USFDA Officials propose for "US FDA - Telangana DCA Regulatory Forum" for future strategic collaboration

This regulatory forum discusses elements of Observed Inspection for future participation of Inspectors of DCA, Telangana as an observer in the US FDA led inspections.

Published On 2023-11-03 09:19 GMT   |   Update On 2023-11-04 05:12 GMT
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Hyderabad: US FDA officials visited Drugs Control Administration, Govt. of Telangana office at Vengal Rao Nagar, Hyderabad on 02nd November, 2023 to meet Sri. V.B. Kamalasan Reddy, IPS, Director General, DCA.

Dr. Sarah McMullen, Country Director, US FDA Indian Office, Dr. Phil Nguyen, International Relations Specialist, Dr. Sudheendra Kulkarni, Senior Technical Advisor are among the FDA officials who visited DCA, Telangana office.

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US FDA Indian Office Officials proposed for “US FDA – Telangana DCA Regulatory Forum” for future strategic collaboration and initiatives. This regulatory forum also discusses elements of Observed Inspection for future participation of Inspectors of DCA, Telangana as an observer in the US FDA led inspections.

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Sri. V.B. Kamalasan Reddy, IPS, Director General, DCA explained the recent regulatory initiatives taken by DCA, Telangana to US FDA Officials viz. Risk-based sampling, advisory issued to industry regarding testing of raw materials Glycerin and Propylene Glycol for DEG and EG content, Vigilance Cell, Risk-based inspections and unannounced inspections carried out by DCA, Telangana.

Read also: Lupin secures tentative USFDA nod for Selexipag for Injection

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