US FDA And Gujarat FDCA To Have Regulatory Forum For 3 Days


Mumbai : The US FDA-Gujarat FDCA regulatory forum is going on 17th, 18th & 19th May 2022. In this meeting, first time 12 officials from US FDA, senior officers from Gujarat FDCA and 4 nominated officers from the CDSCO are participating. In this meeting, US FDA will provide an overview of recent initiatives including OGPS reorganization, and GMP inspectional trends in India.

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 panel discussion.

In last meeting, US FDA officers met the Gujarat Cabinet health minister Rushikeshbhai Patel and Additional chief secretaries health, Manoj Agarval, during their discussion minister suggested them to visit the Gujarat as well India’s best pharmacy college L M Pharmacy College, Ahmedabad and Government Ayurvedic Hospital, Kolwada. On 19th May 2022 US FDA officials planned to visit both the places.

In 2010, Brus Ross had visited Gujarat FDCA first time. “FDCA Gujarat-US FDA Regulatory Forum” was constituted with a view to knowledge sharing, training, Capacity building and information sharing between FDCA Gujarat & US FDA, A first meeting was held on 12th March, 2019, at office of the Commissioner, FDCA, Gandhinagar with Dr Letitia Robinson, country director & other officials from US FDA along with Dr H G Koshia, Commissioner, FDCA, Gujarat & other officers from Gujarat FDCA.

As a part of that 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.

This regulatory forum between the US Food and Drug Administration (FDA) and the Gujarat Food and Drug Control Administration (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 organizations and to explore synergies to advance the public health needs of the regulatory bodies.


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