Indian Regulators have warned both Indian and foreign pharmaceutical companies to beware of a scam involving people posing as U.S. FDA officials, demanding cash payments for approvals.
A western Indian homoeopathic company’s manufacturing facility was visited last month by an FDA "inspector" who informed the company that an FDA approval was in progress, but required a $418 cash payment. The company, later identified by in-pharmatechnologist as local company, Muktesh Healthcare, alerted the Gujarat Food and Drugs Control Administration of the possible scam.
The scam comes at a vulnerable time for India drugmakers, as recent regulatory action on behalf of the U.S. FDA has banned several Indian drugmakers from exporting drugs to the U.S. and a global spotlight has be cast on India compliance issues.
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