|
Gujarat FDCA & US FDA Commissioner discuss on information sharing & capacity building on GMP
|
|
Shardul Nautiyal, Mumbai
September 28 , 2023
|
|
|
The Gujarat Food and Drug Control Administration (FDCA) has comprehensively discussed with the US FDA Commissioner Robert M Califf about the plans to equip Indian drug regulators with enforcement and regulatory compliances related to good manufacturing practices (GMP) among others in a recent meeting in New Delhi.
The meeting also discussed the benefits of the US FDA-Gujarat FDCA Bilateral Regulatory Forum which has been addressing issues related to quality audit for compliance to GMPs among other relevant subjects since 2008.
Ambassador of the United States of America (USA) Eric M Garcetti facilitated the meeting of Gujarat FDCA Commissioner Dr Hemant Koshia with Dr Robert Califf, Commissioner, US FDA on the occasion of his visit to India.
“This meeting was a very historic and significant one because it was a rare opportunity of the US FDA Commissioner visiting India and meeting Gujarat FDCA regulatory officials,” informed Dr Koshia.
Training on audit readiness was the key highlight of the US FDA-Gujarat FDCA Regulatory Forum meet in February 2023 towards achieving compliance and quality. The US FDA delegation which was led by Sarah McMullen, director of the Office of Global Policy and Strategy, US FDA, India Office (INO), New Delhi also had made a factory visit of a cardiac stent manufacturing unit of Sahajanand Laser Technology Ltd (SLTL) at Gandhinagar.
“They had appreciated the high level of quality protocols being followed in manufacturing the cardiac stents,” informed Dr Koshia.
The US FDA officials had also visited the Gujarat FDCA office in the month of August 2021 to attend regulatory forum meetings for information sharing and capacity building to tackle Covid-19 pandemic.
During the last FDA-Gujarat FDCA Regulatory Forum meet held virtually in 2022, Gujarat FDCA discussed plans to scale up presence of more US FDA and WHO-GMP compliant units in Gujarat towards enhancing production of quality medicines for the benefit of patient safety and compliance.
Started in the year 2008, US FDA-Gujarat FDCA Regulatory Forum is based on the premise of training, networking, knowledge sharing and compliance. This helps Indian regulators in understanding regulatory requirements of the US FDA.
Gujarat has more than 1081 WHO-GMP compliance units and more than 140 US FDA approved drug manufacturing units in the country.
A team of US FDA officials had visited Gujarat FDCA in 2019 in which Letitia Robinson, country director, OIP, India Office, US FDA had comprehensively discussed building regulatory compliance in both the US and India.
President Joe Biden nominated Dr. Califf to head the US FDA and Dr. Califf was sworn in on February 17, 2022. Previously, Dr. Califf served as Commissioner of Food and Drugs from February 2016 to January 2017. As the top official of the FDA, Dr. Califf is committed to strengthening programs and policies that enable the agency to carry out its mission to protect and promote public health. Dr. Califf served as the FDA’s Deputy Commissioner for Medical Products and Tobacco from February 2015 until his first appointment as Commissioner in February 2016.
|
|
|
|
|
|
|
|
TOPICS
|
That foods might provide therapeutic benefits is clearly not a new concept. ...
|
|
|
|
|