Latest Update on Metformin - 2025 CDSCO Recommended Grant of Permission for Consideration of Metformin in Pregnancy

The Central Drugs Standard Control Organization (CDSCO) has granted approval for updating the prescribing information for Metformin Sustained Release (SR) tablets (500 mg/1000 mg).

The update allows the Metformin (500 mg/1000 mg) Sustained Release (SR) tablets to be considered for managing gestational diabetes during pregnancy and in the periconceptional phase as an addition or an alternative to insulin therapy when clinically indicated.

The updated approved statement now reads, "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 discretion¹."

Metformin is one of the most widely prescribed anti-diabetic drugs for managing Type 2 Diabetes Mellitus, Prediabetes and is also recommended for women with polycystic ovarian syndrome (PCOS)². Metformin is already widely prescribed in the UK and EU for managing gestational diabetes mellitus (GDM). In these regions, a significant increase in Metformin prescriptions for GDM was observed, rising from less than 5% before 2007 to 42.5% by 2008, with over 85% of pharmacologically treated pregnancies using Metformin as a first-line therapy by 2015³.

The Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK has also updated Metformin’s product information, acknowledging its safety during pregnancy⁴.

A study highlights that in cases of Gestational Diabetes Mellitus (GDM), metformin is the preferred option as it does not increase the risk of congenital abnormalities during pregnancy and is generally well tolerated. Additionally, in GDM, metformin is favoured over insulin as it helps reduce maternal weight gain⁵.

USV Private Limited had made an application to the DCGI, no. SND/CT21/FF/2023/37149 dated 27^th April 2023. Basis the application, a deliberation was later discussed with The Endocrinology & Metabolism Subject Experts Committee (SEC), on 24.10.2024.

After detailed discussion and review the committee recommended CDSCO for grant of permission to update the proposed statement in the prescribing information of Metformin Hydrochloride SR Tablets 500mg/1000mg.

The initial proposed statement was, "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." The committee later recommended adding the phrase "based on treating physician discretion" to the statement¹.

The CDSCO has reviewed and accepted the SEC's recommendation, granting approval to update the prescribing information for Metformin Hydrochloride SR Tablets 500 mg/1000 mg accordingly.

References:

1. CDSCO Approval Document for updation of prescribing information for Metformin Hydrochloride Sustained Release tablets 500 mg /1000 mg.
2. Nasri H, Rafieian-Kopaei M. Metformin: Current knowledge. J Res Med Sci. 2014 Jul;19(7):658-64. Erratum in: J Res Med Sci. 2024 Jan 30;29:6. doi: 10.4103/JRMS.JRMS_62_24. PMID: 25364368; PMCID: PMC4214027.
3. YH, Platt RW, Reynier P, Yu OHY, Filion KB. Use of metformin and insulin among pregnant women with gestation diabetes in the United Kingdom: A population-based cohort study. Diabet Med. 2023 Aug;40(8):e15108. doi: 10.1111/dme.15108. Epub 2023 Apr 17. PMID: 37029772.
4. Medicines and Healthcare products Regulatory Agency. Metformin in pregnancy: Study shows no safety concerns. GOV.UK. www.gov.uk/drug-safety-update/metformin-in-pregnancy-study-shows-no-safety-concerns
5. Hyer S, Balani J, Shehata H. Metformin in Pregnancy: Mechanisms and Clinical Applications. Int J Mol Sci. 2018 Jul 4;19(7):1954. doi: 10.3390/ijms19071954. PMID: 29973490; PMCID: PMC6073429.