India Grants DCGI Approval to Its First Dengue Vaccine, QDENGA

Summary:
India has approved its first dengue vaccine, QDENGA, developed by Takeda Biopharmaceuticals India, after receiving marketing authorisation from the DCGI. Approved for individuals aged 4 to 60 years without the need for pre-vaccination screening, the vaccine protects against all four dengue virus serotypes. Already authorised in over 40 countries and prequalified by the WHO, QDENGA marks a significant milestone in India’s efforts to combat dengue, a disease for which the country accounts for nearly one-third of the global burden. 

India has cleared its first dengue vaccine for commercial use after the Drug Controller General of India (DCGI) granted marketing approval to QDENGA, developed by Takeda Biopharmaceuticals India. Takeda described the authorisation as a significant milestone in the country’s efforts to tackle dengue, a mosquito-borne illness that impacts millions of people annually.

The company said the vaccine is approved for individuals between 4 and 60 years of age and can be administered irrespective of whether they have previously contracted dengue. Unlike certain other dengue vaccines, QDENGA does not require recipients to undergo pre-vaccination screening for prior dengue infection, enabling eligible individuals to be vaccinated without additional testing.

The approval comes as India continues to experience one of the highest dengue burdens globally, with infections rising considerably over the past two decades due to factors such as rapid urbanisation, climate change, expanding mosquito habitats, and population growth.

QDENGA is a live-attenuated tetravalent vaccine developed to provide protection against all four dengue virus serotypes—DENV-1, DENV-2, DENV-3, and DENV-4. The vaccine has already received regulatory approval in more than 40 countries, including the European Union, United Kingdom, Brazil, Indonesia, and Argentina.

With this approval, India joins the growing list of countries using QDENGA at a time when dengue has become one of the nation’s most significant seasonal public health concerns. Takeda also noted that the vaccine has received World Health Organization (WHO) prequalification, confirming that it meets internationally recognised standards for quality, safety, and efficacy.

WHO prequalification also qualifies QDENGA for procurement by international organisations such as UNICEF and the Pan American Health Organization (PAHO).

Dengue remains a major mosquito-borne viral disease affecting public health in more than 125 countries worldwide. India alone accounts for nearly one-third of the global dengue burden, underscoring the importance of expanding access to preventive measures such as vaccination.