In a recent notification dated March 6, 2025, the Employees State Insurance Corporation (ESIC) has issued a significant update regarding the quality of a pharmaceutical drug that has been tested and declared as “Not of Standard Quality” (NSQ). The declaration follows a discrepancy found during the testing process, specifically in the test of “Uniformity of Volume.”
The drug in question was reported by the ESIC MC, PGIMSR & MH, Rajajinagar, Bangalore, and the following key points have been outlined for immediate action:
1. Immediate Suspension of Use
- Action Required: All units are instructed to immediately stop using the batch of the drug that has been confirmed as “Not of Standard Quality.”
2. Replacement and Cost Recovery
- Replacement Process: The firm that supplied the affected batch must provide replacement supplies or recover the costs of the materials, including any testing charges incurred.
3. Restriction on Future Orders
- No Further Orders: ESIC has directed that no orders should be placed with the pharmaceutical firm for this particular drug that has been tested and found to be of substandard quality. This is applicable during the currency of Rate Contract 145C.
4. Regulatory Action as per Quality Control Terms
- Legal Action: Action will be taken as per the “Testing of Drugs – Quality Control” clause in the Terms and Conditions of the respective DG-ESIC RC (Rate Contract).
5. Documentation and Record Maintenance
- Record Keeping: Each respective user unit is required to maintain a record of the actions taken in response to this issue, ensuring proper documentation and follow-up.
This action comes as part of ESIC’s ongoing commitment to ensuring the quality and safety of medicines distributed within its healthcare network. It is a reminder to all stakeholders of the importance of quality control and the consequences of non-compliance with the prescribed standards.
For more details, please refer to the full notification enclosed by the ESIC
