NEW DELHI: In a major step towards dengue prevention, the Central Drugs Standard Control Organisation (CDSCO) has approved Japanese drug maker Takeda Pharmaceutical's QDENGA (TAK-003), making it the first dengue vaccine to receive approval in India.
The company said the vaccine has now been approved in 43 countries, including India, and more than 32 million doses have been distributed globally through public and private programmes.
“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,” the company said in a statement.
QDENGA is a tetravalent live-attenuated vaccine designed to protect against all four dengue virus serotypes. It is administered as two subcutaneous doses, three months apart, and can be given without pre-vaccination testing or prior dengue exposure.
According to the company, reported dengue cases in India have increased 11-fold over the past two decades. India accounts for nearly one-third of the global dengue burden. More than 1.13 lakh dengue cases were reported in 2025, although modelling studies suggest the actual number of infections may be much higher.
QDENGA is recommended by the World Health Organization for use in dengue-endemic areas and has also received WHO prequalification.
According to Dr. Mahender Nayak, Head of Intercontinental Markets, “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.”
“This approval marks an important step forward in strengthening dengue prevention in India.”
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. 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.”
The approval is based on Takeda's global clinical development programme involving 19 Phase 1, 2 and 3 clinical trials with more than 28,000 participants.
The Phase III TIDES (DEN-301) trial involving more than 20,000 participants across eight countries showed an overall vaccine efficacy of 80.2% against virologically confirmed dengue 12 months after the second dose.
The study also showed 90.4% efficacy against dengue-related hospitalisation at 18 months and 84.1% efficacy in preventing dengue-related hospitalisation after 4.5 years. The vaccine has also demonstrated sustained safety and efficacy for up to seven years across all four dengue virus serotypes.
The approval was further supported by data from a Phase III trial conducted in India among people aged 4 to 60 years, which found the vaccine to be safe, well tolerated and immunogenic.
QDENGA is already part of Brazil's National Immunization Program and is available through public programmes in Argentina, Colombia and Indonesia.
The company said it will continue to work with Indian regulatory authorities, public health stakeholders and healthcare providers to support the rollout of QDENGA in India.