- Why in news
- On 21 July 2026, CDSCO granted marketing authorisation to Takeda's Qdenga, India's first approved dengue vaccine, for people aged 4 to 60 years.
- What it is
- Qdenga is a tetravalent live attenuated dengue vaccine made by Takeda GmbH, Germany. It is built with recombinant DNA technology: genes for serotype-specific surface proteins are placed in a dengue type-2 backbone. It targets all four dengue virus serotypes.
- Regulator and law
- CDSCO approved it under the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945.
- Technology
- Live attenuated, tetravalent, made with recombinant DNA in Vero cells on a dengue type-2 backbone. It contains GMOs.
- Dose and route
- Two doses of 0.5 ml, given 3 months apart (0 and 3 months), as a subcutaneous injection.
- Age group
- Indicated for people aged 4 to 60 years.
- Global status
- Approved in 42 countries and WHO prequalified.
- Indian trial
- A pivotal Phase III safety and immunogenicity study was done in the Indian population.
Don’t confuse with Live attenuated vs inactivated vaccine: Qdenga uses weakened live virus components. Inactivated vaccines use killed virus. mRNA vaccines use genetic instructions, not virus.
Don’t confuse with CDSCO vs WHO prequalification: CDSCO is India's national drug regulator and grants marketing authorisation in India. WHO prequalification is a global quality check that lets UN agencies procure a product.
Science and technology: 57 Prelims questions since 2013; most test the concept behind the news, not the news itself. In Mains, 12 news-triggered questions.
Why it matters
- Adds a preventive tool against dengue alongside vector control and case management under the National Vector Borne Disease Control Programme.
- Shows use of recombinant technology in public health, backed by an Indian-population Phase III study.
Problems
- Cost and access: the vaccine is imported, so the price and supply for public programmes are uncertain.
- Two doses need follow-up, and the vaccine does not replace mosquito control.
Way forward
- Assess cost-effectiveness before inclusion in public programmes, and consider local manufacturing.
- Continue vector control, surveillance and post-marketing safety monitoring.
Put in your answer
Regulatory approval: CDSCO approved Qdenga after evaluating quality, safety and efficacy, citing the Drugs and Cosmetics Act, 1940.
Vaccine as complement: The vaccine is expected to complement vector control, surveillance, early diagnosis and case management under the National Vector Borne Disease Control Programme.
- 2022Mains GS3 · Q16Basic principles of vaccine development, how vaccines work, and Indian COVID-19 vaccine approaches
- 2021Prelims Q65Statements on genetic engineering and bacteria/viruses as vectors in recombinant vector vaccines
- 2022Prelims Q39Matching COVID-19 vaccines to platforms: Covishield, Sputnik V, Covaxin
UPSC’s own questions that come close to this issue, from our Prelims and Mains banks.
Prelims practice · Statements
Ours, not from a UPSC paper
Consider the following statements:
- 1.Qdenga, approved by CDSCO in July 2026, is a tetravalent live attenuated dengue vaccine built on a dengue virus type-2 backbone.
- 2.The recommended schedule of Qdenga is a single intramuscular dose for individuals above 18 years of age.
- 3.CDSCO granted the marketing authorisation under the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945.
Which of the statements given above is/are correct?
True or false?
1 of 6
Statements the way Prelims prints them. Say first, then see the fact.
1.Qdenga is the first dengue vaccine approved in India.
True. CDSCO called it the first dengue vaccine approved in the country.
2.The vaccine is a tetravalent live attenuated vaccine built on a dengue virus type-2 backbone.
True. Genes for serotype-specific surface proteins are engineered into a DENV-2 backbone.
3.It is given as a single intramuscular dose.
False. It is two subcutaneous doses of 0.5 ml, 3 months apart.
4.Marketing authorisation was granted by CDSCO under the Drugs and Cosmetics Act, 1940.
True. CDSCO acted under the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945.
5.The vaccine is produced in Vero cells and contains genetically modified organisms.
True. It is made in Vero cells and the release says it contains GMOs.
6.Vaccine manufacturing by an Indian firm in India has been approved by this authorisation.
False. It is made by Takeda GmbH, Germany and imported by Takeda Biopharmaceuticals India Pvt. Ltd.
Written by us from the release, not by UPSC; checked by a second model.
Worth revising until Prelims 2028: most news questions come within two years of the event.