A regulatory forum between the U.S. Food and Drug Administration (US-FDA) and the Drugs Control Administration (DCA) of Telangana took place at Dr. MCR HRD Institute of Telangana on January 31. The event was proposed by the US-FDA India Office in November 2023, aiming to foster strategic collaboration and initiatives between the two regulatory bodies.
This collaboration stems from Telangana’s status as home to over 214 US-FDA registered manufacturing sites, primarily pharmaceutical companies engaged in the production and export of medicines to the United States.
The forum provided a platform for in-depth discussions, with a focus on the ‘Observed Inspection Procedure.’ US-FDA officials explored the prospect of engaging drugs inspectors from the Drugs Control Administration, Telangana, as ‘observers’ in future US-FDA inspections conducted within the State.
Key figures of the US-FDA, including Country Director Sarah McMullen; International Relations Specialist Phil Nguyen, and Senior Technical Advisor Dhruv Shah, participated in the forum.
