India set to dominate generic API market?
all the Drug Master Files for active pharma ingredients (APIs)
received in the US, outstripping their international rivals by a
wide margin.
This is a strong reminder of the emergence of India as a powerhouse of API production, as local firms get increasingly aggressive as they carve out a slice of the $42 billion world market for generic pharmaceuticals. Indian companies exported $2.5 billion-worth of drugs in 2002, but the level of regulatory activity suggests that this share could increase dramatically in the future.
In total, Indian companies filed 119 DMF with the US Food and Drug Administration in 2003, ahead of Italy with 31 and China and Israel with 20-odd piece, according to a report on India's Time News Network. Ranbaxy and Dr Reddys accounted for the largest number of DMFs filed.
DMFs are generic dossiers filed with the FDA in order to allow the API to appear in marketed drugs. Using this approach, an API manufacturer files just one application for a product, which can then be used to support approval of any generic based on that API.
This level of activity suggests that Indian companies will become even more powerful players on the world's generic API stage, as some of the ingredients contained in these DMFs will doubtless underpin some major new generic launches.
In the next five years, it is estimated that drugs with sales of $55-$65 billion will go off-patent in the US alone. The US is the world's largest generics market, with a 30 per cent plus market share.
