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Date: 2022-04-13 Category: Not Applicable State: Union Government Country: India

NOT OF STANDARD QUALITY ALERT FOR THE MONTH OF MAR-2022

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 gazette notification is a 'Not of Standard Quality Alert' issued for March 2022 by the Central Drugs Standard Control Organisation (CDSCO).
  • It identifies three batches of COVID-19 vaccines (ChAdOx1 nCoV-19 corona virus vaccine and Novel Corona Virus - nCoV Vaccine (ZYCOV-D)) that have been found to be spurious based on tests conducted by the Central Drugs Laboratory (CDL), Kasauli.

Key Changes

  • Three specific batches of COVID-19 vaccines are declared as Not of Standard Quality (NSQ) due to failing sterility, biochemical, physical aspects, label review, assay, and identity tests.
  • The affected vaccines are:
  • An unlabelled filled transparent fluid vial purported to be ChAdOx1 nCoV-19 corona virus vaccine.
  • ChAdOx1 nCoV19 corona virus vaccine (Covishield vaccine) batch number 4121MC034, manufactured on 01.07.2021 and expiring on 31.03.2022.
  • Novel Corona Virus - nCoV Vaccine (ZYCOV-D) batch number I457BH110, manufactured on 29.09.2021 and expiring on 28.06.2022.
  • The vaccines were tested at the Central Drugs Laboratory, Kasauli and failed tests including Sterility test, Biochemical Test, Physical aspects, Label Review, Assay, and Identity Test.

Impact Analysis

Impact on Public

  • Anxiety and uncertainty among individuals who may have received these specific batches of vaccines.

Impact on Vaccine Manufacturers

  • Potential legal liabilities if individuals suffer adverse effects from the spurious vaccines.

Impact on Government and Regulatory Bodies

  • Potential for increased costs associated with investigating and addressing the issue of spurious vaccines.

Suggested Action Items

  • Strengthen collaboration between regulatory bodies, manufacturers, and testing laboratories to ensure vaccine quality.

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organisation, the national regulatory body for pharmaceuticals and medical devices in India. Central Drugs Laboratory, Kasauli: A central drug testing laboratory responsible for testing and analyzing drug samples to ensure their quality and safety. ChAdOx1 nCoV-19 corona virus vaccine (Covishield): A COVID-19 vaccine developed by AstraZeneca and Oxford University, and manufactured by Serum Institute of India. Novel Corona Virus - nCoV Vaccine (ZYCOV-D): A COVID-19 vaccine developed and manufactured by Zydus Cadila.
Official Source Record View Original Source →
See Full Document Text
NOT OF STANDARD QUALITY ALERT FOR THE MONTH OF MAR-2022. A. Central Laboratories Expiry Reported by CDSCO S.No. Vaccine Name Batch No. Manufacturing Date Manufactured By NSQ Result Date Laboratory 3 Unlabelled filled -- - -- Spurious Sterility test, Biochemical Central Drugs Laboratory, transparent fluid vial Test, Physical aspects, Kasauli purported to be ChAdoX1 Label Review, Assay, nCoV19 corona virus Identity Test (Spurious) vaccine 4 ChAdoX1 nCoV19 4121MC034 01.07.2021 31.03.2022 Spurious Sterility test, Biochemical Central Drugs Laboratory, corona virus vaccine Test, Physical aspects, Kasauli (Covishiled vaccine) Label Review, Assay, Identity Test (Spurious) 5 Novel Corona Virus - I457BH110 29.09.2021 28.06.2022 Spurious Sterility test, Biochemical Central Drugs Laboratory, nCoV Vaccine (ZYCOV- Test, Physical aspects, Kasauli D) Label Review, Assay, Identity Test (Spurious)

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