Discuss the significance of CDSCO's approval of India's first dengue vaccine in the context of India's vector-borne disease control strategy. What are the regulatory and public health challenges in its rollout?

Dengue remains India's most widespread vector-borne viral disease, with cases running into lakhs annually across nearly every State [3]. Against this backdrop, the Central Drugs Standard Control Organisation's marketing authorisation for Qdenga® (Dengue Tetravalent Vaccine, Live Attenuated) — India's first approved dengue vaccine — marks a shift from a purely vector-centric to a vector-plus-immunity control strategy [1].

Significance for vector-borne disease control

• Adds a preventive tool: control so far rested on vector management, surveillance, early diagnosis and case management under the National Vector Borne Disease Control Programme; the vaccine complements, not replaces, these [1].
• Tetravalent protection: built through recombinant DNA technology in Vero cells on a dengue virus type-2 backbone, it addresses all four serotypes — critical where severe dengue follows secondary infection [1].
• Regulatory maturity: approval under the Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945 rested on quality, safety and efficacy evaluation, with WHO prequalification and approvals in over 40 countries reinforcing confidence [1].
• Spurs indigenous R&D: it sits alongside DengiAll, the ICMR–Panacea Biotec candidate in Phase 3 trials across 19 sites [2].

Regulatory and public health challenges

• Post-marketing surveillance: a live vaccine needs robust pharmacovigilance and AEFI reporting, straining CDSCO's inspection and evaluation capacity.
• Coverage gaps: authorisation covers ages 4–60 years, leaving infants and the elderly dependent on vector control [1].
• Access and cost: being an imported product, affordability and supply security remain concerns until an indigenous vaccine matures [2].
• Delivery: State-level procurement, cold chain, a two-dose schedule three months apart, and vaccine hesitancy complicate uptake [1].

Approval is thus an important beginning rather than an endpoint. An integrated strategy — sustained vector control and surveillance, transparent post-marketing monitoring, and accelerated indigenous development — can convert this scientific milestone into equitable protection, advancing SDG 3 and the constitutional promise of health under Article 21.