Multi-drug resistant TB: What the court ordered

ANAND GROVER | Updated on January 15, 2018

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Administration of a medicine cannot be determined by a patient’s domicile status

In January, the Delhi High Court directed that a teenager with multi-drug resistant Tuberculosis (MDR TB) be administered Bedaquiline, a new third generation antibiotic. The court further directed that no patient be denied access to Bedaquiline for lack of a domicile.

This case has significant implications for tackling TB. And at its heart is the 18-year old Patna girl, who was diagnosed with MDR TB in 2014, and her access to this next-gen medicine.

Bedaquiline was made available through the Revised National Treatment Control Programme (RNTCP) supported conditional access programme (CAP) at six pilot sites in five Indian cities including Delhi (at the LRS Hospital). However, there was no pilot site in the young girl’s hometown of Patna.

The teenager was brought to LRS Hospital for treatment, the doctors opined that she needed Bedquiline. However, she was denied treatment, on the grounds that she did not reside in New Delhi.

Her father had no choice but to approach the Delhi High Court, in December 2016, urging that the Government and LRS Hospital be directed to administer Bedaquiline. His contention was that not doing so was a violation of the patient’s fundamental Right to Life under Article 21 of the Constitution read with Article 12 and Right to Health under the International Covenant on Economic Social and Cultural Rights (ICESCR) that India is signatory to.

Specifically, his writ petition sought relief against the pilot site’s arbitrary imposition of the condition of domicile on patients seeking Bedaquiline, as it was in violation of the patient’s fundamental right under Article 14 on Right to Equality.

With the hospital reluctant to administer Bedaquiline without a fresh Drug Sensitivity Test (DST), Dr ZF Udwadia (a specialist chest physician from Mumbai) and Dr JF Furin (an eminent professor of public health and a practising physician from Harvard Medical School) furnished expert opinions pointing out that there was no requirement for a fresh DST in the RNTCP’s own treatment guidelines for Bedaquiline as the patient qualified on all criteria and the mere fact of her diagnosis as having MDR TB and consequent failure of all possible drug regimens indicated urgent need to administer Bedaquiline.

By January, the father had lost faith in the Hospital's ability to care for his daughter and requested that Bedaquiline be handed over for administration to Dr Udwadia in Mumbai, where his daughter had been shifted post complications.

This was agreed upon and a mutual consent order by Justice Sachdeva was passed late January. Dr Udwadia also started her on a course of Delaminid, another new drug for MDR TB.

The reason why India needed to fight this fight is because drug resistant TB is a public health crisis in India and requires urgent attention.

Drug resistance has variously been linked to poor nutrition hindering successful treatment and low treatment adherence — where patients stop the (usually) 24-week course after the first two-three weeks as they start to improve. Bedaqualine and Delmanid are new anti-TB drugs, arriving on the treatment landscape after nearly 40 years. And current medical research indicates that a complete cure is possible through a combination treatment of standard anti TB drug regimen with Bedaquiline and Delaminid.

While Bedaqualine is approved for use in India since 2013, Delaminid is not yet approved. It can be accessed via the compassionate use provision of the Drugs and Cosmetics Act for personal use through an individual’s treating doctor.

The Government is planning, rightly, to introduce Delaminid. But its success will depend on proactive interventions to use both Bedaqualine and Delaminid by the Government, which has been over cautious with Bedaqualine. This has resulted in low cure rates compared to, say, South Africa, where the government is proactively using Bedaqualine resulting in a cure rate that is double India’s.

(The writer is a Senior Advocate who, with his team from Lawyers Collective, appeared for the petitioners. Views are personal.)

Published on March 17, 2017

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