Government today told Delhi High Court that it will provide a new TB medicine to a Mumbai-based doctor who will be responsible to administer it to an 18-year -old girl suffering from a drug resistant form of the disease.
The decision was arrived at with the consent of the patient's father, following which an order was passed by Justice Sanjeev Sachdeva disposing of the plea to provide the new TB drug to the girl, on the basis of the terms and conditions arrived at between the two sides.
The new TB drug is one of the two optional medicines for her and is not openly available in the country.
The court also said the order has been passed under the peculiar circumstances of the case and should not be treated as a precedent.
As per the terms of the consent order which were taken on record by the court, the government said the patient's doctor will have to move an application before the Drug Controller General of India (DCGI) for permission to get the medicine, Bedaquiline, under "compassionate use basis" and the authority would process the same within 24 hours, if all requisite conditions are fulfilled.
Once the permission is received from DCGI, the doctor has to forward an application to the manufacturer, Janssen - a subsidiary of pharma major Johnson and Johnson - for importing Bedaquiline urgently on "compassionate use basis", it said.
Thereafter, the doctor would have to furnish a copy of DCGI's permission and the application to Janssen, to the DDG of Central TB Division "who shall make the full course of Bedaquiline available through KEM Hospital, Mumbai, to the doctor within two days thereof", the terms of the consent order stated.
The terms also state that as and when Bedaquiline is made available to the doctor by Janssen, on the basis of his application, it shall be handed over to KEM Hospital as and by way of replenishment of the stocks of the medicine.
Meanwhile, Lala Ram Swarup (LRS) Hospital clarified in the consent order that domicile or residence of the patient was not a criteria to determine eligibility for administering the drug under the conditional access programme.
During arguments, senior advocate Anand Grover told the court that the patient's doctor was determining a protocol for administering Bedaquiline with other drugs, after carrying out a fresh drug sensitivity test, as a doctor of LRS told them there have been cases of deaths, which went unreported, after Bedaquiline was given without a proper protocol.
During arguments, advocates Arjun Mitra and Aastha Jain,
appearing for the Centre, said the government was willing to give the medicine from its stock to the patient's doctor when he applies for it.
The government also said that the patient's doctor, Dr Zafir F Udwadia, would have to undertake that the medicine was being administered at his risk.
The patient, who was admitted at LRS, was recently moved to Mumbai, as the hospital had wanted to do more tests before administering Bedaquiline.
However, LRS hospital had later told the court that it was ready to administer the medicine to the patient under its supervision without carrying out any more tests.
The patient's father, Kaushal Tripathi, had claimed in his plea that his daughter meets the requirements under the WHO guidelines and Revised National TB Control programme for being treated by Bedaquiline.
LRS hospital had earlier defended its stand for more tests saying if Bedaquiline is given to a patient suffering from a drug-resistant variant of the disease without carrying out proper tests, it could lead to development of a strain which is resistant to this medication also.
