Synopsis:India’s first approved dengue vaccine, QDENGA, is expected to enter the private market in the first half of 2027, with Dr Reddy’s Laboratories handling its promotion and distribution in partnership with Takeda. The vaccine was approved by the CDSCO in July 2026 for people aged 4 to 60 and is given in two doses three months apart, with the company reporting efficacy against all four dengue virus serotypes.
India’s first approved dengue vaccine is set to enter the country’s private market in 2027, with Hyderabad-based Dr Reddy’s Laboratories partnering with Japanese pharmaceutical company Takeda to promote and distribute its dengue vaccine QDENGA.
It is expected to become available in the first half of 2027, subject to the completion of applicable regulatory processes.
Dr Reddy’s will handle promotion and distribution in the private market, while Takeda will retain legal ownership and the rights to promote and distribute the vaccine in India’s public market.
India’s dengue burden has been growing, with cases increasing 11-fold over the past two decades.
A nationwide dengue surveillance study conducted by the Virus Research and Diagnostic Laboratory network of the Indian Council of Medical Research found that all four dengue virus serotypes, DENV-1 to DENV-4, are circulating across multiple regions of India.
The study also found that around one in 14 patients had a concurrent infection with multiple dengue serotypes.
QDENGA became India’s first CDSCO-approved dengue vaccine after receiving marketing authorisation from the Central Drugs Standard Control Organisation (CDSCO) in July 2026 for individuals aged 4 to 60 years.
Also known as TAK-003, it is a live-attenuated tetravalent dengue vaccine designed to provide immune coverage against all four dengue virus serotypes.
The vaccine is built on a DENV-2 backbone and contains structural proteins from DENV-1, DENV-3 and DENV-4. It is administered in two doses, three months apart.
Takeda said its global clinical programme involved more than 60,000 participants across eight dengue-endemic countries. Its seven-year Phase 3 TIDES trial reported efficacy across all four dengue serotypes through seven years.
QDENGA has been approved in 43 countries since 2022, with more than 32 million doses distributed globally, according to Takeda.
The WHO has recommended the vaccine without pre-vaccination screening for use in high-endemic countries, and it has included the vaccine in its List of Prequalified Vaccines.