Takeda Biopharmaceuticals India announced that the Drug Controller General of India (DCGI) has granted market authorization for QDENGA, the company's dengue vaccine, for the prevention of dengue disease in individuals aged 4–60 years under the New Drugs and Clinical Trials (NDCT) Rules, 2019.

The approval marks the first authorization of a dengue vaccine in India. QDENGA can be administered regardless of previous dengue infection and does not require pre-vaccination screening, representing a significant milestone in the country's efforts to combat one of its most pressing vector-borne diseases.

India accounts for nearly one-third of the global dengue burden. 

While more than 113,000 dengue cases were officially reported in 2025, modelling studies suggest the actual number of infections could run into tens of millions annually, highlighting the need for enhanced preventive strategies.

Dr. Mahender Nayak, Head of Intercontinental Markets at Takeda, 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. 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."

Peter Streibl, General Manager, Southeast Asia and India Cluster at Takeda, emphasized regional collaboration, stating that the company will continue working with governments, healthcare professionals and public health authorities across South and Southeast Asia to support equitable vaccine access alongside surveillance, vector control, public awareness and community engagement initiatives.

Highlighting the scientific significance of the approval, Dr. Goh Choo Beng, Medical Affairs Head, Southeast Asia & India Cluster, noted that all four dengue virus serotypes co-circulate across several parts of India, making broad protection essential. He said QDENGA's approval strengthens India's comprehensive dengue prevention strategy alongside existing public health interventions.

The Indian approval is supported by Takeda's global clinical development program comprising 19 Phase I, II and III clinical trials involving more than 28,000 participants. 

The pivotal Phase III TIDES (DEN-301) study, conducted in over 20,000 participants across eight countries, demonstrated an overall vaccine efficacy of 80.2% against virologically confirmed dengue one year after the second dose and 90.4% efficacy against dengue-related hospitalization at 18 months. 

After 4.5 years, the vaccine continued to show 84.1% efficacy in preventing dengue-related hospitalizations, while seven-year follow-up data demonstrated sustained safety and protection across all four dengue virus serotypes.

The approval is further supported by findings from the Phase III DEN-302 study conducted in India, which established the vaccine's safety, tolerability and immunogenicity among healthy children, adolescents and adults aged 4–60 years.