CDSCO Approves India's First Dengue Vaccine Qdenga®
The Central Drugs Standard Control Organisation (CDSCO), under the Ministry of Health and Family Welfare, has granted marketing authorisation for India's first dengue vaccine - Dengue Tetravalent Vaccine (Live, Attenuated) Qdenga®. The vaccine is manufactured by Takeda GmbH, Germany and will be imported by Takeda Biopharmaceuticals India Pvt. Ltd.
The approval was granted on July 21, 2026 after comprehensive scientific evaluation of the vaccine's quality, safety and efficacy under the Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945. Qdenga® is a recombinant live attenuated tetravalent dengue vaccine produced using recombinant DNA technology in Vero cells, with genes encoding serotype-specific surface proteins engineered into a dengue virus type-2 backbone. The product contains genetically modified organisms and is supplied as a freeze-dried powder for reconstitution.
The vaccine is indicated for prevention of dengue disease in individuals aged 4 to 60 years, with a recommended immunization schedule of two 0.5 ml doses administered subcutaneously at an interval of three months (0 and 3 months). The approval is supported by evidence from an extensive global clinical development program including studies in dengue-endemic and non-endemic regions across more than eight countries, with a pivotal Phase III safety and immunogenicity study conducted in the Indian population covering ages 4-60 years.
Qdenga® has already received regulatory approval in 42 countries including the European Union, United Kingdom, Switzerland, Indonesia, Malaysia and Thailand, and holds WHO prequalification status. Globally, more than 24 million doses have been distributed, with post-marketing surveillance data demonstrating a favourable safety profile and no significant safety concerns identified.
This approval marks an important milestone in India's public health response to dengue and is expected to complement existing vector control, surveillance, early diagnosis and case management measures under the National Vector Borne Disease Control Programme. The Ministry reaffirmed its commitment to ensuring timely access to safe, effective and quality-assured vaccines through robust science-based regulatory frameworks.