About

BioMerieux To Equip Guj FDCA Inspectors On Auditing Drug Quality

BioMerieux To Equip Guj FDCA Inspectors On Auditing Drug Quality


Mumbai, 18 June 2018: To raise the bar ahead in terms of drug quality, French company BioMérieux will train Gujarat Food and Drug Control Administration (FDCA) inspectors to check contamination in medicines imported and exported as per global regulatory requirements. 

 

Standards concerning medical devices and drug quality have been accorded top priority by the Gujarat government in the wake of surprise audits in the country from regulatory authorities of the regulated markets.

 

To upgrade the knowledge of the Gujarat FDCA officers on relevant areas of concern of the regulatory authorities globally and in India, Gujarat government have signed eight such strategic partnerships with overseas and Indian companies in the past.  

 

US FDA team during its visit last year appreciated Gujarat FDCA efforts in the wake of US FDA cyber notice to one of the Gujarat based herbal manufacturer for supplying spurious herbal drugs to the US market. 

 

Following the US FDA cyber notice, Gujarat FDCA tested the samples of the herbal manufacturer at Vadodara testing lab and sent the report to the US FDA for further follow up and actions to be taken on the same

 

Setting up of a rapid microbiological testing lab by Gujarat Medical Services Corporation Limited (GMSCL) with assistance from BioMérieux is also on the anvil. An MoU with Gujarat FDCA has been inked as part of strategic partnership which will usher in knowledge sharing on microbiological testing technologies for the pharmaceutical sector.

 

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 and end product testing for filterable and non filterable products.

 

Meanwhile, Abbott India which has also trained 162 drug inspectors on auditing a medical device manufacturing facility is about to offer training on new medical device (MD) rules 2017. The training is significant as the maximum number of licensed medical device units under Central Licensing Approval Authority (CLAA) scheme are in Gujarat. Gujarat today boasts of having the highest number of 200 plus licensed medical device units under CLAA scheme as against a total of 284 medical device units in the entire country. 

 

The devices currently regulated under CLAA scheme include cardiac stents, drug eluting stents, catheters, intra ocular lenses, IV Cannula, bone cements, heart valves, scalp vein set, orthopaedic implants and internal prosthetic replacements. Pharmabiz