Last Updated on December 31, 2023 by The Health Master
USFDA India Office
In a recent development, the USFDA India Office has put forth a proposal to establish the USFDA – Telangana Drugs Control Administration (DCA) Regulatory Forum.
This initiative aims to foster strategic collaborations and initiatives, marking a significant step towards regulatory excellence.
The proposal was presented during the USFDA officials’ visit to the Telangana DCA office in Hyderabad.
Enhancing Inspection Processes
One of the key objectives of the regulatory forum is to deliberate on the elements of Observed Inspection.
This paves the way for future participation of Inspectors from DCA, Telangana, who will act as observers during inspections led by the USFDA.
This exchange of knowledge and expertise promises to elevate the standard of inspections and regulatory practices.
Noteworthy Encounters
During their visit, the USFDA officials engaged with prominent figures in the Telangana DCA. V.B. Kamalasan Reddy, the director general of DCA, Telangana, played a pivotal role in facilitating discussions.
The delegation from the USFDA included Dr. Sarah McMullen, country director, Dr. Phil Nguyen, International Relations Specialist, and Dr. Sudheendra Kulkarni, senior technical advisor.
Insights into Regulatory Initiatives
Reddy took the opportunity to highlight recent regulatory initiatives implemented by DCA, Telangana.
These include risk-based sampling, advisories to the industry regarding testing of raw materials, such as glycerin and propylene glycol for harmful content, and the establishment of a Vigilance Cell.
Additionally, DCA, Telangana, has been conducting risk-based and unannounced inspections to ensure compliance and safety.
A Sequel to Commissioner Califf’s Visit
This visit follows closely on the heels of USFDA Commissioner Robert M. Califf’s visit in September 2023.
During his visit, Commissioner Califf articulated plans to empower Indian drug regulators with enforcement and regulatory compliance measures, particularly focusing on good manufacturing practices (GMP).
This vision was shared in a meeting with Gujarat Food and Drug Control Administration (FDCA) Commissioner Dr. H. G. Koshia in New Delhi.
Dr. Robert M. Califf: A Brief Background
President Joe Biden nominated Dr. Califf to lead the USFDA, and he assumed office on February 17, 2022.
Prior to his appointment, Dr. Califf served as the USFDA’s Deputy Commissioner for Medical Products and Tobacco, before being appointed Commissioner in February 2016.
USFDA-Gujarat FDCA Bilateral Regulatory Forum: A Resounding Success
The meeting also spotlighted the achievements of the USFDA-Gujarat FDCA Bilateral Regulatory Forum, which has been in operation since 2008.
This forum has been instrumental in addressing quality audit issues, ensuring compliance with GMPs, and discussing other pertinent subjects.
Empowering Compliance through Training
One of the key takeaways from the USFDA-Gujarat FDCA Regulatory Forum meet in February 2023 was the emphasis on audit readiness.
This initiative was aimed at achieving compliance and maintaining high quality standards.
The delegation from the USFDA was led by Sarah McMullen, director of the Office of Global Policy and Strategy, USFDA, India Office (INO), New Delhi.
A Commitment to Safety Amidst a Pandemic
The USFDA officials also made a significant visit to the Gujarat FDCA office in August 2021.
This visit was centered around attending regulatory forum meetings, where information sharing and capacity building were prioritized to combat the Covid-19 pandemic.
Scaling up Compliance for Patient Safety
During the last virtual USFDA-Gujarat FDCA Regulatory Forum meet in 2022, Gujarat FDCA outlined plans to bolster the presence of more USFDA and WHO-GMP compliant units in Gujarat.
This initiative aims to enhance the production of high-quality medicines, ultimately ensuring the safety of patients.
A Legacy of Collaboration: 2008 and Beyond
The USFDA-Gujarat FDCA Regulatory Forum, established in 2008, rests on the pillars of training, networking, knowledge sharing, and compliance.
This invaluable platform aids Indian regulators in comprehending the regulatory requisites set forth by the USFDA.
Bridging Regulatory Compliance: A Joint Effort
In 2019, a dedicated team of USFDA officials visited Gujarat FDCA, led by Letitia Robinson, country director, OIP, India Office, USFDA.
The discussions held were comprehensive, delving into strategies to enhance regulatory compliance in both the US and India.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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