Bedaquiline drug worth close to Rs 3.6 crore is being provided to India, free of cost, under international support mechanism by Stop TB Partnership's Global Drug Facility.
Six hundred tuberculosis (TB) patients will get access to Bedaquiline drug in India for the first time starting this month.
The Union Health Ministry is introducing the drug for patients who have encountered earlier failures in treatment of the infection. Such patients have increasingly gone on to become resistant to basic first line and second line of anti-TB drugs. Doctors, however, suggest treading with caution as the drug is known to cause major side-effects including that of the heart.
The six sites across the country where Bedaquiline will be made available are National Institute of TB and Respiratory Diseases and Rajan Babu TB Institute of Pulmonary Medicine and TB in New Delhi, KEM Hospital in Mumbai, BJ Medical College in Ahmedabad, Thoracic Medicine Hospital in Chennai and Guwahati Medical College in Assam, revealed an RTI query.
Bedaquiline drug worth close to Rs 3.6 crore is being provided to India, free of cost, under international support mechanism by Stop TB Partnership's Global Drug Facility. After the Indian government had sent a requirement to Jannsen Pharmaceutica, it has now received the drug dosages from the company for administration in 600 patients across India, under the Phase I of the conditional access programme.
In spite of the fact that such a large scale testing of the drug will happen in India for the first time, the government is reluctant to call it a 'drug trial.' It says it is testing the operational introduction of Bedaquiline in drug-resistant patients where other drugs have failed. "Bedaquiline is internationally known to be an efficacious drug. In India, it has been made available for a select group of patients initially, so that the physicians understand the methodology of introducing it operationally in patients, clubbing it along with other 6 – 7 TB drugs, that may form a part of the patients' regimen," said Dr Rohit Sarin, director, National Institute of TB and Respiratory Diseases, New Delhi.
For the first two months, the selected cohort of patients will be provided Bedaquiline drug daily, after which, for the next six months, they will be subjected to an intermittent dose of the drug thrice a week.
Bedaquiline is known to have a range of side effects ranging from nausea to liver toxicity and chest pain. Studies have shown that in some cases it may weaken the cardiac muscle cells that send signals to the heart muscles causing it to contract, causing the heart to beat irregularly. "Bedaquiline is known to have an adverse effect on conduction of heart. We have to be extremely cautious about its use and hence we are looking at gradual implementation of the drug programme," said Dr Sarin. "We have no data available for Bedaquiline usage in children. Selected patients will be above the age of 18 years."
According to the latest Medecins Sans Frontiers report, there are concerns over safety of the drug. During trials, 10 out of 79 patients in Bedaquiline group had died as opposed to 2 out of 81 patients in standard treatment group. "Although many of these deaths are attributed to TB itself, the difference is a source of concern and needs careful future monitoring as Bedaquiline use increases," said the report.
Concerns are being raised about how India will sustain the treatment programme after the stocks are exhausted in a year. "Bedaquiline is a patented drug. It is very expensive. Treatment with the drug can cost a patient up to 900US$. The drug should be made available at an affordable price to patients going forward," said Shailly Gupta, spokesperson, MSF access campaign, New Delhi.
Limited access
Bedaquiline was first conditionally approved by US Food and Drug Administration in 2012. According to the latest, barely two per cent patients of all those who can benefit from it have access to the drug.
It is the first TB drug in the last 40 years to be approved for use in drug-resistance cases.
India has an estimate of 70,000 -- 80,000 MDR-TB patients of which 1% - 2% fail treatment, according to WHO
While the Union Health Ministry is supervising the administration of Bedaquiline under the Revised National Tuberculosis Programme (RNTCP), it's sale or supply in private sector in India is prohibited
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