Pharmaceutical companies need to be careful of the FDA import alert pattern
Recently many Indian pharmaceutical companies have been hit by the USFDA with various degrees of warnings and alerts. During this year, major companies like Ranbaxy, Wockhardt along with many others have seen the effects of such alerts and import restrictions.
As most of these were based on the citation that the companies and the manufacturing plant in discussion was not complaint with the good manufacturing practices (GMP). It is essentially important for the Indian drug companies to be more watchful of the FDA import alert pattern and the stringent GMP norms that need to be followed.
As stated by Indian bureau chief, Pharmanewasia.com, Vikas Dandekar, coming out of such events is not an easy task. It seems that it would take around a year or more for the company to re-establish its good manufacturing practice standards and bounce back with its drugs in the US market. It also seems surprising that the domestic regulatory actions do not appear stringent on companies facing import alerts from US and UK regulators.