Serious safety concerns have been raised over India’s generic drugs industry after US regulators said that they would no longer approve products produced at a factory run by the country’s largest maker of medicines.
The US Food and Drug Administration (FDA) said that it had suspended reviews of new products from Ranbaxy’s plant in Paonta Sahib, in northern India, after uncovering “significant questions about the reliability” of information used to support requests to sell drugs in the US.
Shares in Daiichi Sankyo, the Japanese company that bought a majority stake in Ranbaxy for more than $4 billion last year, fell by almost 10 per cent in Tokyo. Ranbaxy plummeted as much as 18 per cent in Mumbai.
Investors fear that the FDA decision could have serious knock-on consequences for the generic version of the world’s most lucrative drug. Ranbaxy holds the right to distribute the first copies of Lipitor, the cholesterol pill developed by Pfizer, which achieved sales of $12.7 billion in 2007.
The Indian company has been the focus of FDA scrutiny for several years. Last year, the watchdog claimed it had evidence to suggest that Ranbaxy used active pharmaceutical ingredients from unapproved sources, resulting in the sale of "subpotent, super potent or adulterated medicines" in the US. It is alleged that test data was fabricated to show that medicines met FDA standards.
In September, it banned Ranbaxy from importing more than 30 generic drugs into the US due to serious manufacturing violations it cited at two company plants in India, including Paonta Sahib.
The US Food and Drug Administration (FDA) said that it had suspended reviews of new products from Ranbaxy’s plant in Paonta Sahib, in northern India, after uncovering “significant questions about the reliability” of information used to support requests to sell drugs in the US.
Shares in Daiichi Sankyo, the Japanese company that bought a majority stake in Ranbaxy for more than $4 billion last year, fell by almost 10 per cent in Tokyo. Ranbaxy plummeted as much as 18 per cent in Mumbai.
Investors fear that the FDA decision could have serious knock-on consequences for the generic version of the world’s most lucrative drug. Ranbaxy holds the right to distribute the first copies of Lipitor, the cholesterol pill developed by Pfizer, which achieved sales of $12.7 billion in 2007.
The Indian company has been the focus of FDA scrutiny for several years. Last year, the watchdog claimed it had evidence to suggest that Ranbaxy used active pharmaceutical ingredients from unapproved sources, resulting in the sale of "subpotent, super potent or adulterated medicines" in the US. It is alleged that test data was fabricated to show that medicines met FDA standards.
In September, it banned Ranbaxy from importing more than 30 generic drugs into the US due to serious manufacturing violations it cited at two company plants in India, including Paonta Sahib.
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