Noida-based National Institute of Biologicals (NIB), the autonomous institute established by the Ministry of Health and Family Welfare is soon to set up the country's biggest facility for regulatory testing of biologicals in the country. The world class main laboratory and animal house, originally designed by the National Institute of Health (NIH), US, is almost ready. The Rs 110 crore project is to be fully operational during the current year, Dr V K Kashyap, director, NIB informed Pharmabiz.

With the facility in place, NIB would be in a position to take up the regulatory testing of all biologicals that are being marketed in the country. The facility would also be utilised in developing standards for quality control testing procedures, establishing linkages with other national and international institutions and training various professionals in the field of quality control of biologicals. The animal house facility of the institute is designed to facilitate preparation of quality control assays required to be put up in animals for the purpose of batch release certification. The institute already has the approval of Committee for the Purpose of Control and Supervision of Experimentation on Animals (CPCSEA). The three existing laboratories of the institute have already been notified as the central laboratories for testing of immunodiagnostic kits, blood reagents and oral polio vaccine. The other functional laboratories of the institute are blood product testing and bacteriology laboratory, nucleic acid amplification testing (NAT) laboratory and recombinant product testing and analytical chemistry laboratory.

"The civil and construction works of the main laboratory are complete. We are in the process of installing critical equipment. The laboratory would be among the best facilities in the world and would help Indian biotechnology industry to scale new heights in the near future," said Dr Kashyap.