HC asks DCGI to speedily decide TB patient's plea for new drug

Delhi High Court today asked the Drug Controller to expeditiously decide the application on behalf of a 18-year-old girl, suffering from a drug resistant form of TB, to import a new drug which is one of the two optional medications to treat her disease.
Justice Sanjeev Sachdeva issued the direction to the Drug Controller General of India (DCGI) after the lawyer for the patient's father said an application has been moved through the doctor to import the drug -- Delamanid -- under a compassionate access programme.
Delamanid, made by Japanese drugmaker Otsuka Pharma, is neither available in Indian markets, nor approved by DCGI.

The court also asked the Centre whether the TB medical centre in Mumbai can administer Bedaquiline, another new TB drug made by pharma major Johnson and Johnson, to the patient, without any new tests, as she has been moved there.
The court also asked the Health Ministry if Bedaquiline can be provided to the doctor treating the girl to be administered to her, if she is not admitted at the KEM Hospital which is the designated TB centre for Mumbai.
The court asked the lawyer for the government to take instructions on these two issues and inform it on January 20.

The direction came after senior advocate Anand Grover, appearing for the patient's father, contended that she was moved to Mumbai yesterday as the Delhi based TB centre, Lala Ram Swarup (LRS) hospital, had wanted to do more tests before administering Bedaquiline.

However, LRS hospital told the court that it was ready to administer the medicine to the patient under its supervision without carrying out any more drug sensitivity tests.
Grover said since they were not informed about the hospital's decision, they had decided to shift the patient and it would be very difficult to bring her back in view of her serious medical condition.

The patient's father, Kaushal Tripathi, has claimed 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.