A vaccine built for dengue-endemic and non-endemic markets alike took nearly four years to reach the country with arguably the largest population exposed to dengue risk. On 21 July 2026, India approved its first one.
GenSci0033
India’s First Dengue Vaccine
Approved in 42 countries first — India became the latest to add Qdenga to its own toolkit.
AUG 2022
First Approval, Indonesia
Indonesia becomes the first country worldwide to approve Qdenga.
5 DEC 2022
European Union Approval
The EU grants Qdenga marketing authorisation across all member states.
BY 2026
42 Countries, WHO Prequalified
Over 24 million doses distributed worldwide, with a favourable safety record.
21 JUL 2026
CDSCO Approves Qdenga
India authorises its first-ever dengue vaccine, for ages 4 to 60.
The pattern: A vaccine developed for global dengue-endemic and non-endemic markets took nearly four years to reach India, the country with arguably the largest population exposed to dengue risk.
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Timeline
- August 2022: Indonesia becomes the first country in the world to approve Qdenga.
- 5 December 2022: The European Union grants Qdenga marketing authorisation across all member states.
- By 2026: Qdenga reaches 42 countries, earns WHO prequalification, and over 24 million doses are distributed worldwide.
- 21 July 2026: CDSCO approves Qdenga as India’s first-ever dengue vaccine, for ages 4 to 60.
Must Know
- On 21 July 2026, India’s drug regulator, the Central Drugs Standard Control Organisation (CDSCO), approved the country’s first-ever dengue vaccine.
- The vaccine is Qdenga® (Dengue Tetravalent Vaccine, Live, Attenuated). It is made by Takeda, and imported by Takeda Biopharmaceuticals India Pvt. Ltd.
- It is approved for people aged 4 to 60 years. It is given as two doses of 0.5 ml each, three months apart.
- Qdenga is a live, attenuated vaccine, built using recombinant DNA technology. It is designed to protect against all four dengue virus serotypes.
- Before India, Qdenga had already been approved in 42 countries, and holds WHO prequalification.
- Globally, more than 24 million doses of the vaccine have already been distributed.
- India’s approval followed a dedicated Phase III safety and immunogenicity study, run specifically in the Indian population, aged 4 to 60.
Good to Know
- Indonesia became the first country in the world to approve Qdenga, in August 2022. The European Union granted its own marketing authorisation on 5 December 2022.
- The vaccine is produced in Vero cells. Genes for dengue’s serotype-specific surface proteins are engineered into a dengue virus type-2 backbone.
- It is supplied as a freeze-dried powder, reconstituted before use, and given as a subcutaneous injection.
- Global clinical trials for Qdenga ran across more than eight countries, including Brazil, Thailand, and Sri Lanka.
- India runs its own dengue-control effort under the National Vector Borne Disease Control Programme (NVBDCP). This is administered by the National Centre for Vector Borne Diseases Control (NCVBDC), which also covers malaria, chikungunya, Japanese encephalitis, kala-azar, and lymphatic filariasis.
- India reported more than 32,000 dengue cases in 2024, up from 18,391 the year before.
Test Yourself
Great to Know
- Dengue is caused by a virus with four distinct serotypes. A person can be infected by each serotype separately, and a second infection with a different serotype carries a higher risk of severe disease.
- The vaccine is expected to complement, not replace, India’s existing dengue-control tools. These include vector control, surveillance, early diagnosis, and case management.
- Post-marketing surveillance, in countries already using Qdenga, has found a favourable safety profile. No significant safety concerns have been identified.
- India’s approval followed the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945. This is the same legal framework that governs every other drug and vaccine approval in the country.
- The vaccine contains genetically modified organisms (GMOs), as part of its recombinant-DNA design.
Current Affairs
- 21 July 2026: CDSCO approved Qdenga, India’s first dengue vaccine, for people aged 4 to 60. The approval followed a Phase III trial conducted specifically in the Indian population, and comes after the vaccine had already reached 42 countries worldwide. (Source: PIB)
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