At least five drug-resistant tuberculosis patients now have a ray of hope, with the Delhi High Court allowing a teenaged patient from Patna to access the highly controlled Bedaquiline drug in Mumbai. Supply of the powerful drug is monitored and has been rolled out in only six cities on a pilot basis.
The Patna teenager, who is suffering from extremely drug resistant (XDR) TB, had moved court after she was denied Bedaquiline as she did not have domicile status in New Delhi, where the drug trial is being conducted. Besides Delhi, one hospital each in Mumbai, Ahmedabad, Chennai and Guwahati have started the trial.
The Delhi High Court order states that “domicile or residence of the patient is not a criterion in determining the eligibility for administration of Bedaquiline under conditional access programme in the respondent No.1 hospital, is taken on record”.
Advocate Anand Grover from the Lawyers Collective, which fought the Patna girl’s case, said the writ petition has taken this on record, and it means that other patients will be benefited by the HC order. “We know of at least five such patients being helped by community organisations. They are from northeastern, eastern, southern and western States,” he said.
Bedaquiline, the first new anti-TB drug in 40 years, was granted accelerated approval by the US FDA in 2012. The medicine, manufactured by a Belgian firm, is first sent to USAID, through which it is procured by the Indian government and distributed to trial sites. So far, the Central government has procured 600 doses of Bedaquiline, but only 164 patients have been administered the drug, including 56 in Mumbai. Discussions are on to increase the number of trial sites, but the Central government is yet to approve the demand.
“The World Health Organisation has also said that India is going slow in rolling out the drug, which has shown good results in South Africa. We should definitely not make patients wait like this,” Mr. Grover said.
The Patna teenager will come to Mumbai as soon as her quota of Bedaquiline is arranged for.
“She is not keeping well. We will come to Mumbai only after the medicines arrive,” her father said. The court order states that the medicine should be handed over to KEM Hospital, which is running the drug trial in Mumbai at the Tuberculosis Hospital, Sewree.
Dr. Zarir Udwadia, the chest physician from Hinduja Hospital who first recommended that the Patna girl be put on Bedaquline, is in charge of administering doses and and monitoring the trial.
