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Drug Survey Report (2014 - 2016)

Locale of the Administrative Block
BSL-2 spacious State of the Art Laboratory Block
Product Testing Laboratories
Product Testing Laboratories
  1. National Institute of Biologicals (NIB) had been set up in 1992 as an apex autonomous Institute under the administrative control of the Ministry of Health & Family Welfare, Government of India for promoting and protecting human health through various activities assigned to it.
  2. The mandate of the Institute includes ensuring provision of quality biological drugs i.e Invitro diagnostics, Vaccines and Biotherapeutics, including therapeutic monoclonal antibodies used by patients suffering from cancer and autoimmune diseases by undertaking high end science based testing with R&D interface for application of science. One of the main functions of the Institute, as per by-laws 3.5.8, is to undertake research, establish linkages and exchange personnel with different institutions in India and abroad for furtherance of its mandate.
    Other subjects forming part of its mandate are 

    (i) developing and validating standards for quality control testing; 

    (ii) developing linkages with other National/ International institutions and keep abreast with worldwide scientific research and technological developments; 

    (iii) providing training facilities in quality control of biological; 

    (iv) assessing from time to time the availability of qualified manpower; and 

    (v) implementing and co-ordinating activities of Haemovigilance Programme of India. 

Sample Receipt & Report Dispatch Unit National Reference Standards Sera Panel

Manufacturing and QC Protocols

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Sample Receipt and Report Dispatch Unit  (SRRDU) Procedure.

  •  SRRDU  has been set up as independent unit in 2008.   The sample receipt unit being the main entry point of all samples to the Institute for testing, this unit has been accredited by NABL for elaborate documentation procedures. The Standard Operating Procedures (SOPs) have been amended to regulate Sample receipt to make the system flexible

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 Revised conditions 

 for purchase of :

 

1. Sera Panels

 

2. National Reference Standards

 

 

 

Revised specification/criteria of acceptance for quality test performed on HIV 1 &/or 2-Ab, HIV 1 p24 Ag, HCV-Ab and HBsAg kits

 
REVISED RATES OF TESTING CHARGES / FEE APPROVED AND APPLICABLE W.E.F. 01.06.2016

Acceptance Criteria for Test & Examination of Blood Glucose Test Strips as per ISO 15197:2003

 

Turnaround time for testing 

 

 

 

Guidance Document for Industry : submission of stability data and related documents for review & expert opinion for granting post approval changes in shelf life of Recombinant Biotherapeutic Products and Therapeutic Monoclonal Antibodies

 

 

Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India

PROPOSED FOR COMMENTS :

 

 

 

 

 

   

 



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