With FDA bans of products from some of India's largest drugmakers has come growing debate about the quality of drugs shipped to the U.S. A new report from the key drug regulator in India is likely to add to that discussion.
According to the Economic Times, sampling by the Drug Controller General of India (DCGI) since December 2012 found that about 2.3% of products tested failed to meet standards. Twenty-six of 1,123 samples failed to qualify, the report said. The sample was much smaller than the 24,000 drugs the regulator checked in 2009 amid reports of counterfeiting, but the percentage was much larger than the 0.046% it reported being substandard at that time.
Many of the products manufactured in India are not shipped to the U.S., and the FDA oversees the drugmakers who do export to the U.S. But the publicity that has resulted from FDA actions against some Indian generic med plants has started to enter the public consciousness, and some doctors, in addition to lawmakers and regulators, have been expressing concern.
"I'm just beginning to realize the gravity of the problem," Dr. Steven Nissen, head of cardiology at the Cleveland Clinic, told Reuters this week. "It's terrible and it is starting to get a lot of traction among physicians."
A week ago, the FDA banned a Sun Pharmaceuticals plant in India from shipping to the U.S. That came after it banned a plant in January owned by India's largest generics drugmaker, Ranbaxy Laboratories. And that action followed a ban of another Ranbaxy plant in September. The agency last year also banned two plants owned by India's Wockhardt. Those actions drew a lot of attention during a trip to India in February by FDA Commissioner Margaret Hamburg.
Hamburg emphasized that most Indian drugmakers shipping to the U.S. have high-quality operations, and some Indian industry officials think regulatory issues with Indian drugmakers are being overblown. Still, worried about the potential fallout from the issues with their peers, some drugmakers there are looking for ways to fight off the tide of bad publicity. According to Reuters, Jefferies India analyst Piyush Nahar said in a recent report that some are considering investing in U.S. or European facilities "to overcome challenges relating to both regulations and perceptions."