Mylan has on Wednesday said the Drug Controller General of India (DCGI) has approved the anti-tuberculosis drug Pretomanid for conditional access under the National Tuberculosis Elimination Program (NTEP).

This makes India the second country in the world to provide regulatory approval for this product.

Pretomanid has been approved as part of a three-drug, six-month all-oral regimen (with option to extend treatment to nine months in certain conditions) consisting of bedaquiline, pretomanid and linezolid, collectively referred to as “BPaL” for the treatment of adult patients with pulmonary extensively drug-resistant TB (XDR-TB), treatment intolerant or non-responsive multidrug-resistant TB (MDR-TB).

Through the conditional access approval from DCGI, Mylan will initially makePretomanid available in India through a donation of 400 treatment courses to the Government’s National Tuberculosis Elimination Programme (NTEP), which provides free, high quality anti-tubercular drugs and care across the country.

The company also will provide commercial access to NTEP at the “global access price” of US $364 for a six-month treatment course, and will be manufacturing it both for domestic and global supply in India.

“To date, Mylan and TB Alliance have secured approvals for Pretomanid in two countries. As important, and thanks to DCGI’s continued focus on the treatment of TB even amidst the evolving Covid-19 pandemic, we achieved the approval in India with record speed,’’ Rajiv Malik, President, Mylan said in a release.

President and CEO of TB Alliance Mel Spigelman, MD said, “By embracing innovation, India has an opportunity to lead the charge to end TB and meet its ambitious goals for eradication.’’

India accounts for approximately a quarter of the world’s TB burden, with an estimated 2.7 million cases per year,[he highest for any country. Of these cases, an estimated 130,000 patients have some form of drug-resistant TB.

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