The government on Friday told the Delhi High Court that it will provide a new medicine against tuberculosis called Bedaquiline 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.
It was also clarified by the government that people who did not belong to the states or cities in which a programme to administer Bedaquiline was underway could now access it for treatment.
This is an important decision because till now, the drug was given out under strict supervision under a pilot project in Delhi, Chennai, Ahmedabad, Guwahati and Mumbai.
The court, however, also said the order has been passed under the peculiar circumstances of the case and should not be treated as a precedent. 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.
The reason Bedaquiline is under strict supervision is because it was approved by regulatory authorities using an accelerated procedure, which means that the trials for Bedaquiline have not been completed.
According to the World Health Organisation, the drug has shown beneficial effect in studies including two Phase IIb trials whereas Phase III trials have not yet been completed.
The reason Bedaquiline was given accelerated approval is that it is a drug that is specifically used to treat TB patients with bacteria that are resistant to anti-TB drugs like rifampicin and isoniazid, and thus, suffer from multidrug-resistant tuberculosis (MDR-TB).
But the apprehension around the drug exists because it has been reported to disturb the function of the heart and liver in particular. "Special caution is needed when the drug is used in the elderly, in pregnant women, and in persons living with HIV who are taking antiretroviral medication (see cautions on the use of specific anti-retroviral drugs below). Bedaquiline should not be used to treat latent TB infection," according to the WHO.
According to TBFacts, the US Food and Drug Administration (FDA) granted approval for Bedaquiline to be used to treat MDR-TB on 28 December, 2012. In October 2013, the Center for Disease Control and Prevention (CDC) in the US issued federal guidelines on the use of the drug.
In February 2016, it was announced that Bedaquiline will be made available in India.
With inputs from PTI
Published Date: Jan 23, 2017 13:33 PM | Updated Date: Jan 23, 2017 13:33 PM