ESIC Issues Alert on Substandard Drug Batch Supplied by Glenmark

The Employees’ State Insurance Corporation (ESIC) has issued a formal notification to its medical and administrative heads nationwide, alerting them to the use of a drug batch declared as “Not of Standard Quality” (NSQ) following laboratory testing.

📋 Drug Details and NSQ Declaration:

🚫 Instructions Issued by ESIC:

1. Immediate Stop Use:
   All ESIC facilities have been directed to immediately stop the use of this specific batch (Batch No. 551) of Clotrimazole + Lignocaine ear drops.
2. Supplier Accountability:
   The supplier (Glenmark Pharmaceuticals Ltd.) is required to:
   • Replace the substandard batch or
   • Refund the cost of the materials supplied,
   • Bear the testing charges, if any.
3. Further Action:
   Additional steps are to be initiated under the Drug Testing and Quality Control clauses of the relevant DG ESIC Tender Enquiry RC Terms & Conditions.

🗂️ Background:

This batch was supplied to ESIC PGIMSR, Kalaburagi, Karnataka, and was later found non-compliant with pharmacopoeial standards during routine quality control testing. The assay for Clotrimazole content did not match the label claim, which is critical for therapeutic efficacy.

🏁 Conclusion:

This alert is part of ESIC’s ongoing vigilance to ensure drug safety and quality across its hospitals and medical institutions. Authorities are expected to strictly comply with the directions to protect patient safety.