New Delhi, July 21, 2026: In a significant breakthrough for India’s public health system, the Central Drugs Standard Control Organisation (CDSCO), operating under the Ministry of Health and Family Welfare, has granted marketing authorization for Qdenga®, making it the first dengue vaccine approved in India for the prevention of dengue disease.
The vaccine, officially known as Dengue Tetravalent Vaccine (Live, Attenuated), is manufactured by Takeda GmbH, Germany, and will be imported and distributed in India by Takeda Biopharmaceuticals India Pvt. Ltd. The approval follows an extensive scientific review of the vaccine’s quality, safety, and efficacy under the provisions of the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945.
Advanced Recombinant Vaccine Technology
Qdenga® is a live, attenuated tetravalent dengue vaccine developed using recombinant DNA technology. It is produced in Vero cells, where genes encoding serotype-specific surface proteins are engineered into a dengue virus type-2 backbone. The vaccine contains genetically modified organisms (GMOs) and is supplied as a freeze-dried powder that is reconstituted before administration.
The vaccine is delivered as a subcutaneous injection and is designed to provide protection against all four dengue virus serotypes, helping reduce the risk of severe dengue infections.
Eligibility and Vaccination Schedule
The vaccine has been approved for individuals aged 4 to 60 years.
The recommended immunization schedule includes:
- Two doses of 0.5 ml each.
- The second dose is administered three months after the first (0 and 3 months).
Strong Clinical Evidence Supports Approval
The CDSCO’s approval is backed by an extensive global clinical development program evaluating the vaccine’s safety, immunogenicity, and efficacy in both dengue-endemic and non-endemic regions.
Clinical trials were conducted across more than eight countries, including Brazil, Thailand, and Sri Lanka. In addition, a pivotal Phase III clinical study was carried out in India, involving participants aged 4 to 60 years, confirming the vaccine’s effectiveness and safety for the Indian population.
Approved in 42 Countries Worldwide
Before receiving approval in India, Qdenga® had already been authorized in 42 countries, including the European Union, the United Kingdom, Switzerland, Indonesia, Malaysia, and Thailand.
The vaccine has also received World Health Organization (WHO) Prequalification, demonstrating that it meets internationally recognized standards for quality, safety, and effectiveness.
Globally, more than 24 million doses have already been distributed. According to post-marketing surveillance data, the vaccine has maintained a strong safety profile, with no significant safety concerns reported in countries where it is currently in use.
Major Boost for India’s Dengue Prevention Strategy
Health officials believe the approval of India’s first dengue vaccine represents a major milestone in the country’s fight against mosquito-borne diseases. The vaccine is expected to strengthen existing efforts under the National Vector Borne Disease Control Programme, complementing initiatives such as vector control, disease surveillance, early diagnosis, and effective case management.
The Ministry of Health and Family Welfare reaffirmed its commitment to ensuring that Indian citizens have timely access to safe, effective, and high-quality vaccines through a science-based regulatory framework.
The approval of Qdenga® is expected to significantly enhance India’s preparedness against dengue and could play a vital role in reducing the disease burden, hospitalizations, and severe dengue cases in the years ahead.
