India approves drug to treat multi-drug resistant TB

The anti-TB drug has been rolled out under the Revised National Tuberculosis Control Programme and is part of the co-ordinated programme between the government and Johnson & Johnson

The Drug Controller General of India has approved Bedaquiline to treat pulmonary multi-drug resistant tuberculosis (MDR TB) and extensively drug resistant tuberculosis (XDR TB). Dubbed as the 'miracle drug', Bedaquiline (trade name Sirturo) is to be available at selected public hospitals across the country, initially in Delhi, Mumbai, Chennai, Guwahati and Ahmedabad.

The anti-TB drug has been rolled out under the Revised National Tuberculosis Control Programme. Janssen, a pharma unit under Johnson & Johnson, manufactures the drug, and is part of the co-ordinated programme between the government and Johnson & Johnson. Some 600 doses will be procured under the Conditional Access programme from Johnson & Johnson and then another 2,000 doses will be brought from USAID. The drug will be given under strict supervision at six government hospitals across the country.

For the government run control programme, 600 patients are to be enrolled across the country, over the next six to nine months, after the required tests. Upon the review of clinical data after two years, the access programme is to be expanded nationwide.

The drug is believed to be the first in decades to have a potential to dramatically improve MDR-TB treatment outcomes, and reduce the number of people who die from the disease. Today, MDR-TB is a major public health concern that threatens developments made in TB care and control worldwide. 'Bedaquiline will be given to multi-drug resistant TB patients with resistance to either all fluoroquinolone and/or all second line injectables and extensive drug resistant TB,' said a senior Health Ministry official.

India has the highest number of tuberculosis cases in the world, and reports 2.2 million new cases of the disease every year. The Global Tuberculosis Report 2015 by the World Health Organisation (WHO) showed that an estimated 2.2 million people were found to be struck by TB in India in 2014, of which more than 70,000 were MDR-TB patients. India accounts for 23% of the total cases of TB worldwide.

Lack of timely diagnosis in rural areas and reaching tribal regions are some of the hurdles in the fight against TB. To this end, 500 Cartridge Based Nucleic Acid Amplification Test (CBNAAT) machines are to be distributed across the country. These are in addition to the existing 121 CBNAAT machines already in operation. The CBNAAT is a revolutionary rapid molecular test that detects Mycobacterium tuberculosis and rifampicin drug resistance simultaneously.

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