CDSCO Panel grants Cipla's Prescribing Information update for Bovine Lipid Extract Surfactant Suspension
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major Cipla's proposal for updating the prescribing information for the bovine lipid extract surfactant without the provided precaution statement of "In minimal invasive techniques (LISA or MIST), the volume of surfactant should be small. After the installation of a large volume surfactant (Bovine) which can initiate cough reflex, the chance of failure is high. But the advantages of LISA (Less Invasive Surfactant Administration), or MIST (Minimal Invasive Surfactant Therapy) is much more than conventional surfactant therapy."
This came after the drug major Cipla presented its proposal before the committee for updating the prescribing information without the provided precaution statement of "In minimal invasive techniques (LISA or MIST), the volume of surfactant should be small. After the installation of a large volume surfactant (Bovine) which can initiate cough reflex, the chance of failure is high. But the advantages of LISA (Less Invasive Surfactant Administration), or MIST (Minimal Invasive Surfactant Therapy) is much more than conventional surfactant therapy."
Bovine pulmonary surfactant was obtained by endotracheal lavage of lungs from newly slaughtered cows followed by differential centrifugation. Lipid extracts of bovine surfactant contained 3% neutral lipid, mainly as cholesterol and diacylglycerol, and 97% phospholipid.
Bovine lipid extract surfactant is commonly used to treat respiratory distress syndrome in premature infants in neonatal intensive care units (NICUs) across Canada, India, South Africa, Iran, Saudi Arabia, Bolivia, and Chile.
It is indicated for rescue treatment of Neonatal Respiratory Distress Syndrome (NRDS/Hyaline Membrane Disease).
At the recent SEC meeting for Pulmonary held on 6th February 2023, the expert panel reviewed the proposal presented by drug major Cipla on updating the prescribing information for Bovine Lipid Extract Surfactant Suspension.
After detailed deliberation, the committee recommended the grant of approval of updated prescribing information.
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