What India Must Do To End TB Conclusively

In 2015, the World Health Organization (WHO) had targeted an 80% reduction in the incidence of TB by 2030, and a 90% reduction by 2035.

To bolster India’s effort to end TB, Prime Minister Narendra Modi brought forward the year by which the country would reduce the incidence of TB by 80% to 2025--that is, five years before the WHO’s goal.

Correspondingly, India’s National Strategic Plan for Tuberculosis Elimination 2017 targeted reducing the incidence of TB to 44 new cases or 65 total cases per 100,000 people by 2025.

Less than 20 months away from 2025, India is far from meeting its end TB goals.

In 2021, the WHO estimated the incidence of TB in India to be 210, having fallen at 3.20% annually between 2016 and 2021. Not far off from this, a new indigenously developed TB incidence estimation model estimated the incidence to have been 196 in 2022 (197 in 2021), and having reduced at 2.17% annually in the previous five years.

Either way, India’s containment of TB is more or less on par with the 2% fall in the incidence rate globally. However, the decline is well below the 10% drop the WHO had targeted to be achieved by 2025, and the 17% decline projected for the following decade, to end TB by 2035.

Unless the fight against TB is stepped up, India will continue to be the country with the highest TB burden in the world, measured in the number of people contracting the disease each year. Mortality due to TB is the third leading cause of years of life lost, in India.

Moreover, the fight to end TB globally was hit the hardest in India by the pandemic. Covid-19 cut the number of newly notified TB cases by a quarter in 2020 while it increased TB mortality by 11% and pulled down the number of patients availing hospital admissions and consultations by 38%.

India will be lucky if it ends TB by 2035, Madhukar Pai, Canada Research Chair in epidemiology and global health and director of the McGill International TB Centre in Montreal, Canada, told IndiaSpend in May 2020, pointing to an 80% drop in monthly notifications of TB because of Covid-19-related disruptions.

TB patients falling through the care net

Researchers model the TB care cascade to estimate the gaps. The number of patients with incident TB who did not access TB tests constitute gap 1, patients who did not get diagnosed constitute gap 2, those who did not register for treatment constitute gap 3, those who were not successfully cured comprise gap 4, and those who relapsed or died even after being treated constitute gap 5.

Gaps represent patient losses--essentially, patients who fell through the TB care net. In this context, India’s most significant gap was gap 1, according to a 2019 study published in PLOS Medicine, that concluded that half of all patient losses in India are individuals with incident TB who didn’t access a TB test.

While the study was based on 2013 data, C. Padmapriyadarsini, director, ICMR-National Institute for Research in Tuberculosis, believes that “TB awareness still seems to be uniformly lacking across both rural and urban India”.

Padmapriyadarsini cited a recently concluded National TB Prevalence Survey that showed that more than 60% of the population did not consult for TB symptoms as they are not aware of it. So, “we should invest more in identifying those with symptoms, diagnose them early on and start treatment early”, she said.

As long as community awareness is low, patients will need to be identified by those in the know, such as doctors and nurses. Such “case finding in India is still weak and requires far more resources”, according to Ramanan Laxminarayan, affiliate professor at the University of Washington, a senior research scholar at Princeton University, and founder and president of the One Health Trust.

“Even though the numbers are going up, they lag the levels that the WHO calls for,” he says. “Each year, about 500,000 incident cases are undetected and not notified. It is difficult to shut down TB transmission as long as there are individuals with active TB in the community that aren’t receiving treatment.”

Filling the diagnosis and treatment gaps

To narrow the gap created by possible TB patients who accessed testing but did not get diagnosed, the government has scaled up the availability of molecular testing machines to diagnose TB, from 1,302 in 2017, to more than 10,000 today. With this, clinicians no longer have to rely on sputum smears for diagnosis. But, the availability of machines still falls short.

“Delays in diagnosis--both due to delays in testing and the use of older tests such as smear microscopy--are still widespread; such delays facilitate spread,” points out Lancelot Pinto, Consultant Respirologist at Mumbai’s P D Hinduja National Hospital and Medical Research Centre.

“The availability of tools to diagnose extra-pulmonary TB in rural areas is a main gap,” agreed Kathirvel S., associate professor, Department of Community Medicine and School of Public Health at the Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh. Extrapulmonary tuberculosis is an infectious disease caused by Mycobacterium tuberculosis in organs other than the lungs.

Coming to gap 3, represented by patients who did not register for treatment, a major challenge is that more than half of the TB patients in the country are cared for by the private sector, where, in spite of mandatory notification, many patients are still not notified.

Last year, when the private sector notified 723,173 patients as against 1,700,438 patients notified by the public sector, the former fell short of its target by 24% while the public sector fell 7% short. But, this was the private sector’s best performance since 2017, when the National Strategic Plan with the vision of a TB-free India was unveiled.

Recognising the role of the private sector in caring for TB patients, the government has drawn up manuals and other documents to guide partnerships with private practitioners, hospitals, laboratories and chemists.

However, “diagnostic and treatment practices in the private sector have been repeatedly shown to be sub-optimal, which propagates the disease and amplifies resistant strains,” observed Pinto.

Kathirvel called out both care in the private sector and informal healthcare providers, especially in urban areas, as concerns, and also migration-related issues in urban areas after diagnosis or treatment initiation. Effective private sector engagement for diagnosis, notification and treatment is the need of the hour.

Gap 4 is made up of patients who started treatment but who were not cured.

In 2021 (the last year for which data on success rates have been made available), India achieved a success rate of 85.5%, meaning that 85 of 100 TB patients notified in that year completed the treatment regimen without any bacteriological evidence of failure, to quote the WHO. The success rate was 79% in 2017 when the National Strategic Plan was launched.

Poverty, a lack of awareness and medicine shortages are some of the key reasons why patients stop the treatment.

To support TB patients through the long treatment regimen, the government is directly transferring money to their bank accounts. Clinicians agree that this financial support is a step in the right direction but some feel that it is not enough to support severely malnourished poor patients.

In April 2022, Tamil Nadu introduced India’s first differentiated TB care model, an initiative to assess newly diagnosed TB patients to identify those with severe malnutrition, respiratory challenges or in dire need of support, and refer such patients for hospitalisation. Called Tamil Nadu-Kasanoi Erappila Thittam (TB death-free project), the project aimed at reducing deaths among TB patients aged 15 years and older, notified by public facilities, by 30%. One in four of the patients assessed were found to be severely undernourished. Scaling up such initiatives would help curtail deaths due to TB.

Additionally, Kathirvel emphasised the need for closer supervision to ensure that treatment timelines are adhered to. For instance, the treatment norms require diagnosed patients to be started on the prescribed regimen within seven days of diagnosis. Also, patients who stop the regimen for whatever reason must be counselled to resume the regimen within 24 hours during the intensive phase, and within seven days in the continuation phase.

Multidrug-resistant TB (MDR-TB) is caused by a strain of TB that does not respond to at least isoniazid and rifampin, the two most powerful TB drugs. Treating MDR-TB is challenging because the fewer medicines it responds to are expensive, not always available and can cause many adverse effects.

“The treatment of MDR-TB is plagued by the lack of universal access to all oral regimens,” added Pinto. “When patients have access to oral regimens, the toxicity and potential lifelong adverse effects of injectables are prevented, thereby making the treatment more acceptable and adherence better.”

Going beyond the ambit of medicine to end TB

Not for nothing is TB called the disease of the poor. The opening note of the Global Tuberculosis Report 2021, by Tedros Adhanom Ghebreyesus, director-general of the WHO, highlights the wide ambit of the battle against TB.

“I want to remind you that the struggle to end TB is not just a struggle against a single disease,” wrote Ghebreyesus. “It’s also the struggle to end poverty, inequity, unsafe housing, discrimination and stigma, and to extend social protection and universal health coverage.”

Globally, the highest ever rate of decline in the incidence of TB at a national level was 10%, first logged in parts of Western Europe just after World War II, a time of “substantial progress towards universal health coverage and social protection, and wider socioeconomic development,” to quote Implementing the End TB Strategy: The Essentials, a WHO document.

What stands out about Western Europe’s example, according to Ravindra Kumar Dewan, Director, National Institute of TB and Respiratory Diseases, is that that decline in the incidence of TB happened without any focused intervention to combat the disease.

“So in that sense, ending TB actually goes beyond the ambit of medicine,” he adds.

More than half a century on, TB rates continue to be sensitive to socio-economic indicators. A British study published in 2012 identified national per capita income and income inequality as “important predictors for TB incidence and prevalence in the WHO European region”. Just those two factors accounted for half of the country-level variation in TB.

A next step forward in India’s battle against TB may therefore be “the introduction of a universal basic income, on the lines of the social support offered in some developed nations, something that has become all the more crucial in the wake of the Covid-19 pandemic that adversely impacted livelihoods of some poorer sections of society”, proposed Dewan.

Preventive therapy will help reduce the number of TB patients

Latent TB is one of the factors that make TB a unique infectious disease. About a quarter of the world’s population carries the bacillus but does not experience any symptoms of disease. These carriers cannot spread the disease but they can develop full blown TB, a risk that is highest in the first two years after picking it up. That said, the possibility of carriers developing active TB throughout their lifetime makes them a reservoir of the disease. So, any strategy that aims to end TB must address such latently infected individuals.

The traditional way of treating latent TB infection was to prescribe isoniazid for six to nine months. But this wasn’t always effective because those without symptoms would not adhere to a long daily regimen simply to prevent the development of a disease, especially when taking isoniazid caused nasty side effects (hepatotoxicity and other adverse effects).

Clinicians today prefer shorter-course simpler treatments such as taking isoniazid with rifapentine once a week for three months.

India made a first move to address latent TB in 2022 by expanding a TB preventive therapy regimen that had been piloted in 2021. The regimen targeted household members of confirmed pulmonary TB patients, and those who are most vulnerable to TB, like those taking immunosuppressive therapy, patients of chronic kidney failure dialysis, people living with HIV, and other high-risk groups.

If the preventive therapy is effectively implemented and covers all the population, including vulnerable groups, Kathirvel expects it to help reduce the incidence by 8-10% per year. However, reaching out to the population with latent TB at large has its own challenges.

“Some clinicians in the private sector believe that treating people with latent TB increases the possibility of developing drug resistance,” says Dewan.

Additionally, clinicians point out that the possibility of reinfection of a person treated for TB or for latent TB, is “high”, in India.

While Dewan admitted that private practitioners are being engaged in workshops to bring them around, to achieve that goal, Pinto suggested conducting scientific studies wherein “the outcome of the treatment of latently infected individuals is modelled for the trade-offs between the prevention of a low lifetime risk of reactivation versus the risks of treatment-associated adverse effects, and the risk of reinfection.”

Last but not the least, it would be a very expensive exercise to screen the entire population (or even close contacts) for latent TB and then treat infected individuals, added Dr Pinto.

Does India have the political will to spend much more on ending TB?

Higher allocations to TB must to achieve strategic plan

Ditiu’s statement about India ending TB by 2025 was subject to certain conditions being met. She stressed the need for continued political will to end TB. She also emphasised the allocation of adequate financial resources to the elimination programme and the decentralisation of diagnostic and treatment services to reach patients beyond cities.

The National Tuberculosis Elimination Programme’s (NTEPs) approved budget for 2022-23 was Rs 2,656.83 crore, more than a fifth lower than the Rs 3,409.94 crore budget for 2021-22. IndiaSpend reached out to the NTEP for comment on the reduced budget. We will update this story when we receive a response.

India’s spending on health is current budgetary allocation to health is 2.1% of the country’s GDP as against, say, 11.9% in the UK.

While India proposes to increase the health spend to 2.5% of the GDP by 2025, if it is to end TB by then too, then the country must increase the allocation to TB.

Kathirvel reckoned that to achieve the national strategic plan for TB elimination targets, the country needs to invest at least three to four times past allocations for the prevention and control of TB.

A holistic approach to end TB

When the WHO set the end TB target in 2015, it envisaged that by 2025, the world would have new tools to push the rate of decline in the TB incidence rate from 10% to 17% per year. Those tools included an effective vaccine to protect people with dormant TB (asymptomatic carriers), a shorter regimen for the treatment of active TB cases, better tests for the diagnosis of latent TB (TB carriers), and safer and more effective treatment for latent tuberculosis infection.

So far, at least three of those four tools have not appeared on the horizon. Only a shorter treatment regimen for latent TB has been introduced.

So, identifying TB cases and handholding them till they cross the finishing line must continue to be the focus of India’s efforts.

Clarion calls to end TB by 2025 may add momentum to the fight against the disease but they cannot replace the simultaneous addressal of the remaining gaps in diagnosis, treatment and spread, and boosting the socioeconomic status of India’s poor.

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