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National Institute of Biologicals

(राष्ट्रीय जैविक संस्थान)

Ministry of Health & Family Welfare, Government of India

स्वास्थ्य एवं परिवार कल्याण मंत्रालय,भारत सरकार

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Participation in Collaborative Studies of 

National & International Organizations

 

S.No.  Name of Study  Collaborator  Period of Study Name of NIB Laboratory Status
1. National Reference Standard preparation of Filgrastim 6 Laboratories (NIB, Filgrastim Stakeholders, & USP) 2015 - Ongoing Recombinant Product Laboratory I Candidate material for National Reference Standard Preparation of Filgrastim has been received from one of the indigenous stakeholder. Logistics has been planned for sending the study material to the various ILC participants
2. National Reference Standard preparation of Insulin Lispro 6 Laboratories (NIB, Insulin Stakeholders, IPC & USP) 2015 - 2018 Recombinant Product Laboratory I 1st National Reference Standard for Insulin Lispro (IPRS) has been officially released by competent authority on Sep 14th, 2018 in meeting at NIB, attended by Official from Indian Pharmacopoeia Commission & Stakeholder
3. Performance validation of indigenously- made glucose sensing device with ICMR support as a collaborating center and also provide expert guidance to the Manufacturers and the other collaborating centers with respect to IQC, ISO15197: 2003 guideline requirements and Performance evaluation protocols and parameters Biochemical Kit Laboratory, NIB and Division of Innovation and Translational Research, ICMR, New Delhi 01.07.17- till date (ongoing) Biochemical Kit Laboratory Biochemical Kit Laboratory, NIB has initiated the phase II activities of ICMR-NIB collaboration. The BKL, NIB with ICMR is organizing a collaborative workshop to be held on 4th - 5th October, 2018 for the participants of five collaborative centres
4. Establishment of the first National Reference Standard for Insulin lispro: Report of a Collaborative Study. Stakeholders, IPC and NIB Study completed Recombinant Product Laboratory - I The National Reference Standard(IPRS) to be released for which the labelling has been done by the lab
5. Collaborative study on Filgrastim Reference standard with USP Hyderabad USP Hyderabad Initiated and in process Recombinant Product Laboratory - I Formalities for transportation of the study material completed (import license granted) Sample for the study yet to be received.
6. Use of Bradford method for protein estimation in Phenol containing allergen extracts Paul Ehlrich Institut- Germany To resolve phenol interference in Modified Lowry’s method for protein estimation Allergen Testing Laboratory Samples awaited
7. Performance validation of three indigenously- made glucose sensing device with ICMR support as a collaborating center and also provide expert guidance to the Manufacturers and other collaborating centers with respect to IQC, ISO15197:2003 guideline requirements and performance evaluation protocols and parameters NIB, Noida and Division of Innovation and Translation Research, ICMR 09 months from the date of signing 01.07.17 Biochemical Kits Laboratory ongoing
8. Laboratory has completed the ILC study programme for PTH reference preparation with NIBSC for content and purity NIBSC, Pottersbar, UK Dec 2016 - Feb 2017 Recombinant Product Laboratory Laboratory has 

sent the compiled test data to NIBSC. Final report will be communicated 

from NIBSC to NIB in July 2017

9. NIBSC collaborative study on "1st WHO reference reagent for the biological activity of Rituximab - like antibodies" NIBSC, UK 2016 - 17 Therapeutic Monoclonal Antibody Lab Testing Completed
10. Workshop on Laboratory Quality Management System in Biotherapeutics Clinical Development Services Agency (CDSA) - THSTI - DBT One Year Quality Management Unit 1. LQMS in Biotherapeutics completed

2. LQMS in Diagnostics proposed in Feb 2017

 

 

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Notifications !!  

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

Acceptance Criteria for Test & Examination of Blood Glucose Test Strips as per ISO 15197:2013new

 

Turnaround time for testing new

 

 

   

 

 

 

 

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