Daijiworld Media Network - New Delhi
New Delhi, Jul 21: India has approved its first vaccine for the prevention of dengue, marking a significant breakthrough in the country's efforts to combat one of its most widespread mosquito-borne diseases, the Ministry of Health and Family Welfare announced on Tuesday.
The Central Drugs Standard Control Organisation (CDSCO) has granted marketing authorisation to Qdenga, a live, attenuated tetravalent dengue vaccine developed by Germany-based Takeda GmbH. The vaccine will be imported and marketed in India by Takeda Biopharmaceuticals India Pvt. Ltd.
The approval came after an extensive scientific review of the vaccine's quality, safety and effectiveness under the provisions of the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945.
Qdenga has been developed using recombinant DNA technology and is designed to provide protection against all four serotypes of the dengue virus, which are responsible for causing the infection. The vaccine is supplied as a freeze-dried formulation that is reconstituted before administration and delivered through a subcutaneous injection.
Health authorities have approved the vaccine for individuals aged 4 to 60 years. The recommended schedule consists of two doses of 0.5 ml, administered three months apart.
According to the Health Ministry, the decision was supported by data from an extensive international clinical development programme that evaluated the vaccine's safety, immune response and effectiveness in both dengue-endemic and non-endemic regions.
The clinical trials included participants from more than eight countries, including Brazil, Thailand and Sri Lanka, while the regulatory assessment also considered findings from a key Phase III clinical study conducted in India involving volunteers between the ages of 4 and 60 years.
Qdenga has already secured regulatory approval in 42 countries, including the European Union, the United Kingdom, Switzerland, Indonesia, Malaysia and Thailand, and has also received World Health Organization (WHO) prequalification.
Globally, more than 24 million doses of the vaccine have been distributed. Government officials said post-marketing surveillance from countries where the vaccine is already in use has shown a favourable safety profile, with no major safety concerns identified.
The Health Ministry said the vaccine will serve as an additional tool in India's dengue control strategy and will complement existing public health measures such as mosquito control, disease surveillance, early detection and clinical management under the National Vector Borne Disease Control Programme.
However, officials stressed that vaccination is not a substitute for preventive measures. They urged continued efforts to eliminate mosquito breeding sites, maintain environmental sanitation and adopt personal protection against mosquito bites.
The government said the approval underscores its commitment to providing timely access to safe, effective and scientifically evaluated vaccines while strengthening the country's preparedness against vector-borne diseases.