Published Jul 20, 2026 | 2:14 PM ⚊ Updated Jul 20, 2026 | 2:14 PM
Qdenga Dengue Vaccine. (Supplied)
Synopsis: India has approved its first dengue vaccine, Qdenga, for individuals aged 4 to 60 years after the DCGI granted market authorisation to Takeda Biopharmaceuticals India. The vaccine protects against all four dengue virus serotypes without requiring prior infection screening, marking a major step forward in dengue prevention and public health preparedness.
India has approved its first dengue vaccine, with the Drug Controller General of India (DCGI) granting market authorisation to Takeda Biopharmaceuticals India’s Qdenga for the prevention of dengue in individuals aged four to 60 years.
The approval, granted under the New Drugs and Clinical Trials (NDCT) Rules, 2019, marks a significant milestone in India’s efforts to combat dengue, a mosquito-borne viral disease that continues to place a heavy burden on the country’s healthcare system. India accounts for nearly one-third of the global dengue burden.
Qdenga is the first dengue vaccine approved in India that can be administered regardless of an individual’s previous dengue infection status. Unlike some earlier dengue vaccines, it does not require pre-vaccination screening, making it easier to deploy in routine immunisation and public health settings if adopted by health authorities.
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It is a tetravalent, live-attenuated vaccine designed to provide protection against all four dengue virus serotypes. The vaccine is administered as two subcutaneous doses of 0.5 mL each, given three months apart.
The DCGI’s decision follows recommendations made earlier this year by the Subject Expert Committee (SEC) on Vaccines under the Central Drugs Standard Control Organisation (CDSCO), after reviewing Indian clinical trial data alongside extensive global evidence.
The approval is supported by Takeda’s global clinical development programme, which included 19 Phase I, II and III clinical trials involving more than 28,000 participants across dengue-endemic and non-endemic regions. This included the pivotal Phase III TIDES (DEN-301) trial, which evaluated the vaccine in over 20,000 participants across eight countries and demonstrated long-term safety and efficacy.
Indian regulatory approval was also based on a Phase III clinical trial conducted in the country among individuals aged 4 to 60 years. According to Takeda, the study showed that the vaccine was well tolerated, safe and capable of generating an immune response in healthy children, adolescents and adults.
“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 hospitalisation across all four serotypes,” said Dr Mahender Nayak, Head of Intercontinental Markets at Takeda in a statement.
Peter Streibl, General Manager, Southeast Asia and India Cluster, said dengue requires coordinated regional action beyond vaccination alone.
“Takeda is committed to working with governments, public health authorities, healthcare professionals and partners across South and Southeast Asia, not only to support access to Qdenga, where approved and recommended, but also to strengthen broader dengue prevention efforts, including surveillance, awareness, vector control and community engagement,” he said in the statement.
Dr Goh Choo Beng, Medical Affairs Head, Southeast Asia and India Cluster, said all four dengue virus serotypes circulate in several parts of India, making broad protection important.
“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,” he said in the statement.
Qdenga has already been approved in 43 countries across Asia, Latin America and Europe and is recommended by the World Health Organization for use in dengue-endemic settings. More than 32 million doses have been distributed globally through public and private immunisation programmes.
Takeda said it will now work with Indian regulatory authorities, public health stakeholders and healthcare providers to support the planning and availability of the vaccine across the country. Earlier, the company also entered into a manufacturing partnership with Hyderabad-based Biological E to produce Qdenga in India for domestic use and global supply.
(Edited by Sumavarsha)
