Ranbaxy's top bosses wanted to destroy proof: Dinesh Thakur
Thakur, a former director of research information at Ranbaxy, has claimed that senior company executives ordered destruction of evidence.
Thakur, a former director of research information & project management at Ranbaxy, has claimed in the US courts that senior company executives ordered destruction of evidence when they were alerted to data fudging, misbranding and adulteration in drugs. Thakur's submission to the courts was reviewed by ET.
"Defendants (Ranbaxy) knowingly concealed from authorities the FDCA and other law violations and requested that Dr. Kumar (Thakur's senior) destroy the evidence of the fraud. Dr. Kumar responded by resigning, although his resignation was not formally announced until March 2005," Thakur has alleged in his submission made to the district court of Maryland in June 2012.
Thakur has not named any senior company executive. Brian Tempest was the managing director of the company in 2004-05 and Malvinder Singh was its president. Tempest's predecessor, DS Brar, had stepped down in mid-2004.
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While Ranbaxy refused to comment on the allegation, US-based Thakur could not be contacted for comment on the development.
Thakur has informed the courts that Kumar was apprised of the situation and he, in turn, reported the matter to the senior management. The former Ranbaxy executive mentions two specific board meetings where Kumar informed the then company board about the malpractice.
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In December 2004, Kumar addressed a smaller group of board members and briefed it on Thakur's findings, which concerned charges of fraudulent claims and documentation related to some of the affected drugs and new drug applications by the company.
Thakur had relocated to India from the US in June 2003 to work at Ranbaxy's Gurgaon R&D centre. Thakur, whose responsibilities included management of Ranbaxy's product and portfolio, set up the firm's program management office, which looked into generation of internal data on formulation and manufacturing of generic drugs.
The probe, according to Thakur, revealed that "there was little or no underlying data, or to the extent the data existed at all, defendants had fabricated it," Thakur has told the courts. "The data was falsified with the knowledge, approval, and at the direction of senior management of Defendants located in India and the US."
Thakur has alleged that a wider probe, conducted between August and November 2004, to include all generic products sold by Ranbaxy revealed other regulatory issues-violation of good manufacturing practices at select facilities and adulterated and misbranded drugs.
"The problems...implicated the quality of hundreds of generic drugs sold by Defendants, including the following fraudulent practices violating cGMP requirements and rendering the drugs adulterated," Thakur has claimed.
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Thakur quit Ranbaxy in April 2005 and then helped the US FDA for two years, during which time he dragged the company to court. "I worked with US regulatory authorities for two years to expose the fraud. In furtherance of this effort, I filed a lawsuit to hold Ranbaxy accountable," Thakur said on Monday.
It took us eight years to help government authorities unravel a complicated trail of falsified records and dangerous manufacturing practices that threatened to compromise the quality and safety of Ranbaxy drugs, he added.
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