Regulatory Practices: Gujarat FDCA Collaborates with USFDA for Strengthening

The focal point of the meeting was to bolster Indian drug regulators' proficiency in enforcing regulatory practices, particularly in the realm of GMP.

The Health Master

September 28, 2023

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Food and Drugs Control Administration FDCA Gujarat — FDCA Gujarat

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Last Updated on January 21, 2024 by The Health Master

Regulatory Practices

In a significant development, Strengthening of Regulatory Practices, the Gujarat Food and Drug Control Administration (FDCA) recently engaged in comprehensive discussions with the Commissioner of the USFDA, Dr. Robert M. Califf, during his visit to New Delhi.

The focal point of the meeting was to bolster Indian drug regulators’ proficiency in enforcing regulatory practices, particularly in the realm of good manufacturing practices (GMP).

This marks a pivotal step towards ensuring the highest standards of pharmaceutical manufacturing and safety.

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USFDA-Gujarat FDCA Bilateral Regulatory Forum

One of the key highlights of the meeting was the discussion surrounding the enduring success of the USFDA-Gujarat FDCA Bilateral Regulatory Forum.

Since its inception in 2008, this forum has been dedicated to addressing a spectrum of issues, including quality audits to ensure compliance with GMPs.

This long-standing collaboration has played a pivotal role in elevating regulatory standards within the pharmaceutical sector.

Diplomatic Facilitation by Ambassador Eric M Garcetti

Facilitating this crucial meeting was Ambassador Eric M. Garcetti of the United States of America.

The envoy played a pivotal role in orchestrating the rendezvous between Dr. Hemant Koshia, Commissioner of Gujarat FDCA, and Dr. Robert Califf, Commissioner of the USFDA, during the latter’s visit to India.

This meeting held immense historical and strategic significance, given the rarity of such high-profile visits.

Empowering Indian Regulators: Focus on Audit Readiness

A major highlight of the USFDA-Gujarat FDCA Regulatory Forum meeting in February 2023 was the emphasis on audit readiness.

This training initiative was geared towards achieving and maintaining compliance and quality in pharmaceutical manufacturing.

The USFDA delegation, headed by Sarah McMullen, Director of the Office of Global Policy and Strategy, India Office (INO), New Delhi, conducted a factory visit to Sahajanand Laser Technology Ltd. (SLTL) at Gandhinagar.

The delegation lauded the stringent quality protocols observed in the manufacturing of cardiac stents.

Previous Engagements: USFDA’s Commitment to Collaboration

The officials from the USFDA had previously visited the Gujarat FDCA office in August 2021 to participate in regulatory forum meetings focused on information sharing and capacity building in the battle against the COVID-19 pandemic.

These engagements underscore the commitment of both parties to fostering a collaborative approach in addressing critical healthcare challenges.

Paving the Way for Quality Medicine Production

During the virtual FDA-Gujarat FDCA Regulatory Forum meet in 2022, Gujarat FDCA put forth plans to augment the presence of more USFDA and WHO-GMP compliant units in the region.

This strategic move is aimed at enhancing the production of high-quality medicines, ultimately safeguarding patient safety and compliance.

Gujarat presently boasts over 1081 WHO-GMP-compliant units and more than 140 USFDA-approved drug manufacturing units.

The Vision of Dr. Robert M Califf

Dr. Robert M. Califf, the Commissioner of the USFDA, assumed office on February 17, 2022, following his nomination by President Joe Biden.

Dr. Califf brings a wealth of experience, having previously served as Commissioner of Food and Drugs from February 2016 to January 2017.

His tenure is characterized by a steadfast commitment to fortifying programs and policies that uphold the agency’s mission of safeguarding public health.

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