India has approved its first vaccine for the prevention of dengue, a major step in strengthening the country's response to one of its fastest-growing mosquito-borne diseases
NEW DELHI — India has approved its first vaccine for the prevention of dengue, a major step in strengthening the country's response to one of its fastest-growing mosquito-borne diseases, an official statement said on Tuesday.
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 developed by Takeda GmbH, Germany.
The vaccine will be imported into the country by Takeda Biopharmaceuticals India Pvt. Ltd.
The approval follows a comprehensive scientific evaluation of the vaccine's quality, safety and efficacy under the provisions of the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945.
Qdenga is a live, attenuated tetravalent vaccine developed using recombinant DNA technology and it is designed to protect against all four dengue virus serotypes, which are responsible for causing the disease.
The vaccine is supplied as a freeze-dried powder for reconstitution and is administered as a subcutaneous injection.
The vaccine has been approved for people aged 4 to 60 years. The recommended immunisation schedule consists of two doses of 0.5 ml each, administered three months apart.
According to the Health Ministry, the approval is backed by data from an extensive global clinical development programme assessing the vaccine's safety, immunogenicity and efficacy in both dengue-endemic and non-endemic countries.
Clinical studies were conducted in participants across more than eight countries, including Brazil, Thailand and Sri Lanka. The regulatory review also included findings from a pivotal Phase III study conducted in India involving people aged 4 to 60 years.
Qdenga has already received regulatory approval in 42 countries, including the European Union, the United Kingdom, Switzerland, Indonesia, Malaysia and Thailand. It has also received World Health Organization (WHO) prequalification.
More than 24 million doses have been distributed globally.
According to the ministry, post-marketing surveillance has demonstrated a favourable safety profile, with no significant safety concerns reported.
As per officials, the vaccine is expected to complement existing measures such as vector control, disease surveillance, early diagnosis and case management under the National Vector Borne Disease Control Programme.
However, the ministry emphasised that vaccination is intended to strengthen—not replace, ongoing dengue prevention efforts, including eliminating mosquito breeding sites and promoting personal protective measures.
According to the government, the approval reflects its commitment to ensuring timely access to safe, effective and quality-assured vaccines through a robust, science-based regulatory framework.