The US Food and Drug Administration (USFDA) Commissioner Dr Scott Gottlieb talked about new steps to facilitate efficient generic drug review to enhance competition, promote access and lower drug prices in a statement. For many of those within the Indian pharma industry, the note is on expected lines with apparently no fine print to be read.
However, the message to Indian pharma is quite clear: The ultimate aim is to bring down the prices and that can be best done by ensuring more competition for the same molecule in the market. This good news for those who have a large portfolio of product filings for the US market but now that the time gap between the player who get the first approval and the subsequent entrants into the market is coming down, it only means increased competition and even more price erosion. Earlier, companies could hope for a gap of 9 months to one year between the first generic entrant into the market and the subsequent players entry. Now, that seems to have dipped to about 3 to 6 months. So, gone are the days when disproportionate profits could be made in the US by generic players this is slowly happening in limited competition products too.
The only writing on the wall for Indian pharma companies is to chase complex and high-end products. Today, for the Indian pharma, analysts say, about 20 to 25 per cent of revenues would be from complex generics and the rest still from generic me-too drugs. The exact share could vary depending on the company and could range between 18 - 20 per cent to 30- 35 per cent range. That too in the complex generics it is still largely the bigger Indian players only so far like Sun Pharma and Dr Reddy's followed by Lupin.
As for the USFDA statement, it said: "The FDA today announced additional steps to encourage generic competition as part of our continued implementation of the Drug Competition Action Plan. This plan has three main components: reducing gaming by branded companies that can delay generic drug entry; resolving scientific and regulatory obstacles that can make it difficult to win approval of generic versions of certain complex drugs; and improving the efficiency and predictability of the FDA's generic review process to reduce the time it takes to get a new generic drug approved and lessen the number of review cycles undergone by generic applications before they can be approved. The new steps we're announcing today go toward achievement of this third goal. We expect to take additional steps this year to promote competition; to help reduce drug prices and improve access to medicine for Americans."