Background

The Central Drugs Standard Control Organization (CDSCO) issued communication regarding the manufacturing and marketing of unapproved Fixed Dose Combinations (FDCs). This follows earlier guidance issued on April 11, 2025, listing certain FDCs as unapproved. During legal proceedings, it was brought to light that one of the FDCs listed — Voglibose 0.2 mg and Metformin Hcl (as SR form) 500 mg — had obtained approval from CDSCO, which was acknowledged by the Hon’ble High Court of Delhi.

The communication clarifies that:

• The FDC, “Voglibose 0.2 mg and Metformin Hcl (as SR form) 500 mg (at S.No. 31),” stands excluded from the list of unapproved FDCs mentioned in the letter dated April 11, 2025.
• This decision was supported by the approval granted by CDSCO and the observations made by the Hon’ble High Court during the hearing on July 14, 2025.
• The exclusion applies with immediate effect from the date of issuance of this letter.