CDSCO approves India’s first dengue vaccine (Qdenga)
CDSCO grants marketing authorisation for Qdenga, India’s first approved dengue vaccine
- The vaccine is a live, attenuated tetravalent dengue vaccine made by Takeda GmbH, Germany and imported by M/s Takeda Biopharmaceuticals India Pvt. Ltd.
- The marketing authorisation followed scientific evaluation of quality, safety, and efficacy under the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945.
- The approval relied on global studies across more than eight countries and an Indian Phase III safety and immunogenicity study in participants aged 4 to 60 years.
- Qdenga® has already received approval in 42 countries and World Health Organization prequalification, and more than 24 million doses have been distributed globally.
What happened
The Central Drugs Standard Control Organisation (CDSCO), under the Ministry of Health and Family Welfare, has granted marketing authorisation for Qdenga®, a live, attenuated tetravalent dengue vaccine manufactured by Takeda GmbH, Germany and to be imported by M/s Takeda Biopharmaceuticals India Pvt. Ltd. The government has described it as India’s first approved dengue vaccine for prevention of dengue disease.
The approval matters because dengue remains a recurring public health challenge in India, and vaccine access can add a preventive layer to the country’s existing disease-control strategy.
UPSC can frame the topic around vaccine regulation, the role of the Central Drugs Standard Control Organisation, and the place of vaccination within dengue control. A mains answer can also discuss why vaccines must complement vector control, surveillance, early diagnosis, and case management rather than replace them.
