-Down to Earth Nearly 83 per cent medicines out of the ambit of price control policy, thus making them out of reach for most patients, say two recent reports Indicating failure of the National Pharmaceutical Pricing Policy (NPPP), 2012 and the Drugs Price Control Order (DPCO), 2013, two recently-released reports have stated that medicines are still not accessible and affordable for the citizens of the country. The reports that were jointly released...
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Ranbaxy drugs fine, say WHO and UK regulator -Rema Nagarajan
-The Times of India NEW DELHI: In yet another twist to the Ranbaxy scandal, the drug regulatory authority of the UK government has issued a statement clarifying that they have found no evidence of any Ranbaxy product in the UK market having been "of unacceptable quality". Last month, WHO had issued a similar statement. It had said that there was no evidence of any of the Ranbaxy products being of unacceptable...
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 »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...
More »Calling big pharma’s bluff -Dwijen Rangnekar
-The Hindu The lesson from the Supreme Court ruling on Gleevec is that pharmaceutical multinational corporations need to focus research on genuine innovations rather than on ways to evergreen their patents The much awaited Supreme Court judgment on Gleevec has been delivered. Novartis has failed in reversing the rejection of its patent. And, predictably - like a scratched record - there have been suggestions that pharma investments in India will dry...
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