Published: Business Standard| Source: PTI , January 28, 2017
Health groups have asked the Centre to incorporate the life-saving anti-TB drug ‘delamanid’ into its Revised National Tuberculosis Control Programme.
In a letter to the Health Ministry, the groups have asked the government to direct a Japanese pharmaceutical company that holds monopoly control over the drug, to register ‘delamanid’ in India without delay.
“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, 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 strains.
“It is 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 is the point of a new potentially life-saving treatment if the people who need it the most cannot access it?,” said Leena Menghaney, Medecins Sans Frontieres (MSF) Access Campaign.
India has some of the highest prevalence of both drug-sensitive (DS-TB) and drug-resistant forms of TB (DR-TB), including multidrug-resistant (MDR-TB) and extensively drug-resistant tuberculosis (XDR-TB) in the world.
In most cases, DR-TB patients face a minimum of nine months of treatment, usually closer to two years, during which they must swallow more than 10,000 pills in addition to six to eight months of painful injections. Side effects caused by the drugs are horrendous, ranging from persistent nausea to deafness and psychosis, MSF said.
It said that there is a “desperate” need for new drugs to improve not just treatment outcomes but also to provide safer alternatives to the most toxic DR-TB drugs.
“Today there is reason for hope with the first two new drugs to be developed for TB in nearly fifty years, bedaquiline (marketed by Janssen / J&J) and delamanid (marketed by Otsuka).
“Both of these drugs have shown strong potential to vastly improve treatment outcomes and have been recommended by the World Health Organization (WHO),” MSF said.
Bedaquiline has been registered in India for use in the TB Programme and the Health Ministry has accepted delivery of 300 treatments under a USAID donation programme.
The drug is strictly regulated and is being rolled out through six centres as per eligibility criteria laid down in the PMDT guidelines, MSF said.