Mylan moves application with DCGI to launch new TB drug Pretomanid in India

"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," Mylan's global president and executive director Rajiv Malik told PTI during his recent visit to India.

HYDERABAD: 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 curing 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," Mylan's global president and executive director Rajiv Malik told PTI 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.

Also, Modi launched a campaign to eradicate TB from India by 2025, five years ahead of a globally-set deadline.

TB Alliance was currently advancing the development of Pretomanid in three ongoing late-stage clinical trials, Mylan had said in April.

Also Read: Mylan, TB Alliance to commercialize Pretomanid to treat TB

Pretomanid is only the third new anti-TB drug approved for use by the US Food and Drug Administration (FDA) 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 the USA during this year-end, he said.

The United States will be the first country in which the product will be launched, and we expect this to occur by the end of this year. In other countries with a high TB burden, Mylan is in the process of filing for registration of Pretomanid with various regulatory authorities, the official said.

Tuberculosis continues to be one of the top 10 causes of death worldwide and the leading infectious killer-disease.

India has the worlds highest share (27 per cent) of all TB cases at 2.7 million and accounted for nearly a third of all TB deaths in 2017. A total of 21.5 lakh TB cases was reported in 2018, an increase of 17 per cent over 18 lakh in 2017, as per the Annual India TB Report for 2019 released recently, a Mylan spokesperson said.