India has approved its first dengue vaccine, with the Drug Controller General of India (DCGI) granting market authorisation to Takeda Biopharmaceuticals India Pvt. Ltd.’s QDENGA (TAK-003) for the prevention of dengue in individuals aged 4 to 60 years. The approval comes amid a sharp rise in dengue cases, with reported infections increasing 11-fold over the past two decades. India accounts for nearly one-third of the global dengue burden, with over 1.13 lakh cases reported in 2025.
QDENGA is designed to protect against all four dengue virus serotypes and can be administered without prior dengue infection or pre-vaccination testing. The vaccine is given in two doses, three months apart, and is recommended by the World Health Organization for use in dengue-endemic regions without pre-vaccination screening. It has already been approved in 43 countries, with more than 32 million doses distributed through public and private immunisationprogrammes worldwide.
The approval is backed by Takeda’s global clinical programme involving over 28,000 participants. The Phase III TIDES trial demonstrated 80.2% efficacy against virologically confirmed dengue one year after the second dose and 90.4% efficacy against dengue-related hospitalisation after 18 months. Long-term data also showed sustained protection and safety for up to seven years.
In Asansol, the approval could strengthen dengue prevention efforts in eastern India, where seasonal outbreaks frequently put pressure on hospitals. Experts say the vaccine could complement existing mosquito-control measures and public awareness campaigns, particularly in urban and industrial regions vulnerable to vector-borne diseases. Availability of the vaccine is also expected to create opportunities for private healthcare providers once commercial rollout begins.
Takeda said it will work with Indian regulators, public health authorities and healthcare providers to support the planning and availability of QDENGA across the country.
