. Collaboration between US FDA and Gujarat FDCA to Implement Joint Project | IGMPI

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Collaboration between US FDA and Gujarat FDCA to Implement Joint Project

Among top three aspects for collaboration- knowledge sharing, capacity building and raising compliance levels, the Gujarat Food and Drug Control Administration (FDCA) is planning to meet US Food and Drug Administration (FDA) officials. As per national data, Gujarat accounts for 28% of Drug exports to various developed markets. In a recent incidence, a US FDA cyber notice was recently issued to one of the Gujarat based manufacturers for supplying spurious herbal drugs to the US market. This prompted Gujarat FDCA totake action and sent the testing samples at Vadodara testing lab. Gujarat FDCA inspectors have been trained through online courses on current good manufacturing practices (cGMP) and good laboratory practices (GLP) in collaboration with US-based Underwriters Laboratories (UL) as part of strategic partnerships for knowledge sharing. UL is a global safety consulting company offering about 700 such courses of which 125 courses are co-authored by the US FDA. This collaboration between 2 regulators facilitatesGujarat’s FDCA’s understanding in regulatory requirements of US FDA. Gujarat saw an increase in pharma exports in the past one decade with US$ 3,060 million worth of exports in 2016 from a quantum of exports worth US$ 562 million in 2006.