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National Institute of Biologicals

(राष्ट्रीय जैविक संस्थान)

Ministry of Health & Family Welfare, Government of India

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Drug Survey Report (2014 - 2016)   

Participations in Collaborative Studies of 

National & International Organizations


S.No.  Name of Study  Collaborator  Period of Study Name of NIB Laboratory Status
1. 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
2. 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

3. 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
4. Validation Protocol of Glucose sensing devices developed with ICMR support (Research of Validation of indigenously made devices) ICMR, HQ 

New Delhi

09 Months

Biochemical Kits Laboratory Collaboration in process
5. 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

6. National Reference Standard preparation of Filgrastim 6 Laboratories (NIB, Filgrastim Stakeholders, & USP) 2015 - 2017 Recombinant Product Laboratory Candidate selection is underway
7. National Reference Standard preparation of Insulin Lispro 6 Laboratories (NIB, Insulin Stakeholders, IPC & USP) 2015 - 2017 Recombinant Product Laboratory Report compiled
8. National Reference Standard preparation of insulin Lispro 6 Laboratories (NIB, Insulin Stakeholders, IPC & USP) 2015 - 2017 Recombinant Product Laboratory Results are received from all labs. Preliminary Report compiled
9. The 1st WHO reference reagent for the biological activities of Rituximab-like monoclonal antibodies NIBSC, UK March 2016 to

May 2016

Therapeutic Monoclonal Antibody Laboratory Samples under Evaluation
10. Development of Techniques and Reagents for Quality Control of Clinically important Indigenous Allergen Extracts ( Cockroach and Moth)

1. Dr. Achla Prasad, S-I


2. Dr. M.K. Agarwal


3. Dr. Deepak Talwar 

Ongoing work on allergen standardisation undertaken at NIB Allergen Testing Lab

Work in Progress

11. Method verification studies for development of IP monograph for rituximab drug product and drug substance Indigenous manufacturers, IPC & CDSCO March to July 2015 Therapeutic Monoclonal Antibody Lab Ongoing




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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