Didn’t meet purity standards by the FDA.
By Deepak Chitnis
WASHINGTON, DC: Lupin Pharmaceuticals Inc, a subsidiary of the India-based Lupin Ltd., has recalled nearly 10,000 bottles of one of its antibacterial drugs after finding that the product did not meet purity standards set by the US Food and Drug Administration (FDA).
The drugs in question are Ethambutol Hydrochloride tablets, with pills of 400 mg and in bottles of 100-count. The drug is manufactured in India, but distributed by Lupin Pharmaceuticals, which is based in Baltimore. The recall of the Lupin drugs was announced on the FDA website, which listed the reason for the recalled “Failed impurities/degradation specifications.”
“This product is being recalled due to an out of specification result for an impurity,” said the FDA, without elaborating as to what the impurity itself actually was. Reports indicate that the recall was initiated on January 27, but is just now being made public, and that it was a voluntary action taken by the company itself, not by the FDA as a kind of punitive measure.
Regardless of if the recall was an FDA-instigated action or not, it’s the latest slam against India’s pharmaceutical sector, which has taken a slew of hits from the US over the past year. Pharmaceutical plants all over India have been singled out by regulatory agencies in the US, almost always the FDA, for having unsanitary conditions and for not abiding by strict manufacturing guidelines.
India’s top pharmaceutical firm, Ranbaxy, has been hit the most, with four plants having been shut down by the FDA due to their failure for adhering to the aforementioned rules. In fact, Ranbaxy’s recent woes have been too much of a hassle for its parent company, Daiichi Sankyo Co. that the Japanese firm is in the process of selling its ownership stake in Ranbaxy to Sun Pharmaceutical.
Sun Pharmaceutical has also fallen on hard times of late; most recently, it came under the US microscope last month, when an import alert was issued against its plant in Karkhadi for not being in line with the FDA’s current Good Manufacturing Practice (cGMP) regulations. Sun Pharmaceutical also had its own recall recently, with 2,500 bottles of its Glumetza product – a generic diabetes medication – getting pulled off of shelves because several bottles had seizure medications mixed in with the diabetes pills.
Lupin Ltd. is India’s fourth-largest drug producer, with Ranbaxy at number one and Sun Pharmaceutical not far below it. Based in Mumbai, it is fastest-growing generic drug maker in the US, Japan, and South Africa, which are the first, second, and fifth-largest pharmaceutical markets in the world, respectively. The company recorded about $1.6 billion in revenue in 2012-2013.