Last Updated on March 22, 2021 by The Health Master
The meet will also discuss plans towards capacity building, training, networking, knowledge sharing and compliance to global regulatory norms.
This is part of the quarterly review meet of Gujarat FDCA and USFDA regulatory forum aimed at sharing experiences of C-19 pandemic with USFDA officials regarding regulatory initiatives done to scale up accessibility of medicines and healthcare at the point of care to help patients and public at large.
Gujarat FDCA discussed plans to scale up presence of more USFDA and WHO-GMP compliant units in Gujarat during the recent USFDA-Gujarat FDCA Regulatory Forum meet held virtually during January 2021 to enhance production of quality medicines.
Gujarat has over 700 plus WHO-GMP units and 130 US FDA approved drug manufacturing units in the country. Gujarat also has the distinction of having 28 per cent of drug exports to developed markets including the US.
The US FDA-Gujarat FDCA Regulatory Forum meet was formed towards enhancing global competitiveness as Gujarat is upgrading Schedule M units to WHO-GMP compliant drug manufacturing units as part of the global harmonization programme.
US FDA-Gujarat FDCA Regulatory Forum was started in the year 2008 to usher in dialogue between senior leaderships of the US FDA and the Gujarat FDCA for future strategic collaborations and knowledge sharing on drug and medical device compliance.
US FDA-Gujarat FDCA Regulatory Forum has also played a pivotal role in equipping Indian regulators and industry on good manufacturing practices (GMP), good distribution practices (GDP) and good lab practices (GLP). It has enhanced the knowledge level of Indian regulators in understanding regulatory requirements of US FDA.
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