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

This is a relevant move as Gujarat accounts for 28% of drug exports to developed markets, including the US.

An MoU was signed recently between the two regulators during the US FDA officials' visit to the Gujarat FDCA office for training the Gujarat drug control officials.

Carl Sciachchitano, senior advisor for scientific international affairs, Office of International Programs (OIP), US FDA; Letitia Robinson, country director, OIP, India Office, US FDA; Thomas Arista, deputy director, OIP, US FDA; Ademola Daramola, international relations specialist, OIP, US FDA; and Dipesh Shah, consumer safety officer, OIP, US FDA were part of the US FDA team which visited the Gujarat FDCA office.

A US FDA cyber notice was recently issued to one of the Gujarat based manufacturers for supplying spurious herbal drugs to the US market. Following the notice, Gujarat FDCA took prompt 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 collaboration with US-based Underwriters Laboratories (UL) as part of strategic partnerships for knowledge sharing with UL which is a global safety consulting company offering about 700 such courses of which 125 courses are authored by the US FDA.

The MoU between the two regulators is the latest in a series of such programmes being ushered in since 2008, which has immensely helped Gujarat drug officials in understanding 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.