Intas Pharmaceuticals Gets CDSCO Panel Nod to Study Recombinant Human Follicle Stimulating Hormone
New Delhi: Intas Pharmaceuticals has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct a Phase I clinical trial of the Recombinant Human Follicle Stimulating Hormone 300 IU Solution for Injection.
However, this approval is subject to the condition that the firm should have tied up with an IVF center in case of an emergency.
This came after the firm presented the protocol to conduct a Phase I clinical study of Recombinant Human Follicle Stimulating Hormone 300 IU Solution for Injection titled " An open label, Phase-I, balanced, randomized, two-treatment, two-period, two-sequence, single subcutaneous dose administration, crossover, bioequivalence study of r-h-FSH (recombinant human follicle stimulating hormone injection), solution for injection of Intas Pharmaceuticals Limited, India with Gonal-f, recombinant human follicle stimulating hormone (r-hFSH) follitropin alfa, solution for injection of Merck serono Ltd. in pituitary down-regulated normal, healthy, adult, human female subjects under fasting conditions." vide Protocol no. 0501-23, Version: 2.0 dated 27-May-2024.
Recombinant Human Follicle Stimulating Hormone 300 IU Solution for Injection belongs to a group of medicines called Gonadotropins. It is used to treat infertility in women (oligo-anovulatory infertile patients in whom the cause of infertility is functional and not due to primary ovarian failure) and to stimulate sperm production in men.
At the recent SEC meeting for reproductive medicine, held on September 18, 2024, the expert panel reviewed the protocol for conducting a Phase I clinical study of recombinant human follicle-stimulating hormone 300 IU Solution for Injection presented by the drug major Intas Pharmaceuticals.
After detailed deliberation, the committee recommended the conduct of the proposed Phase I study with the condition that the firm should have tied up with an IVF center in case of an emergency.
Accordingly, the expert panel suggested that the firm should submit a revised protocol to CDSCO for further evaluation.
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