The Central Drugs Standard Control Organisation (CDSCO) has granted marketing authorisation for Qdenga®, making it India's first approved dengue vaccine for the prevention of dengue disease.
Manufactured by Takeda GmbH, Germany, and to be imported by Takeda Biopharmaceuticals India Pvt. Ltd., the vaccine is approved for individuals aged 4 to 60 years. It is administered as two subcutaneous doses, given three months apart.
The approval follows a comprehensive evaluation of the vaccine's quality, safety, and efficacy, supported by extensive global clinical trials and a pivotal Phase III study conducted in India. Qdenga® has already been approved in 42 countries, has received WHO prequalification, and over 24 million doses have been distributed worldwide.
The approval marks a significant milestone in India's fight against dengue and is expected to strengthen the country's dengue prevention strategy alongside existing vector control, surveillance, early diagnosis, and case management efforts.