CDSCO Committee Recommends SpinoS to Conduct BE Study with Vitamin D Screening Conditions

However, this approval is subjected to the condition that the firm should Screen the volunteers for Vit-D baseline levels and volunteers having normal Vit-D levels should enroll in the study and before check-in of period II, Vit-D levels should be monitored and volunteers having normal Vit-D levels only be continued in the study.

In addition, the committee recommended the firm to submit the revised protocol to CDSCO for further review.

This came after the firm presented the revised Protocol No.SLS-CT-0007-24-VITA Version No.04 Protocol Date 24 Apr 25.

Cholecalciferol (vitamin D3) is in a class of medications called vitamin D analogs. Cholecalciferol is needed by the body for healthy bones, muscles, nerves, and to support the immune system. It works by helping the body to use more of the calcium found in foods or supplements.

The genomic mechanism of 1,25(OH)2D3 action involves the direct binding of 1,25(OH)2D3 activated VDR/RXR to specific DNA sequences [vitamin D response elements (VDREs)] in and around target genes resulting in either activation or repression of transcription.

At the recent SEC meeting for Endocrinology and Metabolism held on 14th May 2025, the expert panel reviewed the revised Protocol No.SLS-CT-0007-24-VITA Version No.04 Protocol Date 24 Apr 25.

After detailed deliberation the committee recommended for conduct of proposed BE study for export purpose only, with the following conditions-

1) Screening of volunteers for Vit-D baseline levels and volunteers having normal Vit-D levels shall only be enrolled in the study.

2) Before check-in of period II, Vit-D levels shall be monitored and volunteers having normal Vit-D levels only be continued in the study.

Accordingly the firm shall submit the revised protocol to CDSCO for further review.

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