Delamanid, one of the most sought after drugs for tuberculosis treatment, is set to roll out in over four months in India in a controlled manner to treat extremely resistant cases of the infectious disease. According to Indian Council of Medical Research (ICMR), the drug manufacturer Otsuka Pharmaceutical has approached the Drug Controller General of India for approval. “The drug should be made available in three or four months. But its use will be controlled,” said Dr Saumya Swaminathan, director ICMR.
In 2016, the Ministry of Health and Family Welfare rolled out Bedaquiline drug for treatment of drug resistant TB for 600 patients across India. It has been made available in five cities– Delhi, Mumbai, Chennai, Guwahati and Ahmedabad– since February 2016 but only over 200 patients have been put on treatment.
In Mumbai, Hinduja Hospital has already procured Delamanid on a case-by-case basis to treat patients that have stopped responding to most of first and second line drugs.
With risk of bacterial resistance to this new class of drug, the government is cautious against rolling it out for every TB patient. Like Bedaquiline, Delamanid’s treatment will be limited to few cities and certain category of patients. Patients with heart ailments, minors and those who are sensitive to first and second line of drugs will not be enrolled.
India accounted for 2.8 million new TB cases in 2015, an increase from 2.2 million in 2014. Every year over 99,000 new drug resistant patients are diagnosed. According to WHO, drug resistant cases are escalating demanding long treatment duration and chances of higher drop outs.
ICMR is also going to research on Bedaquiline resistance in Indian population. A national drug resistance survey is underway to assess 13 drugs used under government-run Revised National Tuberculosis Control Programme. About 5,000 patients who are undergoing treatment at public hospitals will be part of the survey.
“Clinical trials are also underway to reduce treatment duration of drug resistant TB from two years to six months,” Swaminathan said.