HYDERABAD, India – India, home to a quarter of the global tuberculosis (TB) cases, plans to enhance its capacity to fight TB drug resistance and bolster susceptibility testing under a new initiative launched by the Geneva-based nonprofit Foundation for Innovative New Diagnostics (FIND).

At launch, during the 50th Union World Conference on Lung Health in Hyderabad earlier this month, the group said it plans to work with state-level officials in India’s highest-burden TB states: Maharashtra in the west, Himachal Pradesh in the north and Tamil Nadu in the south.

The new initiative, supported by Johnson & Johnson, will help build and strengthen at least seven facilities for TB culture and drug susceptibility testing (C&DST), in line with India’s Revised National TB Control Programme (RNTCP) for 2017-2025. The RNTCP is a national strategic plan that emphasizes, among other things, the need to expand C&DST laboratories. India has committed to end TB in the country by 2025, five years ahead of the official UN target.

The project with FIND aims to provide on-the-ground technical assistance, develop a guidance document on capacity-building and ensure the long-term sustainability of diagnostic labs. The upgrade of the seven sites is expected to be completed by end of 2020.

Each laboratory now has the capacity to test about 9,000 samples every year. The aim of the project is to increase testing capacity by at least six times that number, according to estimates by RNTCP Deputy Director General Kuldeep Sachdeva.

Achieving India’s ambitious TB targets depends “not only on finding those with the disease, but also ensuring they can be treated with drugs that will work, and for this C&DST is essential,” said Sarabjit Chadha, regional technical director at FIND India and South East Asia.

The World Health Organization (WHO) has also recommended setting up at least one TB C&DST laboratory for every 10 million people, which works out to 125 to 130 laboratories for the 1.3 billion Indians.

In addition to the seven new C&DST laboratories set to take off in India, at least 20 more are in the pipeline, Sachdeva said.

India’s RNTCP recommends conducting DST only in patients who have been previously treated for TB or for those with risk factors for resistance. However, the national strategic program for TB 2017-2025 (NSP) says that the government intends to perform DST on all TB samples.

But India is far from these goals.

Currently, India has about 74 RNTCP-certified laboratories to conduct drug susceptibility testing. DST is performed on samples from 257 of 712 districts in the country. In 2017, second-line DST was done on 26,832 samples.

However, a 2018 report in the British medical journal Global Health suggested that “to diagnose the estimated 2.8 million cases of TB and 150 000 cases of MDR-TB every year, the number of laboratories and the number of samples tested in each laboratory will need to be scaled up.”

The announcement of increasing India’s drug susceptibility testing capacity comes amidst rising reports of multidrug-resistance to TB drugs in the country, including natural and acquired resistance to new TB drugs. TB experts at the conference said DST needs urgent attention to prevent the spread of resistance to new drugs.

In August 2018, the Drug Controller General of India (DCGI) granted approval to U.S. pharma company Mylan N.V. ’s Indian arm to market the anti-tuberculosis drug delamanid to treat multidrug-resistant (MDR) tuberculosis. A DGCI committee also approved the use of the drug in the conditional access program through RNTCP, stipulating that the firm should submit monitoring data after three years for further review.

Mylan N.V. is now in talks with India’s DGCI to launch pretomanid to fight drug-resistant tuberculosis. The FDA approved pretomanid for the treatment of MDR-TB in combination with bedaquiline and linezolid.

In 2016, India’s Ministry of Health and Family Welfare introduced bedaquiline, developed by U.S.-based Janssen Research & Development LLC, for the treatment of MDR-TB and extremely drug resistant (XDR-TB) patients across India.

But bedaquiline has not worked well in some cases of drug-resistant TB and there have been cases of the TB bacterium evading bedaquiline, which targets the virus’ energy-synthesis pathway. In 2018, the government-funded Institute of Microbial Technology (IMTECH), the city of Chandigarh and Johnson & Johnson Private Limited started collaborating on four potential new drug targets in parallel to tackle the growing menace of drug-resistant tuberculosis.

India has the highest TB burden in the world, with a quarter of the global TB cases and an estimated 2.69 million infections in 2018. The country adds 1.9 million new cases each year, according to the 2019 World Health Organization’s Global Tuberculosis Report.

With an estimated 3 million TB cases and more than 2 million new cases registered each year, India is among the top 30 countries burdened with TB, the WHO report says. This is despite the fact that overall, the number of TB patients declined in India from 2.74 million in 2017 to 2.69 million in 2018; while the incidence per 1,00,000 population has decreased from 204 in 2017 to 199 in 2018.

An additional cause for concern for India is that 40% of the country’s population carry the TB bacterium but do not show symptoms. This pool of ‘latent’ or ‘silent’ TB infections poses a risk for developing and spreading the infection to others.

India also has the highest numbers of MDR TB, in which strains of TB-causing Mycobacterium tuberculosis become resistant to the two most powerful anti-TB medicines rifampicin and isoniazid. India recorded an estimated 135,000 new cases of drug-resistant TB in 2018, more than any other country, says FIND. Globally, only one in three people with drug-resistant TB are diagnosed and put on treatment, of who only 56% are cured, it says.

Besides helping India expand its TB laboratory capacity, FIND’s parallel ongoing initiatives in India include TB diagnostics including assessment of new diagnostic tools such as liquid culture and drug susceptibility testing; LED fluorescence microscopy for TB detection in resource-poor countries; and Genexpert, a microwave oven-sized test platform developed by FIND and U.S.-based Cepheid (now part of Danaher Corp.), to both simultaneously detect TB and drug resistance.

At the Hyderabad conference, FIND also signed two agreements with India’s not-for-profit Social Alpha which promotes science, technology and innovation entrepreneurship; and the Translational Health Science and Technology Institute (THSTI), based in Faridabad near Delhi; to address India’s diagnostic needs.

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