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On 24 March, the world will be observing ‘World Tuberculosis Day’ to raise public awareness about the devastating health, social and economic consequences of tuberculosis (TB) and to step up efforts to end the global TB epidemic. For India, the Day is all the more important as time is fast ticking away to reach the self-imposed target of eradicating this deadly infectious disease by the year 2025, well ahead of the WHO’s target of 2030 to eradicate this disease from the world. It is a fact that during the last some years, the Central government has introduced pivotal initiatives that are changing the way TB is diagnosed, treated and prevented in the country. To make India a TB-free nation by the year 2025, the Union Health Ministry has periodically been taking several laudable steps. The last few years have seen the country take definitive steps towards the elimination of tuberculosis from the country. The sustained efforts of the National Tuberculosis Elimination Programme have led to an unprecedented increase in TB notifications and significant improvements in timely diagnosis, adherence, and treatment outcomes. To eradicate this dreaded disease from the country, the ministry in the year 2018 made the Revised National Tuberculosis Control Programme (RNTCP) more broad-based by mandating as many as 49,050 private clinics to prescribe free drugs to the TB patients. The government is implementing this scheme with the support of field level staff and an inventory management system called ‘Nikshay Aushadhi’ has been deployed for the purpose. And, in October 2019, the health ministry had launched a country-wide ‘TB Harega Desh Jeetega’ campaign for community participation in the fight against TB. The Indian government’s initiatives are laudable as India has the world’s highest TB burden, with 2.6 million cases and around 4,50,000 fatalities annually which is more than 1 quarter of the global disease burden.
All said and done, for the country to reach the target, standard treatment regimen is also 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 in the world in the year 2013, giving a new ray of hope to millions of patients suffering from this dreaded disease. And in 2018, the WHO placed these new oral drugs in the list of 'priority' drugs for the treatment of MDR-TB. 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 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 company Janssen has 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 evergreening of patent on Bedaquiline will have disastrous consequences for the country’s ambitious target of eradicating TB by 2025, five years ahead of the world target of 2030.
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