Qdenga®: India's First Approved Dengue Vaccine

Science & Technology · Wednesday, 22 July 2026

The Central Drugs Standard Control Organisation granted marketing authorization to Qdenga®, India's first approved dengue vaccine, developed by Takeda GmbH, Germany. It is a live, attenuated tetravalent vaccine built on a dengue type-2 backbone and given in two doses three months apart to people aged 4 to 60 years.

Quick highlights

CDSCO granted marketing authorization to Qdenga®, India's first-ever approved dengue vaccine.
It is a live, attenuated tetravalent vaccine using recombinant DNA technology on a dengue type-2 backbone.
Protects against all four serotypes: DEN-1, DEN-2, DEN-3 and DEN-4.
Indicated for individuals aged 4 to 60 years; two 0.5 ml subcutaneous doses at month 0 and month 3.
Developed and manufactured by Takeda GmbH, Germany; imported by M/s Takeda Biopharmaceuticals India Pvt. Ltd.
Holds WHO prequalification, approval in over 42 countries and over 24 million doses distributed globally.

Context

The Central Drugs Standard Control Organisation (CDSCO) granted official marketing authorization for Qdenga®, approving India's first-ever dengue vaccine.

Key Facts

Qdenga® is a live, attenuated tetravalent dengue vaccine engineered using recombinant DNA technology. It uses a dengue virus type-2 backbone into which genes encoding surface proteins from the other three serotypes are inserted, giving balanced protection against DEN-1, DEN-2, DEN-3 and DEN-4. Manufacturer: Takeda GmbH, Germany; Indian importer and distributor: M/s Takeda Biopharmaceuticals India Pvt. Ltd. Schedule: 0.5 ml subcutaneous injection in two doses three months apart (month 0 and month 3) for ages 4 to 60 years. Credentials: WHO prequalification, approval in over 42 countries including the European Union, the UK, Indonesia and Thailand, over 24 million doses distributed globally, and a successful pivotal Phase III trial in India confirming immunogenicity and safety across diverse Indian populations.

Significance

Approval gives India its first licensed tool for preventing dengue disease across all four circulating serotypes, adding a preventive layer to an outbreak response that has so far relied on vector control and case management. Validation through an Indian Phase III trial strengthens confidence in performance across diverse Indian populations.

Challenges / Way Forward

Roll-out will depend on pricing, cold-chain and distribution capacity, physician awareness and adherence to the two-dose schedule three months apart. Since the vaccine is imported, supply reliability and affordability are key considerations, and it complements rather than replaces vector control measures against Aedes mosquitoes.

Exam Angle

Prelims: CDSCO - national regulator for pharmaceuticals, medical devices and cosmetics under the Directorate General of Health Services, Ministry of Health and Family Welfare, headquartered in New Delhi, with statutory authority from the Drugs and Cosmetics Act 1940 and Drugs Rules 1945; its functions include approval of new drugs and vaccines, control over drug imports, clinical trial governance, and quality surveillance with State Licensing Authorities. Also note live attenuated vs recombinant vaccine platforms and WHO prequalification. Mains GS-2/GS-3: public health regulation and vaccine access.

Remember this

Qdenga® is India's first approved dengue vaccine, cleared by CDSCO.
It is a live, attenuated tetravalent vaccine on a DEN-2 backbone covering DEN-1 to DEN-4.
Two doses, 0.5 ml subcutaneous, at month 0 and month 3, for ages 4-60 years.
Manufactured by Takeda GmbH, Germany; imported by Takeda Biopharmaceuticals India Pvt. Ltd.
WHO prequalified and approved in over 42 countries; 24 million+ doses distributed globally.
CDSCO works under the Directorate General of Health Services, Ministry of Health and Family Welfare, headquartered in New Delhi.
CDSCO's statutory basis: Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945.

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