With multi-drug resistant (MDR) and extensively drug resistant tuberculosis (XDR TB) threatening the country, the government is set to introduce a new TB drug, Bedaquiline, on an experimental basis. The drug will be introduced in areas which have so far reported a large number of MDR TB and XDR TB cases.
The government is in the process of identifying these areas. The drug would be administered to patients found to be resistant to two vital primary drugs in the DOTS Plus regimen.
As per records, nearly two million Indians develop TB each year. Mumbai is emerging as ground zero for MDR TB. Approved by the US regulator in January this year, Bedaquiline is used for treatment of MDR TB as part of combination therapy in adults.
According to the Lancet, results from randomised trials on the efficacy of Bedaquiline showed significant reduction in the infection period. Approval of the drug was also based on studies that showed it “killed” bacteria quicker than the existing drug regimen.
Discovered by scientists at Janssen, the pharmaceuticals unit of Johnson & Johnson, the FDA approval for a new TB drug comes after more than 50 years.
The Indian Council of Medical Research and Central TB Division of DGHS recently convened an expert group for the introduction of Benda-quiline. “It is proposed to introduce the drug in India under controlled conditions at 4-5 DOTS Plus sites to assess its impact on MDR and XDR TB,” Union health minister Ghulam Nabi Azad said.
Twenty-two countries bear 80 per cent of the burden of TB worldwide. According to WHO, there are around nine million new cases of TB detected and close to two million people die of it each year. In India, TB is rated as a major public health problem and the country accounts for one-fifth of global TB cases.