MUMBAI, Oct. 30 -- Two days after the Indian Patent Office rejected the patent application of the US-based Global Alliance for TB Drug Development, or TB Alliance, for BPaL, a combination regimen for drug-resistant tuberculosis, doctors say this does not necessarily mean easy access to the medication is a positive development. The implications of the patent rejection is significant as India has the world's highest number of TB patients, with the World Health Organization (WHO) estimating that 2.71 million people developed TB in India in 2024 - a quarter of global cases. The BPaL-M regimen followed in India was initiated in March 2024. It is a six-month course, considerably shrinking the treatment timeline from the conventional course of 18-24months. While the patent rejection paves the way for easy, affordable and generic drug access to BPaLM treatment in India, pulmonologists say the state government must continue to exercise restraint over free access to these medications. Dr Lancelot Pinto, consultant pulmonologist and epidemiologist with PD Hinduja Hospital said not all drug-resistant TB cases can be prescribed BPaL-M. "There is concern that easy access without strict monitoring could lead to indiscriminate prescription of these medications, which could prove counterproductive and actually lead to further resistance. The current system provides steady access from a few monitored locations." A similar view was echoed by Dr Rohit Hedge, pulmonologist with the government-run JJ Hospital. "These drugs are strictly controlled and not sold commercially. To combat full-blown cases of TB in India, conditional access to certain drugs has been provided to contain the rise of TB. BPaL-M is not an individualised course of treatment but a standardised rapid treatment though not available to all," he says. Patients from government hospitals are granted drugs from National TB Elimination Programme centres in government hospitals, while those from private health facilities are granted access to these drugs through National TB centres in the city. "Both these centres verify the prescriptions and diagnoses before providing the drugs," says Dr Hegde. The Brihanmumbai Municipal Corporation (BMC), the nodal health authority for healthcare in Mumbai, said almost 60% of drug-resistant TB cases in Mumbai are not eligible for this regimen. Civic executive health officer, Dr Santosh Gaikwad, said, "We have found that 60% of patients get excluded from BPaL-M depending on criteria like age, drug sensitivity, pregnancy status, previous history of using any of the drugs in BPaL-M and even comorbidities." Dr Gaikwad, who is also Mumbai's City Tuberculosis Officer (CTO), said challenges to inclusion in the regimen include factors like extrapulmonary TB, young children and patients with prior exposure to key regimen drugs. "Potential adverse effects, particularly linezolid-associated, blood-related and neurological toxicity, that require regular monitoring, are also excluded," explained Dr Gaikwad. He refused to confirm if all eligible patients have received the drug. According to the BMC, Mumbai's drug-resistant tuberculosis cure rate doubled over eight years, reaching 81% in 2025 due to improved diagnosis, treatment, and support systems. However, health activists allege doctors harbour an inherent bias against offering accessible healthcare. Ganesh Acharya, a two-time TB survivor who successfully contested BPaL patents, emphasises that accessible and affordable medication is a matter of life and death. He questions why doctors raise concerns over proven, fast-recovering treatments with lower relapse risks while remaining silent on the indiscriminate prescribing of antibiotics. Echoing these concerns, Loon Gangte from the Delhi Network of Positive People highlights the severity of undergoing over a year of painful antibiotic injections. He asserts that gaining access to shorter, oral, and effective treatment options allows patients to return to work, care for their families, and rebuild their lives....