Overview
On 21 July 2026, the Union Health Ministry announced that India has granted its first marketing authorisation for a dengue vaccine. The approval was given by the CDSCO for the Qdenga. The vaccine will be imported by Takeda Biopharmaceuticals India Pvt. Ltd. and is intended for people aged 4 to 60 years.
Key Developments
- Marketing authorisation granted after a thorough evaluation under the Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945.
- Vaccine is a live, attenuated tetravalent formulation produced in Vero cells.
- Two sub‑cutaneous doses of 0.5 ml each, given three months apart (0 and 3 months).
- Regulatory approval already secured in 42 countries and has WHO prequalification.
- Post‑marketing data from >24 million doses worldwide show a favourable safety profile.
Important Facts
The vaccine contains genetically modified organisms (GMOs) and is supplied as a freeze‑dried powder for reconstitution. Clinical development involved a global programme across more than eight countries, including Brazil, Thailand and Sri Lanka. A pivotal Phase III study in India evaluated safety and immunogenicity in the target age group.
Exam Relevance
Understanding the role of the NVBDCP is essential for GS‑3 questions on public