CDSCO Panel rejects Zydus Healthcare's proposal to waive Phase III CT of Diphenhydramine, Phenylephrine FDC

New Delhi: Denying the proposal for a phase III clinical trial (CT) waiver, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined Zydus Healthcare to conduct a Phase III CT study with the proposed fixed dose combination (FDC) pulmonary drug Diphenhydramine Hydrochloride plus Phenylephrine Hydrochloride (12.5 mg + 5 mg)/ 5 ml Syrup.

In addition, the committee has recommended the firm submit a phase III clinical trial protocol for the pulmonary drug FDC Diphenhydramine Hydrochloride plus Phenylephrine Hydrochloride Syrup.

This came after Zydus Healthcare presented justification for the Phase III CT waiver before the committee.

Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery.

At the recent SEC meeting for pulmonary drugs, the expert panel reviewed the justification for the phase III CT waiver presented by Zydus Healthcare.

After detailed deliberation, the committee reiterated its earlier recommendation dated 04.07.2024 and recommended that the firm should conduct Phase III clinical trial study with the proposed FDC.

Accordingly, the expert panel suggested that the firm should submit the Phase III clinical trial protocol to CDSCO for further review by the committee.

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