CDSCO Panel Asks Glenmark To Justify BE Waiver for FDC Inhalation Suspension With Scientific Evidence
Glenmark
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has advised Glenmark Pharmaceuticals to furnish scientific backing for its request to waive a bioequivalence (BE) study for its proposed fixed-dose combination (FDC) inhalation suspension.
The firm presented its FDC—Glycopyrronium 100 mcg + Vilanterol 50 mcg + Fluticasone Furoate 200 mcg Inhalation Suspension—along with a request for BE study waiver at the SEC (Pulmonary) meeting held on 28th May 2025.
According to the official minutes, “The firm presented their proposal along with request for BE study waiver before the committee.”
Following detailed deliberation, the committee stated, “The committee opined that the firm should submit data/ research evidence and published scientific literature in peer reviewed journal to support that double dose of nebulizer is equivalent to half dose of MDI/DPI.”
The panel concluded, “Accordingly, the firm should submit the above data to CDSCO for further review by the committee.”
This FDC combines three agents frequently used in respiratory therapy:
1. Glycopyrronium bromide is an anticholinergic that reduces airway secretions by selectively blocking muscarinic receptors.
2. Vilanterol is a long-acting beta2-adrenergic agonist (LABA) used for maintenance treatment of chronic obstructive pulmonary disease (COPD).
3. Fluticasone furoate, a corticosteroid, works by suppressing inflammatory responses involving mast cells, eosinophils, and cytokine mediators.
Glenmark now needs to submit peer-reviewed, published data to demonstrate that the systemic and therapeutic equivalence of the nebulized double dose matches that of the MDI/DPI half dose—a critical point for the requested BE waiver.
