India Approves Its First Dengue Vaccine, Marking a Major Milestone in Public Health

New Delhi, July 21: In a landmark move to strengthen dengue prevention and control, the Central Drugs Standard Control Organisation (CDSCO) has granted marketing approval to Qdenga India’s first dengue vaccine. Developed by Takeda GmbH, Germany, the vaccine will be imported and marketed in India by Takeda Biopharmaceuticals India Pvt. Ltd.

The vaccine is approved for the prevention of dengue in individuals aged 4 to 60 years. The recommended vaccination schedule consists of two 0.5 ml doses administered three months apart.

CDSCO approved the vaccine after a comprehensive scientific assessment of its quality, safety and efficacy under the Drugs and Cosmetics Act and Rules. Qdenga is a live attenuated tetravalent dengue vaccine developed using recombinant DNA technology.

The approval is backed by extensive global clinical studies conducted across more than eight countries, including India, Brazil, Thailand and Sri Lanka. A pivotal Phase III trial in India also demonstrated a favourable safety and immunogenicity profile.

Qdenga has already been approved in 42 countries, including the European Union, the United Kingdom, Switzerland, Indonesia, Malaysia and Thailand. It has also received WHO prequalification, with more than 24 million doses distributed worldwide and a strong post-marketing safety record.

The approval is expected to strengthen India’s fight against dengue by complementing ongoing vector control, surveillance, early diagnosis and case management initiatives under the National Vector Borne Disease Control Programme.