When US regulators raised concerns during their visit to a factory operated by Ranbaxy, the Indian generic drugs group, no one involved imagined that their inquiry would last so long, become so public or raise the stakes so high.
Since an inspection by the Food & Drug Administration (FDA) at the Paonta Sahib plant in February 2006, there has been a drawn-out battle for extra information, triggering raids and subpoenas last year from the Department of Justice.
But it was only in the past few days, after the US attorney's office for Maryland filed a court motion to force disclosure of more internal documents from Ranbaxy, that unusually detailed claims have emerged.
The filing alleges "a pattern of systemic fraudulent conduct, including submissions by Ranbaxy to the FDA that contain false and fabricated information . . . failure to timely report the distribution of drugs that were out of specification and attempts to conceal violations of good manufacturing practices".
The accusations could have great impact. In the US alone, Ranbaxy last year reported sales of generic drugs of $390m. It has been an important supplier of antiretroviral medicines to treat HIV patients in the developing world via Pepfar, the US government's Aids programme. It has ambitious plans elsewhere.
Ranbaxy, which stresses it is fully co-operating with the authorities, calls the claims "baseless". It adds that samples of its products have been independently tested and found to be compliant. No charges have been filed against the company.
The spat comes at a time of heightened public concern over drug quality following the discovery in the US at the start of this year of life-threatening substandard Heparin, a blood thinner, in which contamination in raw materials supplied from China was found.
The saga highlighted the difficulties for US regulators to accelerate their capacity to conduct foreign inspections to keep pace with the jump in the purchase of raw materials and manufactured drugs coming from Asia.
For Ranbaxy, the timing is sensitive; last month,Daiichi-Sankyo of Japan announced its intention to buy control of Ranbaxy for up to $4.6bn as part of a process diversifying from its traditional innovative medicines base into the generic drug sector.
News of the US probe has depressed both companies' share price on fears the deal could be called off - a suggestion firmly denied by both groups.
The allegations are not the first concerns involving the company. In 2004, it and Cipla, another Indian generics producer, withdrew antiretroviral medicines for HIV after inspections by the World Health Organisation identified "serious discrepancies" in clinical tests conducted by a common third-party contractor.
But the storm may prove overblown. Inspections constantly raise concerns in western innovative companies as well as generic companies, but details are rarely made public.
Stripped of the aggressive language in the Department of Justice's motion, the FDA's inspection report highlighted sloppy procedures at Ranbaxy and inadequate records to audit its processes, but did not prove that substandard drugs liable to harm patients were being produced.
Whatever the outcome, the case highlights two broader issues concerning quality of medicines. The first is that even good manufacturing practice" inspections such as the FDA's only examine procedures in place at the time of a spot check. There is a case for more frequent follow-ups, and regular testing of batches of medicines delivered to ensure they meet quality standards.
Second, in countries such as India, with a large and vibrant generic drugs sector, there are often different standards for drugs manufactured for domestic use, and those destined for export which are subject to far tougher regulatory scrutiny. Convergence of the two will be an area of increasing attention.
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