FDCA and bioMérieux sign an important MoU


MoU aims towards establishing a training programme in microbiological testing technologies for the pharmaceutical and food sectors

Ahmedabad, March 5: Hemant G. Koshia, Commissioner FDCA and Nicolas Cartier, Corporate VP – bioMerieux, signed the MoU

Food and Drugs Control Administration –FDCA, Government of Gujarat and bioMérieux, a 115 years old French Company today here in Ahmedabad, signed a MoU to establish a training program concerned with microbiological testing technologies and applications for the pharmaceutical and food sectors to better understand the regulatory requirements with respect to the domestic as well as export markets. The MoU was signed by DR. Hemant G.Koshia, Commissioner FDCA andNICOLAS CARTIER, bioMérieux, corporate VP, Industry Unit, Group Portfolio and Strategic Planning in presence of Mr Vanrajsinh Vanzara, Joint Secretary, Health & Family Welfare Dept., Gandhinagar, Mr Arvind Kukrety, Deputy Drug Controller, Zonal office, Ahmedabad, Dr DAVID MYATT, Scientific Marketing Director, Industry / Asia Pacific at bioMerieux, Mr SAURABH RAJADHYAX, Managing Director, bioMerieux India, SHAWN ZHAO, Vice President, ASPAC-Industry Unit, Mr Suresh Kumar – Head bioMerieux India -Industry were also present on the occassion alongwith various dignitaries from pharma industry, microbiology sector and regulators.

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FDCA, Gujarat’s Food & Drugs Laboratory, Vadodara is one of the oldest and biggest Government Laboratory in the country. FDL, Vadodara is the first NABL Accredited Government Laboratory and every year FDL obtain approvals of more and more tests under NABL Accreditation. Since last three consecutive years, FDL, Vadodara is testing highest numbers of drug samples as compared to other Government Laboratories in the country. During recent national survey of drugs sample conducted by Government of India, FDL contributed by testing 6000+ samples, again highest number in country.

This MOU will help Gujarat Government and Pharma Industry in the State, both the regulators and manufacturers meeting the expectations for faster, more accurate and more cost-effective testing. bioMérieux would be instrumental in setting up a state of the art laboratory for the FDCA in Gujarat for pharma and food testing, meeting world standards . Since, Gujarat is the leading pharma hub in the country; it is required to be updated to meet with the emerging challenges of technology and monitor hazardous contaminants and adulterants and other deleterious agents causing public health severely. Therefore, it is important to have rapid monitoring of microorganisms – environmental, spoilage and pathogenic so as to meet the need of Industry as well as regulators in a big way.

Following are the major areaswhere these two partners will expedite their knowledge, services and products to up-grade microbiological technology. It includes Media preparation , quality testing for media -Growth promotion Testing, environmental Monitoring: Active & passive Air Sampling, sterility Testing of raw material, in process testing and end product testing for filterable & non filterable products, detection and confirmation of specified micro organsims 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 & challenge test, food Testing Regulations & Standard Methods, bacterial endotoxin testing in raw material & finished product, testing of Cosmetics & personal Care products. For food testing it would include rapid testing for pathogen screening&Microbial Enumeration-acceptance criteria; that act as quality indicators (spoilage organisms, screening & confirmation of pathogen as per Regulatory Guidelines], environmental, monitoring & trend analysis of microorganisms present in Manufacturing units and preservative efficacy testing for packaged food products.

bioMérieux operating globally, headquartered in Lyon. It 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. bioMérieux designs, develops, manufactures and markets systems i.e. reagents, instruments and software used in Clinical as well as Industrial applications. bioMérieux Industry is a specific business unit of bioMérieux with dedicated R&D, marketing, and commercial resources.

In the fast developing era, the Pharmaceutical, Cosmetic and Food Industries have significant roles to play in public health. In this context it has become increasingly necessary to monitor hazardous contaminants and adulterants and other deleterious agents including chemicals, pesticides, microorganisms, toxins, allergens, etc. in the Pharmaceutical, Cosmetic and Food industries. In the case of chemical health hazard monitoring there are various quick and efficient methods available, however rapid monitoring of microorganisms – environmental, spoilage and pathogenic- is an emerging field driven by manufacturers’ and regulators’ expectations for faster, more accurate and more cost-effective testing. To cater to the needs of the Pharmaceutical, Cosmetic and Food sectors, bioMérieux have developed efficient, accurate and rapid methods for detection and enumeration of pathogenic, environmental and public health indicator organisms.