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Dr Reddy's Laboratories gets CDSCO Panel nod to study Rabeprazole Sodium Modified Release Capsules

New Delhi: Dr. Reddy's Laboratories has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct a Phase III clinical trial study of Rabeprazole Sodium Modified Release Capsules 40 mg.
This came after Dr. Reddy’s Laboratories presented a comparative bioavailability study report and Phase III clinical trial protocol before the committee.
Rabeprazole is an antiulcer drug in the class of proton pump inhibitors. It is a prodrug—in the acid environment of the parietal cells it turns into active sulphenamide form. Rabeprazole inhibits the H+, K+ATPase of the coating gastric cells and dose-dependently suppresses basal and stimulated gastric acid secretion.
Rabeprazole is used to treat duodenal ulcers, gastroesophageal reflux disease (GERD), and Zollinger-Ellison syndrome, a condition where the stomach produces too much acid. It may also be used together with antibiotics (eg, amoxicillin, clarithromycin) to treat ulcers associated with infections caused by H. pylori.
At the recent SEC meeting for gastroenterology and hepatology held on February 27, 2025, the expert panel reviewed the comparative bioavailability study report and Phase III clinical trial protocol.
After detailed deliberation, the committee considered the comparative bioavailability study report and recommended the grant of permission to conduct a Phase III clinical trial study as per the protocol presented by the firm.
Doctor of Pharmacy
Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751