To save lives, hospital to import anti-TB drug from South Africa

Over the past few months, Hinduja Hospital has referred more than 10 patients in the public sector for Bedaquiline  

Hinduja Hospital is trying to import Bedaquiline, an anti-tuberculosis drug, from South Africa for two of its patients suffering from multi-drug resistant TB.

Janssen, the Belgian pharmaceutical company that manufactures the drug, recently phased out its Compassionate Use Programme, under which the hospital had first procured the drug for patients in February 2013. Dr. Zarir Udwadia, a chest physician at the hospital, said, “The company told us that the Compassionate Use Programme (CUP) is over. However, they have opened a little back door where one can buy the medicine through its South African distribution branch. At the preferential pricing offered to India, the drug would cost $900 (₹58,000) for a six-month course. It is not such an impossible price. It also suits us as our patients [a 25-year-old woman from Mumbai, and a 35-year-old man from Bengaluru] are in desperate need of the drug.”

A common practice

Experts say that phasing out the CUP is a common practice by pharma companies after the medicine has been made widely available through government hospitals or other programmes. In an email response to The Hindu, Janssen India’s spokesperson said, “As per conditions laid down by the Drugs Controller General of India [DCGI], the company is permitted to supply the drug exclusively to the Revised National Tuberculosis Control Programme [RNTCP].”

The spokesperson said the DCGI can issue patient-specific licences for importing Bedaquiline on the basis of a recommendation from a treating physician. “Under an individual licence, a patient would be permitted to import Bedaquiline from an international source,” the spokesperson said.

Arduous process

Dr. Udwadia said a permit to import the drug for personal use has to be procured in the patient’s name. Each application is first reviewed by a board of doctors at Janssen and it dispatches the drug after making sure the patient is a suitable candidate. He said a hold-up at the Customs checkpoint is not uncommon. “If all goes well, it still takes at least 45 days for the patient to get the drug,” said Dr. Udwadia, who calls it the ‘will to pill’ time.

In December 2012, Bedaquiline received an accelerated approval by the U.S. Food and Drug Administration. Within weeks, Dr. Udwadia applied for the drug and Hinduja Hospital became the first in the country to procure the drug under Janssen’s compassionate use programme. The hospital has prescribed the drug to 40 patients, the largest number in the country under the programme, and boasts a 70% success rate.

India was first included as part of a global CUP that Janssen coordinated between 2013 and 2016. The firm’s spokesperson said, “From 2016 to 2017, a standalone CUP was initiated in India at the request of the Central Tuberculosis Division as an additional access route for patients, who were not able to access the medicine via RNTCP.”

The government currently has a restrictive policy of giving Bedaquiline under the RNTCP due to the fear of drug resistance . One of the primary criteria is that the patient has to be sensitive to at least three drugs in the background regimen. However, in an article in the medical journal, The Lancet, Dr. Udwadia argued that the clause denies the drug to patients who would benefit the most from it.

Over the past few months, Dr. Udwadia’s team has referred more than 10 patients in the public sector for Bedaquiline, but a majority of them are yet to receive the drug. Dr. Udwadia said, “If I had my way, there will be thousands of patients on the drug who would benefit from it potentially. Desperate patients should not be denied the drug just because you are worried about potential resistance developing five years later.”

Fear of drug resistance

Besides the fear of drug resistance, the government’s apprehension stems from the fact that the drug causes adverse effects such as liver function abnormalities, prolongation of the cardiac QT interval on the electrocardiogram and pancreatitis.

A prolonged QT interval is a known risk factor for sudden cardiac deaths. According to World Health Organization, the all-cause death rate in the group of patients receiving Bedaquiline in the Phase IIb trial was also found to be higher than among patients who did not receive the drug. Bedaquiline and Delamanid are the newest anti-TB drugs to be developed in the past 50 years.

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Printable version | Apr 9, 2021 9:44:38 AM |

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