Gujarat FDCA in A Collaboration with US FDA for Implementing New Projects

The Gujarat Food and Drug Control Administration (FDCA) is planned to meet US Food and Drug Administration (FDA) officials in two or three months time to take forward the collaboration for knowledge sharing, capacity building and raising compliance levels.

This is an important move as Gujarat represents 28% of drug exports to developed markets, including the US. A MoU was signed recently between the two regulators during the US FDA officials visit the Gujarat FDCA office for training the Gujarat drug control officials.

Carl Sciachchitano, senior advisor, Office of International Programs (OIP), US FDA; Thomas Arista, deputy director, OIP, US FDA: Letitia Robinson, country director, OIP, India Office, US FDA; Ademola Daramola, OIP, US FDA; and Dipesh Shah, OIP, US FDA were a part of the US FDA group which went to the Gujarat FDCA office.

To one of the Gujarat based manufacturers, US FDA notice was recently issued for providing spurious herbal drugs to the US market. Following the cyber notice, Gujarat FDCA took immediate action and sent the report to the US FDA for further actions after testing samples at Vadodara testing lab.

Around 100 Gujarat FDCA inspectors have also been trained through online courses on current good manufacturing practices (cGMP) and good laboratory practices (GLP) in a collaboration with US-based Underwriters Laboratories (UL) as a feature of strategic partnerships for knowledge sharing to UL which is a global safety consulting company offering around 700 such courses of which 125 courses are authored by the US FDA.

The MoU between the two regulators is the most recent in a progression of such programmes being introduced since 2008, which has massively helped Gujarat drug officials in understanding regulatory necessities of US FDA.

Gujarat saw an expansion in pharma trades in the previous one decade with US$ 3,060 million worth of exports in 2016 from a quantum of exports worth US$ 562 million of every 2006.


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