Submit Periodic Safety Update Report In Indian Population: CDSCO Panel Tells Intas on rHumanErythropoeitinalfa injection
New Delhi: Reviewing the proposal presented by the drug major Intas Pharmaceuticals for the revision in package insertion of rh-EPO (r Human Erythropoeitinalfa injection), the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to submit safety data from the Indian population including periodic safety update report (PSUR).
This came after the drug maker Intas Pharmaceutical presented the proposal for revision in Package Insert of rh-EPO (r Human Erythropoeitinalfa injection) 3000 IU/0.3ml, 5000 IU/0.5ml, 6000 IU/0.6ml, 20000 IU/1.0ml (vial).
Erythropoietin (EPO) Erythropoietin is a type of protein called a growth factor. It is used to treat a low number of red blood cells (anemia) due to cancer or its treatment.
Erythropoietin is a recombinant form of human erythropoietin used to increase the differentiation of progenitor cells to red blood cells in the treatment of anemia. Erythropoietin (EPO) is a growth factor produced in the kidneys that stimulates the production of red blood cells.
Epoetin is used to treat severe anemia in patients on kidney dialysis or for those not on dialysis. Epoetin may also be used to prevent or treat anemia that is caused by surgery or medicines (eg, zidovudine) that are used for other conditions, such as HIV or cancer.
Erythropoietin (EPO) is an active glycoprotein secreted by the kidney. EPO in blood binds to EPO receptors on the surface of erythroid hematopoietic progenitor cells in bone marrow, which can promote the proliferation and differentiation of erythroid hematopoietic progenitor cells.
After detailed deliberation, the committee recommended the firm present safety data from the Indian population including PSUR safety data to support the proposed changes in PI.
Accordingly, the expert panel suggested that the firm should submit the information to CDSCO for evaluation by the committee.
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