New Delhi, April 27, 2016:World Health Organization has made conditional recommendation for use of Bedaquiline for treatment of Multi drug resistant TB in adult patients. An Expert Committee on Regulation of Newer anti-TB drugs in India examined the matter and approved the drug for conditional use in Revised National TB Control Programme (RNTCP).
The drug has been approved by the Drug Controller General of India under Conditional Access Programme for its use only through Revised National TB Control Programme.
The said drug has been tested in human beings by the producer, i.e. Janssen in phase II, stage 1 and stage 2 clinical trials which were conducted in different settings. A total of 515 patients were given the new drug for 24 weeks in the above mentioned trials.