KEDA’S QDENGA (TAK-003) BECOMES THE FIRST DENGUE VACCINE TO BE APPROVED IN INDIA, MARKING A NEW ERA IN DENGUE PREVENTION

Face2News/Ludhiana

Takeda Biopharmaceuticals India Pvt. Ltd. today announced that the Drug Controller General of India (DCGI) has granted market authorization (CT-20, New Drugs and Clinical Trials (NDCT) Rules, 2019) for QDENGA, Takeda’s dengue vaccine for the prevention of dengue disease in individuals aged 4–60. QDENGA is the first dengue vaccine approved in India and can be used in individuals regardless of previous dengue exposure, without the need for pre-vaccination testing.

This approval marks an important step in strengthening dengue prevention efforts in India, where the disease remains a significant public health challenge.

Dengue is a mosquito-borne viral disease that poses a significant global public health threat, with prevalence in over 125 countries. India accounts for nearly one-third of the global dengue burden.[ii] In 2025, reported cases exceeded 113,000, but modelling analyses suggest the dengue burden in India appears to be higher than reported, likely representing tens of millions of infections each year.[iii] [iv]

Dr. Mahender Nayak, Head of Intercontinental Markets said, “Dengue is a growing public health challenge, and India needs sustained, evidence-based prevention. The latest seven-year data for QDENGA show continued protection against dengue infection and hospitalization across all four serotypes; an important milestone for communities and health systems.

Since its launch in 2022, QDENGA has been approved in 43 countries, with more than 32 million doses distributed globally. This approval marks an important step forward in strengthening dengue prevention in India. Building on Takeda’s 245-year heritage and more than 70 years of vaccine expertise, we remain committed to working with public health authorities, healthcare professionals, and partners to support equitable and sustainable access.”

Peter Streibl, General Manager, Southeast Asia and India Cluster said, “Dengue is a shared regional challenge that requires collaboration across borders and sectors.

Dr. Goh Choo Beng, Medical Affairs Head Southeast Asia & India Cluster said, “India carries a substantial dengue burden, and all four dengue virus serotypes have been documented as co-circulating in several regions. QDENGA is designed to protect against all four serotypes, regardless of prior exposure.