The teenage girl suffering from life-threatening Tuberculosis will finally get access to the life-saving drug Bedaquiline (BDQ). The Centre and the NGO representing her arrived at a consensus before the Delhi High Court on Friday.
The 18-year-old will now be administered Bedaquiline at the P.D. Hinduja National Hospital and Medical Research Centre, Mahim, Mumbai.
On Friday, the team of lawyers from the NGO, Lawyers Collective, representing the girl’s father Kaushal Kishore Tripathi, a government servant, and the Centre's counsel arrived at a consensus that the girl will be administered the drug under the supervision of her doctor and private practitioner Dr Zarir F. Udwadia.
The government will make available a full course of BDQ through KEM Hospital, Mumbai, which is one of the six sites in India for drug administration. Following the decision, Justice Sanjeev Sachdeva disposed of the petition while accepting the order reached by the parties.
The Centre made it clear that the drug would be administered under the supervision of the girl's personal physician who would be monitoring her situation for any cardio-toxicity.
Administrative process
Despite the consensus reached, the patient and her doctor will still need to go through administrative processes before the treatment can begin. As per the agreement , though the Centre has agreed to provide a full course of BDQ to the girl, her doctor or the family will first need to make an application before the Drug Controller General of India to obtain/ import BDQ from the U.S. firm under the Compassionate Use basis.
The Drug Controller will then process the same, following which the girl's doctor will make a request to the U.S. firm, Janssen Pharmaceuticals, a unit of Johnson & Johnson, for importing BDQ, Surabh Chauhan and Varun Jain, Mr. Kaushal's counsel said.
Once that is done, the permission granted by the DGCI and the request sent to the U.S. pharma company will have to be furnished before the Deputy Director General, Central TB Division, who will then make the full course of BDQ available through KEM Hospital to Dr Udwadia.
The parties agreed that since the drug is available with the government in a limited quantity and given on a case-by-case basis, as and when BDQ is sent by Janssen Pharmaceuticals to Dr. Udwadia, it will be handed over to KEM Hospital for replenishment of its stock.
Meanwhile, the National Institute of TB and Respiratory Diseases (NITRD) clarified before the court that domicile or the residence of the patient was not and has never been a criterion for turning away a TB patient in need of BDQ.
Dr. Udwadia had suggested a regimen of BDQ, capreomycin, Moxiflocin, Clofazimine, Thioridazine, Linezolid and delamanid. The NITRD, however, said the regimen was not effective.
Initially the NITRD had refused to administer BDQ without proper tests but the girl's deteriorating condition didn't allow waiting for the test results which would have taken over a month. Later, NITRD agreed on giving the drug but by then, the girl had been shifted to Mumbai.
The NGO Lawyers Collective also took the opinion of Dr. Jennifer Furin, a Lecturer in Global Health, who said the girl satisfied the requirement for the administration of BDQ.
