India approves first dengue vaccine, marks major milestone in disease prevention
CDSCO has approved India's first dengue vaccine, Qdenga, for people aged 4–60 years, adding a major preventive tool to the country's fight against dengue.
Qdenga is a recombinant live attenuated tetravalent dengue vaccine developed using recombinant DNA technology.
NEW DELHI: The Government of India has approved its first dengue vaccine, marking a significant breakthrough in the country’s efforts to combat one of its most widespread mosquito-borne diseases.
The Central Drugs Standard Control Organisation (CDSCO), under the Ministry of Health and Family Welfare, has granted marketing authorisation to Qdenga®, a tetravalent live attenuated dengue vaccine developed by Takeda GmbH, Germany, for the prevention of dengue in individuals aged 4 to 60 years.
The vaccine will be imported and marketed in India by Takeda Biopharmaceuticals India. The approval follows a comprehensive 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 recombinant 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 evaluated the vaccine’s safety, immunogenicity and efficacy in both dengue-endemic and non-endemic countries. Clinical studies were conducted across more than eight countries, including Brazil, Thailand and Sri Lanka, while a pivotal Phase III trial in India assessed the vaccine among individuals aged 4 to 60 years.
Qdenga has already received regulatory approval in 42 countries, including the European Union, the United Kingdom, Switzerland, Indonesia, Malaysia and Thailand, and has also secured World Health Organization (WHO) prequalification. More than 24 million doses have been distributed globally, with post-marketing surveillance reporting a favourable safety profile and no major safety concerns.
The Ministry of Health said the approval represents a major advancement in India’s public health response to dengue and is expected to complement ongoing measures under the National Vector Borne Disease Control Programme, including vector control, disease surveillance, early diagnosis and clinical case management.
With dengue cases continuing to place a seasonal burden on healthcare systems across several states, the availability of an approved vaccine adds an important preventive tool to India’s disease-control strategy. The government said it remains committed to ensuring timely access to safe, effective and quality-assured vaccines through a robust science-based regulatory framework.
