Zydus Asked to Revise Phase III Trial Protocol for Cough Syrup FDC After CDSCO Panel Review
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has recommended key revisions to the Phase III clinical trial protocol for Zydus Healthcare Ltd's fixed-dose combination (FDC) of Dextromethorphan Hydrobromide IP 10 mg and Phenylephrine Hydrochloride IP 5 mg per 5 ml syrup.
The recommendations were made during the Pulmonary SEC meeting held on July 9, 2025, where the firm presented its Phase III clinical trial protocol along with a special invitee (Pediatrician), in line with earlier SEC advice dated June 11, 2025.
After detailed deliberation, the expert panel opined that:
“Patients below 18 years should be excluded from the study.”
“Patients with pre-existing cardiovascular and respiratory disease should be excluded from the study.”
The committee directed the firm to submit a revised Phase III clinical trial protocol to CDSCO for further review in accordance with these recommendations.
Dextromethorphan hydrobromide is a widely used cough suppressant, while phenylephrine hydrochloride functions as a nasal decongestant. The combination is commonly found in over-the-counter formulations for cough, cold, and flu symptom relief.
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