Imperative to take a call on ‘bedaquiline’ to achieve TB-free India

The ‘World Tuberculosis Day’ observed every March 24 is a day that is dedicated to raising public awareness about the devastating health and economic consequences of tuberculosis (TB) and the need to step up efforts to end the deadly disease. Ironically, as regards India, time is fast ticking away as it chases to reach the self-imposed target of eradicating TB by 2025, five years ahead of the 2030 global target set forth by the WHO.

To add forcefulness to the drive, President Droupadi Murmu launched Pradhan Mantri TB Mukt Bharat Abhiyaan, while at the March 2018 TB summit, Prime Minister Narendra Modi urged health authorities to work at eliminating TB in the country by 2025. The Pradhan Mantri TB Mukt Bharat Abhiyaan has been envisioned to bring together all community stakeholders to support those on TB treatment and accelerate the country’s progress towards its elimination. The Centre has been taking several measures, including during Covid lockdown, to contain the spread of TB.

Caught unawares by emergence of multidrug-resistant TB as a public health crisis in 2018, the Union health ministry declared that any failure to report TB cases to the authorities was a criminal offence that attracted stringent punishment. This tough talking has had its effect as there has been a steady increase in the number of TB cases that are being reported. This will help the authorities to visit the more vulnerable sections and areas.

Meanwhile, there have been changes in the way TB is diagnosed, treated and prevented in the country. The last few years have seen the country take definitive steps towards its complete eradication. The sustained efforts of the National Tuberculosis Elimination Programme (NTEP) have led to an unprecedented increase in TB notifications and significant improvements in timely diagnosis, adherence and treatment outcomes.

But all these efforts will not be sufficient to reach the 2025 target given that going by the standard treatment regimen is of considerable significance. After a gap of nearly 50 years, two new-generation drugs for the treatment of multi-drug resistant tuberculosis (MDR-TB) - bedaquiline and delamanid -were introduced to the world in 2013, thereby raising hopes of millions of patients. Five years later, the WHO placed these new oral drugs in the list of 'priority' drugs for the treatment of MDR-TB in 2018. Till then, MDR-TB cases were treated with kanamycin and capreomycin injections, along with another group of drugs called fluoroquinolones. But, these therapies had serious side-effects, including hearing loss and kidney ailments. Moreover, patients have to visit a health facility every day for six months to take injections.

It is now established that bedaquiline is the backbone of the injection-free regimen for the treatment of tuberculosis. And the original patent of bedaquiline base compound, its salts, isomers and enantiomers are set to expire on July 18 this year, giving way to other companies to enter into making this medicine. Unfortunately, the inventor Janssen, a part of Johnson & Johnson, filed multiple patents on bedaquiline in India, not limiting itself to the basic compound patent but also filing secondary patents to stake claims on routine improvements and formulations.

If the subsequent patent for Bedaquiline Fumarate with a wetting agent is granted, it will have the patent right till December 3, 2027. So, the current focus on ever-greening its patent will have disastrous consequences for the country’s ambitious 2025 target.

It is time for the government to take some bold decisions to make this wonder drug available at affordable cost so that the treatment landscape for patients with MDR-TB can be dramatically transformed. At present, in countries excluded from J&J's price cut list, it currently charges between $3,000 and $30,000 for six months of treatment. For some countries, including India, J&J recently cut the price of bedaquiline to $400 for six months of treatment. Even at this rate, this drug is beyond the reach of more than 1.3 lakh of DR-TB patients for whom this drug raises a glimmer of hope. The government should weigh all options, including issuing of compulsory license, to make it available at affordable prices.

History is replete with examples to show that prices of drugs could be reduced even up to 97% through generic competition if the government exercises options like compulsory license. Cancer drug Nexavar is a case in point wherein its price was reduced by a whopping 97% from Rs 2.8 lakh to Rs 8,800. It is time the government takes some tough measures to realise the ambitious goal of eradicating the fatal disease within the next two years.

(The author is freelance journalist with varied experience in different fields)