Use of Bedaquiline: Doctors say Delhi HC order will help more TB patients
The Delhi high court’s decision to allow an 18-year girl from Patna, with severe form of tuberculosis (TB), to access the new drug Bedaquiline could open door for many patients with extreme drug-resistant forms of the infection, said doctors.
The girl’s father was forced to approach the court as his daughter was refused Bedaquline at the Lala Ram Sarup TB Hospital on the grounds that she was not a resident of Delhi. On Friday, the court said the girl will be administered Bedaquiline at Mumbai’s Hinduja Hospital, under supervision of chest physician Dr Zarir Udwadia’s.The patient had consulted Dr Udwadia previously and wanted to receive treatment under him. She will soon come to Mumbai and resume treatment.
The girl’s father, Kishore Tripathi, who works as a Class III government employee told HT that she has been undergoing treatment since 2014. “She was in Class X when she the treatment started, and hasn’t attended school since then. Doctors in Delhi told us that no drugs will work for her and advised me to meet Dr Udwadia in Mumbai. He recommended the Bedaquline drug, but the hospital in Delhi refused to give administer it.”
The court also said the domicile or the residence of the patient is not a criterion for eligibility of Bedaquiline under the government’s conditional access programme. “I am very happy with the court’s hearing. The domicile rule no longer stands,” said advocate Anand Grover from Lawyers’ Collective, the group which fought the girl’s case.
At present, access to Bedaquline in India is strictly regulated, with only six government centres, two in Delhi and one each in Mumbai, Ahmedabad, Guwahati and Chennai, providing the drug to local patients. The medicine is given to patients as a part of the government’s drug trial that started in March 2016.
The court said Dr Udwadia will apply to the Drug Controller General of India (DCGI), seeking permissions to avail Bedaquiline from Belgian manufacturer Janssen Pharmaceuticals on “compassionate use-basis’. Once they send its approval, Hinduja Hospital can get the medicines from KEM Hospital. The court added that the DCGI will clear the application in 24 hours. The drug’s sale is highly regulated so that its use is monitored. This is necessary to prevent patients from developing resistance to the medicine.
Once the doctor receive the drugs from Janssen, which takes about two months, he will return the drugs back to KEM Hospital. The lawyer said that this ‘peculiar mechanisms’ of procuring the drug would ensure early access to her.
Doctors said that the court order will help other patients with drug-resistant tuberculosis which is caused by bacteria that are resistant to treatment with at least two of the most powerful anti-TB medications isoniazid and rifampin. Drug resistant cases are very difficult to treat and result in increased numbers of deaths. “Just like this girl, there are so many other patients who don’t access to Bedaquiline because they are not domiciles of the areas where the government is rolling out Bedaquiline. The hearing will give hope to these patients,” he added.
“The court has made a good decision. At our centre, the patients who are on Bedaquiline are tolerating the drug very well and it should be made accessible to all TB patients who are eligible for this drug,” said a senior doctor from the Group Of T B Hospital, Sewri, Mumbai, one of the six government run centres in India to provide the drug.
The doctor said that out of the 56 patients who are on Bedaquiline in Mumbai, only two patients had to be put off the treatment due to the side effects. “The electrocardiogram reports of these patients were not normal so we stopped the treatment for them, but the others are doing well and we are confident of using the drug,” he added.
However, Dr Vikas Oswal, a city-based TB specialist said that the mechanisms to follow up the patients will have to be strengthened, to minimise drug resistance.