Conduct bioequivalence study: CDSCO Panel tells Zydus Healthcare on Glycopyrrolate, Indacaterol 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.

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