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US FDA-Gujarat FDCA Regulatory Forum meet discusses broad ranging issues

Shardul Nautiyal, Mumbai
Friday, February 3, 2023, 08:00 Hrs  [IST]

The US FDA-Gujarat Food and Drug Control Administration (FDCA) Bilateral Regulatory Forum held recently discussed broad ranging issues related to quality audit for compliance to Good Manufacturing Practices (GMPs) and capacity building among other relevant subjects.

Gujarat today leads in manufacturing high end quality medical devices like intra-ocular lenses (IOL), drug eluting stents (DES) and orthopedic implants. These devices account for 50 to 55% of exports to regulated markets.

“In order to develop a culture of compliance and quality, training on audit readiness was the key highlight of the US FDA-Gujarat FDCA Regulatory Forum meet,” informed Gujarat FDCA Commissioner Dr HG Koshia.

“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 made a factory visit of a cardiac stent manufacturing unit of Sahajanand Laser Technology Ltd (SLTL) at Gandhinagar. They appreciated the high level of quality protocols being followed in manufacturing the cardiac stents,” added Dr Koshia.

Gregory Smith, international relations specialist (pharmaceuticals), Dr. Phillip Nguyen, international relations specialist (BIMO & devices), Dhruv Shah, senior technical advisor (pharmaceuticals) and Dr. Sudheendra Kulkarni, senior technical advisor (BIMO & devices) were a part of the delegation from the US FDA.

Dr. Arvind Patel, chairman, SLTL, Maulik Patel, executive director, SLTL, Preeti Vani, head, medical division, SLTL and Kushal Bhatt, manager –quality assurance (QA), SLTL gave a presentation on the medical devices as a part of the meet.

During the last FDA-Gujarat FDCA Regulatory Forum meet held virtually last year, 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 around 140 US FDA approved drug manufacturing units in the country. The state also boasts of 3533 allopathic manufacturing units and has 6. 9 lakh product license issued till date.

US FDA-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 Covid-19 pandemic with US FDA officials on regulatory initiatives taken to scale up accessibility of medicines and healthcare.

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.


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