Zydus Asked to Revise Phase III Trial Protocol for Cough Syrup FDC After CDSCO Panel Review

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2025-07-18 16:22 GMT | Update On 2025-07-18 16:22 GMT

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.

Also Read: Zydus Gets SEC Nod to Begin Phase IV Trial of Dydrogesterone ER for Habitual Miscarriage

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Dr. Divya Colin

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.

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Zydus Asked to Revise Phase III Trial Protocol for Cough Syrup FDC After CDSCO Panel Review

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