Last Updated on January 21, 2024 by The Health Master
The USFDA–Gujarat Food and Drug Control Administration (FDCA) Bilateral Regulatory Forum will be held in the month of January 2023 for the US and Indian drug regulators to discuss compliance with Good Manufacturing Practices (GMPs) and capacity building, among other relevant subjects.
During the last USFDA-Gujarat FDCA Regulatory Forum meeting held virtually last year, Gujarat FDCA discussed plans to scale up the presence of more USFDA and WHO-GMP-compliant units in Gujarat towards enhancing the production of quality medicines for the benefit of patient safety and compliance.
The USFDA delegation will be led by Sarah McMullen, director of the Office of Global Policy and Strategy, USFDA, India Office (INO), New Delhi.
“The USFDA-Gujarat FDCA Regulatory Forum, which was started in 2008, is based on the premise of training, networking, knowledge sharing, and compliance.”
“This will also help Indian regulators in understanding regulatory requirements of the USFDA.”
“More so as Gujarat has 1081 WHO-GMP compliance units and around 140 USFDA approved drug manufacturing units in the country.”
“The state also has 3,533 allopathic manufacturing units and has issued 6.9 lakh product licenses to date,” Gujarat FDCA Commissioner Dr. H G Koshia stated.
The USFDA-Gujarat FDCA Regulatory Forum will also be instrumental in equipping Indian regulators and industry on good distribution practices (GDP) and good lab practices (GLP).
Last year, in the month of January, officials from Gujarat FDCA shared their experiences of the COVID-19 pandemic with USFDA officials on regulatory initiatives taken to scale up the accessibility of medicines and healthcare.
As a part of knowledge sharing, USFDA officials and Gujarat FDCA officials will also discuss the drug inspection lifecycle, which includes site selection, planning, execution, reporting, evaluation, regulatory action, and case study for future participation as an observer in the USFDA-led inspection.
A team of USFDA officials visited Gujarat FDCA in 2019, during which Letitia Robinson, country director, OIP, India Office, and USFDA comprehensively discussed building regulatory compliance in both the US and India.
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