Health Ministry green lights rolling out of new TB drug regimen

New Delhi: Much to the relief of lakhs of tuberculosis patients, the Union Health Ministry on Friday announced introduction of a new treatment regimen in the national programme for the benefit of multi drug-resistant Tuberculosis (TB) patients, who can be cured within six months with a very high success rate.

The new regimen might be rolled out by December as the ministry would take around three months to procure the medicines and train healthcare workers, health ministry sources told DH, adding that training had already begun.

Known as the BPaLM regimen, it is a four-drug combination – Bedaquiline, Pretomanid, Linezolid and Moxifloxacin – that has been proven safe, more effective and provide a quicker treatment option than the previous MDR-TB treatment procedure.

“While traditional MDR-TB treatments can last up to 20 months with severe side effects, BPaLM regimen can cure the drug-resistant TB in just six months with high treatment success rate,” the ministry said in a statement.

A tweaked version of the regimen without Moxifloxacin can be used to treat another type of drug resistant TB.

“The most important and obvious advantage of the regimen is the duration of treatment (6 months). It is an all-oral regimen with a low overall pill burden, which makes it patient-friendly,” Lancelot Pinto, a specialist at PD Hinduja National Hospital and Medical Research Centre in Mumbai told DH.

The BPaL regimen, which has received recommendations from the US Food and Drug Administration (FDA) in 2019 and the WHO in 2022, has already been rolled out in over 70 countries, including South Africa, Ukraine, Indonesia, Pakistan, Afghanistan, Philippines, and Vietnam.

Even though patient advocacy groups and healthcare professionals have been urging the government for a long time to prioritise its implementation because of the country’s high patient load, India’s approval comes almost two years after the WHO advised its implementation.

India has a target of eliminating TB by 2025 – five years ahead of the UN target of 2030.

According to the WHO’s Global TB Report 2023, the country has the highest drug-resistant TB burden in the world, with an estimated 110,000 new cases emerging annually.

The Central TB Division under the ministry targets to identify 75,000 MDR-TB cases each year but managed to find out only around 66,000 such cases last year, sources said, noting that with the expansion of molecular testing facilities, more cases would be captured. In 2022, less than 64,000 MDR-TB cases were reported from India.

Pinto said adherence to the medicines needed to be closely monitored, as Bedaquiline resistance has been reported in a high proportion among those failing treatment.

"Also drug-susceptibility testing needs to be widely accessible to know whether the regimen is appropriate for a given patient, and private-public partnership is a better way to ensure benefits for maximum number of patients," he said.