How is the door open for cheaper tuberculosis drugs in India?
Johnson & Johnson's bedaquiline extension is rejected by India's patent authorities, paving the way for generic equivalents.
Since the government denied US pharmaceutical firm Johnson & Johnson's request to extend a patent, people in India with drug-resistant tuberculosis may soon have access to life-saving treatment at a far reduced cost.
Bedaquiline's patent expires in July, but the company sought to extend it until 2027, which would have stopped less expensive generic versions from entering the market.
It was viewed as a success for two ladies who had been campaigning to lower the cost of a disease-treating medication for everyone. The medical Group Médecins Sans Frontières backed a case filed in 2019 by South Africans Phumeza Tisle and Nandita Venkatesan to the Indian Patent Office to block Johnson & Johnson's application (MSF).
The patent office's ruling opens the door for other businesses to create accessible versions. According to some health experts, this may reduce treatment costs from $46 (£37) per patient per month to $8 (£6.50) per patient per month.
This development will benefit patients in areas where TB medications are obtained through the World Health Organization because India exports generic medications to numerous low-income nations.
The last option for people with advanced TB is bedaquiline. It has unpleasant side effects, like most treatments for drug-resistant TB, but when the FDA authorized it in 2012, it was the first new medication for the condition in 40 years.
Indian pharmaceutical firms have begun developing generic versions of the medication. Some have pre-qualified to become providers by providing data to the WHO. Versions are anticipated to debut as early as August.
It is worth noting that the prevalence of TB and drug-resistant TB is highest in India. Each day, more than 1,000 Indians pass away from the illness.
Five years ahead of the 2030 worldwide deadline, India's goal is to eradicate TB by 2025.
The Indian government purchased bedaquiline for its TB program, and it is accessible in the majority of TB clinics in major cities but not in smaller towns or rural areas.