The union ministry of health & family welfare has approved the introduction of the BPaLM regimen, a novel treatment for Multi-Drug-Resistant Tuberculosis (MDR-TB) under its National TB Elimination Programme (NTEP) as a highly effective and shorter treatment option.

This regimen includes a new anti-TB drug namely Pretomanid in combination with Bedaquiline and Linezolid (with/without Moxifloxacin). Pretomanid has earlier been approved & licensed for use in India by Central Drugs Standard Control Organization (CDSCO), an official release said on Friday.

The BPaLM regimen, which consists four-drug combination – Bedaquiline, Pretomanid, Linezolid and Moxifloxacin – has been proven to be safe, more effective and 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.  India’s 75,000 drug-resistant TB patients will now be able to avail benefit of this shorter regimen. With the other advantages, there will be an overall saving in cost.

The department of health & family welfare, in consultation with the department of health research, ensured validation of this new TB treatment regimen that witnessed a thorough review of evidences by in-country subject experts. The department of health & family welfare has also got a Health Technology Assessment done through the department of health research to ensure that this MDR-TB treatment option is safe and cost effective.   

This move by the government of India is expected to significantly boost the country’s progress to achieve its national goal of Ending TB. A country-wide time-bound roll out plan of the BPaLM regimen is being prepared by the Central TB Division of Ministry of Health & Family Welfare in consultation with States/UTs, which includes rigorous capacity building of health professionals for safe administration of the new regimen.

Background:
The National Tuberculosis Elimination Programme (NTEP), previously known as Revised National Tuberculosis Control Programme (RNTCP), aims to strategically reduce TB burden in India by 2025, five years ahead of the Sustainable Development Goals. This vision was first articulated by prime minister Narendra Modi at the Delhi End TB Summit in March 2018. In 2020, the RNTCP was renamed as the National TB Elimination Program (NTEP) to emphasize the aim of the Government of India to eliminate TB in India by 2025. It reached over a billion people in 632 districts/reporting units and is responsible for carrying out the Government of India’s five-year National Strategic Plans for TB elimination along with the States/UTs.

The National Strategic Plan for TB Elimination was launched to achieve the target of ending TB by 2025 in a mission mode. It is a multi-pronged approach that aims to detect all TB patients with an emphasis on reaching TB patients seeking care from private providers and undiagnosed TB in high-risk populations. Universal Drug Susceptibility Testing (UDST) is implemented under the NTEP to ensure every diagnosed TB patient is tested to rule out drug resistance before or at the time of treatment initiation itself.

On September 9, 2022, president Droupadi Murmu launched the Pradhan Mantri TB Mukt Bharat Abhiyaan (PMTBMBA) to urge citizens to work collectively towards TB elimination in spirit of Jan Bhaagidari on a war footing. The President also launched the Ni-kshay Mitra initiative to ensure additional diagnostic, nutritional, and vocational support to those on TB treatment, and encouraged elected representatives, corporates, NGOs, and individuals to come forward as donors to help the patients complete their journey towards recovery.  

The Ni-kshay 2.0 portal (https://communitysupport.nikshay.in/) facilitates in providing additional patient support to improve the treatment outcome of TB patients, augmenting community involvement in meeting India’s commitment to end TB by 2025 and leveraging Corporate Social Responsibility opportunities.

India has the world’s largest TB laboratory network with 7,767 rapid molecular testing facilities and 87 culture & drug susceptibility testing laboratories spread across the length & breadth of the country.  This widespread laboratory network will support in timely detection of MDR-TB and quick initiation of TB treatment.