It's double trouble for global pharma companies in India.

Companies say they follow global standards in India as well

Drug majors such as Novartis, Pfizer, Bayer Healthcare, Bristol Mayer Squibb, Sun Pharmaceutical and Dr Reddy’s Laboratories were allegedly involved in clinical trials in which 438 persons died in 2011, according to confidential government data reviewed by Business Standard. While the companies argue they follow the global standards, experts point at the absence of sound regulations as the main culprit. Although the number of deaths in clinical trials has been growing through the years, it fell in 2011 from the previous year mainly because of flat growth in the clinical research market in India.

German pharmaceutical company Bayer AG has formally lodged a challenge against a landmark Indian ruling that allowed a domestic generic drug-maker to produce a low-cost version of an anti-cancer drug for the Indian market. The appeal was filed on Friday 4 May with India's Intellectual Property Appellate Board.

The compulsory licence issued to Natco for manufacture of the anti-cancer drug Nexavar is a landmark decision on many grounds – the first one in India since the 2005 amendment to the 1970 Patents Act and the fi rst in the world issued to a private party. There are some ambiguities in the order, but the door is now open for issue of CLs for a number of patented drugs that are not being worked.

The compulsory licence for Nexavar is only the beginning of a new battle over drug prices. (Editorial)

In a landmark move, the Indian Patent Office announced on Monday that it has issued its first compulsory license to a domestic generic drug-maker. The decision effectively ends German pharmaceutical company Bayer AG's monopoly over an anti-cancer drug and authorises the production of a low-cost version for the Indian market.

The government today asserted India would invoke the flexibility it had under the WTO agreement on Trade Related Intellectual Property Rights (TRIPs) for compulsory licensing of patented drugs to e

Mumbai: In a landmark decision that could set a precedent on how life-saving drugs under patents can be made affordable, the government has allowed a domestic company, Natco Pharma, to manufacture

GERMAN drugmaker Bayer has filed a patent infringement case against Cipla, the largest domestic drugseller, to stop the Mumbaibased company from selling its generic version of Bayer

Delhi HC Ruling Big Victory For Indian Drugmakers

IN A major win for Indian pharma companies, the Delhi High Court (HC) on Tuesday dismissed German drug major Bayer Healthcare