Abbott to Conduct BE Study for Carbimazole 15 mg, Trial Waiver Granted In India
New Delhi: Abbott Healthcare Pvt. Ltd has received the green signal from the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) to conduct a bioequivalence (BE) study for its Carbimazole Tablets I.P. 15 mg, while also securing a clinical trial waiver for the formulation.
The decision was taken during the SEC (Endocrinology & Metabolism) meeting held on 24th July 2025, where the firm presented its proposal for grant of permission to manufacture and market two dosage strengths: Carbimazole Tablets I.P. 2.5 mg and 15 mg.
Carbimazole is an antithyroid medication primarily indicated for the treatment of hyperthyroidism, including Graves' disease. It functions by inhibiting the thyroid peroxidase enzyme, thereby reducing the synthesis of thyroid hormones.
During the meeting, Abbott submitted the therapeutic rationale and justification for introducing both strengths. The firm highlighted that the 2.5 mg formulation would allow for more precise dose titration in sensitive patients, helping clinicians minimize the risk of inducing hypothyroidism. Meanwhile, the 15 mg strength was proposed to improve patient compliance by reducing pill burden in those requiring higher doses.
Along with the justification for a clinical trial waiver, Abbott also submitted the BE study protocol for the 15 mg strength. The BE study is intended to compare the pharmacokinetic profile of the 15 mg formulation with an existing reference product to confirm its bioequivalence.
After detailed deliberation, the expert panel recommended approval for the BE study and granted a clinical trial waiver.
“Permission for conduct of BE study along with clinical trial waiver is granted as per the protocol presented by the firm,” the SEC noted.
