Chennai: Mylan, a global pharmaceutical company, has announced that the Drug Controller General of India (DCGI) has approved the anti-tuberculosis drug pretomanid for conditional access under the National Tuberculosis Elimination Program (NTEP )program, making India the second country in the worldto 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 make its pretomanid available in India through a donation of 400 treatment courses to the government’s National Tuberculosis Elimination Program (NTEP), which provides free, high quality anti- tubercular drugs and care across the country to ensure that the treatment is accessible to patients who need it the most.