Udaipur :Takeda Biopharmaceuticals India Pvt. Ltd. today announced that the Drug Controller General of India (DCGI) has granted market authorization (CT-20, New Drugs andClinical Trials (NDCT) Rules,2019) for QDENGA, Takeda’s dengue vaccinefor the prevention of dengue disease in individuals aged 4–60.QDENGA is the firstdengue vaccine approved in India and can be used in individuals regardless of previous dengue exposure, without the needfor pre-vaccination testing.This approval marks an important step in strengthening dengue prevention efforts in India, where the disease remains a significantpublic healthchallenge.
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.”
Millions of Indiansremain at risk each year due to widespread endemicity,[i] rapid urbanization[ii] and climate-related factors that drive mosquito proliferation.[iii]This has madedengue a year-round public health threat,[iv] with seasonal surges[v] continuing to strain the healthcare systems.[vi]Dengue is also complex to manage, with no specific treatment.[vii]It can rapidly progress to severe, life-threatening complications requiring hospitalization and intensive care.[viii]
Peter Streibl, General Manager, Southeast Asia and India Cluster said, “Dengue is a shared regional challenge that requires collaboration across borders and sectors. Takeda is committed to working with governments, public health authorities, healthcare professionals, and partners across South and Southeast Asia, not only to support access to QDENGA, where approved and recommended, but also to strengthen broader dengue prevention efforts, including surveillance, awareness, vector control, and community engagement. Our aim is to contribute to sustainable, evidence-based solutions that reflect the needs of each country.”
Dr.Goh ChooBeng,Medical Affairs HeadSoutheast 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. Its approval represents an important step in strengthening India’s comprehensive approach to dengue prevention, alongside vector control, surveillance, community awareness and other public health measures.