Science & TechnologyImportant2025-02-01

CDSCO Approves Metformin SR for Pregnancy

Q: 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).

B. 2 only — Statement 1 is incorrect because Metformin SR is approved as an 'addition or an alternative to insulin based on treating physician discretion', not as a mandatory sole replacement. Statement 2 is correct, as the SEC formally recommended the prescribing label update to the CDSCO.

In News

What Happened

On February 1, 2025, the Central Drugs Standard Control Organization (CDSCO) officially approved an update to the prescribing information for Metformin Sustained Release (SR) tablets (500mg and 1000mg). The update permits its use during pregnancy and the periconceptional phase for managing gestational diabetes mellitus (GDM). This decision followed a formal recommendation from the Endocrinology and Metabolism Subject Expert Committee (SEC).

Why It Matters

This policy update is highly significant for maternal health in India, as it provides doctors with a formally approved, safe oral alternative to injectable insulin for treating GDM. It aligns Indian medical protocols with global regulatory standards, such as those from the UK's MHRA, offering a cost-effective and easily manageable treatment for expecting mothers.

Background

History & Context

Historically, Metformin was prescribed off-label for pregnant women with GDM or Polycystic Ovary Syndrome (PCOS), as product labels carried warnings against its use during pregnancy due to a previous lack of definitive clinical guidelines. In April 2023, USV Private Limited submitted an application to update the prescribing label. The CDSCO's Endocrinology and Metabolism Subject Expert Committee (SEC) reviewed global clinical data in October 2024, concluding that Metformin does not increase the risk of congenital abnormalities and is safe for maternal use.

What Changed

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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.
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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.
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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

In Class 11 Biology, Chapter 22 (Chemical Coordination and Integration), the pancreas is discussed as a composite gland secreting insulin to regulate blood glucose levels. Gestational diabetes occurs due to temporary insulin resistance during pregnancy; Metformin acts by increasing cellular sensitivity to insulin and decreasing hepatic glucose production, providing a practical application of endocrine regulation principles.

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).

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