Fresenius Told to Submit Global Data for Calcium Chloride Infusion Approval
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has asked Fresenius Medical Care India Private Limited to submit international approval documents, Phase III clinical trial data, and post-marketing surveillance (PMS) data for its proposed Calcium Chloride Dihydrate 100 mmol/l Solution for Infusion before further regulatory consideration.
The company had submitted a proposal seeking permission to manufacture and market the infusion product in India. The formulation is indicated for calcium substitution in continuous renal replacement therapies (CRRT), sustained low-efficiency daily dialysis (SLEDD), and therapeutic plasma exchange (TPE) where citrate is used for anticoagulation. The product is intended for use in both adults and children.
As part of its application, Fresenius also sought a waiver of Phase III and Phase IV clinical trials, citing widespread international approvals and real-world use of the product.
The expert panel reviewed the proposal during a recent SEC meeting and noted that the formulation has already received approval in multiple countries, including Portugal, the United Kingdom, Brazil, Switzerland, France, Denmark, and other European jurisdictions.
However, following detailed deliberations, the committee recommended that the firm submit the basis of approval in these countries, along with Phase III trial results and post-marketing safety data, to support its case for marketing authorization in India.
The proposal will be reconsidered once the required documents are submitted and reviewed, the committee noted.
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