Rashmi Pant  May 3, 2010

Pharmacovigilance

Pharmacovigilance for “controversial” drugs

The Drug controlling authority in India has recently placed itself into action with reference to rules and regulations related to drug safety for various off patent drugs. The Off patent drugs despite "proven for safety" over the years with bio equivalence studies are still going to face the regulator's scanner. This means that adverse events all nature would have to be documented and placed for the regulator's approval.

More at-

http://blogs.veedacr.com/Lists/Categories/Category.aspx?Name=Pharmaco%20Vigilance