Pharma Spectrum                            Organisation of Pharmaceutical Producers of IndiaVolume 5                      ...
Pharma SpectrumInternational                                                 But as EvaluatePharma reminds us in its lates...
Pharma Spectrumversion of Solodyn minocycline hydrochloride and             system of Swiss drug major Roche (ROG: SIX), t...
Pharma Spectrumof the 72 obese men that AZ had planned to enroll in the    international reference pricing system that lin...
Pharma Spectrum                                                              Health and Human Services during the bilatera...
Pharma Spectrumbegin collaborative research on TB under the Indo-US         The topical drug is a non-steroidal treatment ...
Pharma SpectrumGSK Unit To Buy Basilea Eczema Drug                           India Firm Shakes Up Cancer DrugFor $227m    ...
Pharma SpectrumU.K. Pharma Balks At Value-Based                            Trade Organisation, resisting attempts by the U...
Pharma SpectrumPfizer has also set aside more money--$330 million--to        Australia’s PIC Reports To Ministers Oncover ...
Pharma SpectrumCRAMS Holds Big                  Opportunity          For      The mere passage of a law that requires drug...
Pharma SpectrumUS FDA May Impose Huge Drug UserFee On Generic Imports Soon, India To                         New Appointme...
Pharma SpectrumScientists Float Group                  To     Protect        medicines. The department of pharmaceuticals ...
Pharma Spectrumof seven companies were suspended             after   drugs    approvals given by the competent authority s...
Pharma SpectrumThe Department of Health has set physical targets set to     Amravati, 46 in Aurangabad and 29 in Mumbai re...
Pharma SpectrumTalking to Pharmabiz, Drug Controller General of India       Eli Lilly and Co. focusing on the growing diab...
Pharma Spectrum"Six new AIIMS in the country will start functioning by       caused by invasive non-typhoidal Salmonella (...
Pharma Spectrumsaid. "Our Indian companies are just beginning to realise     After keeping it dormant for many years, thet...
Pharma SpectrumMinistries Oppose                PMO       View       On      GSK Extends $2.6 Billion Bid ForPharma Deal R...
Pharma Spectrum by OPPI
Pharma Spectrum by OPPI
Pharma Spectrum by OPPI
Pharma Spectrum by OPPI
Pharma Spectrum by OPPI
Pharma Spectrum by OPPI
Pharma Spectrum by OPPI
Pharma Spectrum by OPPI
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Pharma Spectrum by OPPI

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July 2012 Issue of Organization of Pharmaceutical Producers in India

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  1. 1. Pharma Spectrum Organisation of Pharmaceutical Producers of IndiaVolume 5 Issue 7 July 2012 INDEX INTERNATIONAL 1. IPR 1 2. Regulatory 2 3. New Products 3 4. R&D / Clinical Trials 4 5. Mergers & Acquisitions / Collaborations 5 6. Pricing 6 7. Trade & Others 7 8. Biotechnology 10 9. Medical Diagnostics / Devices 10 10. New Appointments 10 DOMESTIC 1. IPR 10 2. Regulatory 11 3. New Products 14 4. R&D / Clinical Trials 14 5. Mergers & Acquisitions / Collaborations 16 6. Pricing 18 7. Trade & Others 19 8. Biotechnology 22 9 Medical Diagnostics / Devices 23 10. New Appointments 24 11. OPPI Related News 24 Organisation of Pharmaceutical Producers of India 0
  2. 2. Pharma SpectrumInternational But as EvaluatePharma reminds us in its latest World Preview report, released at this weeks BIO conference, 2012 is far from the end of pharmas patent woes. NextIPR year provides something of a respite, with only $29 billions worth of drugs losing exclusivity.As Compulsory Licensing Spreads, Merck Loses A Patent Ruling OnDrugmakers Adapt Blockbuster NasonexJune 22, 2012, Fierce Pharma June 18, 2012, Fierce PharmaThere is the concept associated with evolution that you Even as the clock is ticking down on the patent for itsmust adapt or die. Now some experts are suggesting the super blockbuster Singulair, Merck got smacked Fridaysame thing for drugmakers when it comes to the growing with a negative decision in its battle with genericmakerthreat of compulsory licensing. Now that China is Apotex over Mercks blockbuster Nasonex spray. Afollowing India into this realm, which allows countries to federal judge in New Jersey ruled against Merck, sayingessentially strip companies of patents if they deem it in Apotexs generic did not step on Mercks patent, thenthe public interest, the tension among big drug separately ruled against Apotex, throwing out its claimdevelopers is rising. that Mercks patent on the nasal spray is invalid.LiveMint quotes a research company in the U.K. saying Mercks general counsel Bruce Kuhlik tells Reuters it maythe research-oriented companies "will have to appeal the decision, while Merck spokesman Ron Rogersrestructure their business plans in emerging markets," to tells Bloomberg, "As far as we know, the FDA has notcompete. Strategies will include making their drugs approved Apotexs application. We do not expect genericcheaper themselves in the countries where the threat of competition near-term." Apotex declined comment.compulsory licensing exists and making sure they areavailable to more poor patients to cut off the incentive China Now Carries A Big Compulsory-to invoke the maneuver. Licensing Stick June 11, 2012, Fierce PharmaBig Pharma Firms May Learn To LiveWith Compulsory Licensing Drugmakers can count compulsory licensing among theJune 22, 2012, Livemint new pitfalls of Chinas huge-and-growing drug market. Thanks to amended intellectual property laws, theWith China amending its patent law on compulsory Chinese government can now force generic drugs ontolicensing soon after India granted the first such permit in the market before branded meds lose patent protection.the country, innovator pharmaceutical firms that bankon patent protection for growth are under pressure to China isnt alone in this, of course; India recently causedrevamp sourcing, distribution and pricing strategies, a dust-up by compelling Bayer to license its cancer drugindustry experts said. Nexavar to Natco Pharma, which promised to sell its copycat version for $176 per month, compared with“The research-oriented companies, which mostly focus Bayers $5,600 monthly price.on the patented technologies that give them an edge,will have to restructure their business plans in emerging US Firm Sues Zydus Cadila Subsidarymarkets now as local governments are taking all possible For Infringement Of Patentsmeasures to lower the healthcare cost,” said a London-based life sciences partner at a global consultant. June 12, 2012, Business Standard A complaint for infringement of patents with regard toBeware: Patent Losses To Climb Back drug for treatment of acne has been filed against ZydusTo $56B By 2015 Pharmaceuticals USA, Inc, a fully owned subsidiary ofJune 20, 2012, Fierce Pharma Ahmedabad-based pharma major Cadila Healthcare Ltd (Zydus Cadila) in a district court of US.For years weve been anticipating 2012 as the steepestpatent cliff, the year when the worlds biggest drugs This complaint petition has been filed by one Arizona-would be slammed with generic competition. No doubt based Medicis Pharmaceutical Corporation (MPC). Zydusabout it, $67 billion in drug sales at risk from patent USA has been accused of seeking approval from theexpirations is a whopping big figure. United States Food and Drug Administration (FDA) to commercially manufacture, use, and selling of a generic Organisation of Pharmaceutical Producers of India 1
  3. 3. Pharma Spectrumversion of Solodyn minocycline hydrochloride and system of Swiss drug major Roche (ROG: SIX), the world’sextended release tablets, before the drug’s patents biggest producer of cancer drugs.which is with MPC, expires. The EMA says this includes looking at whether theChina Amends Patent Law In Fight For deficiencies have an impact on the overall benefit-risk profile for any of the products involved. However, itCheaper Drugs points out that there is at present no evidence of aJune 8, 2012, Moneycontrol.com negative impact for patients and, while the investigations are being conducted, there is no need forChina has overhauled parts of its intellectual property patients or health care professionals to take any action.laws to allow its drugmakers to make cheap copies ofmedicines still under patent protection in a move likely US To Charge Fee On Generic Drug Saleto unnerve foreign pharmaceutical companies. TheChinese move comes within months of a similar move by ApplicationIndia to effectively end the monopoly on an expensive June 21, 2012, Business Standardcancer drug made by Bayer AG by issuing its first so-called "compulsory licence". All generic pharmaceutical companies, including Ranbaxy Laboratories, Cipla, Dr Reddy’s Laboratories, Lupin,Similar action by China will ring alarm bells in Big Glenmark and Torrent Pharma, might soon have to pay aPharma, since the country is a vital growth market at a fee to the US drug regulator when they seek itstime when sales in Western countries are flagging. The permission to sell their products there.amended Chinese patent law allows Beijing to issuecompulsory licences to eligible companies to produce America is the world’s largest drug market. A Genericgeneric versions of patented drugs during state Drug User Fee Act is on the way, to enable the US Foodemergencies, or unusual circumstances, or in the and Drugs Administration (FDA) to levy a user fee ofinterests of the public. around $100,000 on each generic drug application filed for approval, it is learnt. The new norms are likely to beCipla Losses Appeal In US Court For introduced from October.Animal Healthcare Product FDA Panel Turns Thumbs Down OnJune 8, 2012, The Economic Times Sanofis Anti-Clotting DrugDrug firm Cipla today said it has lost an appeal in a US June 20, 2012, Fierce Biotechcourt over a patent case against Merial Ltd regarding ananimal healthcare product. The company had moved the Sanofis attempt to gain its first new drug approval inUS Court of Appeals in Washington against a ruling by two years experienced another setback today as aDistrict Court Georgia that held that the companys sales committee of external experts decisively voted againstof animal healthcare product, PetArmor Plus infringed a an OK for semuloparin, a treatment designed to preventpatent held by Merial Ltd, a subsidiary of Sanofi-Aventis, blood clots among patients receiving chemotherapy.and suspended sales of the product in the US. The advisers concluded that Sanofi didnt proffer a clear"Company has now received an order from the Federal picture of who would benefit from the treatment,Circuit wherein it has affirmed the order of the District particularly worrying given their risk of bleeding. The 14Court with two judges ruling against the company and to 1 landslide likely buried any remaining chance of aone judge in favour of the company," Cipla said in a near-term approval for the treatment.filing to BSE. AstraZeneca’s Obesity Drug StudyRegulatory Stopped After Adverse Event June 20, 2012, Fierce BiotechEMA Investigating Deficiencies In Score one against AstraZeneca in the obesity drug game. Safety reviewers called a stop to the London-based drugRoches Drug Safety Reporting giants Phase I study of an experimental obesityJune 22, 2012, Pharma Letter treatment after a man on the injected drug became sick.The European Medicines Agency revealed yesterday that The drug, code named AZD2820, is a peptideit is working with national medicines agencies to melanocortin-4 receptor partial agonist from AZsinvestigate deficiencies in the medicine safety reporting collaboration with the Cranbury, NJ-based biotech Palatin Technologies. The potential bad reaction hit one Organisation of Pharmaceutical Producers of India 2
  4. 4. Pharma Spectrumof the 72 obese men that AZ had planned to enroll in the international reference pricing system that links thetrial, and the man might have suffered from an allergic price of medicines in Germany to those in countries likereaction to his first shot of the drug. Greece; and a medicines assessment system that links the price of new medicines to generics.US FDA Calls For More Efficacy Data OnPfizers Tafamidis NDA Following US Senate And House Pass OfJune 19, 2012, Pharma Letter FDA Reforms, Now Comes The Detail June 5, 2012, Pharma LetterThe US Food and Drug Administration yesterday issued acomplete response letter regarding drugs behemoth Now that the US House of Representatives and thePfizer’s New Drug Application for tafamidis meglumine, Senate have passed HR 5651 and S 3187 (the FDA Safetyrequesting the completion of a second efficacy study to and Innovation Act), respectively, focus will move to aestablish substantial evidence of effectiveness prior to conference committee, which will iron out differencesan approval. between the bills and reach a compromise, comments Karl Karst on law firm Hyman, Phelps & McNamara’s FDAThe Agency has also asked for additional information on Law Blog.the data within the current tafamidis NDA. Tafamidis is anovel, investigational medication for the treatment of Both bills reauthorize and amend old (PDUFA andtransthyretin familial amyloid polyneuropathy (TTR-FAP) MDUFA) and establish new (GDUFA and BsUFA) user feein adult patients with symptomatic polyneuropathy to statutes, permanently reauthorize the Bestdelay neurologic impairment. Pharmaceuticals for Children Act and the Pediatric Research Equity Act, and create several new provisionsFDA Approves Glaxosmithklines New of law, among other things, he notes.Combo Vaccine MenHibrixJune 18, 2012, Pharma Letter New ProductsThe US Food and Drug Administration has approved USpharma giant GlaxoSmithKline’s MenHibrix(meningococcal groups C and Y and Haemophilus b Dr Reddy’s Laboratories Launchestetanus toxoid conjugate vaccine), a combination Parkinson’s Drug In USvaccine for infants and children aged six weeks through May 8, 2012, The Economic Times18 months, for prevention of invasive disease caused byNeisseria meningitidis serogroups C and Y and Dr Reddys Laboratories has launched in the US marketHaemophilus influenzae type b. ropinirole hydrochloride XR (extended release) tablets used to treat the signs and symptoms of ParkinsonsThe basis for FDA approval of MenHibrix included data disease. Ropinirole hydrochloride XR tablets are theGSK submitted from clinical trials conducted in the USA, bioequivalent generic version of Requip XL tablets, aMexico, Australia, Belgium and Germany over seven registered trademark of pharma giant SmithKlineyears in which 7,521 infants and toddlers received at Beecham.least one dose of MenHibrix. The Indian company has obtained the approval of theGerman Model For Assessment Of New United States Food and Drug Administration for its abbreviated new drug application for ropiniroleMedicines Slammed By EU Pharma hydrochloride XR tablets to launch a generic product.Leaders Requip XL had reported sales of around $58 million forJune 11, 2012, Pharma Letter the 12 months period ended March 2012 in the US market according to IMS Health.Leading pharmaceutical companies in Europe,represented in the European Federation of Ranbaxy To Relaunch Bessling BrandPharmaceutical Industries and Associations (EFPIA), May 29, 2012, The Economic Timesmeeting in Berlin last Friday, called on the Germangovernment for urgent action to protect patient access Ranbaxy Laboratories has received US drug regulatorsto new medicines and ensure that Germany remains a approval to relaunch one of its best selling brand in thehome for pharmaceutical innovation. US after being banned for nearly four years. US Food and Drug Administration (FDA) has approved Absorica, a“Recent years have seen the introduction of a series of novel, patented brand formulation of isotretinoin that ispunitive measures in Germany. A 16% rebate; an used to treat acne. Organisation of Pharmaceutical Producers of India 3
  5. 5. Pharma Spectrum Health and Human Services during the bilateral meetingThe drug has been developed by its Canadian partner between India and the US.Cipher Pharmaceuticals to whom Ranbaxy will payroyalties on net sales of the drug, Ranbaxy said in a The primary aim of this collaboration is to initiate arelease. "Absorica will be the flagship brand for health research relationship between the two countriesRanbaxys specialized dermatology sales force," said to generate a better understanding of the molecular andRanbaxys Americas senior VP and regional director biological mechanisms underlying diabetes, toVenkat Krishnan said. characterize the genetic, social and environmental determinants, and to identify innovative approaches for improving prevention and treatment of diabetes.R&D/Clinical Trials Hit By Red Tape, Clinical Trial Companies Eye South-East Asia ForGlobal R&D Spending Rises 8.2% In ExpansionFY11 June 13, 2012, The Economic TimesJune 22, 2012, Hindu Business Line Pushed to the wall by an overly cautious drug regulatorGlobal R&D spending, after witnessing a decline in fiscal and an alarmist Indian government, clinical trial2010, has grown by 8.2 per cent in FY2011, according to companies are looking at South East Asian countries toa Zinnov study. India’s prominence as an R&D hub is expand their business and escape the red tape of Indiangrowing with the likes of IBM, SAP, Oracle and others authorities.setting up R&D centres and currently, 30 per cent of thetop 1000 R&D spenders across verticals have a presence Clinical research companies (CROs), that were aspiringhere. to become billion- dollar companies by 2010, had to rework their plans after a Parliamentary StandingThis growth has been primarily driven by organisations in Committee report questioned the allegedly unfair andthe semiconductor, industrial and consumer hardware unethical trials conducted on Indian patients .and electrical and electronic sectors. Alzheimer’s Vaccine Trial ProvesResearchers At CCMB Make SuccessfulBreakthrough Discovery To Contain June 8, 2012, Zee NewsDiabetes By Deactivating A GeneJune 21, 2012, Pharmabiz, A Raju Scientists have found a new vaccine to be effective against Alzheimer’s disease. The vaccine, CAD106, canA team of researchers at the Centre for Cellular and prove a breakthrough in the search for a cure for thisMolecular Biology (CCMD) in Hyderabad have come out seriously debilitating dementia disease. Alzheimer’swith a major breakthrough discovery to contain diabetes disease is a complex neurological dementia disease thatby successfully deactivating a gene to regulate the is the cause of much human suffering and a great cost tofunctioning of beta cells in pancreas. society.The malfunction of these beta cells leads to non- According to the World Health Organisation, dementia isproduction of insulin or production of ineffective insulin. the fastest growing global health epidemic of our age.The research team conducted the experiments on the The prevailing hypothesis about its cause involves APPmouse model. In this model, the researchers could (amyloid precursor protein), a protein that resides in thesuccessfully regulate the mass of beta cells in pancreas outer membrane of nerve cells and that, instead of beingof the mouse. broken down, form a harmful substance called beta- amyloid, which accumulates as plaques and kills brain cells.India And US Sign Agreement OnCollaboration In Diabetes Research India, US To Begin CollaborativeJune 19, 2012, The Economic Times Research On Tuberculosis SoonIndian and US have signed an agreement on collaboration June 5, 2012, PharmaBizin Diabetes Research. The agreement was signedbetween Ghulam Nabi Azad, Union Minister for Health Even as tuberculosis (TB) continues to threaten the livesand Family Welfare and Kathleen Sebelius, US Secretary, and wellbeing of thousands of people each year in India and several other countries, India and the US will soon Organisation of Pharmaceutical Producers of India 4
  6. 6. Pharma Spectrumbegin collaborative research on TB under the Indo-US The topical drug is a non-steroidal treatment in Phase IIvaccine action programme (VAP). development for psoriasis and atopic dermatitis, Research Triangle Park, NC-based Stiefel said in aThe main aim of this initiative is to build and enhance statement. Welichem ($WBI.TSX), headquartered inbiomedical and clinical research capacity in India by Burnaby, British Columbia, has gathered safety andestablishing long term longitudinal cohorts of TB patients efficacy evidence on the drug...........and their contacts (or other high TB risk patients) forstudies using state of the art research tools.Zerhouni Trumpets New R&D Mindset Mergers &At SanofiJune 1, 2012, Fierce Biotech Acquisitions /Sanofi has reorganized its research and developmentover the past couple of years, and R&D chief Elias CollaborationsZerhouni offered up some insights about the newmindset at the French drug giant. For example, the India, Norway To Extend Partnership Incompany has emphasized a focus on results of clinicalprograms over the scientific bureaucracy that has been Healthcare Sectorimplicated in the industrys lack of R&D productivity. June 21, 2012, The Economic Times"The project is what matters, not peoples titles,"Zerhouni said, as quoted by Bloomberg. "The least India and Norway have decided to extend by five yearshierarchical the model is, the better." its partnership in healthcare sector after the success of their joint efforts in delivering child and maternal health services. At a meeting in Oslo on Monday between HealthEli Lilly Opens Diabetes R&D Center In Secretary P K Pradhan and Norways Secretary GeneralChina from the Ministry of Foreign Affairs Bente Angell-HansenJune 1, 2012, BioSpectrum Asia signed a letter of intent to initiate Phase II of the Norway India Partnership Initiative (NIPI) on reducingEli Lilly officially opened the Lilly China Research and child and maternal mortality.Development Center (LCRDC) on May 30, keeping with itscommitment towards China. The center will focus on NIPI is a partnership between India and Norway todiscovering innovative diabetes medicines with novel improve delivery of child and maternal health services inmechanisms that can be tailored for the Chinese select states under the National Rural Health Missionpopulation to delay the progression of the disease. (NRHM). The partnership was initiated in 2006 by the Prime Ministers of India and Norway Manmohan Singh andAffecting nearly 90 million Chinese people, diabetes is a Jens Stoltenberg.significant national public health problem, due in part tolonger life expectancies, dietary changes and a Piramal In Talk To Buy US Contractsedentary lifestyle emerging in China. Differences in thegenetic makeup of Asian patients may also play a role in Drug Maker Cambridge For $200 Mdiabetes development and progression, and exploring June 16, 2012, Financial Expressthese differences is a priority for the LCRDC. Piramal Healthcare (PHL) is in talks to buy US contract drug manufacturer Cambridge Major Laboratories (CML)GSK Unit Stiefel Snags Rights To Skin for around $200 million, a person with direct knowledgeDrug For CAD$35M of the development said. “Early stage negotiations areMay 31, 2012, Fierce Biotech on and it will take a while to conclude the deal,” he said.Stiefel Laboratories has injected a new drug in mid-stagedevelopment into its dermatology pipeline. The PHL is the flagship company of the Ajay Piramal-ownedcompany, a unit of GlaxoSmithKline, has ponied up Piramal Group while the Wisconsin-based unlisted CMLCAD$35 million ($33.9 million) in an upfront payment to makes pharmaceutical intermediates and activeWelichem Biotech for rights to an experimental anti- pharmaceutical ingredients (APIs) used in drugs.inflammatory compound dubbed WBI-1001 for marketsoutside of China, Taiwan, Macao and Hong Kong. Organisation of Pharmaceutical Producers of India 5
  7. 7. Pharma SpectrumGSK Unit To Buy Basilea Eczema Drug India Firm Shakes Up Cancer DrugFor $227m Market With Price CutsJune 13, 2012, Financial Express (epaper June 16, 2012, The Economic Timespage 10) Indian pharmaceutical tycoon Yusuf HamiedGlaxoSmithK.ine is to buy Basilea’s new eczema drug revolutionised AIDS treatment more than a decade agoToctino for an initial 146 million pounds ($227 million) to by supplying cut-price drugs to the worlds poor -- andboost its Stiefel dermatology business, the two now he wants to do the same for cancer. Hamied,companies said on Thursday. The Swiss biotech company chairman of generic drugs giant Cipla, last month slashedis also entitled to further payments of up to 50 million the cost of three medicines to fight brain, kidney andpounds if the drug is approved in the United States, as lung cancer in India, making the drugs up to more thanwell as double-digit percentage payments o US sales four times cheaper.begning three years after launch. "I hope well cut prices of many more cancer drugs," he told AFP, adding that he wants to supply the cheaperPricing drugs to Africa and elsewhere. Drugmakers Warn German Pricing IsRoche Slashes MabThera Price In S. Killing InnovationAfrica To Drive Sales June 14, 2012, Fierce PharmaJune 20, 2012, Fierce Pharma As economies have wilted in Europe, Germany has beenDrugmakers are chafing under European price cuts. But all about austerity and how that is the only way to curemore and more, theyre cutting prices on their own in the E.U.s financial woes. But the backlash fromthe developing world. Its part of the strategy to increase drugmakers to German drug pricing has become soemerging markets sales, a recognition of the fact that significant that, for its own consumers, drugmakers warndeveloping countries, a., cant afford drugs at the prices the cure may be becoming worse than the disease.charged in U.S. and Europe, and b., present verydifferent tactical challenges. Novartis pulled its blood pressure medication Rasilamlo from the German market three months after introducingRoche is the latest mover: The Swiss drugmaker has cut it to Germany. Eli Lilly simply bypassed Germany with itsthe price on its MabThera cancer treatment by one-half launch of Trajenta, the diabetes drug its launching inin South Africa. The move will immediately increase Europe with Boehringer Ingelheim.volume, Business Day says. The government hasnt beenable to afford routine use of the pricey drug, which MNCs Get Flexibility In Transfertreats lymphoma, leukemia and rheumatoid arthritis. Pricing; Move Will Dispel Fear AmongNow, more patients can get it. Foreign CompaniesPharma Herd Faces Hurdles With June 11, 2012, The Economic TimesPricey New Drugs The government has allowed multinationals flexibility inJune 20, 2012, Fierce Pharma valuing their transfer of intangibles such as brand to their Indian subsidiaries without any fear of the taxThere was a time when specialty care drugs for diseases department. The government hopes it will dispel thesuch as multiple sclerosis, cancer and rare genetic fears that India was gunning for foreign companies afterdisorders flew under the radar of payers, as the it changed income tax law retrospectively andtreatments gobbled up a modest piece of the overall announced tough tax avoidance rules.prescription-drug spending pie. The new rule will allow multinationals to use any arms-That time is over. With drugmakers flocking to these length methodology to value intangibles such as brandlucrative drug markets, the bar has risen to get name, goodwill, and dealer network that are transferredreimbursement and physician uptake of the expensive to their Indian subsidiary, withdrawing any discretion toproducts. But there are ways to hedge bets in the the tax officer to question the value so determined.specialty care game. Organisation of Pharmaceutical Producers of India 6
  8. 8. Pharma SpectrumU.K. Pharma Balks At Value-Based Trade Organisation, resisting attempts by the US, Japan and some other developed countries to club counterfeitsPricing Ideas or copies of patented drugs with fake or spurious ones.June 7, 2012, Fierce Pharma "The cases of seizure of high quality generic or off-Drugmakers are squaring off against the U.K.s price- patent drugs by third countries that hold patents forsetting proposals. As Britain approaches its new value- these could gain legitimacy if counterfeits are confusedbased pricing system--set to come into effect in 2014--an with fakes," an Indian official told ET. "We cannot allowindustry association warns that the governments… this as it could seriously hinder access to cheap drugs by the poor."ACTA Will Make Life Saving DrugsCostlier For The Poor Anti-Overtime Ruling A DisguisedMay 31, 2012, The Economic Times Blessing For Reps, Recruiters Say June 21, 2012, Fierce PharmaJoseph Munyi, a Kenyan citizen, has been living with HIVfor 8 years and, much like other HIV patients, is The Supreme Court denied pharma sales reps theirunemployed. He has been receiving his medication free overtime. But it may have saved many of their jobs--notof charge on account of government programmes and to mention their bonuses, industry recruiters say. If theoutreach programmes of Medicine Sans Frontieres. His ruling had gone in the reps favor, drugmakers wouldmedication comes in the form of generic drugs. have been on the hook for billions in back pay--and that outlay could have triggered another round of salesforceHowever, this situation may not last long as economic layoffs, Dow Jones reports.interests of few may end up impeding many a publicspirited citizen of the world from executing her bounden The ruling came in GlaxoSmithKlines ($GSK) overtimeduty as a human to ameliorate the conditions of the case, and it likely saved the company hundreds ofunderprivileged. millions, if not billions. Other companies with pending suits would have faced similar liabilities. Plus, the ruling would have inspired other reps to sue their companiesTrade & Others for back pay. Voilá, billions in immediate costs. Indian Drug Outlook Favourable: ICRAMSF Appeals European Nations Not To & Moody’sRatify Anti-Counterfeiting Trade June 21, 2012, The Economic TimesAgreementJune 25, 2012, Pharmabiz, Ramesh Shankar Outlook on the Indian pharmaceutical industry remains favourable, says ICRA & Moody report released onEven as the European Parliament is meeting in July to Wednesday. Domestic formulation market grew by 13-give its final voting on the proposed Anti-Counterfeiting 16% per annum in last five years. According to theTrade Agreement (ACTA), the international medical report, domestic formulation market size stood at Rshumanitarian organization Médecins Sans Frontières 58,300 crore, ranked third in terms of volume and tenth(MSF) has appealed to the contracting states not to sign in terms of value, globally.and ratify the Agreement unless all concerns related toaccess to medicines are fully addressed. The domestic growth was driven mainly by expansion in volumes and new introductions. Lifestyle-relatedTerming the Agreement as a Blank Cheque for Abuse, disorders are driving growth at faster pace in chronicMSF said that the Agreement is flawed and should not be segments along with increasing healthcare spending.accepted in its current form. Enlisting the concerns, theinternational NGO said that ACTA is not restricted to Pfizer Expects To Wrap Up Premprotrademark counterfeiting. Suits For $1.2B Total June 19, 2012, Fierce PharmaIndia, Brazil & China Defend GenericDrugs At WTO The price tag Pfizers Prempro settlements is now in. TheJune 25, 2012, The Economic Times drugmaker has paid $896 million to wrap up about 60% of the patient lawsuits, Bloomberg reports. Thats aboutIndia, Brazil and China have defended the right of poor 6,000 cases, all alleging that its hormone-replacementcountries to access cheap generic medicines at the World drugs caused breast cancer. Organisation of Pharmaceutical Producers of India 7
  9. 9. Pharma SpectrumPfizer has also set aside more money--$330 million--to Australia’s PIC Reports To Ministers Oncover the rest of its Prempro liability. Thats for about4,000 suits still outstanding. Total: $1.226 billion for Treatment And Reimbursement Of10,000 cases, or a little more than $120,000 per case, on Similar Biologicsaverage. June 14, 2012, Pharma LetterDrug Export Up 27% At Rs 60,000 Crore The Australian Pharmaceuticals Industry Council (PIC),In FY 12 with industry group members AusBiotech, Medicines Australia and the GMiA (representing genericJune 19, 2012, The Economic Times drugmakers), has today reported to the federal government on the preferred treatment of follow-onIndias exports of drugs, pharmaceutical & fine chemicals biologics for reimbursement.grew 27% to Rs 60,000 crore for the year ended March2012, according to data compiled by Pharmaceutical The PIC has been considering the issue of regulation ofExports Council of India (Pharmexcil). The export figure similar biologic medicinal products (SBMPs) - also knownis now close to the size of the Indian formulations as biosimilars - and specifically their treatment formarket which currently stands at around Rs 62,000 crore, reimbursement, following a request by the formerwhich is growing at 15-20% annually. Minister for Health and Aging for the PIC to try to reach a sector-wide consensus on a policy for managing theHowever, the exports and the local formulations listing and pricing of biosimilars on the Pharmaceuticalnumbers are not comparable as the exports data include Benefits Scheme (PBS).sale of active pharmaceutical ingredients or basic rawmaterials used to make drug. The revenues of thedomestic market takes into account only branded Drugstores Accuse Pfizer, Teva Offinished medicines. Blocking Effexor Generics June 14, 2012, Fierce PharmaTakeda To Stop Selling 13 Pfizer DrugsIn Japan CVS Caremark and Rite Aid have signed on to the Effexor XR conspiracy theory. In an antitrust lawsuit, theJune 16, 2012, Reuters drugstore chains allege that Pfizers ($PFE) Wyeth unit and Teva Pharmaceutical Industries ($TEVA) colluded toTakeda Pharmaceutical Co, Japans biggest drugmaker, delay generic versions of the blockbuster antidepressant.said on Monday it will stop distributing 13 Pfizer Incdrugs it now sells in Japan at the end of this year and As Reuters points out, its just the latest accusation ofPfizer itself will begin selling them from 2013. The 13 generic-blocking shenanigans boosting sales of Effexordrugs include antibiotic Minomycin, anticancer agents XR, the extended-release version of venlafaxine. Back inTorisel and Mylotarg, and depression treatment Amoxan. December, Walgreen, Kroger, Safeway, Supervalu andThe list did not include Viagra. HEB Grocery together filed a similar suit against the two drugmakers. Both companies have denied theTakeda said it will continue to distribute Prevenar, a allegations.pneumococcus vaccine for children, and the haemophiliaB drug BeneFIX. It also said it and Pfizer will continue towork together on the arthritis drug Enbrel. Indian Companies Eye $1billion Generic OpportunityLipitor Generic’s Mkt Shrinks 96% In US June 13, 2012, The Times of IndiaOn Over-Crowding Its literally a billion-dollar opportunity. In the wake ofJune 16, 2012, The Economic Times patent expiries on three blockbuster drugs over the last six-seven months, an opportunity worth nearly $1.3A higher-than-expected price erosion of cholesterol- billion is up for grabs for domestic generic players. Withlowering Lipitor, the world’s best selling drug, is set to three drugs - Lipitor, Zyprexa and more recently Plavix -affect the earning of Indian drug makers Ranbaxy going off-patent, along with a sharp rupee depreciation,Laboratories and Dr. Reddy’s. The market of a significant revenue upside has emerged for players likeatorvastatin, the generic version of Lipitor, shrunk 96% in Ranbaxy, Dr Reddys and others.the US on May 30-the first day after expiration ofRanbaxy Laboratories’ 180 day marketing exclusivity – as Of this, Ranbaxy is believed to have mopped up anseveral new players entered the market estimated $600-million revenue already from generic Lipitor since it was launched in December last year, analysts say. Organisation of Pharmaceutical Producers of India 8
  10. 10. Pharma SpectrumCRAMS Holds Big Opportunity For The mere passage of a law that requires drug companies to disclose how much money they pay doctors may notIndian Generic change physician prescribing practices, suggests a newJune 8, 2012, The Times of India study. In two states that passed so-called sunshine laws requiring drugmakers to disclose payments, doctorsA global study has resized worldwide market for contract choices of which drugs to prescribe for their patients didresearch and development services, with pharmaceutical not differ much from those of peers in states withoutindustry increasing its reliance on outsourcing to such a law.accelerate development of new medicines. A host ofdomestic companies- Jubilant, Piramal, Divis Labs, However, since the disclosure of information was toQuintiles, Biocon and Syngene- offering businesses like state agencies, not the general public, the state lawsmanufacturing, custom research and clinical trials, are were less likely to influence doctors behavior, onetrying to catch a piece of the action. expert not involved in the research noted. "It was a way of doing a quick analysis to even see if there was anIndia To Take Up With Brazil Issues impact we could measure," said Kavita Nair, the studys senior author and a associate professor at University ofFaced By Pharma Cos Colorado School of Pharmacy in Aurora.June 8, 2012, Hindu Business Line WHO Will Set Generics Apart FromIndia will take up with Brazil the barriers faced by Indianpharmaceutical companies, including procedural delays, Counterfeitsand the consequent increase in costs of exports. The June 4, 2012, DNAprocedural delays happen during inspections, clearancesand registration by the Brazilian authorities. World Health Organisation (WHO) has adopted a resolution to clearly define counterfeit medical productsThe issue is part of Indias campaign in Latin America to (CMP) so as to set them apart from genuine genericboost its pharma exports, including generic drugs, as the drugs. The resolution follows intense lobbying by India atsector also faces similar non-tariff barriers in other Latin the World Health Assembly (WHA) last week and is seenAmerican countries. This will be high on the agenda at as a major diplomatic win.the bilateral discussions during the June 9-15 visit toBrazil by the Commerce Minister, Mr Anand Sharma, The country has worked through back-channel ways atofficial sources said. the inter-governmental level for almost two years to pressurise the international organisation. This also meansUS Regulator Calls For Action On Fake WHO will limit its role to public health issues and not get into the debate of intellectual property rights (IPR).....DrugsJune 7, 2012, Financial Times Memos Show PhRMA, Pfizer Led BigLaws to combat counterfeit drug trafficking are toothless Pharma Support For Healthcare Billand need to be toughened, Margaret Hamburg, June 1, 2012, Fierce Parmacommissioner of the US Food and Drug Administration,said on Wednesday. In an interview with the Financial The cat is out of the bag so to speak with the disclosureTimes, Ms Hamburg said current penalties for peddling of memos today detailing the level of drug industryfake prescription medicines were the same as those for support for passage of President Obamas prizedselling fake Gucci handbags and weaker than healthcare reform. It was never a secret that Big Pharmapunishments for people selling illicit drugs. came on board to support the legislation, but memos released today by a Republican committee show that its“We need legal authorities to give teeth to our actions,” key trade association PhRMA, led by Pfizer, elicitedMs Hamburg said. “We are increasingly concerned that industry support and agreed to pay for advertisingthis is becoming an attractive area for bad guys, campaigns to boost its chances of passage.including organised crime.” Her remarks came after tworecent high-profile cases of fake drugs circulating In return, the administration agreed to stand in the waythrough the US supply chain. of provisions the industry didnt like, Bloomberg reports. The memos show that drugmakers were most concernedDo Doctor-Payment Sunshine Laws about price controls from Medicare and the consumers getting access to cheaper drugs in other countries.Work?June 5, 2012, Reuters Organisation of Pharmaceutical Producers of India 9
  11. 11. Pharma SpectrumUS FDA May Impose Huge Drug UserFee On Generic Imports Soon, India To New AppointmentsHit BadlyMay 28, 2012, Pharmabiz, Suja Nair No Relevant NewsShirodkarThe US FDA may introduce a Generic Drug User Fee Act(GDUFA) soon to curb import of cheap generic drugs intothat country. The proposed Act empowers the USgovernment to fix an exorbitant fee on the import ofeach generic product category coming from any overseassources.The US currently imports about 80 per cent of APIs and Domestic40 per cent of generics made in the overseas locations.The US Food and Drug Administration (FDA) recentlycompleted and submitted its recommendations for the IPRproposed Generic Drug User Fee Act (GDUFA) to theCongress. Nexavar Licence Does Not Violate Trade Pact: Sharma June 15, 2012, Indian ExpressBiotechnology Commerce and Industry Minister Anand Sharma on Thursday said that issuance of compulsory licence toAbbott Stands Alone In Challenge To anti-cancer drug Nexavar by India is not violative of any provision of multi-lateral trade agreement. “We have notBiosimilars Law violated of any WTO agreement...this (invoking CL) isJune 22, 2012, Fierce Pharma very much in conformity with the international agreement under the WTO,” Sharma said whileSo far Abbott Laboratories is having to fly solo in its addressing industry leaders of the pharmaceuticalchallenge to the legality of the biosimilar provision in sectors in Sao Paulo, Brazil.the Affordable Healthcare Act. In a citizens petition filedwith the FDA in April, the biologicsmaker claimed that In March, Hyderabad-based Natco Pharma was allowed toits rheumatoid arthritis drug Humira cannot be copied manufacture and sell cancer-treatment drug Nexavar atbecause it would be illegal to require Abbott to cough up a price over 30 times lower than charged by patent-the trade secrets that it has spent "massive amounts of holder Bayer Corporation, under compulsory licensingmoney" to develop, The Wall Street Journal reports. (CL).Further, it contends that no biologic drug approvedbefore passage of the law should be considered for Patents: A Prize For Inventors Willbiosimilar approval. There has been plenty of opposition Helpfrom those groups that want to see consumers benefit June 2, 2012, Hindu Business Linefrom cheaper biologic drugs coming to market soonerand are concerned the challenge will hold up a new A potentially game-changing idea is that if an inventor ismarket for biosimilars. rewarded with a huge cash award upfront in exchange for his invention becoming available immediately for public use, unseemly patent battles waged acrossMedical Diagnostics continents will be a thing of past./ Devices Patents are country-specific, so much so that a person registering one in his home country has no choice but to also register it in all the countries where the product or process is likely to be used. Under WTO norms, dictatedNo Relevant News by the powerful Western world, the patent-holder enjoys monopoly rights over his invention for 20 years. Organisation of Pharmaceutical Producers of India 10
  12. 12. Pharma SpectrumScientists Float Group To Protect medicines. The department of pharmaceuticals had set up a committee on price negotiations of patentedIntellectual Rights medicines and there has been no substantial outcome onJune 2, 2012, Indian Express the committee,” the commerce ministry said in a note to the group of ministers on pharma pricing policy.Invoking the case of Binayak Sen, four senior scientistshave formed a pressure group of “elder scientists” thatwill take up issues related to “rights of scientists andother intellectual workers”. The group announced its Regulatoryformation in the latest issue of Current Science, jointlypublished by the Indian Academy of Sciences and theCurrent Science Association, and invited opinions. We Will Prove The Poor Can Access Healthcare: Dr Devi Prasad Shetty,“Some time ago, when Binayak Sen, an eminent health Narayana Hrudayalayaactivist and vice-president of the People’s Union for CivilLiberties, was sentenced by a Chhattisgarh court to life June 25, 2012, The Economic Timesimprisonment for sedition..., nine former presidents ofthe three principal Academies of science in India If Dr Devi Prasad Shettys vision comes true, most Indiansendorsed an appeal by more than 50 Nobel laureates..., will have access to quality healthcare. Dr Shetty says thesupporting Sen and urging immediate release,” the group cost of healthcare in India can come down by 50% in thewrote. next 5-10 years, and this will be forced on the hospitals by the government if service providers do not get their act together.How P H Kurien Took On GlobalPatents System To Make Very Costly "If you are going to say the cost of a heart surgery is 3 lakh for a rich man, it is fine. But for somebody who hasDrug Affordable For Poor sold his house, it is unacceptable," he says. Shetty, whoMay 30, 2012, The Economic Times pioneered the low-cost treatment model, said the lower cost is achievable if hospitals increased the number ofIt is said that only God and a few good men and women procedures by 1,000 times.run India. One such man is P H Kurien. For readersunfamiliar with his name, Kurien was Indias ControllerGeneral of Patents, Designs & Trade Marks until March NRHM Funds To Be Linked To States’12, 2012. On March 9, 2012, just three days before he Performanceleft office, he issued the first-ever compulsory licence in June 25, 2012, The Times of IndiaIndia for the manufacture of a drug still under patent. For the first time ever, funds allocated to states underThe licence authorized Indian company Natco to the countrys flagship National Rural Health Missionmanufacture drug Naxevar for which Bayer, a German (NRHM) will be cut by almost 15% if they fail to placemultinational company, holds the patent. This was an doctors and health workers (even on contractual basis)act of major significance for Indias health. Since March to districts with the worst health index.3, 2008, when it got the Indian patent, Bayer hasimported Naxevar, selling its monthly dose at the States will also have to post performance audits ofwhopping price of 2,80,428 or $5,420. Unsurprisingly, health facilities online, failing which up to 7.5% of theironly 2% of Indian patients have been able to afford it. total outlay will be deducted. For the first time, NRHMs programme implementation plan (PIP) for the year 2012-Commerce Ministry Locks Horns With 13 has put in place incentives to reward high performing states and also punish those who fail.Pharma Dept Over Patented MedicinesMay 29, 2012, Financial Express Pharma Units In Himachal UnderCommerce ministry has locked horns with the Scanner For Spurious Drugs Productiondepartment of pharmaceuticals for the latter’s alleged June 22, 2012, The Times of Indiainaction on the plan to bring patented drugs under aprice negotiation system. There is no provision for any Seeing around 25000 crore pharmaceutical industry ofregulation on patented drugs in the proposed new pricing Himachal Pradesh facing credibility crisis due to thepolicy for drugs. production of sub standard drugs, state government has finally started acting against the drug manufacturing“The National Pharmaceutical Pricing Policy is restricted units by suspending their licenses. Recently the licencesto generics alone and does not cover patented Organisation of Pharmaceutical Producers of India 11
  13. 13. Pharma Spectrumof seven companies were suspended after drugs approvals given by the competent authority so far weremanufactured by them failed the test. in order and there was no need to re-examine the approvals given or recall any particular drug from theConsidering the fact 600 pharmaceutical industries market on the grounds of errors in approval process,located in Himachal Pradesh caters to around 50% highly placed sources confirmed.demand of country, over the years Himachal Pradesh hasbecome the largest suppliers of drugs and almost all the Improving The Picture Of India’sstates in India are getting supplies from Himachal. HealthcareIndia In Race To Contain Untreatable June 18, 2012, Business StandardTuberculosis In the din of a slowing economy, falling rupee,June 21, 2012, Livemint rampaging inflation, and incessant political manoeuvrings, India’s list of challenges continues toIndia’s slow response to years of medical warnings now grow. Of all these challenges, there is one that seemsthreatens to turn the country into an incubator for a insurmountable already, and worse, could soon end upmutant strain of tuberculosis (TB) that is proving becoming a calamity, aggravating the suffering ofresistant to all known treatments, raising alarms of a hundreds of millions of Indians.new global health hazard. This challenge relates to the provision of affordable,“We finally have ended up with a virtually untreatable accessible, and accountable healthcare to every singlestrain” of TB in India, said Dr Zarir Udwadia, one of the citizen of India. On just about every single measurablecountry’s leading TB authorities. In December, Dr indicator of healthcare infrastructure, India is rapidlyUdwadia reported in a medical journal that he had four deteriorating.TB patients resistant to all treatment. By January, hehad a dozen cases, then 15. Pharma Cos Sell Drugs 10 Times Cost:CCI Seeks Partnership Agreements MCA June 16, 2012, Financial ExpressWith Global CounterpartsJune 20, 2012, Livemint Leading pharma companies, including GlaxoSmithkline, Pfizer and Ranbaxy, sell commonly used drugs at a rateTo strengthen its extra-territorial jurisdiction, the 10 times the cost of production, a study by theCompetition Commission of India (CCI) is entering into Corporate Affairs Ministry has found. A study by the Costcooperation agreements with its counterparts in other Audit branch of the MCA found drugs like Calpolnations. Extra-territorial jurisdiction relates to acts that manufactured by Glaxosmithkline, Corex Cough Syrup bytake place outside the country but have an effect on Pfizer, Revital by Ranbaxy Global, Omez by Dr Reddyscompetition in India. Labs, Azithral by Alembic and several others were being sold at a mark up of up to 1,123 per cent over the costIndia’s competition watchdog is close to signing a of production.memorandum of understanding (MoU) with the USFederal Trade Commission’s Bureau of Competition, said Worried over the findings of the study, Corporate Affairsa CCI official with direct knowledge of the development. Minister M Veerappa Moily has written to the ministers ofA draft MoU was prepared in November and is awaiting Chemical and Fertilizers M K Alagiri and Health Ghulamthe foreign ministry’s approval. Nabi Azad seeking appropriate action on curbing this practice of pharma companies.CDSCO Rules Out Review Or Recall Of33 Drugs Approved Between Jan 2008 Parliamentary Panel Sceptic AboutTo Oct 2010 Physical Targets For Improving HumanJune 18, 2012, Pharmabiz, Joseph Alexander Resources In Health June 15, 2012, Pharmabiz, Joseph AlexanderCentral Drugs Standard Control Organisation (CDSCO) willnot review or recall the 33 controversial drugs which The Parliamentary Standing Committee on Health haswere reportedly cleared without clinical trials on Indian expressed apprehension on achieving the physical targetspatients during the period of January 2008 to October set for the current Five Year Plan for improving the2010. human resources in the health sector and called for more allocation to paramedical sectors including pharmacists.The regulatory authorities are of the view that all Organisation of Pharmaceutical Producers of India 12
  14. 14. Pharma SpectrumThe Department of Health has set physical targets set to Amravati, 46 in Aurangabad and 29 in Mumbai receivedbe accomplished in Twelfth Five year Plan which notices. "Our drive exposed how many chemists were notincludes training capacity of 80,000 MBBS doctors and following any norms.45,000 specialists per annum by 2020 and bringing downthe doctor: population ratio from 1:2000 to 1:1000. FIPB To Continue As Gate-Keeper OnAzad Visits US FDA; Stresses On Pharma Mergers For Now June 7, 2012, Business LineImportance Of Collaboration With US InFood And Drug Regulation Who will be gate-keeper for the pharmaceuticalJune 14, 2012, PharmaBiz industry, watching over local companies being acquired by foreign owners? The Foreign Investment PromotionThe Union minister for health and family welfare, board (FIPB), the Competition Commission of India (CCI)Ghulam Nabi Azad has stressed on the importance of or both? Until a final call is taken by the ministriescollaboration with the USA in food and drug regulation as involved, the FIPB is set to continue as gate-keeper, saidthis will provide exposure to the Indian regulators to a source, after a meeting on the issue convened by theinternational best practices in this area. Finance Ministry, on Wednesday.Azad was speaking at the headquarters of the US Food Addressing public health concerns raised by the Healthand Drug Regulatory Administration (FDA) at Maryland. Ministry, and to streamline investment in local drugAzad is member of the high level Indian delegation companies, guidelines will be outlined on the FIPB Webvisiting the USA. site, the source said. For instance, companies looking for local acquisitions will have to ensure they continue to manufacture essential medicines (if the acquired entityCSR A Must In Cos Bill was making them); and not discontinue ongoing researchJune 13, 2012, The Economic Times (epaper in critical areas.page2) FDA Foresees Jump In Apps For CancerDecks have been cleared for reintroduction of theCompanies Bill,2011,in the monsoon session. If the bill is Drugspassed after endorsing all the suggestions made by the June 6, 2012, Fiercer BiotechParliamentary Standing Committee on Finance,corporate social responsibility (CSR) would, for the first U.S. regulators expect to review lots of cancer drugs thistime in the world, become mandatory. year. With developers finding ways to get early readouts on efficacy, companies are expediting programs to setThe report recommends that companies with net worth the stage for rapid development and speedy approvals ofabove.500 crore, or an annual turnover of over.1,000 new anti-cancer therapies.crore, earmark 2% of average net profits of three yearstowards CSR. In the draft Companies Bill,2009,the CSR In an interview with Reuters, FDA oncology chief Dr.clause was voluntary though it was mandatory for Richard Pazdur predicts that the agency will receive 20companies to disclose their CSR spends to shareholders. submissions for cancer drugs in 2012. Its too early to tell whether that will lead to an increase in approvals this year, but the number says a lot about intense35% Chemists In Maharashtra Flout participation in cancer drug research around theAbortion Drug Norms: Food And Drug biopharma industry.AdministrationJune 13, 2012, The Times of India DCGI Asks State Drug Controllers To Keep Tab On Trials To Wipe Out IllegalNearly 35% of drug retailers and wholesalers in the statewere found flouting norms claims the Food and Drug PracticesAdministration, which launched a crackdown following June 6, 2012, PharmaBizcases of female feticide in Beed. Out of the 954 retailersand wholesalers inspected in the last six days, 340 were With reports of illegal trials affecting public safety, theserved show-cause notices for irregularities in Central drug authorities have asked all the State drugmaintaining records and selling abortion drugs without a controllers to keep a close tab on the clinical trialsprescription. happening around and stop illegal trials especially those done individually by the doctors without due permissionEighty-eight chemists in the Konkan region were served from the Central Drugs Standard Control Organisationshow-cause notices. Sixty-five chemists in Pune, 50 in (CDSCO). Organisation of Pharmaceutical Producers of India 13
  15. 15. Pharma SpectrumTalking to Pharmabiz, Drug Controller General of India Eli Lilly and Co. focusing on the growing diabetes market(DCGI) Dr G N Singh admitted that there could be is likely to set a new trend in the highly competitiveindividual cases of doctors carrying out trials on their local drug market, where foreign drug makers areown for some companies, Indian or foreign, without aggressively taking on entrenched generic rivals.informing the authorities. Such cases lead to unethicalpractices and cause troubles, he added. The global collaboration combining the portfolio of the two to address a particular disease segment and sellingIndustry Leaders Call For Overhauling the products through a common team in various markets is the first such alliance in the drug industry.Of CDSCO For Better Efficiency,Transparency GSK Launches Metered-Dose Inhalers InJune 4, 2012, Pharmabiz, Nandita Vijay IndiaEven as The Lancet report exposes the inadequacies of June 7, 2012, Business Linethe functioning of Central Drugs Standard ControlOrganization (CDSCO), industry stakeholders have called Asthma patients will now be able to buy the enhancedfor an overhaul of Indias regulatory machinery on a version of a Metered Dose Inhaler (MDI) with a dosepriority basis including staffing policy of the counter, from their local chemists. Multinational drug-organization. maker GlaxoSmithKline Pharmaceuticals has launched the product with this new technology in the country, aAccording to a stakeholder, “A competent CDCSO is of first of its kind, company officials said.utmost importance and requires a leader who isconversant with the nuances of this highly technical and The inhaler has an innovative dose counter that keepsresearch-driven business.” Further, he added, the track of number of doses left. This helps the patients toregulator should have a formal pharmacy education, to take the right number of drug doses. The inhaler also hasdischarge duties efficiently. a locking system which prevents drug wastage when the inhaler is not in use.Dr G N Singhs Term As DCGI ExtendedFor Another 3 MonthsMay 31, 2012, Pharmabiz R&D/Clinical TrialsThe health ministry further extended the tenure of Dr G Doctors Discuss Problems Related ToN Singh with the additional charges of the DrugController General of India (DCGI) by three more months Clinical Acteffective from May 22. The order announcing the same June 22, 2012, The Times of Indiawas issued by the health ministry on May 29 and comesas a great relief to the industry which has been A meeting of city doctors under the banner of Allahabaddemanding for some stability in the position of the drug Medical Association(AMA) was held on Thursday whereregulator of the country. the speakers discussed problems arising after the passage of Clinical Establishment Act by the government.Dr Singh informed that now with this order he will beable to bring in stability to his position by enacting and Addressing the gathering, state president Indian Medicalworking on the mission of the CDSCO to safeguard and association (IMA) Dr Ashok Agarwal said: "the governmentenhance public health by assuring safety, efficacy and is making medical facilities expensive for the commonquality of drugs, cosmetics and medical devices in the man in the same manner as it is increasing the prices ofcountry. essential commodities including sugar, onion, petrol, pulses, rice and green vegetables.New Products Six New AIIMS Will Give Fillip To Medical Research: Ghulam Nabi Azad June 21, 2012, The Economic TimesBoehringer-Lilly Alliance Likely To SetTrend Admitting that inadequate number of doctors hasJune 15, 2012, Livemint affected medical research in the country, Union Health Minister Ghulam Nabi Azad today expressed hope thatThe business alliance between German drug maker the sector would get a fillip with the coming up of sixBoehringer Ingelheim GmbH and US biotechnology firm new AIIMS from next year. Organisation of Pharmaceutical Producers of India 14
  16. 16. Pharma Spectrum"Six new AIIMS in the country will start functioning by caused by invasive non-typhoidal Salmonella (NTS). ThisApril next year in different states, including Jodhpur in strain is most common in the sub Saharan African regionsRajasthan. This will ease pressure on AIIMS Delhi and among malnourished children. About 20-30% of theresearch work will get momentum," he said at a press children are known to die because of this infectiousconference here. disease each year.Pharma Industry Urges Govt To Woo Lab- Grown Vein Transplant MilestoneBack Scientists In Stem Cell ResearchJune 20, 2012, Financial Express June 15, 2012, Indian ExpressAs the government begins to correct deficiencies in the In a first, doctors in Sweden have transplanted into thedrug regulatory process brought forth by a parliamentary body of 10-year-old girl a vein grown in the laboratorypanel, the industry has urged it to woo back Indian from her own stem cells. The core team that performedscientists working with reputed global drug regulatory the procedure was led by Dr Suchitra Holgersson, aagencies of US and UK. transplant medicine specialist originally from Mumbai, and included four other doctors from India. TheIn a letter to union health minister Ghulam Nabi Azad, landmark transplant was published in the British medicalpharma sector captains through the auspices of industry journal The Lancet on Thursday.body Assocham, have said, “It is fortunate that a pool ofIndian origin scientists populate the world’s leading The procedure “could offer a potential new way forregulators like US FDA (Food and Drug Administration) patients lacking healthy veins to undergo dialysis orand UK MHRA (Medicines and Health products Regulatory heart bypass surgery without the problems of syntheticAgency). grafts or the need for lifelong immunosuppressive drugs”, The Lancet said.Indian Platform For Sharing, ViewingResearch Available For Foreign Health Min To Notify Procedures AndInstitutes Quantum Of Compensation To VictimsJune 20, 2012, Business Standard Of Trials Soon June 13, 2012, Pharmabiz, Joseph AlexanderKnimbus, an India-based global search and collaborationplatform for researchers, is set to offer its services in The Health Ministry will soon formally notify theforeign varsities. A platform that connects creators and procedures and amount of compensation to be paid byusers of scientific, technical and medical knowledge to the pharmaceuticals companies, if a volunteer dies oronline content and peer groups, Knimbus is in the gets injured during a clinical trial. “The Government hasprocess of extending services to institutes in the United already published the draft rules for the new scheduleStates and some European countries. Y1 under the Drugs and Cosmetic Rules, 1945 and it is under the stipulated process of examination before theIt has also tied up with a partner in Germany and is in final notification.the process of forging ties with about 25 universities inBangladesh. Knimbus was co-founded by Rahul Agarwalla However, with a view to tighten the norms on clinicaland Tarun Arora in November 2010, and the service went trials, several sections of the amendment have alreadylive in September 2011. been implemented,” Drug Controller General of India (DCGI) Dr G N Singh said. “We are in the process ofBharat Biotech Receives $ 4 Million finalising the detailed procedures and amount of compensation and on making the companies liable forAward From The Wellcome Trust For causes of damages during the trials. This will be notifiedDevelopment And Clinical Trials within a couple of months,” he said.June 19, 2012, The Economic Times Pharma Companies Need AggressiveVaccine manufacturer Bharat Biotech and The University R&D And Patent Filing: Expertsof Maryland Center for Vaccine Development (CVD) havereceived $ 4 million from The Wellcome Trust for clinical June 11, 2012, The Economic Timesdevelopment of a new conjugate vaccine for treating aninfectious disease. Indian pharmaceutical companies need to go for aggressive research and patent filing like China andThe Trust will also fund clinical trials beginning in three Japan and unless spending on R&D is scaled up, it wouldyears to prevent the potentially lethal infectious disease be difficult to create new molecules, industry experts Organisation of Pharmaceutical Producers of India 15
  17. 17. Pharma Spectrumsaid. "Our Indian companies are just beginning to realise After keeping it dormant for many years, thethat they also need an R&D Department, as merely Department of Health Research is fast-tracking for thequality control would not help. final approval from the Cabinet a comprehensive bill to regulate and monitor the entire research on the humanUnless spending on R&D is scaled up, it will be difficult subjects in the country.to create new molecules. It is time to go for aggressiveresearch and patent filing just like China and Japan," Sources said the modified Biomedical Research on HumanDeputy Controller of Patents & Designs, Intellectual Subjects Bill is in the final stages. “The Cabinet note isProperty Office K S Kardam said at a workshop on being prepared for submission and approval. The plansPatenting Pharmaceuticals in India. are afoot to place it before the Parliament this year itself and put into effect,” sources said.R & D in IndiaJune 5, 2012, Indian Express University Of Pune With Serum Institute Complete Animal Study OnForeign direct investment may have slowed, but Indiastill has a vibrant, sophisticated and rapidly evolving Herbal Vaccine, AdjuvantsR&D sector. India should be a compelling proposition for May 30, 2012, Pharmabiz, Nandita Vijaymultinational companies seeking an emerging marketR&D location. The country’s large educated population, University of Pune’s Interdisciplinary School of Healthits low labour costs and its huge and rapidly emerging Sciences and Serum Institute of India, in a collaborativemiddle class suggest the ideal environment for global research programme, have completed animal study onR&D investment. herbal vaccine, adjuvants. The project was supported by Department of Science and Technology.And back in the heady days of 2006, the country wascertainly living up to that potential. FDI in R&D India was In another study, the Pune University along with US-$3.8 billion, more than in China and Eastern Europe based BioVed Pharmaceuticals Inc. went on to researchcombined. on blood disorder properties in cancer bearing animals which is ready for commercialization.Abbott To Strengthen Its ResearchCapability In India, Also Scouts ForUniversity Partner To Spur Innovation Mergers &June 5, 2012, PharmaBizAbbott has now commenced its advanced nutrition Acquisitions /research in collaboration with Syngene. Themultinational drug major has set up the Abbott Nutrition CollaborationsR&D Centre in the Biocon Park which houses the BioconBiopharmaceutical Research Centre (BBRC). Thecompany is also in the process of scouting for a PMO Seeks Legal Opinion On PharmaUniversity partner to spur its innovation in research in FDI Issuethe country. June 25, 2012, Financial ExpressThe company has already tie-up with the University of The Prime Minister’s Office (PMO) has sought a legalIllinois where it has set up a Centre for Nutrition and opinion on whether the Competition Commission of IndiaCognition. In India, Abbott is looking not just to tap the (CCI) can have the mandate of clearing or haltingtalent of young researchers but also look at a similar approvals of proposed brownfield pharma FDI deals oninitiative to advance its research and comprehension on the grounds of public health. In a recent letter sent tothe needs of the Indian nutrition market, said Dr Robert the law ministry, the PMO has sought its views on theH Miller, divisional vice president, Global R&D and matter.Scientific Affairs for Abbott Nutrition. This comes after the multiple arms of government -Dept Of Health Research Fast-Tracking ministry of health and ministry of commerce and industry as well as a section of the domestic industry -Cabinet Nod For Bill To Regulate put up sustained resistance to an earlier decision takenClinical Research in October last year to empower the CCI to assume theMay 30, 2012, Pharmabiz, Joseph Alexander role of the filter of brownfield pharma deals. Organisation of Pharmaceutical Producers of India 16
  18. 18. Pharma SpectrumMinistries Oppose PMO View On GSK Extends $2.6 Billion Bid ForPharma Deal Rules Human Genome SciencesJune 14, 2012, Business Standard June 8, 2012, Fierce PharmaThe ministries of finance, commerce and health appear GlaxoSmithKline said it would and now it has. Itto have locked horns with the Prime Minister’s Office extended its $2.6 billion hostile bid for shares of its(PMO) over the regulation of cross-border deals for partner Human Genome Sciences by three weeks. Theexpansion in the pharmaceutical sector. original offer from GSK of $13 a share was set to expire last night, and since GSK has made it clear that it doesThe Indian Pharmaceutical Alliance (IPA), an association not intend to just fold on this proposal, it pushed therepresenting the domestic industry, had also recently deadline for investors to tender shares to June 29, thewritten to the PMO suggesting joint clearance of company says in an announcement today.brownfield FDI proposals for expansion in pharma by theForeign Investment Promotion Board (FIPB) and Human Genome opposes the deal, saying it values theCompetition Commission of India (CCI). company far too cheaply, and has been urging shareholders to hold out until it can find a morePharmabiz Editorial: Brownfield rewarding alternative, even asking GSK to participate, The Wall Street Journal reports.Projects & FDIJune 13, 2012, Pharmabiz, P.A. Francis Why Fear FDI In Pharma?In October last, at a high level meeting convened by the June 6, 2012, Business LinePrime Minister, it was decided that India will continue toallow foreign direct investment in drugs and It would soon be time for the government to review itspharmaceuticals sector through automatic route for 2011 policy decision on foreign direct investment in thegreenfield projects and in case of brownfield pharma sector. The occasion is ripe to considerinvestments, FDI will be allowed through the Foreign perceptions on the impact of FDI on the industry. TheInvestment Promotion Board (FIPB) for six months. FDI policy for the pharma sector was revised on November 8, 2011, essentially shifting the FDI(in relationThese acquisitions will, however, be routed through the to the brownfield investments) from the automatic toCompetition Commission of India for the six months approval route. FDI in the sector is permitted up to 100period. During this period, when the FIPB clears the per cent.acquisitions, necessary enabling regulations will be putin place by the CCI for effectively overseeing mergers The decision was a sequel to the acquisition spree byand acquisitions so as to ensure a balance between multinational corporations — notably Matrix by Mylanpublic health concerns and flow of FDI into the pharma (2006), Ranbaxy by Dai-ichi Sankyo (2008), Shantasector. Biotechnics by Sanofi Aventis (2009), Orchid Chemicals by Hospira (2009), and Piramal Healthcare by Abbott Laboratories (2010).Empower Competition: Need To HaveBetter Coordination Between Sector FDI In Drug Firms ResumesRegulators And CCI June 1, 2012, The Economic Times (epaperJune 12, 2012, The Economic Times page 24)The corporate affairs ministry has reportedly sought to The Foreign Investment Promotion Board (FIPB) hasbring all sectors including telecom and banking under the resumed clearing investment proposals in Indian drugambit of the Competition Commission of India (CCI). This companies, a move that will revive deal flow in the.is a good idea. The CCIs remit is to oversee competition, 62,000-crore domestic pharma sector.check abuse of monopoly power and curtail unfair tradepractices. The board has cleared four proposals of foreign financial investors, but again deferred a decision on stake buys byThe job cannot be left to sectoral regulators. This is not multinational drug companies, extending uncertaintyto say that the CCI should become a super-regulator. over new rules to check rising cases of promoters ofInstead, it should help sectoral regulators - be it the RBI domestic drug companies selling out to foreign players.or the telecom regulator - to arrive at informed decisionsin cases where there is a violation of fair play. At its meeting on May 9, the FIPB cleared Pethico Pharmaceuticals proposal to raise.490 crore by selling a 22% stake through the foreign currency convertible bond Organisation of Pharmaceutical Producers of India 17

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