What happened
The Central Drugs Standard Control Organisation (CDSCO), under the Ministry of Health and Family Welfare, has granted marketing authorisation for Qdenga®, a live, attenuated tetravalent dengue vaccine manufactured by Takeda GmbH, Germany and to be imported by M/s Takeda Biopharmaceuticals India Pvt. Ltd. The government has described it as India’s first approved dengue vaccine for prevention of dengue disease.
The approval matters because dengue remains a recurring public health challenge in India, and vaccine access can add a preventive layer to the country’s existing disease-control strategy.
Background and earlier position
Before this approval, India relied mainly on vector control, surveillance, early diagnosis, and case management under the National Vector Borne Disease Control Programme. India did not have an approved dengue vaccine in routine use.
The CDSCO said the authorisation followed scientific evaluation of the vaccine’s quality, safety, and efficacy under the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945. The vaccine uses recombinant DNA technology, is produced in Vero cells, and contains genetically modified organisms.
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