-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...
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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 »UN report highlights benefits of school meal programmes in crisis settings
-The United Nations A United Nations report released today stresses the importance of providing meals for schoolchildren, particularly in times of crisis, and notes that this is still lacking in many developing countries. "School feeding assures that where quality education is available, children are able to take advantage of the opportunity to learn," said the Executive Director of the World Food Programme (WFP), Ertharin Cousin. "It's an investment that pays off in the...
More »Armed with whistle-blower policy, Ranbaxy to look ahead-Sushmi Dey
-The Business Standard Patient safety & quality our guidance now, says Sawhney Trouble-hit Ranbaxy Laboratories has introduced a whistle-blower policy within the company to encourage transparency and address concerns internally, so that bigger problems could be averted. In his first interaction with the media (the first part of which was published on Sunday) since the drug maker pleaded guilty of making fraudulent statements to the US Food and Drugs Administration (FDA) under its...
More »Ranbaxy case may take a toll on other Indian drug makers
-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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