CDSCO Grants Marketing Authorization to Qdenga – India's First Approved Dengue Vaccine

Recently, the Central Drugs Standard Control Organization (CDSCO) granted marketing authorization to Qdenga (Dengue Tetravalent Vaccine – Live, Attenuated). With this approval, Qdenga has become the first vaccine approved in India for the prevention of dengue.

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¨     The CDSCO, under the Ministry of Health and Family Welfare, approved QDENGA®, developed by Takeda GmbH, Germany, for individuals aged 4–60 years.

¨     The approval was granted after a comprehensive scientific evaluation under the Drugs and Cosmetics Act, 1940, Drugs Rules, 1945, and New Drugs and Clinical Trials (NDCT) Rules, 2019.

¨     The vaccine is expected to complement India’s existing dengue control strategy, including vector control, surveillance, early diagnosis and case management under the National Vector Borne Disease Control Programme (NVBDCP).

¨     QDENGA has received WHO prequalification and regulatory approval in over 40 countries, including the European Union, the United Kingdom, Switzerland, Indonesia, Malaysia and Thailand.

¨     QDENGA is part of Brazil’s National Immunisation Program and is available through public immunisation programmes in Argentina, Colombia and Indonesia.

QDENGA (Dengue Tetravalent Vaccine)

¨     Developed by Takeda GmbH, Germany.

¨     Imported and marketed in India by Takeda Biopharmaceuticals India Pvt. Ltd.

Type of Vaccine:

¨     Live, attenuated tetravalent dengue vaccine.

¨     Developed using recombinant DNA technology.

¨     Produced in Vero cells using a DENV-2 (dengue virus type-2) backbone engineered with serotype-specific surface proteins.

¨     Contains genetically modified organisms (GMOs).

¨     Supplied as a freeze-dried powder for reconstitution.

¨     Protection: Designed to protect against all four dengue virus serotypes (DENV-1, DENV-2, DENV-3 and DENV-4).

¨     Can be administered irrespective of previous dengue infection.

¨     No pre-vaccination screening or serological testing is required.

¨     Eligibility: Approved for individuals aged 4–60 years.

Significance of QDENGA

¨     High Global Disease Burden: About half of the world’s population is at risk of dengue, with an estimated 100–400 million infections occurring annually, according to the World Health Organization.

¨     Addresses India’s High Dengue Burden: India accounts for nearly one-third of the global dengue burden and is among the 30 most highly endemic countries for dengue.

¨     According to the National Centre for Vector-Borne Disease Control (NCVBDC), 1,21,824 dengue cases and 121 deaths were reported in 2025, while the caseload exceeded 2 lakh in 2023 and 2024.

¨     Strengthens India’s Dengue Prevention Strategy: Introduces the first approved dengue vaccine in India, adding vaccination to the country’s existing dengue prevention measures.

¨     Reduces Economic Burden: Dengue places a significant medical and economic burden on India, with a 2019 Journal of Infection and Public Health study estimating its overall economic cost at US$5.71 billion in 2016.

Dengue

¨     Dengue (also known as break-bone fever) is a mosquito-borne viral disease caused by the dengue virus (DENV).

¨     It is transmitted primarily through the bite of infected female Aedes aegypti mosquitoes; Aedes albopictus can also act as a vector.

¨     The disease is endemic in more than 100 countries, mainly in tropical and subtropical regions.

¨     The dengue virus has four distinct serotypes—DENV-1, DENV-2, DENV-3 and DENV-4—and infection with one serotype provides lifelong immunity only against that serotype, while a subsequent infection with a different serotype increases the risk of severe dengue.

¨     Symptoms: Symptoms usually appear 4–10 days after infection, last 2–7 days, and commonly include high fever, severe headache, pain behind the eyes, muscle and joint pain, nausea, vomiting, skin rash and swollen glands.

¨     Severe Dengue: Warning signs of severe dengue include severe abdominal pain, persistent vomiting, rapid breathing, bleeding gums or nose, blood in vomit or stool, extreme weakness and restlessness.

¨     Diagnosis: Dengue is diagnosed through Nucleic Acid Amplification Tests (NAATs), antigen tests, ELISA-based antibody tests and Rapid Diagnostic Tests (RDTs).