India has approved its first vaccine for the prevention of dengue, marking a significant step in the country’s fight against this mosquito-borne disease. The Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health and Family Welfare, has granted marketing approval for ‘Qdenga’. It is a ‘live, attenuated tetravalent’ dengue vaccine developed by the German company Takeda GmbH and will be imported by Takeda Biopharmaceuticals India Pvt. Ltd.
This vaccine has been approved for individuals aged 4 to 60 years and will be administered in two 0.5 ml doses, spaced three months apart. This approval follows a rigorous assessment of the vaccine’s quality, safety, and efficacy under India’s ‘Drugs and Cosmetics Act’ and associated regulations.
This decision is based on data from global clinical trials conducted across several dengue-endemic and non-endemic countries, as well as a Phase III study involving Indian participants. Qdenga has already received regulatory approval in 42 countries and obtained pre-qualification from the World Health Organization (WHO), additionally, more than 24 million doses have been distributed worldwide.
Health officials stated that this vaccine is expected to further strengthen India’s dengue prevention strategy. It will prove beneficial in complementing existing measures such as vector control, disease surveillance, early detection, and clinical management.
(PIB)
