Blowing The Whistle On Ranbaxy

Dinesh Thakur’s “whistleblower” complaint describes his 2004 investigation into the integrity of the data underlying Ranbaxy’s pending and approved drug applications and findings of systemic fraud.

In his “whistleblower” complaint filed under the False Claims Act, former Ranbaxy Laboratories Ltd. Director of Project & Information Management Dinesh Thakur describes how he initiated a comprehensive, company-wide investigation and audit of the firm’s antiretroviral (ARV) and non-antiretroviral drug portfolios in August 2004. The investigation, which was conducted with the knowledge and support of R&D head Rajinder Kumar, was intended to assess whether Ranbaxy or its contract research organizations had falsified data for drug applications. Below are excerpts from Thakur’s first amended complaint, filed in February 2010, that describe his investigation, findings and outcome.

“After identifying the ARV drugs manufactured by Defendants, Relator contacted the functional groups responsible for the formulation, testing, and post-registration commercial manufacturing of the generic drugs. As part of his investigation, Relator requested the underlying records and raw data (patient records, stability tests, chromatograms, etc.) allegedly substantiating the drugs’ formulation, bioequivalence, and stability data filed with regulatory bodies. He discovered that there was little or no underlying data or, to the extent the data existed at all, Defendants had fabricated it.”

“Relator interviewed management of Defendant RLL during the investigation to identify the extent and scope of the data fraud. Interviews were conducted with managers in charge of bioequivalence studies, stability studies, regulatory affairs, quality assurance, and scale-up operations, among other departments. During these meetings, Relator confirmed that Defendants had engaged in a pattern of conduct to knowingly fabricate data that was incorporated into filings with regulators in an effort to deceive regulators into approving Defendants’ generic drugs. The falsified data affected the entire portfolio of generic ARV drugs manufactured by Defendants. The data was falsified with the knowledge, approval, and at the direction of senior management of Defendants located in India and the United States.”

“Relator identified specific [non-ARV] drugs, their registration status in particular countries, and the missing or falsified data for each. The problems he identified implicated the quality of hundreds of generic drugs sold by Defendants, including the following fraudulent practices violating cGMP requirements and rendering the drugs adulterated:

• Bioequivalence studies were filed with regulatory authorities based on formulations which were different from the formulation documented to the regulators;
• Bioequivalence data was falsified;
• Bioequivalence studies for some drugs were conducted on innovator drugs which were ground up, encapsulated, and misrepresented as a formulation developed by Defendants;
• Bioequivalence and stability studies were conducted on small research and development batches of product, as opposed to exhibit batches;
• Stability studies filed with regulatory authorities were fabricated;
• Stability studies filed with regulatory authorities were of a different formulation than proposed;
• Stability studies were performed in one manufacturing location but filed as at a different location;
• Individual dissolution values in the stability studies were fabricated;
• Batch sizes for stability and bioequivalence were intentionally misrepresented in the registration of the products;
• Stability shelf-life data was fabricated and submitted as part of the registration;
• Substandard API that failed testing and specifications was blended with good API in an effort to have the drug pass specifications;
• Research, development and commercial manufacturing of the generic drugs were not in compliance with current good manufacturing practices as required by the FDCA.”

“The formulation problems, falsification of bioequivalence and/or stability data, and commercial manufacturing of drugs that failed to comply with cGMP requirements affected all ANDAs filed with FDA between 1998 and 2005 and continued thereafter.”

“Relator notified Dr. Kumar of his findings, who reported them to senior management. On or about September 21-24, 2004, during a closed-door board of directors meeting in Thailand, Dr. Kumar addressed the board about the data falsification. … Upon information and belief, Dr. Kumar notified the board members of Relator’s investigation and the systemic fraud in formulation, bioequivalence, and stability filings with regulators in the United States and other countries to obtain approval for the ARVs and non-ARV drugs in Defendants’ portfolio.

In December 2004, Dr. Kumar addressed a subset of the board held out as a scientific committee. In advance of the meeting, Relator prepared documentation for use by Dr. Kumar to brief the meeting participants on Relator’s findings. The documentation addressed the risk to Defendants ANDA portfolio, some of the affected drugs, the fraud discovered by Relator, and a patient-oriented mitigation plan.

Upon information and belief, Defendants knowingly concealed from authorities the FDCA and other law violations and requested that Dr. Kumar destroy the evidence of the fraud. Dr. Kumar responded by resigning, although his resignation was not formally announced until March 2005.”