TB patients are desperate for access to a patented drug. Govt must act now

Afflicting over 22 lakh Indians and killing nearly 220,000 every year, Tuberculosis is no doubt a deadly disease that requires serious, constant attention.

If that wasn't dire enough, India also has the most drug-resistant cases of TB in the world after China, with the latest available data putting the number at 248,000 in 2013.

As a share of the country's total population, this number might appear small but that by no means makes drug-resistant TB less serious a national malady. Its treatment does, after all, consume nearly 40% of the annual budget for the Revised National Tuberculosis Control Programme, the TB control initiative run by the central government.

Also Read: Out of 22 countries, India ranks 14th in TB prevalence

To tackle the rising incidence of drug-resistant TB, its survivors and various public health groups have written to the health ministry for incorporating the patented drug Delamanid into the RNTCP. Delamanid has proved effective in treating drug-resistant TB.

"People living with MDR and XDR are receiving inadequate treatment in India," says Paul Lhungdim of the Delhi Network of Positive People, using the acronyms for multidrug-resistant TB and extensively drug-resistant TB. "Often people die as they can't access the medication needed to compose a suitable treatment regimen for them. Otsuka has denied us access to the new anti-TB drug Delamanid for a really long time."

Now, public health groups are urging the government to direct Otsuka, the manufacturer of Delamanid, to register the drug and ensure it's supplied for the RNTCP. "If the pharmaceutical corporation does not make the drug available in the country, the health ministry should proceed to find generic suppliers for government use. Doing so will save many thousands of lives," Lhungdim adds.

People with drug-resistant TB require a minimum nine months of treatment that can extend up to two years. The treatment regimen includes continuous intake of pills and injections.

Two pharmaceutical companies, Jannsen, the pharmaceutical division of Johnson & Johnson, and Otsuka, have developed drugs - Bedaquiline and Delamanid, respectively - that can improve treatment outcomes, and have been recommended by the WHO.

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Both firms, however, have patented their drugs and, thus, enjoy monopoly over their pricing and distribution. But if the health ministry heeds the public appeal and includes Otsuka's drug into the RNTCP programme, India would be able to treat its TB patients much more effectively.

"Otsuka has not initiated the process of making Delamanid available in the Indian market. Not working the patents on Delamanid is adversely affecting people living with drug-resistant TB. The government should intervene and direct Otsuka to provide the drug under the country's TB programme," says Anand Grover of the Lawyers Collective.

Currently, India has barely enough Bedaquiline to treat about 300 patients. The cache was acquired under a USAID donation programme and would be distributed through five centres under the TB programme. Delamanid is yet to be incorporated into the programme although the drug was patented over eight years ago.

As per RNTCP regulations, Bedaquiline would be available only at the TB programme's centres in Delhi, Mumbai, Ahmedabad, Chennai and Guwahati. However, early this month, the Delhi High Court, ruling on the petition of a MDR-TB patient, ordered that residential proof or domicile is not necessary to access a life-saving drug.

"Patents are not granted merely to enable the patentee to enjoy a monopoly, but on the condition that the patentee make the drug available in the country. Yet more than eight years since Delamanid was first granted a patent in India, the drug is still not accessible to TB patients diagnosed with drug-resistant TB," says Leena Menghaney at Médecins Sans Frontières' Access Campaign for affordable drugs.

"The recent case before the Delhi High Court highlights the urgent need for newer TB drugs to be made accessible to patients with MDR-TB or XDR-TB as a matter of right. Delamanid is a critical new medicine for managing various forms of drug-resistant TB, especially for younger patients, so its non-availability is unacceptable," says Dr Gopal Dabade of the All India Drug Action Network.

Also Read: New tuberculosis drug, Bedaquiline, in the offing, but not a panacea