US FDA guides its foreign offices to make better decisions on products meant for US markets

Dr Albinus D'saSaturday, September 01, 2012 The US Food & Drug Administration (US FDA) is very keen in figuring out the most appropriate and relevant information about the products that are developed for their markets by foreign countries, said Dr Albinus D'sa, deputy country director for US FDA-India Office.He said the regulatory agency guides the officials at their centres in various countries to make better decisions on all products meant for US markets. Speaking in a seminar on 'Regulatory Affairs' organised by Drug Information Association's India-Tamil Nadu chapter in Chennai, he said US FDA is focusing on the regulatory capacity building of any country, especially that of India. The FDA official praised the initiatives being taken by Tamil Nadu regulatory authorities. The products being developed for the US market, and those reviewed for marketing authorization in US are strictly regulated by its officials. Likewise, the products that are presented for entry into that country and those currently in its market are also undergoing proper regulatory mechanism. According to him, FDA adopts several methods of regulations wherein the regulators are strong and vigilant, but often it faces challenges of various kinds.He said the impact of globalization can be seen in the pharmaceutical sector also. It has resulted in pouring pharma products into the US market through its ports and airports and now the level of imports shot up to 2 trillion dollars. The boundaries of US are no longer a barrier and the products are no longer inspected elsewhere other than in the border points, D'sa said.Dr R Ezhil Arasan, chairman of Dr VRE Research Laboratories, said measures to assess the efficacy, safety and quality of drugs is very complex and differs from country to country. There are also differences in the way the drugs are distributed and accessed by the consumers. Another speaker Dr C Sudhakaran said awareness about the use of drugs is necessary today as in most occasions the consumers are not in a position to make decisions about how to use drugs, what kind of drugs to be used, when to be used etc. He said no medicine is completely safe or without reaction.Teachers and students of medical colleges, pharmacy colleges, researchers from Clinical Research Organisations and manufacturing companies working in various parts of the state attended the seminar, said Dr Annabelle Rajasekharan, Head, DIA- TN Chapter.