Intas Gets CDSCO Panel Nod To Manufacture, Market Tacrolimus Liquid Tablets
New Delhi: The drug major Intas Pharmaceutical has got approval from the Subject Expert Committee ( SEC) functional under the Central Drug Standard Control Organization (CDSCO) to manufacture and market the immunosuppressive agent Tacrolimus.
However, this approval is subject to the condition that Intas Pharmaceutical should conduct a Phase-IV clinical trial for which the firm should submit Phase IV clinical trial protocol within 3 months from the date of approval of the drug.
This came after Intas Pharmaceutical presented a Phase-III Clinical trial of the drug Tacrolimus Liquid Tablets 0.3mg report before the committee.
Tacrolimus belongs to a group of medicines known as immunosuppressive agents. Tacrolimus is a calcineurin inhibitor used to prevent organ transplant rejection and to treat moderate to severe atopic dermatitis.
Tacrolimus is an immunosuppressive drug whose main use is after an organ transplant to reduce the activity of the patient's immune system and so the risk of organ rejection. It is also used in a topical preparation in the treatment of severe atopic dermatitis, severe refractory uveitis after bone marrow transplants, and the skin condition vitiligo. It reduces peptidyl-prolyl isomerase activity by binding to the immunophilin FKBP-12 (FK506 binding protein) creating a new complex. This FKBP12-FK506 complex inhibits calcineurin which inhibits T-lymphocyte signal transduction and IL-2 transcription.
Tacrolimus binds to an immunophilin, FK506 binding protein (FKBP). This complex inhibits calcineurin phosphatase. The drug inhibits calcium-dependent events, such as interleukin-2 gene transcription, nitric oxide synthase activation, cell degranulation, and apoptosis.
Earlier at the 44th SEC meeting for Analgesic and Rheumatology, Intas Pharmaceuticals had received approval from the CDSCO panel to conduct a phase III clinical trial.
In continuation, at the recent SEC meeting for Analgesic and Rheumatology held on 8th August 2023, the expert panel reviewed the Phase-III Clinical trial report of Tacrolimus Liquid Tablets 0.3mg presented by the drug major Intas Pharmaceuticals.
After detailed deliberation, the committee recommended the grant of permission to manufacture and marketing of Tacrolimus Lipid Tablets 3mg subject to the condition that the firm should conduct Phase-IV CT for which the firm should submit Phase IV clinical trial protocol within 3 months from the date of approval of the drug.
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