Home› India› Ministry of Health and Family Welfare› NOT OF STANDARD QUALITY ALERT FOR THE MONTH OF MARCH-2019...
Date: 2019-04-05 Category: Not Applicable State: Union Government Country: India

NOT OF STANDARD QUALITY ALERT FOR THE MONTH OF MARCH-2019

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

Research with AI Agent Chat with Document Generate Summary Translate Helpful Share Add to Project Create Task

Executive Summary & Key Takeaways

What it means

  • This is a Not of Standard Quality (NSQ) alert issued for the month of March 2019.
  • The alert pertains to a specific batch of Diphtheria, Tetanus, Pertussis (Whole cell), Hepatitis B (rDNA) & Haemophilus influenzae Type-b Conjugate vaccine (Adsorbed) vaccine.

Key Changes

  • Batch number 220106717A of the Diphtheria, Tetanus, Pertussis (Whole cell), Hepatitis B (rDNA) & Haemophilus influenzae Type-b Conjugate vaccine (Adsorbed) vaccine, manufactured by M/s Biological E Ltd, is declared as Not of Standard Quality (NSQ).
  • The vaccine batch was manufactured in October 2017 and had an expiry date of March 2020.
  • The NSQ result was reported by the Central Drugs Laboratory (CDL), Kasauli, and is based on physical aspect examination.

Impact Analysis

Impact on M/s Biological E Ltd

  • Review of manufacturing processes and quality control procedures is essential.

Impact on Central Drugs Standard Control Organization (CDSCO)

  • Public communication regarding the NSQ alert and any subsequent actions taken.

Impact on Public Health

  • Communication to healthcare providers regarding the NSQ alert and guidance on managing patients who may have received the affected batch.

Suggested Action Items for Corporate Affairs

  • Assess potential legal and financial implications of the NSQ alert.

Key Entities Referenced

M/s Biological E Ltd: Manufacturer of the Diphtheria, Tetanus, Pertussis (Whole cell), Hepatitis B (rDNA) & Haemophilus influenzae Type-b Conjugate vaccine (Adsorbed) vaccine. Located in Telangana, India. Central Drugs Laboratory (CDL), Kasauli: The CDSCO laboratory that reported the Not of Standard Quality (NSQ) result. CDSCO: Central Drugs Standard Control Organisation, the national regulatory body for pharmaceuticals and medical devices in India. Diphtheria, Tetanus, Pertussis (Whole cell), Hepatitis B (rDNA) & Haemophilus influenzae Type-b Conjugate vaccine (Adsorbed): The specific vaccine that is subject of the NSQ alert.
Official Source Record View Original Source →
See Full Document Text
NOT OF STANDARD QUALITY ALERT FOR THE MONTH OF Mar-2019. A. Central Laboratories Expiry S.No. Vaccine Name Batch No. Manufacturing Date Manufactured By NSQ Result Reported by CDSCO Laboratory Date 1 Diphtheria,Tetanus,Pertussis( 220106717A Oct-17 Mar'20 M/s Biological E Ltd, Plot no. 1, SP Physical aspect Central Drugs Laboratory, Kasauli Whole cell) ,Hepatitis B (rDNA) Biotech Park, Phase II, Kolthur & Haemophilus influenzae Type- (Village), Shameerpet (mandal), Ranga Reddy (District), Telangana b Conjugate vaccine (Adsorbed) - 500078

Continue your research

Related Documents from Ministry of Health and Family Welfare