India being a signatory to the World Health Organisation (WHO) Global End TB Strategy, the country should have a 90 per cent reduction in TB incidence and mortality by 2035 and an elimination of catastrophic health expenditure.
Amid mounting international pressure on India to handle Tuberculosis (TB) on a priority basis, and unmet targets of the government, the Indian Council of Medical Research (ICMR) has decided to conduct clinical trials for evaluating current vaccines and drugs for TB.
India being a signatory to the World Health Organisation (WHO) Global End TB Strategy, the country should have a 90 per cent reduction in TB incidence and mortality by 2035 and an elimination of catastrophic health expenditure.
"It is evident now that such a reduction cannot be achieved only with the existing tools and strategies. There is a strong need to undertake active research activities so as to identify newer Anti Tuberculosis Treatment (ATT) drug regimes, evaluate new drugs, test TB vaccines, and validate new diagnostics tools," a senior ICMR officials said.
The ICMR is looking at research results to guide cost effective treatment guidelines for local needs and the TB control program. "Keeping in view the stringent national and international guidelines for conduct of clinical trials, ICMR has decided to initiate conduct of clinical trials for regulatory submissions and for academic purposes," the ICMR officials said. It will loop in government hospitals, medical colleges, research institutions, organizations, private hospitals, and practitioners for the research.
The list of proposed clinical trials include: phase-I trials — efficacy study of rifampicin (450mg and 600mg) and Piperine (225mg) compared with standard rifampicin therapy in newly diagnosed sputum positive pulmonary tuberculosis patients as an adjuvant to the standard TB therapy; a phase II —open label randomised controlled clinical trial to evaluate the safety, tolerability, pharmacokinetics and anti-bacterial activity of high dose rifampicin when given along with other anti-TB drugs in adults with newly diagnosed pulmonary tuberculosis.
Also, a phase-III — multicentric open label randomised clinical trial to assess the efficacy and safety of delamanid in combination with bedaquiline, linezolid and clofazimine in participants with XDR-TB; and inhibition of host-induced mycobacterial efflux pumps as a novel strategy to counter drug tolerance and virulence of pulmonary tuberculosis are also proposed.
According to WHO, India tops the list of the world's missed TB cases. Almost 24 per cent of the world's missed TB cases are from India, and 50 per cent of detected cases are not reported. According to TB India 2016 Annual Report, the incidence of TB had declined from 216 to 167 per one lakh population. On an average, TB has declined at 0.91 per cent per year over the last 24 years.
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
 "Tuberculosis")
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
)
){kind=small}
){kind=small}
)
)
)
)
)
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}