-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...

-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...

-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...

-The Economic Times NEW DELHI: The government's ambitious Manufacturing thrust has run into trouble even before it could take off with many states expressing difficulty in acquiring the vast tracts of land needed to set up dedicated zones. Five states have written to the Department of Industrial Policy and Promotion, requesting it to consider revising the minimum land requirement (from existing 5,000 hectare) for developing National Manufacturing Investment Zones (NMIZs). These include Assam,...

-The Times of India MUMBAI: A Mumbai hospital has put up a notice advising its doctors to avoid prescribing drugs manufactured by Ranbaxy Laboratories. This comes a fortnight after Ranbaxy Laboratories agreed to pay a $500-million penalty to US authorities for "selling adulterated drugs" in the American market. It is not known whether the two are linked. Consultants at Jaslok Hospital said an advisory was put up at the receptionist's circular desk...