Holds first Annual Regulatory Forum meeting with USFDA officials in Hyderabad
HYDERABAD, JANUARY 31, 2024: The Telangana Drugs Control Administration in its combat against spurious drugs and check illegal activities including unlicensed manufacturing of drugs in chemical factors has collaborated with the US Drug regulator, USFDA (US Food and Drug Administration).
Accordingly, the first Annual regulatory forum between USFDA and DCA Telangana was conducted in Hyderabad on Wednesday. DCA Director-General VB Kamalasan Reddy, USFDA India Office Director Dr Sarah McMullen, International relations specialist Dr Phil Nyuyen, Consumer safety officers (drugs) Yvins Dezan and Guerlain Ulysee, senior technical advisor Dr Sudheendra Kumar and senior technical advisor (drugs) Druv Shah participated in the meeting.
During the Annual Regulatory Forum, DCA Director-General Kamalasan Reddy made a presentation on regulatory programme overview, current operations and initiatives taken by DCA Telangana. Dr Sarah McMullen, Country Director, US FDA presented an overview of their recent initiatives, USFDA inspection trends in India. US FDA officials have given 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.
The USFDA officials also discussed about ‘Observed Inspection SOP’, for future participation of DCA, Telangana inspectors as ‘observers’ in the US FDA led inspections. This annual regulatory forum between the USFDA India Office and Drugs Control Administration, Telangana is designed to identify best practices for future strategic collaboration and initiatives. The forum also provided an opportunity for USFDA and Drugs Control Administration, Telangana to provide an overview of operations and learn about one another’s current practices for further engagements.
As the State Regulatory Authority of Telangana, which contributes to more than 35 percent of ‘pharmaceutical production’ in India, Drugs Control Administration, Telangana has taken several regulatory initiatives viz. Risk-based inspections, Risk-based sampling, stringent testing guidelines to the industry regarding testing of raw materials Glycerin and Propylene Glycol for DEG and EG content for assuring safety of cough syrups, creation of vigilance cell for detection of clandestine activities, unannounced inspections of chemical/intermediate units, stringent review for approval of licences to the manufacturers etc., thus creating a stringent regulatory environment and better oversight with respect to the medicines manufactured in the State of Telangana.
In this context, a team of USFDA officials led by Dr Sarah McMullen, Country Director, US FDA Indian Office, who visited Drugs Control Administration office at Vengalrao Nagar, Hyderabad on 2nd November, 2023 proposed for “US FDA – Telangana DCA Regulatory Forum” for future strategic collaboration and initiatives, as Telangana State has more than 214 USFDA registered manufacturing sites i.e. pharmaceutical companies that manufacture, export medicines to USA.
