Johnson & Johnson gets govt panel nod to sell ‘wonder TB drug’ for minors without local trial

Bedaquiline was approved by US FDA in December 2014 after multiple trials worldwide. It is recognised by WHO as an ‘essential drug’ for treating TB.

Representational image | Johnson and Johnson Inc | Flickr

New Delhi: The Narendra Modi government’s drugs advisory panel has allowed Johnson & Johnson’s Bedaquiline, touted as a potential “wonder drug” for multidrug-resistant tuberculosis (MDR-TB), to be sold in India for minors without going through local clinical trials.

The Subject Expert Committee (SEC) took the decision at a meeting on 18 November following a proposal from Johnson & Johnson (J&J) seeking a waiver of local clinical trials. The oral drug is manufactured by the company’s Belgian subsidiary Janssen. The drug has been administered to adults in India since 2018. 

The World Health Organization (WHO), earlier this year, advised countries to treat TB patients with all-oral medications, including Bedaquiline, instead of injections, which require people to visit clinics and hospitals. If patients were required to visit medical facilities amid the Covid pandemic, it was feared that their well-timed dosages might be disrupted.

A high proportion of individuals with MDR-TB has also been known to develop permanent hearing loss due to ototoxicity — the tendency of a medicine to be toxic to the ear — caused by an injectable drug called aminoglycosides.

The SEC advises the apex drug regulator, the Drug Controller General of India (DCGI), on applications seeking approvals for new drugs, vaccines, and clinical trials. 

In 2019, under new clinical trial rules, the government decided that the regulator can waive local clinical trials for critical drugs if they have been approved anywhere outside the country. Bedaquiline was approved by the US Food and Drug Administration (FDA) in December 2014 after multiple trials worldwide.

For use among adult and paediatric patients  

Bedaquiline is recognised by the WHO as an “essential drug” for treating TB. The drug is prescribed only to MDR-TB patients who have no other options left for treatment.

The SEC’s decision came to light after the minutes of the 18 November meeting were uploaded on the website of the Central Drugs Standard Control Organisation (CDSCO), the DCGI-headed health ministry arm that regulates the quality of drugs and vaccines in India.

“After detailed deliberation, the committee has recommended for the grant of permission for import and marketing of Bedaquiline tablets 20mg indicated in adult patients and pediatric patients,” according to the minutes. 

Adult patients are those aged over 18 years whereas pediatric patients are those between 5 and 18 years of age, weighing at least 15 kg. 

The drug, the minutes state, will be given as part of combination therapy for pulmonary tuberculosis due to multidrug resistant mycobacterium tuberculosis (MDR-TB). It will be subject to conditional access through the government’s National Tuberculosis Elimination Programme — Revised National TB Control Programme (NTEP-RNTCP). 

Under the conditional access programme, the drug is only given to patients through government establishments.

WHO guidelines allow using a combination of bedaquiline with another drug called delamanid in extremely critical cases.

According to the WHO’s consolidated guidelines on tuberculosis, the combination may be used in patients who have limited options for other treatment, due to an extensive drug-resistance profile or intolerance to other second-line TB medications.

India’s TB burden 

The Modi government aims to rid India of TB by 2025, five years ahead of the target set under the United Nations’ Sustainable Development Goals.

Nearly 100 crore people suffer from TB globally. India accounts for around 27 per cent of these cases, according to a WHO report.

In 2018, the Indian government decided to expand the use of Bedaquiline by six folds, encouraged by the results of the drug on the reduction in mortality rates in South Africa — one of the countries with the highest TB burdens. 

International humanitarian NGO Medecins Sans Frontieres (MSF) said it welcomed “the Indian drug regulatory authority’s decision to allow the use of bedaquiline for adolescents below the age of 18 years under the National TB Elimination Programme”.

“The lack of registration in India for paediatric use of bedaquiline for adolescents and delamanid for children between 3 to 6 years by J&J and Otsuka, respectively, limited options for children with DR-TB… limiting the scale-up of all oral regimens for this very vulnerable cohort, who are at the greatest risk of life-long disability due to hearing loss from the continued use of injectables,” said Leena Menghaney, the South Asia head for MSF, in a statement.