The FDA’s ongoing engagement with our regulatory counterparts in India is critical to our ability to effectively promote the health and safety of American and Indian consumers,” Hamburg said in a statement. “I look forward to enhancing our existing relationship and identifying additional opportunities for collaboration.”
Generic-drug makers Ranbaxy Laboratories Ltd. and Wockhardt Ltd. have both been banned from selling medicines in the U.S. from Indian plants based on quality issues. Most recently, Ranbaxy’s fourth facility was prohibited last month from distributing products to the U.S. after FDA inspectors found the company was re-testing medicines to gain favorable results after initial analyses failed.
Now the commissioner come to see why she and her department has a constant headache from Indian companies.Only if she knew what the normal medicines manufactured for the Local market really comprises of.It is common knowledge that the drugs manufactured in India if tested with FDA standards would fail some would be termed dangerous and harmful for human consumption, may be even for veterinary use.Little does the government do to address the situation and this is a department which is in the highly corrupt category......did the Mango party leader have the guts to address this situation in his state nor label the purveyors of bad drugs as corrupt....not by a long shot. As this would open a pandora's box which he even cannot control.