CORRUPT COMPANIES-OUR HEALTH IS AT RISK
Read the following news from Indian Express patiently if you are really interested in your health.Full news has been copied and pasted below with he full report given by the Singapore Arbitration Tribunal.
The important point is the drug company Ranbaxy was sold to a Japanese company Daiichi.At the time of transaction when it was sold and upto now they coveniently hidden the fact that the company has duped the drug control departments in about 40 countries to get quick approval of some 200 formulations including formulations for AIDS.
When Daiichi came to this fact in the latest development the Ranbaxy ex-owner Mr.Malvender Singh who sold the company cleverfully replied that it is a matter of malpractice by some employees and not by Ranbaxy and is conspired by Pfizer.
Now who ever they conspired against whom it does not matter to us but we the public and our health is under serious danger and conspiracy.
The center of the matter is they gave fraud and duped reports about their formulations in about 40 countries to get quick approvals.Their aim is only to make billions and trillions by putting public health at risk.
Now one kitten has come out but we do not know how many kittens are still in hide.
These big big drug companies like pfizer they have a number of cases against them in USA.
The medical profession has been purely commercialised.Highly bueuarocratic.
The Forensic Law clearly states that high risk medicines,such as sedative,norcotics and those which may affect the normal physiology of the body should not be dispensed on the counter as OTC.
But drug companies are freely advertice their products which are prescription medicines in the newspapers and magazines with attractive images and descriptions which may encourages a person to go for self medication without caution as the advertisement does not mention about its side effects.
Paracetamol a commonly used for fever and headache has liver effects on over usage.How many people knows this.Aspirin if use frequently to a child may precipitate serious Rye's Syndrom in which the baby become gray in colour with serious complications.
Tetracyclines should not be given to a child in growing age as it will affect bone growth.
Please be care with drugs and drug companies.
Should bury data, said Ranbaxy chief when R&D head revealed fudge: Tribunal order
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The Indian Express
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On October 14, 2004, Rajinder
Kumar, head of R&D, presented the Self Assessment Report (SAR) to
the company’s science committee detailing how the pharma giant had
“falsified data” for more than 200 drugs to obtain quick regulatory
approvals from authorities in over 40 countries.Present in the room were chairman Tejendra Khanna; Malvinder Singh, then president of pharmaceuticals and Ranbaxy’s owner; Brian Tempest, Chief Executive Officer (CEO); and top executives.
Khanna, according to Tempest who recalled that meeting at the Singapore arbitration tribunal, “said something to the effect that ‘Ranbaxy should just bury the data.” As reported Thursday, the order implicates the Ranbaxy top brass in a range of alleged irregularities.
Apparently frustrated at how the top management had responded to his findings, Kumar resigned the next day. Seven months later, in a letter to the management, he put on record some of the responses at the meeting: One board member (said): “Can we bury the data.” Falsification of data, said another senior Ranbaxy executive, only happened with few products and everyone did it.
Chairman Khanna quit the board three years later and was appointed by the UPA government as Lieutenant Governor of Delhi.
Significantly, the minutes of this crucial science committee meeting — circulated internally — made no mention of the SAR or of any board member’s response to the document.
In his letter on April 20, 2005, Kumar expressed his disappointment with the Ranbaxy management and, referring to the October 14 meeting, said that he had presented a plan to resolve the SAR issues.
READ | How Ranbaxy ‘buried info on fraud, duped its owners’
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When contacted by The Indian
Express, Khanna said: “The statement supposedly attributed to me by Dr
Brian Tempest is completely denied. I always stood for complete and
unfailing compliance with all regulatory requirements and emphasised
that Ranbaxy should maintain an impeccable and zero tolerance record in
such matters. In my Chairman’s messages which can be seen from published
Annual Reports of the Company, there were unequivocal exhortations to
maintain highest standards of quality assurance and regulatory
compliance”.Tempest did not reply to an emailed query from The Indian Express.
The tribunal fined Malvinder Singh and his brother Shivinder Singh Rs 3,500 crore for defrauding Daiichi Sankyo by “deliberately” withholding information about the SAR and its significance from the Japanese pharma company. Daiichi had purchased a majority stake in Ranbaxy from the Singh brothers and for Rs 19,804 crore on November, 2008.
The tribunal noted that SAR, which was forwarded to the US Food and Drug Administration by Kumar’s principal assistant Dinesh Thakur in 2005, was the basis of investigations by USFDA and the US Department of Justice. It culminated with Ranbaxy, under Daiichi, paying $500 m to the DOJ in 2013.
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Internal emails exchanged between Tsutomu Une, Ranbaxy Board chairman and Daiichi Sankyo’s points person in India, and Daiichi’s consultant Dick Van Duyne also reinforce the tribunal’s indictment.
On November 19, 2009, according to the tribunal, well over a year after Daiichi acquired Ranbaxy, Une commented that the DOJ had a “smoking gun” (a reference to the SAR) that could have, according to his diary entry for that day, created a “high possibility of a criminal penalty”.
In due course, this and Une’s other diary entries had a central role in the indictment.
Une’s email to Daiichi’s consultant Duyne noted that “the bad thing is the involvement of top management in the current compliance issues are identified”. He also recorded that he had come to know that Ranbaxy “management wanted the evidence destroyed”.
Van Duyne wanted to know who was this “top” management. Une replied: “The in-house email communications before 2006 has been provided by the whisperer...and DOJ found out that R’s (Ranbaxy’s) auditor as well as outside auditor cautioned to the Board members the issues which are exactly the same reasons as those relevant to the AIP (Application Integrity Policy).”
The FDA had invoked AIP which effectively suspended all new or pending applications or supplemental applications for drug approval against Ranbaxy on February, 2009.
Une added: “Furthermore, Dr Tempest and MS (an apparent reference to Malvinder Singh) ordered to break all the documents relating to the issues.This is the reason why the cases could be criminal even (though) no patients was (sic) harmed by the products. Also this is why FDA insists the issues caused by the corporate culture.”
RHC Holding, where Malvinder and Shivinder Singh are the promoters, was asked specifically by The Indian Express about this statement of Une talking about Malvinder Singh asking to “break (discarding) the documents.” The company replied: “The matter is sub judice and we cannot offer any comment in view of the confidentiality requirements.” Une, who is still with Daiichi Sankyo, did not respond to queries from The Indian Express.
Consider the salient points made in the arbitration order:
# SAR listed more than 200 drugs, including antiretroviral drugs for AIDS patients, where Ranbaxy is alleged to have used fabricated data to get approvals from authorities of more than 40 countries.
# Daiichi did not have a clue about SAR because Ranbaxy top brass withheld the report and its significance. The top brass named in the tribunal’s order include former owner and CEO Malvinder Singh, former COO Atul Sobti (who became CEO after Singh left the company in May 2009), former executive director of regulatory affairs Abha Pant, Ranbaxy’s General Counsel and senior Vice President of Global Intellectual Property Jay Deshmukh and his successor Lavesh Samtani. (Malvinder Singh’s brother Shivinder Singh was a non-executive director and was said to be not involved in the day to day affairs)
# Even Sanjeev Puri, Malvinder Singh’s then personal attorney, and V K Kaul, Malvinder Singh’s close family friend who was Ranbaxy’s independent director until late 2008, were also well aware of the SAR’s significance. Both were in touch with Daiichi Sankyo though the entire duration of the sale process and the subsequent handholding phase but did not reveal anything about it to the new owners.
# Had it not been for the SAR, the fine for Ranbaxy’s alleged violations of Current Good Manufacturing Practice (cGMP) violations, would not have been beyond $100 million — the cGMP regulations for drugs and biological products stipulate certain minimum requirements that must be met for the methods, facilities, and controls used in manufacturing, processing and packaging.
# That Daiichi was unaware of the fraud is evident in the fact that even after it took control of the Ranbaxy board in December 2008, Malvinder Singh was allowed to continue as the CEO till May 2009. That’s the year Daiichi forced him to step down for “incompetence”, rather than “dishonesty”. It was only in November 2009, that Daiichi came to know of SAR and its significance, and its impact on the US regulatory investigations on the company.
# In deal talks in 2007-08, Malvinder Singh and his team told Daiichi, in “carefully crafted language,” that the DOJ investigations were merely a “fishing expedition.” That it could only implicate some employees and not Ranbaxy, that it was a conspiracy initiated by its competitor Pfizer. These were not “honest answers.” And Malvinder Singh and his team knew that these were not accurate and “which they knew would provide the claimant with the comfort to enter the share purchase and share subscription agreement.”
Malvinder Singh’s stance changed during the arbitration hearing: he first claimed that he “did not know” about the SAR but later claimed that he did not regard the SAR as important to the ongoing FDA and DOJ investigations and therefore there was no reason to mention it to Daiichi. “His adherence to his position at the hearing undermined his overall credibility in the eyes of the tribunal and leads it to conclude that he must have taken a conscious decision not to inform Daiichi”, the tribunal said.
Ironically, midway through the Singapore tribunal hearing, the Singh brothers said that documents disclosed to Daiichi Sankyo before the signing of share purchase deal — which happened in June, 2008 — had given them enough “cause” to be concerned that Ranbaxy was a “corrupt’ organisation. Therefore, the brothers claimed that despite the assurance of Malvinder Singh and his team, Daiichi Sankyo ought to have been aware of such “corrupt” concerns but had decided to ignore them and proceed with the acquisition.
Tearing this apart, the tribunal made it clear that it “is not an attractive argument for the Singh brothers to make, especially in circumstances where they simultaneously have argued that no false representation were made”.
The Indian Express contacted key players indicted in the Singapore order
“The matter is sub judice and we cannot offer any comment in view of the confidentiality requirements.” The brothers have a majority shareholding in RHC Holding, a private limited company with assets of over Rs 10,000 crore. Listed companies such as Fortis Healthcare and Religare, and unlisted companies including SRL Diagnostics and Fortis Healthworld, are controlled through RHC Holding.
Jay Deshmukh, who was Ranbaxy’s then General Counsel: “Everything I did or did not do in dealing with Daiichi Sankyo (DS) at the time of the merger was pursuant to the express instructions of Malvinder Singh (who I reported to) — I objected to those instructions at the time, but felt I had no choice. I urged the management and Mr Singh to remedy the problems and to tell DS (Daiichi Sankyo) the truth, but he refused. Since leaving Ranbaxy, I have done everything in my power to remedy the situation.” Deshmukh is in Washington as partner at a California-based law firm.
Abha Pant resigned in 2011 as Vice President, Regulatory Affairs. “I am not aware of what is written in the tribunal and would not comment on anything till I see what you are referring to you.”
Rajinder Kumar, who was the Head, Research and Development, Ranbaxy in 2004, did not reply to the emailed queries. Kumar resigned a day after he presented the SAR to the Ranbaxy management on October 15, 2004. Kumar currently is President and chief medical officer of Vitas Pharma. He works from the company’s British office.
Mails sent to Daiichi Sankyo did not elicit a response. Atul Sobti, who resigned as the CEO of Ranbaxy in August 2010, did not respond to the emailed queries. Lavesh Samtani, who became Ranbaxy’s de facto General Counsel once Deshmukh left the company in March, 2009, did not respond to the emailed queries. He is currently the General Counsel and Executive Vice-President (Business Development) of New Jersey based pharma company BionPharma. The newspaper could not get in touch with V K Kaul and Sanjeev Puri.
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