The delay in approval of generic drug applications, which has been slowly declining annually, witnessed its lowest run-rate in the first half of fiscal 2015 (which is defined by the US Food and Drug Administration as year ending October 30). Data collated by JPMorgan analysts shows that average approvals based on cumulative applications has dropped from 61% in fiscal 2005 to 47% in fiscal 2012 and is now hovering at 28%, reports Pallavi Ail in Mumbai.
The regulator had introduced the GDUFA programme in 2012, specifically to accelerate the number of pending drug approvals and it hoped to achieve this by increasing number of drug reviewers and imposing a user fee on the applicants.
“Longer waiting time for ANDA approval has impacted growth for some Indian companies given lack of new product launches,” JP Morgan analysts wrote in a note dated November 19. “This was especially aggravated in the September 2014 quarter for Indian generic players with industry witnessing price erosion from channel consolidation in the US with the upside from new launches.”
Dr Reddy’s Laboratories chief operating officer Abhijit Mukherjee pointed out that decline in generic drug approvals did impact its sales to some extent in the quarter ended September 30. He said that the company is cautiously optimistic for the next quarter but the slowness in approval is witnessed throughout the sector.
Glenmark Pharmaceuticals president of North America business also mentioned during the second quarter analyst conference call that there has been a backlog in generic drug applications in the US.