-Vikalp Once again, India is under pressure from the US to revise its patent law. Anyone familiar with the activities of the United States Trade Representatives (USTR) would know that this is nothing new. It has been among the USTR's primary mandates to use trade restrictions in order to persuade (to put it mildly) countries to strengthen their IPR laws. There is, however, a qualitative difference between the actions it has...

-The Hindu In a significant development for the pharmaceutical industry, the Supreme Court has rejected multinational Bayer's appeal to block production and sales of the low cost version of its kidney cancer drug, sorafenib tosylate (branded as Nexavar), by Natco Pharmaceuticals. Hyderabad-based Natco was granted the first and to date only compulsory licence (CL) by the government in 2012 to make and sell a patented drug at a fraction of the...

-Business Standard This would be in addition to 348 drugs already under price ceiling The National Pharmaceutical Pricing Authority (NPPA) has capped the prices of another 52 essential drugs, in a move that could impact drug manufacturers Lupin, Cadila Healthcare and Merck. This is in addition to the 348 drugs already under a price ceiling. The majority of the 52 new drugs are antibiotics, painkillers and medicines used for treating cancer and skin...

-Business Standard Domestic regulators need to be stricter about quality violations to protect both Indian Pharma exports as well as the country's image Even as major Indian drug companies continue to make news for impurities in the medicines they make and faulty - or if the USFDA is to be believed, falsified - data that many generate after testing of samples show quality problem, it seems strange that domestic authorities are silent...

-The Telegraph Regulators in several European countries are suspending marketing approval for 25 generic drugs because of concerns over the quality of data from human studies conducted by an Indian contract research company, a French medical safety agency said on Friday. Drug regulators in Belgium, France, Germany and Luxembourg have decided to suspend the marketing authorisation for the generic drugs after they discovered "irregularities" in documents relating to human studies conducted by...