New Delhi: In response to a proposal by Fresenius Medical Care, the Specialty Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) has recommended the company to submit the rationale for approval along with phase III clinical trial data of calcium chloride dihydrate and post-marketing surveillance data from approved countries for further consideration.
       The company previously filed an application to manufacture and market calcium chloride dihydrate solution at a concentration of 100 mmol/L, which is used for “calcium replacement therapy in continuous renal replacement therapy (CRRT), continuous low-efficiency (daily) dialysis (CLED) and therapeutic plasma exchange (TPE) with citrate anticoagulation. The product is suitable for adults and children” and stated the reasons for exclusion from phase III and phase IV clinical trials.
       The committee noted that the product has been approved in European countries such as Portugal, the United Kingdom, Brazil, Switzerland, France and Denmark.
       The compound calcium chloride dihydrate is CaCl2 2H2O, which is calcium chloride containing two molecules of water per unit of calcium chloride. It is a white crystalline substance, readily soluble in water and hygroscopic, i.e. capable of absorbing moisture from the air.
       Calcium chloride dihydrate is a compound that can be used as a solvent system to dissolve chitin when dissolved in methanol. It plays an important role in breaking the crystal structure of chitin and has a wide range of applications in the field of chemistry.
       At the SEC Nephrology meeting held on May 20, 2025, the panel reviewed a proposal to approve the manufacture and marketing of 100 mmol/L calcium chloride dihydrate infusion solution for use in “calcium replacement therapy in continuous renal replacement therapy (CRRT), continuous low-efficiency (daily) dialysis (SLEDD), and therapeutic plasma exchange (TPE) with citrate anticoagulation. The product is indicated in adults and children” and provided justification for exemptions from phase III and IV clinical trials.
       Following detailed discussion, the committee recommended that the basis for approval, as well as phase III clinical trial data and post-marketing surveillance data from countries that have approved the drug, be submitted to the committee for further consideration.
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       Dr. Divya Kolin is a PharmD graduate with extensive clinical and hospital experience and excellent diagnostic and therapeutic skills. She has also worked as an oncology pharmacist in the oncology department at Mysore Medical College and Research Institute. She is currently pursuing her career in clinical research and clinical data management. She has been working with Medical Dialogue since January 2022.
       Dr Kamal Kant Kohli, MBBS, MD, CP, is a thoracic specialist with over 30 years of experience and specializes in clinical writing. He joins Medical Dialogues as the Editor-in-Chief of Medical News. Apart from writing articles, as the Editor, he is responsible for proofreading and reviewing all medical content published in Medical Dialogues, including content from journals, research papers, medical conferences, guidelines, etc. Email: drkohli@medicaldialogues.in Contact: 011-43720751
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