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?

Q. 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? (15 marks, 250-350 words)

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.

(~330 words)

Sources: 1. CDSCO Approves India's First Dengue Vaccine, Strengthening National Dengue Prevention Efforts, PIB (2026) — Qdenga marketing authorisation, Takeda GmbH, 4–60 years age band, DENV-2 backbone/Vero cells, Drugs and Cosmetics Act 1940 basis, WHO prequalification, two-dose schedule, complementarity with NVBDCP 2. ICMR and Panacea Biotec initiate the First Dengue Vaccine Phase 3 Clinical Trial in India with Indigenous Dengue Vaccine, DengiAll, PIB (2024) — indigenous DengiAll candidate, Phase 3 across 19 sites, domestic development pathway 3. Dengue Cases and Deaths in the Country, National Center for Vector Borne Diseases Control (NCVBDC), MoHFW — State-wise annual dengue case and death burden