Two key drugs for drug resistant TB are now essential medicines. But will patients benefit?

The price ceiling of these medicines, also referred to as scheduled drugs, are fixed as per the Drug Price Control Order, 2013.

The move to add some patented drugs in the NLEM has been hailed by many as these crucial drugs have been hard to access for many in India for long. But will the development improve accessibility?

Concerns remain, mainly for delamanid, a drug by Japanese drugmaker Otsuka that is very useful in treating drug resistant tuberculosis (DR-TB) in children and extremely drug resistant tuberculosis (XDR-TB) in adults.

Deepening TB crisis

India has the highest burden of TB and MDR-TB in the world, disproportionately high even for India’s population. As per the annual TB report released in March this year, the country had a total of 19,33,381 new and relapsed tuberculosis patients in 2021.

This also included nearly 1,20,000 multiple drug restsant or MDR TB patients, who are resistant to at least isoniazid and rifampin, the two most potent TB drugs used to treat the disease. Within this pool, nearly 20 percent or about 24,000 patients are identified as XDR TB patients, who, apart from being resistant to isoniazid and rifampin, are also resistant to fluoroquinolone and at least one of three injectable second-line drugs: amikacin, kanamycin and capreomycin.

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It has been estimated that the risk of death due to MDR TB may be 7.5 to 8.5 times higher as compared to TB. In 2020, the bacterial disease had caused 4.93 lakh deaths in India, which was 13 percent higher than the previous year.

MDR, pre-XDR and XDR TB, on top of the more benign form of the ailment, spell trouble for a country that aims to eliminate the bacterial disease by 2025.

Bedaquiline and Delamanid

Bedaquiline, a drug by Johnson & Johnson, which was launched in the Indian market at Rs 7 lakh per vial, is purchased by the Union health ministry’s National TB Elimination programme and provided free of cost to about 60,000 MDR TB patients who reach out to authorised centres for treatment.

This drug has made a name for itself by raising the treatment success rate of MDR TB from around 50 percent to 93 percent and cutting the treatment duration by 75 percent, from 2 years to 6 months, noted infectious disease specialist Dr Ishwar Gilada.

The government, meanwhile, manages to procure just about 8,000 treatments of delamanid, which costs about Rs 1.5 lakh per vial, which means that about 75 percent of the patients needing it may not be getting it.

Leena Menghaney, lawyer and India Head and Global IP Advisor at Medecins Sans Frontieres – Access Campaign, said that including these drugs in the NLEM is a good signal to all health departments that these medicines are essential and important for public procurement.

The key barrier that needs to be addressed, she said, is India’s higher level of fluoroquinolone resistance, which translates into pre-XDR cases and a number of patients who need both bedaquiline and delamanid.

She pointed out that the government started with just 400 treatments of Delamanid which has now been escalated to about 8,000 treatments, but as Mumbai alone has 700-800 cases of the pre-XDR or XDR genome, Maharashtra alone could utilise almost 10 percent of what is being procured centrally.

“So, the government should be cognisant and willing to procure more treatments of bedaquiline and delamanid,” she stressed.

E-mail queries sent to Johnson & Johnson and Otsuka by Moneycontrol on their plans to raise the availability of these two drugs in India have not yielded a response.

Officials in the Union health ministry, too, refused to comment on the issue, saying that the matter is before the Bombay High Court and is subjudice.

Two MDR TB survivors had filed a public interest litigation in the High Court last year seeking directions to the Centre to allow non-commercial production of the two drugs.

A step forward but not far enough

According to pharma analyst Salil Kallianpur, the inclusion of bedaquiline and delamanid in the NLEM is a good move but not enough.

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“Despite TB drugs being given for free, India is home to the highest number of MDR/XDR TB cases,” he said.  “This is because drugs issued through the government national TB programme don’t reach all the needy — inadequate infrastructure and budgets limit its reach.”

He pointed out that the private health sector doesn’t participate in this programme and therefore access to these centres and the two medicines is unlikely to improve if they’re routed via the same suboptimal channels.

According to Kallianpur, the government needs to drastically improve the implementation of the national TB control programme by increasing its budget allocation and should also quickly roll out a daily fixed-dose regimen under direct observation of doctors throughout the country.

“Currently drugs are given away at primary health centres where doctor absenteeism is high,” he added. “The private sector in the country, where at least 50 percent of TB cases are reported, needs to be engaged rapidly and efficiently to distribute free TB drugs, especially bedaquiline and delamanid.”