-Newsclick.in A few weeks back Fortune magazine and CNN carried a long online blog titled ‘Dirty Medicine' by Dinesh Thakur, a former employ of Ranbaxy, where he recounts how he came across several procedural and other lapses in the company's manufacturing facilities. Since then the Fortune blog has become one of the most widely circulated and commented upon business stories in the world. The story received attention as it came in the...
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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 »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 »House panel: Government clearing harmful drugs -Rupali Mukherjee
-The Times of India MUMBAI: You could be popping certain pills and combinations that are illegally approved, harmful, cleared without proper clinical trials or even banned in the US and other countries. Delivering a severe rap on the government's knuckles, a parliamentary standing committee on health has charged it with "dilly-dallying and procrastination'' over serious irregularities in approval of life-saving medicines, not following the global ban on harmful drugs, and failing...
More »Committee on drugs calls for 20 sub-panels-Vidya Krishnan
-Live Mint An investigation found DCGI cleared drugs without conducting mandatory clinical trials After five rounds of consultations in six months, a committee tasked with making recommendations on cleaning up India’s drugs-approval process and ending the cosy relationship between doctors, pharmaceutical companies and government officials had no suggestions to offer by way of a crackdown. It has, instead, suggested setting up 20 sub-committees. The report submitted to the health ministry in November is...
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