US FDA shelves India office plan

The US Food and Drug Administration has scrapped plans to open a $5.0 million office in New Dehli, India, saying it has no plans to open any other offices in Asia for the forseeable future. David Lepay, the FDA's senior advisor for clinical science, made the announcement at a session on Asian drug trials at the 42nd annual meeting of the Drug Information Association in Philadephia, USA. Dr Lepay also told the seminar that the FDA currently performs only 5% of its international inspections in the Asia/Pacific region.

Local reports circulated two years ago, saying that the FDA was planning to open offices in India, with an initial investment of $5.0 million, reflecting the number of FDA-approved facilies in the country. The aim of the office would have been to assist Indian drugmakers in complying with procedures for filing for marketing approval of products for distribution in the USA, as well as for applications for site inspections.