CDSCO Requests Additional Clinical Data from Fresenius for Calcium Chloride Infusion Approval in India

Key Insights

• Fresenius submitted a proposal to manufacture and market calcium chloride dihydrate 100 mmol/l solution for infusion in India for use in renal replacement therapies and plasma exchange procedures.
• The company sought waivers for Phase III and Phase IV clinical trials, citing existing approvals in Portugal, UK, Brazil, Switzerland, France, Denmark and other European countries.
• India's SEC committee for Renal recommended that Fresenius submit basis of approval, Phase III clinical trial data, and post-marketing surveillance data from approved countries before further consideration.

India's Central Drugs Standard Control Organisation (CDSCO) has requested additional clinical data from Fresenius before approving the company's calcium chloride dihydrate infusion for renal replacement therapies. The decision came during a recent Subject Expert Committee (SEC) meeting for Renal held on May 20, 2025.

Regulatory Review Process

Fresenius had submitted a proposal seeking permission to manufacture and market calcium chloride dihydrate 100 mmol/l solution for infusion 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 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 noted that the applied product has already received approval in multiple countries, including Portugal, the United Kingdom, Brazil, Switzerland, France, Denmark, and other European jurisdictions.

Committee Recommendations

Following detailed deliberations, the committee recommended that Fresenius 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.

Product Specifications

Calcium chloride dihydrate is the chemical compound CaCl2·2H2O, a form of calcium chloride containing two water molecules per unit of calcium chloride. It is a white crystalline solid, readily soluble in water, and hygroscopic, meaning it absorbs moisture from the air. The compound plays a crucial role in various medical applications, particularly in renal replacement therapies where calcium supplementation is necessary during procedures using citrate anticoagulation.

The regulatory review reflects India's stringent approach to drug approvals, requiring comprehensive clinical evidence even for products with established international safety profiles.