Indian regulators have released a document alerting domestic pharmaceutical companies and foreign pharmaceutical companies to a scam targeted at Indian drug companies. State officials and foreign regulators have been alerted as well.
The scam was brought to the attention of the Indian government last month when an individual claiming to be from the FDA approached a homoeopathic company’s manufacturing facility. The individual asked to inspect the company’s exports process, and claimed that there would be a 26,000 rupee cash fee (418 US dollars) required for FDA approval.
The company contacted the Indian state of Gujarat’s Food and Drugs Control Administration (GFDCA). GFDCA’s commissioner, H.F. Koshia, released a statement on the matter, “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.”
The scams have come to light as the US federal government has pressured India to increase the standards of its drugs. Multinational pharmaceutical companies have lobbied the US for a stronger stance against Indian regulators, which many believe allow production of lower quality products. FDA Commissioner Margaret Hamburg is currently visiting India in an attempt to create greater balance between US FDA standards and Indian standards for pharmaceutical companies. There have been no official agreements made on US policy toward Indian pharmaceuticals imports, however, US pressure on Indian regulators is said to be strong.