A plaque with the logo of Johnson & Johnson. Photo: Reuters/File
New Delhi: A Government of India drugs advisory committee has approved the use of Johnson & Johnson’s (J&J) bedaquiline – used to treat tuberculosis (TB) – for minor patients in the country without conducting any local clinical trials first.
Following a proposal from J&J seeking a waiver of the trials, a subject expert committee (SEC) on November 18 decided to allow the American pharmaceutical firm to sell the drug for paediatric use without requiring clinical trials in India, The Print reported. The SEC advises the Central Drugs Standard Control Organisation (CDSCO), the country’s apex drug regulator, on new drugs and clinical trials.
The minutes of the meeting were uploaded on the website of the CDSCO.
In June, the WHO had urged countries to facilitate access to fully orally administered drugs, including bedaquiline, for patients with multidrug-resistant (MDR) TB to replace the use of injections, which required patients to visit clinics and hospitals, and which would have proven difficult during the pandemic.
Bedaquiline is manufactured by J&J’s Belgian subsidiary Janssen, and has been provided to adults for treatment in India since 2018. The WHO recognises bedaquiline as an “essential drug”, and is seen as a last-resort option for people with MDR TB.
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A 2019 government notification on new clinical trial rules allowed regulators to waive local clinical trials for a new drug if it has already been approved and marketed outside the country. Bedaquiline was approved by the US Food and Drug Administration (FDA) in December 2014.
“After detailed deliberation, the committee has recommended the grant of permission for import and marketing of 20 mg bedaquiline tablets indicated in adult and paediatric patients,” the minutes of the SEC meeting state. Paediatric patients are those between 5 and 18 years, and who weigh at least 15 kg.
The drug will form part of the combination therapy for pulmonary tuberculosis, according to the minutes of the meeting. Bedaquline will be subject to conditional access through the government’s National Tuberculosis Elimination Programme – Revised National TB Control Programme, meaning it will be given to patients only through government establishments.
WHO allows using bedaquiline in combination with the drug delamanid in extremely critical cases, when patients have limited options for other treatments.
India’s high TB burden
India accounts for over a fourth of the world’s TB burden and the country has been the biggest contributor to the rise in TB’s global burden.
While the government aims to eliminate the disease by 2025, the WHO estimates that many cases go undetected. This is true not just of India, but other countries also.
Though across the globe, there has been an increase in TB notifications, the WHO estimates that there are several million more cases which are not detected. In 2019, 2.9 million people were newly diagnosed with TB but the organisation estimated that 10 million people developed TB in that year. “This gap is due to a combination of underreporting of people diagnosed with TB and underdiagnosis (if people with TB cannot access health care or are not diagnosed when they do),” the WHO said.
India accounts for 17% of the global “gap”, followed by Nigeria (11%), Indonesia (10%), Pakistan (8%) and the Philippines (7%).
A recent WHO report said that disruptions caused by the COVID-19 pandemic could derail the progress that has been made in tackling TB, which is the world’s deadliest infectious disease. The report said that apart from hindering new notifications of the disease, those who have been diagnosed with TB are facing difficulties in accessing healthcare facilities.