Hetero Labs' Acarbose-Sitagliptin-Metformin FDC Rejected by CDSCO Panel Over GI Risk
New Delhi: In a setback to Hetero Labs Limited, the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organisation (CDSCO) has declined to recommend approval for the fixed-dose combination (FDC) of Acarbose, Sitagliptin Phosphate Monohydrate, and Metformin Hydrochloride film-coated tablets proposed by the drugmaker.
The proposal was reviewed at the recent SEC meeting for Endocrinology and Metabolism held on 11th June 2025, where the firm presented the FDC along with justification for the combination. This review was taken up in light of an earlier SEC recommendation dated 13.11.2024.
Following detailed deliberation, the committee opined that:
“The firm did not present the rationality of the three drug combination for better efficacy and safety.”
Additionally, the expert panel expressed concerns about gastrointestinal side effects, stating:
“GI adverse effect will be high for proposed three drug combination.”
In view of the above, the committee did not recommend approval for the proposed FDC.
The combination includes three anti-diabetic agents used in managing type 2 diabetes through complementary mechanisms. Acarbose delays carbohydrate absorption, Sitagliptin enhances insulin secretion and lowers glucagon levels, while Metformin reduces hepatic glucose production and improves insulin sensitivity. However, combining all three without strong clinical justification or supporting safety data appears to have raised efficacy and tolerability concerns.
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