New Delhi: Six months after the launch of ‘miracle’ drug bedaquiline - the most effective treatment for multi drug resistant tuberculosis - the Indian government has enrolled a mere 36 patients across five States. Experts now worry that the prohibitively expensive drug, costing Rs. 30 lakh per patient, will expire due to the ‘glacial pace’ of enrolment.
Bedaquiline is used exclusively to treat patients who have failed to respond to first and second-line anti-TB medicine. The Indian government had received a donation of 300 doses from the United States Agency for International Development (USAID), with another batch of 300 doses to be donated next year.
“India has been really remiss with its bedaquiline programme. Since it was announced only a handful of patients have been enrolled. For a country as advanced as India, with thousands of patients who would benefit from new drugs, this glacial pace is really disappointing. Other countries like South Africa, Swaziland or even Belarus have accomplished so much. They have put nearly 5% of their MDR TB patients on bedaquiline within a year. India has made a lot of promises about new drugs on paper but they are failing to deliver. As far as bedaquiline is concerned, this looks like another one of India’s broken promise,” said Jennifer J Furin, lecturer on Global Health and Social Medicine at Harvard Medical School.
As part of a Compassionate Access Programme (CAP), the pharmaceutical company Janssen that holds the patent for this drug, had donated 600 doses to USAID, which gave half of the medicines to the Indian government in March this year. The drug was to be introduced in 104 districts across five States - Delhi, Mumbai, Chennai, Ahmedabad or Guwahati.
According to the World Health Organization (WHO), India shoulders 71,000 multi-drug resistant tuberculosis patients. Its report says nearly 10% of all multi-drug resistant TB patients have extensively drug resistant TB or XDR-TB, for whom both the first and second lines of antibiotic treatment have failed. By conservative estimates, India is likely to have nearly 7,000 XDR-TB patients: only 36 are currently on the government’s access programme.
Since this is the first drug in decades to dramatically improve MDR-TB treatment outcomes, the Indian government set stringent eligibility criteria, allowing only patients residing close to the treatment centres.
“We understand that the enrolment has been slow. Keeping that in mind, we have now relaxed the technical criteria. We will now start using the drugs on patients who are resistant to any fluoroquinolone. The geographical criteria have also been relaxed. Now patients in the entire city and not just the immediate neighbourhood will be eligible. We had to take these precautions to ensure that this drug does not get used irrationally. It can lead to resistance and once a patient is resistant to this, there are no options left,” said Dr. Sunil Kharpade, head of the Central TB Division of the Health Ministry.
