Published Apr 05, 2026 | 7:00 AM ⚊ Updated Apr 05, 2026 | 7:00 AM
Representational image. Credit: iStock
Synopsis: India may soon see its first approved dengue vaccine as the SEC under CDSCO has recommended import permission for Takeda’s Qdenga (TDV) for ages 4–60. Backed by global approvals and Indian trials, the vaccine promises safer, broader protection. With Hyderabad-based Biological E set to manufacture millions of doses, this marks a major public health milestone.
India may be on the verge of getting its first approved dengue vaccine after the Subject Expert Committee (SEC) on Vaccines under the Central Drugs Standard Control Organisation (CDSCO) recommended granting import permission for Takeda’s Dengue Tetravalent Vaccine (TDV), commonly known as Qdenga, on 19 March 2026.
The recommendation, if accepted by the Drugs Controller General of India (DCGI), would allow the vaccine to be marketed for individuals aged 4 to 60 years, covering a wide swathe of the population in a country where dengue remains a serious and growing public health concern.
The SEC’s green light follows a Phase III clinical trial conducted in India on 480 healthy adults, adolescents and children aged 4 to 60 years across two cohorts. According to the committee’s meeting minutes, “the vaccine was found to be tolerated, safe and immunogenic in healthy adults, adolescents and children as per the presented report.”
The recommendation came after Takeda’s Indian arm, M/s Takeda Biopharmaceuticals India Pvt. Ltd., submitted a complete clinical study report to the committee, following an earlier SEC recommendation in August 2025.
The trial was formally titled “A randomised, double-blind, placebo-controlled, Phase III trial to investigate the safety and immunogenicity of Dengue Tetravalent Vaccine (TDV) administered subcutaneously to healthy subjects aged 4 to 60 in India.”
Qdenga is not an untested product. Developed by Japan-based Takeda Pharmaceutical, the live-attenuated vaccine contains weakened versions of all four serotypes of the dengue-causing DENV virus and is already approved in 41 countries, including those in the EU, UK, Switzerland, Indonesia, Malaysia, and Thailand.
The committee noted that the vaccine is WHO pre-qualified and that approximately 24.4 million doses have been distributed globally since launch. It further observed that the “post-marketing safety profile has remained largely consistent with clinical trials” and that “no new significant safety information has been identified for the important potential risks covered in the risk management plan.”
Takeda has conducted 20 clinical trials globally across more than 28,000 subjects aged 1.5 to 60 years. A comprehensive review of 19 studies found that over 90 percent of adults and children developed an immune response against all four dengue serotypes after two doses, with the vaccine showing more than 50 percent efficacy in reducing cases.
After detailed deliberation, the SEC recommended “grant of new drug permission for import of Dengue Tetravalent Vaccine (TDV) in individuals from 4 to 60 years of age,” making the indicated age range broader than even the EU approval, which covers individuals from 4 years of age, and the WHO pre-qualification, which is indicated from 6 years of age.
On the WHO’s broader guidance, the committee also noted that “as per WHO position paper on dengue vaccines, WHO recommends the introduction of vaccine in routine immunisation programs in individuals from 6 to 16 years of age in areas where high dengue transmission poses a significant public health problem, without pre-vaccination screening.”
The SEC has not given an unconditional nod. The committee stipulated that the “firm should conduct post-marketing safety and effectiveness study in Indian population within six months of introduction of the vaccine in Indian market.” This condition reflects the regulator’s intent to closely monitor the real-world performance of the vaccine across India’s large and diverse population.
The approval push has a strong domestic angle. In February 2024, Takeda announced a manufacturing partnership with Hyderabad-based Biological E to produce up to 50 million doses of Qdenga annually in India, with plans to scale to 100 million doses a year within the decade. This means India would not only be a market for the vaccine but also a significant global manufacturing hub.
Dengue is endemic in over 100 countries and roughly half the world’s population is at risk. Asian countries account for 70 percent of the global dengue burden. India, with its tropical climate and dense urban populations, sees hundreds of thousands of cases every year, and the numbers have been rising steadily.
Currently, there is no specific treatment for dengue and prevention has largely depended on vector-control measures such as eliminating mosquito breeding sites. A safe and effective vaccine that does not require pre-vaccination screening would mark a significant shift in India’s public health approach.
