-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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SC ‘very serious’ tag on Ranbaxy charges-R Balaji
-The Telegraph New Delhi: The Supreme Court today observed that even if there was a grain of truth in the charges that Ranbaxy was supplying adulterated drugs, it was a "very, very serious matter" but refrained from issuing any orders till it received "prima facie material". The court said that drug-testing standards in the US were different from those in India, and what was happening in America might not necessarily be happening...
More »Hospitals, chemists to wait for regulatory word on Ranbaxy
-PTI Drug regulator DGCI is conducting a "focussed scrutiny" of medicines sold by Ranbaxy and some other drug makers, but says it remains confident of the quality standards of Indian medicines despite concerns raised by US authorities over some of Ranbaxy's products. While the company continues to assert that its drugs meet all regulatory standards, a few hospitals and pharmacies have adopted a cautious stand on use of its products. However, a majority...
More »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 »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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