The Ahmedabad-based Cadila Healthcare Ltd (Zydus) will be soon marketing in the country 'Infasurf' (calfactant), a lung surfactant for new- born babies, developed by well-known US-based scientist Dr. Bruce A Holm.
Calfactant contains a combination of lipids and proteins that can prevent and treat respiratory failure in newborn infants. The drug, which comes in vial form, has to be injected into the lungs of newborns with the help of endotracheal tube.
The company is currently undergoing clinical studies of the product and is expecting marketing approval from the DCGI by the first quarter of the next financial year, according to Dr. Ravindar Mittal, medical director, Cadila Healthcare.
"In some babies of the age between 3-6 weeks, the lung cells are not developed to make natural lung surfactants, which lubricate the lung tissues and help the respiratory process. The deficiency of the surfactant could therefore be fatal to the baby. Infasurf can help reduce the rate of mortality of pre-term newborns and is closest to that of natural surfactant," said Dr. Holm.
Infasurf is a sterile, organic extract of calf lung lavage, contains both SP-B and C, with a protein-B level that's closest to that of natural surfactant. In US, the drug is licensed to ONY Inc and is sold in more than six countries.
In India, companies like GSK are marketing lung surfactants like beractant, which is derived from natural bovine lung extract.
Dr. Holm is a professor in the Department of Pediatrics, obstetrics and gynecology, and pharmacology and toxicology at the State University of New York (SUNY).