Ranbaxy denies allegation of substandard drug sale; gets nod for stake sale

Mumbai: Ranbaxy Laboratories Ltd has denied reports that it had sold substandard drugs in the United States and is under investigations by the US authorities.

Denying allegations of fraudulent misconduct by US Department of Justice, India's biggest drug-maker Ranbaxy Laboratories has said there is no evidence to support the charges against it.

''Except for the issues that have already been fully aired with the government, Ranbaxy knows of no evidence to support these allegations,'' the company said while filing its response before the District Court of Maryland in the US. It also submitted that it would continue its co-operation with the US Food and Drug Administrator (USFDA) investigation on the issues and would address all concerns which the government counsel may have.

The company also added that despite repeated requests to the US authority to share the details of the ''concerns raised by the government,'' the US government has still not shared the details. ''The government has chosen not to share such information yet, which is entirely consistent with the Department of Justice's ordinary practice in investigations,'' said the company in its 8-page response filed through its law firm London & Mead and Buc & Beardsley.

The response further said, ''if and when the government choose to share the details of its concern, Ranbaxy commits to responsibly respond to, and resolve those concerns.''

The company said, ''it would be willing to share its concerns in a form that permits timely investigations.''

The Department of Justice has filed a motion against Ranbaxy before the District Court of Maryland alleging that the company submitting false and fabricated information to the USFDA about its abbreviated new drug applications (ANDA).

Daiichi Sankyo, Japan's third-largest drugmaker, agreed June 11 to buy the 34.8 per cent stake of Ranbaxy's chief executive Malvinder Singh and his family, and a portion of about $1 billion of preferential stock.

Ranbaxy, meanwhile, said it received shareholders approval for allotment of over 70 million shares to Daiichi Sankyo.

The shareholders of the company at the extraordinary general meeting held today approved the allotment of 46,258,063 equity shares and 23,834,333 warrants to Daiichi Sankyo company on preferential basis, Ranbaxy said in a filing with the Bombay Stock Exchange.

Ranbaxy would issue over 4.62 crore equity shares at Rs737 each and over 23.8 million warrants convertible into one equity share of Rs737 a piece, the company added.

The Japanese drug firm has also made an open offer to pick up a further 20 per cent stake in Ranbaxy for up to Rs6,818.65 crore.