Mysore/Mysuru: Dr. Sarah McMullen, Country Director, United States Food and Drug Administration (US-FDA) India Office (INO), inaugurated the ‘Centre of Excellence in Regulatory Sciences’ at JSS College of Pharmacy, Mysuru, on Nov. 30.
India has the highest number of US-FDA approved pharmaceutical plants outside United States. Regulatory Sciences is pivotal in obtaining marketing authorisation from Regulatory agencies like US-FDA.
Dr. T.M. Pramod Kumar, Principal and Dean, JSS College of Pharmacy, welcomed the US-FDA INO team — Dr. Sarah McMullen, Country Director; Gregory Smith, International Relation Specialist – Drugs; Dr. Sudheendra Kulkarni, Medical Product Safety Coordinator – BIMO, Devices; Dhruv Shah, Medical Product Safety Coordinator – Drugs and other dignitaries.
Dr. C.G. Betsurmath, Executive Secretary, JSS Mahavidyapeetha, who presided over the event, briefed about JSS Mutt and Universities under JSS Mahavidyapeetha and the social activities.
Dr. Surinder Singh, Vice- Chancellor, JSS Academy of Higher Education and Research (JSS AHER), spoke about the significance of Pharmaceutical Industry personnel designing the curriculum for better outcome while Dr. Prashant Vishwanath, Dean (Research), JSS AHER, conveyed best wishes to the Centre for future endeavours.
Dr. Sarah McMullen briefed about US-FDA and the significance of India inGlobal platform.
FDA regulated US imports from India and OGPS (Office of Global Policy and Strategy) mission, FDA Registered Pharmaceutical firms and Pharmaceutical Inspections in India and the overview on India Office (INO) focus areas like Advanced Manufacturing Technologies, Biopharmaceuticals, Real World Evidence/ Data, Nitrosamine Impurities, Innovations and Stakeholders was presented.
The ceremony was hosted by Dr. M.P. Venkatesh, Associate Professor and co-ordinated by Dr. V. Balamuralidhara, Head, Department of Pharmaceutics. Dr. Bangarurajan, Professor, JSS College of Pharmacy, proposed a vote of thanks.