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Date: 2018-10-11 Category: Not Applicable State: Union Government Country: India

NOT OF STANDARD QUALITY ALERT FOR THE MONTH OF SEP-2018

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 Not of Standard Quality (NSQ) alert issued for September 2018 concerning specific batches of Poliomyelitis Vaccine live oral I.P. Divalent (Bivalent/bOPV).

Key Changes

  • Two batches (B100318) of Poliomyelitis Vaccine live oral I.P. Divalent (Bivalent/bOPV) manufactured by M/s Bio med., located in Bulandshar, U.P. are declared as Not of Standard Quality.
  • The manufacturing date for both batches is March 2018, and the expiry date is February 2020.
  • The NSQ result, reported by the Central Drugs Laboratory, Kasauli, indicates the detection of Type 2 serotype of Polio virus in the mentioned batches.
  • The alert was issued in September 2018.

Impact Analysis

Impact on Patients/Public Health

  • Need for investigation to determine the extent of distribution of the affected batches and potential recall.

Impact on M/s Bio med.

  • Suspension or cancellation of manufacturing license possible.

Impact on CDSCO

  • Need to ensure robust testing mechanisms in CDSCO laboratories.

Suggested Action Items

  • Inform relevant government health departments and international organizations (e.g., WHO, UNICEF) about the NSQ alert.

Key Entities Referenced

Poliomyelitis Vaccine live oral I.P. Divalent (Bivalent/bOPV): Oral polio vaccine (OPV) that protects against two types of poliovirus. M/s Bio med.: Manufacturer of the affected Poliomyelitis Vaccine live oral I.P. Divalent (Bivalent/bOPV) batches, located in Bulandshar, U.P. Central Drugs Laboratory, Kasauli: CDSCO laboratory responsible for testing and reporting the NSQ result. CDSCO: Central Drugs Standard Control Organisation, 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-2018. A. Central Laboratories S.No. Vaccine Name Batch No. Manufacturing Expiry Date Date Manufactured By NSQ Result Reported by CDSCO Laboratory 1 Poliomyelitis Vaccine live oral B100318 Mar'18 Feb'20 M/s Bio med., C-96, Bulandshar Identity: Type 2 Central Drugs Laboratory, Kasauli I.P. Divalent (Bivalent/bOPV) Road, Industrial Area, Ghaziabad- serotype of Polio virus 201009, U.P- 201009 detected 2 Poliomyelitis Vaccine live oral B100318 Mar'18 Feb'20 M/s Bio med., C-96, Bulandshar Identity: Type 2 Central Drugs Laboratory, Kasauli I.P. Divalent (Bivalent/bOPV) Road, Industrial Area, Ghaziabad- serotype of Polio virus 201009, U.P- 201009 detected

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