Ajanta Pharma Told to Revise BE Study Protocol for Cilnidipine, Metoprolol FDC
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has reviewed the proposal by Ajanta Pharma Limited for Cilnidipine IP 20 mg + Metoprolol Succinate IP 47.5 mg eq. to Metoprolol Tartrate 50 mg (ER) film-coated bilayered tablets and has asked the firm to revise its Bioequivalence (BE) study protocol.
The review was conducted during the SEC (Cardiovascular) meeting held on September 11, 2025, at CDSCO (HQ), New Delhi, under file number FDC/MA/25/000127.
As per the minutes of the meeting, the firm presented its proposal along with the BE study protocol under fasting condition before the committee. After detailed deliberation, the committee recommended modifying the inclusion criteria in the presented BE study protocol. The SEC specified that, “For female participants, the minimum Hb% cut-off value should be more than 12 g/dl.”
Accordingly, the committee directed that the firm submit a revised BE study protocol under fasting condition, as well as a BE study protocol under fed condition, along with the Phase III clinical trial (CT) protocol to CDSCO for further review by the committee.
The decision forms part of the committee’s continuous efforts to ensure that all proposed Fixed Dose Combination (FDC) formulations undergo rigorous scientific and ethical scrutiny before receiving regulatory consideration. By enforcing inclusion criteria related to hemoglobin levels, the SEC aims to maintain uniform safety and study quality standards across gender groups.
The proposed combination includes Cilnidipine, a fourth-generation calcium channel blocker that provides dual L-type and N-type calcium channel inhibition, and Metoprolol Succinate, an extended-release beta-blocker known for its efficacy in controlling blood pressure and heart rate. This FDC is designed to improve treatment adherence among patients with hypertension by combining two well-established antihypertensive agents in a single tablet.
Ajanta Pharma Limited, an Indian pharmaceutical company with a strong focus on specialty therapeutic areas, including cardiology, dermatology, and ophthalmology, has been expanding its cardiovascular portfolio through the development of advanced dosage formulations.
The SEC’s recommendation emphasizes ensuring comprehensive bioequivalence testing and robust clinical evaluation under both fasting and fed conditions before moving toward market authorization, aligning with India’s regulatory framework for cardiovascular FDC approvals.
