SEC Committee Recommends Metformin SR for Gestational Diabetes; Final Approval Pending
The Endocrinology & Metabolism Subject Experts Committee (SEC), under the Central Drugs Standard Control Organization (CDSCO), recently reviewed the use of Metformin Hydrochloride Sustained-Release (SR) Tablets for the management of gestational diabetes. Following the review, the SEC has recommended the consideration of Metformin SR 500 mg & Metformin SR 1000 mg for use during pregnancy, at the treating physician's discretion, as an adjunct or alternative to insulin therapy.
Metformin is one of the most widely used first-line agent for the management of type 2 diabetes, Prediabetes and is also approved for the treatment of Polycystic Ovary Syndrome (PCOS) with established insulin resistance. Its applicability and safety during pregnancy and the peri-conceptional period were recently evaluated by the Subject Expert Committee (SEC) in the presence of gynecologists and neonatalogists as special invitees. Its use in gestational diabetes is currently under review by regulatory authority.
Based on the prescription data and already available approval in EU and UK presented by Pharma major USV Pvt limited in this special population, the committee recommended the CDSCO for grant of permission to update the proposed statement in the prescribing information of Metformin Hydrochloride SR Tablets 500mg and 1000mg.
The prescribing information for Metformin Hydrochloride SR Tablets 500mg and 1000mg will be updated to indicate that
“if clinically needed, Metformin may be considered during pregnancy or the periconceptional phase, as an addition or alternative to insulin, at the treating physician's discretion”.
The final grant of approval for the change in the prescribing information is awaited from DCGI/ CDSCO and any changes to the approved labelling will be communicated accordingly. Healthcare professionals are advised to continue following current treatment guidelines until the official regulatory update is issued.
Disclaimer: “The use of Metformin during pregnancy is still under review and subject to final regulatory approval”
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