-The Business Standard The tussle between the US Food and Drug Administration (US FDA) and Ranbaxy is likely to hit the plans of Indian pharmaceutical companies of making it big in the US generic drugs market. Apart from the fact that their image may take a beating, the additional scrutiny on abbreviated new drug applications (ANDAs) from India would lead to more delays in drug approvals. Last week, Ranbaxy had agreed to...
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Ranbaxy's dark chapter-Bhupesh Bhandari
-The Business Standard Why have Indian authorities woken up to the Ranbaxy case only now? The matter had been simmering for several years The Ranbaxy affair is one of the darkest chapters of India's business history. The company has admitted it fudged data so that it could launch its products in the United States. It has now paid $500 million as a penalty to settle the case. It is worse than Ramalinga...
More »Ranbaxy fined $500 m for flawed generics-Narayan Lakshman
-The Hindu Ranbaxy, one of India's largest pharmaceutical companies, has agreed to pay $500 million fines levied by U.S. authorities for selling adulterated drugs and lying to federal regulators in a case that is part of an ongoing crackdown on the quality of generic drugs flowing into the U.S. The deal struck on Monday, said to be the largest financial penalty against a generic drug company for violations of FDA standards, came...
More »Strong medicine for poor countries-Nayanima Basu
-The Business Standard The Novartis verdict by the Supreme Court emphasised the importance of flexibilities in drug patent laws, in contrast to Western countries which are seeking TRIPS-plus hardening through free-trade agreements As curtains on the six-year-long legal tussle with Swiss drug giant Novartis AG finally came down earlier this month, the Indian government did not waste a second in hailing the Indian patent law which it said was in "full...
More »In the ‘pharmacy of the world’ -PT Jyothi Datta
-The Hindu Business Line From maker of versions of drugs, India's pharmaceutical industry has turned a top innovator Twenty years ago, Ranbaxy was a home-spun drug-maker. The Indian Patents Act allowed companies to make chemically-similar versions of innovative drugs. Visionaries in the pharmaceutical sector, like Parvinder Singh (Ranbaxy's key architect and member of its promoter family) and Anji Reddy (founder of Dr Reddy's Laboratories), were alive. And the pharmaceutical industry did not have...
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