India approves first dengue vaccine for ages 4 to 60 years
India has approved its first dengue vaccine, the Dengue Tetravalent Vaccine (Live, Attenuated) – Qdenga. The Central Drugs Standard Control Organisation (CDSCO) granted marketing authorisation for the vaccine, which will be imported by Takeda Biopharmaceuticals India Pvt. Ltd. from Takeda GmbH, Germany.
The vaccine is indicated for the prevention of dengue in individuals aged 4 to 60 years. In a statement issued on Tuesday (July 21, 2026), the Union Health Ministry said that the approval was granted after a comprehensive scientific evaluation of the vaccine's quality, safety and efficacy in accordance with the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945.
Qdenga is a live, attenuated tetravalent dengue vaccine developed using recombinant DNA technology. It is produced in Vero cells, with genes encoding serotype-specific surface proteins engineered into a dengue virus type-2 backbone. The product contains genetically modified organisms (GMOs).
It is supplied as a freeze-dried powder for reconstitution and is administered as a subcutaneous injection. The recommended immunisation schedule consists of two doses of 0.5 ml each, administered at an interval of three months (0 and 3 months).
The Ministry said that the approval is supported by evidence from an extensive global clinical development programme evaluating the vaccine's safety, immunogenicity and efficacy across dengue-endemic and non-endemic regions. Clinical studies involved participants from more than eight countries, including Brazil, Thailand and Sri Lanka. A pivotal Phase III safety and immunogenicity study was conducted in the Indian population covering individuals aged 4 to 60 years.
The vaccine has already received regulatory approval in 42 countries, including the European Union, the United Kingdom, Switzerland, Indonesia, Malaysia and Thailand. It has also received World Health Organization (WHO) prequalification.
Globally, more than 24 million doses of the vaccine have been distributed. Post-marketing surveillance data from countries where the vaccine is in use have demonstrated a favourable safety profile, with no significant safety concerns identified.
The Ministry stated: “The approval of the country’s first dengue vaccine marks an important milestone in India’s public health response to dengue and is expected to complement the ongoing vector control, surveillance, early diagnosis and case management measures being implemented under the National Vector Borne Disease Control Programme.”
