CDSCO Approves Metformin Use in Pregnancy and Peri-Conceptional Phase

The Endocrinology and Metabolism Subject Expert Committee (SEC) under CDSCO has approved updating the prescribing information for Metformin Hydrochloride SR Tablets (500 mg and 1000 mg), enabling its use during pregnancy and the peri-conceptional phase based on the discretion of treating physicians.

As part of this update, the following statement will be added to the prescribing information

"If clinically needed, the use of Metformin can be considered during pregnancy and in the peri-conceptional phase as an addition or an alternative to insulin based on treating physician discretion."

Metformin is one of the most widely used first-line treatments for type 2 diabetes and prediabetes, and is also approved for managing Polycystic Ovary Syndrome (PCOS) in patients with established insulin resistance. With this update allowing its use during pregnancy as an additional option for glycemic control.

This decision follows a proposal submitted by USV Pvt. Ltd. on 24.10.2024, which underwent detailed deliberations by the Subject Expert Committee (SEC). The committee reviewed the safety and applicability of Metformin during pregnancy and the peri-conceptional phase in consultation with gynecologists and neonatologists invited as special experts.

This regulatory approval in India aligns with other international practices and provides an additional therapeutic option for pregnant women requiring effective glycemic control.

Reference:

1. CDSCO Approval Document for updation of prescribing information for Metformin Hydrochloride Sustained Release tablets 500 mg /1000 mg.