The Employees’ State Insurance Corporation (ESIC) has issued a notification alerting stakeholders about a batch of Sodium Bicarbonate Injection that has failed quality testing and has been officially classified as “Not of Standard Quality” (NSQ).
🔍 Details of the Affected Drug:
- Name of the Drug: Sodium Bicarbonate Injection (Each ampoule contains 7.5%, 10ml)
- Brand/Firm: Swiss Parenterals Limited
- Batch Number: 240115A
- Report No. & Date: PH-5967, dated 25.08.2025
- Testing Laboratory: Government Analyst, Karnataka
- Deficiency: Failed sterility test; non-conformance to Indian Pharmacopoeia (IP) standards
- Reported by: ESIC Medical College, Gulbarga, Karnataka
⚠️ Key Directives Issued:
- Immediate cessation of use of the affected batch across all facilities.
- Replacement or recovery of the cost of the drug and testing charges from the manufacturer (Swiss Parenterals Ltd).
- Further action to be initiated as per terms and conditions outlined in the DGESIC Tender Enquiry/RC 152.
📄 Official Action:
The sterility test failure raises serious concerns about the safety of the injectable medication, which is often used in emergency and critical care. ESIC’s swift action is in line with its commitment to ensuring drug safety and compliance with IP standards.
Healthcare institutions, pharmacists, and procurement officers are advised to take immediate action as per ESIC’s instructions and report any further discrepancies or adverse reactions linked to this product.