The Subject Expert Committee (SEC) on Gastroenterology and Hepatology has declined to recommend approval of a Fixed Dose Combination (FDC) containing Dexlansoprazole (enteric coated pellets) 60 mg and Domperidone (sustained release pellets) 30 mg capsules proposed by MSN Laboratories Private Limited.
The decision was taken during the 08th/26 SEC meeting held on 9 July 2026 at the CDSCO Headquarters, New Delhi, after the company presented its proposal before the committee.
During its deliberations, the committee noted that the Domperidone sustained-release formulation received CDSCO approval nearly 20 years ago. However, the SEC had already declined to recommend the same FDC in its meeting held on 18 March 2021.
The committee further observed that Domperidone sustained-release is not approved internationally. It also emphasized that the updated patient safety profile available since the original approval raises concerns regarding the desirability of the proposed combination.
Based on these observations, the SEC did not recommend approval of the proposed fixed-dose combination of Dexlansoprazole 60 mg and Domperidone SR 30 mg capsules. The recommendation will now be considered by the Central Drugs Standard Control Organisation (CDSCO) as part of the regulatory decision-making process.
