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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. 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
2. 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.
3. 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
4. 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
5. 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

6. 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
7. 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






Notifications !!  


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


Turnaround time for testing new








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