US FDA India Office soon to initiate US FDA-Telangana DCA Regulatory Forum for future strategic collaborations

US FDA India Office soon to initiate US FDA-Telangana DCA Regulatory Forum for future strategic collaborations

Posted on November 9, 2023 Updated on November 6, 2023

The US FDA India Office has proposed to initiate US FDA – Telangana Drugs Control Administration (DCA) Regulatory Forum for future strategic collaborations and initiatives during their recent visit to the Telangana DCA office in Hyderabad.

This regulatory forum will discuss elements of Observed Inspection for future participation of Inspectors of DCA, Telangana as an observer in the US FDA led inspections.
US FDA officials, during the visit met V.B. Kamalasan Reddy, director general, DCA, Telangana. Dr. Sarah McMullen, country director, US FDA Indian Office, Dr. Phil Nguyen, International Relations Specialist, Dr. Sudheendra Kulkarni, senior technical advisor were among the FDA officials who visited DCA, Telangana office.

During the discussions with the US FDA officials, Reddy explained about the recent regulatory initiatives taken by DCA, Telangana such as risk-based sampling, advisory issued to industry regarding testing of raw materials glycerin and propylene glycol for diethylene glycol (DEG) and ethylene glycol (EG) content, Vigilance Cell, risk-based inspections and unannounced inspections carried out by DCA, Telangana.

This visit comes close on the heels of the recent visit of US FDA Commissioner Robert M Califf in September 2023 who spoke about the plans to equip Indian drug regulators with enforcement and regulatory compliances related to good manufacturing practices (GMP) among others in a meeting with Gujarat Food and Drug Control Administration (FDCA) Commissioner Dr H G Koshia in New Delhi.

President Joe Biden nominated Dr. Califf to head the US FDA and Dr Califf was sworn in on February 17, 2022. 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.

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.

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 was led by Sarah McMullen, director of the Office of Global Policy and Strategy, US FDA, India Office (INO), New Delhi.
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 US 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.
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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