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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
Major hospitals could tell doctors not to prescribe Ranbaxy drugs
After the US and Indian authorities, the medicines manufactured by Ranbaxy Laboratories are now under the scanner of hospitals, too. Mumbai's leading Jaslok Hospital has already put up a notice advising its doctors to avoid prescribing Ranbaxy drugs, while some others are reviewing the matter.
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Ranbaxy got FDA raps on US facilities under Daiichi, too
The operational issues between the US drug regulator and Ranbaxy Laboratories do not seem to have been limited to its Indian facilities and the term of its former promoters.
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D G Shah | Indian pharma's generic challenge
The following two quotes from the United States Food and Drug Administration (FDA) news releases may help put the Ranbaxy controversy in perspective. The first sums up what it is that drives the FDA and the second is typical of the challenge the pharmaceutical industry faces.
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(The author is Secretary General of the Indian Pharmaceutical Alliance, which comprises 18 leading Indian companies engaged in R&D)
Armed with whistle-blower policy, Ranbaxy to look ahead
Trouble-hit Ranbaxy Laboratories has introduced a whistle-blower policy within the company to encourage transparency and address concerns internally, so that bigger problems could be averted.
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I can stand behind every pill: Ranbaxy CEO
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D G Shah | Indian pharma's generic challenge
The following two quotes from the United States Food and Drug Administration (FDA) news releases may help put the Ranbaxy controversy in perspective. The first sums up what it is that drives the FDA and the second is typical of the challenge the pharmaceutical industry faces.
Click here to read full column
(The author is Secretary General of the Indian Pharmaceutical Alliance, which comprises 18 leading Indian companies engaged in R&D)
Armed with whistle-blower policy, Ranbaxy to look ahead
Trouble-hit Ranbaxy Laboratories has introduced a whistle-blower policy within the company to encourage transparency and address concerns internally, so that bigger problems could be averted.
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I can stand behind every pill: Ranbaxy CEO
Drug maker Ranbaxy Laboratories, which recently pleaded guilty of making fraudulent statements to the US Food and Drugs Administration (US FDA) and agreed to pay $500 million as penalty, now believes the worst is over and it is set to make a new beginning by re-establishing credibility among all its stakeholders and customers.
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Weekend Ruminations | TN Ninan: a country for scandal?
The truth, as recent events have brought home forcefully, is that corruption has permeated fields that have nothing to do with politics and government.
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Kiran Mazumdar Shaw | Ranbaxy a wake-up call for Indian pharma
India has been a front runner in the global generic market and has earned a strong reputation as a reliable provider of good quality, affordable treatment options for patients the world over. This one incident of quality and regulatory non-compliance by Ranbaxy has the potential of eroding the high credibility that the Indian pharma industry enjoys.
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(The writer is Chairman and Managing Director, Biocon)
Weekend Special | Search for remedies
Who caused the fiasco at Ranbaxy that threatens to tarnish the reputation of the entire Indian pharmaceutical industry?
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Crucial board meeting in Thakur's testimony goes missing
The crucial “closed-door meeting of the board of directors” referred to by whistleblower Dinesh Thakur in his testimony against Ranbaxy didn’t take place at all, if one goes by Ranbaxy’s official filings.
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Ranbaxy cloud hasn't affected sales
Chemists and pharmacists continue to sell its medicines and doctors prescribe these irrespective of the recent developments. Medical practitioners feel the issues around quality raised some years earlier had been rectified and aren’t a risk to health.
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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”.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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Ranbaxy's $500 mn outflow already factored in: analysts
Say company will now be able to focus on improving its core business
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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.
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Ranbaxy’s US troubles
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2006: US Food and Drug Administration (FDA) inspectors note allegations about Ranbaxy’s practices
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2007: Whistle-blower’s lawsuit alleges the company defrauded Federal programmes
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2008: Ranbaxy’s three facilities — at Paonta Sahib and Batamandi (Himachal Pradesh) and Dewas (in Madhya Pradesh) — come under FDA’s scrutiny
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December 2011: Ranbaxy sets aside $500 million to resolve potential criminal and civil liabilities
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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
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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
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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
