CDSCO Approves India's First Dengue Vaccine, Strengthening National Dengue Prevention Efforts

📌 Summary:

• CDSCO (under Ministry of Health & Family Welfare) granted marketing authorisation for the Dengue Tetravalent Vaccine (Live, Attenuated) – Qdenga®, India's first dengue vaccine
• Manufactured by Takeda GmbH (Germany), imported by Takeda Biopharmaceuticals India; indicated for prevention of dengue in individuals aged 4–60 years; two doses (0 and 3 months)
• Qdenga® is a live, attenuated, recombinant tetravalent vaccine produced in Vero cells on a dengue virus type-2 backbone; contains genetically modified organisms (GMOs)
• Approved after scientific evaluation under the Drugs and Cosmetics Act, 1940 & Drugs Rules, 1945; supported by a pivotal Phase III study in the Indian population and trials across 8+ countries (Brazil, Thailand, Sri Lanka)
• Already approved in 42 countries (EU, UK, Switzerland, Indonesia, Malaysia, Thailand) with WHO prequalification; over 24 million doses distributed globally
• Complements vector control, surveillance and case management under the National Vector Borne Disease Control Programme

🎯 UPSC Relevance: GS3 S&T/health — vaccine regulation, biotechnology, public health response to vector-borne diseases

📝 Prelims Facts:

• Qdenga® = first dengue vaccine approved in India; for ages 4–60; two doses
• Regulator: CDSCO (Central Drugs Standard Control Organisation); manufacturer Takeda GmbH
• Contains GMOs; has WHO prequalification; approved in 42 countries

🔑 Key Term: Live attenuated vaccine — a vaccine using a weakened form of the pathogen that stimulates immunity without causing disease