India's ongoing TB program is inadequate, according to National Strategic Plan (NSP). TB infections can be reduced by nearly 80 percent over the next eight years by expanding TB elimination program to the private sector, improving surveillance and monitoring of patients, and increasing the funds for existing TB control program.
The country's ongoing TB program is inadequate, the NSP says, seeking five times the funding allocated to TB control over the last three years put together.
"If the new NSP can be fully funded, and fully implemented, it could be a game-changer for India," said Madhukar Pai, Associate Director of the McGill International TB Centre at McGill University in Canada. "Even if elimination by 2025 is unlikely, the country will at least get closer to the End TB Strategy timeline of 2035."
At 2.8 million, India had 27 percent of the world's new TB cases in 2015. Tuberculosis is treatable, but the WHO estimates TB treatment does not reach 41 percent of patients.
The proposed NSP puts forth an ambitious target -- reducing the incidence of TB from 217 new cases per 100,000 people in 2015 to 44 cases, a 79.7 percent reduction over a decade. In comparison, TB incidence in India reduced 22 percent in the decade to 2015.
India's gains in TB treatment are by no means negligible -- from 1997 to 2016, its TB control program saved 7.75 million lives, directly and indirectly, through reduced transmission of TB, according to a February 2017 study.
However, "the rate of decline is too slow to meet the 2020 Sustainable Development Goals and 2035 End TB targets," the NSP says, adding that prior efforts cannot be continued and a new strategy is needed.
The NSP proposes a budget of Rs 16,649 crore for the three-year period from 2017 to 2020, five times what the TB program received in the last three years put together -- Rs 3,323 crore.
"If resources do not follow the NSP, then I fear this will be yet another wasted opportunity to make real progress," Pai said.
In the past, the central TB program, known as the Revised National Tuberculosis Control Program (RNTCP) -- an overhaul of the failed National Tuberculosis Program which began in 1962 -- has received less money than requested -- and needed. If funding does not increase, the national TB control program would have to reduce the number and scale of the programs it has proposed in the NSP.
Further, even though the NSP targets an 80 percent reduction in new TB cases by 2025, it says early modelling exercises show that "increased coverage of care both in public and private sector will result in a decline by roughly half the TB incidence in the country over a decade", which means the incidence would reduce to roughly 109 cases per 100,000 people by 2025.
The challenge: Barring some pilot projects over the last two years, RNTCP has solely focused on patients who come to the government system, even though the private sector in India treats an estimated 2.2 million TB cases.
"If we are talking about elimination, we can't only talk about the public sector. Everyone who might have TB should be included," especially as the private sector engages with half, if not more of TB patients, said Soumya Swaminathan, Director General of the Indian Council for Medical Research (ICMR).
Involving the private sector can help the government keep track of TB cases, while also ensuring patients get the correct treatment. For instance, in 2015, just three districts -- Patna, Mumbai, and Mehsana -- which implemented a pilot program to involve the private sector, recorded 18 percent of all TB registrations from the private sector, according to the NSP.
"The approach will be to first capture all TB patients by attracting TB notification from private providers and then work to improve the quality of care," the NSP says.
Until 2012, when the government made it mandatory for private doctors to report cases to the government, no government or private agency kept a nationwide track of how many patients were diagnosed or treated successfully in the private sector. Since 2012, more and more TB cases in the private sector have been registered -- known as notifications -- with the government over the last two years, with 19 percent of all registered TB cases coming from the private sector in 2017.
The NSP proposes incentives to private-sector healthcare providers: Rs 250 on registering a TB case, Rs 250 on completion of every month of treatment, and Rs 500 on completion of the entire course of TB treatment. The NSP also proposes an incentive of Rs 2,750 to the private health provider for notifying and managing a drug-resistant patient, and Rs 6,750 for completion of the 24-month treatment.
Drug-resistant TB, which can be of several different types, is a more potent form of the disease in which the TB bacteria become resistant to one or more of the known TB medicines. Patients are deemed rifampicin-resistant when they are resistant to the main anti-TB drug, and multi-drug resistant when they are resistant to the strongest TB medicines, rifampicin and isoniazid, in addition to any others.
Even after these incentives, "the cost of involving the private sector is almost the same or marginally higher than the cost in the public sector," says the draft NSP.
The challenge: India needs "an army" of people to engage with the private sector, trained to track, monitor and work with a variety of healthcare providers ranging from big hospitals to AYUSH (Ayurveda, Yoga and Naturopathy, Unani, Siddha) practitioners, Swaminathan said. This would require additional training and a larger workforce because health workers today are not equipped to work outside of the public sector, she explained.
Only 295 of the 764 positions of coordinator for private sector engagement have been filled, the draft NSP says, adding that not only do coordinators lack capacity, limited efforts have been made to build their capacity.
The challenge: In 2015, India had 130,000 estimated cases of drug-resistant TB (including multi-drug resistant), according to the WHO. About 2.5 percent of new TB cases were rifampicin-resistant, or multi-drug resistant. Further, 16 percent of all previously treated TB cases were multi-drug resistant. Treatment of drug-resistant TB takes longer and is more expensive than treating regular TB.
"Within the public sector, there is heavy dependence on an insensitive diagnostic test which cannot diagnose drug resistance," the draft NSP notes.
The solution: The NSP proposes scaling of rapid molecular tests that diagnose drug resistance better. It says all patients diagnosed with TB should be tested for resistance to rifampicin. In 2016, 29.7 percent of those registered with the government -- 520,000 patients -- were tested for drug resistance, according to the NSP.
The NSP also suggests tracing all people who have been in contact with a drug-resistant patient and testing them for drug-resistant TB.
Further, because many don't seek treatment for TB, it is "highly imperative to shift from the passive to active" in looking for people infected with TB, the NSP says. It proposes actively sending healthcare workers for a community screening of vulnerable populations such as those living in slums, prisons, old-age homes, refugee camps and tribal areas, as well as construction workers, the homeless, street children and mine workers.
The challenge: Out of those TB patients who reached the government system - 72 percent of India's total TB cases in 2013 -- more than half a million patients were either not diagnosed correctly, or diagnosed but not registered for treatment.
Further, not everyone who registers for TB treatment is cured. In 2014, for instance, 37 percent of those who were re-treated -- after they defaulted on treatment or did not get cured with the previous treatment regime -- remained uncured, according to data from the 2016 annual TB report.
Those who are untreated or partially treated can spread the disease to others, and potentially increase drug-resistant forms of the disease.
As such there is little information on long-term health outcomes, the NSP says, which means the TB program would be unaware if a patient who successfully completed treatment relapsed after six months.
Patients might not complete treatment because of high economic and health costs to the patient and the family as the disease and the side-effects of treatment might make it difficult for patients to work. Or, patients might stop treatment because they start feeling better and do not understand the need to complete the treatment regime.
The solution: By 2020, the NSP proposes to ensure TB patients and their families incur no economic costs, whether of treating the disease or taking care of a patient. For this, the program proposes a Rs 2,000 direct benefit transfer for patients' nutritional support during the course of treatment.
The program will also provide a monthly support of Rs 500 to incentivise treatment completion.
The program suggests collecting patients' Aadhaar numbers, a unique government-issued identification number, and phone numbers to track their treatment status. It also suggests scaling up of programs that use call centers for user-friendly private reporting and patient monitoring.
Further, the NSP proposes implementing a WHO-recommended 9-11 month treatment regimen for multidrug-resistant TB, shorter than the current 24-27 month treatment that is difficult to complete. The shorter treatment will be provided to all TB patients resistant to the main anti-TB drug, rifampicin, by the end of 2017, the NSP said.
To reach the goal of elimination, "we will have to prevent people from getting tuberculosis 40 years from now", Swaminathan said. This is possible with a strategy that not only treats active TB cases but develops new vaccines for the disease or preventive medicines, for which, she said, "research and innovation are critical."