Zydus Gets CDSCO Panel Nod to Market Sodium Chloride Nebuliser Solution
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has recommended granting permission to Zydus Healthcare Limited to manufacture and market Sodium Chloride Nebuliser Solution BP 3% w/v, after accepting the firm's justification for a clinical trial waiver.
The proposal, filed under SND/MA/25/000144, was presented during the Pulmonary SEC meeting held on September 10, 2025, at CDSCO (HQ), New Delhi.
Zydus Healthcare presented its application seeking approval for Sodium Chloride Nebuliser Solution 3% w/v along with the package insert and justification for waiver of clinical trials before the committee. The company highlighted that the formulation is a standard hypertonic saline solution used globally as a nebulised therapy for patients with cystic fibrosis, bronchiectasis, and chronic pulmonary conditions, where it helps clear mucus and improve lung function.
After detailed deliberation, the committee accepted the justification for the clinical trial waiver and recommended granting permission to manufacture and market Sodium Chloride Nebuliser Solution 3% w/v.
However, the committee stipulated conditions to ensure continued safety monitoring. The firm must conduct a Phase IV clinical study and submit the Phase IV study protocol to CDSCO within three months of approval. Furthermore, the SEC advised Zydus to revise and resubmit the package insert, specifically addressing posology, dosage administration method, contraindications, and warnings, for further review by the committee.
Zydus Healthcare, part of the Ahmedabad-based Zydus Lifesciences group, is one of India’s pharmaceutical companies known for its strong respiratory and critical care portfolio.
