Sun Pharma Gets CDSCO Panel Nod to Conduct Active Post-Marketing Study for Antacid Combination Tablet

The firm had presented the required active post-marketing surveillance protocol to the committee in accordance with the condition mentioned in the CT-23 permission, and the submission was taken up for detailed deliberation.

This chewable tablet formulation combines Sodium Alginate, Sodium Bicarbonate, and Calcium Carbonate, ingredients commonly used in antacid and reflux-related management. Sodium Alginate functions as a raft-forming agent that creates a physical barrier to prevent gastric contents from refluxing into the esophagus. Sodium Bicarbonate, an antacid, works rapidly to neutralize excess gastric acid, while Calcium Carbonate provides additional acid-neutralizing capacity and offers longer duration of action. The uncoated chewable format further supports ease of administration for patients requiring quick relief from symptoms of acidity and heartburn.

Sun Pharma, one of India’s prominent pharmaceutical manufacturers with a global presence across more than 100 countries, markets a wide portfolio across gastroenterology, cardiology, dermatology, and neurological therapeutics, with this formulation contributing to its gastrointestinal care category.

As per the CT-23 requirement dated 09.04.2025, the company submitted the active post-marketing surveillance protocol for review. After examining the details, the committee recommended the conduct of the proposed study, noting that the firm had complied with the condition attached to the manufacturing and marketing permission. The surveillance will allow systematic evaluation of safety and effectiveness once the product is used in real-world clinical settings, enabling continuous monitoring of patient outcomes following market availability.

The committee also specified that the results of the study, when available, should be submitted to CDSCO for review by the expert panel.