Akums Gets CDSCO Panel Nod To Manufacture, Market Antidiabetic FDC Drug

Glimepiride is a sulfonylurea class of drugs. Glimepiride is used to treat high blood sugar levels caused by type 2 diabetes. It may be used alone or in combination with insulin or another oral medicine such as metformin. In type 2 diabetes, insulin produced by the pancreas is not able to get sugar into the cells of the body where it can work properly.

Metformin, classified as a biguanide drug, effectively lowers blood glucose levels by decreasing glucose production in the liver, diminishing intestinal absorption, and enhancing insulin sensitivity. As a result, metformin effectively lowers both basal and postprandial blood glucose levels.

At the recent SEC meeting for Endocrinology and Metabolism held on 24th January 2023, the expert panel reviewed the proposal along with the BE report of higher strength of the FDC Dapagliflozin Propanediol Monohydrate plus Glimepiride plus Metformin Hydrochloride film-coated bilayered tablet.

After detailed deliberation, the committee recommended the grant of permission to manufacture and market the product after submission of data including dissolution data and justification for BE waiver as per the BE Study guideline with the condition that the firm should conduct Active PMS study.

Accordingly, the expert panel suggested that the firm should submit an active PMS study protocol to CDSCO within 03 months of approval for review by the committee.

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