Last Updated on January 23, 2021 by The Health Master
Officials from Gujarat Food and Drug Control Administration (FDCA) shared their experiences of C-19 pandemic with USFDA officials regarding timely policy interventions and regulatory initiatives done to scale up accessibility of medicines and healthcare at the point of care to help patients and public at large.
During the recent USFDA-Gujarat FDCA Regulatory Forum meet held virtually, Gujarat FDCA discussed plans to scale up presence of more USFDA and WHO-GMP compliant units in Gujarat towards enhancing production of quality medicines for the benefit of patient safety and compliance.
The US FDA-Gujarat FDCA Regulatory Forum meet is a relevant step towards enhancing global competitiveness as Gujarat is aggressively moving towards upgradation of Schedule M units to WHO-GMP compliant drug manufacturing units as part of the global harmonization programme.
The meet also discussed plans towards capacity building, training, networking, knowledge sharing and compliance.
“During the discussion, we also highlighted how essential commodities like masks and sanitisers production was enhanced 10 times and 3 times respectively besides scaling up production of medicines and vaccines like HCQ, favipiravir and remdesivir five times during the course of lockdown when the entire world was grappling to find a cure to the dreaded virus,” explained Gujarat FDCA Commissioner Dr HG Koshia.
US FDA-Gujarat FDCA Regulatory Forum was started in the year 2008 to usher in dialogue between senior leaderships of the USFDA 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.
It was reiterated during the regulatory forum meeting that there is a need for risk based inspections and embracing global standards through upgradation of Schedule M units to WHO-GMP compliant units to retain India’s position as pharmacy of the world.
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.
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