Unique Pharma Asked 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 directed Unique Pharmaceutical Laboratories to revise its Bioequivalence (BE) study protocol for the proposed fixed-dose combination (FDC) of Cilnidipine IP 20 mg + Metoprolol Succinate IP equivalent to Metoprolol Tartrate 50 mg (ER) film-coated tablet.
The proposal, filed under FDC/MA/25/000185, was reviewed during the SEC (Cardiovascular) meeting held on September 11, 2025, at CDSCO (HQ), New Delhi.
As per the official minutes, 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 advised that the firm submit a revised BE study protocol under fasting condition, a BE study protocol under fed condition, and the Phase III clinical trial (CT) protocol to CDSCO for further review by the committee.
The SEC’s recommendation aims to ensure that the BE study design adheres to scientifically validated inclusion criteria and uniform parameters for both male and female subjects, enhancing the reliability of bioequivalence data prior to clinical approval.
This proposed combination comprises Cilnidipine, a fourth-generation calcium channel blocker with dual L-type and N-type channel inhibition, and Metoprolol Succinate, an extended-release cardioselective beta-blocker. Together, the two drugs act synergistically to manage hypertension by reducing peripheral vascular resistance and controlling heart rate, thereby offering improved blood pressure control and cardiovascular protection.
Unique Pharmaceutical Laboratories, a part of the Unique Group of Companies, is engaged in manufacturing and marketing a wide portfolio of therapeutic formulations, including cardiovascular, gastrointestinal, and critical care products. With its growing focus on fixed-dose combinations and extended-release technologies, the firm continues to strengthen its position in the Indian cardiovascular drug market.
The SEC’s decision ensures that before regulatory consideration, the proposed FDC undergoes a comprehensive evaluation under both fasting and fed conditions, along with a Phase III clinical assessment, aligning with India’s stringent bioequivalence and safety review standards.
