ESIC Issues Warning on “Not of Standard Quality” Drug

On December 19, 2024, the Employees’ State Insurance Corporation (ESIC) issued a critical notification regarding the testing of a drug found to be “Not of Standard Quality”. The corporation has directed immediate action to ensure that this drug/item is no longer used and that all necessary steps are taken in compliance with the guidelines.

Name of the Drug : Thyroxine Sodium – Tab/Cap to contain : Thyroxine Sodium 25mcg/Throx 25

Key Points of the Notification:

  1. Drug Declared “Not of Standard Quality”: The concerned drug/item has been tested and reported as being “Not of Standard Quality”. As a result, its use must be halted immediately to prevent any health risks or further complications.
  2. Action as per Testing Guidelines: The ESIC has directed that actions be taken in accordance with the “Testing of Drugs-Quality Control” clause in the terms and conditions of the DG-ESIC RC (Director General – ESIC Regional Centres). This ensures that proper procedures are followed to manage such situations.
  3. Recovery of Costs: The notification specifies that the replacement of supplies or the cost of the material must be recovered from the supplying firm. Additionally, if any testing charges were incurred, these too should be recovered from the firm responsible for supplying the substandard product.
  4. Record-Keeping: It is mandatory for the respective user units to maintain detailed records of the actions taken in response to this notification. This includes documenting any follow-up actions and ensuring proper compliance with the stated directives.

Conclusion:

ESIC’s directive highlights the importance of maintaining quality control in healthcare products and services. All concerned units and suppliers are urged to comply promptly with the notification, ensuring the safety of beneficiaries and preventing further distribution of substandard drugs.

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