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IN THE SUPREME COURT OF INDIA ORIGINAL JURISDICTION Writ Petition (CRL.) 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. 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 Writ petition (PIL) Respondents U/ Art.32 & 21 of the Petitioner OF 2013

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 Honble 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 underpoliced 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 mlange 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 emails. 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 email, 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."

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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.

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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 observations. FAD dt. April 3, 2008 found Ranbaxy to the FDA-483

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 betalactam 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:

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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-betalactam products. b. Batch production and control records for betalactam (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 betalactam 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 nonbeta-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 betalactam 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 nonpenicillin 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 finished multiple are

cephalosporin manufactured.

products

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 betalactams 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 betalactam contamination [Attachments 16a (iii) through 16a (vi)] in February 2008. However, your March 2008 reports states that the archival room was decontaminated and reassessed for beta-lactam contamination [see Attachments 16a (viii) and (ix)]. d. Your response (page 50) indicates that testing of non-penicillin or products for traces of

penicillin

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: Semisynthetic 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 aseptic of

ISO[redacted] conditions

during

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., Tool"), that contacts "Product sterile was Uniformity API during

the [redacted] process, prior to use.

depyrogenated

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 unidirectional compromised ISO [redacted]

airflow conditions were not 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 (supporting clean) area. Your response indicates that your new [redacted] [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 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 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 Ranbaxy is

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. 120250 (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-fastestgrowing 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:

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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

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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 dont 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 Honble 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 Honble court be pleased to issue writ of mandamus/direction to the respondent no.1 directing them

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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 Honble 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: Manohar Lal Sharma Advocate Drawn on : Filed on : 4.6.2013 5.6.2013 Filed by: Manohar Lal Sharma Advocate In-person

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IN THE SUPREME COURT OF INDIA ORIGINAL JURISDICTION Writ Petition (Crl) no. IN THE MATTER OF Manohar Lal Sharma Advocate 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 Petitioner OF 2013

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IN THE SUPREME COURT OF INDIA ORIGINAL JURISDICTION Writ Petition (Crl) no. OF 2013

IN THE MATTER OF Manohar Lal Sharma Advocate Versus Union of India & Another Respondents Petitioner

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

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INDEX 1. LISTING PROFORMA 2. DATE OF EVENTS 3. Writ Petition with affidavit
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

A-A1 B-E 1-58 59-66

67-70

6. Annexure P-3 True copy of the news release by FDA dt. 25.2.2009

71-72

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

73-79

i. Dt. 13th may 2013 issued by Department 80-82 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

83 84-85

10.

I.A. NO.

of 2013

86-87

Application for stay & direction