An MoU was signed recently between the Gujarat Food and Drug Control Administration (FDCA) and US Food and Drug Administration (FDA) for training the drug control officials in Gujarat on par with the US FDA inspectors towards providing safe and efficacious medicines globally.

The MoU was signed as part of US FDA visit to the Gujarat FDCA office as part of the global harmonization programme towards capacity building, training, networking, knowledge sharing and compliance. This becomes more significant as Gujarat shares 28% of drug exports to developed markets and the US.

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, USFDA, 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.

Gujarat FDCA also gave a presentation to the US FDA team apprising the latter on the Gujarat pharma industry following which US FDA team appreciated the proactive efforts of Gujarat FDCA towards enforcing effective compliance in the state.

Said Gujarat FDCA Commissioner Dr HG Koshia, “US FDA team has appreciated Gujarat FDCA efforts in the wake of USFDA 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.”

The MoU between the two regulators is latest in the 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.

Around 100 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). These courses are as per the training imparted to US FDA inspectors which are of immense help to the drug inspectors conducting inspection on the shop floor of a drug facility.

The initiative is also a 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.