In order to equip field and lab staff on microbiological testing, Gujarat Food and Drugs Control Administration (FDCA) has tied up with French Company bioMérieux to conduct a training programme 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 pathogenic, environmental and public health indicator organisms to cater to the needs of pharmaceutical and cosmetic sector.
Says Dr H G Koshia, Commissioner FDCA,” It is necessary to have rapid monitoring of microorganisms - environmental, spoilage and pathogenic to meet Industry needs and of regulators in a big way. An MoU on the same with the Gujarat Government will help pharma industry in the state to meet regulators and manufacturers expectations for faster, accurate and more cost-effective testing.”
Headquartered in Lyon, bioMérieux which operates globally has an over-arching commitment to public health, operating in over 150 countries. The company is a leading international diagnostics group that specializes in the field of in vitro diagnostics for clinical and industrial applications.
“The French company would be instrumental in setting up a state of the art laboratory for the FDCA in Gujarat for pharma testing on par with global standards. This is required to meet emerging challenges of technology and monitor hazardous contaminants, adulterants and deleterious agents causing public health severely.” he added.
The partnership will 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, detection and confirmation of specified micro organisms as per harmonized pharmacopeia, 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.
Gujarat FDCA, 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. Every year FDL obtains approvals of more and more tests under NABL Accreditation. Since last three consecutive years, FDL, Vadodara is testing the highest numbers of drug samples as compared to other government laboratories in the country.
During recent national drugs sample survey conducted by Government of India, FDL contributed by testing 6000 + samples, again highest number in the country.