Dr. Reddy's Labs Gets CDSCO Panel Nod To Manufacture, Market Esomeprazole Gastro resistant capsules

New Delhi: The pharmaceutical major Dr. Reddy's Laboratories has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to manufacture and market EsomeprazoleGastro resistant capsules IP 40 mg.

In addition to the above, the committee recommended the firm revise prescribing information for Esomeprazole Gastro Resistant Capsules IP 40 mg in line with the innovator’s reference product.

This came after Dr. Reddy's Lab presented the proposal for grant of permission to manufacture and market Esomeprazole Gastro Resistant Capsules IP 40 mg, along with the bioequivalence (BE) study report and justification for the waiver of the clinical trial study.

Esomeprazole is a proton pump inhibitor used to treat GERD, reduce the risk of NSAID-associated gastric ulcers, eradicate H. pylori, and treat conditions causing gastric acid hypersecretion.

Esomeprazole is indicated for the treatment of acid-reflux disorders, including healing and maintenance of erosive esophagitis, and symptomatic gastroesophageal reflux disease (GERD), peptic ulcer disease, H. pylori eradication, prevention of gastrointestinal bleeds with NSAID use, and for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome.

Esomeprazole exerts its stomach acid-suppressing effects by preventing the final step in gastric acid production by covalently binding to sulfhydryl groups of cysteines found on the (H+, K+)-ATPase enzyme at the secretory surface of gastric parietal cells. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus. As the binding of esomeprazole to the (H+, K+)-ATPase enzyme is irreversible and a new enzyme needs to be expressed in order to resume acid secretion, esomeprazole's duration of antisecretory effect persists longer than 24 hours.

At the recent SEC meeting for gastroenterology and hepatology held on 21st January 2025, the expert panel reviewed the proposal for grant of permission to manufacture and market Esomeprazole gastroresistant capsules IP 40 mg along with the BE study report and justification for the waiver of the clinical trial study.

After detailed deliberation, the committee recommended the grant of permission to manufacture and market Esomeprazole gastroresistant capsules (IP 40 mg) in applied indications.

Furthermore, the committee recommended to revise prescribing information of Esomeprazole Gastro Resistant capsules IP 40 mg in-line with the innovator’s reference product.

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