New Delhi: The US government has offered to withdraw a motion seeking to force Ranbaxy Laboratories Ltd, India’s largest drug maker, to turn over audit reports and other documents if the almost 500,000 pages submitted last week are found to be complete.
‘The Economic Times’ had first reported on the development in a page one story published on Thursday.
The US government asked to have until 6 October to review the materials from Ranbaxy, according to a filing to the district court of Maryland, southern division. “Upon confirmation that the production is complete, or if not, that a supplemental production will be forthcoming, the government will withdraw the motion,” the filing said. The motion will be reopened if the government decides that Ranbaxy improperly withheld any “responsive, non-privileged documents,” the government said in the filing. The US is probing whether Ranbaxy, based in Gurgaon, near New Delhi, destroyed reports it was required to keep, falsified data and failed to meet quality control specifications in manufacturing the generic drugs it sells. Ranbaxy has denied the allegations and agreed to produce all the documents.
Under review: Ranbaxy’s Malvinder Mohan Singh. The US is probing whether the firm destroyed records it was required to keep. Ramesh Pathania / Mint
Separately, the US drug regulator had on 16 September blocked the sale of more than 30 generic medicines made in two factories by Ranbaxy, because of deficiencies in manufacturing processes. The US Food and Drug Administration said there was no evidence that Ranbaxy’s drugs were harmful.
(Staff Writer contributed to this story.)