Intas Pharma Gets CDSCO Panel Okay To Study Human Normal Immunoglobulin
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New Delhi: Pharmaceutical major Intas Pharma has got the go-head from the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) to conduct the Phase III Clinical Trial of immunizing agent Human Normal Immunoglobulin for Intravenous Administration IP/EP, 5% and 10% Solution.
However, the permission is conditional upon the submission of a principal investigator (PI) undertaking and the requirement that the clinical trial sites be geographically dispersed.
This came in line with the proposal presented by the drug maker Intas Pharma along with the Phase III clinical trial protocol of immunizing agent Human Normal Immunoglobulin for Intravenous Administration IP/EP, 5% and 10% Solution before the committee for export purpose.
Immune globulin belongs to class of agents called immunostimulants. It works by producing antibodies against foreign substances thereby fighting against infection.
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