Dr Reddy's Laboratories Gets CDSCO Panel Nod To Study Rebamipide, Sodium Alginate Suspension

New Delhi: The drug major Dr Reddy's Laboratories has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the bioavailability/bioequivalence (BA/BE) study of the gastroprotective drug Rebamipide and Sodium Alginate Suspension (100 mg and 500 mg per 10 mL) and (100 mg + 1000 mg per 10 mL) for export purposes only.

This came after Dr. Reddy's Laboratories presented Protocol No. CS23165, ver. 00, dated 05.01.2024 for BA/BE study for export purposes only.

Bioavailability and bioequivalence studies are important in the process of approving pharmaceutical products for marketing. Bioavailability is defined as the rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action. For a bioequivalence study, two or more bioavailability studies are conducted to compare the results between reference and test products.

Rebamipide belongs to the group of stomach drugs that have the effects of antacid, anti-reflux, and anti-peptic ulcer. Rebamipide is usually used to treat gastric ulcers and to improve gastric mucosal lesions (erosion, bleeding, redness, and edema) in acute gastritis and acute exacerbation of chronic gastritis.

Sodium alginate (SA) is a natural anionic polysaccharide that exists abundantly on the seafloor. It was extracted from brown algae (such as Macrocystis aeruginosa and Sargassum) and bacteria (such as Pseudomonas aeruginosa and nitrogen-fixing bacteria). For industrial use, SA was mainly extracted from marine algae. Alginate salts are multivalent additives such as binder and thickening agents, emulsifiers, gelling agents, and stabilizers for suspensions.

At the recent SEC meeting for gastroenterology and hepatology held on June 20, 2024, the expert panel reviewed Protocol No. CS23165, ver. 00 dated 05.01.2024 for BA/BE study for export purposes.

After detailed deliberation, the committee recommended the grant of permission to conduct the proposed BA/BE study for export purposes only

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