-The Telegraph The Supreme Court today refrained from passing any order on a plea for early listing of a PIL that had sought closure of pharmaceutical giant Ranbaxy, recently penalised by US authorities for allegedly supplying adulterated and substandard drugs. The public interest petition sought registration of criminal cases under the penal code and also the Drugs and Cosmetics Act, 1947, against company officials for allegedly cheating millions of patients in the...
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US drug regulator detects lapses in Hospira's TN unit -Rajesh Chandramouli
-The Times of India CHENNAI: The US Food and Drug Administration (FDA) has rapped pharma giant Hospira for serious lapses in manufacturing of drugs at its Sriperumbudur unit. The US agency has warned the firm that this could result in drugs made at the plant not being allowed entry into the US. Hospira, in a regulatory filing, said it had received a warning letter from the agency . The letter followed an...
More »Indian Pharma's generic challenge-DG Shah
-The Business Standard USFDA's zero tolerance policy requires our drug firms to reorient not just processes but organisational cultures to serve that market credibly The following two quotes from the United States Food and Drug Administration (FDA) news releases may help put the Ranbaxy controversy in perspective. The first sums up what it is that drives the FDA and the second is typical of the challenge the pharmaceutical industry faces. (1) "The consent...
More »Drugs, Ranbaxy and lies
-The Hindu Seven years after the first warning in June 2006 from the U.S. Food and Drug Administration (FDA) and five years after the Department of Justice initiated legal proceedings against the company, Ranbaxy is back in the news for the same wrong reasons. Last fortnight it pleaded guilty to felony charges in the U.S., admitting to selling adulterated drugs with intent to defraud, not reporting that its drugs failed...
More »Dinesh Thakur, an ex-Ranbaxy employee who blew the whistle on the company, interviewed by The Economic Times
-The Economic Times Indian Pharmaceutical company Ranbaxy recently paid $500 million to the US government to settle civil and criminal charges for making fraudulent statements to the US FDA and selling adulterated drugs in the US. Dinesh Thakur, an ex-Ranbaxy employee who blew the whistle on the company, talks to ET about the five-year long investigation and the future of generic drug companies in the US. Edited Excerpts: * You think you...
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