure cases put on re-treatment
3- Default cases put on re-treatment
This diagram denotes that, the success rates and the two adverse outcomes (death, failure) in all the three types (relapse, failure and default) of over the year are almost similar and default rate seems rather increasing which is of great concern and needs special attention. Among smear positive re-treatment cases the treatment success rate has been > 68% since implementation. High default rates > 15% has been an area of concern among the re-treatment cases. Death rates among re-treatment cases have been higher when compared to the death rates among new smear positive.
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The National Strategic Plan with vision of "TB free India" and the objective of "Universal Access" for quality diagnosis and treatment for all TB patients in the community and the extended Stop TB Partnership target for "Elimination of TB i.e. to reduce incidence <1 per million population by 2050" are the thrust areas of RNTCP for coming years. ,
Challenges to RNTCP
Some of the bottlenecks in TB control in India: about 40% dormant TB infections, HIV-TB co-infection, increasing burden of diabetes mellitus, widespread under-nutrition, overcrowded living, travelling and working conditions especially in urban areas due to rural-urban migration, unchecked use of alcohol and smoking, MDR and XDR TB, and poor involvement of private sector in TB control. ,,
Based on the results of Gujarat, Maharashtra (2005-2006), and Andhra Pradesh (2007-2008) Drug Resistance Surveillance (DRS) Surveys, estimated proportion of MDR-TB is 2.1% (1.5-2.7%) in new TB cases and 15% (13-17%) in previously treated cases.  The global data shows that 32% of relapse cases are actually MDR-TB. Improving success rate of RNTCP treatment (by effective DOTS) will prevent relapses and may also reduce number of MDR-TB cases in India.  By February 2013, Programmatic Management of Drug-resistant TB (PMDT) services were available in all 35 states of the country across 638 districts covering a population of 1089 million (92%) and were being rapidly scaled up to include remaining districts by 24 March 2013. 
Extensively drug-resistant TB (XDR-TB), a subset of MDR-TB with resistance to second line anti-TB drugs, has been reported in India. Results of the second-line Gujarat DRS survey have shown that there is no XDR amongst new cases and the prevalence among retreatment cases is 0.5%.  Standardized treatment regimen for XDR TB under daily DOT includes (6-12 m) Capreomycin, PAS, Moxifloxacin, high dose INH, Clofazimine, Linezolid, Amoxy-Clavulanic Acid/(18 m) all the above drugs except Capreomycin. Clarithromycin and thiacetazone are used as substitute drugs in case of intolerance. 
Though only 5% of incident TB patients in India are HIV infected, in absolute terms it ranks 2nd in the world and accounts for about 10% of the global burden of HIV-associated TB. 
A recent study from Bangladesh revealed that almost 36% of all sputum smear-positive (SS+) TB cases were detected and managed by the private sector providers.  In a study conducted in Hong Kong (China) in 2004, it was found that of the 1662 cases recruited into the study, 42.6% first presented to private doctors.  India has a huge and poorly regulated private medical sector and it has been reported that, nearly 50-70% of TB patients continue to prefer private healthcare.  Profligate use of existing commercial sero-diagnostic assays in the diagnosis of TB by the private sector without sufficient evidence of their utility resulted in the Government of India banning the import, manufacture, distribution and sale of these test materials in June 2012.  The enforcement of this ban is a challenge.
As Public Private Mix (PPM), RNTCP has involved over 1971 NGOs, 10,894 private practitioners, 150 corporate hospitals, and 297 medical collages in implementation of RNTCP. 
Stigma and discrimination faced by TB patients and particularly those with TB-HIVcoinfection are major obstacles in the path of the success of the program.
All these challenges need to be addressed to achieve the better impact of the program.
To conclude, the meticulous implementation of all the principles of DOTS, WHO Stop TB Strategy and Universal Access (National Strategic Plan) will definitely help in achieving TB elimination goal by 2050.
The lead author, Dr. Devidas T Khedkar has worked in the State Health Services of Maharashtra Government, India for 30 years before joining academics. He has extensive field experience in implementation of National Tuberculosis Control Program and subsequently the Revised National Tuberculosis Control Program in the State of Maharashtra. He has also undergone Training Course for Program Managers for RNTCP at the National Tuberculosis Institute (NTI) Bengaluru, India.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5]