149915683 Ranbaxy Writ Petition

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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