Source:-\u00a0hindustantimes.com<\/p>\n
The Union health ministry is considering a proposal to allow bedaquiline, a controlled-access drug used in the treatment of multi-drug resistant tuberculosis (MDR-TB), to be open for prescription in the private sector.<\/p>\n
Being a controlled-access drug, bedaquiline is dispensed only by the government to people with MDR-TB. At least four courses of treatment are needed. The drug costs Rs 28,000 per course, which means the cost per patient is Rs 1.12 lakh on medicine alone.<\/p>\n
Around 2.1 million people have TB in India, of which an estimated 30,000 people have MDR-TB. Only 6,500 patients are on the bedaquiline-based treatment regimen, which may cause severe side effects such as heart problems and hearing impairment. \u201cTechnical opinion is being sought as there is no consensus among experts on opening access to the private sector,\u201d said a senior health ministry official familiar with developments.<\/p>\n
The health ministry, in collaboration with the departments of health research, biotechnology etc, is working out an institutional mechanism to give bedaquiline to patients in the private sector. \u201cThere is a huge pharma lobby that is building an argument for putting everyone on bedaquiline, but it doesn\u2019t work like that. Even though it is being hailed as a wonder drug, it has side effects that include hearing loss. It\u2019s a new drug, so we don\u2019t really have adequate data on its long-term treatment outcome,\u201d the official quoted above said.<\/p>\n
\u201cPeople 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,\u201d he added.<\/p>\n
The ministry has begun compiling data on treatment outcome for all oral treatment<\/p>\n
regimens among Indians, which also includes the bedaquiline-related course. \u201cAbout 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,\u201d the official said.<\/p>\n
There will be strict vigilance. \u201cSince it is a long-term regimen, it\u2019s verifiable. A call will be taken soon,\u201d said a second ministry official, requesting anonymity.<\/p>\n
Balram Bhargava, secretary of the department of health research, said, \u201cThe meeting will be held very soon.\u201d<\/p>\n
The United States Agency for International Development (USAID) has provided 22,000 doses to the government. \u201cWe don\u2019t want to deny patients newer drugs if it benefits them, so we\u00a0are considering the idea,\u201d said the first health ministry official.<\/p>\n
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