While most drugs from India are generics, sometimes Indian products are used by Big Pharma for their top brands, like AstraZeneca's Nexium.
One of India's solutions to get lower-cost meds for its impoverished and uninsured--compulsory licenses--has ignited drugmakers' ire. And with an Indian committee currently assessing a batch of patented drugs as compulsory licensing candidates, the U.S. is fighting back--politely, at least so far.
Indian CRO GVK Biosciences has become a global player since Sequoia Capital first bought a stake back in 2007, and now the venture capital stalwart is looking to sell its share at more than three times the price, according to The Economic Times.
In an effort to get itself into a place where it can again ship from its FDA-approved plants in India, Ranbaxy Laboratories says it is taking a hard look at how it runs its API operations.
One of the issues that the FDA has uncovered at several Indian drug manufacturing plants it has inspected is a penchant for messing with drug analytics to get the data companies need for drugs to be approved. Now the FDA has sent a warning letter to yet another Indian drugmaker accusing its analytics lab of making up sample weights used to test drugs, then using the results in FDA drug applications.
India moved one step closer to approving critical changes to laws governing its medical devices. In a regulatory push, the country's health ministry agreed to examine recommendations of the standing committee on a new amendments bill, the Indo Asian News Service reported.
In the last 6 months the FDA has banned two more Ranbaxy plants, leaving it with just one of 5 FDA-approved facilities able to serve the U.S. So the maker of generics will try yet again to put things right so that it can sell more products in its largest market.
The FDA has taken some tough action against Indian drugmakers like Ranbaxy Laboratories. It has a dozen inspectors stationed in India and will beef that up to 19. But the agency doesn't have it out for Indian drugmakers, FDA Commissioner Margaret Hamburg insists. Its actions there just reflects that India has become one of the biggest links in the global supply chain.
Getting costs down on vaccines is always a big deal to countries like India, and so the government there is putting pressure on GlaxoSmithKline and Merck to give it a break on the human papillomavirus (HPV) vaccines, according to The New Indian Express.
FDA Commissioner Margaret Hamburg returned from her trip to India talking up cooperation and collaboration between regulators there and the FDA. Not all regulators there, however, sounded as enthusiastic as she did.