Mylan working with DCGI to launch new TB drug in India

Multinational pharmaceutical company Mylan is working with Drug Controller General of India (DCGI) to launch Pretomanid, a medicine used to treat drug-resistant tuberculosis (TB), a top official of the US drug major has said.

Non-profit drug developer TB Alliance and Mylan NV had in April announced a global collaboration to make the experimental drug pretomanid for cure of pulmonary tuberculosis.

“We have submitted the new drug application to the office of DCGI. We are in an advanced stage of discussion and are working with the office of DCGI... Mylan will be in a position to launch the product in India soon after receiving approvals from DCGI,” Mylans global president and executive director, Mr. Rajiv Malik said during his recent visit to India.

This drug is important for India because Prime Minister Narendra Modi said India would get rid of tuberculosis by 2025, he added.

TB Alliance was currently advancing the development of pretomanid in three ongoing late-stage clinical trials, Mylan had said in April. Pretomanid is only the third new anti-TB drug approved for use by the USFDA in more than 40 years and is the first to be developed and registered by a not-for-profit organisation.

Mylan expects the drug to be launched in USA during this year-end.