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Journalism of Courage
A US Congressional Committee is set to launch an investigation into the US Food and Drugs Administration (USFDA) handling of allegations against India’s second largest drug company. Ranbaxy Laboratories Ltd, which has a turnover of Rs 1,075 crore, has been accused of selling potentially adulterated drugs. The pharmaceutical major has already come under the purview of the USFDA and the US Department of Justice (DoJ) for allegedly filing false papers and fraudulent practices.
US newspaper Star-Ledger had reported on Thursday that the Congressional Committee’s inquiry was to find whether the USFDA knowingly approved unsafe and ineffective medicines manufactured by the Gurgaon-headquartered company. It quoted John Dingell, chairman of the US House Energy and Commerce Committee, as saying: “If these allegations are true, Ranbaxy has imperiled the safety of Americans… I would like to know whether FDA officials knew about these allegations and what, if any, action was taken.”
According to the report, the House committee is set to examine the approvals given to Ranbaxy drugs and potential violation of manufacturing regulations. It also states that the committee will also look at as to why the FDA continued to approve medicines made by Ranbaxy while at the same time questioning its manufacturing practices.
When contacted, a Ranbaxy spokesperson said they were neither aware of any US Congressional Committee inquiry nor have received any communication to that effect. “All Ranbaxy plants were current good manufacturing practices (CGMP) compliant and is producing medicine that meets global norms,” he said.
Ranbaxy maintains that it shall continue to fully cooperate with the USFDA and the US of Department of Justice (DoJ) in all respects.
Ranbaxy shares, which gained 15 per cent on Wednesday, erased early gains and fell nearly 4 per cent to Rs 452.20.
The malady
•Ranbaxy has already come under the purview of the USFDA for allegedly filing false papers and fraudulent practices
•Congressional Committee to inquire whether the USFDA knowingly approved unsafe and ineffective medicines manufactured by Ranbaxy
•Company spokesperson says Ranbaxy neither aware of any US Congressional Committee inquiry nor has it received any communication to that effect
