In a significant step towards strengthening India’s fight against dengue, the Central Drugs Standard Control Organisation (CDSCO) has granted marketing authorisation to the country’s first dengue vaccine, Qdenga®, for the prevention of dengue disease in individuals aged 4 to 60 years.
The vaccine, developed by Takeda GmbH, Germany, will be imported and marketed in India by Takeda Biopharmaceuticals India Pvt. Ltd. The approval has been granted by the CDSCO under the Ministry of Health and Family Welfare following a comprehensive scientific evaluation of its 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 manufactured in Vero cells using a dengue virus type-2 backbone engineered with serotype-specific surface proteins. The vaccine is supplied as a freeze-dried powder for reconstitution and is administered through a subcutaneous injection.
The approved immunisation schedule consists of two doses of 0.5 ml each, to be administered three months apart.
The approval is backed by extensive global clinical evidence evaluating the vaccine’s safety, immunogenicity and efficacy across dengue-endemic as well as non-endemic regions. Clinical studies involved participants from more than eight countries, including Brazil, Thailand and Sri Lanka. The evaluation also included a pivotal Phase III study conducted in India involving individuals aged 4 to 60 years.
According to the Ministry of Health and Family Welfare, the vaccine has already secured regulatory approval in 42 countries, including the European Union, the United Kingdom, Switzerland, Indonesia, Malaysia and Thailand, and has received World Health Organization (WHO) prequalification. More than 24 million doses have been distributed globally, with post-marketing surveillance indicating a favourable safety profile and no significant safety concerns.
The ministry said the approval marks an important milestone in India’s public health response to dengue and is expected to complement ongoing efforts under the National Vector Borne Disease Control Programme, including vector control, disease surveillance, early diagnosis and effective case management.
