India’s First Dengue Vaccine

Qdenga is India’s first dengue vaccine. The Central Drugs Standard Control Organisation (CDSCO) approved it on 21 July 2026. CDSCO is India’s drug regulator.

What are the key facts?

• Takeda GmbH makes it in Germany.
• Takeda Biopharmaceuticals India imports it.
• It is for people aged 4 to 60 years.
• The schedule is two doses of 0.5 ml.
• The doses are three months apart.

What is the memory hook?

Think “Qdenga, CDSCO, 4 to 60, two doses”.

Qdenga is a live, attenuated vaccine. Attenuated means the virus is weakened. It is tetravalent, which means it covers all four dengue serotypes.

How is it made?

• Recombinant DNA technology is used.
• It is produced in Vero cells.
• Genes for serotype-specific surface proteins are placed into a dengue type-2 backbone.
• It contains genetically modified organisms (GMOs).

How is it given?

It comes as a freeze-dried powder. A health worker mixes it before use. It is given as an injection under the skin.

What is the memory hook?

Think “weak live virus, dengue-2 backbone”.

The approval rests on a global programme and an Indian study. A trial gives the vaccine to many people and compares them with people who got a dummy shot. That shows whether the vaccine works and is safe.

Which countries took part?

The main global trial tested the vaccine in children and teenagers aged 4 to 16. Takeda says it ran in eight countries:

• Brazil
• Colombia
• Panama
• Dominican Republic
• Nicaragua
• Philippines
• Thailand
• Sri Lanka

Five are in Latin America and three are in Asia. Dengue is common in all eight. That mix lets researchers see how the vaccine behaves where the virus is always present.

What are the other key numbers?

• An Indian Phase III study tested safety and immunogenicity in people aged 4 to 60.
• Immunogenicity means how well the vaccine triggers an immune response.
• The vaccine has approval in 42 countries.
• More than 24 million doses have been distributed worldwide.
• Follow-up data show a favourable safety profile.

What is the memory hook?

Think “8 trial countries, 42 approvals, 24 million doses”.

Indonesia did, not India. Its regulator, BPOM, approved Qdenga on 22 August 2022. That approval covered people aged six to 45.

What happened next?

• The World Health Organization (WHO) prequalified it in May 2024.
• Prequalification lets United Nations agencies buy a vaccine.
• India’s approval came on 21 July 2026.
• That was nearly four years after Indonesia.

What is the memory hook?

Think “Indonesia 2022, WHO 2024, India 2026”.

CDSCO’s Subject Expert Committee reviewed the data in March 2026. It set a condition for Takeda.

What are the conditions?

• A post-marketing study in India.
• The study must start within six months of launch.
• It checks safety and effectiveness in Indian people.
• The approval followed the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945.
• Launch date, price and use in government programmes are not announced.

What is the memory hook?

Think “March review, six-month study”.

No. WHO advises that vaccination be part of a wider plan.

What does WHO say?

• Use it mainly in children aged 6 to 16.
• Use it where dengue spread is high.
• It does not currently recommend routine use below age six.
• Lower efficacy was seen in that group.
• Keep vector control, surveillance, case management and community work going.

What else is in the pipeline?

Panacea Biotec has an Indian tetravalent vaccine in a Phase III trial with the Indian Council of Medical Research (ICMR).

What is the memory hook?

Think “vaccine plus mosquito control”.

Four mix-ups come up again and again.

What are the traps?

• Who approved? CDSCO, not ICMR or the Indian Pharmacopoeia Commission.
• Which country first? Indonesia in 2022, not India.
• Which age band? India says 4 to 60. WHO focuses on 6 to 16.
• Which type? Live attenuated, with four serotypes.

How do you remember them?

Think “CDSCO approves, Indonesia first”.