Signaling a major breakthrough in terms of assessing drug quality in real time and seamless manner, Gujarat Medical Services Corporation Ltd (GMSCL) is in the process of procuring equipment for setting up rapid microbiological testing lab at Vadodara which will bring turnaround time for drug testing from 14 days to just 4 hours.
In order to set up lab, French Company bioMérieux which has signed MoU with Gujarat Food and Drug Control Administration (FDCA) will help GMSCL as a part of strategic partnership for knowledge sharing and training for pharmaceutical sector.
Informed Gujarat FDCA Commissioner Dr H G Koshia, “The rapid microbiological testing lab which is scheduled to be operational in couple of months time will enhance the drug testing capabilities by five times. Currently with the lab infrastructure in Gujarat, we are testing 14, 000 samples per month. With rapid microbiological testing facility, we will be able to test 100 plus samples in a day.”
The testing lab which is estimated to cost Rs. 4.5 Crore has the competency to detect and enumerate pathogenic, environmental and public health indicator organisms in drugs to cater to regulatory requirements globally. Meanwhile, Gujarat Government is also in the process of recruiting lab staff for rapid microbiological testing.
The partnership will also offer knowledge, services and products to up-grade microbiological technology which includes media preparation, quality testing for media -growth promotion testing, environmental monitoring, active and passive air sampling, 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, bacterial endotoxin testing in raw material and finished product, testing of cosmetics and personal care products.
The MoU was signed earlier this year between Dr Hemant 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, Zonal office, Ahmedabad.
Meanwhile, Gujarat FDCA is also in the process of upgrading its lab infrastructure. As of today, Gujarat’s Food and Drugs Laboratory (FDL), Vadodara is one of the oldest and biggest government laboratory in the country. FDL, Vadodara is the first NABL accredited government laboratory. Since last three consecutive years, FDL, Vadodara is testing the highest numbers of drug samples as compared to other government laboratories in the country.
Shardul Nautiyal, Mumbai,Source:ET
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nice to know.