As BPaL loses patent fight, doctors urge caution

MUMBAI: 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

MUMBAI: 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.”

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.

The BMC also says the cure rate of drug-resistant tuberculosis patients in Mumbai has doubled in the last eight years, reaching 81% in 2025. This reflected improvements in diagnosis, treatment and patient support systems, it claimed.

However, health activists like Ganesh Acharya, a two-time TB survivor and a co-petitioner who successfully contested the BPaL patents, alleges an inherent bias from doctors against offering accessible healthcare.

“Providing accessible and affordable medication for TB is critical – it is literally a question of life and death. If there is a line of treatment available with good evidence about quick recovery and lower chances of relapse, why should there be a concern? I wonder why doctors never raise their voices against indiscriminate prescribing of antibiotics,” says Acharya, who has been part of global initiatives such as Medicines Sans Frontiers.

Adds Loon Gangte from the Delhi Network of Positive People (DNP+), “Only those who have been treated for TB know what it feels like to go through more than a year of antibiotics with painful injections. Access to a shorter, oral and effective treatment can mean returning to work, caring for families once again, and rebuilding lives.”