After US, India to probe Ranbaxy's documents

Health ministry tells DCGI to examine past dossiers, drug applications

In what could be the beginning of fresh troubles for Ranbaxy Laboratories, which has just managed to settle long-pending issues with the US Department of Justice after agreeing to pay a penalty of $500 million, the health ministry in India, too, has decided to initiate a probe.

The Drugs Controller General of India (DCGI) had been ordered to examine all the dossiers and drug applications on the basis of which approvals had been granted to Ranbaxy in the past, a ministry source in know of the developments said. The future course of action would be decided after DCGI’s report, expected to come within a month.

“We have to look at the whole thing very comprehensively. DCGI has been asked to go through the US order in detail and then examine the documents, dossiers and approvals to Ranbaxy in India. The regulator will evaluate all documents to see whether there has been any compromise in safety, quality, efficacy, or even in submitting data for seeking approvals,” the source told Business Standard. Top DCGI officials confirmed the move.

All the officials spoken to said Ranbaxy could face severe penalty under the Drugs and Cosmetics Act if it was found guilty of violation of any provision under Indian law.

An email query sent to Ranbaxy did not elicit any response.

According to the health ministry source, the drug regulator will initially study the US court’s order and the report of the US Food and Drug Administration (FDA) and examine the period under their review — primarily pre-2005 — in the Indian context. However, DCGI officials said the probe might be extended, if required. “We can look at records even beyond that period. We will certainly look at approvals in the recent years to ascertain that the drugs currently available in the market are safe and efficacious,” a top DCGI official said.

During its 2006 and 2008 inspections of Ranbaxy’s manufacturing facilities in India, US FDA had found violations, incomplete testing records and inadequate stability programme, and manufacturing practices that did not follow regulations. Ranbaxy, then a promoter-run company with a majority stake held by Malvinder Mohan Singh and family, was acquired by Japanese drug major Daiichi Sankyo in 2008. Singh, who continued as the company’s CEO & MD even after the acquisition, finally stepped down in May 2009.

The officials said the regulator might seek additional documents and information from Ranbaxy, as well as people involved in the probe of the matter, to ascertain no wrongdoing had taken place in India

An e–mail query sent to Ranbaxy did not elicit any response.

Early last week, Ranbaxy, which pleaded guilty to making fraudulent statements to the US FDA about how it tested drugs at two of its Indian plants, agreed to pay a criminal fine and forfeiture totalling $150 million and to settle civil claims for $350 million in order to resolve fraud allegations made in a whistle-blower's lawsuit and federal criminal charges.

This is the largest false claims case involving a generics drugs manufacturer in the US. Ranbaxy, in papers filed in Federal court in Baltimore, admitted it had sold batches of drugs that were improperly manufactured, stored and tested.

The generic drugs at issue were manufactured at Ranbaxy's facilities in Paonta Sahib and Dewas, India. They include acne drug Sotret, epilepsy and nerve pain drug gabapentin, and antibiotic ciprofloxacin.
AN AILING DRUG MAKER?

• 2006: US FDA notes allegations about Ranbaxy’s practices
• 2007: Whistle-blower’s lawsuit alleges the company defrauded Federal programmes
• Jun 2008: Daiichi Sankyo acquires a majority stake in Ranbaxy
• Sep 2008: Ranbaxy’s three facilities — at Paonta Sahib, Batamandi and Dewas — come under FDA’s lens; 30 drugs from Indian facilities banned
• Dec 2011: Ranbaxy sets aside $500 million to resolve potential criminal and civil liabilities
• Dec 2011: Ranbaxy signs a consent decree with the US authorities, putting to end the regulatory tussle; but it still can’t make drugs at the three Indian units, besides an American one, for the US market
• Jan 2012: Company reaches a settlement agreement with FDA; agrees to stop making drugs for the US market at two plants until these were brought up to US standards
• May 2012: Ranbaxy hires two US-based consultants to advise it on remedial work at its manufacturing units in India
• May 13, 2013: Criminal charges filed