This puts an end to the uncertainty regarding availability and cost of the drug, which would have been available here at a discounted price of $400 (roughly Rs 27,500) per patient– a price considered too high, especially for people with multi-drug resistant TB (a form of disease that does not respond to the most commonly-used TB medicines), who have to take multiple pills.
Bedaquiline, considered a wonder-drug for MDR-TB patients, is the first new TB medicine to be introduced in India in nearly 50 years, and is supplied free to patients under the government-run TB control programme. India has the highest burden of TB in the world, accounting for more than a quarter of all cases worldwide, with nearly 1.5 lakh new cases of multidrug-resistant TB (MDR-TB) a year.
Since 2016, India has accessed bedaquiline through a global four-year donation program by Janssen Pharmaceuticals, J&J’s drug arm, with US Agency for International Development.
Of the first donation of 10,000 courses, only 50% have been used till now, which in effect means 5,000 MDR patients are on the regimen. This has raised concerns by health activists on the programme’s slow implementation.
“We are aiming to treat around 20,000 MDR patients this year, with each district having a RNTCP (Revised National TB Control Programme) centre for drug-resistant patients soon. The conditional access programme will continue, and those in the private sector with the capacity and skills to monitor patients, can partner with us”, Kuldeep Singh Sachdeva DDG, Central TB Division told TOI.
Given the rise of antimicrobial resistance and keeping in mind the drug’s side-effects, government wants to be cautious with its roll-out.
When contacted, Sanjiv Navangul, MD Janssen India, said the company is donating an additional 10,000 courses this year as it did not want patient’s access (to bedaquiline) getting affected.
Bedaquiline is one of up to seven drugs that are necessary for a treatment regimen for MDRTB, and many patients need to take bedaquiline for over six months, which further escalates treatment costs, experts say. The regimen for drug resistant TB by WHO recommends use of bedaquiline, to be prioritised along with levofloxacin/ moxifloxacin and linezolid, replacing painful and toxic injections with severe side-effects like hearing loss in patients.
Further, the company’s patent on bedaquiline in India has been challenged by two tuberculosis survivors. If granted, activists say, J&J’s monopoly on bedaquiline would be extended from 2023 to 2027, delaying entry of generics, in high burden TB countries.
A J&J spokesperson had earlier said “a formulation patent would not prevent generic manufacturers from developing the active pharmaceutical ingredient in their own formulations after July 2023”.
News credit : Indiatimes