CDSCO panel rejects Akums Drugs Proposal for PK/PD study of Cholecalciferol aqueous injection
Written By : Dr. Divya Colin
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-04-27 12:30 GMT | Update On 2025-04-27 12:30 GMT
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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.
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