In the densely populated monazite-bearing sands of Kerala, on the southwest coast of India, natural radiation dose rates range from 1. 0 to over 35.0 mGy per year in certain well-defined high-level natural radiation areas. As a part of the program to assess the health effects of this naturally occurring high-level natural radiation on human populations, monitoring of newborns is being undertaken to determine the incidence of congenital malformations. From August 1995 to December 1998, a total of 36,805 newborns were screened, including 212 (0.58%) stillbirths. There were 36,263 singletons, 536 (1.45%) twins, and 6 born as triplets. The overall incidence of malformations was 1.46% and was dependent on maternal age. The stillborns exhibited a very high malformation rate of 20.75% compared to 1.35% among the live births. Likewise, twins also had a higher malformation rate (2.99%) compared to singletons (1.44%). About 3.5% of the newborns originated from consanguineous marriages. Consanguinity also led to a relatively higher rate of malformations (1.97%) as well as of stillbirths (1.18%). About 92% of the deliveries took place by the maternal age of 29 years and only 1.2% among women above 34 years old. The stratification of newborns with malformations, stillbirths or twinning showed no correlation with the natural radiation levels in the different areas. Thus no significant differences were observed in any of the reproductive parameters between the two population groups based on the monitoring of 26,151 newborns from high-level natural radiation and 10,654 from normal-level natural radiation (dose rate </=1.5 mGy/year) areas of the Kerala coast.