GUWAHATI: The Central Drugs Standard Control Organisation (CDSCO) has approved Qdenga®, India's first vaccine for the prevention of dengue, for individuals aged 4 to 60 years.
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Manufactured by Takeda GmbH, Germany, and imported by Takeda Biopharmaceuticals India Pvt. Ltd., the vaccine received marketing authorisation from the Ministry of Health and Family Welfare after a scientific evaluation of its quality, safety and efficacy under the provisions of 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 vaccine is supplied as a freeze-dried powder for reconstitution and is administered as a subcutaneous injection.
The approved immunisation schedule consists of two doses of 0.5 ml each, administered three months apart.
The approval is backed by an extensive global clinical development programme that assessed the vaccine's safety, immunogenicity and efficacy across both dengue-endemic and non-endemic regions. Clinical trials involved participants from more than eight countries, including Brazil, Thailand and Sri Lanka, along with a pivotal Phase III safety and immunogenicity study in India involving individuals aged 4 to 60 years.
Qdenga® has already been approved in 42 countries, including the European Union, the United Kingdom, Switzerland, Indonesia, Malaysia and Thailand, and has also received World Health Organization (WHO) prequalification. Globally, more than 24 million doses of the vaccine have been distributed. According to post-marketing surveillance data, the vaccine has demonstrated a favourable safety profile, with no significant safety concerns reported.
The approval marks a significant milestone in India's public health response to dengue and is expected to strengthen ongoing efforts under the National Vector Borne Disease Control Programme, complementing existing measures such as vector control, disease surveillance, early diagnosis and case management.
The Ministry of Health and Family Welfare said it remains committed to ensuring timely access to safe, effective and quality-assured vaccines and medicines through a robust, science-based regulatory framework.