Drugs short supply in US offers huge opportunity for Indian pharma industry
Off patent generic drugs manufactured in India are the key sources of cure for the diseases affecting the populations of the developed world. However, it needs to be seen if the western world is getting enough of those medicines for curing those diseases at the appropriate time intervals. The off patent drugs which any pharmaceutical company, including Indian, file at the USFDA are called as Abbreviated New Drug Approvals (ANDA).
Data collection and research findings from the US FDA website reveal that there has been a consolidation in the number of ANDA filings in the 4 year period of 2012-2015. The number of ANDA filings has practically remained steady despite the approval timelines for a generic drug application going to as high as 27-30 months. More than 2000 ANDA applications are approved each year and least 500 fall under the new drug approvals category each year considering the period from 2012-2015
There is also another category of ANDA approvals and that is known as the tentative approval category. Many Indian pharmaceutical companies have received tentative ANDA approvals in the period 2012-2015. At least 100 drug applications fall under the tentative approval category each year and 50 percent of them are granted by the USFDA to Indian pharmaceuticals companies. Of the top 20 companies in the ANDA tentative approval list, 14 companies are Indian pharmaceutical manufacturers too.