India Approves Shorter, More Effective BPaLM Regimen for Drug-Resistant TB
Key Insights
India's Health Ministry has approved the BPaLM regimen for Multi-Drug-Resistant Tuberculosis (search) (MDR-TB) treatment, offering a shorter, more effective option.
The BPaLM regimen, consisting of bedaquiline, pretomanid, linezolid, and moxifloxacin, has demonstrated higher success rates over a six-month treatment period.
Pretomanid, a key drug in the BPaLM combination, has been licensed for use in India by the Central Drugs Standard Control Organization (search) (CDSCO).
The Union Ministry of Health & Family Welfare has approved the implementation of the BPaLM regimen for Multi-Drug-Resistant Tuberculosis (search) (MDR-TB) under the National TB Elimination Program (NTEP). This innovative approach, utilizing bedaquiline, pretomanid, linezolid, and moxifloxacin, offers a more effective, safer, and quicker treatment compared to traditional methods.
BPaLM Regimen: A Significant Advancement
Traditional MDR-TB treatments could last up to 20 months and were associated with severe side effects. The newly approved BPaLM regimen significantly reduces the treatment duration to six months, demonstrating higher success rates. This shorter regimen is expected to benefit approximately 75,000 drug-resistant TB patients in India, saving both time and resources.
Key Components and Regulatory Approval
Pretomanid, a crucial component of the BPaLM combination, has been licensed for use in India by the Central Drugs Standard Control Organization (search) (CDSCO). The regimen's validation involved thorough review by in-country experts and a Health Technology Assessment, ensuring its safety and cost-effectiveness for both patients and healthcare providers.
National TB Elimination Program (NTEP) Rollout
The National TB Elimination Program (NTEP) will spearhead the rollout of the BPaLM regimen across India. This includes rigorous capacity building and training programs for healthcare professionals to ensure the safe and effective administration of the new treatment. India's extensive TB laboratory network, comprising nearly 7,800 rapid molecular testing facilities and over 80 culture & drug susceptibility testing labs, will support timely diagnosis and treatment initiation.
Aligned with National Goals
This initiative aligns with the government's objective to eliminate TB by 2025, five years ahead of the global Sustainable Development Goal (SDG) target. The approval of the BPaLM regimen underscores the commitment to improving health outcomes and eradicating TB, as envisioned during the Delhi End TB Summit in 2018.