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Pharma Spectrum Organisation of Pharmaceutical Producers of India

Volume 4

Issue 8

August 2011

1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. IPR Regulatory New Products R&D / Clinical Trials Mergers & Acquisitions / Collaborations Pricing Trade & Others Animal Health Biotechnology Medical Diagnostics / Devices New Appointments 1 3 6 7 11 14 14 18 18 19 20

1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. IPR Regulatory New Products R&D / Clinical Trials Mergers & Acquisitions / Collaborations Pricing Trade & Others Animal Health Biotechnology Medical Diagnostics / Devices New Appointments OPPI Related News 20 20 24 25 28 28 29 32 32 33 33 34

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Pharma Spectrum

Pressure Mounts For A New Form Of Medical Innovation To Improve Access To Medicines
July 19, 2011, Pharma Letter -mounts-for-a-new-form-of-medical-innovation-toimprove-access-tomedicines.html?utm_source=2009_11_06Pharma+Clean&utm_campaign=30d1ce47ceRSS_EMAIL_CAMPAIGN&utm_medium=email A second meeting has been hosted in the European Parliament by Carl Schlyter (Greens-EFA, Sweden) on the subject of improving access to medicines though Medical Innovation Prizes and civil society is uniting to put pressure on the European institutions to support a model of medical innovation which meets public health need.

annual market size for the drug in the US stands close to $100 million. Only about three weeks back, Astellas had filed a patent suit against Sagent Strides, a joint venture between the two companies Strides Arcolab and Sagent Pharma in the district court of New Jersey in the US. Sagent Pharma is a specialty injectible firm based out of US.

DRL Sued For Patent Infringement

July 14, 2011, Zeebiz News .aspx?newscatid=3&newsid=27067 Roche Palo ALTO LLC and Helsinn Healthcare SA filed a patent infringement litigation against Dr Reddy's Laboratories for anti-nausea drug Aloxi. A patent infringement case has been filed in federal court in the New Jersey district on July 8, alleging that the generic drug makers will violate two patents of the drug that expire in 2024. Aloxi injection is used in adults to help prevent the nausea and vomiting due to chemotherapy. Apart from Dr Reddy's, Roche has also filed suits against Sandoz Inc and Teva Pharmaceuticals over the same issue.

Ranbaxy Refusing To Pay Legal Costs, Cover Losses, Says US Drugstore Chain
July 18, 2011, Economic Times A retailer of Ranbaxy drugs in the US has filed a complaint alleging that the Indian drugmaker has refused to cover the legal costs and losses the retailer has suffered in defending the company for selling a generic drug that has shown undesirable side effects. Pennsylvania-based Rite Aid, the third-largest drugstore chain in the US, is currently fighting numerous cases in the US, with consumers seeking damages for not warning them about the side effects of heartburn and nausea drug 'metoclopramide', whose original and generic version it sold at its stores.

Brazil Patent Office Scores Victory Over Multaq Case

July 13, 2011, Pharma Letter The Brazilian Instituto Nacional da Propriedade Industrial (INPI) won another victory in the courts related to pharmaceutical patents. The Specialized Section of the Federal Court of Appeal of the 2nd Region unanimously upheld the decision which keeps a pharmaceutical product in the public domain. The drug in question was dronedarone, the active ingredient of French drug major Sanofis (Euronext: SAN) atrial fibrillation drug Multaq.

Strides To Settle Patent Dispute With Astella

July 16, 2011, Financial Express Bangalore-based sterile injectible firm, Strides Arcolab, is close to settling its ongoing patent dispute with Tokyobased innovator firm Astella Pharma over drug Adenosine injection (brand name Adenoscan) in the US market. The

Pfizer Bids For Extension In EU



July 11, 2011, Fierce Pharma Pfizer is poised for a Lipitor reprieve in Europe. The company has asked for 6 months' of additional exclusivity in most EU countries under regulations designed to

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Pharma Spectrum
promote pediatric drug trials. The extension could be worth almost $800 million as it staves off generic competition until May 2012, the Financial Times reports. Pfizer is in line for the 6-month extension because of studies in children with a genetic disorder that causes high cholesterol. The company plans to launch a chewable, grape-flavored version of Lipitor in November as a result of those trials. "Pfizer certainly pulled off a bit of a coup," Heart UK's Dermot Neely told the FT.

Glenmark Daiichi




July 5, 2011, Hindu Business Line e2158240.ece Glenmark has settled its litigation with Daiichi Sankyo Inc and Genzyme Corporation over the sale of Glenmark's generic version of Colesevelam Hydrochloride in the US. This is the sixth settlement in less than two years for the company. Daiichi Sankyo markets Colesevelam Hydrochloride as a powder for oral suspension and as a tablet under the Welchol brand name, to treat cholesterol and type-2 diabetes mellitus.

Pressing For Strong IPR Regime In FTA With India: EU Tells WTO
July 11, 2011, The Economic Times ndicators/pressing-for-strong-ipr-regime-in-fta-withindia-eu-tells-wto/articleshow/9171874.cms The European Union has informed the WTO that it is pressing for inclusion of strong IPR regime in the free trade agreement under negotiations with India even as the Commerce Ministry has maintained that New Delhi will not yield to the EU on this issue. The 27-nation bloc gave this input to the World Trade Organisation (WTO) which has recently completed a Trade Policy Review of the EU. According to the policy document, the EU has concluded FTAs with Central America, Colombia and Peru, which include detailed provisions on effective protection and enforcement of Intellectual Property Rights (IPR).

Teva Sold Generic Lipitor In UK, Despite Ongoing Patent Proection, FT Reports
July 4, 2011, Pharma Letter Despite the fact that US drugs behemoth Pfizer (NYSE: PFE) has patent protection for its blockbuster cholesterol lowerer Lipitor (atorvastatin) well into next year, Israelheadquartered Teva Pharmaceutical Industries (Nasdaq: TEVA) last month started selling a generic version Lipitor in the UK, reports the Financial Times.

UK Judge Denies AstraZeneca/ Medimmune Patent Rights

July 7, 2011, Pharma Letter The High Court this week ruled that Anglo-Swedish drug major AstraZeneca (LSE: AZN) subsidiary MedImmunes two patents on screening techniques used in drugs including Swiss pharma companies Roche (ROG: SIX) and Novartis (NOVN: VX) wet age-related macular degeneration Lucentis (ranibizumab) treatment were invalid, clearing the way for both companies to produce the drug without paying royalties to MedImmune, the Financial Times reported. A spokeswoman for AstraZeneca told The Pharma Letter that, in January 2009, MedImmune informed Novartis that the importation, manufacture, marketing and distribution of Lucentis in Europe infringed the firms patents.

Cipla Gets US Court Order Over Patent Infringement, To Appeal

July 1, 2011, Mint Drug major Cipla today said it has received an order from a US district court that the sale of its animal healthcare product, PetArmor Plus, has infringed on the patent held by Merial Ltd. The company has received an order dated 21 June, 2011, from a US District Court, Middle District of Georgia, against a petition filed by Merial Limited ruling that the sales of PetArmor Plus allegedly infringed a patent held by Merial Ltd, Cipla said in a filing to the Bombay Stock Exchange. Future sales of PetArmor Plus have been suspended in the United States, it added. The district court has stayed the above order for 60 days in order to enable the company to appeal, Cipla said, adding that it is in the process of filing an appeal against the order.

Organisation of Pharmaceutical Producers of India

Pharma Spectrum Calls For Wider Data Exclusivity Reforms Should Not Be Supported In Australia, Says GMiA
June 28, 2011, Pharma Letter Most of the worlds population live with no more than six years or no data exclusivity at all, with regard to pharmaceutical patents. Many countries have no data exclusivity including major markets such as India and Brazil. Many countries such as Australia, New Zealand, China, Singapore, South Korea, Israel, Chile, Taiwan, Turkey, Jordan and Saudi Arabia have five or six years data exclusivity. Only Japan, the USA and Europe (bound under the single European Union law) currently have data exclusivity periods that are for 10 or more years...... There was much awaited good news for Anglo-Swedish drug major AstraZeneca (LSE: AZN) last night, when the US Food and Drug Administration approved the companys blood-thinning drug Brilinta (ticagrelor) to reduce cardiovascular death and heart attack in patients with acute coronary syndromes (ACS). AstraZenecas shares rose as high as 2.7% to $50.77 in after-market trading in the USA last night.

Merck & Co Gets EU Approval For Victrelis; Pfizer Withdraws Macugen Indication Extension
July 20, 2011, Pharma Letter US drug giant Merck & Co says that the European Commission has approved Victrelis (boceprevir) for the treatment of chronic hepatitis C (CHC) genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy. Chronic hepatitis C virus (HCV) is a potentially serious viral infection of the liver that affects an estimated four million people in Europe. The drug was cleared for this indication by the US Food and Drug Administration in the spring (The Pharma Letter May 16).

US House Passage Of Patent Reform Legislation Gets Mixed Reception

June 27, 2011, Pharma Letter The US House of Representatives last week passed HR 1249, the Leahy-Smith America Invents Act, with broad bipartisan support. The Senate passed its version of the bill (S 23) on March 8 by a vote of 95 to 5. The two chambers will now work out differences between the bills and then a final vote on a compromise bill will have to take place (likely in the Senate). The legislation also takes steps to help the underfunded US Patents Office deal with a backlog of 1.2 million pending applications, which forces inventors to wait three years for a decision.

WHO Calls For Ban On Unreliable TB Blood Tests

July 20, 2011, Medical Express "Based on the evidence, (these) tests lead to misdiagnosis and mistreatment of patients. They are a waste of time and resources," Mario Raviglione, director of the WHO Stop TB Department, told reporters. "We are calling on governments to ban the use of these tests." An estimated two million such diagnostics, which look for antibodies or antigens in the blood, are used every year, and up to half of them could give false results, Karin Weyer, who works for the same department, said. She warned that companies which continued to sell these diagnostic tools would be knowingly selling a faulty product.

US FDA At Last Approves AstraZeneca Blood-Thinning Drug Brilinta
July 21, 2011, Pharma Letter

Organisation of Pharmaceutical Producers of India

Pharma Spectrum AstraZeneca Wins FDA Approval For Blockbuster Hopeful Brilinta
July 20, 2011, Fierce Biotech The FDA has approved AstraZeneca's blood thinner Brilinta (ticagrelor) for acute coronary syndromes, breaking the Big Pharma company's long losing streak at the agency and pushing the regulator's approval record on new drugs so far this year to 21--a match for all of last year. But the approval did come with a catch: AstraZeneca will have to conduct a risk evaluation and mitigation strategy program, including outreach to make sure doctors tell patients the risk of bleeding rises when they take aspirin at doses above 100 milligrams a day. Millennium Development Goals and other public health challenges. The five BRICS countries are bringing a new voice, a new perspective and new solutions to todays global challenges, said UNAIDS Executive Director Michel Sidibe who participated in the First BRICS Health Ministers Meeting, together with World Health Organization Director General Margaret Chan.

FDA Approves Dr Reddys Generic Version Of GlaxoSmithKlines Arixtra

July 13, 2011, First World B8753C47A2BF8AA44F7CADCD49 The FDA on Wednesday approved a generic version of GlaxoSmithKlines Arixtra (fondaparinux) manufactured by Dr. Reddys for use in treating deep vein thrombosis (DVT). Dr. Reddys version is the only generic of Arixtra approved to date and CEO G.V. Prasad noted that "given that this is a complex generic molecule, which is difficult to manufacture at scale, competition is likely to be limited for the foreseeable future." The executive said that the generic will be introduced into the US market in a phased launch. Dr. Reddys initially filed for FDA approval of its version of the product in March 2009, but a decision was delayed due to concerns about the drugs manufacturing process, which involves more than 50 stages, as well as largescale synthesis. The Indian drugmaker will manufacture the product in four doses in pre-filled, single- dose syringes using a patented process developed by Alchemia.

French Regs




July 14, 2011, Fierce Pharma The scandal surrounding Servier's Mediator drug in France has spawned a new approach to regulating pharma. Under pressure from an increasingly distrustful public, Health Minister Xavier Bertrand has proposed sweeping changes to France's regulatory framework, InPharm reports. French regulators have been feeling the political heat from recent disclosures linking as many as 2,000 deaths with the now-withdrawn diabetes drug Mediator. The Servier drug was allowed to stay on the market in France after it had been withdrawn for safety reasons in other European markets.

Pfizer, J&J's Alzheimer's Drug Might Get Boost From FDA Trial Rules
July 12, 2011, Fierce Biotech There are no good drugs yet for treating Alzheimer's disease, which is notoriously complex and poses many challenges to developers. Yet with the nudging of industry and academics, the FDA has loosened some safety restrictions on trials for amyloid-lowering drugs against the disease, making it that much easier for companies like Pfizer, J&J and Eli Lilly to advance their experimental treatments, Reuters reports today. Since a dozen Alzheimer's patients had a brain-swelling condition in a 2008 study of Pfizer and J&J's drug bapineuzumab, the FDA has made developers perform additional testing on patients who are in trials for such treatments and has restricted patients from participating

First Meeting Of BRICS Health Ministers Brings New Leadership To Global Health
July 13, 2011, Pharma Letter Universal access to medicines was a key topic of discussion at a meeting this week of health ministers from Brazil, Russia, India, China and South Africa (BRICS) in Beijing, China. The meeting, hosted by the government of China, aimed to identify opportunities for BRICS countries to promote wider access to affordable, quality-assured medicines, with a view to reaching the

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if they have had more than two occurrences of certain small blood leaks in the brain, Reuters reports. Is it too soon for the FDA to call 2011 a good year for drug approvals? Maybe not. CDER director Janet Woodcock claims that new chemical and molecular entity approvals have reached a 20-year high, and that two-thirds of drug applications are reviewed in a timely matter. So far this year 20 drugs have been approved, compared to just 21 in all of 2011. Her remarks were delivered in testimony before a U.S. House of Representatives subcommittee on health. The drug industry and FDA are indeed having a banner year.

WHO Lauds India's Effort To Combat HIV In Africa, S America

July 12, 2011, Indian Express International health organisations today lauded India for providing effective and affordable medicines to combat Meningitis and HIV/AIDS in Africa and South America.Appreciating India's role, the Director General of World Health Organisation, (WHO), Dr Margaret Chan made a particular mention of the supply of medicines at an affordable cost by Indian pharmaceutical companies to help dealing with the outbreak of Meningitis in Africa at the first BRICS Health Ministers conference here.Union Health Minister, Ghulam Nabi Azad along with Ministers from member countries attended the conference. While all the multi national companies declined to supply the vaccine at cheaper rates Serum Institute of India did so for as cheap as 50 cents for a unit, which saved millions of lives in Africa, Chan said.The conference was held here today to discuss steps to deepen cooperation and coordination among the member countries on health related issues.

USFDA Bans Import Of Drugs From Dr Reddy's Mexico Plant

July 7, 2011, Economic Times The US health regulator has imposed an import ban on products made at Dr Reddy's Laboratories' Mexican plant for violation of current good manufacturing practices (CGMP). According to a notice on the US Food and Drug Administration (USFDA), the American drug regulator has imposed an import ban on products made at Dr Reddy's Mexican arm -- Industrias Quimicas Falcon de Mexico SA for violation of good manufacturing practice rules. The company's Mexican arm, which produces intermediates and active pharmaceutical ingredients had received a warning a letter from the USFDA last month. The import ban follows a warning letter issued by the USFDA on June 3. The regulator cited "lack of corrective actions" by the firm after it had sought certain explanations following an inspection of the company's Mexico facility in November 2010.

EU Plans Revision Of GMP Regulation To Target Indian Pharma Manufacturers

July 11, 2011, Pharmabiz, Joseph Alexander 0&sid=1 The Swedish authorities are pushing for tighter environment laws by the European Union targeting the pharmaceutical production by the third world countries in general and India in particular. The current proposal by the Swedish Medical Products Agency (MPA), if gets through, may put Indian manufacturing units under added pressure. The health ministers of the EU have already informally discussed the proposal to revise the EU legislation on Good Manufacturing Practices (GMP) and report by the MPA that was submitted to the Swedish government.

Cadila Gets USFDA Warning For Violating Manufacturing Norms At Gujarat Plant
July 7, 2011, Business Standard The US Food and Drug Administration (USFDA) has issued a warning to Cadila Healthcare for violation of current goods manufacturing practice (CGMP) regulations for finished pharmaceuticals at its facility in Gujarat. The regulator has given the company 15 days to take corrective measures and report back to it. In a letter to the chairman of the company, Pankaj Patel, dated June 21, the US regulator said it had identified significant violations of CGMP regulations for finished

Woodcock: New Drug Approvals Reach 20-Year High

July 8, 2011, Fierce Biotech

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pharmaceuticals during its inspection of the company's plant at Sanand, in Gujarat earlier this year. Attorney General Lisa Madigan alleged that GSK and SB Pharmco engaged in unfair and deceptive practices when they manufactured and distributed certain lots of the drugs Kytril, Bactroban, Paxil CR and Avandamet. Madigan and other attorneys general involved in the case alleged that from 2001 to 2004, drug batches were manufactured improperly at a facility in Cidra, Puerto Rico. The investigation involved instances in which certain batches were not sterilized or medication contained different dosages than indicated on the bottle, among other alleged violations.

EMA Publishes Format For Submission Of Information On Medicines; Welcomes Falsified Medicines Directive
July 5, 2011, Pharma Letter The European Medicines Agency says it has reached the first milestone in the implementation of the new pharmacovigilance legislation, by publishing the format in which pharmaceutical companies need to submit information on all of the medicines authorized or registered in the European Union. The format shows the types of information that companies will need to submit to the EMA by the legal deadline of 2 July 2012.

New Products
Eisai Announces Japan Launch Anticancer Agent Halaven
July 20, 2011, BioSpectrum Asia 685.asp Eisai announced the launch of its novel anticancer agent Halaven in Japan for the treatment of inoperable or recurrent breast cancer. Halaven is the first novel anticancer agent to be discovered and developed by the Eisai. Having simultaneously submitted marketing authorization applications to the regulatory authorities in Japan, the United States and the European Union (EU) in March 2010, the company first launched Halaven in the US in November of the same year, and began marketing the agent in the UK, Germany and other European countries in April 2011.


Canadians Waiting Over Two-And-AHalf Years For Governments To Approve New Drugs
July 1, 2011, Pharma Letter s-waiting-over-two-and-a-half-years-for-governments-toapprove-new-drugs.html?utm_source=2009_11_06Pharma+Clean&utm_campaign=46f947aa61RSS_EMAIL_CAMPAIGN&utm_medium=email Canadas federal and provincial government bureaucracies are taking more than two-and-a-half years on average to approve new prescription drugs, thereby depriving many Canadians of the latest in new medicines, finds a new report from the Fraser Institute, Canadas leading public policy think-tank. On average, it takes Health Canada nearly 16 months to approve new drugs as safe and effective.

Optimer Launches Fidaxomicin Tabs To Treat CDAD In Patients 18 Years Of Age And Older
July 20, 2011, Pharmabiz, San Diego 5&sid=2 Optimer Pharmaceuticals, Inc. announced the commercial launch of DIFICID (fidaxomicin) tablets for the treatment of Clostridium Difficile-Associated Diarrhoea (CDAD) in patients 18 years of age and older. In two large phase III clinical studies, DIFICID had clinical response rates at the end of the 10-day treatment period that were non-inferior to oral vancomycin. In addition, DIFICID was superior to vancomycin in sustained clinical response, defined as clinical response at the end of treatment and survival without proven or suspected CDAD recurrence through 25 days beyond the end of treatment. With the commercial availability of

GSK To Pay $40.75M To Settle Case Involving P.R. Plant

June 23, 2011, Fierce Pharma GlaxoSmithKline and its SB Pharmco Puerto Rico unit have agreed to pay $40.75 million to 37 states and the District of Columbia over allegations of violating drug manufacturing standards. In a statement, Illinois

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DIFICID, Optimer is initiating a Patient Assistance Program to help eligible uninsured and underinsured patients gain access to this important treatment option. 454 Life Sciences, a Roche Company (SWX:RO)(SWX:ROG)(Pink Sheets:RHHBY), announced today the launch and immediate availability of the new GS FLX+ System, an instrument capable of generating extra-long sequencing reads up to 1,000 by in length. This new level of performance presents a major milestone in the life science's industry, making it the first high-throughput sequencing technology to deliver millions of bases from reads with accuracy and lengths that are comparable to Sanger-based methods.

Daiichi Sankyo Launches LIXIANA In Japan

July 19, 2011, BioSpectrum Asia 6667.asp?nl=%5b%5bforstats Building on its cardiovascular portfolio, Daiichi Sankyo, a pharmaceuticals company with its head office in Tokyo, announced the launch of LIXIANA in Japan. It received the first marketing approval for the edoxaban 15 mg and 30 mg tablets by the Japanese Ministry of Health, Labour and Welfare in April 2011. This is the first time edoxaban will be commercially available to patients in any global market. Edoxaban is a once-daily, oral anticoagulant that specifically, reversibly and directly inhibits the enzyme, Factor Xa, a clotting factor in the blood. Results from clinical studies supported the approval of edoxaban for the prevention of venous thromboembolism (VTE) in patients with total knee arthroplasty, total hip arthroplasty and hip fracture surgery. VTE is the term for the generation of a blood clot and the obstruction of a vein or a pulmonary artery by a blood clot.

R&D/Clinical Trials
Approvals For New Pharma Products In 2011 Could Exceed Previous Year, Reports Fitch; Citeline Says Ph IIIs Up 13%
June 28, 2011, Pharma Letter s-for-new-pharma-products-in-2011-could-exceedprevious-year-reports-fitch-citeline-says-ph-iiis-up13.html?utm_source=2009_11_06Pharma+Clean&utm_campaign=27af5a7c21RSS_EMAIL_CAMPAIGN&utm_medium=email The pharmaceutical R&D pipeline for new pharmaceutical products remains strong for the remainder of 2011, according to a new Fitch Ratings report, titled Global Pharmaceutical R&D Pipeline - First Quarter 2011, which expects that drug developers will be actively introducing a full range of new medicines to both the specialty and primary care markets before yearend. Fitch-rated pharmaceutical companies have applications for 18 New Molecular Entities (NMEs) filed with the drug regulatory agencies in Europe or the USA with anticipated near-term review deadlines.

Abbott Plans New Formulations Of HIV Medicines

July 18, 2011, BioSpectrum Asia 6650.asp?nl=%5b%5bforstats Global Pharma company Abbott has announced that it plans to develop two new formulations of its HIV medicines, Kaletra (lopinavir/ritonavir) and Norvir (ritonavir), to offer new formulation options for people living with HIV-1. The company is currently investigating a new powder formulation of Norvir as well as a coformulation of three HIV medicines lopinavir, ritonavir and 3TC (lamivudine). The Norvir powder formulation is planned to make it easier to store the medicine. The investigational fixeddose combination of lopinavir, ritonavir and 3TC combines three established HIV medicines and could reduce the daily number of tablets taken by a patient. Additionally, this tablet may offer a more cost-effective treatment option to patients.

New Studies Raise Hopes For Pfizer, J&J Alzheimer's Treatment

July 20, 2011, Fierce Biotech New studies are raising hopes that bapineuzumab, an experimental Alzheimer's drug, may be safer than researchers for Pfizer and J&J had expected after cases of brain swelling were reported among the patients

454 Life Sciences Launches New GS FLX+ System For High-Throughput Sequencing
June 28, 2011, News Medical

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Pharma Spectrum
taking the drug. The condition could decrease over time, according to scientists. "It looks like we can treat people for a number of years safely," Dr. Steven Salloway of Butler Hospital and Brown University in Providence, RI, told the Alzheimer's Association International Conference in Paris. Since a dozen Alzheimer's patients had a brain-swelling condition in a 2008 study of bapineuzumab........ 704576442901100190640.html Two studies released Wednesday show AIDS drugs can sharply reduce the risk of heterosexuals acquiring HIV, adding to a growing number of new methods to slow the spread of the virus world-wide. A bottle of antiretroviral drug Truvada, the brand name of emtricitabine, is shown at a California pharmacy in November 2010. Researchers found that couples in Africa, in which one partner had HIV but the other didn't, had an average of 73% fewer infections when given daily doses of that drug and another medication. Many researchers now believe science has developed sufficient tools to contain the pandemic, which is thought to infect about 2.6 million people annually. But tight budgets may limit deployment of these methods.

Merck Chief Stands By His Big R&D Spend

July 18, 2011, Fierce Biotech Don't expect Merck CEO Ken Frazier to offer any apologies for the company's big R&D budget. "Science and innovation are in the DNA of the company," he told reporters for the Wall Street Journal. "The science will lead us to another big breakthrough. "Sure, he adds, investors and analysts may throw a few "brickbats" in his direction as steep R&D costs bite into the bottom line, but that's a burden he's willing to bear. "I'm trying to run the company in a way that I can satisfy the short- and intermediate-term needs of investors without sacrificing really what we're about."

Report Highlights Urgent Need For Rethink On Biopharma Industry Innovation

July 13, 2011, Pharma Letter Life sciences companies with very effective innovation programs typically produce twice as many new products as those without effective programs. This was a key finding of a new Economist Intelligence Unit survey sponsored by Quintiles, which highlights the urgent need for biopharmaceutical industry innovation. The survey comes as the biopharma sector reaches the patent cliff - this year and next, seven of the worlds 15 top-selling drugs, accounting for nearly $50 billion in sales in 2009, will go off-patent.

India, Denmark To Promote Research In Stem Cell, Traditional Medicines

July 15, 2011, Pharmabiz, Joseph Alexander 3&sid=1 India and Denmark will launch joint strategic research programme in the areas of biotechnology and life sciences, especially in the emerging sectors like stem cells and cell therapy with a view to strengthen the research efforts and work developing leads. The joint programme, to be launched by early 2012, will be in accordance with the Memorandum of Understanding (MoU) signed in 2004 between the Department of Biotechnology (DBT) and the Danish Ministry of Science, Technology and Innovation (MSTI) aimed at further developing and strengthening the IndoDanish research collaboration within health science biotechnology.

OHE Report Recommends Prize System To Boost R&D In Fight Against Superbugs
July 8, 2011, Pharma Letter A new report today by the Office of Health Economics (OHE), which is linked with the Association of the British Pharmaceutical Industry (ABPI), has called for a shake up in the way future antibiotics are to be rewarded in Europe so that biopharmaceutical companies can spend more to fight superbugs.

AIDS Drugs Can Prevent Infection, Studies Show

July 14, 2011, Wall Street Journal

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Pharma Spectrum Ex-Pfizer R&D Chief Lamattina Criticizes Short-Term Pharma Strategy
July 7, 2011, Fierce Biotech John LaMattina has some advice for Pfizer, where he worked for 30 years before retiring as the head of research. Once the pharma giant finishes chopping the R&D budget to around $6.5 billion, he says, Pfizer will only be committing 10% to 11% of its 2012 estimated revenue to R&D. And by shortchanging R&D now to satisfy the short-term profit demands of analysts and investors, he adds, Pfizer will likely be haunted by the anemic funding in years to come. "This industry historically has spent anywhere from 15% to 20% of top-line sales in R&D," LaMattina told Reuters. "It's their lifeblood. If you don't have new products you don't have a business anymore." Added LaMattina: "In the short term, I guess that's OK in terms of delivering for shareholders. But four, five, 10 years out, I'm not sure that is going to be a very good position to be in." With diabetes on the rise all over the world, especially in developing countries like India, the pharmaceutical industry is shifting its focus to developing drugs that help ease the lifestyles of sufferers of the disease. The number of medicines under development for diabetes by member companies of PhRMA (Pharmaceutical Research and Manufacturers of America, a consortium of all major research based pharmaceutical companies in the world) has increased from 95 in 2008 to over 230 in 2010. These medicines are in different stages of FDA approval and for treatment of the different types of diabetes. More than half of the drugs under development are for type 2 diabetes, which is the most common type of diabetes in India. These developments would therefore, help contribute to a decrease in the overall burden of diabetes in India, according to a spokesman for the PhRMA.

Novel Approach For Multiple Sclerosis Treatment Identified By Biogen Idec

July 4, 2011, Pharma Letter US biotech firm Biogen Idec (Nasdaq: BIIB) has revealed results from a study that suggest that inhibiting death receptor-6 (DR6) function may represent a novel approach in the treatment of multiple sclerosis by blocking autoimmune response while promoting remyelination. Data from in vitro and in vivo models were published online today and will be published in the July print issue of Nature Medicine. Biogen is already well represented in the current $10 billion a year MS sector, with Avonex and Tysabri (natalizumab), the latter co-marketed with Irelands Elan.

Roche Tarceva Progression-Free Chemotherapy

Nearly Doubles Survival Vs

July 7, 2011, Pharma Letter In a trial dubbed EURTAC, the first Phase III study to include Western lung cancer patients first-line treatment with erlotinib, Swiss drug major Roches (ROG: SIX) blockbuster Tarceva, nearly doubled progression-free survival compared with chemotherapy, according to research presented at the 14th World Conference on Lung Cancer in Amsterdam, Netherlands, hosted by the International Association for the Study of Lung Cancer (IASLC). Erlotinib is a tyrosine kinase inhibitor (TKI) that targets the epidermal growth factor receptor (EGFR).

EU Commission's Research Funding Plans Slammed By Scientists And NGOs

July 4, 2011, Pharma Letter In an open letter sent last week to the President and Members of the European Commission, as well as the European Parliament and the European Union member states, 98 civil society and research organisations from 22 European countries warned that the Commission's draft proposals for the next Research funding framework (2014-2020) fail to address the real challenges faced by

As Many As 230 Drugs Targeting Diabetes Under Development By PhRMA Member Companies
July 5, 2011, Pharmabiz, Joseph Alexander 6&sid=1

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Pharma Spectrum
European societies and call for a research agenda geared towards the needs of society and the environment rather than those of big business. Under the Canada-India Agreement for Scientific and Technological Cooperation aimed at fostering joint Research and Development (R&D) projects, the two sides will launch R&D projects in all areas of biotechnology including life sciences and medical devices. The Ontario-India programme has now called for proposals for collaborative projects with a view to develop innovative products and products, especially in the life science and medical devices sectors.

India Behind China, Innovation Efficiency



July 4, 2011, Business Standard India has improved its position to ninth this year from 101st in 2010 in an index that ranks countries on their innovative outcomes compared to the inputs available, but Pakistan and China are ahead of us. The Innovation Efficiency Index, compiled in a report by business school INSEAD and industry chamber CII, highlights those counties that achieve more on innovations from less conditions. Cote d'lvoire tops the list on this index, released in Geneva, followed by Nigeria, China and Pakistan. The Innovation Efficiency Index is part of an overall global innovation index. India's position on this latter, more comprehensive, index slipped to 62nd this year from 56th in 2010.

Lilly Outlines Turnaround Strategy As CEO Calls Research Cuts "Nuts"

June 30, 2011, Fierce Biotech You have to give Eli Lilly CEO John Lechleiter credit for consistency. In a fast-changing biopharma world in which some of its top rivals are scrambling to create new R&D models, he's sticking with his research team and refusing to budge on investor pressure to hack at its multibilliondollar R&D budget--despite a string of setbacks in the clinic. "I never thought I'd live to see this, but investors are actually thinking to cut R&D--that's the hot topic of the day," he told Reuters in an exclusive interview at BIO's big confab in Washington, D.C. "This is kind of nuts, but this is what's being talked about." And he wasn't finished.

Sanofi Enters Research Pact With Weill Cornell Medical College To Discover New Treatments For Tuberculosis
July 1, 2011, Pharmabiz, P.A. Francis 9&sid=2 Sanofi announced that it entered into a research collaboration with Weill Cornell Medical College to identify new anti-infectives that aim to shorten the course of treatment of tuberculosis (TB) and could provide effective therapies against drug-susceptible and drug-resistant strains of TB. Under the terms of the collaboration, Sanofi will provide 80,000 chemical compounds to Dr Carl Nathans laboratory at Weill Cornell, where the compounds will be screened to assess their ability to inhibit growth of Mycobacterium tuberculosis.

Clinical Trial Drug Dropouts Reach Unsustainable Levels, Says Thomson Reuters Repo
June 28, 2011, Pharma Letter The pharmaceutical industry spent less on drug R&D last year than at any time in the last three years, according to data released today from the 2011 Pharmaceutical R&D Factbook compiled by CMR International, a Thomson Reuters business. Overall expenditure on discovering and developing new medicines amounted to an estimated $68 billion last year, down nearly 3% on the $70 billion spent in both 2008 and 2009, according to the data release released yesterday.

India, Canada To Launch Collaborative R&D Projects In Biotech, Medical Devices Sectors
July 1, 2011, Pharmabiz, Joseph Alexander 6&sid=1

Organisation of Pharmaceutical Producers of India


Pharma Spectrum 347mn People Have Worldwide, Says Study

June 27, 2011, Indian Express An estimated 347 million people are suffering from diabetes worldwide, said an international study published in The Lancet medical journal. Researchers from Imperial College London and Harvard University analysed data from 2.7 million people, aged 25 and over, across every continent, using statistical techniques to project a worldwide figure, to estimate diabetes prevalence. They claim the total number of people with diabetes which can be fatal has risen from 153 million to 347 million in the past three decades, considerably higher than a 2009 estimate of 285 million....


that the companies have signed a definitive agreement under which Bristol-Myers Squibb will acquire privately held Amira Pharmaceuticals, a small-molecule pharmaceutical company focused on the discovery and early development of new drugs to treat inflammatory and fibrotic diseases. Under the terms of the agreement, Bristol-Myers Squibb will acquire all of Amira Pharmaceuticals issued and outstanding shares of capital stock and stock equivalents in an all-cash transaction for a purchase price of $325 million upfront and potential additional milestone payments totalling $150 million.

Astellas Licenses Vical Vax For $130M

July 21, 2011, Fierce Vaccines Japan's Astellas will pay up to $130 million to license a vaccine to prevent cytomegalovirus (CMV) reactivation in transplant recipients. The disease is typically dormant in those who are healthy but can cause illness in immunocompromised people. A Phase III trial of TransVax in hematopoietic stem cell transplant recipients and a Phase II study in solid organ transplant patients are slated to begin in 2012.

Mergers & Acquisitions / Collaborations

Dr Reddys Acquires JB Chems Unit
July 23, 2011, The Times of India Dr Reddy's announced on Friday that it has entered into an agreement with JB Chemicals & Pharmaceuticals to acquire their pharmaceutical prescription portfolio in the Russia and other CIS regions, for $34.85 million (around Rs 155 crore). The agreement involves acquisition of 20 brands, including key ones like Metrogyl and Jocet. Dr Reddy's has also entered into a supply agreement with JB Chemicals for the continued manufacturing and supply of these products associated with the acquired brands, says a company statement.

Pfizer To Acquire Icagen

July 21, 2011, BioSpectrum Asia 6692.asp?nl=%5b%5bforstats Pfizer and Icagen announced that they have entered into a definitive merger agreement. Pfizer, which currently owns approximately 11 percent of Icagens fully diluted shares, will acquire the remaining 8.3 million shares at a price of $6 per share. The aggregate transaction value, including the value of the shares currently owned by Pfizer, is approximately $56 million. In 2007, Pfizer and Icagen entered into a worldwide collaboration for the discovery, development and commercialization of compounds that modify three specific sodium ion channels as new potential treatments for pain and related disorders.

Bristol-Myers Squibb To Acquire Amira Pharmaceuticals

July 22, 2011, BioSpectrum Asia 6695.asp?nl=[[forstats Bristol-Myers Squibb, a global pharmaceutical company, and US-based Amira Pharmaceuticals have announced

Merck & Co Expands Collaboration With Roche On Hep C Drug Victrelis

July 21, 2011, Pharma Letter US drug giant Merck & Co has signed a new non-exclusive agreement with Swiss major Roche (ROG: SIX) for the global promotion, upon appropriate marketing approvals,

Organisation of Pharmaceutical Producers of India


Pharma Spectrum
of Victrelis (boceprevir) as part of a triple combination therapy regimen with peginterferon alfa and ribavirin (peg/riba). Under the terms of the deal, Roche and Merck will work together in global markets, including Europe, Asia and Latin America, to educate physicians and patients about hepatitis C virus (HCV). Flush with Botox bucks, Allergan has struck a deal to buy Vicept Therapeutics for $75 million upfront and up to $200 million in milestones, snaring an mid-stage topical treatment for rosacea. Adding to its R&D pipeline for dermatology, Allergan gains V-101, Vicept's lead therapy, along with two early-stage programs. Malvern, PA-based Vicept was founded back in 2009 with backing from Vivo Ventures, Fidelity Biosciences and Sofinnova Ventures. A year ago the trio of VCs invested $16 million in Vicept's Series A. They stand to come out well ahead in the buyout. Dr. Neal Walker, Vicept's president and chief executive officer and a board certified dermatologist, founded the company.

Novartis' Interest In Buying Gen-Probe Fizzles, WSJ Reports

July 20, 2011, Fierce Pharma Novartis' appetite for deals is expected to grow in the near future, but the Swiss drug giant may no longer be interested in gobbling up diagnostic test provider GenProbe. After speculation that Novartis' interest in GenProbe had waned, sources with knowledge of the deal told the Wall Street Journal that the drug company was no longer seeking a buyout of the San Diego-based diagnostic test maker. The news yesterday put a dent in Gen-Probe's stock price, which fell 2.47% to $62.41 per share. Novartis drops out of the picture as a likely buyer of Gen-Probe-which makes diagnostic tests for HIV and other infectious diseases--after the drug maker's CEO Joe Jimenez revealed earlier this month....

Granules-Omnichem To Put $20 Mn In Mfg Facility

July 14, 2011, Business Standard City-based pharmaceutical company Granules India is setting up a bulk drugs and intermediaries manufacturing facility in Visakhapatnam with an investment of $20 million (around Rs 90 crore) in joint venture with Belgian pharmaceutical firm Ajinomoto OmniChem. The JV, equally owned by the two companies, is targeted to offer high-value active pharmaceutical ingredients (APIs) and intermediaries to pharmaceutical players. "We are excited to enter the contract manufacturing sector through a partnership with OmniChem, which is a highly reputed company with an established track record in the sector.

US, India To Develop Data Access Platform

July 20, 2011, Mint India and the US are collaborating on the development of a technology platform to enable local state agencies to reorganize data, some of which is restricted, in a format accessible on the Web. The move is aimed at improving transparency in governance by the United Progressive Alliance (UPA) government, which has been facing charges of corruption in recent times. This (platform) will be similar to an existing initiative by the United States government called and will be developed completely free of cost, said Aneesh Chopra, chief technology officer, office of science and technology in the US and an adviser to President Barack Obama.

Sandoz Expands Strategic Alliance With Nipro In Japan; Shionogi Licenses Drug To Ildong
July 14, 2011, Pharma Letter Sandoz, a generics subsidiary of US drug major Novartis has entered into a strategic alliance with Japans Nipro Corp, which will focus on a broad range of cross-licensing and co-development opportunities for the Japanese generics market. Sandoz and Nipro, who have been working together on various product licensing deals since 2007, will now expand their cooperation to include a wider affiliation

Allergan Scoops Up Fledgling Vicept In $275M Buyout Pact

July 19, 2011, Fierce Biotech

Organisation of Pharmaceutical Producers of India


Pharma Spectrum
with respect to the development, production and commercialization of generic pharmaceutical products in Japan. US drug major Bristol-Myers Squibb (NYSE: BMY) has signed a global agreement with French biotech firm Innate Pharma (Euronext Paris: FR0010331421 IPH) for the development and commercialization of IPH2102, a novel antibody in Phase I development for the treatment of cancer.

Pharma Execs Expect Aggressive M&A Strategy To Develop Products, Spur Growth: KPMG Survey
July 13, 2011, Pharma Letter On the hunt for new therapies and new customers to drive growth, pharmaceutical executives will step up acquisition activity in the coming year, according to a recent survey by KPMG, a US audit, tax and advisory services firm, which surveyed around 100 drug industry execs in the USA. In the KPMG survey, 83% of executives said it is likely their company will be involved in a merger or acquisition as a buyer or seller in the next two years.

Jubilant Pharma





June 29, 2011, Financial Express Drug firm Jubilant Life Sciences on Tuesday said its USbased arm has entered into an agreement with Janssen Pharmaceutica NV to deliver pre-clinical candidates in the area of neuroscience to the Belgium-based firm. The pact will span an initial period of three years and focus on multiple targets in the area of neuroscience, Jubilant Life Sciences said in a statement. The agreement was signed between Jubilants US arm Jubilant Discovery Services and Janssen Pharmaceutica, it said. As per the deal, Janssen will transfer ongoing efforts on selected drug discovery targets to Jubilant, it added.

Cant Beat? Join. Innovator Gilead In Novel Generics Deal

July 13, 2011, DNA Money US-based biopharmaceuticals maker Gilead Sciences Inc has entered into agreements with four Indian generic drug makers Hetero Drugs, Matrix Laboratories, Ranbaxy Laboratories and Strides Arcolab for manufacturing and marketing three of its new HIV drugs, marking a new model in out-licensing of intellectual property. The three drugs are still in Phase III development and are expected to come out of trials sometime in the first quarter next year. Subsequently, the molecules will go through the approval process. By tying up with the generic companies ahead of the completion of trials, Gilead is preparing to launch the drugs on its own as an innovator along with the generic makers.

Glenmark Receives $25 Sanofi As Upfront Payment



June 28, 2011, The Economic Times Glenmark Pharma today said its USD 613 million (over Rs 2,745 crore) outlicensing deal with Sanofi has been approved by the US authorities and has also received an upfront payment of USD 25 million (over Rs 110 crore) from the French drug-maker. Last month Glenmark Pharmaceuticals SA, a whollyowned subsidiary of Glenmark Pharmaceuticals, had outlicensed its novel monoclonal antibody ' GBR 500' aimed at treating digestive system disorders, to French drug-maker Sanofi for as much as USD 613 million.

Bristol-Myers Squibb In Up To $465 Million Deal With Innate Pharma For Cancer Antibody
July 7, 2011, Pharma Letter

Organisation of Pharmaceutical Producers of India


Pharma Spectrum

Study: MS Drugs' Benefits Carry A Steep Price
July 21, 2011, Fierce Pharma A new study on the pricing of multiple sclerosis drugs-which found, essentially, that they're too expensive, at least in the U.S.--tags a few issues that people like to chat about casually. But what if they were seriously addressed? That would only raise all sorts of political, ethical and philosophical questions. The Neurology study analyzed the cost-benefit data of four drugs using U.S. prices: Biogen Idec's Avonex, Teva Pharmaceutical's Copaxone, Bayer's Betaseron and Merck KGaA's Rebif. Although the numbers on each drug varied, the general conclusion was that it costs more than $800,000 for each patient to gain a year's worth of quality of life.

Following the intensive efforts of the Secretariat General of the Greek Ministry of Health, which is responsible for the pricing of medicines in the country, and the respective Directorate for Medicines and Pharmacies, the new Price Bulletin has now been uploaded on the web sites of the Ministry of Health and the Greek pharmaceutical industry association, the SFEE. Last year, the Greek government introduced draconian drug price cuts of 25% (The Pharma Letters passim. The Ministry of Health implemented the law and more specifically Article 14 of Law 3840/2010, according to which the prices of medicines in Greece may not be lower than the average of the three lowest prices in the 22 European Union countries, said the SFEE in a press statement.

Trade & Others

With EU, US Out Of Reach, Biocons Drivers Are Clear
July 22, 2011, DNA Money Homegrown biotech company Biocon is turning focus to the emerging markets as headwinds blow in the US and Europe. Markets in Latin America, Asia, Africa and the Middle East will be the new growth triggers, said Kiran Mazumdar Shaw, CMD, Biocon. The regulated markets have not yet opened up, so opportunity will be sought in other geographies, Shaw said in a conference call. The domestic branded formulations business, which includes insulin (diabetes), statin (cardiology), nephrology, oncology and immunodermatology businesses, will also see renewed focus.

German Pharma Counts Cost Of Drug Price Controls, Calls For Review
July 18, 2011, Pharma Letter The clamour against the recent drug pricing reforms in Germany has grown steadily louder. Last week Eli Lillys chief executive called for an overhaul of AMNOG, the complex new vetting procedure that determine whether a new drug provides an additional benefit, and, consequently, its market price (The Pharma Letters July 11, January 28). In addition, the German Pharma Association VFA has highlighted the cost of the price freeze and increase in the mandatory discount pharma firms are obliged to offer the state health insurance system, and called for a review of the policy.

Fonda Upshot: Reddys Finds Complex Generics A Good Bet

July 21, 2011, DNA Money Egged on by the US Food and Drugs Administrations (FDA) approval for its limited-competition generic Arixtra (fondaparinux sodium), Dr Reddys Laboratories is altering its generics strategy to focus more on complex molecules for all future launches. The idea? Gain from minimum competition in the US. We will work on more complex molecules and to that effect we may not see a high number of filings (with the FDA) as well. This would also add to the increase in the R&D cost, GV Prasad, the companys CEO, said.

New Greek Drug Price Bulletin Now Published, Despite Industry Arguments
July 11, 2011, Pharma Letter

Organisation of Pharmaceutical Producers of India


Pharma Spectrum Healthcare To Add 4M Jobs Through 2018

July 19, 2011, Fierce Healthcare The healthcare industry will experience some of the fastest job growth through 2018, with home health aides and personal and home care aides leading the pack at 460,900 new jobs and 375,800 new jobs, respectively. In fact, half of the 20 fastest growing occupations are in healthcare, according to Bureau of Labor Statistics (BLS) data. The BLS also predicts that roughly 26 percent of all new jobs created in the U.S. economy will be in the healthcare and social assistance industry. Thanks to an aging population and longer life expectancies, public and private hospitals, nursing and residential care facilities, and individual and family services are expected to grow by a total of 4 million new jobs, notes the BLS. Metoclopramide is the generic copy of Wyeths Reglan, which has been sued by patients in the US now known as Reglan Litigation after being found to have side effects, including serious irreversible body movement disorder.

How Will The Generics Biz Cure Its Blockbuster Hangover?

July 18, 2011, Fierce Pharma Anyone who's been watching pharma knows that the number of big new drugs has been dropping. That's obviously a problem for Big Pharma. But it's going to become a problem for branded drugmakers' major nemesis: the generics industry. Makers of copycat meds like to knock off blockbusters because they stand to deliver more return on the upfront investment. As branded drugmakers increasingly turn out smaller, more specialized meds, there will be fewer big drugs to copy.

Asia, Africa, S America To Be Fastest Growing Pharma Markets: Kiran Das

July 19, 2011, Pharmabiz, Nandita Vijay 2&sid=1 Asia, Africa and Latin America are the fastest growing pharma markets in the world today. Generics globally and speciality drugs in developed markets are tipped to be the most sought-after growth drivers for companies across the world, according to Kiran Das, executive vice president, Sven Genetech Limited, a Jupiter Bioscience Group Company. Major growth driver in the medium term will be 'pharmemerging' markets, where the growth would result primarily through generics and biosimilars. Key focus would be on specific therapies covering oncology, central nervous system, diabetes, respiratory, cardiology and nephrology. Speciality medicines will continue to grow owing to increased usage, newer indication approvals and expanding user base.

Merck Job Cuts Set To Accelerate

July 14, 2011, Fierce Pharma Merck's long-planned job cuts are set to accelerate. The company announced its intent to shed some 15,000 jobs by 2012 last year, but thousands of those jobs have yet to go. Sources tell Pharmalot that Merck plans to amp up its layoff process soon, probably early next month. Merck announced the cuts in the wake of its 2009 merger with Schering-Plough. The idea was to save some $3.5 billion by slashing the payroll by 10% and shuttering facilities. Such an enormous restructuring plan takes time, of course, and as of March, Merck still had about 8,000 jobs remaining to be cut, Pharmalot figures

US Drugstore Chain Rite Aid Sues Ranbaxy

July 19, 2011, Hindu Business Line e2247749.ece US-based drugstore chain Rite Aid Corporation has sued Ranbaxy Laboratories to recover the litigation cost spent in lawsuits involving the Indian firms generic drug metoclopramide used to treat vomiting and nausea but found to have adverse side effects.

PhRMA: U.S. Drug Discounts Could Cost 260K Jobs

July 12, 2011, Fierce Pharma While President Barack Obama and congressional leaders jockey for position in the U.S. debt reduction talks, the pharma industry is doing some negotiating of its own. That's because lawmakers are proposing billions in additional cuts in drug spending, provided via discounts from drugmakers.

Organisation of Pharmaceutical Producers of India


Pharma Spectrum
The pharma industry already agreed to increased drug discounts as part of Obama's healthcare reform package. But with budget shortfalls forcing cuts to state spending-and deficit-minded politicians digging in for federal cuts--pharma is once again in the firing line. While worldwide spending on sales reps and other drug marketing grew slightly last year to roughly $91 billion, the sources of that growth lay in China, Japan and Latin America. In the U.S. and Europe, companies made major cuts. The slight global growth in spending on sales reps depended on double-digit increases in sales-force spending in those three emerging markets. Many major drugmakers added significantly to their sales forces in those markets, according to the analysis by market research firm Cegedim Strategic Data.

Biopharma Should Be Part Of Transatlantic Trade And Economic Discussions, Lilly CEO Urges
July 12, 2011, Pharma Letter ma-should-be-part-of-transatlantic-trade-and-economicdiscussions-lilly-ceo-urges.html?utm_source=2009_11_06Pharma+Clean&utm_campaign=5ed5a361a9RSS_EMAIL_CAMPAIGN&utm_medium=email John Lechleiter, chairman, president and chief executive of US drugs major Eli Lilly (NYSE: LSE) has urged that biopharmaceuticals be included in transatlantic trade and economic discussions. Dr Lechleiter, who last week slammed German health care reform (The Pharma Letter July 11), participated in the American Council on Germany's conference on "The Transatlantic Partnership in the 21st Century," joining US Federal Reserve Bank Chairman Paul Volcker; German State Secretary in the Federal Finance Ministry Jorg Asmussen; and Handlesblatt editor-in-chief Gabor Steingart in a panel discussion. "Biopharmaceutical innovation has enormous global economic and social benefits," said Dr Lechleiter, noting that "new medicines are one of the most cost-effective investments we can make to improve health care and enable more efficient use of health care budgets.

Domestic Generic Exports Get A Boost With Bar-Coding

July 8, 2011, The Times of India Domestic generic exports are expected to get a further boost once bar-coding is implemented in phases over the next year, as a result of which drug consignments would be better tracked and monitored. With consignments carrying a unique identification code, origin of exports can now be traced. This would also help in establishing India as a quality supplier of drugs, industry experts say-. The government recently decided to stagger the implementation of bar-coding on export consignments, with barcodes on 'primary level' packaging such as medicine strips, vials or bottles becoming mandatory from July 2012.

Chinese Docs Trade Up To Jobs In Pharma Sales

July 11, 2011, Fierce Pharma What's a low-paid Chinese doctor to do? Become a pharma rep. As Bloomberg reports, physicians in China are abandoning medical practice for jobs in drug sales, finding that they can better their $300-a-month doctors' salary by marketing drugs, rather than prescribing them. The human resources firm Aon predicts that as many as 14,000 Chinese doctors will join foreign drugmakers over the next 5 years. Such is one unintended consequence of Big Pharma's Chinese gold rush.

Ranbaxy Recalls Skin Care Drug From UK

July 7, 2011, Business Standard Ranbaxy Ltd has been asked by the UK Medicines and Healthcare products Regulatory Agency (MHRA), the largest drug regulator in Europe, to recall its drugs used to treat skin infections. Ranbaxy (UK) Ltd was recalling all unexpired stock of Isotretinoin 20mg capsules due to a potential issue with bio-equivalence in comparison with the originator product, UK MHRA said in its notification. The European Commission has also decided to suspend marketing authorisation for Isotretinoin as a temporary measure. A company spokesperson refused to comment.

Nine Of 10 Big Pharmas Cut Sales Reps In 2010

July 8, 2011, Fierce Pharma

Organisation of Pharmaceutical Producers of India


Pharma Spectrum GSK Launches Next Revamp Of SalesRep Pay

July 7, 2011, Fierce Pharma GlaxoSmithKline made news last year by announcing it would overhaul sales-rep compensation. The aim: Aligning reps' performance goals with company values, GSK said. Transparency and integrity, for two. The company didn't say so directly, but the implication was that the usual sales quotas and bonuses incentivized behavior that didn't exactly conform to those values. In January, GSK got rid of individual sales goals, and now, the second stage of that plan is coming to fruition. Instead of earning bonuses based on sales goals, reps will now have their incentive pay determined by three things: their own selling skills, evaluations from doctors and the performance of their business units as a whole. Millions of people dependent on life-saving generic drugs to treat HIV/AIDS will die if India stops producing cheap drugs for the disease due to its trade deal with the European Union, the head of UNAIDS warned on Tuesday. The EU and India are currently negotiating a free-trade agreement, which campaigners say will restrict India's ability to produce anti-retroviral (ARV) drugs, preventing the world's poor from accessing cheap drugs for their treatment.

Drugs Cos Eye US Entry After FDA Cheeks

July 5, 2011, Economic Times (epaper Page No. 5) d=5&pagesize=&edid=ET&edlabel=ETM&mydateHid=0507-2011&pubname=Economic+Times++Mumbai&edname=Mumbai&publabel=ET The US drug regulator has inspected manufacturing plants of at least half a dozen Indian drugmakers in the past few weeks, raising hopes among some of these companies that they will shortly be able to export medicines from their units to the worlds largest drug market. Several industry executives said teams of inspectors of the US Food and Drugs Administration (FDA) did not find any major deficiency during their inspection of facilities of Ranbaxy Laboratories, Orchid Chemicals & Pharmaceuticals, Emcure Pharma, Nectar LifeSciences and Ind Swift Laboratories over the course of the past four weeks.

Harvard Docs Punished For Undisclosed Pharma Ties

July 5, 2011, Fierce Pharma Three Harvard Medical School psychiatrists who made headlines for their ties to the pharma industry are now being sanctioned by the school and its affiliated Massachusetts General Hospital. According to the Harvard Crimson, Joseph Biederman, Thomas Spencer and Timothy Wilens are barred from paid, industrysponsored work for one year. And for two years after that, they will have to get upfront approval from Harvard and Mass General for any industry-paid activities. The three men sent a letter of apology to their colleagues, saying Harvard and Mass General determined they had violated conflicts of interest policies, the Crimson reports. The actual violations weren't listed, but a U.S. Senate investigation found in 2008 they had failed to report some $4.2 million in payments from drug companies as required by university policy.

Tough UK Bribery Act To Cover Indian Companies

July 3, 2011, The Economic Times Indian companies with offices in the UK and British companies operating in India will be covered by a tough new act that seeks to prosecute companies and individuals who not only offer or receive bribes but also fail to prevent bribery. The Bribery Act 2010, which comes into force today, overhauls existing British laws dating back to 1889 and creates offences in the UK or abroad that carry prison terms of up to 10 years and unlimited fines. Failure to prevent bribery has also been made an offence under the act.

Millions Will Die If India Stops AIDS Drugs: U.N.

July 5, 2011, Reuters thNewsMolt

Organisation of Pharmaceutical Producers of India


Pharma Spectrum Japan Ushers In Big Meds From AZ, GSK, Merck
July 1, 2011, Fierce Pharma Japanese health regulators spread some happiness yesterday, granting marketing approval to several major Big Pharma products. AstraZeneca, GlaxoSmithKline, and Merck each got the nod for a key drug that's already marketed elsewhere, but still awaiting launch in Japan. In each case, as the world's second largest drug market, Japanese approval could be a boon. In AstraZeneca's case, in fact, the drug is Nexium, and its Japanese approval will offer a tailwind just as it's nearing the end of its patent life in other markets. Daiichi Sankyo has signed on to co-promote and distribute the stomach drug, while AZ will manufacture the product. Might Bayer be a potential buyer for Pfizer's animal health business? The German drugmaker wants to grow its animal health unit, research exec Andreas Busch tells Dow Jones. Part of that growth would be through acquisition, with another chunk coming from converting human treatments for use in cats and dogs. Busch wouldn't say just where Bayer might be looking for animal-health buys. But he said the company is definitely scouting the territory. "It would be stupid not to be looking in the present environment for assets in animal health, and we continue to look at attractive assets as they become available," Busch told the news service, "because we believe the animal health business could be a very important pillar of our overall diversified health care strategy."

Pfizer To Shed Vet Unit, Keep Generics

July 7, 2011, Fierce Pharma Deep into its reassessment of non-pharma business units, Pfizer has signaled its intentions. It's looking at selling its animal health and nutrition businesses. Offloading the units would help the company refocus on segments of its business that promise more growth, for instance, its offpatent drugs unit. That's a business the company intends to keep, Pfizer said in a statement. The consumer healthcare business will also stay. The potential animal health and nutrition sales would be a trade: $5.5 billion in annual revenues in return for greater focus on pharma and sale proceeds that could be returned to shareholders.

Animal Health
Lilly Eyes Vet Assets; Pfizer Says All Or Nothing
July 22, 2011, Fierce Pharma Might Eli Lilly emerge as a buyer for Pfizer's animal health business? CFO Derica Rice told Lilly investors that the company is keeping an eye on Pfizer's plans for the unit, which may be sold or spun off. If Lilly likes any of the available assets, it would pursue them, Rice said. When asked about that pledge, Pfizer said that it doesn't envision selling off the animal health business in pieces. The whole unit would be sold or spun off, spokeswoman Joan Campion told Bloomberg. "While we are evaluating a variety of options including a sale, spin-off or other transaction, we believe we will favor one overall option rather than dividing assets and business operations," Campion told the news service.

Pakistan Can Emerge As Biotechnology Leader
July 22, 2011, Pharma Letter -can-emerge-as-biotechnology-leader.html Lahore?Provincial Minister for Agriculture, Malik Ahmad Ali Aulakh has said that 21 century is the century of Biotechnology and Pakistan has tremendous potential to emerge as Biotechnology leader. Speaking at a seminar on Bio-technology at Lahore ...

Note To Pfizer: Bayer Shopping For Vet Buys

July 13, 2011, Fierce Pharma

Organisation of Pharmaceutical Producers of India


Pharma Spectrum Indian Drug Makers Bet Big On Local Biosimilar Market
July 8, 2011, Business Standard Indian pharmaceutical players, who want to reap a pie of the global biosimilar (copies of biological drugs) markets, are trying their luck at regional markets first. Players, including Dr Reddys, Cipla and Lupin are strengthening their presence in the regional markets such as India and South East Asia with new biosimilar launches. According to statistics released by Datamonitor, the Indian biosimilars market is expected to grow to $580 million by 2012. Biosimilars are generic versions of innovative biotech drugs. The absence of clear regulatory norms for biosimilars, especially in regulated markets like the US, is a hurdle for generic drug makers. for their discovery of the Helicobacter pylori bacterium and its role in gastritis and peptic-ulcer disease.

Eli Lilly Plans Investment To Boost Its Biotech Capabilities

June 29, 2011, Pharma Letter US drug major Eli Lilly (NYSE: LLY) yesterday revealed plans for a multi-million dollar investment to expand its existing biotechnology capabilities, at the BIO International Convention taking place in Washington DC. The amount of the investment was not disclosed.

GAVI Funds Pneumococcal Vaccines To Reduce Childhood Mortality

July 2, 2011, Pharmabiz 3&sid=1 Global Alliance for Vaccines and Immunisation (GAVI), has funded the Pneumococcal vaccines to reduce childhood mortality. The Governments of Central African Republic, Benin and Cameroon will introduce vaccines in the coming weeks to combat pneumonia, one of the biggest killers of children worldwide. The roll-outs of the pneumococcal vaccines in countries such as CAR, Cameroon and Benin have been made possible through an innovative finance mechanism pioneered by GAVI called the Advance Market Commitment (AMC).

Medical Diagnostics / Devices

Researchers Incorporate Cellavista System In Cell Platform
July 21, 2011, MDBR News A research team from the Institute of Chemistry and Biological Chemistry at Zurich University of Applied Sciences has used Roche's high-throughput Cellavista Imaging System in the development of an automated liquid-handling cell culture platform for isolating, expanding and characterizing human primary cells. Roche's Cellavista Imaging System is used for noninvasively measuring of cell expansion and fluorescence measurement of cell quality, The Cellavista Imaging System uses brightfield and fluorescence detection with multiwell plates, chamber slides or RoboFlasks.

Roche Culture

Nobel Prize Winner To Transform Cancer Bug To Flu Vaccine

June 29, 2011, Fierce Biotech Australian scientist Barry Marshall continues to make hay with the cancer-making stomach bacterium that won him a Nobel Prize. He's planning to use the bug in a drinkable flu vaccine that's slated to begin trials next year. Marshall, founder of Ondek, shows that his business acumen rivals his scientific expertise. "We're focusing on flu because we think that would be attractive to investors," he says in a Bloomberg report. He and J. Robin Warren won the 2005 Nobel Prize in Medicine with

Chinese Market To Drive Firm's Business In Asia

July 21, 2011, China Daily

Medical Multinational healthcare devices manufacturer Cook Medical Inc expects to almost triple its business in the Asia-Pacific region by 2015 on the back of continuing strong growth in China, according to the company's senior executives.

Organisation of Pharmaceutical Producers of India


Pharma Spectrum
"Cook's annual sales growth in China will continue to exceed 60 percent this year, and we forecast this growth momentum continuing in the coming years," Philip Nowell, vice-president of US-based Cook Medical, told China Daily.

Cipla Wins Pre-Grant Opposition Against Novartis For Dispersible Tabs Containing Deferacirox
June 30, Shirodkar 2011, Pharmabiz, Suja Nair 6&sid=1 The Chennai patent office has granted a pre-grant opposition in favour of Cipla for dispersible tablets containing 'deferacirox'. Out of the four grounds under which Cipla had filed for the pre grant opposition, the Patent office upheld two of it. Novartis had filed an application for patent for their invention titled, dispersible tablets containing deferacirox in 2007 with the Chennai patent office. Cipla had subsequently filed a pre-grant opposition through their Attorney Gopakumar Nair Associates under section 25(1) of the Patents Act.

Medical Device Investment Boost



July 20, 2011, North _Medical_device_investments_up.html New Jersey's medical device start-up companies received $25 million in venture capital funding during the second quarter, despite investor apprehension of tighter government regulations in that sector. In Bergen and Passaic counties, hundreds of firms, both small and large, compete in the marketplace. There are roughly 250 registered medical device companies in the two counties, about 30 percent of New Jersey companies in that industry, according to data from the Food and Drug Administration.

New Appointments
Major Changes At US FDA, With New Posts And Appointments
July 19, 2011, Pharma Letter The world of FDA regulation is changing rapidly and, in an effort to keep current, US Food and Drug Administration Commissioner Margaret Hamburg has announced a major reorganization The structure of the Office of the Commissioner that I inherited was created in 1970, when the FDA consisted of three centers and a field office, Dr Hamburg said in an e-mail to agency staff. By 2011, we had grown to seven centers, and a Commissioners Office with more than 1,600 staff.

CDSCO Issues Guidance Document For Import & Registration Of APIs, Formulations
July 25, 2011, Pharmabiz, Ramesh Shankar 4&sid=1 The Central Drugs Standard Control Organization (CDSCO) has issued Guidance document on common submission format for import and registration of Active Pharma Ingredients (APIs) and finished formulations in India. The main purpose of the document is to provide guidance for submission of application in Form 40 to the CDSCO for registration certificate and issuing license for import of drugs into India. The document is intended to provide non-binding guidance for use in the import and registration of bulk drugs and finished formulations in India.

Organisation of Pharmaceutical Producers of India


Pharma Spectrum DoP Moots National Authority For Drugs & Therapeutics With CDSCO Under It
July 25, 2011, Pharmabiz, Jospeh Alexander 5&sid=1 Even as the move to set up a Central Drug Authority (CDA) by the Health Ministry with a view to centralising the operations of the pharmaceutical sector is stuck for three years now, the Department of Pharmaceuticals (DoP) is now mooting a proposal to set up the National Authority for Drugs and Therapeutics (NADT). The Department is learnt to have made a draft proposal in this regard, though it is yet to make the proposal public or consult the stakeholders on the formation of the new authority. Sources said, the proposal was still in the draft stage and details would be disclosed for consideration and comments by all concerned after finalisation. mandatory for corporates to earmark part of their profit for corporate social responsibility (CSR) initiatives. India Inc, the Minister said, needs to develop a culture of voluntary CSR ... CSR cannot be considered only as a charity it is more of a social business ... As my predecessor has said that 2 per cent mandatory provision (for CSR spend in the Companies Bill 2009), will stay.

DoP Takes Steps To Assess Current Status Of Regulatory Matters Relating To Exports
July 20, 2011, Pharmabiz, Joseph Alexander 3&sid=1 The Department of Pharmaceuticals (DoP) has launched an exercise to assess the current status of regulatory matters regarding exports, such as IPR, TRIPS, patent linkage, free trade agreements and data exclusivity, with purpose of getting a comprehensive view about the problems and then take up the issues with concerned departments and agencies. The DoP has asked the Pharmaceutical Export Promotion Council (Pharmexcil) to submit the current status report on all issues concerning the exports, especially exports to the European Union. The issues related to compliance with standards in other countries will also be covered. The DoP has set up a panel for taking up the studies and making the report.

DCGI Stops Attending Office After Madras HC Order On July 20 Against His Extension
July 23, 2011, Pharmabiz, Ramesh Shankar 3&sid=1 The Madras High Court's recent interim order, staying the 9-month extension given to Drugs Control General of India (DCGI), has virtually made the Central Drugs Standard Control Organisation (CDSCO) without a functioning head, as the DCGI Dr Surinder Singh stopped attending the office after the court order on July 20. Sources said that ever since the court order, the DCGI has proceeded on leave as the court has stayed until further orders the union health ministry's recent order in which it had given nine months extension to Dr Singh to continue in the position of DCGI. The court held that the extension order given to Dr Sigh by the government without the permission of the court was in contravention of the laws of the land as the issue was sub judice as a case on the appointment of the DCGI was pending with the court.

National Pharmacovigilance Programme To Be Extended To 20 More Centres

July 20, 2011, Pharmabiz, Ramesh Shankar 2&sid=1 The national pharmacovigilance programme (PvPI), launched late last year at 20 centres across the country with an aim to ensure that the benefits of use of medicine outweighs the risks thus safeguarding the health of Indian population, will be extended to 20 more centres soon. Some of the centres which have been selected for the expansion of the PvPI included: Grant Medical College & Sir J J Group of Hospital, Byculla, Mumbai; Lokmanya Tilak Municipal Medical College & General Hospital, Mumbai; Godavari Foundation's Dr Ulhas Patil Medical College, Jalgaon, Maharashtra; Padamashree Dr D Y Patil Medical College Hospital & Research Centre, Pimpri, Pune.............

Voluntary CSR Not Working, To Be Made Mandatory, Says Moily

July 21, 2011, Indian Express Regretting that the concept of voluntary CSR has not picked up in India, Corporate Affairs Minister Veerappa Moily today said the new Companies Bill would make it

Organisation of Pharmaceutical Producers of India


Pharma Spectrum Health Ministry To Press For Cap For FDI In Pharma Sector, Despite Planning Panel's Stand
July 18, 2011, Pharmabiz, Joseph Alexander 6&sid=1 The Union health ministry will stick to its alreadyconveyed stand of restricting foreign direct investment (FDI) in the pharmaceutical sector, even as the Planning Commission has reportedly voiced concern against enforcing a cap in the sector. Sources in the Ministry, responding to the recent statement of Planning Commission deputy chairman Montek Singh Ahluwalia, said the Ministry had already made its stand clear in the inter-ministerial group set up to study the issue and would stand by it. account of the inordinate delay in finalising and clearing the National Pharmaceutical Policy which sought to put a basket of 354 essential drugs under price control.

Cabinet Note Soon On Manufacturing Policy: Sharma

July 14, 2011, Hindustan times

New Amid strong signs of an industrial slowdown, commerce and industry minister Anand Sharma on Wednesday said a cabinet note will soon be prepared to formalise the proposed national manufacturing policy paving the way for creating Indias own versions of China-style mega industrial cities peppered across the country equipped with production units, public utilities, residential areas, schools and hospitals. Some fine tuning is required. A committee of secretaries headed by the principal secretary to the Prime Minister is looking into it, Sharma said during a meeting with senior members of the Confederation of Indian Industry (CII).

Drug Units Upset Over Inclusion Of Many Old Drugs In 'New Drugs List' By DCGI
July 18, 2011, Pharmabiz, Ramesh Shankar 7&sid=1 Deeply annoyed over the Drug Controller General of India (DCGI) Dr Surinder Singh's practice of approving and including several old drugs in the 'List of New Drugs', a section of the industry will soon meet senior officials in the union health ministry to apprise them of the consequences of the actions of the DCGI and also to restrain the DCGI from including old drugs in 'New Drugs List'. Sources said that the industry, especially the small and medium sector, is annoyed over the DCGI's practice of including old drugs in the 'List of New Drugs' as that prevents the manufacturers from getting licenses for these drugs from the state drug authorities.

IRDA Against TPAs Servicing StateSponsored Health Scheme

July 13, 2011, The Economic Times Insurance regulator Irda does not want third party administrators to service health schemes floated by either states or the central government since these do not fall within its regulatory regime and the government is not subject to regulatory oversight of the regulator. The third party administrator (TPA) processes insurance claims and handles payment for health cover policies on behalf of insurers. It is basically outsourcing of the administration of the claims processing because the TPA is performing a task traditionally handled by an insurer.

Pharmabiz Editorial: New Policy With NLEM

July 14, 2011, Pharmabiz, P.A. Francis 25&sid=3 Efforts to come out with a new drug policy are once again on with governments renewed initiative to prepare a revised National List of Essential Medicines in accordance with the recommendations of an expert committee. The new list contains a total of 348 medicines by categorising them as per therapeutic areas. The Department of Pharmaceuticals had come out with the idea of considering the NLEM as life-saving drugs on

DBT Pushing NBRA Bill For Passage During Forthcoming Parliament Session
July 13, 2011, Pharmabiz, Joseph Alexander 0&sid=1 The Department of Biotechnology (DBT) is taking all efforts to push the long-pending National Biotechnology Regulatory Authority (NBRA) Bill for the passage in Parliament during the forthcoming session itself. The remaining formalities for introducing the bill have

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been completed and necessary approvals had been given for the bill to be introduced in the Parliament, sources said. Though the bill was scheduled for the last budget session, it did not come up because of the prolonged stalemate in the House. The Biotechnology Industry Partnership Programme (BIPP), under the Department of Biotechnology (DBT), has announced the second special call for proposals for development of affordable healthcare products and technologies as part of its goal to nurture research and development, and innovation in the biotech sector. The proposals have been invited for developing products of superior levels of quality, safety and efficacy in the areas of diagnostics, vaccines, regenerative medicines, therapeutics, bio-medical devices and other allied areas. The proposals can be submitted till August 1, according to the official note.

6 Million May Die Of Tobacco Epidemic In 2011: WHO

July 11, 2011, Indian Express A new report by the World Health Organization (WHO) has suggested that the tobacco epidemic is likely to kill nearly six million people this year. As per the report, while more than five million of them will be users or exusers of smoked and smokeless tobacco, more than 600,000 will be passive smokers. By 2030, tobacco could kill eight million people a year, it said. The international health agency has, therefore, urged countries to make large graphic health warnings mandatory on tobacco packaging. According to WHO, which recommends the warnings among its six demandreduction measures, the pictorial depictions have proven to discourage tobacco use.

World Bank Okays $1-B Credit For Rural Livelihood Project

July 7, 2011, Business Line The World Bank has approved $1-billion credit for National Rural Livelihoods Project (NRLP), which it said is aimed at strengthening the implementation of Indias newly launched National Rural Livelihoods Mission (NRLM). NRLM is one of the worlds largest poverty reduction initiatives of about $7.7 billion, aiming to reach 350 million people or almost a quarter of Indias population..............

New FDA Act To Be Tabled In Cabinet Soon

July 9, 2011, Hindustan Times The state government is all set to embrace the new Food Safety & Standards Act, 2006 (FSSA) from August 5, 2011. The new Act, which will be implemented throughout the country at the same time, will bring a sense of uniformity and lay down standards for articles of food and to regulate their manufacture, storage, distribution, sale and import to ensure the availability of safe and wholesome food. Apart from improving the current infrastructure and staff strength, the Food & Drugs Administration (FDA), is also looking at getting more financial assistance to support the upgrade.

DoP Once Again To Take Up Barcoding Issue With Commerce Ministry

July 5, 2011, Pharmabiz, Ramesh Shankar 7&sid=1 With mounting pressure from the small and medium pharma industries to stall the introduction of barcoding for exports, which is to become mandatory in phased manner from October 1 this year, the Department of Pharmaceuticals (DoP) will once again take up the issue with the union commerce ministry to sort out the issues arising out of the mandatory implementation of barcoding. According to sources, the DoP has asked the industry to provide more inputs on barcoding and the problems being faced by the industry to implement the new system, which is being implemented by the commerce ministry to check the export of spurious (fake) drugs from the country.

BIPP Announces Second Special Call For Developing Affordable Healthcare Products
July 8, 2011, Pharmabiz, Joseph Alexander 7&sid=1

Organisation of Pharmaceutical Producers of India


Pharma Spectrum Zonal Offices To Have Bigger Say Drug Approvals

July 3, 2011, Business Standard Apex drug regulator Drugs Controller General of India (DCGI) is planning a major decentralisation drive that would see over half the mandatory approvals given by its Delhi headquarters being passed on to its regional offices spread across the country. The move is expected to help the domestic pharmaceutical industry, since it would result in faster clearances of several regulatory requirements. For DCGI, it would ensure better monitoring of the quality of medicines and medical devices and also help keep a watch on clinical trials.

New Products
Glaxo Adds New Drugs To Cancer Portfolio
July 23, 2011, Mint newdrugs-to-cancer.html?atype=tp GlaxoSmithKline Pharmaceuticals Ltd is targeting Indias Rs.1,200 crore cancer treatment market by introducing at least one cancer medicine a year in the next four to five years. The local unit of the UKs biggest drug maker will source these medicines from its global parents cancer drug research projects and through licensing arrangements with other companies. We had followed the same strategy to be big in cardiology, diabeteology and skincare areas a few years ago, and its already one of the key providers of these therapies in the local market, said Hasit Joshipura, managing director of the Indian unit.

Polio Drive Sees Highest Turnout Since 2009, 69% Kids Immunized
June 27, 2011, The Times of India The BMC was finally able to make a breakthrough on Sunday when almost 68% of city's children below the age of five years were immunized against polio. The Pulse Polio drive saw a better turnout than previous drives in the last two years. Till 2009, BMC's coverage was above 70%, which dropped below 63% thereafter. The drive last month saw an all-time low, with only 57.58% children covered. "The target this time was 9,49,800 children, of which 6,45,253 were vaccinated against polio. The coverage is 10% more than the last drive," said Dr Kishore Harugoli, in-charge, Pulse Polio drive, BMC.

Marck Bio To Launch Pacacetamol IV In Plastic Pack

July 5, 2011, Hindu Business Line e2155877.ece Marck Biosciences Ltd, manufacturer and marketer of sterile dosages and Blow-Fill-Seal (BFS) specialist, will soon launch the world's first-ever Paracetamol IV in plastic pack manufactured using BFS technology. Marck will be contract manufacturing Paracetamol IV and also launch it under its own brand name of Febramol IV' in India as well, Mr Bhavesh Patel, Managing Director, said here. After three years' efforts, he said, Marck overcame the challenge of developing Paracetamol IV in BFS pack to launch it. The company expects nearly $1 million in sales of this product in the first year of its launch. The Ahmedabad-based company, which pioneered the export of Paracetamol IV to West Africa, South-East and West Asian markets, will now reach out to the Indian markets.

DCGI Finally Probes Erring Pharma Firm

June 25, 2011, The Pioneer It took almost four months for the drug regulator to crack the whip on a Hyderabad-based pharmaceutical company after it was found using poverty-stricken women from Andhra Pradesh as guinea pigs in its clinical trials for anti-cancer drugs. Taking stringent note of the matter, the Director Controller General of India (DCGI) on Friday suspended all the ongoing clinical trials on Exemestane tablets being conducted by Axis Clinical Ltd at its centre at Serlingampally, Miyapur in Hyderabad.

British Biologicals Set To Enter Into Trauma Care Nutrition, To Launch 2 New Products
July 4, 2011, Pharmabiz, Nandita Vijay 5&sid=1 Nutraceutical major British Biologicals has now lined up two nutritional products Promaxe and Nutrizen from its

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Pharma Spectrum
Criticare Division to address the conditions like burns, post surgery and multiple trauma which require adequate nutrient and metabolic support to control pain and uneasiness. The state of stress on the body expends large amounts of energy to heal inflammation, support immune function and tissue repair. Comprehending the needs for protein rich supplements providing high calories for trauma patents recovering from major injuries, British Biologicals research team came out with the two products which are the revenue generators of the future.

India Must Support R&D For Neglected Diseases

July 25, 2011, The Economic Times /india-must-support-rd-for-neglecteddiseases/articleshow/9353332.cms Pharmaceutical exports from India have grown impressively by 15% to $10.3 billion for 2010-2011 . Yet, the shocking reality of 1,000 deaths due to tropical diseases plunges the nation deep into the darkness of negligence . India has been neglecting funding research of diseases such as tuberculosis,malaria,sleeping sickness and ahost of others, while funds are poured into honing treatments fordiabetes,anxiety andsleeplessness . With infectious diseases causing 17 million deaths annually the world over, Dr Krishna Ella, Chairman of Bharat Biotech, underscores the need for India to support a business strategy driven by public health needs and not profits alone.

Shasun Test-Marketing Branded Drugs For Diabetes, Hearty Disease

July 2, 2011, Hindu Business Line e2150770.ece The Chennai-based Shasun Pharmaceuticals, which plans to enter the branded generics space, has begun testmarketing drugs for diabetes and cardiovascular disease in Tamil Nadu. The prescription-driven products in the oral solid form, expected to be 5-10 per cent cheaper than existing products, will hit the pharmacies in July. Shasun's sales representatives have begun working with over 100 pharmacies and talking to doctors about the benefits of these drugs, which have higher bio availability, Mr Abhaya Kumar, Managing Director, Shasun, told Business Line.

Need Of Better Regulation Of Clinical Trials

July 21, 2011, The Economic Times In India, there have been no guidelines providing for uniform formats and procedures to be used by pharmaceutical companies and clinical research organisations (CRO) for reporting serious adverse events (SAE) in clinical trials. On May 12, 2011, through Draft Guidance on Reporting SAEs, the Central Drug Standard Control Organisation (CDSCO) aims to, inter alia, achieve such uniformity and completeness of data filed by companies and CROs for SAE reporting in clinical trials. This nine-page draft guidance requires causality assessment by investigator and the medical monitor of sponsor or CRO to clearly mention whether the SAE is related or not related, and prohibits usage of situations such as unlikely, possibly, suspected, doubtful, etc.

Glaxo Launching Fast-Action Crocin

June 28, 2011, Hindu Business Line e2139381.ece GlaxoSmithKline Asia has launched Crocin Advance', which the company claims disintegrates faster than the standard Paracetamol tablets, thus working faster. Crocin's new innovation comes with proprietary OptiZorb' disintegration technology to speed up relief. Unlike the standard Paracetamol tablets that take a long time to disperse in the stomach, the OptiZorb technology ensures that medicine is released five times faster and thus gets to work much more quickly, said a press release. Due to this advanced technology, the same trusted ingredient, Paracetamol, reaches blood levels much faster and gets to work faster, without compromising on safety parameters and suitability characteristics, says Dr Usha Rani, Additional Professor of Pharmacology, Nizam Institute Hyderabad.

Desi Pharma Cos Seek Innovation InHouse

July 19, 2011, The Times of India Pharma industry has long debated a successful strategy for drug discovery whether it should be pursued within the fold of the parent company, or by hiving off into a separate venture. Globally companies like Novartis, Pfizer and Teva, have successfully created hybrid

R&D/Clinical Trials

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Pharma Spectrum
models, integrating both innovation and generic (metoo) drugs, while most domestic drug companies hived off their innovative research into a separate venture. Now that is changing with most companies like Glenmark, Lupin, Dr Reddy`s and Piramal pursuing innovative research within the company. A few years ago the industry practice was to hive off the research unit to bring in new technology and talent, specific only for drug discovery. The governments department of biotechnology (DBT) and Piramal Life Sciences (PLS) have renewed their joint drug discovery research project for another three years. The public-private partnership, initiated in February 2008, was aimed at screening thousands of bio-molecules extracted from the countrys microbial diversity spread across varied geographies for medicinal properties. Over the last three years, we were able to identify 14,000 bioactive molecules from a total of 2, 45,000 living organisms found in extremely varied climatic conditions across the country. Extracts from these microbes were screened for biological activities across four different therapeutic areas namely cancer, diabetes, inflammation and infectious diseases.

ICMR To Begin Behavioural And Social Science Research On Microbicides For HIV Prevention
July 19, 2011, Pharmabiz, Ramesh Shankar 4&sid=1 The Indian Council of Medical Research (ICMR) will soon begin behavioural and social science research on microbicides for HIV prevention. Microbicides are antimicrobial topical products that reduce the risk of sexual transmission of HIV and other sexually transmitted pathogens and could potentially offer Indian women safe, effective, acceptable and affordable protection against this deadly disease. The broad areas of research will cover several specific research topics pertaining to behavioural and socio science research on microbicides.

DCGI Embarks On Auditing Of CROs To Ensure BA/BE Studies Are Conducted As Per Norms
July 15, 2011, Pharmabiz, Ramesh Shankar 9&sid=1 To ensure that the bio-availability and bio-equivalence (BA/BE) studies are performed strictly in accordance with the applicable regulatory provisions and prescribed guidelines in the country, the Drugs Controller General of India (DCGI) has started auditing of all the clinical research organisations (CROs) in the country. According to sources, the DCGI office has already completed auditing of CROs in Andhra Pradesh and Mumbai. Now, the CDSCO panel will start auditing of CROs in other states also. Earlier, the DCGI had formed panels for auditing of CROs which included assistant drug controllers and drug inspectors.

Clinical Trial Data Disclosure Set To Be More Transparent

July 17, 2011, Business Standard Drug clinical trials conducted in the country would soon be more transparent, as apex medicine regulator, Drugs Controller General of India (DCGI), is planning to make public disclosure of more trial details mandatory. Currently, pharmaceutical companies and contract research organisations engaged in clinical research are required to just register their approved trials on a dedicated website maintained by the Indian Council of Medical Research. If the DCGI plans materialise, the companies would have to provide the details....

NIH Funds New Research Toward An HIV Cure

July 13, 2011, Pharmabiz 1&sid=2 Five-year grants total $14 million in first year three research teams focused on developing strategies that could help to rid the body of HIV are receiving grants totalling more than $14 million a year, for up to five years, the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health announced. The grants are part of the Martin Delaney Collaboratory, a funding opportunity designed to foster public-private partnerships to accelerate progress toward an HIV cure. Delaney, an influential AIDS activist, died of liver cancer in 2009.

Piramal, DBT Renew Drug Research Venture For 3 Yrs

July 16, 2011, Business Standard

Organisation of Pharmaceutical Producers of India


Pharma Spectrum Pharmabiz Editorial: Credibility Of R&D

July 6, 2011, Pharmabiz, P.A. Francis 11&sid=3 The financial performances of worlds top 15 pharmaceutical companies during 2010 indicate a gloomy prospects for these well established leaders of this once prosperous industry. Both sales and profits of these powerful brand companies are on the decline mainly on account of expiration of patents and withdrawal of many drugs from the market over the years. This trend is going to continue in the years to come as well with continuing patent expiries and very few new blockbusters entering the market. A Pharmabiz study of the performances of top 15 global companies shows that their profits declined sharply by 20.1 per cent to $85,955 million in 2010 from $107,595 million in the previous year. The infective (L3) stage of Wuchereria bancrofti is the one that initiates infection in human after getting itself transmitted through the bite of infective mosquitoes. Detection/ diagnosis of presence of L3 stage of the filarial parasite is important for monitoring the transmission of infection in a filariasis endemic area, delimiting filariasis endemic areas and monitoring control operation such as recently launched Global Programme for Elimination of Lymphatic Filariasis in all the endemic countries.

Study: India's R&D Efforts Should Turn To Drug Collaborations

June 27, 2011, Fierce Biotech A new survey gives India's R&D industry some high marks from a range of multinational biopharma companies, with most planning to increase the number of clinical studies underway on the subcontinent. But even as the field grows, India has been able to command only a tiny fraction of the money being spent on drug research around the world. And Indian companies will have to do a lot more than offer lower-cost studies in order to command a bigger share of the world's pharma research budget. That's the word from Boston Consulting Group, which found that a solid 70 percent of the execs they surveyed have been satisfied with their R&D alliances in India. But even while many lay the foundation for more clinical research, India has only 1 percent of the global R&D budget for trials.

Indian Pharma Cos Up R&D Investment

June 29, 2011, The Times of India Even as global pharma biggies slashed their research and development (R&D) spends for the first time ever in 2010, domestic companies have stepped on the gas. Over the last few years, domestic companies have been increasing their research expenditure, and now invest around 6% of their sales in pursuing R&D. As against this, global biggies spend a little over 13% of their sales in innovation, which now seems to be slowing down. Global drug majors started applying brakes on research spends following the financial meltdown in 2008, after decades of relentless increases.

ICMR To Commercialise Newly Developed Technology For Diagnosis Of Infective (L3) Stage Larvae
June 28, 2011, Pharmabiz, Ramesh Shankar 9&sid=1 The Indian Council of Medical Research (ICMR) will soon commercialise its newly developed technology which is a process for diagnosis of infective (L3) stage larvae of Wuchereria bancrofti in vector mosquito Culex quinquefasciatus. To commercialise this newly developed technology, the ICMR has invited proposals from companies interested in commercializing this process.

India Attracting More Investments In BioPharma R&D But Still Lacks Recognition As Innovation Partner, Says BCG
June 27, 2011, Pharma Letter More than 70% of the 40 global BioPharma executives in a recent survey are satisfied with their R&D alliances in India, and three out of four expect to increase their R&D activities in India. Despite such positive appraisals, India continues to play a relatively small role in BioPharma innovation, according to a new report by the Boston Consulting Group (BCG).

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Mergers & Acquisitions / Collaborations

DIPP Sets Tough Riders In Lifting FDI Caps Till 49%
July 22, 2011, Financial Express The governments plan to remove sectoral FDI caps below 49% would come with a set of riders as it wants to closely scrutinise sensitive sectors like insurance, news media and defence once the liberal regime is in place. The department of industrial policy and promotion (DIPP), which earlier suggested 49% as the lower threshold for FDI cap, now wants to make it mandatory for all joint ventures seeking approval to increase foreign investment to 49% to have Indian citizens as their MD and CEO. Such firms should also have a governmentnominated director on their boards.

Planning Commission deputy chairman Montek Singh Ahluwalia on Monday endorsed allowing 100% foreign direct investment (FDI) in the pharmaceutical sector. "I endorse the view that there should be no case for rollback from 100% FDI," Ahluwalia said in response to a question posed to him at a conference. Large multinational pharma companies that have of late been acquiring Indian companies, known for their generics business, have opposed any move to reduce the ceiling amid pressure from local industry lobbies. Industry groups backed by domestic players have been seeking restrictions on mergers and acquisitions arguing that India would turn into a contract manufacturing centre and would lose its edge.

Glaxo Will Price Its Drugs 25-40% Cheaper In India
July 23, 2011, DNA Money GlaxoSmithKline Pharmaceuticals will sell its drugs at prices at least 25% less than those it charges in the US. This is as per the tier-pricing model the company has adopted, under which prices are decided based on a countrys gross domestic product. The company on Friday launched two drugs, Revolade and Votrient, in the local market. Revolade, an oral drug used in the treatment of a rare chronic blood disorder that involves depletion of platelets, is priced at Rs28,000 per monthly dosage. On the other hand, Votrient, priced at Rs56,000 per monthly dosage, is used in treatment of advanced cancer of the kidney cells.

Lupin Mulls Sale Of Its Indian Unit That Markets Drugs

July 19, 2011, The Economic Times Lupin Limited , the world's largest maker of drugs to fight tuberculosis, is considering selling its unit that markets drugs in India, said two people with knowledge of the matter. Founding shareholders who own a combined 47% of the Mumbai-based company have started the process of finding a buyer for the operations, said the people, who declined to be identified because the discussions are private. The Indian business may be worth at least $1 billion, one person said. Selling the Indian medicines unit, which accounted for 32% of Lupin's 57.1 billion ($1.3 billion) of revenue in the year ended March 31, may help finance investments in more profitable markets overseas.

Cheaper Clones Of Pricey Drugs May Be An SMS Away

July 14, 2011, The Economic Times (epaper page 6) d=6&pagesize=&edid=ET&edlabel=ETM&mydateHid=1407-2011&pubname=Economic+Times++Mumbai&edname=Mumbai&publabel=ET Consumers may soon be able to choose the cheapest brand of a drug prescribed by doctors. The government is set to roll out an SMS-based service where a consumer can send the brand name of a prescribed drug in a text message. He will get an SMS reply with a list of brands of the same medicine along with their prices, providing him an option to choose the cheapest brand.

Montek Bats For 100% FDI In Pharma

July 12, 2011, The Times of India

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Pharma Spectrum
The programme is being executed by the National Pharmaceutical Pricing Authority (NPPA), an autonomous government body responsible for monitoring prices of drugs to make medicines affordable for masses, along with the department of pharmaceuticals, a person familiar with the development said. Poised for the next wave of innovation, tuberculosis drugs are unlikely to mimic the pricing disaster' witnessed globally in the HIV/AIDS drugs segment, says Dr Melvin K. Spigelman, President and Chief Executive of TB Alliance. There has been a global effort to make new TB drugs affordable, he said, adding that stakeholders in the segment, including drug-makers, had met last month in Geneva on the issue. Lessons have been learnt from the pricing disasters' of HIV drugs, Dr Spigelman, told Business Line, adding that drug-makers have realised the social component' involved in developing multi-drug resistant (MDR) TB drugs.

Chemicals Ministry Directs NPPA To Coordinate With Health Ministry Against Circumvention Of DPCO Provisions
July 12, 2011, Pharmabiz, Joseph Alexander 0&sid=1 Taking a serious view of the alleged instances of drug manufacturers circumventing the provisions of the DPCO, the Chemicals and Fertilisers Ministry has directed the National Pharmaceutical Pricing Authority (NPPA) to take up the matter with the union health ministry to ensure that such practices do not continue. In the wake of the recent doping instances by the sports persons, Minister of State for Chemicals and Fertilizers Srikant Kumar Jena reviewed the situation concerning the composition of various multivitamin drugs etc, being sold in the market. He reviewed the control of NPPA over various multi-vitamins and mineral tablets/capsules etc being marketed in the country.

NPPA Asks Pharma Cos Not To Change Prices Fixed For Scheduled Bulk Drugs While Review Petition Under Process
June 30, 2011, Pharmabiz, Joseph Alexander 7&sid=1 The National Pharmaceutical Pricing Authority (NPPA) has warned the companies against hiking the prices of bulk drugs under the scheduled category and its formulations while review petition is under process after the agency fixing the prices. The NPPA has asked the industry to make fresh application for revision of prices, if companies want to do so during this window period. The stern instruction comes from the price monitoring agency after it reportedly came across some instances in which the companies were conveniently dodging the prices fixed on the grounds of moving review petitions. There was rather confusion, if not deliberate act to dodge prices, among the industry with regard to whether the old or new prices should be followed. This is aimed at clarifying this point, sources in the NPPA said.

NPPA Revises Prices Of Three Bulk Drugs, 100 Formulation Packs

July 5, 2011, Pharmabiz
bulk 3&sid=1 The National Pharmaceutical Pricing Authority (NPPA) has revised prices of 100 formulation packs and three bulk drugs, namely cefadroxyl monohydrate, metronidazole and metronidazole benzoate. The agency has also removed methylprednisolone from the list of Scheduled drugs. In exercise of the powers, conferred by sub-paragraph (1) of paragraph 3 of the Drugs (Prices Control) Order, 1995 read with SO 637 (E), dated the September 4, 1997 issued by the Ministry of Chemicals and Fertilizers, the National Pharmaceutical Pricing Authority hereby notify that bulk drug methylprednisolone does not come in the category of scheduled bulk drugs...............

Trade & Others

Chemists Fear Rs 5k Crore Hit If Antibiotics Sale Curbed
July 25, 2011, Business Standard Chemists across the country are up in arms against the health ministrys plans to restrict the sale of 90 commonly prescribed antibiotics as they argue it may

Next-Gen TB Drugs Will Be Immune To Pricing Disaster

July 3, 2011, Hindu Business Line

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lead to an estimated loss of business worth Rs 5,000 crore for the retail medical shops. All India Organisation of Chemists and Druggists (AIOCD), the apex body of over 700,000 licensed medicine sellers, fears the move will make chemists responsible for ensuring the authenticity of a prescription. Any sales, carried against prescriptions from unregistered medical practitioners may invite fine and imprisonment to the chemist, says the draft rule being worked out by the ministry.

Intel To Provide Technology Platform Solutions To Pharma Supply Chain Management

July 15, 2011, Pharmabiz, Nandita Vijay 5&sid=1 Chip maker Intel is now looking to provide technology platform solutions in the pharmaceutical supply chain management. In this regard, it has made maiden efforts to sensitize the small and medium scale enterprises(SMEs) on the advantages of using Information Technology in their business. The company has defined a strategy Technology for the next billion users to help companies in the pharma supply chain management to transform their operations from basic applications of information technology to a more broad based business intelligence tool.

Overdose Of Expired Antibiotics Killing Ailing Pharma Companies

July 20, 2011, DNA Hindustan Antibiotics Ltd (HAL) in Pune is sitting on unsold antibiotics worth Rs21.79 crore and 40% of these lying in the companys godowns have expired, says a June audit report. The firm the countrys first public sector company has dues of Rs19 crore since 2008. It achieved Rs85 crore production in 2010-11, but drugs worth more than Rs20 crore were left unsold. HAL insiders say the company with 900 employees has the potential for revival but there is a deliberate attempt to kill it. Union agriculture minister Sharad Pawar, who was president of the Hindustan Antibiotics Mazdoor Sangh (HAMS) for 13 years, had played a key role in the companys revival. MP Supriya Sule, Pawars daughter, has been leading HAMS for the past one year.

Competition Commission Directs USV Not To Terminate Its C&F Agency With Santuka Associates
July 13, 2011, Pharmabiz, Peethaambaran Kunnathoor 8&sid=1 The Competition Commission of India on July 1 this year made absolute the interim order it passed on 16.05.2011 under section 33 of the Competition Act 2002 directing the Mumbai-based manufacturing company US Vitamins Ltd not to terminate its C&F agency with Santuka Associates Pvt Ltd based at Cuttack in Orissa. Further, the Commission had wanted the national trade body, All India Organization of Chemists and Druggists (AIOCD) led by Jagannath S Shinde, not to issue any direction or threat to USV Ltd for terminating its C&F agency with Santuka Associates, the informant (petitioner).

Pharma Cos Ride New Products, Log 13.5% Growth

July 18, 2011, Financial Express The domestic pharma industry continued to clock double-digit growth of 13.5% during the April-June quarter of the financial year. This is marginally up against the growth registered in the corresponding quarter of the previous year during which the comparable growth stood at 12.6%, according to pharma research agency, Aiocd Awacs. The healthy growth in the domestic formulations business has mainly come on the back of new product launches and entry of pharma firms into unexplored and underexplored non-metro and rural markets. Monthly sequential growth in June stood at 12.6%, a few shades lower than the growth in May, which stood at slightly over 14%.

Pfizer, Ranbaxy Tie Up With ITC To Sell Over-The-Counter Products In Rural Areas
July 12, 2011, Hindu Business Line e2219121.ece?homepage=true Ranbaxy's pain product Volini or Pfizer's top-grosser multivitamin Becosule, for instance, may no longer be just an urban main-stay, and could well be available in rural markets, as well. Drug-majors Ranbaxy and Pfizer have formalised an alliance with fast-moving-consumer-

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goods (FMCG) company ITC to tap the rural markets for their over-the-counter (OTC) products. The development was confirmed by sources from both pharmaceutical companies, though details were not disclosed. While it is not clear whether the OTC products would be available only with chemists in the hinterland or the products would trickle into grocery and kirana stores as well the pharmaceutical industry has been long advocating a formal policy for OTC products. The first email service I used was Sabeer Bhatias Hotmail. Finding that to be clunky after Microsoft bought the company in December 1997 for $400 million, I moved to the cooler, hipper Yahoo Mail in October 1999. Then came Google and its fall-in-love service Gmail, to which I moved in January 2005. Six years after I used it, in March 2011, I finally paid $5 (Rs 225) to get 20 GB of extra storage space. Yahoo, like dozens of other email providers, knew that Hotmail was offering free email and got into the business. Google knew that the email business had proliferated and was free and it got into the business.

CII Releases 'Code On Business Ethics'

July 5, 2011, Express India In a move to check corruption and ensure transparency among business communities, the Confederation of Indian Industry (CII) on Tuesday released a 'Code on Business Ethics' for its member companies. "(The Code) is intended to strengthen the institutional framework that would help drive ethical practices in the organisation. CII wanted to take a lead in this initiative," CII PresidentDesignate Adi Godrej told reporters after releasing the Code at the CII-National Council Meeting. CII would would distribute the Code to its 8,000 member companies and though it was not mandatory to follow it, they were expected to follow it as a guide, Godrej, also the Chairman of Godrej Group, said.

Exports To Get Hit As DGFT Yet To Issue Notification Postponing Barcoding System Beyond July 1
June 28, 2011, Pharmabiz, Joseph Alexander 0&sid=1 With the Director General of Foreign Trade (DGFT) is yet to issue notification changing the date on the implementation of barcoding system from the earlier schedule of July 1, confusion and apprehension have gripped the industry and the exports are likely to be hit if notification does not come in time. The commerce ministry had already sent out strong feelers to the industry that the proposed 2D barcoding and tracking system would not be imposed from July 1 as notified already and it would be delayed to be enforced in a phased manner from October 1, 2011. However, no notification has come yet from the DGFT so far, putting the industry in a fix.

Bausch & Lomb enters pharma mkt;to sell drugs for eye diseases
June 30, 2011, Mint 54/Bausch-amp-Lomb-enters-pharm.html Foraying into the Indian pharmaceutical market, eyecare firm Bausch & Lomb Thursday said it has entered into a deal with Bangalore-based Micro Labs for contract manufacturing of medicines to treat eye diseases. Bausch & Lomb already has good presence in the domestic eyecare market, especially in segments such as vision care and surgical instruments. As per the memorandum of understanding (MoU), Bausch & Lomb will utilise facilities of Micro Labs to manufacture its pharmaceutical products for the Indian market. We will use their (Micro Labs) facilities to put out our products in the market, Bausch & Lomb India & Thailand managing director Harish Natarajan told reporters here.

Schedule HX On Antibiotics A Concern: Chemists

June 27, 2011, Business Standard -hxantibioticsconcern-chemists/440443/ The government's recent move to amend the Drugs & Cosmetics Rules 1945 and insert Schedule HX on the misuse of antibiotics would only hit the availability of antibiotics for 65 per cent of rural and urban population, J S Shinde, president, All India Organisation of Chemists & Druggist (AIOCD), has said. In a memorandum submitted to Prime Minister Manmohan Singh, President Pratibha Patil, health minister Gulam Nabi Azad and the Drug Controller General of India, Shinde said, We appreciate the move

Competition Commission Legitimises Cartelisation

June 30, 2011, Hindustan Times


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and support the government in curbing the misuse of antibiotics and other drugs. While Schedule HX is formulated to curb the misuse of antibiotics in view of the news of 'super bug',....

July 7, 2011, Hindu Business Line Often seen as an extension of the pharmaceutical business, the country's estimated Rs 2,000-crore animal health industry is looking to raise its profile locally, besides aspiring to become food factory to the world. Be it the milk you drink, the eggs or meat you eat animal health takes care of human health, says an industry veteran, underlining the need for quality standards on products for domestic consumption and exports. Calling for an independent regulatory authority, he says, at present the Drug-Controller General of India (DCGI) oversees animal health products as well. With a potential to grow three-fold, given the right regulatory impetus the opportunity waiting to explode in domestic animal health is, nevertheless, not going unnoticed, say industry-insiders.

Operating Profit Of 100 Indian Pharma Cos Jumps By 22%, Net Sales Up By 13% In 2010-11
June 27, 2011, Pharmabiz, Sanjay Pingle 2&sid=1 Indian pharmaceutical industry reported a satisfactory performance during 2010-11 with only marginal growth in sales and operating profits. This is despite stiff competition, challenging economic conditions, cost cutting measures in the US and Europe and government intervention in highly regulated markets. The earnings before depreciation, interest, tax and adjustments (EBDITA) of Pharmabiz sample of 100 listed pharma entities increased by 21.9 per cent to Rs.23,317 crore from Rs.19,133 crore in the previous year. The EBDITA margins improved to 22.5 per cent from 20.9 per cent. These companies recommended handsome dividend to shareholders and created healthy reserve position during 2010-11.

Cipla's Animal Healthcare Infringes Patent: US Court

June 30, 2011, Indian Commodity

Product Cipla has received an order from US court, ruling that sales of its animal healthcare product allegedly infringed a patent held by Merial. The sales of the PetArmor Plus have been suspended in the US. The company is in process of filling appeal against the order. The company's net profit for the quarter ended March 31, 2011 has declined by 22.33% at Rs 214.00 crore as compared to Rs 275.53 crore for the quarter ended March 31, 2010. Its total income has increased by 19% to Rs 1689.55 crore for the quarter under review from Rs 1419.77 crore in the corresponding previous quarter.

Import Of Drugs Under Price Control May Be Hit

June 27, 2011, Business Standard The import of medicines under price control may be stuck for at least a month, as apex drug price regulator, National Pharmaceutical Pricing Authority (NPPA), is unlikely to consider price revision applications for dozens of imported drugs during its monthly price review meeting next week. Every consignment of imported medicine that fall under the scheduled list of price-controlled drugs needs an approval from the NPPA before it reaches the country's distribution channels. A delay in clearance would result in the stocks being stuck in the point of entry, industry sources said.

DBT Formulates Special Programme To Establish Institutional Level Biotech Hubs In North Eastern States
July 11, 2011, Pharmabiz, Ramesh Shankar 8&sid=1 Aiming to promote education and research in biology, life science and biotechnology in the north eastern states of the country, the Department of Biotechnology (DBT), ministry of science and technology, has

Animal Health
Animal Health Business Set To Take Wings

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formulated a special programme under which it will establish institutional level biotech hubs in the region. Senior officials in the DBT said that the broad purpose of the programme is to promote education and research in biotechnology, biology, life science and to attract brilliant young students to build their career in different fields of biological sciences and biotechnology. family. I could have had more options if I had consulted a doctor then, said the south Mumbai resident.

New Appointments / Transfers

R S Gujral Appointed Finance Secy
July 20, 2011, The Times of India Finance minister Pranab Mukherjee is nearly ready with his A-team for the next budget with the government on Tuesday appointing revenue secretary Raminder Singh Gujral as the new finance secretary. Gujral, who is higher in the seniority list among his batchmatesexpenditure secretary Sumit Bose and economic affairs secretary R Gopalan was the surprise pick given that he was not in the reckoning till his appointment in the revenue department three weeks ago. TOI was the first to report that Gujral, a 1976 batch IAS officer from the Haryana cadre, would be the next finance secretary.

DBT Completes Draft Guidelines On Preclinical Trial Data For Similar Biologics
June 27, Shirodkar 2011, Pharmabiz, Suja Nair 0&sid=1 The Department of Biotechnology (DBT) has drafted a set of guidelines for conducting pre-clinical trials of biosimilars in the country. The Department is now waiting for draft notes on clinical trials for biosimilars from the Drug Controller General of India (DCGI) to complete this work on guidelines. Manufacture and marketing of biosimilars in India are currently governed by the Environment Protection Act of 1970 and the Drugs and Cosmetic Act. Even though biosimilars is regulated under these provisions of these acts, there is no specific set of rules this sector in the country today.

BJP's Sushil Modi To Head GST Panel

July 18, 2011, Times of India After differing over almost everything for several months, including goods and services tax (GST), there is finally consensus between the Congress and the BJP on appointing Bihar deputy chief minister Sushil Kumar Modi as the new head of the empowered group of finance ministry that is looking to usher in the biggest tax reform in the country. Sources said the BJP -- which had earlier advised Modi against chairing the empowered committee -- has now given the green signal for his appointment and his formal election would take place on Monday. State finance ministers are scheduled to meet Union finance minister Pranab Mukherjee at 11.30 am on Monday, which will be followed by a meeting of the empowered committee, where Modi will be formally elected.

Medical Diagnostics / Devices

Conventional Test May Fail To Detect Breast Cancer Early
July 8, 2011, Hindustan Times Last week, when doctors handed over the diagnosis of advanced breast cancer to Zaheera Khan, 74, she wished she had taken note of the changes she had been feeling in her breasts. Doctors told Khan (name changed on request) that the tumour in her right breast had got fixed to her chest wall and therefore surgery was not a viable option. For the past six months, I had been feeling something lumpy and hard in my right breast. I knew something was amiss but I was scared and didnt even tell my

NRN To Head Public Health Council As Chairperson

July 12, 2011, The Times of India (epaper page 10) 33

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Pharma Spectrum d=10&pagesize=&edid=TOI&edlabel=TOIM&mydateHid=12 -07-2011&pubname=Times+of+India++Mumbai&edname=Mumbai&publabel=TOI Infosys founder N R Narayana Murthyis the new chairperson of the Public Health Foundation of India (PHFI).The governing council on Monday unanimously elected Murthy to succeed Dr Y V Reddy, who was functioning as the interim chairman since March 2011. The post had been lying vacant since former MD of McKinsey & Co,Rajat Gupta,stepped down after the US securities and exchange commission named him a coconspirator in an insider trading scam along with billionaire Raj Rajaratnam. Department of Pharmaceuticals will nominate 60 members representing the NGOs and the consumer organisations, with a view to give adequate weight to the public interest organisations, according to a notice by the DoP.......... The forum will have two members from each of the pharma industry associations like IDMA, BDMA, OPPI, IPA, CIPI, FICCI, FOPE, SPIC, ASSOCHAM and CII. Earlier there was only one member from each of the association. There will be also ten members from chemists associations.

DoP Reconstitutes Board Of Governors For NIPER After Long Gap

June 27, 2011, Pharmabiz, Joseph Alexander 3&sid=1 The Department of Pharmaceuticals (DoP) has reconstituted the Board of Governors for the premier National Institute of Pharmaceutical Education and Research (NIPER), Mohali, after it remained without a board for a long time. The Department has constituted the 20-member Board with Dr V M Katoch, the Secretary of the Department of Health Research, as the chairperson. Director of the NIPER, Joint Secretary in-charge of Pharmaceutical Industry in the DoP, Secretary, Technical Education in the Government of Punjab, Financial Advisor to the DoP, Drug Controller General of India (DCGI), and Membersecretary of the All India Council for Technical Education (AICTE) will be ex-officio members

Novartis & Apos; S Ranjit Shahani: Patenting Innovation &Apos;Is The Best Protection For Patients &Apos
July 19, 2011, Stainstrapsdress Concern is growing that patents hinder access to lifesaving drugs in developing countries. While India clearly has made progress in advancing intellectual property rights, more needs to be done to align the countrys approach with international obligations and standards. In an interview with India Knowledge@Wharton, Ranjit Shahani, country president of the Novartis Group in India, spoke about the importance of safeguarding intellectual property and its impact on affordability and access to medicine. Novartis is challenging the denial of a patent for its cancer drug Glivec, as it is known in India. (In the U.S., the drug is called Gleevec.) Shahani was president of the Organization of Pharmaceutical Producers of India (OPPI) from 2001 to 2007, is president of the Bombay Chamber of Commerce and Industry and chairman of INTERPAT in India, and was on the council of the International Federation of Pharmaceutical Manufacturers & Associations. He has lobbied for strong product patent law, data protection, liberalization of the price control mechanism, and legislation against counterfeit drugs.

OPPI Related News

Pharmaceutical Advisory Forum To Be Revamped With 60 Nominated Members
July 25, 2011, Pharmabiz, Joseph Alexander tml The Pharmaceutical Advisory Forum, an official platform of all the stakeholders and consumers in the pharmaceutical sector under the Ministry of Chemicals and Fertilisers, will be revamped and expanded by including more members from the non-governmental and consumer organisations. Instead of the earlier number of 30 members, to be nominated into the body, now the

Planning Commission Deputy Chairman Montek Singh Ahluwalia Endorses 100% FDI In Pharma
July 12, 2011, The Economic Times Planning Commission deputy chairman Montek Singh Ahluwalia on Monday endorsed allowing 100% foreign direct investment (FDI) in the pharmaceutical sector. "I endorse the view that there should be no case for

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rollback from 100% FDI," Ahluwalia said in response to a question posed to him at a conference........ While the foreign companies have supported the move saying that a reduction in the ceiling would mark the first instance of a sectoral cap being reduced in India. "FDI should not stand for funds deserting India, "Novartis president Ranjit Shahani, who is president of the OPPI, a lobby group representing multinational drug companies had told TOI last week. OPPI has argued that the government has tools available with it to address concerns raised by the domestic players and civil society groups.

Organisation of Pharmaceutical Producers of India