CDSCO approves Qdenga, India's first dengue vaccine
The Central Drugs Standard Control Organisation (CDSCO) granted marketing authorisation for Qdenga, a live attenuated tetravalent dengue vaccine made by Takeda GmbH, Germany, the first dengue vaccine approved in India (announced 21 July 2026).
Summary
Qdenga (Dengue Tetravalent Vaccine, Live, Attenuated) has been approved by the Central Drugs Standard Control Organisation (CDSCO) for the prevention of dengue in people aged 4 to 60 years, making Qdenga the first dengue vaccine approved in India. Qdenga is manufactured by Takeda GmbH, Germany, and will be imported by Takeda Biopharmaceuticals India Pvt. Ltd. Qdenga is made with recombinant DNA technology in Vero cells, with serotype-specific genes engineered into a dengue virus type-2 backbone, and is given as two subcutaneous doses of 0.5 ml at 0 and 3 months. The approval followed evaluation under the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945; Qdenga is approved in 42 countries and has WHO prequalification.
Key facts
- Regulator
- CDSCO, Ministry of Health and Family Welfare
- Vaccine
- Qdenga – Dengue Tetravalent Vaccine (Live, Attenuated)
- Manufacturer
- Takeda GmbH, Germany (importer: Takeda Biopharmaceuticals India Pvt. Ltd.)
- Age group
- 4 to 60 years
- Schedule
- Two doses of 0.5 ml, at 0 and 3 months, subcutaneous
- Technology
- Recombinant DNA; dengue virus type-2 backbone; produced in Vero cells
- Global status
- Approved in 42 countries; WHO prequalified
Practice MCQs 4 questions
Which body granted marketing authorisation to Qdenga, India's first approved dengue vaccine, in July 2026?
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Correct answer: B — Central Drugs Standard Control Organisation (CDSCO)
CDSCO, under the Ministry of Health and Family Welfare, granted the marketing authorisation.
For which age group has the Qdenga dengue vaccine been approved in India?
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Correct answer: C — 4 to 60 years
Qdenga is indicated for the prevention of dengue in individuals 4 to 60 years of age.
Which company manufactures the Qdenga dengue vaccine approved by CDSCO?
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Correct answer: D — Takeda GmbH, Germany
Qdenga is manufactured by Takeda GmbH, Germany, and imported by Takeda Biopharmaceuticals India Pvt. Ltd.
Consider the following statements about the Qdenga dengue vaccine: 1. Qdenga is given as two doses three months apart. 2. Qdenga is administered as an intramuscular injection. 3. Qdenga uses a dengue virus type-2 backbone. Which of the statements given above are correct?
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Correct answer: B — 1 and 3 only
Statements 1 and 3 are correct. Statement 2 is wrong: Qdenga is given as a subcutaneous injection.