Father of the 18-year-old extremely drug resistant TB (XDR-TB) patient had approached the Delhi HC to get access to the drug, only hope for the survival of his daughter
A 19-year-old girl from Patna, Bihar, will finally get access to a 'miracle TB drug', Bedaquiline, after her father sought the intervention of the Delhi High Court (HC). The drug, the first anti-TB drug to be made available in the market after 40 years, is considered as the last resort for most patients.
According to the petition of the girl, a domicile of Bihar, she was refused administration of the drug at the Delhi-based Lala Ram Sarup (LRS) TB Hospital, since access to Bedaquiline has, in practice, been restricted to those who are domiciled in the six sites where the drug is available. Since March 2016, the Central TB Division has made Bedaquiline available at these sites -- two centres in Delhi and one each in Mumbai, Ahmedabad, Chennai and Guwahati.
Bedaquiline is currently available to less than 600 drug-resistant patients in the six hospitals and is governed by a rigorous selection criteria.
Through this order, Justice Sanjeev Sachdeva ruled that patients who wish to avail of the drug would not be denied on grounds of domicile. The drug, which is strictly regulated by the government, will now be made available to renowned TB expert Dr Zarir Udwadia, who is currently treating the patient in Mumbai's Hinduja Hospital. The court also allowed Udwadia to continue treatment as requested by the patient.
"The decision is good news to poor TB patients. It is sad that the HC had to intervene and doctors weren't able to do it for patients," said a senior doctor from the Sewri TB hospital, Asia's largest facility to treat TB, in Mumbai.
The court also directed the Drug Controller General (DCG) of India to "expeditiously" process the application for the drug 'Delamanid', as sought by the petitioner through Dr Udwadia under the Compassionate Use Programme (CUP).
The Bihar resident was first diagnosed with TB in 2013 and was being treated at LRS hospital since. In late 2014, test results showed that she had extreme drug-resistant TB, - a dangerous form of the disease indicating that the TB bacteria infecting her were not responding to multiple first and second-line drugs. Soon, she also became resistant to eight other drugs and the doctors had almost given up hope on her.
"She saw me after having failed to respond to the treatment given to her for two years. What upsets me is her treating doctors still denied her access to a life-saving drug," said Dr Udwadia. India has 28 lakh TB patients, the largest in the world. Of this, around 79,000 suffer from aggressive drug-resistant type TB. About 4.78 lakh people die of TB annually in the country
"She is a brave 19-year-old, desperate to live," Dr Udwadia said. "Responding to the HC's order, senior advocate Anand Grover from the Lawyers Collective, who represented the patient, said: "Moving for a CUA would have delayed her access by months. It is good the government has agreed to allow Bedaquiline to be administered and supervised through her treating physician."
Why is Bedaquiline controlled so strongly?
Last known drug, also called 'miracle drug' Resistance to Bedaquiline could exhaust all options
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