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Conduct bioequivalence study: CDSCO Panel tells Zydus Healthcare on Glycopyrrolate, Indacaterol Metered dose inhalation
![Conduct bioequivalence study: CDSCO Panel tells Zydus Healthcare on Glycopyrrolate, Indacaterol Metered dose inhalation Conduct bioequivalence study: CDSCO Panel tells Zydus Healthcare on Glycopyrrolate, Indacaterol Metered dose inhalation](https://medicaldialogues.in/h-upload/2022/12/09/750x450_193442-zydus-healthcare.webp)
New Delhi: Rejecting the clinical trial waiver proposal, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Zydus Healthcare to conduct a bioequivalence study (BE) of Glycopyrrolate plus Indacaterol Maleate Metered dose inhalation.
This came after Zydus Healthcare presented a proposal along with BE protocol and justification for clinical trial waiver before the committee.
Glycopyrrolate is an anticholinergic agent used to treat hyperhidrosis, severe drooling, and COPD, used with other medications to treat ulcers, and used in anesthesia. Glycopyrrolate is a racemic mixture of two enantiomers. They are both quaternary ammonium compounds and long-acting muscarinic antagonists. It is one of the most commonly prescribed anticholinergic medications. Glycopyrronium is a muscarinic antagonist with the highest affinity for M1 receptors, followed by M3, M2/M4, and M5.
Indacaterol is an inhaled long-acting beta-2 adrenergic agonist used to relax bronchial smooth muscle and improve symptoms and airflow obstruction caused by Chronic Obstructive Pulmonary Disease (COPD) and moderate to severe asthma.
Indacaterol works by stimulating adrenergic beta-2 receptors in the smooth muscle of the airways. This causes relaxation of the muscle, thereby increasing the diameter of the airways, which become constricted in asthma and COPD.
At the recent SEC meeting for Pulmonary held on 5th December 2023, the expert panel reviewed the proposal along with the BE protocol and justification for CT waiver of the FDC Glycopyrrolate plus Indacaterol Maleate Metered dose inhalation presented by drug major Zydus Healthcare.
After detailed deliberation, the committee recommended that the firm should conduct a BE study.
In addition, the expert panel stated, "Clinical trial waiver was not considered at this stage."
Following the above the committee suggested to the firm that the result of the BE study should be presented before the committee for review.
Also Read: Modify phase III clinical trial protocol: CDSCO panel tells Akum Pharma on antidiabetic FDC
Doctor of Pharmacy
Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: editorial@medicaldialogues.in. Contact no. 011-43720751