Regulatory Focus™ > News Articles > That FDA Official Requesting Bribe Money Probably Isn't an FDA Official, Indian Regulators Warn

That FDA Official Requesting Bribe Money Probably Isn't an FDA Official, Indian Regulators Warn

Posted 18 February 2014 | By Alexander Gaffney, RAC

A note to Indian and other pharmaceutical manufacturers: If a person claiming to be from the US Food and Drug Administration (FDA) asks you for an in-person cash payment of several hundred dollars to make sure your export registration gets approved, it's probably a scam, according to Indian regulators.

According to PharmaBiz, a homeopathic pharmaceutical company recently encountered such a scenario, in which its manufacturing facility was approached by someone claiming to be an FDA regulatory official there to inspect the company's pending export registration application.

"During the meeting he informed [the company] that their file was currently in process of getting approval from a senior official from the US regulatory office in India, after which the company will be eligible to export homoeopathic products to US," PharmaBiz reported. "However, during the meeting he stressed that to ensure the registration the company needs to make full payment of fees of Rs.26000 in cash."

While that's a relatively small sum-about $420 USD-it was apparently enough to raise the suspicions of the company being inspected, but not enough for them to "take any requisite action." The scammer was able to escape, PharmaBiz added.

According to the Gujarat Food and Drugs Control Administration, a regional Indian regulatory body, the case also isn't the first involving someone posing as a regulator.

"It has come to our notice that more companies have been targeted and fallen prey to such scam," it wrote in a statement. All companies approached by someone demanding or requesting money in person are urged to contact police and regulators immediately.

The Gujarat FDCA has been keeping the local FDA field office abreast of the situation as well, the regulator said.


PharmaBiz report

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