TB miracle drug still not used on any patient so far

Two months after the Union health ministry launched a miracle drug for tuberculosis, Bedaquiline, with great pomp and show, the drug has not been put to use on a single patient. While the drug is available at the six sites shortlisted by the government, experts are waiting for the “ drug powder” used to check the drug susceptibility before it is prescribed to a patient. Bedaquiline is the only drug which can be used on multi-drug resistant cases where all other drugs have failed.

“Bedaquiline cannot be given to patients until the DST — which is a drug susceptibility test — are done. A ‘specific’ powder is needed to check the drug resistancy. Till the drug technicians don’t get it, the drug cannot be given to anyone,” an official said on condition of anonymity.

The health ministry had shortlisted six centres in India, including Ahmedabad, Gujarat, Chennai, Delhi and Guwahati, where the drug is launched for its introduction on patients who are found to be resistant to two vital primary drugs in DOTS Plus regimen. While, the government had in March procured 600 courses of Bedaquiline, it is lying unused, thanks to the callous approach of the government which is yet to procure the drug powder for laboratory testing for drug susceptibility. “Bedaquiline has to be preserved till the end. One patient would need 200 tablets. After it is introduced, the drug would help over 600 patients,” added the official.

Bedaquiline, the “miracle drug” for rising drug-resistant population in India can be used as part of the treatment for patients suffering from multi-drug resistance (MDR) and extensively drug resistant (XDR) strains of bacteria. The drug was launch by Union health minister J.P. Nadda ahead of World TB day on March 21. Bedaquiline is the first new TB drug to be approved by the US FDA in over 50 years.

As per government records, nearly two million Indians develop TB each year. Mumbai is emerging as the ground zero of multi drug resistant TB. Approved by the US regulator, Bedaquiline is used for treatment of multi-drug resistant TB as part of a combination therapy in adults. Earlier, results from randomised trials on the efficacy of the Bedaquiline which was published in the Lancet showed “significant reduction” in the infection period. The drug’s approval was also based on studies that showed it killed bacteria more quickly than a control group taking the standard regimen.

Discovered by scientists at Janssen, the pharmaceuticals unit of Johnson & Johnson, the FDA approval for a new TB drug comes after more than 50 years. Significantly, the drug also got a push from the World Health Organisation (WHO) recently after it advised on the inclusion of Bedaquiline on the combination therapy of MDR TB in accordance with its existing guidelines.

Twenty two countries, including South Africa, bear 80 per cent of the burden of TB worldwide. According to WHO, there are around 9 million new cases of TB detected and close to 2 million people die from the disease each year. In India, TB is rated as a major public health problem and the country accounts for one-fifth of the global TB cases.

It is estimated that annually around 3,30,000 Indians die due to TB and emergence of multidrug-resistant TB in recent years poses a much serious health threat throughout the world. In India, 12 extensively drug resistant TB cases were detected at Hinduja Hospital of Mumbai early few years back.