The World Health organisation (WHO) may have included miracle drug Delamanid on the list of medicine recommended for the treatment of highly drug resistant tuberculosis (TB) since April 2014, but it remains out of reach to the thousands of patients in the country. The sector has now urged the Government to find its generic suppliers for the national anti-TB programme to save them from early deaths.
Delamanid is a critical new medicine to manage multi-drug resistant (M/XDR) TB especially for younger patients and is not easily available as currently Japanese company Ostuka Pharmaceuticals Co ltd holds monopoly over the drug. The drug has to be imported when needed.
In a recent letter to the Union Health Ministry, drug-resistant TB (XDR-TB) survivors, networks of people living with HIV and public health organisations have sought inclusion of the life-saving anti-TB drug into its Revised National Tuberculosis Control Programme at the earliest.
Bedaquiline, which is also beneficial in treating MDR-XDR cases, is already registered in India for use in the TB Programme, however Delamanid is yet to be registered here.
"Otsuka has denied us access to Delamanid drug for a really long time. We urge the Government to direct the company to register the drug and to ensure that it is supplied to the TB Programme.
"If the pharmaceutical corporation does not make the drug available in the country, the Ministry should work to find generic suppliers for Government use. Doing so will save many thousands of lives, said Paul lhungdim from Delhi Network of Positive People.
Dr Gopal Dabade, All India Drug Action Network talked about the recent court case before the Delhi High Court which highlighted the urgent need for newer TB drugs to be made accessible to patients who have developed resistant to routine anti-TB drugs.
“It is high time that both the Japanese pharmaceutical corporation Otsuka and the concerned health authorities prioritise access to it to the public in need, and promote rational use of anti TB drugs,” he added.
“Otsuka Pharmaceuticals has not initiated the process of making delamanid available in the Indian market. Not working the patents on Delamanid is adversely affecting the patients. The Government should intervene and direct Otsuka to provide the drug under the RNTCP," said Anand Grover, lawyers Collective leena Menghaney, Medecins Sans Frontieres (MSF) Access Campaign noted that patents are not granted merely to enable the patentee to enjoy a monopoly, but on the condition that the patent holder make the drug available in the country. "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 strains," she said.
She noted that it was beyond unacceptable to know that there are medicines out there that could offer hope to people with DR-TB who have exhausted all other treatment options, but that so few people have access to them. What's the point of a new potentially life-saving treatment if the people who need it the most cannot access itIJ