CDSCO Panel Asks Akums to Conduct PK/PD Study for High-Dose Vitamin D3 Injection with Added Subjects
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has asked Akums Drugs & Pharmaceuticals Limited to conduct a pharmacokinetic/pharmacodynamic (PK/PD) study for its Cholecalciferol Aqueous Injection 600,000 IU, with additional 20 study subjects as per presented protocol with condition to monitor the adverse effect.
The matter was discussed in light of the earlier SEC recommendation dated 22.05.2025, following which the firm submitted a revised PK/PD protocol (BIOS/2025/082 Ver 02) for evaluation before the committee.
Cholecalciferol, commonly known as Vitamin D3, is widely used for the treatment and prevention of vitamin D deficiency and related bone disorders. High-dose injectable formulations, such as 600,000 IU, are typically administered in cases requiring rapid replenishment of vitamin D levels.
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Cholecalciferol Aqueous Injection 600,000 IU is a high-potency VitaminD3 injection (usually 600,000 IU in 1-2 ml) designed to treat severe vitamin D deficiency and malabsorption issues. It acts by increasing calcium absorption in the body for bone health. Administered by professionals, usually intramuscularly, it acts quickly to boost vitamin D levels
Upon detailed deliberation, the committee reviewed the revised study protocol and recommended that the PK/PD study be conducted with an additional 20 study subjects as proposed.
Further, the SEC emphasized that adverse effects must be closely monitored throughout the duration of the study to ensure patient safety.
