भारत सरकार | Government of India                                                                                                                   Font: Website In - Hindi Language

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National Institute of Biologicals

(राष्ट्रीय जैविक संस्थान)

Central Drugs Laboratory & Central Medical Device Testing Laboratory

(केन्द्रीय औषधि प्रयोगशाला और केन्द्रीय चिकित्सा उपकरण परीक्षण प्रयोगशाला)

Ministry of Health & Family Welfare, Government of India

(स्वास्थ्य एवं परिवार कल्याण मंत्रालय,भारत सरकार)

Nib Logo



 

Due to Covid-19 pandemic, all the Training Programmes scheduled for the Financial Year 2020-21 including summer trainings/winter trainings/project work remain suspended till further notification.
  1. The National Institute of Biologicals (NIB) had been set up in 1992 as an autonomous Institute under the aegis of the Ministry of Health & Family Welfare, Government of India.The Institute is located at A-32, Sector-62, NOIDA, Uttar Pradesh in an area of 74,000 Sq.M.The scientists of the institute are committed towards their duty and follow the mandates and functions meticulously.Some of them are as here under:

    i) to ensure quality of Biological and Biotherapeutic products, both imported and manufactured indigenously available in the Indian market. 
    ii) to contribute in finalizing the specifications for biological products to be incorporated in Indian Pharmacopoeia.
    iii) to prepare National Reference Standards for biological products.
    iv) to train technical personnel in the public and private sectors in the field of Quality Control of Biological products and Haemovigilance programme. 
    v)to collaborate with other National and International Scientific Institutions/ organizations in pgrading technologies and keeping abreast of scientific advances made in the field of quality assessment of Biological and Biotherapeutic products.
    vi) to extend technical expertise during joint inspections of manufacturing premises of biological products with the officers of CDSCO. 
    vii) to implement the Haemovigilance Programme of India to promote safe blood transfusion practices.

     

    The Laboratory and Animal House facility of the Institute, constructed in February, 2006, have 42 Biosafety Level (BSL)-2 laboratories equipped with modern scientific equipment for testing of Biological and Biotherapeutic products. There are 20 walk-in-cold rooms and 03 walk-in-deep freezers (-20°C), and 64 bio-safety cabinets. All equipment are under Annual Maintenance Contract (AMC) or Comprehensive Maintenance Contract (CMC) and are regularly calibrated by a NABL accredited calibration laboratory. The expenditure made by the Institute on salaries, maintenance, procurement of reagents, chemicals, scientific equipment etc., is met from the grants given by the Ministry of Health & Family Welfare, Govt. of India. The revenue generated from testing of biologicals is deposited in the consolidated fund of Government of India with Ministry of Health & Family Welfare.


     


Notifications !!  

 

 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 kitsnew

 

 

WHO Collaborating Centre for Quality Control of HIV, HCV, HBsAg and Syphilis In-Vitro Diagnostic Assaysnew

 
Support Cell for WHO Pre-Qualification Programme for In-Vitro Diagnosticsnew

 

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

Revised Acceptance Criteria for Test & Examination of Blood Glucose Test Strips as per ISO 15197:2013 & applicability of the same as per instruction of the DCG(I), dated 09.05.2018new

 

Turnaround time for testing new

 

 

 

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 Antibodiesnew

 

 

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

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