TB Drug Patent Rejected: Access or Resistance?

India's patent office recently rejected the patent application for BPaL, a combination regimen for drug-resistant tuberculosis developed by the US-based TB Alliance. This decision, made on October 28, 2026, is significant given India's status as the country with the highest number of TB patients globally, accounting for a quarter of worldwide cases as per WHO estimates.

The BPaL-M regimen, a six-month course, has been implemented in India since March 2024, drastically reducing treatment duration from the conventional 18-24 months. The patent rejection theoretically paves the way for more affordable generic drug access. However, pulmonologists express concerns.

Dr. Lancelot Pinto and Dr. Rohit Hedge highlight that BPaL-M is not suitable for all drug-resistant TB cases. They warn that easy access without strict monitoring might lead to indiscriminate prescriptions, potentially increasing drug resistance. Currently, access is controlled through monitored locations via the National TB Elimination Programme.

Approximately 60% of drug-resistant TB patients in Mumbai are ineligible for the regimen due to factors like age, drug sensitivity, pregnancy, or previous exposure to BPaL-M components. Additionally, potential adverse effects, particularly those associated with linezolid, require regular monitoring, excluding some patients. Despite these challenges, Mumbai has seen its drug-resistant TB cure rate double in eight years, reaching 81% in 2025.

Health activists argue for accessible and affordable medication, emphasizing the life-saving potential of shorter treatment courses. They question the doctors' concerns about prescribing BPaL-M while antibiotic resistance from other sources is not similarly scrutinized. The debate underscores the balance between ensuring broad access to essential TB treatments and preventing the emergence of further resistance.