Ranbaxy faked test records: US FDA

Says company did it to sell drugs which did not meet quality standards

NEW DELHI: The United States Food and Drugs Administration has filed a complaint against Indian drugmaker Ranbaxy Laboratories Ltd with a local court, saying that the quality of drugs made at one of its domestic plants is poor, according to a person familiar with the matter.

Ranbaxy, however, defended itself saying the court has not initiated any proceedings against the company. “Ranbaxy strongly denies these allegations contained in the motion,” said a company spokesperson.

A motion has been filed, but not granted, with FDA seeking certain documents from Ranbaxy, the spokesperson said. “No legal proceedings have been initiated against Ranbaxy,” said the spokesperson. “We continue to cooperate with the US Department of Justice and we continue to remain committed to providing high-quality generics to the US markets and patients,” he said.

Bloomberg adds: US prosecutors are probing allegations that Ranbaxy faked test data to make it appear that its products met federal quality standards, the Star-Ledger of Newark, New Jersey reported, citing court papers.

Ranbaxy drugs had too little or too much active ingredient or lacked the labelled shelf life and didn’t meet US FDA standards, federal prosecutors said in court papers filed July 3 in US District Court of Maryland, according to the Star-Ledger.

“We’re still working with Food and Drug and the other authorities to resolve any questions,” said Charles Caprariello, a Ranbaxy spokesman at the company’s US operations in Plainsboro, New Jersey, according to the newspaper. “We’ve been conscientious in trying to provide information to the government.”  dnasunday@dnaindia.net