Trends of congenital rubella syndrome among infants (0–11 months old) in India: a multicentre hospital-based sentinel surveillance (2016–2025)

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Background: India aims to eliminate measles and rubella by 2026. In this study we analysed surveillance data from 2016 to 2025 from a facility-based surveillance of 16 sentinel sites across India to understand the burden and trend of congenital rubella syndrome (CRS). Methods: CRS surveillance included eligible infants between 0 and 11 months of age with suspected CRS, defined as the presence of congenital heart defects, hearing impairment, ocular abnormalities or maternal history of rash during pregnancy. All enrolled infants underwent comprehensive clinical evaluation, including cardiac, ophthalmologic, and hearing assessments. Serum samples were tested for rubella-specific IgM and IgG antibodies. The final analysis summarised clinical characteristics and trend of laboratory-confirmed CRS infants. Findings: Between November 2016 and May 2025, 8953 infants with suspected CRS were enrolled across 16 sentinel sites, among them 583 (6.5%) patients were classified as having laboratory-confirmed CRS. The proportion of laboratory-confirmed patients declined from 24.9% in 2017 to 2.5% in 2025. Among laboratory-confirmed CRS patients, 81.3% had structural heart defects, 26.8% had hearing impairment, and 24.2% had any of the group A ocular sign (cataract, glaucoma or pigmentary retinopathy). Of the 583 infants with laboratory-confirmed CRS, 541 were tested for rubella virus by RT-PCR, of whom 56 (10.4%) were positive, with no positive detections after 2021. Follow-up information was available for 452 laboratory-confirmed CRS patients, of whom 126 died, with a cumulative probability of death by one year of 32.2% (95% CI 26.7-38.4). Interpretation: The observed decline in the proportion of laboratory-confirmed CRS among suspected CRS infants in this facility-based surveillance is consistent with declining rubella virus transmission in India, although changes in surveillance sensitivity over time could not be excluded. Sustained high-quality surveillance is essential to monitor progress towards CRS elimination in the country. Funding: CRS surveillance was funded by the Ministry of Health and Family Welfare, Govt of India, through Gavi, the Vaccine Alliance (Grant number: 00101970).

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