India approves its first dengue vaccine as DCGI clears Takeda's Qdenga for ages four to 60

India's Drugs Controller General has granted market authorisation to Qdenga, Takeda's live-attenuated tetravalent dengue vaccine, for people aged four to 60. The clearance was reported on 21 July 2026 by Akashvani News, the news service of the Government of India. It is the first dengue vaccine ever approved in India, a country that reports among the world's largest dengue burdens.

The product is Qdenga, developed under the code TAK-003. It is a live-attenuated tetravalent vaccine, covering all four dengue serotypes: DENV-1, DENV-2, DENV-3 and DENV-4. The applicant is Takeda Biopharmaceuticals India Private Limited. The dosing schedule is two doses given three months apart.

The approved population is ages 4 to 60 regardless of prior dengue infection history, and the label does not require pre-vaccination serological screening. That is the practical difference from the earlier-generation dengue vaccine Dengvaxia, whose use was restricted after evidence of worse outcomes in seronegative recipients.

The regulatory chain ran through the Central Drugs Standard Control Organisation, whose Subject Expert Committee on vaccines recommended the proposal on 19 March 2026. The recommendation was made conditional on post-marketing safety and effectiveness studies beginning within six months of market introduction.

India-specific evidence came from a phase 3 study in 480 Indian participants. That study found the vaccine tolerated, safe and immunogenic across the age groups it tested.

The global evidence base is larger. The development programme enrolled more than 28,000 subjects and reported immune responses above 90 per cent against all four serotypes. Qdenga is prequalified by the World Health Organization. According to a disclosure by Dr. Reddy's Laboratories, the vaccine has been approved in 43 countries since 2022, with more than 32 million doses distributed.

Domestic supply is being built out in parallel. Biological E Limited of Hyderabad partnered with Takeda in February 2024 to manufacture up to 50 million doses a year, with stated headroom to scale towards 100 million doses within a decade.

On 18 September 2026 Dr. Reddy's Laboratories disclosed to Indian regulators, and in an SEC Form 6-K exhibit, that it had secured exclusive rights to distribute and market Qdenga in India's private market. Takeda retains public-market commercialisation, brand oversight, manufacturing and importation. There was no upfront consideration and no milestone payments; other terms are confidential. M.V. Ramana, Chief Executive Officer of Global Generics at Dr. Reddy's Laboratories, said: "As the second-largest vaccine player in India, we believe the introduction of India's first approved dengue vaccine is an important development for the country's healthcare landscape." Private-market availability is anticipated in the first half of 2027, with disease-awareness work and healthcare-professional engagement in the interim.

One caveat attaches to the public record of the approval. The exact date of the DCGI order is not published on the Central Drugs Standard Control Organisation's website, whose list of new drugs approved in 2026 had not been updated past 10 March 2026. The date given here is the publication date of the Government of India's own news report of the clearance.

Three things follow from the approval. The post-marketing safety and effectiveness study condition set by the Subject Expert Committee has to be met, with those studies beginning within six months of market introduction. The Biological E manufacturing ramp has to deliver against its stated capacity. And any decision on introducing the vaccine into India's public immunisation programme remains open.