Cadila Gets CDSCO Panel Nod To Manufacture, Market Cholecalciferol aqueous injection

This came after the firm presented the proposal of manufacture and marketing permission for a Cholecalciferol aqueous injection of 6,00,000 IU along with serum calcium level data of both the groups (Reference vs Test) after drug administration in the PK/PD study before the committee.

Cholecalciferol is a steroid hormone produced in the skin when exposed to ultraviolet light or obtained from dietary sources. The active form of cholecalciferol, 1,25-dihydroxycholecalciferol (calcitriol) plays an important role in maintaining blood calcium and phosphorus levels and mineralization of bone.

The activated form of cholecalciferol binds to vitamin D receptors and modulates gene expression. This leads to an increase in serum calcium concentrations by increasing intestinal absorption of phosphorus and calcium, promoting distal renal tubular reabsorption of calcium and increasing osteoclastic resorption.

Cholecalciferol (vitamin D3) is used as a dietary supplement when the amount of vitamin D in the diet is not enough. Cholecalciferol (vitamin D3) is also used along with calcium to prevent and treat bone diseases such as rickets (softening and weakening of bones in children caused by lack of vitamin D), osteomalacia (softening and weakening of bones in adults caused by lack of vitamin D), and osteoporosis (a condition in which the bones become thin and weak and break easily).

At the recent SEC meeting for endocrinology and metabolism held on 19th & 20th January 2023, the expert panel reviewed the proposal presented by Cadila Pharmaceuticals for the manufacturing and marketing of Cholecalciferol aqueous injection of 6,00,000 IU.

After detailed deliberation, the committee recommended the grant of permission for the manufacture and market of Cholecalciferol aqueous injection 6,00,000 IU for the proposed indication as “Indicated for the treatment of Vitamin D3 deficiency”.