India has the highest burden of TB in the world, an estimated 2 million cases annually, accounting for approximately one fifth of the global incidence.
It is estimated that about 40% of the Indian population is infected with TB bacteria, the vast majority of whom have latent rather than active TB disease. It is also estimated by the World Health Organisation (WHO) that 300,000 people die from TB each year in India.
TB care in India is provided by the Revised National TB Control Programme as well as through private sector health facilities.
The Indian government’s Revised National TB Control Programme (RNTCP) was started in 1997 and was then expanded across India until the entire nation was covered by March 2006. The program uses the WHO recommended Directly Observed Treatment Short Course (DOTS) strategy and reaches over a billion people in 632 districts/reporting units.
The initial objectives of the RNTCP in India were:
New sputum positive patients are those people who have never received TB treatment before, or who have taken TB drugs for less than a month, and who have had a positive result to a sputum test, which diagnoses them as having TB.1
In 2010 the RNTCP achieved a treatment success rate of 88% of NSP patients and a case detection rate of more than 70% of the estimated NSP people in the community.
At this time there was no appropriate treatment with second line drugs for people with drug resistant TB.
In 2010 the RNTCP made a major policy decision that it would change focus and adopt the concept of Universal Access to quality diagnosis and TB treatment for all TB patients in India.
This involves extending the reach of RNTCP services to all people diagnosed with TB, as well as improving the quality of existing services.
The aim is to achieve the following targets by the end of 2015:
The RNTCP plans to achieve these targets by:
In India TB care is provided by both public and non public sector health facilities. Patients from the public sector are usually managed within program settings as specified by the RNTCP and this includes collecting the information below on the provision of TB patient care.
|Year||Population of India covered under RNTCP||Total TB cases||Total smear positive TB cases||New smear positive TB cases||New smear negative TB cases||New extra pulmonary TB cases||Retreatment cases|
The RNTCP has tried to involve non public health providers in promoting TB care, but it is believed that many patients continue to seek treatment elsewhere and currently go unreported. Whilst national data for India is not available a number of studies and surveys of TB prevalence including self reporting of TB prevalence have suggested that up to 46% of patients may not be currently reported.2
There are are many reasons why people in India may seek care outside the RNTCP. These include:
“Many people are unaware that all the medicines needed to treat TB patients are available free of cost at Indian government hospitals. Most people tend to spend huge amounts in private hospitals.”3
The private sector in India, unfortunately, has been a source of mismanagement of TB and hence drug resistance. This includes the use of incorrect diagnostics (e.g. blood tests), incorrect regimes and a lack of supervision to ensure all TB patients complete their TB treatment. So every effort must be made to engage the private sector in India and improve the quality of care provided by private practioners.4
There is also a lack of regulation for over the counter drugs for TB and this contributes to the problems of drug resistant TB. There have been calls for the Indian government to do more to educate patients about the appropriate tests and the right treatment for TB.5
With the aim of improving the collection of patient care information, in May 2012 India declared TB to be a notifiable disease, meaning that in future all private doctors, caregivers and clinics treating a TB patient must report every case of TB to the government.6
Comments made in response to this move include concerns about enforcement of notification by private practioners;
“This is definitely a positive step forward. But, I am skeptical about the practical possibility in implementing the policy. Most private practioners consider themselves unaccountable to the government. .. The government should be clear about the action that will be taken in case of non compliance of the private practioners.”
There was also concern about whether when people are referred to the RNTCP from the private sector there will be a good enough service, and whether in practice treatment will be available.
A year later it appeared that the concern about whether all patients would be notified was justified, as it was said that:7
“A year after TB patient reporting to the government has been made mandatory for private practioners and hospitals, most cases are going unreported.”
Dr Kl Sahu, State TB officer, Madhya Pradesh
According to Indian government data of the estimated 90,000 TB cases handled by private doctors, only 5,000 were reported in Madhya Pradesh. However, in other parts of India although there has been a slow start to reporting there are now beginning to be improvements. In Pune there have been 727 new TB cases reported by private hospitals and clinics between May 2012 and July 2013.8
“Initially the response was poor but now, with constant follow-up, private doctors and hospitals have started notifying us of the TB cases”
S T Pardeshi, Medical officer of health, Pune Municipal Corporation
In addition to paediatric dosages being in short supply, the central government was also unable to provide sufficient quantities of the TB drugs rifampicin, streptomycin and kanamycin, although the shortages of adult dosages was apparently being solved by letting states buy the medicines themselves from private suppliers, and making emergency purchases.
Mario Raviglione, the head of the WHO’s TB department, said that India’s problem is surprising because Indian drug makers supply the vast majority of the world’s TB patients. “In India this shouldn’t happen,” he said “You are a producer of drugs.”
Drug resistant TB has frequently been encountered in India and its presence has been known virtually from the time anti TB drugs were introduced for the treatment of TB. The prevalence of multi drug resistant (MDR) TB has though been believed to be at a low level in most regions of the country. Various studies have found MDR TB levels of about 3% in new cases and around 12-17% in retreatment cases. However even if there is such a small percentage of cases it still translates in India into large absolute numbers.
Before 2010 all patients receiving treatment through the RNTCP were placed in one of three categories according to such criteria as to whether they had received treatment before, whether they were seriously ill and whether they were sputum positive. However, all categories received different combinations of the four main first line anti TB drugs, with the addition of streptomycin and a slightly longer course of treatment for those who had received TB treatment before.
There had started to be some criticism of this approach and in particular the lack of second line drugs and appropriate regimes for people who had failed their first treatment and who were the people most likely to already have drug resistant TB .10 The only people able to receive second line drugs were those who were taking part in some pilot DOTS-plus MDR TB programs which had been initiated in 2007 in Gujarat and Maharashtra. Although these services had been extended to further states, by September 2010 only 2,985 MDR TB patients had been started on treatment.
In early 2010 the RNTCP had acknowledged that:
“as yet the management of patients with multi drug resistant TB is inadequate”
and it launched new guidelines referred to as the DOTS-Plus guidelines for the management and treatment of patients with drug resistant TB. DOTS-Plus traditionally refers to DOTS programmes that add components for MDR TB diagnosis, management and treatment. The new guidelines emphasised that there was to be full integration of DOTS and DOTS Plus activities under the RNTCP.
As the treatment of MDR TB is more complex than drug sensitive TB, and as access to laboratory facilities is needed for diagnosis, the actually provision of the MDR TB services was to be carried out in designated DOTS-Plus sites. The stated aim was to treat 30,000 MDR TB cases annually by 2012-2013.
Traditionally the view in India had been that MDR TB is not easily transmissible and that most drug resistant TB arises from the failure of people to take their drugs properly, rather than from them becoming infected with an MDR TB strain. Therefore a high quality DOTS program, and supervising people taking their drugs should prevent the emergence of resistance.
However, the DOTS-Plus guidelines acknowledge that ongoing transmission of drug resistant strains is also a significant source of new drug resistant cases, and that timely identification of MDR TB cases and their treatment with appropriate regimens are essential to stop transmission, quite apart from the humanitarian aspects of providing appropriate treatment for people with drug resistant TB. However, despite this the DOTS-Plus guidelines emphasise that the basic DOTS programme without the MDR components must continue to be the priority for TB control in India. In addition the guidelines say that in every DOTS implementing unit of the country, DOTS should be prioritised above DOTS-Plus.
Although the aim was to be treating 30,000 MDR TB cases annually by 2012-2013, by the end of 2011 just 10,267 MDR patients had been diagnosed, and only 6,994 provided with treatment. However, it is becoming clear that progress is being made, as in Mumbai it was said in June 2013 that 3,600 patients were being treated for MDR TB, whereas two years before Mumbai was treating only 280 such patients.11
Totally, sometimes referred to as extremely drug resistant TB, is TB which is resistant to all the first and second line TB drugs. It is almost but not totally impossible to treat.
In January 2012 it was reported that twelve cases of this type of TB had been reported in Mumbai. It was said that this type of TB had emerged because of the failure of the health system and that:
“These patients have received erratic, unsupervised second line drugs, added individually and often in incorrect doses, from multiple private practioners.”
However, within a couple of weeks the Indian health authorities had rejected these claims, saying that all the cases were in fact XDR TB.12 In April though the Indian government apparently quietly confirmed the strain.13
In August 2012 it was reported that of 6,561 people screened for TB in Mumbai, 1,407 had been diagnosed with multi drug resistant TB, and of these 885 have been put on treatment.14 These are much higher figures than those found in 2010 and 2011. In 2011 only 354 people were screened, of whom 181 were diagnosed and 156 were put on treatment.
TBFacts.org has more about totally drug resistant TB.
TB India 2012 Revised National TB Control Programme Annual Status Report, New Delhi, 2012www.tbcindia.nic.in/documents.html#
Revised National Tuberculosis Control Programme DOTS-Plus Guidelines, 2010www.tbcindia.nic.in/DOTSplus.html