The Employees’ State Insurance Corporation (ESIC) has issued a notification regarding a specific batch of Tranexamic Acid Injection IP (500 mg/5ml), which has been officially declared “Not of Standard Quality (NSQ)” upon testing. This drug was procured via an authorized distributor under the Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) channel.
The flagged batch was tested and reported by the Central Drugs Laboratory (CDL), Kolkata. ESIC has directed all concerned units to immediately cease usage of the identified batch and initiate appropriate actions, including recovery of costs from the supplier.
⚠️ Drug Quality Alert: Key Details
| Parameter | Details |
| Drug Name | Tranexamic Acid Injection IP |
| Strength/Volume | 500 mg/5ml |
| Batch Number | 224-185 |
| Manufacture Date | February 2024 |
| Expiry Date | January 2026 |
| Manufacturer | M/s Zee Laboratories Ltd, Paonta Sahib, H.P. |
| Authorized Distributor | M/s Mahaveer Drugs |
| Testing Laboratory | Central Drugs Laboratory (COL), Kolkata |
| Report Number & Date | KOL/LS/2025-for 26/282 dated 28.05.2025 |
| Reason for NSQ | Failed “Related Substances” and “Assay of Tranexamic Acid” tests |
| Reported From | ESIC Super Speciality Hospital, Sanathnagar-Plus, Hyderabad |
📝 Action Points Directed by ESIC:
- Immediate stop on the use of the specified batch across all user units.
- Initiate recovery of material cost or seek replacement as per MoU from the authorized distributor.
- Document actions taken and maintain records at respective user locations.
- Notification issued with the approval of the Medical Commissioner (Procurement).
This directive underscores ESIC’s continued commitment to ensuring the safety and quality of drugs supplied to its healthcare facilities.
