Strategic Partnership: Telangana DCA and USFDA collaborate for drug regulation

As a part of these efforts, a one-day ‘Annual Regulatory Forum’, featuring senior USFDA officials and TSDCA was held on Hyderabad on Wednesday.

Hyderabad: The Telangana State Drug Control Administration (DCA) on Wednesday announced collaboration with United States Food and Drug Administration (USFDA) to establish an efficient regulatory framework, identify best practices and co-operation in future strategic initiatives.

As a part of these efforts, a one-day ‘Annual Regulatory Forum’, featuring senior USFDA officials and TSDCA was held on Hyderabad on Wednesday.

---

On the occasion, Dr. Sarah McMullen, Country Director, US FDA presented an overview of their recent initiatives including USFDA inspection trends in India. During the meeting, the US FDA officials made presentations on USFDA Medical Products Program Overview and their mechanisms related to manufacturing facility oversight and regulatory actions, approaches to the Pharmaceutical Quality System and Risk-based approach for GMP Inspections.

“This annual regulatory forum between the USFDA India Office and DCA, Telangana is designed to identify best practices for future strategic collaboration and initiatives,” DG, DCA, V B Kamalasan Reddy said.

While interacting with US FDA officials, Kamalasan Reddy highlighted major regulatory initiatives including risk- based inspections, sampling, stringent testing guidelines to the industry regarding testing of raw materials Glycerin and Propylene Glycol for DEG and EG content.

The forum also provided an opportunity for USFDA and Drugs Control Administration, Telangana to provide an overview of operations and learn about each other’s current practices for further engagements.