LRS CASE
Hospital following protocol on conditional access to bedaquiline, govt counsel
tells court
Patients
with extensively drug-resistant tuberculosis (XDR TB) can separately import the
potentially life-saving `bedaquiline' if they don't qualify for the drug under
India's conditional access programme with US drugmaker Johnson & Johnson,
the government has said.
The issue
was brought up on Monday when an XDR TB patient's father took New Delhi's LRS
TB hospital to the Delhi High Court for refusing to administer bedaquiline
because the patient was not a Delhi resident.
The
patient, who is from Bihar, is not under LRS' care anymore, argued the counsel
for the hospital at the Delhi court. The counsel said the patient could procure
the bedaquiline directly from J&J with the help of Zarir F Udwadia, a
Mumbai-based consultant chest physician who recommended its use.
LRS is
not in a position to follow the line of treatment suggested by Udwadia, the
counsel said. The hospital also doesn't have the equipment required to conduct
the pyrosequencing test sought by the patient's father, Kaushal Kumar Tripathi,
LRS' counsel told the court.
“We will
not be able to do it (provide bedaquiline) because we are sticking to the
protocol that is prescribed,“ said the hospital's counsel. “If Dr Udwadia wants
to continue the treatment, then he may try to get the bedaquiline under compassionate
grounds....“ However, according to Dr Udwadia, it takes around 45 days for the
drug to reach patients if they apply under compassionate use. “This convoluted
and hectic procedure facilitated disbursement of only 56 therapies of
bedaquiline in India from January 2013 to September 2015 when the company
suspended its global compassionate use programme,“ he told ET.
Janssen,
the J&J subsidiary which manufactures the drug, said it continues to
provide the compassionate use programme in India, but said it cannot comment on
how the government's conditional access programme is working.
“Since
2013, we have received 88 applications in India for compassionate access to
bedaquiline, from public and private sector physici ans and hospitals across
the country. Based on inclusion and exclusion criteria as per our global
medical guidelines and aligned with the WHORNTCP criteria for use of
bedaquiline, 65 patients have been approved for access under the compassionate
use programme,“ a Jansen spokesperson told ET.
One of
the reasons for the controlled access to these new TB drugs in the government
centres offering them is because of logistical issues, the government said.
“The six
centres providing bedaquiline under the Conditional Access Programme are the
only ones equipped and trained to manage the programme so far,“ Sunil Khaparde,
Deputy Director General-TB of the government's Central TB Division, told ET.
“Patients need to be constantly monitored, which is why these centres are
currently administering the drug only to residents of these six states,“ he
said So far, the government has procured 300 doses of bedaquiline from J&J,
of which it has administered nearly 200 doses, Khaparde told ET. Justice
Sanjeev Sachdeva is expected to hear the case next on Wednesday.
ET VIEW:
Increase
Availability
The
government must make procedures to procure and distribute TB drugs simple and
easy. Non-availability of TB drugs, be it through private clinics or
governmentfunded health care centres, is detrimental to patients, results in
complications and proliferation of drug resistant strains of TB. The human and
economic cost of not simplifying the sourcing of TB drugs is far too high. The
government must take steps to remedy the situation.
Source: THE ECONOMIC TIMES-4th January,2017
