Takeda Biopharmaceuticals India Pvt. Ltd. on Monday announced that the Drug Controller General of India (DCGI) has granted market authorisation for QDENGA (TAK-003), making it the first dengue vaccine approved in India. Cleared for use in individuals aged 4-60 years, the vaccine can be administered regardless of prior dengue infection and does not require pre-vaccination screening, marking a significant milestone in the country’s dengue prevention efforts.
The approval comes as India continues to face a rising dengue burden, with reported cases increasing 11-fold over the past two decades. India accounts for nearly one-third of global dengue cases, with more than 1.13 lakh reported infections in 2025, although modelling studies suggest the actual annual burden is significantly higher. QDENGA, a live-attenuated tetravalent vaccine targeting all four dengue virus serotypes, is administered in a two-dose regimen three months apart and is recommended by the World Health Organization for use in dengue-endemic settings. The vaccine has now been approved in 43 countries, with more than 32 million doses distributed globally through public and private immunisationprogrammes.
The approval is based on Takeda’s clinical development programme spanning 19 Phase I, II and III trials involving over 28,000 participants. The pivotal Phase III TIDES study reported 80.2% efficacy against virologically confirmed dengue after 12 months and 90.4% efficacy against dengue-related hospitalisation after 18 months, with long-term data showing sustained protection and safety for up to seven years. A separate Phase III study in India also confirmed the vaccine’s safety, tolerability and immunogenicity in adults, adolescents and children.
Siliguri is expected to be an important market for QDENGA as the city serves as the healthcare and commercial hub for North Bengal and the Northeast. With increasing awareness of dengue prevention, expanding private healthcare infrastructure and seasonal outbreaks across the region, hospitals, paediatricians and vaccination centres in Siliguri are likely to see growing interest in preventive immunisation. Industry observers believe the launch could strengthen access to advanced dengue prevention solutions while supporting the region’s expanding healthcare market.
Takeda said it will work closely with Indian regulatory authorities, healthcare professionals and public health stakeholders to support the phased availability of QDENGA and strengthen dengue prevention through surveillance, awareness, vector control and community engagement initiatives.
