Feature: Indian pharma cos seek faster clearance as GDUFA I nears end

Indian pharma companies may finally be looking at a better rate of clearances from the US Food and Drug Administration as the third year of GDUFA (Generic Drug User Fee Amendment of 2012) draws to a close.

As of fiscal year 2014, there is a backlog of about 4,000 Abbreviated New Drug Applications (ANDA) significantly up from 2,866 in FY 2012, according to the FDA. Indian companies make up for about 25% of the 4,000 ANDA’s. A report by HSBC Global Research expects the number of ANDA’s to have gone up to about 4,200 till March in FY 2015 on the back of higher filings and slower approvals.

Last month the FDA sought the reauthorization of GDUFA. The amendment is set to expire on September 30, 2017, following a five year term. GDUFA was first passed into law in 2012 under the Food and Drug Administration Safety and Innovation Act (FDASIA), a piece of legislation with several reform measures as well as user fee components targeted at increasing the funding for FDA.