The Union health ministry may allow the private sector to use bedaquiline, a controlled-access drug used in the treatment of multi-drug resistant tuberculosis (MDR-TB).
Since the drug has controlled access, bedaquiline is dispensed only by the government to people with MDR-TB. Now the health ministry jointly with the departments of health research, biotechnology and other related departments is considering an institutional mechanism to give bedaquiline to patients in the private sector. A health ministry official said that there is a huge pharma lobby that is building an argument for putting everyone on bedaquiline, but it doesn’t work like that. “Even though it is being hailed as a wonder drug, it has side effects that include hearing loss. It’s a new drug. So we don’t really have adequate data on its long-term treatment outcome,” he added.
“People generally assume bedaquiline is safer than other drugs but they forget that compared to a 6-8 months course for other medicines, a bedaquiline-based regimen could go up to 18-24 months. The longer duration could have its effects that our experts are looking at,” he added.
The health ministry has started collecting data on the treatment outcome for all oral treatment regimens among Indians. “About 20 patients in the private sector in Mumbai have been given conditional bedaquiline access by the government. But the entire private sector can be given access only if they strictly adhere to the drug-compliance regimen for complete cure and to stop the patient developing extremely drug-resistant TB,” an official said. The United States Agency for International Development (USAID) has provided 22,000 doses of the drug to the government. “We don’t want to deny patients newer drugs if it benefits them, so we are considering the idea,” he added.
In India around 2.1 million people have TB. Among them, an estimated 30,000 people have MDR-TB. Only 6500 patients are on the bedaquiline-based treatment regimen. The side effects of this treatment can include heart problems and hearing impairment. The drug costs Rs 28,000 per course, which means the cost per patient is Rs 1.12 lakh on medicine alone.

Source: Hindustan Times.

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