Indian Regulators Warn Pharmaceutical Companies Of Fake FDA Officials Demanding Cash Payments For Approvals

 @SnehaShankar30 on February 19 2014 2:57 AM
drugs
Glenmark has issued a recall for its generic ulcer drug sold in the U.S. Reuters/Srdjan Zivulovic

Regulators in the western Indian state of Gujarat sent a note on Wednesday to both Indian and foreign pharmaceutical companies operating in the country, warning them to beware of a scam involving people posing as U.S. Food and Drugs Administration, or FDA, officials.

A local pharmaceutical industry news website reported Tuesday that a homoeopathic company’s manufacturing facility was approached by a person last month claiming to be from the FDA, and asking to inspect the company’s export-registration process. During the meeting, he let the company know that an FDA approval was in the works and that the company would have to pay 26,000 rupees ($418) in cash to complete the process. The demand for a cash payment made the company suspicious and led it to alert the Gujarat Food and Drugs Control Administration, or GFDCA, of a possible scam.

“We would like to caution all the manufacturers that no regulatory agency ever demands money in the form of cash, especially for approval and registration purposes. It has come to our notice that more companies have been targeted and falling prey to such scams,” H.G. Koshia, GFDCA's commissioner said, according to Pharmabiz. The department also reportedly has posted a warning on its website about such incidents along with a photograph of an authentic FDCA official responsible for the administration's licensing portal.

Meanwhile, FDA Commissioner Margaret Hamburg, who is on a visit to India, is trying to draw a balance between standards required by the FDA and the manufacturing standards of Indian companies. Recent reports had also stated that Indian drug regulators would accompany FDA investigators on visits to local drug manufacturing units in the country to get a better understanding of the FDA's quality requirements.

Join the Discussion