Reading the news sometimes gives me a disorienting sense of déjà vu. I felt it again when I read that Ranbaxy (Gurgaon, Haryana, India) had recalled a batch of its acne drug isotretinoin after the US Food and Drug Administration found that the product’s dissolution-test results were out of specification. Didn’t this happen once before?
Yes, in fact. The Indian generics company withdrew all lots of its antibiotic nitrofurantoin after discovering that the product did not meet approved laboratory specifications. Ranbaxy took the precaution because the nonconforming product might increase nausea and vomiting.
The latest recall includes only 1303 cartons of isotretinoin capsules that, according to the company, are “not likely to cause adverse health consequences.” Yet it is an unwelcome reminder that Ranbaxy has run afoul of FDA many times in the past year and a half. The agency has accused the company of deviating from good manufacturing practice and falsifying laboratory tests.
The string of bad news that has come to light since Ranbaxy became a subsidiary of Daiichi Sankyo (Tokyo) has transformed the Indian company from a powerhouse into a dark horse. I’m probably not the only observer wondering whether the company will regain the confidence of regulators and consumers—and whether the recent change in Ranbaxy’s leadership will help it do so. The honchos at Daiichi Sankyo must be hoping that their ward hasn’t become an albatross around their necks.