New Delhi: A dengue vaccine could be one of the first to benefit from a government decision that allows certain drugs and vaccines approved in specified countries to be launched in India without clinical trials. The vaccine, QDenga, is manufactured by Japanese pharmaceutical firm Takeda. Last year, the World Health Organisation (WHO) had recommended QDenga for use in endemic countries.
But in India, the Central Drugs Standard Control Organisation (CDSCO) had earlier this year approved a proposal to conduct a phase 3 trial of QDenga to prove its safety and efficacy in the Indian population. On 7 August, the CDSCO issued an order which said that under rule 101 of the New Drugs and Clinical Trial Rules, 2019, the central government has waived local clinical trials for the approval of new drugs. A Takeda spokesperson told ThePrint, “We are currently in discussions with the Indian regulator for appropriate regulatory approvals and will launch the vaccine post receipt of approval by Indian health authorities, in compliance with all regulatory requirements of the country.
” If that happens, it will be a significant boost for India’s fight against dengue, which featured in the WHO’s 2019 list of top 10 threats to global health, and is a major public health burden in India. Even though QDenga is being seen as a promising preventive tool against all four strains of dengue, lack of robust evidence to support this makes some scientists sceptical. They say that a vaccine being deve.