In a major milestone in India’s fight against dengue, the Central Drugs Standard Control Organisation (CDSCO) has granted marketing authorisation to Qdenga, the country’s first approved vaccine for the prevention of dengue disease.
Developed by Takeda, Germany, the Dengue Tetravalent Vaccine (Live, Attenuated) will be imported and marketed in India by Takeda Biopharmaceuticals India. The approval was issued under the Ministry of Health and Family Welfare following a detailed scientific review of the vaccine’s 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 produced in Vero cells, with genes encoding serotype-specific surface proteins engineered into a dengue virus type-2 backbone. The vaccine contains genetically modified organisms (GMOs) and is supplied as a freeze-dried powder, which is reconstituted before administration as a subcutaneous injection.
The vaccine is approved for individuals aged 4 to 60 years. The recommended vaccination schedule consists of two 0.5 ml doses, given three months apart.
The CDSCO’s approval is backed by data from Takeda’s global clinical development programme, which evaluated the vaccine’s safety, immunogenicity and efficacy in both dengue-endemic and non-endemic regions. Clinical studies included participants from more than eight countries, such as Brazil, Thailand and Sri Lanka. The review also considered findings from a pivotal Phase III safety and immunogenicity study conducted in India involving participants between 4 and 60 years of age.
Qdenga has already secured regulatory approvals in 42 countries, including the European Union, the United Kingdom, Switzerland, Indonesia, Malaysia and Thailand. It has also received World Health Organization (WHO) prequalification, and more than 24 million doses have been distributed worldwide. According to post-marketing surveillance data, the vaccine has demonstrated a favourable safety profile with no significant safety concerns reported.
The approval of India’s first dengue vaccine is expected to strengthen the country’s dengue prevention strategy by complementing existing measures such as vector control, disease surveillance, early diagnosis and case management under the National Vector Borne Disease Control Programme.
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.
