India has approved its first dengue vaccine, QDENGA, developed by Takeda GmbH, Germany, and imported by Takeda Biopharmaceuticals India Pvt. Ltd. The Central Drugs Standard Control Organisation (CDSCO) granted marketing authorisation on July 21, 2026, after a comprehensive scientific evaluation of the vaccine’s quality, safety and efficacy.
QDENGA is a live, attenuated tetravalent dengue vaccine developed using recombinant DNA technology. It is designed to protect against all four dengue virus serotypes and is supplied as a freeze-dried powder for reconstitution. The vaccine is administered as a subcutaneous injection.
The vaccine has been approved for individuals aged 4 to 60 years. The recommended immunisation schedule consists of two doses of 0.5 ml each, administered three months apart. The approval is supported by extensive global clinical studies conducted in more than eight countries, including Brazil, Thailand and Sri Lanka, along with a pivotal Phase III trial in India.
Globally, QDENGA has already received regulatory approval in 42 countries and has been prequalified by the World Health Organization (WHO). More than 24 million doses have been distributed worldwide, with post-marketing surveillance data confirming a favourable safety profile.
The Health Ministry stated that the approval of India’s first dengue vaccine marks a significant milestone in public health and will complement existing dengue control measures such as vector control, disease surveillance, early diagnosis and case management under the National Vector Borne Disease Control Programme.
