Date: 18-Sep-2019

Gujarat FDCA partners with US FDA for capacity building of drug inspectors

The Gujarat Food and Drug Control Administration (FDCA) has partnered with US FDA for capacity building of its state drug inspectors through knowledge sharing and training. A quarterly review meeting of Gujarat FDCA with the US FDA officials concluded recently which chalked out plans to equip drug inspectors on the latest global regulatory demands for effective compliance through knowledge sharing. As part of the global harmonization programme to enhance regulatory output and compliance, US FDA and Gujarat FDCA officials deliberated on four components of capacity building like training, networking, knowledge sharing and compliance, informed Gujarat FDCA Commissioner Dr H G Koshia. US FDA visit is an important development as Gujarat has the maximum number of US FDA approved drug manufacturing units in the country. The visit is an important milestone as domestic industry is expected to address risk based inspections and embrace global standards in the current scenario through upgradation of Schedule M units to WHO -GMP compliant units. Gujarat FDCA inspectors have already been trained in current good manufacturing practices (cGMP) and good laboratory practices (GLP) in collaboration with foreign regulatory agencies earlier. US FDA team had also visited the Vadodara drug testing lab in the past which is the largest lab in the country and also houses Asia's first government rapid microbiological testing lab.