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New bulk drug export norms to comply with EU standards

-The Hindu The Commerce and Industry Ministry, on Thursday, issued new guidelines for pharmaceutical makers to comply with the European Union (EU) Good Manufacturing Practice (GMP) standards. In a statement issued here, the Ministry says such a move will give a boost to Pharma exports from India. "India has demonstrated its keenness to meet international requirements for exports of pharmaceutical products yet again by taking timely action for complying with the new...

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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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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...

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New drug price regime to alter structure-Ramnath Subbu

-The Hindu   The average impact on industry profitability may be around 20 per cent The Indian consumer will benefit under the new Drug Pricing Control Order 2013 (DPCO 2013) which has been notified and will replace the DPCO 1995. The new order will bring 652 drugs under price control and will enable the National Pharmaceutical Pricing Policy 2012 to regulate prices of 348 drugs covered under the National List of Essential Medicines...

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Drug prices set to fall by up to 80%-Rupali Mukherjee

-The Times of India MUMBAI: The government on Thursday issued the long-pending drug price control order, paving the way for the implementation of national pharmaceutical pricing policy, which will lead to a reduction in prices of medicines on an average by 20-25%, and in some life-saving ones, by up to 80%. Prices of 652 formulations under 27 therapeutic areas like anti-allergic (cetrizine), cardiac (aten), gastro-intestinal medicines (ocid), pain-killers ( paracetamol) and anti-diabetic...

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