-The Economic Times MUMBAI: The United States Food and Drug Administration (USFDA), widely considered the world's most stringent regulatory authority, has said India's share in generic exports to the US over the years is an indication of the good manufacturing norms practised by Indian drugmakers. As the Ranbaxy scandal threatens to tarnish India's image as a hub of manufacturing world-class generic drugs, the statement, by USFDA's spokesman Chris Kelly in an...
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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 »The right medicine
-The Business Standard Govt should streamline its free medicines plan The Centre is reportedly going to shelve a plan to procure generic drugs for free supply to patients throughout the country. This is a serious error. Reportedly, states will instead be asked to do so; but, if a perceived inability to procure, stock and distribute these drugs is the reason for backtracking on the plan, how precisely will states be free of...
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...
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