-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...
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Drugs on hold over doubts about Indian trials
-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...
More »MNCs deprive India of vital drugs -Rupali Mukherjee
-The Times of India MUMBAI: Some multinational companies (MNCs) have been delaying the launch of life-saving drugs in India years after getting monopoly rights, while cheaper generic versions of exorbitantly-priced medicines are going off the shelves under the product patenting law. Corporates such as Japanese firm Otsuka Pharmaceuticals, US-based Bristol Myers-Squibb (BMS) and Swiss firm Novartis are deferring the launch of medicines critical for treatment of serious non-communicable diseases like cancer, HIV,...
More »Billing for wallet shock -Digbijay Mishra
-Business Standard Indian and other generic drug firms face prospect of US legislature debating compensation for undue price rises Indian generic drug makers might, if a proposed US law comes about, need to pay a rebate to the federal Medicaid programme there when prices of their medications outpace inflation. A Bill is to be introduced in the US Senate by a member, aimed to cushion the impact on taxpayers in this manner...
More »A reality check on intellectual property concerns -Moushami Joshi and Srividhya Ragavan
-The Hindu The Working Group on Intellectual Property can serve as a platform where real time solutions to meet India's need for low-cost medicines can be addressed After what seemed like a historic trip for Prime Minister Narendra Modi, which held out the promise of reshaping India-U.S. relations positively, the initiation of the Out-of-Cycle Review (OCR) by the United States Trade Representative (USTR) has brought a sobering reality check as to what...
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