This is almost a game changer to a degree but the sales due to the price have not been large in India so there’s not a big impact expected. If one goes through it might make you wonder who might be next on the list. Even here in the US we have problems affording expensive cancer drugs and some of the generics run in short supply that are affordable.
India did not start giving patents until the year 2005 and they have a law which I guess is what they used here to grant a compulsory license if the drugs were not affordable. Come to think of it, maybe that’s not a bad law after all? One message I guess this does send out is that they want affordable drugs and we certainly use enough generic drugs manufactured either in India or by Indian companies here in the US too. This was the first time the law was used in India and we shall see if it by chanced opens up any floodgates when it comes to drug pricing in the future as what’s to stop India or any other country from considering a similar move. BD
MUMBAI, India — India’s government on Monday authorized a drug manufacturer to make and sell a generic copy of a patented Bayer cancer drug, saying that Bayer charged a price that was unaffordable to most of the nation.
The decision by the controller general of patents, designs and trademarks was the first time a so-called compulsory license of a patented drug had been granted in India.
Legal specialists and patient advocates said it could open the door to a flood of other compulsory licenses in India and possibly in other developing countries, creating a new supply of cheap generic drugs.
According to the decision, Bayer must license the drug Nexavar, or sorafenib, to Natco Pharma, an Indian company. In exchange, Natco must pay Bayer a 6 percent royalty on its net sales and must sell the drug for 8,800 rupees ($176) a month, about 3 percent of the 280,000 rupees ($5,600) that Bayer charges for it in India. Natco’s drug will be for use only in India, the decision said.
Nexavar, which Bayer developed with Onyx Pharmaceuticals, a California biotechnology company, is used to treat advanced kidney cancer and liver cancer and has been shown to extend lives by a median of about three months. Fewer than 200 Indians used the drug, a tablet, in 2011. Advocates for cheaper generic medicines cheered the decision, which they said could provide a model for developing countries.