CDSCO panel rejects Akums Drugs Proposal for PK/PD study of Cholecalciferol aqueous injection
New Delhi: Noting that adequate safety measures are not incorporated in the proposed protocol, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has rejected Akums Drugs and Pharmaceuticals' proposed pharmacokinetic/pharmacodynamic (PK/PD) study of drug product Cholecalciferol aqueous injection 600000 IU/2 ml.
This came after the firm presented the proposal of PK/PD study protocol CHOL-23-007 ver.00, dated 25th Nov. 2024, of drug product cholecalciferol aqueous injection 600000 IU/2 ml before the committee.
The expert panel noted that adequate safety measures are not incorporated in the proposed protocol, i.e., urinary calcium/creatinine ratio, long-term follow-up, and GFR (glomerular filtration rate).
Cholecalciferol aqueous injection is a specific formulation of vitamin D3 (cholecalciferol) designed for rapid and efficient delivery in an aqueous (water-based) solution. Cholecalciferol, also known as vitamin D3, is a fat-soluble nutrient that the body needs in small amounts to function properly. The skin produces it when exposed to UVB light, and it's also present in some foods and available as a supplement.
Cholecalciferol helps the body use calcium and phosphorus to build strong bones and teeth. It also helps the body absorb more calcium and phosphorus from food and encourages the kidneys to retain calcium instead of excreting it.
At the recent SEC meeting for endocrinology and metabolism held on 25th March 2025, the expert panel reviewed the proposal of PK/PD study protocol CHOL-23-007 ver.00 dated 25th Nov. 2024 of drug product cholecalciferol aqueous injection 600000 IU/2 ml.
The committee observed that the proposed protocol lacks adequate safety measures, such as monitoring the urinary calcium/creatinine ratio, ensuring long-term follow-up, and assessing GFR.
In line with the above, after detailed deliberation, the committee did not recommend the proposed study protocol.
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