As part of its renewed focus to upgrade compliance levels in 170 US FDA approved units in Gujarat, US FDA and Gujarat Food and Drug Control Administration (FDCA) would soon meet to chalk out a plan for training drug inspectors for effective oversight and audit preparedness in manufacturing facilities.
This becomes relevant because Gujarat shares 28% of drug exports to developed markets and the US.
“The purpose and intent behind the meet is to help drug inspectors get idea about audit preparedness implemented in the regulated markets and help manufacturing units maintain compliance levels of global standards,” says Gujarat FDCA Commissioner Dr HG Koshia.
This is followed by an MoU signed 4 months ago between US FDA and Gujarat FDCA as part of the global harmonization programme towards capacity building, training, networking, knowledge sharing and compliance.
US FDA delegation comprising 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 also visited Gujarat FDCA to apprise themselves of the scenario. .
During the meet, Gujarat FDCA also gave a presentation to the US FDA team apprising the latter on the Gujarat pharma industry. US FDA team appreciated the proactive efforts of Gujarat FDCA towards enforcing effective compliance in the state.
Genesis of US FDA collaboration with Gujarat FDCA goes back to the year 2008 towards understanding global regulatory requirements and upgrading compliance levels.
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.
US-based consulting firm World Compliance Seminars (WCS) also recently conducted a workshop at Ahmedabad on how to be prepared timely for US FDA inspections and develop quality culture from bottom to top management in Indian pharma companies.
The seminar covered relevant aspects like what FDA investigators look for in a pharmaceutical product and API facility and how to be equipped to avoid last minute rush. It dealt with topics like Data Integrity and role of Data Integrity in various functions, current FDA expectations, current trends of FDA, 483, warning letters among other relevant areas.