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Date: 2017-10-11 Category: Not Applicable State: Union Government Country: India

NOT OF STANDARD QUALITY ALERT FOR THE MONTH OF SEP-2017

Issued by Ministry of Health and Family Welfare · Central Drugs Standard Control Organization

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Executive Summary & Key Takeaways

What it means

  • This is a notification regarding a vaccine batch that has been declared Not of Standard Quality (NSQ).

Key Changes

  • Tetanus Vaccine (adsorbed) I.P (AbhayTox), Batch No. Tox 23B/15, manufactured by M/s Human Biological Institute, Hyderabad, is declared NSQ.
  • The vaccine batch was manufactured in April 2015 and has an expiry date of March 2018.
  • The NSQ result is based on physical aspect testing conducted by the Central Drugs Laboratory, Kasauli.

Impact Analysis

Impact on Patients/Public

  • Could erode public trust in the vaccine and the manufacturer.

Impact on Manufacturer (M/s Human Biological Institute)

  • Legal implications and potential liabilities if patients are harmed.

Impact on Regulatory Bodies (CDSCO, Central Drugs Laboratory)

  • Necessitates further investigation to determine the root cause of the NSQ finding.

Suggested Action Items

  • Establish a system to track individuals who received the affected batch and offer revaccination if necessary.

Key Entities Referenced

Tetanus Vaccine (adsorbed) I.P (AbhayTox): The specific vaccine that was found to be Not of Standard Quality. M/s Human Biological Institute: The manufacturer of the Tetanus Vaccine (adsorbed) I.P (AbhayTox) located in Hyderabad. Central Drugs Laboratory, Kasauli: The CDSCO laboratory that conducted the testing and reported the NSQ result based on physical aspect. CDSCO: Central Drugs Standard Control Organization, the national regulatory body for pharmaceuticals and medical devices in India.
Official Source Record View Original Source →
See Full Document Text
NOT OF STANDARD QUALITY ALERT FOR THE MONTH OF SEP-2017. A. Central Laboratories S.No. Vaccine Name Batch No. Manufacturing Expiry Date Date Manufactured By NSQ Result Reported by CDSCO Laboratory 1 Tetanus Vaccine(adsorbed) Tox 23B/15 Apr-15 Mar-18 M/s Human Biological Institute, (A division Physical aspect Central Drugs Laboratory, Kasauli I.P (AbhayTox) of Indian Immunologicals Limited), Rakshapuram, Gachibowli Post, Hyderabad- 500032

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