Kochi: Takeda Biopharmaceuticals announced in a press release that the Drug Controller General of India (DCGI) has granted marketing approval for Qdenga (TAK-003), a dengue preventive vaccine. Company officials specified that the vaccine can be administered to individuals aged between 4 and 60 years without prior testing for dengue history, and it has been developed to provide protection against all four dengue virus serotypes. The approval comes at a time when dengue cases reported in the country have increased 11-fold over the past two decades. India accounts for nearly one-third of the global dengue burden. Statistics indicate that more than 1.13 lakh dengue cases were reported in the country in 2025.
The approval was granted based on global clinical trials involving over 28,000 participants alongside Indian Phase-3 trials. The vaccine is administered in two doses with a three-month interval. The company stated that this vaccine, which is recommended by the World Health Organization, has received approval in 43 countries, including India, and over 32 million doses have been distributed globally. The company also claimed that this is the first dengue vaccine to receive approval in India.
