Eris Gets CDSCO Panel Nod To Dapagliflozin-Bisoprolol-Sacubitril Valsartan Combo Kit, Phase IV Trial Mandated
New Delhi: The Subject Expert Committee (SEC) under the Cardiovascular division of the Central Drugs Standard Control Organisation (CDSCO) has approved the manufacturing and marketing application submitted by Eris Lifesciences Limited for its Combi-Kit of Dapagliflozin + Bisoprolol + Sacubitril and Valsartan, with the condition to conduct a Phase IV clinical trial.
The proposal was reviewed during the SEC Cardiovascular meeting held on 10th July 2025 at CDSCO headquarters, New Delhi.
Eris Lifesciences presented its application along with a justification for a bioequivalence (BE) study waiver and a Phase III clinical trial (CT) waiver before the committee. The proposed Combi-Kit includes combinations of:
Dapagliflozin Propanediol equivalent to Dapagliflozin 10 mg (multiple doses)
Bisoprolol Fumarate IP 1.25 mg/2.5 mg/5 mg/10 mg
Sacubitril and Valsartan IP in strengths of 50 mg (24 mg and 26 mg), 100 mg (49 mg and 51 mg), and 200 mg (97 mg and 103 mg)
The committee noted that a higher strength of this combination — the Combi-Kit of Dapagliflozin 10 mg + Bisoprolol 10 mg + Sacubitril and Valsartan 200 mg — had already been approved to the firm.
After detailed deliberation, the committee considered the request for waiver of BE and Phase III CT and recommended granting permission for the manufacturing and marketing of the proposed Combi-Kit, subject to the condition that the firm conducts a Phase IV clinical trial.
The committee further directed that Eris Lifesciences must submit the Phase IV clinical trial protocol to CDSCO within three months of the FDC approval for review by the committee.
The approval was officially recorded in the recommendations of the SEC Cardiovascular meeting dated 10th July 2025, reflecting the regulatory process for fixed-dose combinations in India that combines antidiabetic and cardiovascular therapies for patient benefit.
