India Pharma Outlook Team | Wednesday, 08 October 2025
The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has given its green light to Zydus Healthcare Limited for the production and sale of Sodium Chloride Nebuliser Solution BP 3% w/v.
This follows the decision of the company’s request to be exempted from conducting a clinical trial. The Pulmonary SEC meeting on September 10, 2025, at CDSCO headquarters, New Delhi, was the venue of the decision.
The company, under SND/MA/25/000144, filed a proposal for a new drug application with a draft package insert and a clinical trial waiver justification document. Zydus was of the view that the product is nothing but a highly concentrated saline standard solution, which is becoming more and more common as a nebulised therapy in the treatment of cystic fibrosis and bronchiectasis
Researchers have proved the treatment’s efficacy in the elimination of mucus and general improvement of lung function.
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Due to the comprehensive appraisal, the SEC took on board the reasons for the waiver and gave the recommendation for the product to be manufactured as well as marketed. Nevertheless, to guarantee ongoing safety observation, the committee allotted roles.
Zydus is obligated to organize a Phase IV clinical trial and submit the study protocol to CDSCO within three months of receiving the green light. Moreover, the SEC asked for a modified version of the package insert, in which posology, dosage administration, contraindications, and warnings will be more thoroughly explained for further examination.
