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US FDA-Gujarat FDCA Regulatory Forum to be held from 17th to 19th May

In this meeting, 12 officials from the US FDA, senior officers from Gujarat FDCA and four drug officers nominated by Drugs Controller General of India (DCGI) will participate

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The US Food and Drug Administration (FDA)-Gujarat Food and Drug Control Administration (FDCA) Regulatory Forum is being held from 17th to 19th May, 2022. In this meeting, 12 officials from the US FDA, senior officers from Gujarat FDCA and four drug officers nominated by Drugs Controller General of India (DCGI) will participate.

Besides, the US FDA will provide an overview of recent initiatives, including OGPS reorganisation and GMP inspectional trends in India. The US FDA officials and Gujarat FDCA officials will discuss on Drug Inspection Lifecycle: site selection, planning, execution, reporting, evaluation and regulatory action, case study, and discuss elements of Observed Inspection SOP for future participation as an observer in the US FDA-led inspection followed by a panel discussion.

This regulatory forum between the US FDA and Gujarat FDCA is designed as a collaborative effort to identify initiatives to further strategic collaboration in regulatory systems. The forum will also provide an opportunity to share information about the existing practices of the organisations and to explore synergies to advance the public health needs of the regulatory bodies.

Earlier, a meeting was held on 12th March, 2019, at office of the Commissioner, FDCA, Gandhinagar, with Dr Letitia Robinson, Country Director and other officials from the US FDA, along with Dr HG Koshia, Commissioner, FDCA, Gujarat, and other officers from Gujarat FDCA.

As a part of the meeting, it was decided to organise quarterly subsequently meeting between both the regulatory bodies for the exchange/discussion of technical advancement and other regulatory-related information.

In the last meeting, the US FDA officers had met the Gujarat cabinet health minister Rushikeshbhai Patel and additional chief secretary (health), Manoj Agarval. During their discussion, the minister suggested them to visit LM Pharmacy College, Ahmedabad and Government Ayurvedic Hospital, Kolwada on 19th May, 2022.