CDSCO Approves India's First Dengue Vaccine: Strengthening National Dengue Prevention Efforts

India has cleared its first-ever dengue vaccine. On 21 July 2026, the Central Drugs Standard Control Organisation (CDSCO), functioning under the Ministry of Health and Family Welfare, granted marketing authorisation to Qdenga® — the Dengue Tetravalent Vaccine (Live, Attenuated). The vaccine is manufactured by Takeda GmbH in Germany and will be imported into India by Takeda Biopharmaceuticals India Pvt. Ltd. The clearance followed a detailed scientific review of the vaccine's quality, safety, and efficacy, carried out under the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945.

Qdenga: India's First Dengue Vaccine

Qdenga® is a live, attenuated tetravalent vaccine built using recombinant DNA technology and grown in Vero cells. Since it contains genetically modified organisms, it's supplied as a freeze-dried powder that must be reconstituted before it's given as a subcutaneous injection.

Who Can Take India's First Dengue Vaccine?

The vaccine is meant for people aged 4 to 60 years. It's given in two doses of 0.5 ml each, spaced three months apart.

Who Approves India's First Dengue Vaccine?

CDSCO, functioning under India's Ministry of Health and Family Welfare, is the regulator that granted this approval. Its decision rests on global clinical trial data gathered from Brazil, Thailand, Sri Lanka, and other countries, along with a dedicated Phase III safety and immunogenicity study conducted specifically on the Indian population.

How Is Qdenga Used Globally?

Qdenga® already has regulatory approval in 42 countries, including the UK, the European Union, Switzerland, Indonesia, and Malaysia, and carries WHO prequalification. More than 24 million doses have been distributed worldwide, and post-marketing data hasn't flagged any major safety concerns.

This approval is expected to strengthen India's dengue response alongside existing vector-control, surveillance, and treatment efforts under the National Vector-Borne Disease Control Programme.