India Regulators To Deny Generics Approval Of Drugs With Patents
This article was originally published in PharmAsia News
Executive Summary
India's drug regulators plan to change part of the approval process and block generics from getting clearance for copies of medicines with Indian patents. The country's drug controller general said regulators would use lists of patented drugs provided by brand companies and "we will not give any marketing approval to their generic versions." The move is expected to draw opposition from generics makers on grounds the DCGI lacks the authority to make the change. Drug Controller General Surinder Singh said the new system was expected to be completed in two or three months. Indian law does not provide five-year patent protection from generics, as in the United States. (Click here for more