Indian pharmaceutical companies are still in the process of trying the generics market in the US instead of going all out to tap the same. The US generics market expected to touch $25 billion by 2010 presents the biggest market for Indian pharmaceutical companies but they haven't been able to penetrate the market in a big way though most of them have outlined their strategy vis-à-vis the US generics market.
Industry sources claim that though the Indian companies have outlined their strategy to enter the US generics market, they have not started to do so vigoursly. "Instead they are having a wait and watch policy which will harm them in a big way. Agreed that the US has also been slow in opening up the generics market what with it imposing all sorts of non-trade barriers, it is high time the Indian companies implement their strategy as far the US is concerned. Unfortunately, the bigger names too have not penetrated the US market in a big way," an industry source claimed.
What has deterred the Indian companies from going all way out is the case of suits against them and time for some of the drugs to go off-patent. "The two have been a deterrent to the Indian companies. While some are making sure they don't have any cases against them, others are waiting for the off-patent regime to come into play and US FDA approval for some drugs to go over-the-counter," industry sources added.
The sources however claim that though the US presents the biggest market for Indian companies, the US in association with some countries have been putting up non-trade barriers to save the home-bred companies. They point out to the instance of ciprofloxacin for fight against anthrax. Though Ranbaxy had a strong point it was put down in favour of Bayer, the original developer. "The prices were high yet Bayer got the order. So indiscrimination will be another non-trade barrier that Indian companies will have to face," the sources added.
A deterrent for Indian companies is the mandatory requirement of International Community of Harmonisation (ICH) norms for companies to enter the US market. The US along with UK and Japan had agreed recently to make the norms mandatory for foreign pharmaceutical companies before entering the respective markets. "We have never been speaking of ICH norms and here suddenly they say it is mandatory. We have companies here still trying to get the US FDA norms and if you start speaking of ICH norms, everything goes awry," sources added.