The FDA sent a warning letter to Canton Laboratories in Vadodara, India, in February for a list of serious infractions, including falsifying data. The agency has taken the next step, issuing an import alert that bans products from the facility.
In the latest black eye for India's pharma industry, Lupin is recalling some 10,000 bottles of its Suprax antibiotic in the U.S. The pills fell short of standards for purity, the FDA said in a statement on its website.
The Open Source Drug Discovery program India set up in 2008 promised to disrupt the current model and deliver new treatments for neglected diseases. Six years later, OSDD is still working towards these goals, but has run up against shortages in two age-old areas: Money and skills.
India may now be taking compulsory licensing one step further, with domestic Natco Pharma asking the country's patent office to deny Gilead Sciences protection on its brand-new hep C treatment in the first place.
Indian authorities, who have been criticized for turning a blind eye to serious problems at Ranbaxy Laboratories plants there, have stopped a Ranbaxy API plant in Toansa from being able to sell products outside of India.
Novartis, already in a legal battle to try to keep India's Wockhardt from launching a generic of its diabetes blockbuster Galvus, says it is now trying to prevent Biocon from doing the same thing.
The FDA has banned a handful of plants from some of India's biggest drugmakers in the last year, actions that have led to grumbling that the regulator is picking on Indian-owned operations. But now a plant in India owned by a Canadian firm has gotten the same treatment, an import alert that blocks products from being shipped to the U.S.
The FDA has again issued an import alert against a plant owned by Canadian generic drugmaker Apotex, this one in India. The last time the agency took that kind of action, Apotex took the matter to international authorities in a North American Free Trade Agreement complaint.
Chalk up a win for Bayer KGaA in its running battle in India over a compulsory license granted to Natco to produce a cheap knock-off of its cancer drug Nexavar. The drug is being sold in India but a high court there says that is as far as the Indian drugmaker can go with it for now.
The steady string of warning letters issued to Indian drug and ingredient makers as the FDA has added to its staff in India is fueling the perception that the country has issues when it comes to quality. Now another warning letter has been issued.