In 2015, India accounted for nearly 2.8 million (27%) of the 10.4 million new tuberculosis (TB) cases in the world, and 0.48 million (29%) of the 1.8 million TB deaths globally. Yet, India brings up the rear on most critical fronts to fight the disease. This has been clearly highlighted by the ‘Out of Step’ report. Released recently by Médecins Sans Frontières (MSF) and the Stop TB Partnership, the report surveyed 29 countries that account for 82% of the global TB burden.
Lag in practice, policy
Correct and timely diagnosis of TB is the first step in treating the disease and preventing its spread. Unfortunately, both the private and public sector in India heavily rely on smear microscopy as the initial diagnostic test. This is despite smear microscopy’s ability to diagnose only about 50% of the positive cases. The over-reliance on the century-old method becomes particularly worrying as the private sector caters to 70% of TB patients.
Except in people with presumptive drug-resistant TB or extrapulmonary TB, children, and people living with HIV, smear microscopy is still used as the initial diagnostic test in the public sector. With only about 735 Xpert MTB/RIF molecular diagnostic machines available at reference or tertiary hospitals across the country, Xpert is not used as the initial TB diagnostic test.
In fact, India lags behind even at the policy level — Xpert is to be used as the initial diagnostic test only for high-risk groups. Unfortunately, Xpert is not widely available even for this limited target group. As per the 2015 National Strategic Plan review, the expansion of Xpert in India has been “slow”. The Central TB Division plans to increase the number of Xpert machines to over 1,000 by 2019.
With restricted supplies, the availability of delamanid for the needy is likely to be similar to bedaquiline’s.
Ironically, an even simpler initiative such as changing over to daily drug regimen for drug-sensitive TB is yet to be implemented across India. Except for one province of China, India is the only country in the world that continues using intermittent dosing (thrice weekly) during the intensive phase of treatment, says the report. Unlike the daily regimen, the thrice-weekly approach more than triples drug resistance risk. “That is because even if one of the three doses is missed, it can result in sub-therapeutic drug levels, and TB bacteria can mutate and become resistant,” Prof. Madhukar Pai, associate director, McGill International TB Centre, McGill University, Montreal, Canada says in an email.
Restricted drug supplies
According to the report, only 21% of people with multidrug-resistant TB (MDR-TB) in India are on treatment relative to the estimated incidence. The estimated number of MDR-TB cases in the world stands at 5,80,000, of which 40% have died and only 1,25,000 are on treatment. In 2016, the World Health Organization (WHO) recommended a shorter (nine-month) regimen to treat MDR-TB. But India is yet to make the shorter MDR-TB regimen as part of India’s national TB control policy, the report says.
Though India’s TB control policy follows WHO’s guidance for bedaquiline drug for adults with MDR-TB, the drug is currently available only in five cities — Ahmedabad, Delhi, Chennai, Mumbai and Guwahati. “Based on the limited use of the drug in these five cities, it has been decided to expand the availability in the rest of the country,” Union Health Minister J.P. Nadda said in a written reply to Rajya Sabha in April this year.
“Delamanid, which is another drug to treat MDR-TB, has been approved for use in India by the Drug Controller General of India. Four hundred courses have been ordered,” says Dr. Soumya Swaminathan, Director-General of the Indian Council of Medical Research (ICMR). With restricted supplies, the availability of delamanid for the needy is likely to be similar to bedaquiline’s.
“Out of Step reveals that countries are too conservative in implementing new treatment regimens that could signiﬁcantly improve cure rates for drug-resistant TB, and help curb the spread of drug-resistant strains,” notes the report. This observation seems to be particularly pertinent in the case of India.
India’s failing continues even in the case of treating paediatric TB (children weighing less than 25 kg) cases, which is increasing in number. It was only a few months ago that India finally introduced fixed-dose combination (FDC) drugs for paediatric TB. It was introduced in six States and will be extended to the remaining States only by the end of this year. The FDCs will go a long way in improving adherence to treatment and accurate dosing for children.
The ‘missing’ cases
At 41%, India has a huge gap between the estimated and detected cases. The ‘missing’ cases (the gap between estimated and notified cases) is made up of two groups — one is the undiagnosed TB, and the other is the group that is managed in the private sector but not notified to the national TB control programme. According to WHO’s 2016 Global TB report, between 2013 and 2015, India accounted for 34% increase in notifications, which is by the private sector.
“We don’t have a precise breakdown of undiagnosed TB cases and those treated by the private sector. But TB drug sales in the private sector as well as patient pathways analyses clearly show that a large number of TB patients are being managed in the private sector. So, from my viewpoint, a majority of the missing cases are in the private sector, and that is why private sector engagement is so critical for India,” says Prof. Pai.