Bedaquiline, the “miracle drug” for the rising drug-resistant population in India, will soon be available as part of treatment for patients suffering from multi-drug-resistant (MDR) and extensively-drug-resistant (XDR) tuberculosis (TB). Union health minister J.P. Nadda will launch the drug ahead of World TB day on March 21. Bedaquiline is the first new TB drug to be approved by the US Federal drug Administration in over 50 years.
To begin with, the drug will be launched in Delhi, Mumbai, Chennai, Guwahati and Ahmedabad and will eventually be introduced all over the country for the patients who are found to be resistant to two vital primary drugs in the DOTS Plus regimen.
As per government records, nearly two million Indians develop TB each year. Mumbai is emerging as ground zero for MDR TB. The launch of the new drug, officials say, is likely to help over 600 patients.
Approved by the US regulator, bedaquiline is used for treatment of MDR TB as part of combination therapy for adults.
Earlier, results from randomised trials on the efficacy of bedaquiline, which was published in the Lancet, showed “significant reduction” in the infection period. Approval of the drug was also based on studies that showed it killed bacteria more quickly than a control group taking the standard regimen. FDA approval for a new TB drug discovered by scientists at Janssen, the pharmaceutical unit of Johnson & Johnson, comes after more than 50 years. Significantly, the drug also got a push from the World Health Organisation (WHO) which advised the inclusion of bedaquiline in the combination therapy for MDR TB in accordance with its existing guidelines.
While eradication of TB continues to be a major health challenge for India, based on the encouraging results on the efficacy of the drug the Indian Council of Medical Research and Central TB Division of DGHS recently convened an expert group for the introduction of bedaquiline in India. “It is proposed to introduce the drug in India under controlled conditions at 6 DOTS plus sites to assess its impact on multi-drug- and extensively-drug-resistant TB.”
Twenty-two countries, including South Africa, bear 80 per cent of the burden of TB worldwide.
According to WHO, there are around nine million new TB cases detected and close to two million people die of the disease yearly.
In India, TB is rated as a major public health problem and the country accounts for one-fifth of the global total.
It is estimated that annually around 3,30,000 Indians died of TB and emergence of MDR TB in recent years. In India, 12 EDR TB cases were detected at Mumbai’s Hinduja Hospital a few years ago.
Health ministry officials say the discovery of bedaquiline may provide new hope to patients suffering from the deadly disease.
http://www.asianage.com/india/miracle-drug-tb-will-be-available-india-soon-965
