India Regulators To Deny Generics Approval Of Drugs With Patents
This article was originally published in PharmAsia News
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
You may also be interested in...
US FDA looks to post-marketing studies to address elements of the NDA that were not central to its initial swift approval as the first COVID-19 therapy, including pediatric use and the interaction of hepatotoxicity and dose duration.
But advisory committee members caution against including pediatric population in COVID-19 vaccine trials, and one member expresses concern that Pfizer is testing those as young as 12 years of age. Agency is in discussions with product sponsors about enrollment of adolescents.
Public Company Edition: Four health care special purpose acquisition vehicles went public and two others announced mergers, but only one biopharma firm priced an IPO during the week of 19-23 October. Replimune’s $250m offering led recent FOPOs.