-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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Ranbaxy's dark chapter-Bhupesh Bhandari
-The Business Standard Why have Indian authorities woken up to the Ranbaxy case only now? The matter had been simmering for several years The Ranbaxy affair is one of the darkest chapters of India's business history. The company has admitted it fudged data so that it could launch its products in the United States. It has now paid $500 million as a penalty to settle the case. It is worse than Ramalinga...
More »Tamil Nadu bans gutka, pan masala -R Satyanarayana
-The Times of India CHENNAI: The Tamil Nadu government has decided to ban the production, stocking, distribution and sale of tobacco products such as gutka and pan masala in the state. The decision came in the backdrop of the Supreme Court's remarks in a case recently, seeking to know the action taken by state governments in curbing the use of tobacco and its products. The order will be passed in a...
More »Johnson & Johnson’s licence for cosmetics cancelled -Jyoti Shelar
-Mumbai Mirror The Food and Drug Administration (FDA) recently cancelled Johnson & Johnson India's licence to produce cosmetic products at their Mulund plant. FDA's order will come into effect from June 24. According to FDA officials, the order was issued in a case dating back to 2007 when they found that 15 batches of Johnson & Johnson baby powder were sterilised by ethylene oxide, a known carcinogenic and irritant. "While ethylene oxide can...
More »Shortage of MTP pills, thanks to tighter norms of Food and Drug Administration -Pratibha Masand
-The Times of India MUMBAI: Bhavin Dave was married for six weeks when his wife realized she was pregnant. Both rushed to a doctor, who said the best way to deal with the unplanned pregnancy was to use a medical termination of pregnancy (MTP) drug. She prescribed the pills and that was when their ordeal began. Bhavin (name changed) scrambled from pharmacy to pharmacy with the prescription, but to no avail. He...
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