The Gujarat Food and Drug Control Administration (FDCA) is getting to host a gathering with US FDA officials in May 2021 for information sharing and capacity building to tackle Covid-19 pandemic.
The meet also will discuss plans towards capacity building, training, networking, knowledge sharing and compliance to global regulatory norms.
This is a part of the quarterly review meet of Gujarat FDCA and US FDA regulatory forum aimed toward sharing experiences of Covid-19 pandemic with US FDA officials regarding regulatory initiatives done to proportion accessibility of medicines and healthcare at the purpose of care to assist patients and public at large.
Gujarat FDCA discussed plans to proportion presence of more US FDA and WHO-GMP compliant units in Gujarat during the recent US FDA-Gujarat FDCA Regulatory Forum meet held virtually during January 2021 to reinforce production of quality medicines.
Gujarat has over 700 plus WHO-GMP units and 130 US FDA approved drug manufacturing units within the country. Gujarat also has the excellence of getting 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 a part of the worldwide harmonization programme.
US FDA-Gujarat FDCA Regulatory Forum was started within the year 2008 to inaugurate dialogue between senior leaderships of the US FDA and therefore 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’s enhanced the knowledge level of Indian regulators in understanding regulatory requirements folks FDA