CDSCO Greenlights India's First Dengue Vaccine: Massive Leap for National Public Health Strategy

CDSCO Greenlights India's First Dengue Vaccine: Massive Leap for National Public Health Strategy​

CDSCO Approves Qdenga®, Marking Milestone in India's Dengue Prevention Efforts​

In a pivotal moment for Indian public health, the Central Drugs Standard Control Organisation (CDSCO) has granted marketing authorization for the Dengue Tetravalent Vaccine (Live, Attenuated) - Qdenga®. This landmark approval represents the first dengue vaccine authorized in India to combat the rising threat of the disease.

The vaccine, manufactured by Takeda GmbH and imported by M/s Takeda Biopharmaceuticals India Pvt. Ltd., has undergone a comprehensive scientific review by the Ministry of Health and Family Welfare. The approval aligns with the provisions of the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945, certifying its quality, safety, and efficacy in the national context.

Understanding Qdenga® Technology and Scope​

Qdenga® is a state-of-the-art live, attenuated tetravalent dengue vaccine utilizing recombinant DNA technology. It is produced using Vero cells and contains genetically modified organisms (GMOs). The vaccine is administered as a subcutaneous injection and supplied as a freeze-dried powder requiring reconstitution.

The recommended use for this critical vaccine spans individuals aged 4 to 60 years. The protective immunization schedule requires two doses of 0.5 ml, administered at an interval of three months (at zero and three months).

Global Validation and Clinical Evidence Bolsters Approval​

The domestic approval is strongly underpinned by extensive global clinical development data concerning the vaccine’s immunogenicity, safety, and efficacy across varied regions. The comprehensive trials included participants from over eight countries, including Thailand, Brazil, and Sri Lanka.

Crucially, the evaluation process incorporated a pivotal Phase III study focused on the Indian population, ensuring local relevance in its effectiveness profile. Beyond this evidence base, the vaccine has secured regulatory approval in 42 nations, including major markets like the European Union, the United Kingdom, and Indonesia.

International Trust and Post-Market Surveillance Data​

Qdenga® holds World Health Organization (WHO) prequalification status, lending significant global weight to its safety profile. Internationally, over 24 million doses of this vaccine have already been distributed globally.

Post-marketing surveillance data from countries utilizing the vaccine has consistently demonstrated a favorable safety profile, with no major safety concerns being identified in usage environments. This international robustness significantly strengthens India’s commitment to public health preparedness.

Strengthening National Vector Borne Disease Control Programme​

The approval of India's inaugural dengue vaccine is recognized as a crucial milestone in the nation’s public health response strategy. It complements existing measures under the National Vector Borne Disease Control Programme.

This proactive measure will be integrated with ongoing efforts focused on vector control, early diagnosis, and proper case management. The Ministry of Health and Family Welfare remains dedicated to providing timely access to safe and effective vaccines through its science-based regulatory framework.