Latest Update on Metformin – 2025 CDSCO Approval for Use in Pregnancy

Great news for gestational diabetes management! The Central Drugs Standard Control Organization (CDSCO) has approved an important update for Metformin Sustained Release (SR) tablets (500 mg/1000 mg), allowing it to be considered for use during pregnancy and in the periconceptional phase as an addition or alternative to insulin therapy, when necessary.

What’s New?

The updated prescribing information now states:
“If clinically needed, the use of Metformin can be considered during pregnancy and in the periconceptional phase as an addition or an alternative to insulin based on treating physician discretion.”

This means doctors now have more flexibility in treating gestational diabetes mellitus (GDM) with Metformin SR tablets, reducing dependence on insulin when appropriate.

Why This Approval Matters

✔ Metformin is widely used for Type 2 Diabetes, Prediabetes, and PCOS.
✔ Already recommended in the UK and EU for gestational diabetes, with a major rise in prescriptions.
✔ Safer than insulin for GDM—reduces maternal weight gain without increasing congenital abnormality risks.
✔ Endorsed by MHRA (UK), confirming Metformin’s safety in pregnancy.

What Led to This Approval?

USV Private Limited applied for approval in April 2023, which was reviewed by the Endocrinology & Metabolism Subject Experts Committee (SEC) in October 2024. After a detailed review, CDSCO officially accepted the update, ensuring doctors have clear guidelines when prescribing Metformin for gestational diabetes management.

📢 Doctors and healthcare professionals should consider this CDSCO-approved update when treating pregnant women with GDM.

🔹 Assess individual patient needs before prescribing Metformin.
🔹 Educate expecting mothers about safe GDM management options.
🔹 Stay updated on evolving guidelines for diabetes care during pregnancy.

🚨 Metformin’s approval for pregnancy use marks a major step in improving maternal health. Let’s ensure better diabetes management for expecting mothers!

To register for our next masterclass please click here https://linktr.ee/docpreneur

Melbourne, Australia
(Sat - Thursday)
(10am - 05 pm)