US sues Ranbaxy for forging clinical data

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US sues Ranbaxy for forging clinical data

P B Jayakumar / Mumbai July 13, 2008, 0:29 IST

Pharma major denies charges, to file response tomorrow.

The US government has filed a suit against Ranbaxy Laboratories,

India's largest pharmaceutical company, and its US-based consultant

Parexel Consulting for concealing and forging crucial data to get a

favourable judgement on an ongoing investigation into the sale of sub-

standard drugs in that country.

The suit, filed with the District Court of land, has sought a

direction to Ranbaxy and Parexel to submit all relevant documents for

verification.

If proved, the allegations could have a serious impact on Ranbaxy's

US operations that contributed 23 per cent to the company's total

turnover of over Rs 6,000 crore.

When contacted, a Ranbaxy spokesperson said " a motion has been filed

(not granted) seeking certain documents and no legal proceedings in

the sense of a prosecution have been started. Ranbaxy strongly denies

the allegations contained in the motion. Meanwhile, we continue to co-

operate with the inquiry. "

He said the allegations of " systematic fraudulent conduct' about

drugs manufactured in the company's plant in India " are baseless as

the US FDA has verified over 200 random samples of various products

marketed by the company in the US and all were found to be complying

with all the specifications as per the filing.

Ranbaxy said it would file its response to the court on July 14.

According to the US court document, the investigation involves

allegations of conspiracy, false statements and fraud relating to the

health care benefit programme of the US Government and failure to

maintain quality control systems and records at Ranbaxy's

manufacturing facilities in India.

The US Department of Justice is also investigating whether Ranbaxy

committed " contract fraud and submitted false claims to Federal

health benefit programmes, fabricated bio-equivalence and stability

data (necessary to prove efficacy of a drug) to support marketing

applications filed with the US drug regulator for selling generic

drugs in the US and for supply of generic HIV/AIDS drugs under the US

President's Emergency Plan for AIDS Relief (PEPFAR) " .

The investigation stems from an FDA inspection of Ranbaxy's

facilities at Panota Sahib in June 2006, where it found discrepancies

in manufacturing processes and maintanence of data. In this

connection, the federal agents had raided Ranbaxy's US office last

year.

Ranbaxy and Parexel Consulting, which was appointed by Ranbaxy to

rectify the defects, have been charged with withholding and forging

crucial information from the regulator to get clearance for further

manufacturing of drugs at its Panota Sahib facility.

The outstanding documents demanded by the agency include two specific

draft standard operating procedures (SoPs), details on the Toansa

plant and the API facilities of Panota sahib, validation protocals

and reports for two products, and certain quality control procedures,

detailed by the consultant.

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