India has approved its first dengue vaccine, marking a major step in the country’s efforts to combat one of its fastest-growing vector-borne diseases.
The Drug Controller General of India (DCGI) on Monday granted market authorisation under the New Drugs and Clinical Trials Rules, 2019, to Takeda’s dengue vaccine, QDENGA, for individuals aged 4 to 60 years.
The vaccine is administered in two doses, three months apart, and is designed to provide protection against all four dengue virus serotypes. Unlike an earlier internationally available dengue vaccine, QDENGA can be given regardless of whether a person has previously been infected with dengue and does not require pre-vaccination screening.
According to Dr. Mahender Nayak, Head of Intercontinental Markets at Takeda, the vaccine is expected to be launched in India during the first half of 2027. The company is working with regulators and other stakeholders to prepare for the rollout, while pricing is yet to be finalised.
The approval is based on findings from a Phase III clinical trial involving Indian participants aged 4 to 60 years, which showed the vaccine to be safe, well tolerated and capable of generating an immune response. Takeda said the vaccine has also received World Health Organization (WHO) prequalification and is recommended by the WHO for use in dengue-endemic regions without the need for pre-vaccination screening.
The approval comes as dengue continues to pose a significant public health challenge in India. Takeda said reported dengue cases in the country have increased 11-fold over the past two decades. A modelling study published in Nature estimated that India accounts for nearly 34% of the global dengue burden—the highest share of any country.
According to the company, more than 1.13 lakh dengue cases were reported in India in 2025. Dengue, transmitted by Aedes mosquitoes, has no specific antiviral treatment and can quickly progress to severe illness requiring hospitalisation.
“All four dengue virus serotypes circulate in India, contributing to recurrent outbreaks,” said Dr. Goh Choo Beng, Head of Medical Affairs for Takeda’s Southeast Asia and India Cluster.
Takeda said QDENGA has been approved in 43 countries, with more than 32 million doses distributed through public and private immunisation programmes worldwide. The company said it will work closely with Indian regulatory authorities and healthcare stakeholders to support the vaccine’s rollout.
