Globally, out of the half-a-million people who develop DR-TB (drug-resistant-tuberculosis) each year, India currently contributes over 25 per cent of the burden. On an annual basis, there are at over 1,00,000 new cases of DR-TB in India.
After a gap of 50 years, new antibiotics, bedaquiline and delamanid, now provide opportunities to high-burden countries like India to improve the efficacy of their DR-TB treatment.
Looking at the extraordinary need for these new drugs to reduce treatment failure and death, India’s National Drug Regulatory Authority allowed the Central TB Division (CTD) to progressively include bedaquiline and delamanid in treatment regimens to improve treatment outcomes for adults, adolescents and children with multi-drug resistant (MDR) and extensively drug resistant (XDR) TB.
The introduction of these two new drugs in the country’s TB programme could be a game changer in the fight against this public health emergency. In the last two years, it has spurred CTD to scale up testing for drug resistance across the country as the drugs cannot be prescribed, as per WHO recommendations, without diagnosis of the resistant strain and pattern. Pharmacovigilance and monitoring of adverse effects of DR-TB drugs have been strengthened.
These drugs are also the backbone of India’s announcement in September 2019 that it will scale up injection free DR-TB treatment, improving not just treatment outcomes but also preventing permanent disabilities in patients, such as hearing loss.
Benefits to children
Perhaps the greatest benefits could be in children with DR-TB who can now potentially be treated with injectable-free regimens as safety data on different age groups becomes available. Hearing loss, a frequent severe adverse event caused by injectables, has a profound impact on children’s development.
Despite the benefits to the TB programme, till now CTD has acquired the new TB drugs, patented in India till 2023, as donations from pharmaceutical corporations and the United States Agency for International Development. In particular, the quantity of delamanid under the donation has been severely limited to just 400 six-month treatments, leaving children with DR-TB without access to the drug in many parts of the country alongside reports that the drug is in short supply and stocked out in many States.
Donations of medical products are not sustainable for ensuring long-term access to treatment for patients and therefore the CTD has embarked on negotiations with the patent holders on the price at which the new drugs will be supplied to the programme.
There is no doubt that prices of the new drugs are a consideration for the CTD as it seeks to provide an injection-free regimen to all patients with DR-TB, who are registered with it. A six-month course of bedaquiline is available to the TB programme at approximately $30,000 per patient and delamanid prices are more than double that.
The negotiations launched, in the absence of competition and multiple suppliers, have been long and protracted.
India failed to achieve significant reduction in prices over what South Africa had already achieved in 2019. Tenders in the case of bedaquiline had to be re-issued, and in the case of delamanid, finalisation of the bid only came after the programme was facing shortages.
The experience of dealing with single-source supply due to patent monopolies is new to the Indian Ministry of Health, with tenders not receiving any competitive bids. The absence of any credible threat from the Health Ministry and the TB Programme that generic sources will be roped in under government use licensing could see prices remain stagnant globally, despite scale-up of volumes till 2023, when the patents on these drugs expire and generic suppliers enter the market.
If alternative sources are to be encouraged before the patents expire in 2023, the government, across all ministries, must give a clear signal to the domestic industry to manufacture and register the new TB drugs for domestic and global supply. For that to happen, the government needs to figure out how compulsory licensing provisions can be applied in public health emergencies.
The writer is a lawyer and South Asia Head of Médecins Sans Frontières’ (MSF - Doctors without Borders) Access Campaign.
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