As the 53rd Union World Conference on Lung Health gets underway in Paris this Wednesday, patient groups will be tuning into the research being presented there, in search of newer, shorter treatments to tackle tuberculosis (TB).

One such available treatment that has experts in India calling for its adoption is the BPal three-drug regimen (Bedaquiline, Pretomanid, and Linezolid) to treat highly drug-resistant TB.

At least three letters have gone out this year, from TB patient and advocacy groups to decision-makers, including the Prime Minister, Health Minister, Health Secretary, and the Indian Council of Medical Research chief, among others, drawing their attention to BPal and to include it in the national efforts to control TB.

Raising the curious case of BPal, experts wonder why the regimen has not been adopted yet, especially since India accounted for a sizable population with TB and has set itself a steep deadline to end the disease in 2025, five years ahead of the global deadline. And in this case, medicine supply was not an issue, as the pharmaceutical companies making these drugs – Macleods, Mylan, Lupin – are also based in India, industry and health experts told businessline.

India needs to adopt the BPal regimen as it reduces the pill-burden for patients and showed a treatment success rate of over 90 percent, said Blessina Kumar, Global Coalition of TB Advocates. Referring to letters sent to the authorities by over 600 TB -affected community members, among others, she said, the Centre needed to first place an order to procure these medicines.

‘Supply not an issue’

Non-profit drug developer TB Alliance’s drug Pretomanid — only the third new medicine developed for TB in over 40 years — is part of BPal.

Sandeep Juneja, Senior Vice-President (Market Access) at TB Alliance, points out:, “With a high DR-TB burden, India’s people and health system can very much benefit from the wide adoption of the BPaL regimen for treating DR-TB. However, as to why the regimen has not been implemented in the country, that question would be best answered by the Indian TB program.”

According to him, “Supply and readiness of manufacturers to supply in India is not an issue. Pretomanid is being actively supplied worldwide. Currently, more than 70 countries have procured pretomanid for use in BPaL-based regimens to treat more than 32,000 people with drug-resistant TB.”

Shorter duration

Just last month, a group of experts calling for BPal adoption, pointed out, the treatment duration of 26 weeks contrasted with existing conventional treatment for DR-TB, that requires patients to take over 4000 to 5000 tablets over 18 to 21 months, they said in a statement. Having received recommendations from the US Food and Drug Administration (2019) and the World Health Organization (2022,) - BPal has been rolled out in countries, including South Africa, Ukraine, Indonesia, Pakistan, Afghanistan, Philippines, and Vietnam, they pointed out.

In fact, the TB community’s follow-up letter points out, “ India has the highest burden of drug-resistant TB in the world. The current treatment regimen that is available in India has an efficacy of less than 60 percent. The lack of successful outcomes to drug-resistant TB would have to be accepted if there existed no alternative to this conventional treatment. BPaL (Bedaquiline, Pretomanid, Linezolid) / BPaL(M) (Bedaquiline, Pretomanid, Linezolid, Moxifloxacin), which has been rolled out in over 64 countries around the world, have proven to have over 90 percent effectiveness in programmatic settings. This is a significant step forward in the treatment of this deadly disease. Unfortunately, the 119,000 people affected by DR-TB in India every year have no access to this novel regimen as it has not been rolled out despite WHO approval and guidance in 2022.” 

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