CDSCO Approves Metformin SR for Pregnancy
In News
What Happened
Why It Matters
Background
History & Context
What Changed
- ▶
BEFORE: Prescribing labels for Metformin carried warnings against use in pregnant women unless absolutely necessary, lacking explicit regulatory approval for GDM. NOW: The updated label explicitly states that Metformin SR can be considered during pregnancy and the periconceptional phase at the physician's discretion.
- ▶
BEFORE: Insulin was the primary, formally approved pharmacological intervention for GDM in India, which required painful injections and strict cold chain storage. NOW: Metformin SR serves as a formally approved oral addition or alternative to insulin, significantly easing patient compliance.
- ▶
BEFORE: Doctors prescribing Metformin for GDM were doing so off-label, assuming potential legal and clinical risks. NOW: Healthcare professionals have clear regulatory backing from the CDSCO to prescribe Metformin SR 500mg and 1000mg for pregnant patients.
Prelims Angle
NCERT Connection
Practice Questions
Q1
Correct Statement(s)Which of the following statements is/are correct regarding the CDSCO's 2025 approval for Metformin Sustained Release (SR)? 1. It mandates Metformin SR as the only allowed first-line treatment over insulin for gestational diabetes mellitus. 2. The approval was based on recommendations by the Endocrinology and Metabolism Subject Expert Committee (SEC).