Government may allow private sector to use key drug used for treating tuberculosis

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.

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 US$400 per course for Indian patients.

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 side effects such as heart problems. “Technical opinion is being sought as there is no consensus among experts on opening access to the private sector,” said a senior health ministry official familiar with developments.

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. “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,” the official quoted above said.

The drug is quite safe according to Johnson and Johnson (J&J), the manufacturers of bedaquiline.

“…there is no scientific evidence of hearing loss with bedaquiline. In fact, per the latest WHO guidelines issued in December 2018, bedaquiline is now recommended as part of long-course regimens in lieu of injectables, which cause deafness in 40-60% of patients receiving them,” said the company in an emailed response.

“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 J&J’s response added that the drug per se is not to be taken for two years.

“While MDR-TB treatment is complex and may require up to two years of treatment, bedaquiline should be given for a maximum of six months as part of the treatment as per its approved indication.”

The ministry has begun compiling data on treatment outcome for all oral treatment regimens among Indians, which also includes the bedaquiline-related course. “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,” the official said.

There will be strict vigilance. “Since it is a long-term regimen, it’s verifiable. A call will be taken soon,” said a second ministry official, requesting anonymity.

Balram Bhargava, secretary of the department of health research, said, “The meeting will be held very soon.”

The United States Agency for International Development (USAID) has provided 22,000 doses to the government. “We don’t want to deny patients newer drugs if it benefits them, so we are considering the idea,” said the first health ministry official.