New Delhi: The Drug Controller General of India (DCGI) has granted market authorisation to the country’s first dengue vaccine QDENGA, developed by Takeda Biopharmaceuticals India.
Approved for people aged 4 to 60 years, it can be given regardless of whether a person has previously been infected with dengue, as reported by The Times of India.
QDENGA does not require pre-vaccination screening, unlike some other dengue vaccines, allowing eligible individuals to receive it without first being tested for past dengue infection.
Takeda has said that the approval marks a major step in India’s fight against dengue, a mosquito-borne disease that affects millions of people every year.
At least 131 people died of dengue in India in 2025. Several deaths in remote parts of the country may have gone unreported.
“Since its launch in 2022, QDENGA has been approved in 43 countries, with more than 32 million doses distributed globally. This approval marks an important step forward in strengthening dengue prevention in India,” said Mahender Nayak, head of Intercontinental Markets at Takeda.
Long-term data collected over seven years showed that the vaccine continues to protect against dengue infection and hospitalisation caused by all four dengue virus serotypes, the company said.
The Indian approval is based on findings from Takeda’s global clinical development programme, which included 19 Phase I, II and III clinical trials involving more than 28,000 participants in countries where dengue is common as well as regions where it is not.
DCGI’s decision was also supported by results from the Phase III DEN-302 clinical trial conducted in India, which assessed the vaccine’s safety and immune response in people between 4 and 60 years of age.
QDENGA is given as two injections of 0.5 ml, administered under the skin three months apart.
India carries one of the world’s highest dengue burdens, with all four virus serotypes circulating simultaneously in several parts of the country, Takeda said.
“QDENGA is designed to protect against all four serotypes, regardless of prior exposure. Its approval represents an important step in strengthening India’s comprehensive approach to dengue prevention, alongside vector control, surveillance, community awareness and other public health measures,” said Goh Choo Beng, medical affairs head for Takeda’s Southeast Asia and India Cluster.
The World Health Organization (WHO) recommends QDENGA for use in dengue-endemic regions and supports its inclusion in public immunisation programmes in high-transmission areas without requiring pre-vaccination screening, the company added.
The vaccine has also received WHO prequalification, confirming that it meets international standards for quality, safety and effectiveness. This also makes the vaccine eligible for procurement by global agencies such as UNICEF and the Pan American Health Organization (PAHO).
Dengue, a mosquito-borne viral disease, is prevalent in more than 125 countries. According to the company, India accounts for nearly one-third of the global dengue burden, with rapid urbanisation, climate change and widespread mosquito breeding continuing to increase the risk of infection across the country.
