and who advocate letting companies regulate/monitor themselves.


http://www.bloomberg.com/news/2014-02 ... es-u-s-fda-head-says.html

India Drugmakers Carry Onus of Knowing Rules, U.S. FDA Head Says
By Ketaki Gokhale and Harsha Subramaniam Feb 18, 2014 10:14 AM ET 2 Comments Email Print

Indian companies that supply a quarter of the medicines used in the U.S. must take responsibility for understanding the quality-control rules necessary to export their products, the top U.S. drug regulator said after an eight-day trip to that country....
When the agency?s inspectors visited the plant in July, they found inconsistencies in drug-test results, urine spilling over open drains, soiled uniforms and mold growing in a raw-material storage area, according to findings detailed in an official document obtained by Bloomberg News via a Freedom of Information Act request.

FDA inspections of drug facilities in India rose to 195 in 2012 from 11 in 2002, according to data from the regulator.....