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.
Immunoglobulins are an essential part of the immune system which recognizes the antigens or foreign elements in the body and help in their destruction. It also helps to reduce inflammation by improving one's immunity. Human Normal Immunoglobulin belongs to the class of medications called immunizing agents. It is used to treat immunoglobulin (antibody) deficiencies and inflammatory disorders. It is primarily used to treat immunoglobulin deficiency in patients with primary immunodeficiency ( PID), which is present from birth, and secondary immunodeficiency( SID), developed in the later stages of life.
Human Normal Immunoglobulin is also used to treat inflammatory disorders such as primary immune thrombocytopenia, Guillain-Barre syndrome, Kawasaki disease, and chronic inflammatory demyelinating polyneuropathy( CIDP ), and multifocal motor neuropathy. It replaces the deficient antibodies mandatory to fight against infections and inflammation. It performs exactly as the immunoglobulins present in the body.
At the recent SEC meeting for Oncology and Hematology held on 13.07.2022, the subject expert panel reviewed the proposal and the phase III protocol of immunizing agent Human Normal Immunoglobulin for Intravenous Administration IP/EP, 5% and 10% Solution
After detailed deliberation, the committee recommended for grant of permission for conducting the proposed Phase III clinical trial with the following conditions:
1. The clinical trial sites should be geographically distributed and accordingly PI undertaking should be submitted.
2. Undertaking stating that the product to be used in the trial is the same as approved in India in respect of indication (PIT) and dosage schedule for which the trial is proposed, to be submitted.
Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement/treatment or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2024 Minerva Medical Treatment Pvt Ltd