In March 2016, in his Mann Ki Baat address, Prime Minister Narendra Modi urged people to make India TB-free; in 2018 he set the target to “eliminate TB by 2025”. To fulfil this goal, the Health Ministry rolled out the National Strategic Plan (NSP) 2017-2025 to “eliminate” TB by 2025. Though the Plan outlined a paradigm shift in approach and strategy to achieve the ambitious goal, by 2020, it became clear that the NSP will not be able to meet these objectives. A new National Strategic Plan 2020-2025 to end TB was launched.
On the diagnostics front, NSP 2017-2025 wanted to reduce the number of presumptive TB patients who are offered sputum smear microscopy from over 9.1 million in 2015 to 5.8 million in 2022, while increasing the number of molecular tests from 40,000 in 2015 to over 13.4 million in 2022. As per the India TB report, in 2022, India was far from reaching the ambitious target set by the NSP 2017-2025 — smear microscopy was used for detecting 77% (13.9 million) of presumptive TB cases and just 23% (4.1 million) cases were detected using a molecular test.
If India failed to meet the diagnostic goals set out by NSP 2017-2025, the revised National Strategic Plan 2020-2025 has raised the bar even higher for precision tests to be used for initial diagnosis. Three years after the launch of the revised NSP, India is nowhere near meeting this target.
One of the main objectives of the revised NSP is the early detection of presumptive TB cases. It says there should be “prompt diagnosis” using highly sensitive diagnostic tests for detecting presumptive TB cases “at the first point of contact” both in the private and public sectors. Also, there should be universal access to high quality TB diagnosis including drug resistant TB in the country.
Under the prioritised set of actions to be taken over the NSP period 2020-2025, the revised plan underlines the need to “scale-up advanced diagnostics services and TB surveillance capacity by replacing sputum microscopy services with new precision diagnostic tools”. And it clearly states that smear microscopy services should be replaced with precision diagnostic tools, which is molecular tests, “in all TB diagnostic centres in the country”. Three years after the revised NSP was chalked out and just two more years left for meeting the 2025 target of “eliminating” TB from the country, replacing smear microscopy services with molecular tests is yet to become a reality. This when the revised NSP insists on “rapid/prioritised transition of TB diagnosis from smear microscopy to molecular testing using NAAT right up to the block level”.
Of bigger concern is that in 2022, bacteriologically confirmed cases among notified TB patients in the public sector was just 59% (1.07 million) and a meagre 28% (nearly 0.16 million) in the private sector. This could mean a sizable number of diagnoses are based on X-rays and clinical evaluation without bacteriological confirmation.
Grimmer still is that results for at least rifampicin resistance among the bacteriologically confirmed TB patients was just 77% (0.82 million). Universal drug-susceptibility testing in all drug-sensitive TB cases is crucial for early identification of drug-resistant TB. The revised NSP clearly states that NTEP should provide “universal access” to drug resistance testing, which is yet to happen.
In November 2019, WHO and the Joint Monitoring Mission undertook an intensive review of the TB programme. Among the set of recommendations listed out by the team that represent the “minimum required” to fulfil the Prime Minister’s 2025 goal is the urgent need to replace smear microscopy with molecular tests across the country.
In order to further increase the availability of advanced molecular tests across the country and at double-quick time to meet the 2025 goal, the WHO-JMM team has recommended that NTEP should utilise the molecular testing capacity available in the private sector to get 20 million molecular tests done annually.
Besides limited availability of 5,090 machines to undertake molecular tests, there are additional challenges in terms of availability of trained personnel to run these advanced tests and shortage of molecular tests. With molecular test stocks being limited, there is huge compulsion to use the scarce resource to first test the most vulnerable groups with presumptive TB such as paediatric population, people with extrapulmonary TB, people who are HIV positive, and previously treated patients. Besides digital chest X-ray screening, the revised NSP too emphasises the need for replacing smear microscopy with rapid molecular diagnostic tests for active case finding. The revised NSP has highlighted the challenge of lack of access to the latest NAAT-based molecular tests at the peripheral health institutions for active case finding. Finally, all presumptive TB cases detected using smear microscopy need to be tested for drug resistance using molecular tests. All these challenges underline the compulsion to outsource molecular tests to the private sector to improve case detection at the first point of contact till such time universal access to molecular tests in the public sector becomes a reality.
