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US FDA officials visit Guj FDCA to demonstrate rapid screening method

Suja Nair Shirodkar, MumbaiFriday, February 17, 2012, 08:00 Hrs  [IST]

Representatives from the United States Food and Drugs Administration (FDA) recently visited the office of the Gujarat Food and Drug Control Administration (FDCA) to discuss and demonstrate the use and importance of rapid screening method in testing. Gujarat FDCA is the only state regulatory body that the US FDA is visiting during its visit to India, the rest being done through CDSCO's office.

The four-member delegation from the US FDA included Dr Lucinda Buhse, director, division of pharmaceutical analysis (DPA), Centre for Drug Evaluation and Research (CDER); Dr Benjamin J Westenberger, deputy director, DPA, CDER; Dr John Kauffman, research chemist, DPA, CDER and Dr Albinus D'sa, deputy country director, US FDA India.

During their visit to Gujarat, they gave hands on demonstration on the use of rapid screening methods on x-ray fluorescence; ion mobility; raman and near infrared analyser to the regulators and the stakeholders.

Dr H G Koshia, commissioner, Gujarat FDCA informed that the workshop was very useful in imparting training to the state regulators on the importance of adopting the new technologies for easy and effective screening of products. “Gujarat FDCA has always been pro-active in adopting latest technological innovations that can helps us in improving our services and standards. The presentation done by the US officials have been very impressive and we may consider adopting this method into our system so that it will help us to upgrade our systems according to the changing trends and demands and make it more technology based,” he pointed out.

He further informed that his office is planning to propose to the government to support this venture so that they can adopt it for the surveillance and screening of products as it is both user-friendly and easily manageable for the regulators for quick and effective survey. The goal of this programme was to cater not only to the regulators of the state but also to the stakeholders as well since they can also use rapid screening methods while buying products from other markets to ensure safety and efficacy of their products.

Dr Koshia informed that the workshop helped to understand clearly the analytical methods including chemometric methods of analysis that can be deployed by field laboratories and inspectors for the screening of cosmetics dietary supplements, pharmaceutical ingredients and finished products.

This visit helped the US regulators to connect with the regulatory authorities in the state and industry on wider scale, so as to discuss common interests in rapid screening of pharmaceutical products and other regulated products. Following Gujarat, the delegation is expected to visit Mumbai and Hyderabad as well.

 
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