Daiichi admits Ranbaxy hid info from US drug regulators

23 May 2013

Daiichi Sankyo Co, the Japanese pharmaceutical company that has bought a majority stake in Indian generic drug maker Ranbaxy Laboratories, today agreed that the promoters of Ranbaxy hid information regarding US regulatory probes.

"Daiichi Sankyo believes that certain former shareholders of Ranbaxy concealed and misrepresented critical information concerning the US DoJ [Department of Justice] and FDA [Federal Drug Agency] investigations," the Japanese company said in a statement on its website on Wednesday.

Daiichi Sankyo did not name the shareholders while saying that ''certain former shareholders concealed and misrepresented critical information'' and ''legal remedies'' are being pursued.

Last week, Ranbaxy pleaded guilty to felony charges related to drug safety and agreed to pay $500 million in civil and criminal fines under a settlement with the DoJ.

In 2008, Daiichi spent $4.2 billion to acquire a 63.9-per cent stake in Ranbaxy from the controlling shareholder group, led by brothers Malvinder Singh and Shivinder Singh.

Ranbaxy's troubles with the FDA became public only after the deal.

Ranbaxy's $500-million fraud settlement is the largest in history involving a generic drug manufacturer.

The company acknowledged that it failed to conduct proper safety and quality tests of several drugs manufactured at the Indian plants, including generic versions of common medicines, like gabapentin, which treats epilepsy and nerve pain, and the antibiotic ciprofloxacin.

Ranbaxy has long history of falling foul of the FDA, which has investigated its Indian manufacturing plants and found them wanting. Nonetheless, it claimed that there are no reports of patients being harmed by its drugs.