Without a magic wand, India cannot eliminate TB by 2025

GeneXpert

Only 93,000 MDR-TB cases have been diagnosed till 2015 in India.

At the end of 50 years of tuberculosis control activities, the disease remains a major health challenge in India. As per new estimates, the number of new cases every year has risen to 2.8 million and mortality is put at 4,80,000 each year. These figures may go up when the national TB prevalence survey is undertaken in 2017-18. Against this backdrop, the Ministry of Health and Family Welfare, in its national strategic plan for tuberculosis elimination (2017-2025), has set a highly ambitious goal of “achieving a rapid decline in burden of TB, morbidity and mortality while working towards elimination of TB by 2025.”

Though the Revised National Tuberculosis Control Programme (RNTCP) has treated 10 million patients, the rate of decline has been slow. Providing universal access to early diagnosis and treatment and improving case detection were the main goals of the national strategic plan 2012-17. But the RNTCP failed on both counts, as the Joint Monitoring Mission report of 2015 pointed out. Going by the current rate of decline, India is far from reaching the 2030 Sustainable Development Goals — reducing the number of deaths by 90% and TB incidence by 80% compared with 2015. Yet, the latest report for TB elimination calls for reducing TB incidence from 217 per 1,00,000 in 2015 to 142 by 2020 and 44 by 2025 and reduce mortality from 32 to 15 by 2020 and 3 per 1,00,000 by 2025.

Incidentally, nearly 50% of people in India are latently infected with TB. According to CDC, 5-10% of infected people will develop TB disease at some time in their lives. “About half of those people who develop TB will do so within the first two years of infection,” the CDC says. With the latently infected people acting as a reservoir, it will be nearly impossible to eliminate TB in India by 2025.

Radical approaches are needed to come anywhere close to reaching these ambitious targets. Most importantly, the TB control programme plans to do away with the strategy of waiting for patients to walk in to get tested and instead engage in detecting more cases, both drug-sensitive and drug-resistant. The emphasis will be on using highly sensitive diagnostic tests, undertaking universal testing for drug-resistant TB, reaching out to TB patients seeking care from private doctors and targeting people belonging to high-risk populations.

The other priority is to provide anti-TB treatment — irrespective of where patients seek care from, public or private — and ensure that they complete the treatment. For the first time, the TB control programme talks of having in place patient-friendly systems to provide treatment and social support. It seeks to make the daily regimen universal; currently, the thrice weekly regimen is followed by RNTCP, and the daily regimen has been introduced only in five States. There will be a rapid scale-up of short-course regimens for drug-resistant TB and drug sensitivity testing-guided treatment. In 2013, India “achieved complete geographical coverage” for MDR-TB (multi-drug-resistant tuberculosis) diagnosis and treatment.  Yet, only 93,000 people with MDR-TB had been diagnosed and put on treatment till 2015; several MDR-TB cases are simply not diagnosed.

What next?

Though Bedaquiline, the drug for people who do not respond to any anti-TB medicine, is provided in six sites in the country, the number of beneficiaries is very small. It has been a battle to get the drug for treatment, as in the case of an 18-year-old who had to approach the Supreme Court for help. Yet, the report envisages a countrywide scale-up of Bedaquiline and Delamanid.

In a marked departure, the report underscores the need to prevent the emergence of TB in susceptible populations. One such segment is those in contact with a recently diagnosed pulmonary TB. Incidentally, active-case finding is already a part of the RNTCP programme but rarely implemented. It wants to increase active case finding to 100% by 2020. Since RNTCP expenditure has increased by 27% since 2012 and is inadequately funded, the Ministry proposes to increase funding to ₹16,500 crore.

Acknowledging that the business-as-usual approach will not get the Health Ministry anywhere close to the goals, it has earmarked critical components that will be addressed on priority. These include sending customised SMSes to improve drug compliance, incentivising private doctors to notify cases and providing free medicines to patients approaching the private sector, facilitating nutritional support to TB patients, including financial support, rewarding States performing well in controlling TB, and using management information systems to monitor all aspects of TB control. “The ultimate impact of this national strategic plan will be transformational improvements in the end TB efforts of India,” the report says. It plans to take a “detect-treat-prevent-build approach” in its war against TB.

Published in The Hindu on March 19, 2017

TB treatment programme in India may be generating more MDR cases

 

Mycobacterium - Photo -  CDC

The Joint Monitoring Mission has emphasised the need for RNTCP to speed up implementation of the transition to daily dosing. – Photo: CDC

The Joint Monitoring Mission 2015 has come down heavily on the Revised National Tuberculosis Control Programme (RNTCP) and the Ministry of Health and Family Welfare for their inability to handle the MDR-TB crisis in the country. The report released last month reflects on the findings, conclusions, and recommendations made by it in 2012.

Despite its inability to diagnose drug-resistant TB, the national programme’s heavy dependence on the century-old, insensitive smear microscopy as a primary diagnostic tool has been strongly criticised. Besides the lack of sensitivity, the microscopy is ill-equipped to diagnose drug-resistant TB. This is particularly worrying as the number of drug-resistant cases is steadily increasing.

The Standards for Tuberculosis Care in India (STCI) — a document drawn up by the Central TB Division in consultation with the WHO and national TB institutes — advocates drug sensitivity testing for all presumed MDR-TB cases. However, this may not become a reality in the near future. “Progress is threatened by slow uptake of the new molecular test” the JMM says. “Procurement of these tests is unaccountably delayed.”

“The RNTCP currently treats patients without knowing their resistance profile,” states the Joint Monitoring Mission report. This along with its current regimen of thrice weekly drugs even to those with prior resistance has been associated with “failure and amplification” of resistance to rifampicin drug. “It is therefore likely, under programme conditions, to be generating more MDR cases,” it says.

While private doctors treat patients with daily dosing, the RNTCP follows a thrice weekly strategy. The report has emphasised the need to “accelerate implementation of the transition to daily dosing.”

According to the report, turning to “universal drug susceptibility testing and switching to a daily regimen with adherence support” can go a long way in addressing the problem of unwittingly exacerbating TB drug resistance in the country.

According to Dr. Soumya Swaminathan, Director of the Chennai-based National Institute for Research in Tuberculosis, the RNTCP is planning to start daily dosing using fixed dose combination in 5-6 States and then expand it to the rest of the country. “RNTCP is currently procuring drugs to make this shift,” she said.

Another failing of the TB programme pertains to the mandatory TB notification by the private practitioners. “In spite of mandatory notification, TB patients [treated by private doctors] are not notified to the RNTCP,” the report says. It wants the Ministry to develop e-Nikshay, an advanced version to the existing Nikshay system for notifying TB patients.

The national strategic plan (NSP) for TB control for 2012-17 developed by the Union Ministry of Health & Family Welfare had raised the bar for tackling the rapidly growing TB epidemic in the country. The main goals of the strategic plan are to provide universal access to early diagnosis and treatment and improve case detection.

Due to faltering on both counts, the JMM reports that the “implementation of the NSP for 2012-2017 is not on track — projected increases in case detection by the RNTCP have not occurred, vital procurements are delayed and many planned activities have not been implemented.”

Worse, about two-thirds of the recommendations made by the Joint Monitoring Mission 2012 have “not been fully implemented.” For the most part, the Central TB Division has “completed the policy work requested. Work is held up for lack of timely decisions, especially at central level,” it states.

Recommendations

With the cost of treating a person with TB going up to 39 per cent of the household’s annual expenditure, the report has recommended that the Ministry of Health minimises the out-of-pocket expenditure by families by “supporting the cost of TB testing and [providing] free drugs.” It also wants the government to eliminate taxation on TB diagnostics and drugs considering TB as a public health emergency.

In order to ensure that patients receive the standards for TB care for India, the JMM has recommended that the government establishes a “state-of-art TB surveillance system for capturing all TB cases, public and privately-treated.” This is essential for the country to “capture and respond to local and focal epidemics.”

Published in the Hindu on May 7, 2015

Editorial: No room for haste

Published in The Hindu on October 2, 2012

The past year has witnessed unprecedented official efforts to rein in the growing tuberculosis epidemic. In 2011 alone, 1.2 million new TB cases were reported while 60,000 patients already inflicted died. In reality, the real incidence, most likely was much higher — the number of new cases diagnosed and treated by private practitioners has not been factored in. It is to change this that TB was made a notifiable disease in May this year. The government had to bite the bullet as effective interventions can be taken only if a system is in place to capture the true incidence and prevalence of the disease, including the drug-resistant cases. Herein lies the biggest challenge — ensuring every new case diagnosed by the private health sector is accounted for. This can be achieved only if the government engages with the private sector by first taking it into confidence. The draft versions of the Joint Monitoring Mission (JMM) and the National Strategic Plan for TB Control, 2012-2017 have made strong recommendations to engage the private health sector to stem the spread of TB. The government, which very recently sent out guidelines on notification, requires every private health institution, including laboratories, to provide the personal details of a patient — name, address, mobile number and unique identification number (Aadhar or driving licence). The objective is to provide a support system to patients seeking private healthcare in terms of treatment initiation, adherence, follow-up and default retrieval — tasks that are beyond the private sector’s capacity.

The goal is laudable but it is quite unlikely that the TB Control programme can achieve all of its highly ambitious objectives in the short term. The most significant obstacle will be the reluctance of patients and some doctors to part with personal data. This despite the fact that such sharing is mandatory in the U.S. and many other developed countries, and that the Medical Council of India’s code of ethics warrants such sharing. Hence, consensus and confidence-building measures have to be undertaken on a massive scale to bring private healthcare providers on board and make them open to the idea of sharing details. According to the draft JMM report, about one million TB cases per year are not reported. While the National Rural Health Mission has found some innovative ways of increasing manpower, urban areas lack the infrastructure to handle additional cases. This needs fixing. Most importantly, the TB control programme, which uses the interrupted regimen, has to show flexibility and allow the private sector to continue following the WHO recommended daily fixed-dose regimen.

TB control: challenges in engagement

Published in The Hindu on September 20, 2012

Engaging the private practitioners in the fight against TB is easier said than done. For instance, there is a dichotomy in the way the public and private sector treat a TB patient. Private practitioners prefer to treat their patients with a daily fixed dose combination therapy while the RNTCP is built on an intermittent (thrice a week) treatment.

“India is the only country in the world that gives intermittent treatment,” says Dr Nalini Krishnan, Director of Chennai-based REACH. “It’s because it is easy to administer by the DOTS providers and has less toxicity.” For the doctors from the private sector, compliance becomes an issue when it is intermittent. “Hence they prefer daily treatment,” she says. The World Health Organisation not only endorses daily therapy with fixed dose combination, but is also pressuring India to convert to daily treatment. Still, the government and private practitioners are not on the same page. “The failure of the programme to acknowledge the acceptability of WHO endorsed daily fixed dose combination therapy administered in the private sector undermines its credibility and creates conflict with private providers,” the draft points out. “The programme so far has remained rigid in its recognition of other internationally accepted protocols for diagnosis and treatment of TB.”

“Clinical trials have shown that thrice a week regimen and daily regimen are same in terms of efficacy (cure rate). So efficacy wise the two regimens are same, but convenience becomes a factor with RNTCP’s DOT,” says Dr. Soumya Swaminathan, Director of the Chennai-based National Institute for Research in Tuberculosis (earlier called the Tuberculosis Research Centre). “There is nothing wrong in daily regimen and doctors are justified in prescribing daily regimen.”

Both the draft Joint Monitoring Mission and the draft National Strategy Plan for Tuberculosis Control 2012-2017 have recommended developing Indian standards of TB care that is applicable to all sectors (public and private). “The programme needs to take steps to develop Indian Standards of TB care which recognize the evidence based rational treatment for TB even outside the programmes as well as gather evidence and examine the necessity of new treatment regimens for TB,” the Strategy Plan underlines. “There should be a menu of treatments so doctors can choose any one. This will give doctors the flexibility,” Dr. Swaminathan says. “But government insists on interrupted regimen. It is not flexible as of now.”

While the RNTCP’s regimen is for six months, private practitioners want the therapy to be continued for nine months in the case of extra-pulmonary TB. Unlike the HIV programme, where NGOs are empowered to diagnose and treat patients according to the government guidelines, RNTCP is yet to decentralise DOTS programme. “RNTCP hesitates to include other stakeholders for providing DOT,” Dr. Krishnan says. This is highlighted by the fact that the draft clearly brings out the unwillingness of the government to involve other stakeholders. “The [RNTCP] programme needs to examine the process adopted by the other programmes and examine the possibilities of replicating them,” it highlights.

Incentives-linked plan to detect TB cases

Published in The Hindu on September 11, 2012

The national strategic plan for TB control for 2012-17 developed by the Union Ministry of Health & Family Welfare has raised the bar for tackling the fast- growing TB epidemic in the country. The main goal of the strategic plan is to provide universal access to early diagnosis and effective treatment.

According to the draft report of the fifth Joint Monitoring Mission (JMM) of the Revised National Tuberculosis Control Programme , the strategic plan, if implemented in full earnest, would save about 7,50,000 lives over the next five years.

To achieve this goal, the JMM has recommended some commendable strategies.

At the outset it has recognised the compulsion to comprehensively engage with the private sector for “prompt and accurate diagnosis, and appropriate care.”

The government had very recently made TB a notifiable disease. This will help in maintaining a national record of every patient who is diagnosed with TB by doctors in the private and public sector. In order to achieve maximum co-operation from the doctors, the report has, for the first time, spelled out the need to provide incentives for reporting cases.

Apart from stopping easy availability of anti-TB drugs, there are plans of “restricting the availability of impending new anti-TB drugs to authorised outlets.” This would be done by putting in place stringent and accountable distribution controls.

Another novel recommendation is to make available subsidised anti-TB drug kits to the private sector on a quid pro basis. The availability of the subsidised kits would be “linked to notification and programme-provided treatment support.”

A tectonic shift is being planned in the way new cases are detected. The current system is a passive one, wherein case detection is initiated by the patients themselves. This greatly reduces case detection. To overcome this hurdle, there are plans of introducing a “provider-initiated screening pathway.” This will focus on clinical risk groups and socially vulnerable groups.

Another way of increasing the number of TB patients diagnosed is to provide automated electronic payments for both referrals and treatment support. Using automated electronic payment mode would avoid the problems of delay or failure in payment.