Drug maker Ranbaxy Laboratories has asked two senior executives to exit for its failure to comply with regulatory issues cited by the US Food and Drug Administration (FDA), according to reports by television channels.
According to a report, the executives are T G Chandrashekhar, vice-president, global quality and analytical research, and Abha Pant, executive director for regulatory affairs.
A spokesperson at Ranbaxy, however, denied the reports. “The TV reports are incorrect, since the two persons named in the story, Abha Pant and T G Chandrashekhar, continue to be on the rolls of Ranbaxy,” the company said in an emailed response.
Business Standard could not reach the two executives.
Chandrashekhar heads a team of 320-plus scientists for analytical research and around 1,500 personnel for global quality management at Ranbaxy, the largest drug maker in India.
In September 2008, the USFDA banned over 30 generic medicines manufactured by Ranbaxy after two of its manufacturing plants, at Dewas and Paonta Sahib, were found to deviate from the US current Good Manufacturing Practice standards. The FDA also banned production from these facilities till the issues were resolved.
The US contributes around 25 per cent of Ranbaxy’s sales. The company has a good pipeline of exclusive six-month sale opportunities (for being the first to challenge the patent) of drugs, which are going off patent in the coming years in the US market.
“The company continues to co-operate with the USFDA and the Department of Justice for early resolution of all outstanding issues,” Ranbaxy had said in August.
Industry experts said the issues cited by the FDA at its two facilities included serious violations such as falsification of data and it would take more time for the company to get out of the trouble.
In August, Atul Sobti, chief executive and managing director of Ranbaxy, stepped down and Arun Sawhney, president for global pharmaceutical business, was appointed as the managing director.
