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IN THE SUPREME COURT OF INDIA
ORIGINAL JURISDICTION
Writ Petition (CRL.) OF 2013
IN THE MATTER OF
Manohar Lal Sharma Advocate
S.C.B.L.No.-1 Supreme court of India
New Delhi-01
Residence of 31 Gyangudery
Vrindaban Mathura, U.P. Petitioner
VERSUS
1. UNION OF INDIA
Through Secretary
a. Ministry of Commerce & Industry
Shastry Bhavan , New Delhi 01
b. Ministry of health & welfare
Nirman Bhawan, C-Wing, New Delhi,110001
2. Ranbaxy Laboratories Ltd.
Through CEO and Managing Director
Corporate Office: Plot 90, Sector 32,
Gurgaon -122001 (Haryana), INDIA
Also at 12th Floor, Devika Towers,
6, Nehru Place New Delhi-110019
3. Central Bureau of Investigation
Through Director
Plot no.5-B, 6th floor , CGO Complex
Lodhi Road New Delhi 11,0003 Respondents
Writ petition (PIL) U/ Art.32 & 21 of the
constitution of India read with the Drug and
cosmetic Act of 1940 , PC Act ,92 and
s.320/326/327/420 & 120B of IPC .
To, The Hon’ble Chief Justice of India
And His Companion Judges of
The Supreme Court of India.
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The Petitioner most respectfully Showeth:
1. That Petitioner, citizen of India & by profession an advocate, is filing
present writ petition (PIL) under Art.32 read with Art.21 of the
constitution of India for issuing writ of mandamus/proper writ direction
for the protection of the life of the citizen of India coupler with further
relief for C.B.I. Investigation & prosecution for supplying of forged
medicines in the country and abroad in the interest of justice.
2. That Petitioner has not applied /approached to the respondent for the
relief as prayed for as respondent has issued press note dt.3rd Jun 2013 to
support action of the respondent no.2 indirectly.
3. That Ranbaxy Laboratories Limited is a public company incorporated under
Indian law with headquarters in Gurgaon, India. Ranbaxy, Inc., incorporated in
Delaware, is the United States subsidiary of Ranbaxy Laboratories Limited. Ohm
Laboratories, Inc., incorporated in New Jersey; Ranbaxy Pharmaceuticals, Inc.,
incorporated in Florida; Ranbaxy Laboratories, Inc., incorporated in Delaware;
and Ranbaxy USA, Inc., incorporated in Florida, are all subsidiaries of Ranbaxy,
Inc. At all relevant times, Ranbaxy distributed and sold in the United States
pharmaceutical products that were manufactured at its facilities in Paonta
Sahib, India, and Dewas in India.
4. That following question is also to be decided in the interest of justice:-
a. Whether respondent allow forged medicines to the citizen of India?
b. Whether supply and production of forged medicines is liable to be
stopped or not?
c. Whether producers & suppliers of forged medicines are liable to be
prosecuted or not under IPC?
d. Whether supply of forged medicine is not amount of cold blooded
murder?
5. It is an established investigated comprehensive picture of how one under-
policed and far-flung generics company operated. It is not a tale of cutting
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corners or lax manufacturing practices but one of outright fraud, in which
the company knowingly sold substandard drugs around the world,
including in India , Africa and U.S.A. while working to deceive regulators.
The impact on patients will likely never be known. But it is clear that
millions of people worldwide got medicine of dubious quality from
Ranbaxy and suffered for their life which is a heinous crime.
6. Today's global market for generic drugs is $242 billion and growing. In
India millions of innocent peoples are victims of the fraud of forged
medicines supplied by the Ranbaxy. In America American have embraced
generics as a vital way to control costs, a trend likely only to accelerate as
health reform extends treatment to millions and their population ages
similarly in India.
7. The USA FDA has increased its inspections of foreign plants in recent
years with a goal of reaching parity with the frequency of domestic
inspections. It now has agents based in India and other countries. Even if
the frequency were equal, the inspections themselves are not. Due to
complex logistics, foreign inspections can last less than a week and allow
companies weeks of advance notice, while domestic ones can last up to six
weeks and are unannounced. "The reality is that we simply don't know
what we're dealing with," says Dr. Roger Bate, an international
pharmaceutical expert. "No one has actually gone into these sites to expose
what's going on."
a. In the late 1980s several generic-drug companies were caught
fabricating data and bribing FDA officials to gain approval. In the
scandal's wake, the FDA tightened regulations. It required that a
company make three large "exhibit" batches to demonstrate that it
could dramatically scale up its manufacturing, undergo inspection,
and use an independent company to perform bioequivalence tests
before an ANDA was approved. The purpose, says David Nelson,
who exposed the 1980s scandal as a senior investigator for the
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House Energy and Commerce Committee, from which he retired in
2009, was to "prevent the systematic submission of false
information" to get FDA approval.
b. The ANDA offered a lucrative reward for the company that risked
almost certain litigation by first challenging a patent. If successful,
the company got six months of exclusive sales after the patent
lapsed, allowing the generics company to charge up to 80% of the
brand-name price during that period. After that, other generics
companies could jump in, and the price would drop to about 5% of
the original price. Being first was the real jackpot. Consequently,
first-to-file status became such an obsession that generic-drug
company executives camped out in the FDA parking lot to file their
paperwork first.
c. Ranbaxy learned how to game this system, according to former
employees. To hasten the pace of its applications, Ranbaxy
sometimes skipped a crucial intermediate step. Instead of making
three medium-size exhibit batches and testing those for
bioequivalence and stability, as required, Ranbaxy tested earlier
and much smaller research-and-development batches that were
easier to control and less costly to make. In some FDA applications,
it represented these as much larger exhibit batches and presented
the data as proof. And then there was the ultimate shortcut: using
brand-name drugs as stand-ins for its own in bioequivalence
studies.
d. These deceptions greatly accelerated the pace of the company's FDA
applications. They were also a grave public-health breach. Once
Ranbaxy got FDA approval, it leaped straight into making
commercial-size batches without any meaningful dry runs. The test
results on file with the FDA were meaningless, and the drugs
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Ranbaxy was actually selling on the U.S. market were an unknown
quantity, having never been comprehensively tested before.
8. As dependence on generic drugs from Ranbaxy has grown, so have
questions about their oversight and safety. A report by the USA
Government Accountability Office found that in 2009, regulators
inspected only 11% of foreign drug manufacturing plants, while they
inspected 40% of domestic ones. In India all inspection are done upon
paper work and mixed with corruption.
9. That Ranbaxy was the first foreign generics manufacturer to sell drugs in
the U.S. and rose rapidly to become, today, the sixth-largest generic-drug
maker in the country, with more than $1 billion in U.S. sales last year (and
$2.3 billion worldwide). The company, now majority owned by Japanese
drug maker Daiichi Sankyo, sells its products in more than 150 countries
and has 14,600 employees. It is situated at Gurgaon just 20 kilometer
away from Delhi. True facts reveals to the petitioners to file present writ
Petition are as follow:-
10. Since last several years Ranbaxy , has been supplying adulterated /forged
medicines to the citizen of India , Africa, and other countries including the
USA. Upon a written complaint Food and Drug Administration , for Short
FDA, of USA , did investigation, inspected their manufacturing unites at
Ponta sahib and Dewas in India and found that adulterated drugs are
being manufactured in their factory which is not only useless but is also
dangerous to the life of patient. A criminal case , United state v/s
Ranbaxy USA Inc, was filed in the USA court at Atlanta. After detailed
investigation it is found that allegation was correct. Ranbaxy admitted
that they filed false records, statement and declaration. Their medicines
were/are adulterated and not fit for human consumption for treatment
and are dangerous for the life. They agreed to pay $500 million to settle
the claim and also fine. Unfortunately Ranbaxy has been selling their same
adulterated medicines in India since last several years but due to
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corruption and vested interest nothing was disclosed. Not only this even
after USA court declaration and admission about adulterated drugs
respondent no.1 did not take any steps to prohibit/ban upon the Ranbaxy
medicines in India. However Jaslok Hospital of Mumbai has banned upon
all medicines supply by the Ranbaxy.
11. Dr. Rajinder Kumar, Ranbaxy's head of research and development, had
joined the generic-drug company just two months earlier from
GlaxoSmithKline, where he had served as global head of psychiatry for
clinical research and development.
12. Dinesh Thakur , a 35 yeasr old an American-trained engineer and a
naturalized U.S. citizen, had worked at Bristol-Myers Squibb (BMY) in
New Jersey for 10 years. In 2002 a former mentor recruited him to
Ranbaxy by appealing to his native patriotism. So he had moved his wife
and baby son to Gurgaon to join India's largest drugmaker and its first
multinational pharmaceutical company in June 2003. In India, Thakur's
job, as director of research information and project management, was to
impose some order and transparency on the chaotic global pipeline. Even
though Ranbaxy lacked polish, Thakur had no reason to doubt that it
made safe, effective drugs.
13. In May 2004, three months before Thakur embarked on his research, Dr.
Kathy Spreen joined Ranbaxy's U.S. office as executive director of clinical
medicine and pharmacovigilance. A 15-year veteran of Wyeth and
AstraZeneca (AZN), she was there to help launch the company's brand
products division, which planned to create new dosages and formulations
of existing drugs. Spreen envisioned her job as that of a regulatory coach,
to help guide Ranbaxy through the FDA's intricate system.
a. At first, the company's science seemed to exceed her expectations.
She had been on the job a few months and was preparing slides for
a presentation about the company's launch of Riomet, a version of
the diabetes drug Metformin, when she noticed something
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remarkable. The data showing the concentration of Ranbaxy's drug
in the bloodstream appeared to match that of the brand name
perfectly. "Look how good this company is," she remembers
thinking. "The bioequivalence data is super-imposable on the drugs
we are modeling."
b. About a month later, while comparing the data for Sotret, the
company's version of the acne drug Isotretinoin, Spreen found it
similarly super-imposable on the brand-name data. That's when she
began to worry. "If it's too good to be true," she recalls thinking,
"it's probably made up."
c. By definition, data is tricky. Even two batches of the same drug
made by the same company at the same plant under the exact same
conditions will have slight variations. Test results for a similar or
copycat drug made by a different company with a different formula
should look different.
14. In August 2004,Thakur confronted his assignment to investigate possible
fraud at his own company, Thakur gave each of his project managers a
part of the world and asked them to compare Ranbaxy's manufacturing
data against the claims made to regulators. His own efforts began with a
visit to a company regulatory official.
a. Thakur found that the company culture was for management to
dictate the results it wanted and for those beneath to bend the
process to achieve it. He described how Ranbaxy took its greatest
liberties in markets where regulation was weakest and the risk of
discovery was lowest. He acknowledged there was no data
supporting some of Ranbaxy's drug applications in those regions
and that management knew that, according to Thakur. After
initially discouraging him, the official grudgingly directed him to
begin his inquiry with the Africa portfolio.
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15. On the morning of Aug. 18, 2004 Dr. Rajinder Kumar returned previous
day from South Africa having a meeting with government regulators.
Meeting had not gone well. Dinesh Thakur hastily arranged a meeting
with his boss at the offices of the Ranbaxy Laboratories in Gurgaon.
Kumar handed him a letter from the World Health Organization. It
summarized the results of an inspection that WHO had done at Vimta
Laboratories, an Indian company that Ranbaxy hired to administer clinical
tests of its AIDS medicine. The inspection had focused on antiretroviral
(ARV) drugs that Ranbaxy was selling to the South African government to
save the lives of its AIDS-ravaged population. The problem went deeper.
He directed Thakur to put aside his other responsibilities and go through
the company's portfolio -- ultimately, every drug, every market, every
production line -- and uncover the truth about Ranbaxy's testing
practices and where the company's liabilities lay.
a. Thakur left Kumar's office stunned. He returned home that evening
to find his 3-year-old son playing on the front lawn.
“The previous year in India, the boy had developed a serious
ear infection. A pediatrician prescribed Ranbaxy's version of
amoxiclav, a powerful antibiotic. For three scary days, his
son's 102° fever persisted, despite the medicine. Finally, the
pediatrician changed the prescription to the brand-name
antibiotic made by GlaxoSmithKline (GSK). Within a day, his
fever disappeared. Thakur hadn't thought about it much
before. Now he took the boy in his arms and resolved not to
give his family any more Ranbaxy drugs until he knew the
truth.
16. September 2004 Thakur unearthed over the next months formed some of
the most devastating allegations ever made about the conduct of a drug
company. His information would lead Ranbaxy into a multiyear regulatory
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battle with the FDA, and into the crosshairs of a Justice Department
investigation that, almost nine years later, has finally come to a resolution.
a. Company scientists told to Thakur's staff that they were directed to
substitute cheaper, lower-quality ingredients in place of better
ingredients, to manipulate test parameters to accommodate higher
impurities, and even to substitute brand-name drugs in lieu of their
own generics in bioequivalence tests to produce better results.
b. After just 10 days of intensive research, Thakur's team had learned
enough to send preliminary information on the Latin American,
Indian, and the "rest of world" markets to Raj Kumar, who then
compiled the findings into a four-page report for then-CEO Brian
Tempest.
c. It is further revealed that confidential report laid bare systemic
fraud in Ranbaxy's worldwide regulatory filings. It found that "the
majority of products filed in Brazil, Mexico, Middle East, Russia,
Romania, Myanmar, Thailand, Vietnam, Malaysia, African Nations,
have data submitted which did not exist or data from different
products and from different countries ..." The company not only
invented data but also fraudulently mixed and matched data, taking
the best results from manufacturing in one market and presenting it
to regulators elsewhere as data unique to the drugs in their
markets.
d. Sometimes all the data were made up. In India and Latin America,
the report noted the "non-availability" of validation methods,
stability data, and bio-equivalence reports. In short, Ranbaxy had
almost no method whatsoever for validating the content of the
drugs in those markets. The drugs for Brazil were particularly
troubling. The report showed that of the 163 drug products
approved and sold there since 2000, only eight had been fully and
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accurately tested. The rest had been filed with phony data because
they had been only partially tested, or not at all.
e. For its HIV drugs, the report found that Ranbaxy had used
ingredients that failed purity tests and blended them with good
ingredients until the resulting mix met requirements. Such a
mélange could degrade or become toxic far more quickly than drugs
made from the high-quality materials required.
f. In a "private and confidential" e-mail sent to CEO Tempest along
with his report, Kumar noted that "it appears that some of these
issues were apparent over a year ago and I cannot find any
documents which sought to address these concerns or resolve the
issues ..." Kumar emphasized that he could "not allow any
information to be used for any dossier unless fully supported by
data." He made it clear that he planned to follow the law.
17. In 2004 So important was this to the company's business that the
European vice president then went on to make an extraordinary
suggestion to Singh: that CEO Tempest "and yourself have been passing
through the U.K. on a regular basis and I would ask you to in future also
make yourself available for carrying samples back." (Ultimately, another
employee was found to carry those particular samples.)
a. In general, those who carried the drugs for Ranbaxy were given a
letter claiming the products were for research and development and
had no commercial value. This wasn't true. In June 2004, one
executive got stopped by Indian customs with hundred of packs
(worth thousands of dollars) of an antinausea drug, Kytril, that he
hadn't declared. The drugs were seized, according to internal e-
mails. In one, a Ranbaxy executive noted that this was "an illegal
way of bringing the medicine in to India."
b. Ranbaxy CEO Tempest had assured Kumar that the company would
do the right thing. So on an evening in late 2004, several months
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after assigning Thakur to dig up the truth, Kumar found himself
before five members of the scientific committee of the board of
directors, including Tempest and the chairman of the board.
c. Kumar had a PowerPoint presentation of 24 slides. It made clear
that Ranbaxy had lied to regulators and falsified data in every
country examined in the report. "More than 200 products in more
than 40 countries" have "elements of data that were fabricated to
support business needs," the PowerPoint reported. "Business
needs," the report showed, was a euphemism for ways in which
Ranbaxy could minimize cost, maximize profit, and dupe regulators
into approving substandard drugs.
d. No market or type of drug was exempt, including antiretrovirals
purchased by the U.S. and WHO as part of a program to fight HIV
in Africa. In Europe, for example, the company used ingredients
from unapproved sources, invented shelf-life data, tested different
formulations of the drug than the ones it sold, and made
undocumented changes to the manufacturing process.
e. In entire markets -- including Brazil, Kenya, Ethiopia, Uganda,
Egypt, Myanmar, Thailand, Vietnam, Peru, and the Dominican
Republic -- the company had simply not tested the drugs and had
invented all the data. Noting Ranbaxy's agreement to manufacture
brand-name drugs, a slide stated, "We have also put our partners
(Bayer & Merck (MRK) in Mexico and in South Africa) at risk by
using suspect data."
f. Kumar proposed a drastic course: pull all compromised drugs off
the market; repeat all suspect tests; inform regulators of every case
of switched data; and create a process for linking the right data to
the right drugs. As the PowerPoint stated,
g. "A short-term loss of revenue is better than a long-term losing
proposition for the entire business."
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h. Kumar completed the presentation to a silent boardroom. Only one
director, a scientist, showed any surprise about the findings. The
others appeared more astonished by Kumar's declaration that if he
was not given full authority to fix the problems, he would resign.
Within two days of the board meeting, he submitted his resignation:
"… given the serious nature of the issues we discussed," he wrote,
his only choice was to withdraw "gracefully but immediately." He
had been at Ranbaxy less than four months.
18. On Nov. 9, 2004, just days after the board meeting, it appeared to the
outside world that Ranbaxy had made a strong commitment to quality. It
withdrew from the WHO prequalified list all seven of its ARV drugs tested
by Vimta Labs and pledged to retest and resubmit them. The move even
won praise from some AIDS advocates who believed Ranbaxy had tackled
the problem of a rogue contractor, Vimta, head on. But inside the
company, as events would make clear in the following months, the
executives had decided against disclosing any further problems. (In an e-
mail, Vimta's technical director, Harriman Vungal, says the studies it
performed for Ranbaxy were "carried out as required" and "were not
intended for submission outside India. Ranbaxy, on its own, had
submitted to other countries and Vimta was unaware of what was
submitted to WHO or others.")
19. Thakur remained behind. But with Kumar's departure, he had lost his
protection. Three months after the board presentation, the company's
internal auditors arrived at his department for what they called a routine
review. They stayed for 10 weeks, combing through his department's books
and interviewing staff. In late April the company accused him of browsing
porn sites from his office computer.
a. Thakur vehemently denied doing so. Furious, he got his network
administrator to pore through the computer records and found that
the corporate IT department had logged in to his division's servers
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and planted his IP address on several searches, Thakur asserts. On
April 24, 2005, Thakur says, he presented Ranbaxy with evidence of
computer tampering and submitted his resignation.
b. Thakur knew the drugs weren't good. They had high impurities,
degraded easily, and would be useless at best in hot, humid
conditions. They would be taken by the world's poorest patients in
sub-Saharan Africa, who had almost no medical infrastructure and
no recourse for complaints.
20. On Aug.15, 2005 , four months after resigning from the company, Thakur
opened a Yahoo e-mail account and wrote under a pseudonym to top
regulators in the U.S., Britain, the WHO, and Brazil. Posing as a company
scientist and using broken English, he claimed that Ranbaxy was forcing
him to falsify data. He got no reply. The letter was not nearly authoritative
or detailed enough to penetrate the system.
a. Finally he wrote directly to FDA commissioner Lester Crawford and
alleged that Ranbaxy was selling "untested, spurious, ineffective
medication." He added, I "plead with you to put a stop to this
crime."
b. Edwin Rivera-Martinez, then chief of investigations and
preapproval compliance in the FDA's center for drug evaluation and
research, wrote back and asked if Thakur would consent to a
conference call. Thakur had initially hoped to set regulators on the
trail but limit his own involvement. Reluctantly, he agreed.
c. To Thakur, the wrongdoing was black and white. He had given
proof and expected action. But 10 days after the conference call, the
FDA announced that it had approved Ranbaxy's application for the
first pediatric-AIDS drug for the U.S. market, Zidovudine. "Given
all the data you have in your possession today about the criminal
activities of this company in registering ARVs with fabricated data,
I am confused how the USFDA could give such an approval,"
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Thakur wrote to Rivera-Martinez. The bureaucrat wrote back that
because the drug had been approved before Thakur made contact,
only actual proof of fraud could reverse the decision.
21. That in 2005, the applications of 22 high-priority products needed
routine updates in at least one country. All had been made at the Dewas
manufacturing plant south of New Delhi and none had been tested
adequately. "Data is not available for any of the products," the head of the
stability group at Dewas wrote in an e-mail. One executive responsible for
Europe objected strenuously to the filing of false data and wrote to
colleagues, "I do not intend spending a stint in a European prison ..."
a. As part of the new plan, Ranbaxy decided to move all
manufacturing for U.S. drugs and HIV medications for the PEPFAR
program from the troubled Dewas plant to the newer Paonta Sahib
facility in the hope that by severing links to the past fraudulent
manufacturing -- and beginning to submit legitimate data on this
group of drugs -- regulators would not detect the past misbehavior.
22. That on Jan. 8, 2005 Publicly, company executives spun the change as a
response to big American demand. "We have changed the site of
manufacture of the product from Dewas to Paonta Sahib facility to
facilitate handling high business requirements," a Ranbaxy executive
wrote to a Unicef official on Jan. 8, 2005, explaining the shift for an AIDS
drug.
a. But four days later, as the company prepared to resubmit its ARV
data to WHO, the company's HIV project manager reiterated the
point of the company's new strategy in an e-mail, cc'ed to CEO
Tempest. "We have been reasonably successful in keeping WHO
from looking closely at the stability data in the past," the manager
wrote, adding, "The last thing we want is to have another inspection
at Dewas until we fix all the process and validation issues once and
for all."
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23. In January 2006, Malvinder Singh, the founder's grandson,
succeeded Brian Tempest as Ranbaxy's managing director and CEO. At 33,
with an MBA from Duke University, Singh was brash and competitive. The
Indian business press dubbed him the Pharaoh of Pharma, and hailed him
as an "out-of-the-box decision-maker. His biggest problem was the FDA's
decision not to accept new applications from the Paonta Sahib plant.
Ranbaxy desperately needed a green light there.
24. On Feb. 20, 2006 A team of FDA inspectors arrived at Paonta Sahib on
Feb. 20, 2006, and stayed for five days. When they had last visited, in
December 2004, without the benefit of inside information, the result had
been a clean bill of health. This time, they knew where to look, and what
they found was disturbing: Raw data was routinely discarded; the
company's standard operating procedure approved the discarding and
disregarding of data; patient complaints went uninvestigated; and stability
testing was a shambles.
a. During stability testing, drugs are placed in chambers that resemble
big refrigerators that can replicate different climates, and then they
are tested at intervals to see when and how the drugs' ingredients
break down. At Paonta Sahib, inspectors found stability chambers
full of stray drug samples but no logbooks identifying the contents
or the dates of when they were entered or tested. The inspectors
also took and tested samples of Sotret, Ranbaxy's version of the
acne drug Accutane, and found that it degraded far in advance of its
expiration date.
b. The findings were serious. Four months later in a warning letter,
the FDA said that it would not consider any new applications for
drugs made at the site until the company could demonstrate
corrections. But that did nothing to stop all the drugs that were
already on the market, drugs that had been approved, or
applications submitted from other sites. Rivera-Martinez sounded
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almost plaintive when he wrote to Thakur that spring: "We are
under a lot of pressure to approve Ranbaxy's generic version of
Pravastatin [a cholesterol-lowering drug] when the patent
exclusivity runs out this Thursday."
25. November 2006, Mr. Singh led a delegation to FDA headquarters to try to
reverse the decision. Up to that point, the company had hardly been
conciliatory. When FDA inspectors had discovered the standard operating
procedures that allowed for the discarding and disregarding of data,
Ranbaxy blamed semantics. It wrote to the FDA, "We now understand the
negative connotation that these words may have conveyed, but we can
assure you" the company had "never thrown away or ignored" any data.
Ranbaxy even disparaged the agency's science, claiming that FDA test
results showing that Sotret degraded more quickly than stated were due to
the FDA's inaccurate testing method. (Years later, in its 2013 guilty plea,
Ranbaxy would admit that Sotret was one of the adulterated drugs it had
sold.)
a. Singh and his team presented new quality-improvement plans to
skeptical regulators. Unmoved, the regulators refused to lift the stay
and upped the ante, asking Ranbaxy to turn over audits done by its
outside consultant, Parexel, which the company was claiming were
confidential. The meeting ended in a standoff.
26. On Feb. 14, 2007, Vincent Fabiano was at his desk at Ranbaxy's U.S.
headquarters in Princeton, N.J., an FDA criminal investigator enterredc
in office directing Fabiano to step away from his desk as directed. The
building was surrounded by police cars, and panic was spreading. "People
were freaking out, crying," recalls a former employee. "They took every
computer. There were people with guns." Employees called the search
warrant the Great Valentines Day Raid.
a. As the news ricocheted from New Jersey to New Delhi, Ranbaxy
issued a statement: "This action has come as a surprise. The
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company is not aware of any wrongdoing. It is cooperating fully
with officials."
b. Company officials crying for search warrant thereupon statement
came from assistant commissioner that the search warrant did not
relate to drug quality or manufacturing, he assumed the issue was
accounting fraud and put the matter aside. They add "Your first
obligation is to public health."
c. The criminal investigation was humming. Ranbaxy executives were
stopped in transit at American airports and questioned. The U.S.
Attorney's office issued subpoenas, and the FDA tested close to 100
samples of Ranbaxy drugs.
27. On April 13, 2007, Dinesh S. Thakur filed a qui tam action in the United
States District Court for the District of Maryland ("Court") captioned United
States ex ref. Dinesh S. Thakur v. Ranbaxy USA, Inc., et al., Civil Action No.
1:07-009624FM (D. Md.) pursuant to the quitam provisions of the False
Claims Act, 31 U.S.C. § 3730(b) (the "Civil Action").
28. May 2007 Thakur filed confidential complaint in a seal cover under
whistleblower Act describing true facts “how the company fabricated and
falsified data to win FDA approvals”
29. In 2008 the rough outlines of the fraud at Ranbaxy first emerged in the
USA in 2008 a court filing by the Justice Department. But its extent and
depth and the involvement of top company executives have not been
previously revealed. USA FDA/ agency halted the importation of 30
different drugs from two of Ranbaxy's manufacturing plants in India and
invoked a rare Application Integrity Policy, stopping the review of new
drug applications from the Paonta Sahib manufacturing site until Ranbaxy
proved their truthfulness.
30. January 28 - February 12, 2008 FDA Investigators Thomas J. Arista and
Robert D. Tollefsen of USA conducted inspection of manufacturing
Rambaxy unit at Dewas India. The inspection revealed significant
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deviations from U.S. current good manufacturing practice (CGMP)
Regulations (Title 21, Code of Federal Regulations, Parts 210 and 211) in
the manufacture of sterile and non-sterile finished products. In addition,
violations of statutory requirements, Section 501(a)(2)(B) of the Act, were
documented with respect to the manufacturing and control of active
pharmaceutical ingredients (APIs). These CGMP deviations were listed on
an Inspectional Observations (FDA-483) form issued to Dr. T.G.
Chandrashekhar, Vice President Global Quality and Analytical Research,
at the close of the inspection. These deviations cause Ranbaxy drug
products to be adulterated within the meaning of Section 501(a)(2)(B) of
the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C.
351(a)(2)(B)]. Section 501(a)(2)(B) of the Act requires that all drugs be
manufactured, processed, packed, and held in compliance with current
good manufacturing practice.
31. March 3rd to 7th of 2008 FDA of USA conducted another inspection of
manufacturing Ranbaxy unit at Batamandi (Unit-II) in Ponta Sahib and
issued another warning letter to Ranbaxy after inspecting their Batamandi
(Unit-II) in Ponta Sahib during the period of March 3rd to 7th of 2008
disclosing defect serious in manufacturing drug product.
32. On June 11, 2008, Singh stunned the Indian business world by
announcing that he and his brother were selling their 34% stake in
Ranbaxy to the Japanese drugmaker Daiichi Sankyo for $2 billion. Overall,
Daiichi Sankyo shelled out $4.6 billion to take control of the company.
Singh agreed to stay on for five years as CEO.
33. July 2008 , three weeks later, the U.S. Attorney's office in Baltimore filed
a motion in U.S. district court demanding that Ranbaxy hand over the
Parexel audit documents. It alleged that the violations at Paonta Sahib
"continue to result in the introduction of adulterated and misbranded
products into interstate commerce with the intent to defraud or mislead."
19
a. On Capitol Hill, David Nelson was enraged. Despite the FDA's
reassurances to the contrary, the case was all about drug quality.
The FDA had "deceived the committee," he says. Furthermore, if
the drugs were an ongoing threat, why hadn't the FDA stopped
Ranbaxy from selling them?
b. By mid-July, the saga had reached new heights. Congress had
begun investigating the FDA. The inquiry, by the House Energy and
Commerce Committee's subcommittee on oversight and
investigations, focused on the agency's alleged inaction. The new
FDA commissioner at the time, Dr. Andrew von Eschenbach,
defended the agency, explaining that the FDA had not stopped the
drugs because the samples it had tested met specifications. But that
wasn't exactly true. The agency's own testing had shown that Sotret
degraded far more rapidly than the company claimed.
c. Everywhere the FDA had looked, its inspectors found fraud. Four
months earlier, at a unit of Paonta Sahib, agency investigators
discovered that supervisors who had supposedly overseen critical
manufacturing steps weren't even at the plant on the days they
signed off on the tests. "The culture of the company was corrupt to
its core," says Nelson. As congressional investigators turned up the
heat, the agency finally cracked down.
34. In September 2008, it announced it was restricting the import of 30 drug
products made by Ranbaxy (11 of which had been approved after Thakur's
first contact with the FDA three years earlier).
a. Agency still did nothing to recall the very same drugs on pharmacy
shelves all over America, despite finding that Ranbaxy had
committed fraud on a massive scale. Nelson says that under FDA
rules, the agency should have required Ranbaxy to recall every one
of its drugs and resubmit every application.
20
b. The illicit drug runs continued well after the company had pledged
to the FDA that it would operate squarely within regulations. From
2007 to 2008 alone, 17 executives from the New Jersey office took
undeclared drugs through Indian customs, four of them multiple
times, according to a document given to the FDA.
35. On 16th September 2008 issued a warning letter dt. 16th Sept. 2008 to the
Ranbaxy after FDA did inspection of Ranbaxy pharmaceutical
manufacturing facility in Dewas, India by Investigators Thomas J. Arista
and Robert D. Tollefsen during the period of January 28 - February 12,
2008 ..
FDA reviewed the Established Inspection Report (EIR) and
Ranbaxy response dt. April 3, 2008 to the FDA-483
observations. FAD found Ranbaxy response as failure to
adequately address multiple, serious deficiencies. Specific
areas of concern included the following:
Beta –Lactum Continment Control Program
Interim controls for the containment of beta-lactam
antibiotics such as penicillins, cephalosporins, and penems
are inadequate. Specifically:
i. Failure to adequately establish separate or defined areas for
the manufacture and processing of non-penicillin beta-
lactam products to prevent contamination or mix-ups [21
CFR 211.42(c)(5)]. Operations related to the manufacturing,
processing, and packaging of penicillins are not adequately
separated from non-penicillin products [21 CFR 211.42(d)].
1. During the inspection, our investigators observed
inadequate containment practices regarding the
handling and movement of personnel, equipment, and
materials as follows:
21
a. QC personnel move about freely collecting
samples and engaging in other activities (i.e.,
documentation) between the manufacturing
blocks for betalactam (penicillin,
cephalosporin, and penem) and non-beta-
lactam products.
b. Batch production and control records for beta-
lactam (penicillin and cephalosporin) products
were moved from their respective
manufacturing blocks through the campus to
the administration building for storage.
c. Personnel that dispatch and work in the beta-
lactam API warehouses (penicillin and
cephalosporin) move about freely on the
manufacturing campus.
d. Personnel working in the cephalosporin
API [redacted] dispensing area were observed
with powder on their gowns and coming in
direct contact with the outer surface of a bulk
material bag that was then placed on transport
equipment that can enter non-beta-lactam
areas.
e. Operators and transport equipment (i.e.,
forklift) used to convey beta-lactam and non-
beta-lactam materials to their respective
manufacturing blocks on the manufacturing
campus were observed interacting with and in
very close proximity to other personnel that
move about freely on the campus.
22
In your response, you reported that personnel in beta-
lactam dispensing areas are required to decontaminate
their gowns by wiping with [redacted] when powder is
observed on their gowns before leaving the dispensing
booth with bagged material. However, your response
lacked data to ensure that all gown parts can be
adequately decontaminated, and the procedures (SOPs)
provided in your response (attachment #s 16[i] and [ii])
have no instructions on how the operators ensure
adequate decontamination of their gowns. Furthermore,
these SOPs do not provide the wiping steps intended to
render operator gowns, plastic bags, corrugated
cardboard boxes, and other surfaces mentioned in the
SOPs, free of beta-lactam contamination. In your
response to this Warning Letter, please provide an
explanation of this approach, its capacity for robustness,
methods and qualification of the wiping techniques on
the aforementioned materials to ensure decontamination
of beta-lactam residues with the [redacted]. Your
response also failed to address the
decontamination [redacted] effectiveness in neutralizing
beta-lactams on the items that procedures require to be
wiped with [redacted]. The effectiveness of this
neutralizing [redacted] on different materials should be
demonstrated through lab studies.
2. Your containment control and monitoring programs
are inadequate to prevent cross contamination of non-
penicillin pharmaceutical products (APIs and finished
dosage forms) with possible residues of penicillin,
cephalosporin, or penem compounds, as follows:
23
a. The containment monitoring program failed to
include monitoring (surface sampling/testing)
for residual traces of penem (i.e., imipenem)
type betalactams in non-penem manufacturing
blocks [redacted] and [redacted].
b. Surface monitoring (sampling/testing) for
residual traces of penicillin type beta-lactams is
not performed in the Penem Block where
penem sterile parenterals are manufactured or
in Block [redacted] where multiple
cephalosporin finished products are
manufactured.
c. Surface monitoring for residual traces of
cephalosporin type beta-lactams is not
performed in the General Block [redacted]
where multiple non-beta-lactam finished
products are manufactured or in the Penem
Block where sterile parenterals are
manufactured.
d. There was no written documentation reflecting
the decontamination of materials, documents,
and sample containers prior to removal from
the penicillin or cephalosporin manufacturing
blocks through the [redacted]
e. There were no written procedures established
to address decontamination methods with
the [redacted]
f. The containment control program does not
include contingency (corrective action)
procedures when beta-lactam contamination is
24
found exceeding established action levels in the
manufacturing blocks.
ii. Your April 3, 2008 response, although lengthy, raised many
concerns. For example, your response indicates that you are
aware, as reported in your Environmental Control Program
(Attachment 16.d [ii]), that beta-lactam compounds such as
penicillins (i.e., amoxicillin), cephalosporins (i.e., cefaclor,
cefadroxil), and penems (i.e., imipenem) have human
sensitizing and cross-reactivity properties that require
manufacturing controls to prevent cross contamination of
non-penicillin (non-beta-lactams and among beta-lactams)
products in your multi-product manufacturing campus.
However, your procedures lack any sampling of production
areas for traces of penem compounds, and various
production locations were not sampled for the penicillins
and cephalosporins you process.
iii. Furthermore, your response did not include procedures
addressing how to respond to a situation in which beta-
lactams are found in the plant. Containment control program
procedures should include provisions for detecting and
correcting containment deficiencies. Beta-lactam
contamination on surfaces alerts a firm that contamination is
present in the manufacturing environment due to poor
containment practices. This can lead to cross contamination
of pharmaceutical products that were exposed in that
environment. Your procedures should require adequate
investigations to determine the cause of a positive residue
finding and the extent of any contamination. In addition, the
procedures should define the steps to be taken to determine
25
the extent of the contamination and for identifying products
potentially affected if such a breach occurs.
iv. Aside from the above, additional information is needed
regarding the validity of the reported negative test result
findings from the site assessments for residues of penicillins
and cephalosporins performed during July 2006 through
March 2008, as follows:
a. Your response lacked data showing that surface
testing is capable of reflecting true levels of
contamination. The swab surface sampling
recovery studies should establish that a valid
swab sampling technique is in place for
penicillins and cephalosporins on all types of
surface substrate material mentioned in your
firm's reports. Also, the surface recovery
studies should demonstrate recovery of
the [redacted] different types of cephalosporin
compounds processed in Block [redacted].
Your response only provided data on 2 of
the [redacted] products. The sampling
procedures should address sampling from
qualified surfaces. Validation data should show
that surface sampling is capable of reflecting
true levels of contamination and include the
percentage of recovery for each type of surface
sampled. Recovery study results should be
provided in your response.
We are concerned that it could be difficult to
detect beta-lactam contamination on porous
surface materials such as operator gowns,
26
corrugated cardboard boxes, and other types of
materials mentioned in these reports.
Furthermore, the sites identified by your firm
for sampling should be sufficient,
representative, and include worst case areas.
Justification for the selected sampling sites
should be provided in your response.
b. We are concerned about the units reported in
your response letter for sample test results of
air, product and surfaces. For example, the air
samples were reported in surface area
units[redacted] and not in the volume of air
sampled (see response page 51). Product
testing was also reported in surface area
units [redacted] and not in weight, volume
amounts, or dosage type sampled (see response
page 50). The surface sampling was reported
in [redacted] and not [redacted] (see response
page 52). The larger swab sampling area
provides more reliable detection of
contamination. It is important to note that the
purpose of the swabbing program is to detect
low levels of a sensitizing drug in the
environment and sampling smaller areas may
not ensure detection.
c. We are concerned with your justification for
decontaminating an area a month after the
prior site assessment reported no traces of
beta-lactam contamination (see response page
52). For example, this assessment reports that
27
the archival room that stored beta-lactam
batch production records (located in the
Administration block) had no traces of beta-
lactam contamination [Attachments 16a (iii)
through 16a (vi)] in February 2008. However,
your March 2008 reports states that the
archival room was decontaminated and re-
assessed for beta-lactam contamination [see
Attachments 16a (viii) and (ix)].
d. Your response (page 50) indicates that testing
of non-penicillin products for traces of
penicillin or cehalosporin contamination
indicated results below the limit of detection
(e.g.,[redacted] for penicillin). We are
concerned with your response since testing for
residues of beta-lactams in other beta-lactams
usually requires much more sophisticated test
methodology than the [redacted] method you
are currently employing. (We note that you are
using a method similar to FDA's codified
method under 21 CFR 211.176). However, as
reported in your Environmental Control
Program (Attachment 16d (ii)), the codified
method is limited to detection of a few
penicillins in a limited number of products.
Therefore unless you can demonstrate to the
contrary, this method is not appropriate. In
your response to this Warning Letter, please
indicate which products were tested, and
specify whether testing included traces of
28
penicillin residues in cephalosporin products
or cephalosporin residues in penem products
or any other drug products.
e. The Contamination Control and Risk Analysis
provided in your response [Attachment 16d (i)]
failed to address potential contamination
between betalactams to include all the
deficiencies mentioned above under item 1 of
this letter.
Production Records
v. Batch production and control records do not include
complete information relating to the production and control
of each batch produced [21 CFR 211.188(b)] in that:
1. A. Production records failed to document weight or
measure of excipients dispensed and used in
production of non-sterile finished drug products that
are manufactured in the following plants: Semi-
synthetic Penicillin Block ([redacted]-Block), General
Block ([redacted]-Block), and Cephalosporin Block
([redacted]-Block).
2. Production records also lack second person
verification to ensure that the weight or measure of
excipients was correct.
3. Media fill batch production records for sterile finished
products lacked complete information. For example,
records did not document the name or initials of the
individual operators who executed the manufacturing
instructions, nor the individuals who performed the
29
visual inspection of the media filled vials. These media
fill batches were submitted in support of the ANDA.
4. Media fill batch production records for sterile APIs
also were incomplete in that they failed to document
whether the required [redacted] integrity test was
executed. These media fill batches were provided as
supportive information to the ANDA.
vi. Your response only addresses procedural improvements and
discusses some related training. It failed to include an
assessment of all batches shipped to the U.S. market with
production records that lacked documentation of weight or
measure of excipients dispensed in production of non-sterile
finished drug products manufactured in the following plants:
Semisynthetic Penicillin Block [redacted] Block), General
Block[redacted] Block and Cephalosporin
Block [redacted] Block). Our records indicate that batches
produced in Blocks are being shipped to the U.S. market for
distribution. Please provide an assessment or a affected US
batches.
vii. Failure Investigations
Your procedures do not provide for a thorough review of
unexplained discrepancies or failure of a batch or any of its
components to meet its specifications whether or not the
batch has been already distributed [21CFR 211.192].
A. Sterility failures of four sterile API batches were
inadequately investigated, as follows:
1. The investigation failed to confirm the root
cause conclusion that microbes found
in [redacted] water samples were the cause of
30
the contamination, in that these isolates were
not shown (characterized to their genus and
species level) to be related to the batch sterility
failure isolate [redacted].
2. The investigation failed to accurately report
results. The investigation report dated
September 4, 2007 inaccurately states that
isolates from each of the 4 batches were further
identified to their genus and species level.
However the contaminant of one of the API
batches that failed sterility [Batch [redacted]]
was never characterized to genus and species
level.
3. Environmental and personnel monitoring
microbial sample results were not addressed by
the sterility failure investigation reports. We
note that your firm collects numerous samples
with results from personnel, equipment, and
air, from within the sterile API production
area, and identifies these microbes. However,
these data were not assessed or reported and
the failure investigation reports are missing
this testing.
ii. Your response to the FDA 483 observation concerning the
root cause conclusion in the investigation commits to
implementing procedural changes that will address future
sterility failures to ensure full characterization of
investigational isolates. However, your response does not
address how you intend to complete the failure investigation
for the four API batches that failed sterility testing, to ensure
31
the root cause for the failures is identified and appropriate
corrective and preventive measures are implemented. Your
response to the inaccuracy of your records for sterile API
batch [redacted] does not address which controls will be
implemented to ensure completeness and accuracy in
reports. Your response to unreported data in failure
investigation reports also does not address FDA's concern on
the existence of unreported data associated with the
manufacture of other drug products that may be in the U.S.
market. Please provide this information in your response.
1. …
2. Your rejection of two (2) non-sterile finished product
batches for failing to meet release specifications
for [redacted] was inadequately investigated in that:
a. There were no records identifying assignable
cause, nor implementation of corrective
measures. For example, the investigation
report did not identify any assignable cause or
follow-up measures to determine the cause.
b. Review of the batch production records for the
rejected batches found that the actual weights
or measures of the [redacted] excipient was not
documented in the batch production records of
the two (2) failed batches. This information
was not noted by the failure investigation.
Your response failed to address the reason the actual weight
or measure of the [redacted] excipient was not documented
in batch production records and was not addressed by the
failure investigation reports. The lack of weight or
measurement information in records prevents verification
32
that the correct amounts of excipients were dispensed for the
two failed lots. Additionally, your April 3, 2008, response
indicates that the Quality Assurance Unit will complete a
review of other investigation reports lacking root cause and
response action, and supplement these reports if necessary
by April 30, 2008. Please provide this information in your
response to this letter.
viii. Quality Control Unit The Quality Control Unit (QCU) failed
to ensure that its organizational structure, procedures,
processes, resources, and activities are adequate to ensure
that APIs and drug products, sterile and non-sterile, meet
their intended specifications for quality and purity [21 CFR
211.22]. This same issue also applies to APIs produced at this
site.
1. The QCU regularly signs off and approves production
records although the records are incomplete for
weight or measure of excipients used in non-sterile
finished drug products as reported under item 2.A. of
this letter.
2. The QCU failed to evaluate cleaning and sanitizing of
the [redacted]. Additionally, the CU did not evaluate
microbial and non-viable particle ingress from
the [redacted] into the aseptic filling areas where
finished sterile drugs are processed as reported under
item 5.D.2.of this letter.
3. The QCU regularly signs off and approves inadequate
failure investigation reports related to sterility failures
of sterile APIs and rejections of non-sterile drug
products as reported under items 3.A. and 3.B. of this
letter.
33
Furthermore, we are concerned that deviations regarding
inadequate recordkeeping and failure investigations cited on
the current FDA-483 are similar to the deviations from the
previous FDA-483 issued to your site on March 2, 2006. For
example, the previous inspection conducted 2/27 - 3/2/06
resulted in the issuance of a 6-item FDA-483, which included
inadequate failure investigations and lack of controls for
analytical test records and batch production records. It is
evident that your firm has not corrected the documentation
and investigative practices at this site.
The FDA-483 observations and your previous responses
indicate that the Quality Control Unit (QCU) was not
independent and did not properly discharge its quality
assurance and quality control responsibilities. We recognize
the commitments to improve the quality organization in your
response. However, your response failed to address global
corrections to prevent reoccurrence.
ix. Aseptic Operations Procedures designed to prevent
microbiological contamination of drug products and APIs
purported to be sterile are not adequately written and
followed to include adequate validation of the aseptic
process. [21 CFR 211.113(b)]
1. Process simulations (media fills) for sterile API
processes do not simulate actual commercial
production procedures in that the 2005 2006 and
2007 media fills failed to include a media fill with the
operator held [redacted] product loading lines from
the API sterile [redacted] train to the [redacted].
Your response indicates that the revised media fill protocols
now include the loading lines. Your response indicates that the
34
new media fills would be completed by May 15, 2008 in the
API facility, although we have not received further updates on
the conduct and findings of these media fills.
2. Media fills for parenteral (sterile drug products) filling
operations were inadequately performed to qualify
aseptic processes in that documentation failed to
include the specific reasons (assignable cause) filled
vials were removed and not [redacted] during the
media fill operation. The removal and destruction of
filled vials [integral units] can present a bias to the
final media fill results.
Your response indicates that the corrected media fill protocols
and procedures will account (reconciliation) for all filled units
during media fill runs. Your response indicates that the new
media fills would be completed by April 30, 2008 in the
finished dosage facility. However, you have not provided
updates on the latest media fills.
3. Various instances of poor aseptic practices were
observed throughout the manual unloading and
transferring processes of the [redacted] sterile API
during aseptic processing. These include:
a. Production personnel were observed handling
a [redacted] hose without sanitizing its outer
surfaces. The exterior surface of
this [redacted] hose comes in direct contact
with the [redacted] sterile API.
b. Operators were observed handling or touching
various work surfaces, equipment, small stools,
and tables, which were not wiped with
sanitizing[redacted].
35
c. There were no records to document that
the [redacted] door or external surfaces of
the [redacted] are sanitized as required by
procedures.
4. Various instances of poor aseptic practices during
aseptic parenteral filling were also observed during
the manual installation of the [redacted] transfer
tubes, and the [redacted]flowing device as part of the
aseptic transfer of the sterile API (in the [redacted]) to
the finished dosage aseptic filling line. These include:
1. During the aseptic connection of
the [redacted] and electrical connection an
operator was observed coming in direct contact
with the unsanitized [redacted]surfaces of
the [redacted].
2. The aseptic equipment and areas where aseptic
connections were performed were positioned
below the [redacted] and within close
proximity of its[redacted], which were not
cleaned and sanitized, exposing this area to
possible contamination.
3. There is also a contamination risk during
aseptic filling due to the unsanitized equipment
(e.g., possible contamination due to ingress
from access panel and[redacted])
Your response to 5.D.2 above a ears to provide adequate
corrective actions for the cleaning and sanitization of
the [redacted]. However, the lifting of
the [redacted] above, and in close proximity to the filing
line, is unacceptable. This practice promotes ingress of
36
microbial and non-viable contamination. Your response
does not address the effect of the [redacted] position on
the unidirectional airflow and maintenance of
ISO[redacted] conditions during aseptic manual
connections, transfer and filling of sterile product.
5. Utensils and equipment that directly contact sterile
API during transfer and [redacted] of
the[redacted] are inadequate to ensure that these
APIs are maintained sterile and pyrogen-free. For
example:
a. Several pits/holes were observed in the weld at
the end of the large[redacted]. Additionally,
there was a crack observed between the handle
and the end of the large [redacted]. These holes
and crack create a challenge for sterilization of
this [redacted].
b. There were no written standard operating
procedures or records documenting that the
small [redacted] a.k.a., "Product Uniformity
Tool"), that contacts sterile API during
the [redacted] process, was depyrogenated
prior to use.
Your response failed to include the actual depyrogenation
qualification of the Product Uniformity Tool. Provide an
assessment for all utensils and equipment to determine
possible effects of inadequate design for use with sterile
products and a corrective action plan to ensure repair or
replacement with proper design and function.
37
x. The controls to prevent contamination or mix-ups in defined
(critical and supporting clean) areas are deficient regarding
operations related to aseptic processing of drug products [21
CFR 211.42(c)(10)].
1. For parenteral operations, smoke studies were not
conducted to demonstrate unidirectional airflow and
sweeping action over and away from the product
under dynamic conditions during numerous aseptic
operations in classified areas of the vial filling facility.
For example:
1. Various manual operations performed with
the [redacted] such as dispensing sterile
API and connecting equipment to
this [redacted] were not included in smoke
studies.
2. Other significant manual aseptic activities
that can affect airflow, including opening
and closing the fill equipment access panels
during routine aseptic filling operations,
were not evaluated in smoke studies.
3. There was no evaluation performed to
demonstrate that personnel activities (e.g.,
manual transfer of material into or out of
the ISO [redacted] and
ISO[redacted] areas) do not compromise
the unidirectional airflow pattern.
4. There was no evaluation performed to
demonstrate that the horizontal airflow
from the [redacted] does not negatively
38
impact upon the vertical airflow within the
aseptic Willing areas.
Your response indicates that you have prepared a
comprehensive protocol for performing airflow pattern
testing to include all aseptic operations in both the
dispensing and filling areas and hope to video record these
tests. Your response also indicates that the Quality Review of
these smoke studies will be completed and approved prior to
initiation of media fill studies, which were targeted to be
completed by April 30, 2008. However, your firm has not
provided an update on all airflow pattern findings and your
evaluation of these study results.
2. For sterile API operations, smoke studies were not
representative of actual operations to demonstrate
unidirectional airflow and sweeping action over and
away from the product under dynamic conditions
during numerous aseptic operations in classified areas
processing sterile APIs. For example:
a. There are no smoke study evaluations to
demonstrate that the personnel activities
during the [redacted] of sterile API from
the [redacted] do not disturb the unidirectional
airflow in front of the to prevent compromising
the sterile API.
b. The smoke study performed for the set up of
the [redacted] equipment did not actually
reflect the manner with which the equipment
and manual aseptic connections are made.
c. There are no controls (e.g. physical barrier,
curtains) in place to ensure that the
39
[redacted] room's ISO [redacted]
unidirectional airflow conditions were not
compromised during routine operations
performed within the ISO [redacted]area.
d. The smoke study performed for
the [redacted] steps did not accurately reflect
the manner in which routine aseptic
connections are made.
Your response indicates that you have prepared
comprehensive protocols for performing airflow pattern
testing to include all aseptic operations in line with sterile
API production and hope to video record these tests.
According to your protocol, smoke studies were to be
completed prior to the next media fills which were targeted
to be completed by May 15, 2008. However, your firm has
not provided an update on all airflow pattern findings and
your evaluation of these study results.
3. Failure to conduct aseptic connections of sterile API
materials in critical areas (ISO [redacted]) and
demonstrate providing [redacted] unidirectional air
flow over the connections. For example, the manual
aseptic connections for sterile APIs performed prior
to [redacted] were done in an ISO [redacted]
(supporting clean) area.
Your response indicates that your new [redacted]
unidirectional air flow (UAF) unit would be qualified by April
7, 2008 and the smoke study would be completed prior to
media fills that were targeted to be completed by May 15,
2008. However, your firm has not provided an update on the
40
airflow pattern findings for the [redacted]UAF unit and your
evaluation of these studies.
4. Viewing locations are inadequate to assess processing
operations in ISO [redacted] sterile API and drug
product operations. The aseptic processing facility
lacks appropriate viewing facilities for aseptic
operations in order to assess the control systems
necessary to prevent contamination or mix-ups during
the course of aseptic processing. For example, the
door windows and their locations, used to observe
routine operations, precludes the In-Process Quality
Assurance (IPQA) and Management from observing
all phases of either the [redacted]aseptic API
processes or the aseptic finished drug product
processes.”
True copy of the warning letter dt. 16th
September 2008 issued by FDA of USA is
being filed as Annexure P-1 ( 59-66)
36. On 16th September 2008 issued another warning letter dt. 16th Sept.
2008 to the Ranbaxy after FDA did inspection of Ranbaxy
pharmaceutical manufacturing facility at Ponta sahib.
“The March 2008 inspection also found that the Batamandi
(Unit II) site is under the same production and quality
management as the existing Paonta Sahib site. In addition,
the inspection found that the existing Paonta Sahib site was
involved in various aspects of testing and production for the
Batamandi site. In a letter dated May 12, 2008, FDA
informed you that the duplicative drug registration for the
Batamandi (Unit II) facility had been withdrawn by the
agency, because we consider the Batamandi (Unit II) facility
41
to be a part of the existing Paonta Sahib facility. As such, the
violations observed during the March 2008 inspection are
indications of continuing CGMP deficiencies in the quality
systems at the Paonta Sahib facility, including the failure of
production and quality management to prevent such
deficiencies. We issued a Warning Letter to the Paonta Sahib
facility on June 15, 2006 citing significant deficiencies
related to your stability testing program, including: failure to
maintain complete records of data related to stability sample
testing, and deficiencies related to storage, inventory
management, and testing of stability samples at defined
intervals.”
“Our review included your May 1, 2008 response to the FDA
483 Inspectional Observations. We acknowledge that some
corrections have been implemented, including your
withdrawal of the [redacted] ANDA due to deficiencies noted
in equipment cleaning logs and batch production and control
records for the exhibit batches of [redacted] manufactured in
July - August, 2006. However, we are concerned that these
instances of discrepancies observed during the March 2008
inspection, are indications of continuing, systemic CGMP
deficiencies at the Paonta Sahib facility. These include:
Written records of major equipment cleaning and use
are inaccurate and do not provide assurance that
persons double-checked the performance of
equipment cleaning, because there is no assurance
that those persons responsible for determining that
work was performed were present at the time of
equipment cleaning [21 CFR 211.182].”
42
“During the inspection, our investigative team uncovered
fourteen (14) instances (Observation# la, b, c, e, f, g, h, k, l,
m p, q, t, and u on the FDA 483) where cleaning records for
equipment used in manufacturing operations (V-
blender, [redacted], etc) included initials or signatures of
employees who reportedly verified cleaning of equipment but
were not shown as present by security log records. According
to the security log used to record the entry of all personnel
entering and exiting the Batamandi (Unit II) facility, the
supervisors who initialed or signed the "Checked by
Production Executive" or "Cleared by QA Executive" block
were not present in the Batamandi facility on the days this
equipment was cleaned. For example, two of these records
each involved entries for five separate dates where the
employee signing for verification (hereafter "Employee 1")
was not present according to the security log
records (Observations #1(a) and (b)).
With regard to entries made by another employee (hereafter
"Employee 2"), your May 1, 2008 response states, "An
investigation conducted following the issuance of the 483
revealed that the handwritten logs maintained by the
security detail at the gate to the Batamandi (Unit II) facility
were not intended to and cannot be assumed to provide an
accurate accounting of entry in and out of the facility on any
given day.
" You maintain that the security log was not intended
to be accurate, yet you acknowledge its accuracy in the
same paragraph of the response when you state, "The
security log and other records show that [Employee 2]
43
was present at the facility on every other day on which
his signature appears on batch documents."
“Your response also acknowledges the accuracy of the
security log when referring to entries made by Employee 1
and another employee (hereafter "Employee 3"). With regard
to multiple entries made by Employee 3, your response
states that this individual was not present to verify cleaning
operations . With regard to numerous entries made by
Employee 1, your response states:"[Employee 1] apparently
was not present during the manufacturing of the exhibit
batches and related equipment cleaning. [Employee 1]
believed that he did not have to be physically present during
an activity in order to sign off as having checked the activity
on batch records. Instead, he asked [Employee 4] to bring
the batch records to him at the Paonta Sahib facility so he
could check and sign them."
This statement in your response regarding Employee 1
demonstrates a lack of knowledge by the employee regarding
the fundamental purpose of independent verification under
CGMP, and the failure of your firm to ensure that employees
conducting and recording these checks understood these
essential requirements. The requirement for independent
verification applies to functions during drug manufacturing
that involve human judgment and consequently are
susceptible to human error. Verification of equipment
cleaning operations and other critical drug manufacturing
operations (e.g., weighing of raw materials, formulation,
laboratory calculations) is fundamental to assuring that
procedures or work are adequately performed to reduce the
risk of human error. This basic function in the manufacture
44
of drug products is an essential part of U.S. CGMP
regulations and is one important example of the necessary
steps your company needs to implement to ensure product
quality.
Incomplete or inadequate cleaning of equipment can lead to
cross contamination or inadvertent contamination of drug
products with residual cleaning agents or solvents. The
purpose of 21 CFR 211.182 is to assure that a second person
determine that appropriate cleaning and maintenance was
performed on equipment. Simply reviewing the cleaning log
afterwards, without being present at the time of cleaning,
does not meet this requirement. We also note that for the
multiple examples where you admit that Employee 3 was not
present at the time of cleaning, you have failed to provide
any explanation for this significant deviation from CGMP
requirements.
In your response to this Warning Letter, please explain how
the supervisor responsible for verifying the cleanliness of
equipment handles verification of cleaning, including
whether this individual must inspect the equipment. Please
also include documentation regarding your investigation into
these incidents, and possible similar incidents not observed
by FDA, where employees signed or initialed cleaning
records as having verified the steps when, in reality, they
were not present at the plant to conduct this verification.
Please also describe the steps you have taken to prevent
recurrence of these and similar events.
2. Batch production and control records prepared for each
batch of drug product produced do not include complete
information relating to the production and control of each
45
batch, in that the persons performing, directly supervising or
checking each significant step in the operation may not have
been present on the dates or times these steps or operations
were conducted [21 CFR 211.188(b)(11)].
Our investigative team found four instances (Observation#
1d, j, o, and s on the FDA-483) of batch production records
containing the initials for Employee 1 in the "Checked by"
column for manufacturing steps. According to the security
log, though, this employee was not in the Batamandi (Unit
II) facility on the dates when he reportedly supervised these
manufacturing activities. One record involved six separate
dates where the employee signing for verification was not
present according to the security log records. These instances
include manufacturing steps related to charging of
components.
In three instances (Observation# li, n, and r on the FDA
483), the batch production records include the initials of
Employee 4 and another employee (hereafter "Employee 5")
in the "Carried out by" column after a recorded "Start Time"
and "Finish Time." However, according to the security log,
these employees were not present at the Batamandi (Unit II)
facility at the actual times these operations were conducted.”
True copy True copy of the warning letter dt.
16th September 2008 issued by FDA of USA is
being filed as Annexure P-2 ( 67-70 )
37. On 25th Faberuary 2009 FDA issued press release declaring as follow:
“The U.S. Food and Drug Administration today announced that a
facility owned by India-based Ranbaxy Laboratories falsified data
and test results in approved and pending drug applications. The
46
facility, Paonta Sahib, has been under an FDA Import Alert since
September 2008.
The FDA is continuing to investigate this matter to ensure the safety
and efficacy of marketed drugs associated with Ranbaxy's Paonta
Sahib site. To date, the FDA has no evidence that these drugs do not
meet their quality specifications and has not identified any health
risks associated with currently marketed Ranbaxy products.
In the meantime, the FDA recommends that patients not disrupt
their drug therapy because this could jeopardize their health.
Individuals who are concerned about their medications should talk
with their health care professional.
The affected applications are for drugs that fall into three
categories:
• Approved drugs made at the Paonta Sahib site for the U.S.
market;
• Drugs pending approval at the FDA that are not yet
marketed; and
• Certain drugs manufactured in the United States that relied
on data from the Paonta Sahib facility.
Companies must provide truthful and accurate information in their
marketing applications, said Janet Woodcock, M.D., director of the
FDA's Center for Drug Evaluation and Research (CDER). The
American public expects and deserves no less.
To address the falsified data, the FDA has invoked its Application
Integrity Policy (AIP) against the Paonta Sahib facility. The AIP is
invoked when a company's actions raise significant questions about
the integrity of data in drug applications. This AIP covers
applications that rely on data generated by the Paonta Sahib facility
only.
47
Under the AIP, the FDA has asked Ranbaxy to cooperate with the
agency to resolve the questions of data integrity and reliability. This
would include implementing a Corrective Action Operating Plan
(CAOP) to provide assurance of the integrity and reliability of data
from the Paonta Sahib facility. A CAOP includes, but is not limited
to, conducting a third-party independent audit of applications
associated with Paonta Sahib.
When the AIP is implemented, the FDA stops all substantive
scientific review of any new or pending drug approval applications
that contain data generated by the Paonta Sahib facility.
The FDA's investigations revealed a pattern of questionable data
raising significant questions regarding the reliability of certain
applications, and this warrants applying the Application Integrity
Policy, said Deborah Autor, director of CDER's Office of
Compliance. Today's action reflects the FDA's continued vigilance
and its steadfast commitment to safeguarding the public's health.
True copy of the news release by FDA dt. 25.2.2009 is
being filed as Annexure P-3 ( 71-72 )
38. On 25th February 2009 Department of health and Human services ,
FOOD and DRUG Administration , Silver Spring MD 20993 , after
conducting various inspection as above and securing response from
Ranbaxy concluded that Ranbaxy has been supplying faulted and
defective medicine which is dangerous to the life of the citizen of USA.
They disclosed various reasons and facts and also confirmed that filed
reply by Ranbaxy was false , fraudulent and untrue . in their issued letter
dt. 25. February 2009 FDA finally declared :
“The Center for Drug Evaluation and Research has determined that
Ranbaxy Laboratories Limited (Ranbaxy) submitted untrue
statements of material fact in abbreviated and new drug
applications filed with the Agency. These findings concern the
48
submission of information, such as from stability test results in
support of pending and approved drug applications, from the
Ranbaxy Laboratories Limited site located at Paonta Sahib,
Sirmour District, Himachal Pradesh, India, (herein referred to as
the “Paonta Sahib site”). The following are examples of the
observations that support our conclusion that Ranbaxy submitted
untrue statements of material fact in drug applications filed with
the Agency:”
In conclusion FDA declared :-
“These and other findings indicate a pattern and practice of
submitting untrue statements of material fact and other wrongful
conduct, which raise significant questions regarding the reliability
of the data and information contained in applications (pending and
approved) that your firm has filed with the Agency and which
contain data developed at the Ranbaxy Laboratories, Paonta Sahib
site.”
True copy of the letter dt. 25.2. 2009 issued by FDA is being
filed as Annexure P-4 ( 73-79)
39. In February 2009 the FDA punished Ranbaxy anew, labeling the
company with the drug regulator's version of a scarlet "A": The agency
imposed a so-called Application Integrity Policy. That meant a dramatic
shift in the regulatory dynamic. No longer would the FDA have the burden
of proving fraud if it wanted to block a Ranbaxy product. The onus had
flipped, and now the company would have to prove its
products weren't fraudulent in order to get them approved.
40. That on February 26, 2010, Relator filed a First Amended Complaint in the
District of Maryland under the same caption and case number, and this First
Amended Complaint sets forth the current allegations in the qui tarn action.
41. That in April 2010, Ranbaxy issued another in a mounting series of
recalls, this time for a pediatric antibiotic of amoxicillin and clavulanate
49
potassium. In a statement, a Ranbaxy spokesman said that while the
company's own testing found the drug to be within specification, "the
company has decided to recall all the lots in question as a matter of
caution, given its commitment to the health and safety of patients." The
oral suspension turned brown, instead of white, on being mixed. It was the
same drug that Thakur had given his feverish young son, with no effect,
seven years earlier.
42. On January 2011 The U.S. Department of Justice added more restrictions
in January 2012, when it placed Ranbaxy under a sweeping consent
decree. This time Ranbaxy was barred from selling drugs in the U.S. that
were made at several of its Indian plants until the quality could be verified.
The Justice Department also required the company to undergo
independent auditing.
43. November 2011 despite the ongoing regulatory and legal travails, in
November 2011, the FDA allowed Ranbaxy to proceed with exclusive first
rights to sell a generic version of the anti-cholesterol medication Lipitor.
One year later, Ranbaxy recalled 41 lots of generic Lipitor after glass
particles were found inside them. In March of this year, the FDA permitted
Ranbaxy to resume sales of the drug.
44. In January 2012 the Justice Department placed Ranbaxy under a
sweeping consent decree, describing the action as "ground breaking in its
international reach." The decree prohibited the company from selling
drugs in the U.S. that were made at several of Ranbaxy's Indian
manufacturing plants until the quality could be verified. It also required
the company to undergo independent auditing.
45. Not long after Ranbaxy purchased the isotretinoin, the company
submitted its new data to the FDA, which approved it. Within a year the
company was forced to start recalling its Sotret again because the drug was
degrading faster than it was supposed to -- the very problem that had been
occurring before.
50
46. On January 25, 2012, Ranbaxy Laboratories Limited, agreed to enter into a
settlement agreement On such date as may be determined by the Court,
Ranbaxy USA, Inc. will enter a plea of guilty pursuant to Fed. R. Crim. P.
11(c)(1)(C) (the "Plea Agreement") to an Information to be filed in United
States of America v. Ranbaxy USA, Inc., Criminal Action No. [to be
assigned] (D. Md.) (the "Criminal Action") that will allege a violation of
Title 21, United States Code, Sections 331(a), 331(e), 333(a)(2) and
351(a)(2)(B), and Title 18, USC, Sections 2 and 1001.
47. On January 25, 2012 Ranbaxy consented to the entry of a Consent Decree of
Permanent Injunction (the "Consent Decree") to a Complaint filed in United
States of America v. Ranbaxy Laboratories, Ltd, et al., Civil Action No. 12-
0250 (D. Md.) that alleges a violation of Title 21, United States Code, Sections
331(a), 331(d), 331(e), and 331(k), namely, the introduction of adulterated drugs
into interstate commerce, the delivery of unapproved new drugs into interstate
commerce, failing to make required reports to the Food and Drug
Administration, and causing drugs to be adulterated while the drugs were held
for sale after shipment in interstate commerce, in violation of the Food, Drug
and Cosmetic Act.
48. That Ranbaxy admitted their guilt and entered into an agreement before the
court and court declared in settlement agreement as follow;-
a. Admitted as The United States contends that it and the Medicaid
Participating States have certain civil claims against Ranbaxy, as
specified in Paragraph 2 below, for allegedly engaging in the following
conduct concerning the manufacture, distribution, and sale of the
Covered Drugs at various points during the period from April 1, 2003,
through September 16, 2010 ("Covered Conduct"):
“Ranbaxy knowingly manufactured, distributed, and sold in
interstate commerce, and made false statements (including in
annual reports to the Food and Drug Administration) about,
certain batches, lots, or portions of lots of the Covered Drugs
51
during the period referenced above in violation of the Federal
Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. §§ 331, 351,
352, and 355, including batches, lots, or portions of lots of the
Covered Drugs (1) the strength of which materially differed
from, or the purity or quality of which materially fell below,
the strength, purity, or quality which they purported or were
represented to possess, or (2) that were not manufactured
according to the approved formulation and were, therefore,
unapproved new drugs, in violation of the FDCA, 21 U.S.C. §§
331(d) and 355(a), and were not "covered outpatient drugs"
under 42 U.S.C. § 1396r-8(k)(2).
As a result of the foregoing alleged conduct, the United
States contends that Ranbaxy knowingly caused false and/or
fraudulent claims to be submitted to, or caused purchases by,
the Federal Health Care Programs.”
49. That Ranbaxy was in a stronger position in the U.S. than it was before its
entanglement with the FDA. By the end of 2012, it was the fourth-fastest-
growing pharmaceutical company in the U.S., both by sales and number of
prescriptions. Much of this growth can be attributed to sales of its generic
Lipitor. (That momentum stalled after the recall and the entry of new
competitors selling that medication.) Ranbaxy has survived one disaster
and punishment after another.
a. The congressional inquiry into the FDA petered out over the years.
But under the direction of David Nelson, investigators interviewed
the FDA inspectors who went to Paonta Sahib and asked them a
simple question: Would they feel comfortable taking Ranbaxy
drugs? "Every single inspector that went to India said they would
never take a Ranbaxy drug," says Nelson, "like eight out of eight."
52
b. They were not alone. One by one, each of the former Ranbaxy
executives Fortune interviewed had determined, while still at the
company, to stop taking Ranbaxy drugs.
50. That in November 2012, IN USA Ranbaxy had to recall millions of pills
after tiny glass particles were discovered in some of them.
51. That in pursuance to the agreement court excused Rambaxy subject to
payment of $500 Million and other fine.
52. On 13 may 2013 in Baltimore federal court Indian generic drug-maker
Ranbaxy Laboratories pleaded guilty Monday to seven federal criminal
counts of selling adulterated drugs with intent to defraud, failing to report
that its drugs didn't meet specifications, and making intentionally false
statements to the government.
a. As part of the proceedings in Baltimore federal court Monday
morning, a whistleblower lawsuit against Ranbaxy was also
unsealed. It describes how the company fabricated and falsified
data to win FDA approvals.
b. Ranbaxy pleaded guilty to seven federal criminal counts of selling
adulterated drugs with intent to defraud, failing to report that its
drugs didn't meet specifications, and making intentionally false
statements to the government. Ranbaxy agreed to pay $500 million
in fines, forfeitures, and penalties -- the most ever levied against a
generic-drug company. (No current or former Ranbaxy executives
were charged with crimes.
c. The company will pay a total of $500 million in criminal and civil
penalties to resolve the criminal case and the whistleblower suit.
Thakur will receive more than $48 million as part of the resolution
of the case.
53. On 16th may 2013 State of Alaska . Department of law issued press
release:
53
“Attorney General Michael Geraghty announced today that Alaska
joined with other states and the federal government in a $500
million dollar settlement to resolve civil and criminal allegations
that Ranbaxy, a generic pharmaceutical manufacturer based in
Gurgaon, India, introduced adulterated drugs into interstate
commerce. As a result, false or fraudulent claims were submitted to
Alaska's Medicaid Program.
The civil suit filed in the United States District Court for the District
of Maryland under the federal False Claims Act alleged that
Ranbaxy knowingly manufactured, distributed and sold generic
pharmaceutical products, whose strength, purity and/or quality fell
below the standards required by the FDA. The products at issue
consisted of 26 generic pharmaceutical products manufactured at
two separate facilities in Paonta Sahib and Dewas, India at various
times between April 1, 2003 and September 16, 2010.
Ranbaxy agreed to pay the states and the federal government $350
million dollars in civil damages and penalties to resolve the civil
allegations involving the two Indian manufacturing plants. Alaska
recovered $376,793.64 for losses directly attributable to the Alaska
Medicaid program. Ranbaxy USA pled guilty to seven felony counts
alleging violations of the U.S. Food, Drug, and Cosmetic Act, and
agreed to pay $150 million dollars in criminal fines and forfeitures.
Also, Ranbaxy entered into a consent decree in January 2012 with
the federal government to address outstanding current good
manufacturing practice (cGMP) and data integrity issues in the two
Indian manufacturing plants at issue. These provisions include a
wide range of actions to correct its violations and to ensure that the
violations do not occur again.
The State of Alaska Medicaid program has recovered over
$2,309,000.00 in joint civil actions with the National Association
54
of Medicaid Fraud Control Units since July 1, 2012. The Alaska
Medicaid Fraud Control Unit (MFCU) is part of the Attorney
General's Office. The MFCU is responsible for investigating and
prosecuting Medicaid fraud and abuse, neglect or financial
exploitations of patients in any facility that accepts Medicaid funds.
Information about the MFCU or links for reporting Medicaid Fraud,
abuse or neglect can be found on the MFCU website.”
True copy of the court proceeding order press release dt.13th and
16th May 2013 issued on by the State of Alaska . Department of law
is being filed as Annexure P-5 colly ( 80-83)
54. On 3rd Jun 2013 Respondent overlooking interest of the general public
and fraud and fraudulent production and sell of life saving medicines by
the Ranbaxy as proved and admitted in the USA via investigation during
last 41/2 years and admitted in the USA court as above , issued a press
note in support of Ranbaxy actions in indirect way. True copy of the press
note dated 3rd Jun 2013 issued by ministry of commerce is being filed as
Annexure P-6 (84-85
55. That it raises serious questions about whether our government can
effectively safeguard a drug supply. Despite above facts as all the actions
taken by federal authorities, there is a deeply troubling aspect to the
government's role in the saga of Ranbaxy. Even as ever more details of the
company's long-running misconduct emerged, drug regulators permitted
Ranbaxy to keep on selling many of its products and respondent have not
taken any action in India it is due to corruption and political nexus.
56. That the petition isx being filed on the following amongst other following
GROUND
a. Because medicines is the last effort for life saving effort for a human
if it is adulterated there is no way to save the life. Supply of
adulterated drug is a heinous crime and is amount to commit
murder and person who knowingly do it is liable to be prosecuted
55
u/s 326, 327, 320 and 420 of I.P.C. couple with seizure of their
entire properties for fine as it is earned through supply of forged
medicine.
b. Because above said admitted facts clearly disclosed that Ranbaxy
has been manufacturing and supplying adulterated drug in India as
well as to other country which has resulted in to death also of
several unknown patient attracting s.27A of the Cosmetic and Drug
Act of 1940 punishable imprisonment not less than 5 years or for
life with fine not less than Rs. 10,000/-
c. Because supply of adulterated medicine, knowingly and deliberately
for exploitation of money and business is a heinous offense is
strictly prohibited u/s 18 of the Drug Act.
d. Because offense of adulterated drug has already been proved in
UD\SA inspection and investigation. Ranbaxy had admitted their
guilt before the USA court. It is also admitted facts that same
medicine has been being manufactured in the same Ponta sahib and
Dewas Plant & has been being supplied in India since last several
years. Off course we don’t know casualties happened due to these
drugs as never had such records.
e. Because respondent is duty bound to prohibit production and to
seal such company & factories u/s 18 of the Drug Act.
f. Because in the above said admitted facts and circumstances
respondent must cancelled Ranbaxy license couple with imposition
of heavy penalty in billion dollars to compensate cost of life taken
by the Ranbaxy medicines.
g. Because Respondent is duty bound under Art.21 to protect life of
the citizen of India but indirect support to Ranbaxy is a serious
violation of law and a cruelty to the humanity.
h. Because heart of medicines manufacturing is documentation.
Without it, there is no way to verify quality, investigate problems, or
56
know whether your drug will improve health or harm it. Because
the most minuscule changes can make the difference between a
robust product and one that degrades and becomes toxic, each step
must be recorded and validated. Any misrepresentation, mixing of
data streams or deviation from procedure invalidates -- and
potentially adulterates -- the drugs. Within fourfold corruption
circumstance in India it is difficult to maintain /control over
accurate medicines supply. Therefore Indian drug controller, who
kept sleep during this period within the result of the USA
investigation, is also liable for the similar punishment and
prosecution for corruption and conspiracy for allowing adulterated
drug supply in India resultant of death of thousands cancer & heart
patient under IPC & PCT Act 1992.
i. Because Ranbaxy directors deserve punishment no less then death
punishment couple with seizure of their entire properties for
committing offence for grievous hurt leads to paid, blood infection
& death. Ranbaxy has been supplying adulterated medicines for all
range of decease i.e. headache, fever, cancer, heart, eye, ears,
mental, HIV, Aids & other decease which are ineffective dangerous
to life and has leads to deaths of several people without knowing
true facts about Ranbaxy adulterated drugs. Alleged offence has
been being committed since a long period and liable to be
prosecuted u/s 320, 326, 327 and 420 of IPC read with u/s 27-A of
the Drug Act.
57. That Petitioner has not filed any other writ petition before this Hon’ble
court or in the High court for the relief as prayed herein.
PRAYER
Therefore within the aforesaid facts and circumstances & in the interest of
justice this Hon’ble court be pleased to issue writ of mandamus/direction to
the respondent no.1 directing them
57
1. to cancel all medicine manufacturing license issued to the
Ranbaxy & their group companies. AND
2. to seal/close down Ranbaxy manufacturing unit situated at
Ponta Sahib, Dewas and others, if any, u/s 18 of the drug and
cosmetic act 1940. AND
3. To prohibits Ranbaxy to supply any kind of Medicines in India
u/s 18 of the drug and cosmetic Act 1940. AND
4. Be further pleased to direct respondent no.3 to initiate
investigation and to prosecute all ex and present directors of the
Ranbaxy under s.326, 327, 320, 420 & 120-B of IPC read with s.
27A & 18 of the Drug and cosmetic Act of 1940. AND
5. To seize entire property of the all directors, ex-& present
directors, of the company for penalty u/s 27(a) of the Drug and
cosmetic act 1940. AND
6. Be further pleased to direct respondent no.3 to initiate
investigation/inquiry and to prosecute Central Drug Standards
Control Organization & its responsible officers/ directors/
inspectors under PC Act 92 read with s. 326, 327, 320, 420 &
120 of IPC.
7. Pass such other order or further orders, as this Hon’ble court
may deem fit and proper under the facts and circumstances of
the case.
AND FOR THIS ACT OF KINDNESS, THE PETITIONER AS ARE DUTY BOUND
SHALL EVER PRAYS.
Drawn and settled by: Filed by:
Manohar Lal Sharma Advocate Manohar Lal Sharma Advocate
In-person
Drawn on : 4.6.2013
Filed on : 5.6.2013
58
IN THE SUPREME COURT OF INDIA
ORIGINAL JURISDICTION
Writ Petition (Crl) no. OF 2013
IN THE MATTER OF
Manohar Lal Sharma Advocate Petitioner
Versus
Union of India & Other Respondents
AFFIDAVIT
I, Manohar Lal Sharma S/O Late Shri P.L. Sharma ,practicing advocate
presently practicing in Supreme Court at S.C.B. Lib. No.-1 Supreme Court
of India ,New Delhi, Petitioner do hereby solemnly affirm, state and
declares as under
1. That I am the petitioner in the above writ petition and as such I am aware
of the facts of this case and I am competent to swear this affidavit.
2. That contents of this accompanied writ & contents of the date of events
(page B-C) writ petition (para 1-57) and (pages 1-58 ) and accompanied
interim application for stay & direction are true and correct to the best of
my belief and knowledge.
3. That the field annexure P-1 to p-6 are true copies of their respective
originals.
DEPONENT
VERIFICATION
I , the above named deponent do hereby declare and verify on oath that
the contents of this affidavit are true to my knowledge ,nothing material
has been concealed therefrom and no part of it is false. Verified at New
Delhi on this 6.6.2013
DEPONENT
59
IN THE SUPREME COURT OF INDIA
ORIGINAL JURISDICTION
Writ Petition (Crl) no. OF 2013
IN THE MATTER OF
Manohar Lal Sharma Advocate Petitioner
Versus
Union of India & Another Respondents
WITH
CRL.M.P. no. of 2013 Application for stay & direction
WITH
PAPER BOOK
{ KINDLY SEE INSIDE FOR INDEX}
Manohar Lal Sharma Advocate
(Petitioner - in-person)
Mob: 9810279220
60
INDEX
1. LISTING PROFORMA A-A1
2. DATE OF EVENTS B-E
3. Writ Petition with affidavit 1-58
4. Annexure P-1
True copy of the warning letter dt. 16th
September 2008 issued by FDA of USA
5. Annexure P-2
True copy True copy of the warning letter dt. 16th
September 2008 issued by FDA of USA
59-66
67-70
6. Annexure P-3
True copy of the news release by FDA dt.
25.2.2009
7. Annexure P-4
True copy of the letter dt. 25.2. 2009 issued
by FDA of USA
8. Annexure P-5 colly
True copy of the court proceeding order via press
release
i. Dt. 13th may 2013 issued by Department
of Justice
ii. dt.16th May 2013 issued on by the State of
Alaska . Department of law
9. Annexure P-6
True copy of the press note dated 3rd Jun 2013
issued by ministry of commerce
71-72
73-79
80-82
83
84-85
10. I.A. NO. of 2013
Application for stay & direction
86-87