BackHealth ministry approves new tuberculosis drug
The technical group on tuberculosis in the health ministry has given approval to Delamanid, which is in its phase 3 clinical trials
PremiumNew Delhi: Perturbed by the increasing number of multi-drug resistant (MDR) and extensive drug resistant (XDR) tuberculosis cases in India, the health ministry has approved the use of a new drug in the treatment of such cases.
The technical group on tuberculosis in the ministry of health has given approval to Delamanid, which is in its phase 3 clinical trials.
“We are losing a lot of patients to XDR and MDR tuberculosis. We need more than one drug for treating patients in the backdrop of increasing drug resistance in patients. Delmanid proved to be a good alternative. We will initially conduct a trial with this drug on over 400 patients in a controlled manner," said Jagdish Prasad, director general of health services in the ministry.
“Currently, around 50% of patients don’t respond to tuberculosis treatment. Delamanid has proved effective in many clinical trials in South Africa and Japan. Taking a cue from this, we are expecting that over 70-80% patients will respond to tuberculosis treatment," he said.
The bactericidal drug (that kills Tuberculosis bacteria) will be included in the Revised National TB Control Program (RNTCP) from this month in parallel to Bedaquiline, another therapy.
“The government may not replace Bedaquiline with Delamanid because there is always a need for alternative drugs for combating tuberculosis. Both the drugs will be used in parallel. Those who are given Bedaquiline will not be given Delamanid and vice versa," said Prasad.
Bedaquiline was launched by the ministry of health in 2016 and is currently available for patients in five cities—Mumbai, Delhi, Guwahati, Chennai and Ahmedabad.
“Though both Delamanid and Bedaquiline are in phase 3 trials but globally the research results have been promising. In fact, in India we are planning to conduct clinical trials by combining both the drugs for the benefit of patients. This has never been explored anywhere in the world," said Soumya Swaminathan, director general of the Indian Council of Medical Research (ICMR) and secretary, department of health research. “We are also planning to cut short the tuberculosis treatment from one year to six months."
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