Process to set up Asia’s first rapid microbiological testing lab begins as GMSCL appoints agency to procure equipment
A rapid microbiological testing lab to assess drug quality in real time would soon be a reality as the Gujarat Medical Services Corporation Ltd (GMSCL) has finally selected an agency based on a tendering process to procure equipment and set up the lab. An amount of Rs.4.5 crore has also been allocated for the same by the Gujarat government.
Rapid microbiological testing facility will test 100 plus samples in a day and help detect pathogenic organisms in drugs which will help Indian manufacturers cater to the global regulatory requirements. French company bioMérieux has already signed an MoU with Gujarat Food and Drug Control Administration (FDCA) to help GMSCL set up lab which will bring turnaround time for drug testing from 14 days to just 4 hours.
Informed Gujarat FDCA Commissioner Dr H G Koshia, “Procurement of equipment is being done on war footing with the appointment of an agency. Further, manpower to run the lab has been recruited and once the equipment is installed it will become operational any time.”
Earlier this year, an MoU was signed between Dr H G Koshia, Commissioner FDCA and Nicolas Cartier, bioMérieux, corporate VP, industry unit, group portfolio and strategic planning in the presence of Vanrajsinh Vanzara, joint secretary, health and family welfare department, Gandhinagar and Arvind Kukrety, deputy drug controller, CDSCO Zonal office, Ahmedabad.
The partnership in the form of MoU will usher in knowledge, services and products to upgrade microbiological technology, environmental monitoring, sterility testing of raw material, in process testing and end product testing for filterable and non-filterable products.
It also includes detection and confirmation of specified micro organisms as per harmonized pharmacopoeia, trend analysis of microorganisms isolated from the environment and products, bio- burden testing of non-sterile products, antimicrobial efficacy testing, disinfection efficacy testing, preservative efficacy testing and challenge test among others.
As part of the strategic partnership, bioMérieux will conduct training programmes on microbiological testing technologies and applications for the pharmaceutical sector to cater to the regulatory requirements of domestic and export markets.
The French company has developed efficient, accurate and rapid methods for detection and enumeration of public health indicator organisms to cater to the needs of pharmaceutical and cosmetic sector.
Headquartered in Lyon, bioMérieux which operates in over 150 countries specializes in the field of in vitro diagnostics for clinical and industrial applications.