Number of patients getting this drug to go up from 2,000 to 12,000 to help India eliminate TB by 2025.
New Delhi: The health ministry has decided to increase the administration of Bedaquiline — dubbed a potential wonder drug to treat multidrug-resistant tuberculosis (TB) — by six folds, ThePrint has learnt.
The move is in line with Prime Minister Narendra Modi’s announcement earlier this year that India was on its way to eliminate TB by 2025, five years ahead of the global target of 2030.
Encouraged by the results of the drug on the reduction in mortality rates in South Africa – a high burden country for TB – India will also increase the number of patients consuming Bedaquiline from the present 2,000 to 12,000 by the end of next year, government officials said.
“A target has been set to end TB globally by 2030. I would like to announce that we have set a target to eradicate it from India five years ahead, by 2025,” Modi had said while addressing the Delhi End-TB Summit in March this year.
However, a month later, a study by medical journal Lancet said that India’s TB crisis is likely to get worse and its severe form — multidrug resistant-tuberculosis (MDR-TB) — will become more common than it is now.
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Putting more patients on the wonder drug
Bedaquiline, manufactured by Belgian pharma major Janssen, a subsidiary of Johnson & Johnson, received safety and effectiveness clearances from US Food and Drug Administration in December 2014 after multiple trails worldwide.
The drug is recognised by the World Health Organization (WHO) as an “essential drug” in treating TB.
According to the ministry’s internal estimates, India accounts for nearly 1.4 lakh people who do not respond to first-line drugs. Currently, only 2,000 patients are on Bedaquiline.
“By the end of 2019, around 12,000 patients will be put on the course of Bedaquiline,” said a senior bureaucrat in the health ministry.
The drug is prescribed only to MDR-TB patients who have no other options left for treatment.
The ministry has trained more than 10,000 doctors from government hospitals across 759 districts to handle the side-effects of the drug. It has also tied up with Indian Medical Association to train 50,000 doctors from private hospitals to handle critical TB cases.
Earlier, the government was not open to the idea of including private hospitals under the TB eradication programme fearing misuse of the prescription.
However, with an increasing number of cases notified by private hospitals, the decision is being reconsidered. Sample this: According to government data, 17 lakh TB patients have been notified across India from January to 13 November this year. Of these, 4 lakh cases – or around 24 per cent – came from private hospitals.
“We have started exploring options to make the drug available through private doctors. The discussions are going on and we are likely to cherry-pick popular private hospitals across the country,” said the official quoted earlier.
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Government’s ‘delayed response’
Bedaquiline was the first new drug to treat tuberculosis in the past four decades. So, despite side effects and limited data available, American drug regulator, US FDA, gave Bedaquiline an accelerated approval with guidelines and warnings.
For the past many years, India limited the access to the drug as its safety profile was not established through phase 3 clinical trials.
WHO recommended it to treat multidrug-resistant TB for those with no other option. But in 2017, WHO reassessed the data and continued to recommend Bedaquiline and cured 63 per cent of patients.
However, according to Indian government officials, most of the country’s doctors lacked the confidence to prescribe the drug due to a strict treatment regimen and related side-effects.
“If you miss a dose or develop immunity against the drug, there is no other option to cure TB and death is inevitable. Hence, it was not an easy task for doctors to prescribe the drug and they chose to stick with the regular treatment regimen,” said Dr K.K. Aggarwal, former president of the Indian Medical Association.