Friday, 24 May 2013

Complete Coverage | Ranbaxy: in need of a booster dose - Business Standard

Three months after Daiichi Sankyo, Japan's number three drugmaker, entered a deal in June 2008 to buy 63.9% stake in Ranbaxy from the controlling shareholder group led by brothers Malvinder Singh and Shivinder Singh for $4.2 billion, the USFDA issued import alerts and banned 30 Ranbaxy drugs being supplied from its Indian facilities to the US.

Although the deal was concluded in November 2008, two months after the USFDA action, it was perhaps too late for Daiichi to exit. Ranbaxy, as Daiichi has claimed now, had covered up the regulatory investigations at the time of the deal.

Recently, the issue came under spotlight when Ranbaxy pleaded guilty to felony charges related to drug safety and agreed to pay $500 million in civil and criminal fines under a settlement with the US Department of Justice.

Former executive of Ranbaxy and whistle blower Dinesh Thakur's suit, alleging fraud by the company, blew the lid off the controversy. Ranbaxy, in papers filed in Federal court in Baltimore, admitted it had sold batches of drugs that were improperly manufactured, stored and tested.

These generic drugs 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.

Now, even the health ministry in India has begun probing the dossiers and drug applications on the basis of which approvals had been granted to Ranbaxy in the past to assess whether there was any compromise on safety of medicine.


Here's a chronology of how Ranbaxy's alleged dubious actions dented India Inc's image



Daiichi was given all updates: Malvinder Singh

Malvinder Mohan Singh, the former Ranbaxy promoter and now executive chairman of Fortis Healthcare, terms Daiichi Sankyo charges as "false and baseless".

Click here to read full interview



Sebi could play a role in Ranbaxy-Daiichi episode

The Securities and Exchange Board of India (Sebi) could probe the company on the basis of possible violations of the takeover code or under laws governing fraudulent trade practices, if it is found Daiichi's claims are true and information was withheld on investigations into Ranbaxy by American authorities, say lawyers.

Click here to read more



For image lift, Daiichi to raise Japanese strength in Ranbaxy

Faced with severe trust deficit, Ranbaxy Laboratories is now struggling to rebuild its image. To ensure compliance and accountability, Daiichi Sankyo, the company's Japanese parent, plans to induct more Japanese executives into Ranbaxy's senior management and executive team in India, sources said.

Click here to read more



Ranbaxy case may take a toll on other Indian drug makers

The tussle between the US Food and Drug Administration (US FDA) and Ranbaxy is likely to hit the plans of Indian pharmaceutical companies of making it big in the US generic drugs market.

Click here to read more



Bhupesh Bhandari  | Ranbaxy's dark chapter

The Ranbaxy affair is one of the darkest chapters of India's business history. The company has admitted it fudged data so that it could launch its products in the United States.

Click here to read full column



Analysis | Ranbaxy: Will it ever recover?

There is no denying the fact that the damage to Ranbaxy's brand is huge and may take a long time, if at all, to be repaired.

Click here to read full article



Daiichi pursuing legal action on ex-shareholders

Daiichi Sankyo, the Japanese parent of Ranbaxy Laboratories, has said it believes that certain shareholders of the Indian company concealed and misrepresented critical information. The company is now pursuing legal remedies.

Click here to read more



Daiichi Sankyo says it was misled over Ranbaxy probes

Japanese drugmaker Daiichi Sankyo Co, which bought control of Ranbaxy" Laboratories in 2008, said it believes unnamed former shareholders of the company hid information regarding US regulatory probes into Ranbaxy.

Click here to read more



Ranbaxy has taken steps to ensure quality control: Sawhney

Drug major Ranbaxy Laboratories today said it has taken several steps in recent years, including investment of $300 million across manufacturing facilities, to ensure safety and efficacy of its products in the global market.

Click here to read more



After US, India to probe Ranbaxy's documents

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.

Click here to read more


Edit | Recovering a reputation


The man who blew the whistle and walked away with $49 mn

Dinesh Thakur, the whistle-blower who put Ranbaxy in the dock, was heading the company's information technology division for research and development (R&D) until eight years ago.

Click here to read more



Ranbaxy's $500 mn outflow already factored in: analysts

Say company will now be able to focus on improving its core business

Click here to read more



Ranbaxy to pay $500 mn to settle US fraud charges

The country's biggest drugmaker, Ranbaxy Laboratories has agreed to pay $500 million (around Rs 2,743 crore) to resolve fraud allegations made in a whistle-blower's lawsuit and federal criminal charges that the company sold adulterated drugs and lied about it to US regulators. This is the largest false claims case involving a generics drugs manufacturer.

Click here to read more


Ranbaxy's US troubles

  • 2006: US Food and Drug Administration (FDA) inspectors note allegations about Ranbaxy's practices
     
  • 2007: Whistle-blower's lawsuit alleges the company defrauded Federal programmes
     
  • 2008: Ranbaxy's three facilities — at Paonta Sahib and Batamandi (Himachal Pradesh) and Dewas (in Madhya Pradesh) — come under FDA's scrutiny
     
  • December 2011: Ranbaxy sets aside $500 million to resolve potential criminal and civil liabilities
     
  • December 2011: Ranbaxy signs a consent decree with the American authorities, putting an end to the regulatory tussle; but Ranbaxy still cannot make drugs at the Paonta Sahib, Batamandi, Dewas and Gloversville, NY, facilities for the US market
     
  • January 2012: Company reaches a settlement agreement with FDA; agrees to stop making drugs for the US market at two plants until these are brought up to US standards
     
  • May 2012: Ranbaxy hires two US-based consultants to advise it on remedial work to be done at its manufacturing units in India
     
  • May 13, 2013: Criminal charges filed


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