The Employees’ State Insurance Corporation (ESIC) has flagged a batch of Ondansetron Oral Solution 2 mg/5 ml as “Not of Standard Quality (NSQ)”, following a lab report from the Central Drugs Laboratory (CDL), Kolkata. The batch has failed to meet Indian Pharmacopoeia (IP) standards, specifically in the test for “Related Substances”.
Details of the NSQ Batch:
| Parameter | Details |
| Drug Name | Ondansetron Oral Solution 2 mg/5 ml |
| Batch No. | ONES1004 |
| Manufacturer | M/s Wings Biotech |
| Distributor Partner | M/s Mahaveer (PMBI Authorized) |
| Testing Lab | CDL, Kolkata |
| NSQ Reason | Failed IP test for “Related Substances” |
| Lab Report No. | KOL/LS/2025-26/97 |
| Report Date | April 25, 2025 |
| Manufacturing Date | September 2024 |
| Expiry Date | August 2026 |
| Reported by | ESIC MC PGIMSR & MH, Rajajinagar, Bangalore-10 |
Actions Directed by ESIC:
Immediate stoppage of use of the specified batch at all ESIC facilities.
All Drawing and Disbursing Officers (DDOs) are instructed to:
- Take appropriate steps in line with the MoU terms.
- Maintain detailed records of the actions taken.
This communication has been issued with the approval of the Medical Commissioner (Procurement) to protect patient safety and ensure regulatory compliance in public healthcare.
