India approves first dengue vaccine amid rising disease burden

Published 20 July 2026 · health

India has approved its first dengue vaccine, giving Japanese drugmaker Takeda Pharmaceutical Co.'s Indian arm, Takeda Biopharmaceuticals India Pvt. Ltd, market authorization for QDENGA. The

India has approved its first dengue vaccine, giving Japanese drugmaker Takeda Pharmaceutical Co.'s Indian arm, Takeda Biopharmaceuticals India Pvt. Ltd, market authorization for QDENGA. The Drug Controller General of India (DCGI) approved the live-attenuated vaccine for people aged 4-60 under the CT-20, New Drugs and Clinical Trials (NDCT) Rules, 2019, Takeda India said in a statement on Monday. QDENGA can be administered without pre-vaccination screening, regardless of prior dengue exposure. Also Read | India bets ₹10,000 crore on a leap from generic drugs to biologics The approval marks a new step in dengue prevention in India, where there is no specific treatment for the disease and patients are treated based on symptoms. Dengue can also progress rapidly to severe, life-threatening complications requiring hospitalization. A mosquito-borne viral disease, Dengue is found in more than 125 countries. India accounts for nearly one-third of the global dengue burden.

Reported cases exceeded 113,000 in 2025, but modelling analyses suggest the actual burden could be far higher, potentially representing tens of millions of infections each year. The gap between reported cases and the likely scale of infection reflects the difficulty of tracking a disease that is now widespread, with rapid urbanization and climate factors adding to the pressure on healthcare systems. Meanwhile, indigenous clinical candidates. including targeted vaccine developments by domestic manufacturers like Panacea Biotec, Bharat Biotech, the Serum Institute of India, and Indian Immunologicals, remain in various stages of clinical trials as India looks to expand its future preventative arsenal. Also Read | Drug lab rejects Bio-Med rabies vaccine batch over quality issues Seven years of data “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,” said Dr. Mahender Nayak, head of Intercontinental Markets, Takeda India.

According to Nayak, QDENGA has been approved in 43 countries since its launch in 2022, with more than 32 million doses distributed globally. Nayak said the company would work with public health authorities, healthcare professionals and other partners to support equitable and sustainable access to the vaccine in India. “India carries a substantial dengue burden, and all four dengue virus serotypes have been documented as co-circulating in several regions.” said Dr. Goh Choo Beng, medical affairs head Southeast Asia and India Cluster, Takeda. Choo Beng added that QDENGA's approval would complement existing dengue-prevention measures, including vector control, surveillance and community awareness. The company said the Indian approval was based on Takeda’s global clinical development programme, which involved 19 phase 1, 2 and 3 clinical trials with more than 28,000 participants in endemic and non-endemic regions. The pivotal phase III TIDES (DEN-301) trial evaluated the vaccine in more than 20,000 participants across eight countries.