India may be trying to steal the FDA's executive prosecution thunder. The country's supreme court has ruled that directors of pharmaceutical companies are liable for criminal prosecution when they are found responsible for manufacturing defective drugs that pose a significant health threat.
The FDA, under Commissioner Margaret Hamburg, announced its intention more than a year ago to pursue executive prosecutions, to resume use of a tool it had wielded more than half a century ago. That announcement has been followed by select reminders in the press, which include the drafting of its guidelines for such prosecutions, as well as hints that the background work may be under way for several cases.
The ruling in India follows dismissal of an appeal by directors of Denis Chem Lab, according to the Economic Times, who challenged their prosecution for supplying drugs contaminated with fungus. The court rejected their argument that the state's complaint against them contained "bald statements," the paper says, and no allegations specific to them.
The appeal was filed by Dinesh Patel and "certain other directors." The court ruled that directors are responsible for the affairs of the company; when a drug manufactured by the company is found to be defective, all directors can be prosecuted.
Given the potential public health impact, the court said it was unwilling to consider technicalities cited by the defendants. Justices deferred to the lower court ruling. "It will be open for the directors to show to the trial court that they had nothing to do with the manufacture process and, therefore, they should not be held liable," the supreme court said.
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