Quality, patents tax India connections
India's drug industry feels the US has been harsh on its manufacturing practices, but a slew of complaints regarding both manufacturing and intellectual property issues have flowed in since FDA Commissioner Margaret Hamburg's visit to shore up cooperation and information-sharing between the two countries.
Among the recent issues are two recalls: Bloomberg reports that both Sun Pharmaceuticals and Ranbaxy issued recalls of prescription generics due to bottling errors.
A consumer complaint triggered Sun's recall of 2,528 bottles of the diabetes medication metformin hydrochloride because an anti-seizure medication was mixed in with the blood-sugar controlling medication. Meanwhile, Ranbaxy recalled lots of generic Lipitor because 20mg doses were mixed in with 10mg ones. Reuters notes that this was Ranbaxy's second atorvastatin recall in 15 months.
Manufacturing quality has been a go-to issue of late, but Reuters reported Thursday on one of many other issues that hang in the background when discussing India: patents. Reuters notes that the industry is worried about the country's compulsory licensing procedure, which allows the government to essentially override patent protections for a greater public good. India invoked such a license for Bayer's Nexavar cancer drug in 2012, despite a patent that still had legal life to it.
“The constant threat of compulsory licenses hangs like a Damocles sword over patent-holders,” a managing director at Novartis told Reuters.