Fixed Dose Combination of Metformin-Voglibose Now CDSCO Approved
New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has clarified that the fixed-dose combination (FDC) of Voglibose 0.2 mg and Metformin Hydrochloride (SR) 500 mg is an approved formulation, removing it from the earlier list of unapproved FDCs.
In a communication to all State and UT Drugs Controllers, CDSCO referred to its earlier letter dated April 11, 2025, which listed certain FDCs as unapproved.
However, following a review, the regulator confirmed that the Voglibose-Metformin sustained release (SR) combination (listed at S. No. 31 in that letter) had already received CDSCO approval. The matter was also taken note of by the Hon’ble Delhi High Court during a hearing on July 14, 2025.
Consequently, the regulator has now formally excluded this FDC from the unapproved list circulated earlier.
A Voglibose-Metformin SR combination is a medication for type 2 diabetes that helps control high blood sugar levels by combining two drugs with different mechanisms of action: Voglibose, an alpha-glucosidase inhibitor, and Metformin, a biguanide.
Voglibose is an alpha-glucosidase inhibitor indicated in the management of postprandial blood glucose in patients with type II diabetes. Metformin is a biguanide antihyperglycemic used in conjunction with diet and exercise for glycemic control in type 2 diabetes mellitus.
Earlier, the Medical Dialogues Team had reported that the Central Drugs Standard Control Organisation (CDSCO) had issued a stern directive to all State and Union Territory Drug Controllers, instructing them to immediately stop the manufacture and sale of 35 unapproved Fixed Dose Combinations (FDCs), including Metformin Hydrochloride IP (as Prolonged-Release) 500mg and Voglibose IP 0.2mg Tablet.
In its latest communication, the drug regulator noted,
"In this regard, it may be mentioned that one of the FDCs, namely Voglibose 0.2 mg and Metformin HCL (as SR form) 500 mg (at S.No. 31), has been found to be approved by CDSCO and the same was also recorded by the Hon'ble High Court, Delhi, during the hearing on 14.07.2025.Accordingly, the FDC, i.e., Voglibose 0.2 mg and Metformin Hcl (as SR form) 500 mg (at S.No. 31), stands excluded from the list of unapproved FDCs in the letter dated 11.04.2025."
