Abbott Healthcare Gets CDSCO Panel Nod for Carbimazole Tablets 2.5 mg and 15 mg
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has granted permission to Abbott Healthcare for the manufacture and marketing of Carbimazole Tablets 2.5 mg and 15 mg after reviewing the bioequivalence (BE) study report submitted by the company.
The recommendation was made during the SEC (Endocrinology and Metabolism) meeting held on June 10, 2026. The company presented the BE study report for Carbimazole Tablets I.P. 15 mg in response to an earlier recommendation made by the committee on July 24, 2025. The proposed strengths are intended for use in indications that have already been approved.
During its review, the committee noted that Carbimazole tablets in strengths of 5 mg and 20 mg are already approved both in India and internationally. The expert panel also considered the dosing recommendations outlined in the Summary of Product Characteristics (SmPC).
According to the approved prescribing information, the initial dose for adults generally ranges from 20 mg to 60 mg per day. For children and adolescents aged 3 to 17 years, the recommended starting dose is 0.5 mg per kilogram of body weight per day, administered in two or three divided doses.
The committee further observed that the proposed strength of 2.5 mg is for dose titration.
Carbimazole is an antithyroid medication commonly used in the management of hyperthyroidism and other conditions associated with excessive thyroid hormone production. The drug works by inhibiting the synthesis of thyroid hormones, thereby helping to restore normal thyroid function.
After detailed deliberations, the committee accepted the bioequivalence study report submitted by the company and recommended the grant of permission for the manufacture and marketing of Carbimazole Tablets I.P. 2.5 mg and 15 mg.
