The Central Drugs Standard Control Organization (CDSCO) has issued a clarification stating that the Fixed-Dose Combination (FDC) containing Voglibose 0.2 mg and Metformin HCl (as SR form) 500mg is approved by the CDSCO and must be excluded from a previously circulated list of unapproved FDCs.
The circular, dated September 10, 2025, references a previous letter from the CDSCO dated April 11, 2025, concerning the manufacturing and marketing of unapproved FDCs.
The exclusion of the Voglibose and Metformin HCl combination (listed at S.No. 31 in the prior document) is based on the finding that it was approved by the CDSCO, a fact that was also recorded by the Delhi High Court during a hearing on July 14, 2025.
Accordingly, the FDC, Voglibose 0.2 mg and Metformin HCl (as SR form) 500mg, no longer falls under the category of unapproved FDCs mentioned in the April 11, 2025, letter.