Ranbaxy taken to task by FDA over manufacturing woes
pharmafile | January 31, 2012 | News story | Manufacturing and Production |Â Â FDA, Ranbaxy, manufacturing, woesÂ
Indian pharma company Ranbaxy will be banned from manufacturing drugs at certain plants for the US market until it corrects ongoing deficiencies in current Good Manufacturing Practice (cGMP), according to a consent decree signed by the firm.
The firm will also be banned from providing medicines for use in the President’s Emergency Plan for AIDS Relief (PEPFAR) programme.
Ranbaxy has agreed to remedy its long-running production woes at Indian sites in Paonta Sahib, Batamandi and Dewas, as well as to “correct data integrity problems at numerous facilities” in its network.
A facility in Gloversville, New York, operated by US subsidiary Ohm Laboratories, has already been shut down because of the manufacturing quality problems. Meanwhile, the three Indian facilities have been under an import alert imposed by the US FDA since 2008.
“Because this company continued to violate cGMP regulations and falsify information on drug applications, the FDA took these actions in an effort to protect consumers,” commented Dara Corrigan, the FDA’s associate commissioner for regulatory affairs.
The consent decree cites Ranbaxy, its US subsidiary and three senior executives, namely: Dale Adkisson, senior vice president and head of global quality; Arun Sawhney, chief executive and managing director; and Venkatachalam Krishnan, regional director Americas.
The decree “is the next step in the process of finalizing our agreement with the FDA to resolve this legacy issue”, said Sawhney.
Under the terms of the decree, Ranbaxy has agreed to hire a third-party expert to carry out an internal review and audit of the facilities, implement measures to ensure data integrity in the company’s drug applications, and withdraw any applications found to contain ‘untrue statements’ or ‘irregularities’, according to an FDA statement.
An audit will have to be undertaken to confirm adherence to regulations once the company deems it has come back into compliance, and an individual in the company must be appointed as the person responsible for all quality control and assurance activities. Ranbaxy will also be required to set up an audit office to monitor its applications.
The company has also set aside a $500 million contingency fund to meet any criminal or civil liabilities associated with its manufacturing problems. More immediate penalties include a requirement to forego first-to-file market exclusivity for three generic products, with another five at risk of losing that status if it does not meet the requirements of the decree.
Phil Taylor
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