Present relevant data about dose in patient: CDSCO Panel Tells Cipla on FDC of Torsemide Plus Spironolactone 5mg/25 mg

New Delhi: Citing that the data/literature presented by the drug major Cipla for the fixed-dose combination (FDC) drug Torsemide and Spironolactone (5 mg/25 mg) is not relevant, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to present the relevant literature about the 5mg dose of Torsemide and the 25 mg dose of Spironolactone in the patient population.

This came after the drug major Cipla presented literature for the proposed FDC in light of the earlier SEC recommendation dated 22/10/2024.

Torsemide belongs to the group of medicines called loop diuretics (water pills). This medicine works by acting on the kidneys to increase the flow of urine. Torsemide causes excretion of sodium chloride and water by inhibiting sodium and chloride reabsorption in the ascending loop of Henle and distal collecting tubule. The effect is caused by blocking the chloride-binding site of the Na+/K+/2Cl- cotransport mechanism.

Torsemide is used alone or in combination with other medications to treat high blood pressure. Torsemide is used to treat edema (fluid retention; excess fluid held in body tissues) caused by various medical problems, including heart, kidney, or liver disease.

Spironolactone belongs to a class of medications known as potassium-sparing diuretics. Spironolactone is used in combination with other medicines to treat high blood pressure (hypertension) and heart failure. Lowering blood pressure can reduce the risk of strokes and heart attacks. Spironolactone is also used to lessen the need for hospitalization for heart failure.

At the earlier SEC meeting, the expert panel opined that the firm needs to submit the published literature about the 5mg dose of torsemide and the 25 mg dose of spironolactone in the patient population for further review by the committee.

At the recent SEC meeting for Cardiovascular held on 5th March 2025, the expert panel reviewed the literature of the FDC Torsemide plus Spironolactone.

After detailed deliberation, the committee opined that the data/literature submitted by the firm is not relevant.

Therefore,the expert panel stated that the firm should present again the relevant literature as required in the last deliberation and updates, if any.

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