Pharma Spectrum

Document Sample
Pharma Spectrum Powered By Docstoc
					                                                                      Pharma Spectrum
                            Organisation of Pharmaceutical Producers of India

Volume 4                           Issue 12                          December 2011

             1.    IPR                                                     1
             2.    Regulatory                                              1
             3.    New Products                                            4
             4.    R&D / Clinical Trials                                   4
             5.    Mergers & Acquisitions / Collaborations                 6
             6.    Pricing                                                 8
             7.    Trade & Others                                          9
             8.    Animal Health                                          12
             9.    Biotechnology                                          12
             10.   Medical Diagnostics / Devices                          13
             11.   New Appointments                                       13

             1.    IPR                                                    14
             2.    Regulatory                                             15
             3.    New Products                                           18
             4.    R&D / Clinical Trials                                  18
             5.    Mergers & Acquisitions / Collaborations                21
             6.    Pricing                                                22
             7.    Trade & Others                                         23
             8.    Animal Health                                          26
             9.    Biotechnology                                          26
             10.   Medical Diagnostics / Devices                          27
             11.   New Appointments                                       27
             12.   OPPI Related News                                      28

                      Organisation of Pharmaceutical Producers of India        0
                                                                                               Pharma Spectrum


International                                                to-the-editor-canadian-intellectual-property.html

                                                             The characterization of the CMAJ article by Paul

IPR                                                          Grootendorst and Aidan Hollis regarding the need for
                                                             reform of Canada's intellectual property regime for
                                                             pharmaceuticals as an endorsement of the brand-name
                                                             drug industry's position on the EU's pharmaceutical IP
Amgen's New Enbrel Patent Could                              proposals as part of trade discussions with Canada is
Delay Biosims For 17 Years                                   completely inaccurate.
November 23, 2011, Fierce Pharma                Important Decision For The Biotech
enbrel-patent-could-delay-biosims-17-years/2011-11-          Industry From UK Supreme Court
                                                             November 3, 2011, Pharma Letter
Would-be Enbrel copycats, get out your handkerchiefs.
Amgen says it has a new patent protecting the                t-decision-for-the-biotech-industry-from-uk-supreme-
blockbuster anti-inflammatory drug, which could protect      court.html
it from generic rivals for another 17 years. If the patent
holds up, then drugmakers with biosimilar ambitions--        The UK‘s Supreme Court yesterday gave guidance on the
including Merck, which has teamed up with South              patentability of gene sequence inventions, with its
Korea's Hanwha Chemical to develop an Enbrel version--       judgment in Human Genome Sciences (Nasdaq: HGSI)
will find those aims squashed until 2028.                    versus Eli Lilly (NYSE: LLY), the first patent case that it
                                                             has considered.
Enbrel had been expected to fall off patent in October of
next year, although biosimilar versions weren't likely to    Following a patent challenge by US pharmaceutical
immediately make their debut. Indeed, Amgen officials        major Eli Lilly, the UK‘s Court of Appeal last year upheld
have said they don't expect to face Enbrel biosimilars       an earlier ruling invalidating a patent on neutrokine-
for 5 years, partly because of use and formulation           alpha - a gene sequence held by Human Genome
patents, as The New York Times points out.                   Sciences, and thus potentially Benlysta (belimumab), a
                                                             treatment for the auto-immune disease lupus………

Affymax And Janssen Biotech Enter
$13    Million
               Peginesatide Patent
November 11, 2011, Pharma Letter          US Healthcare Reforms Booster For
and-janssen-biotech-enter-13-million-peginesatide-           Software Cos
patent-settlement.html                                       November 25, 2011, Hindu Business Line
US biotech firm Affymax says it has reached a global         economy/info-tech/article2656632.ece
settlement agreement with Janssen Biotech, a subsidiary
of health care major Johnson & Johnson NYSE: JNJ) and        The Obama administration recently said nearly $1 billion
certain of its affiliated companies to end the arbitration   of Federal funds allocated in last year's health reform
and litigation related to certain intellectual property      law will go toward innovation programmes designed to
emerging from a 1992-1995 research collaboration.            improve patient care. This is good news for companies
                                                             such as US-based software service providers, such as
Under the accord, Affymax obtains a release of claims, a     Cognizant Technology Solutions and Dell Healthcare and
covenant not to sue and license to the intellectual          Life Sciences Services (both have large operations in
property in dispute, thereby eliminating potential claims    India), to work on some of the programmes.
by Janssen regarding the use, manufacture, import, sale
and licensing of anemia drug candidate peginesatide          The healthcare system in the US is undergoing a major
worldwide.                                                   transformation, and information technology is the
                                                             backbone of these efforts to change the way health care
Letter To The Editor:                       Canadian         is delivered, said Mr August Calhoun, Vice-President of
                                                             Dell Healthcare and Life Sciences Services.
Intellectual Property
November 10, 2011, Pharma Letter

                                     Organisation of Pharmaceutical Producers of India                     1
                                                                                                  Pharma Spectrum

Problems Identified In Canada’s Drug                           The ambitious goal of setting up a nationwide,
                                                               interconnected, private and secure electronic health
Regulatory System                                              records system isn't yet a reality -- but we're getting
November 23, 2011, Pharma Letter                               closer. The 2009 Recovery Act, better known as the             stimulus bill, set aside more than $20 billion for
s-identified-in-canadas-drug-regulatory-                       incentives to health care providers that deploy and
system.html?utm_source=2009_11_06-                             meaningfully use certified electronic health records
Pharma+Clean&utm_campaign=e0b7568cc6-                          systems in their offices or hospitals.
                                                               The first incentives are set to go out in the form of
A report presented to the Canadian Parliament this week        $22,000 Medicaid payments to early adopters within the
by John Wiersema, Interim Auditor General of Canada,           next six months. Since we're still in the early phases, it's
identified failings in the operations of the regulatory        hard to get clear numbers for adoption rates. Prior to
agency Health Canada. It found that, while Health              the bill, just 17% of physicians' offices and 12% of
Canada is fulfilling some key responsibilities in regulating   hospitals had implemented some kind of electronic
pharmaceuticals, it is failing to monitor the safety of        health records system.
drugs on the market and to warn Canadians in a timely
manner when new risks with those products are flagged,         Increase In US Drug Recalls And
and is struggling with transparency of some of its
activities.                                                    Warning Caused By Manufacturing
                                                               Errors And Regulatory Non-Compliance
The Office of the Auditor General examined how Health
Canada regulates clinical trials of new pharmaceutical
                                                               Issues, Says GBI
drugs and reviews submissions seeking approval of new          November 15, 2011, Pharma Letter
drugs for sale in Canada or of changes to drugs already
on the market.                                                 -in-us-drug-recalls-and-warning-caused-by-
Health 2020: WHO's Missing Link?
November 19, 2011, The Lancet                                  The numbers of warning letters and drug recalls issued          by and reported to the US Food and Drug Administration
0140-6736(11)61762-5/fulltext                                  (FDA) are increasing; this is causing a significant loss of
                                                               revenues for pharmaceutical companies, according to a
WHO's European office is making progress with its              new report from GBI Research.
innovative new strategy to tackle the region's health
problems. But will member states and the rest of WHO
take note? Robert Walgate reports. With 76% of WHO's
                                                               Judge Orders GSK To Mediation In
(2012—13) funding being voluntary, a budget reduction          Avandia Suits
of 13% from its current (2010—11) biennium, and                November 9, 2011, Fierce Pharma
fundamental reform underway in which member states   
seem keen to restrict WHO's role to technical advice,          mediation-avandia-suits/2011-11-
observers, shaking their heads over the future of the          09?utm_medium=nl&utm_source=internal
agency, have called for inspiration.
                                                               A U.S. judge is twisting GlaxoSmithKline's arm. The
And now they might have it, in the form of Health 2020,        drugmaker, facing some 20,000 outstanding claims of
a radical reconceptualisation of health underway at the        injury from its controversial diabetes drug Avandia, has
European Regional Office of WHO in Copenhagen. But             been ordered to mediation in one court, with 75 days to
will member states take notice?                                wrap up 85% of the cases consolidated there, Bloomberg
National Electronic               Health       Records
                                                               The order from Judge Cynthia Rufe comes about a week
Network Gets Closer                                            after GSK said it was nearing a $3 billion settlement of
November 18, 2011, CNN Money                                   federal probes into off-label marketing of Avandia and           other drugs. Last year, the company agreed to pay $750
1524032&ids=0ScjgNd30UczAId3wOd3sPdz8Vb3gQcz0Oc3               million to wrap up investigations into substandard
wOeiMRczAPc3wRczAIczcMd38Rcj8V&aag=true&freq=wee               manufacturing.

                                      Organisation of Pharmaceutical Producers of India                       2
                                                                                             Pharma Spectrum

US FDA Approves Bayers Xarelto                              coronary syndrome area. J&J holds the U.S. rights to the
November 8, 2011, BioSpectrum Asia           "Atrial fibrillation can lead to the formation of blood
7433.asp                                                    clots, which can travel to the brain, blocking blood flow
                                                            and causing a disabling stroke," said Dr. Norman
Bayer HealthCare has announced that the US Food and         Stockbridge, a director in the FDA's Center for Drug
Drug Administration (FDA) has approved once-daily           Evaluation and Research. "This approval gives doctors
Xarelto (rivaroxaban) to protect patients with non-         and patients another treatment option for a condition
valvular atrial fibrillation from the risk of stroke and    that must be managed carefully."
systemic embolism.

Rivaroxaban is the only oral anticoagulant now approved     GSK Will Pay $3 Bn To Settle US Drug
in the US that provides the benefits of once-daily fixed    Row
dosing and no need for routine blood monitoring, two        November 4, 2011, Business Standard
important considerations when treatment needs to be
maintained over time.                                       will-pay-3-bn-to-settle-us-drug-row/454526/

US FDA Claims More NDA Approvals                            GlaxoSmithKline PLC (GSK) on Thursday announced it had
Than Other Countries, With 35 In                            reached a $3-billion settlement agreement with the US
                                                            to conclude the global consumer healthcare company‘s
Fiscal Year 2011                                            most     significant  ongoing    Federal   government
November 4, 2011, Pharma Letter                             investigations.
claims-more-nda-approvals-than-other-countries-with-        The ‗in-principle‘ settlement of $3 billion is covered by
35-in-fiscal-year-2011.html?utm_source=2009_11_06-          existing provisions. GSK expects to make payments under
Pharma+Clean&utm_campaign=10c000cc46-                       a final agreement next year. These payments will be
RSS_EMAIL_CAMPAIGN&utm_medium=email                         funded through existing cash resources, the company
                                                            said in a statement.
The US Food and Drug Administration, which in the past
has been criticized for slow approval on new drugs, has     EU OKs Two New Indications For Novo
revealed that, over the past 12 months, it approved 35
new medicines. This is among the highest number of          Nordisk’s Levemir
approvals in the past decade, surpassed only by 2009        November 3, 2011, Pharma Letter
Many of the drugs are important advances for patients,      levemir.html?utm_source=2009_11_06-
including: two new treatments for hepatitis C; a drug for   Pharma+Clean&utm_campaign=7498dfee4a-
late-stage prostate cancer; the first new drug for          RSS_EMAIL_CAMPAIGN&utm_medium=email
Hodgkin‘s lymphoma in 30 years; and the first new drug
for lupus in 50 years.                                      There was good news for Danish insulin giant Novo
                                                            Nordisk yesterday, when the European Commission
J&J Wins Blockbuster Approval To                            approved the extended use of the firm‘s basal insulin
                                                            analogue, Levemir (insulin detemir), in children aged
Market Xarelto For Stroke Prevention                        two to five years with type 1 diabetes, making insulin
November 4, 2011, Fierce Biotech                            detemir the only basal insulin analogue for use in this        young patient group supported by its Summary of
blockbuster-approval-market-xarelto-stroke-                 Product Characteristics (SmPC).
04?utm_medium=nl&utm_source=internal                        The extended license to market insulin detemir is based
                                                            on a positive opinion granted in September by the
The FDA has given Johnson & Johnson the green light to      European Committee for Medicinal Products for Human
market Xarelto to prevent stroke among patients             Use (CHMP) and data that demonstrate that insulin
suffering from atrial fibrillation--opening up a            detemir is an equally efficacious treatment option for
blockbuster market involving more than 2 million            two to five-year-old children with type 1 diabetes,
patients. Bayer, which holds ex-U.S. rights, has already    compared with NPH.
estimated peak sales at close to $3 billion, and the
treatment has the potential to work in the acute

                                    Organisation of Pharmaceutical Producers of India                    3
                                                                                               Pharma Spectrum

US FDA Approves Abbott's Next-                               Launch Of The First Generic Version Of
Generation Xience Prime Drug Eluting                         Nexium In Canada, Brings Billions Of
Stent                                                        Dollars Of Savings To The Canadian
November 2, 2011, Pharmabiz                                  Healthcare System           November 1, 2011, CNW Newswire
US Food and Drug Administration (FDA) has approved           of-dollars-of-savings-to-the-canadian-healthcare-system
Abbott's next-generation Xience Prime Everolimus Eluting
Coronary Stent System for the treatment of coronary          Apotex Inc., the largest Canadian owned pharmaceutical
artery disease. Abbott, the worldwide leader in drug         company, launched today Apo-Esomeprazole, a generic
eluting stent technology, said that with the introduction    version of AstraZeneca's Nexium®, a gastric proton pump
of Xience Prime in the US, the company now offers            inhibitor (PPI). With initial launches to the provinces of
physicians an expanded range of drug eluting stents          Québec, Nova Scotia, New Brunswick, and Ontario,
supported by the clinical results from the SPIRIT family     Apotex has now released product to the remainder of the
of trials.                                                   Canadian market.
Xience Prime, which uses the same drug and                   The brand product costs the public and private
biocompatible polymer as the Xience V Everolimus             healthcare budgets close to $300 million per year.
Eluting Coronary Stent System, features an enhanced          Apotex is the only generic pharmaceutical company to
stent design and a delivery system designed for greater      have successfully litigated the Nexium® patents,
flexibility, ideal radial strength, excellent longitudinal   bringing the first generic alternative to market 8 years
strength and more accurate stent placement.                  prior to all patents expiring.

New Products                                                 R&D/Clinical Trials
GE Healthcare Launches Microscopy                            Deloitte: The Price Of R&D Success
                                                             Soars As Investment Returns Shrivel
System, Deltavision OMX Blaze
                                                             November 21, 2011, Fierce Biotech
November 2, 2011, Pharmabiz                                   success-soars-investment-returns-shrivel/2011-11-21
                                                             In just one year, Big Pharma's average cost of bringing a
Applied Precision Inc., a GE Healthcare company,             new drug to the marketplace has shot up 23%, soaring
recently launched DeltaVision OMX Blaze, a research          from $830 million to more than a billion dollars this year,
microscopy system designed to reach the next level in        according to a new report from Deloitte. Analyzing the
the evolution of super-resolution imaging by employing a     internal rate of return for the world's 12 largest pharma
proprietary, ultra-fast, illumination module and the         R&D operations, Deloitte concluded that the rise in
latest advanced high-speed camera technologies.              development costs has a lot to do with the massive
                                                             shakeup that has been underway in many--though not
OMX Blaze is the world‘s first system capable of             all--of the biggest groups, with the average number of
acquiring moving images of live cells at super-resolution    late-stage compounds in development plunging from 23
in all three dimensions. The new DeltaVision OMX Blaze       to 18.
system‘s speed of image acquisition enables researchers
to follow tagged proteins within the same living cell,       Taking stock of the new math at the Big Pharma
over time, in three-dimensional space, at near molecular     companies, Deloitte concluded that the internal rate of
resolution. This makes it possible to start answering new    return has dropped from 11.8% to 8.4%, a 29% drop,
kinds of research questions about how certain structures     though Deloitte analysts carefully note that the slide has
in cells behave, what they interact with, and how long       a lot to do with a higher rate of return that's been
the events last.                                             garnered for commercial products.

                                     Organisation of Pharmaceutical Producers of India                     4
                                                                                               Pharma Spectrum

EC Outlines New Incentives To Spur                          In a 28-person study, researchers focused on interferon
                                                            alpha, a protein that can determine the severity of
Antibiotic R&D                                              lupus. They administered four doses of a vaccine against
November 17, 2011, Fierce Biotech                           the protein (manufactured by Neovacs), which caused an         antibody response. "This is an early, first step. It appears
incentives-spur-antibiotic-rd/2011-11-17                    to be safe.

Faced with a growing threat from a phalanx of superbugs     MNCs Eye Ventures With Pharma Cos
and a long-standing industry disinterest in committing
resources to low-margin antibiotics, European officials     For R&D, Outsourcing: PwC Report
are hoping to jumpstart R&D work in the field with a set    November 6, 2011, MSN News
of tailored incentives for drug developers.       
The move drew quick support from Europe's pharma
trade association, the EFPIA, and GlaxoSmithKline CEO       In order to benefit from robust growth of the domestic
Andrew Witty, whose company remains among a handful         pharma industry, multinational firms are looking at
of big players that retain an interest in the field. The    alliances and partnerships for not only sourcing out
European Commission says that it wants to adapt the         products, but also to expand R&D, says a report. The
existing €2 billion Innovative Medicines Initiative.        pharma market is expected to grow at a CAGR of 15-20
                                                            per cent to reach a value anywhere between USD 50
India-EU To Begin Joint Research In                         billion and USD 74 billion by 2020, says a PwC report,
                                                            titled, ''India Pharma Inc: Enhancing Value through
The Field Of Biotechnology Applied To                       Alliances & Partnerships''.
Human Health
November 10, 2011, Pharmabiz, Ramesh                        International pharma companies have acquired domestic
                                                            companies to maximise their capabilities in serving
Shankar                                                     global markets in the recent past. According to the          report, earlier alliances were formed to source out
1&sid=1                                                     products, but today, the initiative has expanded into
Under the New INDIGO Partnership Programme (NPP) on
Biotechnology applied to Human Health, India and the
European Union (EU) will soon begin joint research in the   Daiichi Sets Up Vaccine R&D Unit In
field of biotechnology applied to human health. Apart       Japan
from India, the other participating countries under the     November 3, 2011, Fierce Vaccines
programme are Austria, France, Germany, Israel,   
Norway, Portugal and Spain.                                 vaccine-rd-unit-japan/2011-11-03
The primary aim of the programme is to reinforce EU-        Daiichi Sankyo has established a new Tokyo-based
India cooperation in thematic areas of mutual interest,     vaccine research unit at its existing Kasai R&D Center in
recognising the fact that biotechnology is one of India‘s   Japan. The move follows the April announcement that
research strengths while health is a field of rising        Daiichi had set up another research unit inside
importance both in India and Europe.                        the National Institute of Biomedical Innovation in Osaka,
                                                            where the Japanese developer says it's already
Researchers Find Two Potential Lupus                        conducting exploratory vaccine research and searching
Vax Treatments                                              for new adjuvants.
November 9, 2011, Fierce Vaccines                           Researchers at the Tokyo unit will be hunting for new       vaccines for infectious diseases, according to Daiichi's
two-potential-lupus-vax-treatments/2011-11-                 release. "Now, with two vaccine research units and
09?utm_medium=nl&utm_source=internal                        partnerships with organizations inside and outside of the
                                                            group, Daiichi Sankyo is poised to fully realize its
After 5 decades without a new treatment, lupus patients     dedication to producing new vaccines through continuing
got a reprieve in March with Human Genome Sciences'         research efforts and to supplying safe and effective
Benlysta. But doctors believe there are still better        existing vaccines to the healthcare professionals and
options down the pipeline for patients with the             other persons in Japan who are waiting for them," the
autoimmune disease. Two recent studies have brought         pharma company said in a statement.
the promise of more treatment options in the form of

                                    Organisation of Pharmaceutical Producers of India                      5
                                                                                              Pharma Spectrum

Roche Strikes Cancer Research Deal                          ―The growing ineffectiveness of antibiotics is already a
                                                            serious problem today and a potential health time bomb
With China's Biobay                                         for the future.
October 31, 2011, Fierce Biotech
                                                            Mergers &
In case you missed the news last week, cancer drug giant
Roche wants to spread its research bets in China. The
Swiss drugmaker has made a deal involving China's state-    Acquisitions /
owned BioBay and Harvard University to advance new
drugs against cancer and other diseases, Bloomberg

Roche and BioBay, which is a biotech research center        UCB Adds To CNS Portfolio                          With
operator in Suzhou, China, plans to share equally funding
of a project focused on Harvard-discovered science,
                                                            Acquisition    Of     Lectus’                       Key
Roche partnering chief Dan Zabrowski told Bloomberg.        Pharmaceutical Assets
                                                            November 23, 2011, Pharma Letter
Eli Lilly Foundation               Commits         $30
Million To TB Study                                         pharmaceutical-assets.html?utm_source=2009_11_06-
October 28,         2011,     Drug     Discovery       &    Pharma+Clean&utm_campaign=45b791bfef-
Development                                                 RSS_EMAIL_CAMPAIGN&utm_medium=email
30-Million-to-TB-Study102811.aspx                           Belgian drugmaker UCB (Euronext Brussels: UCB) has
                                                            acquired the key pharmaceutical assets of closely-held,
The Eli Lilly and Company Foundation has committed $30      UK based drug developer Lectus Therapeutics via a
million in funding to further support The Lilly MDR-TB      licence and acquisition agreement. Lectus is focusing on
Partnership in its fight against multidrug-resistant        next-generation ion channel modulators.
tuberculosis. Lilly launched The Lilly MDR-TB Partnership
in 2003 to strengthen the global battle against             Pfizer   To     Acquire                     Excaliard
multidrug-resistant tuberculosis (MDR-TB).
Lilly originally committed $70 million to launch the        November 23, 2011, BioSpectrum Asia
partnership, elevate MDR-TB on the global health  
agenda, and transfer technology for two Lilly medicines     7520.asp?nl=%5b%5bforstats
used to treat MDR-TB to other manufacturers. In 2007,
Lilly expanded the original duration and scope for the      Pfizer and Excaliard Pharmaceuticals, announced that
partnership by committing an additional $50 million……..     they have entered into a definitive agreement under
                                                            which Pfizer will acquire Excaliard, a privately owned
EFPIA Supports A New R&D Model To                           biopharmaceutical company focused on developing novel
                                                            drugs for the treatment of skin fibrosis, more commonly
Tackle Antimicrobial Resistance                             referred to as skin scarring. The acquisition is expected
October 27, 2011, Pharma Letter                             to close before the end of the year.
supports-a-new-rd-model-to-tackle-antimicrobial-            Excaliard‘s lead product, EXC 001, an antisense
resistance.html?utm_source=2009_11_06-                      oligonucleotide in phase 2, is designed to interrupt the
Pharma+Clean&utm_campaign=fbfafca52b-                       process of fibrosis by inhibiting expression of connective
RSS_EMAIL_CAMPAIGN&utm_medium=email                         tissue growth factor (CTGF). CTGF is a growth factor
                                                            that can be over expressed in damaged skin or tissue
A vote of the European Parliament‘s Health Committee        following surgery or traumatic injury and lead to
on the threat posed by antimicrobial resistance, to cope    disfiguring skin scarring.
with this growing problem, calling for more research and
better monitoring of the effects of antimicrobials, was
adopted yesterday.

                                    Organisation of Pharmaceutical Producers of India                    6
                                                                                              Pharma Spectrum

US Health Insurer To Sell Cover Via JV                      The agreement provides Signum with research support
                                                            and milestone payments. GSK receives the exclusive
With TTK                                                    right of Signum's proprietary phosphatase screening
November 21, 2011, Money                        technology for GSK's research and development activities             in neurosciences.
products_621612.html                                        Baxter Completes Acquisition Of Baxa
The diversified TTK Group and US- based health service      Corporation
provider Cigna have signed a joint venture agreement to     November 11, 2011, BioSpectrum Asia
sell a range of health, wellness and insurance products.
Cigna and TTK have begun the process of seeking             7454.asp?nl=[[forstats
approval     from     the  Insurance    Regulatory  and
Development Authority and plan to submit a                  Baxter International announced that the company has
comprehensive filing early next year, the companies said    completed its planned acquisition of Baxa Corporation, a
in a joint press statement here.                            privately held global company based in Englewood,
                                                            Colo., for a cash consideration of $380 million. Baxa
"Full licence to operate would not be expected until        develops pharmacy technology that enhances the
2013," the statement said, without disclosing the           efficiency and safety of oral and IV dose preparation and
financial terms of the agreement. "With over 80 years of    delivery.
customer experience, the TTK Group brings a strong
brand, local market knowledge and proven strategies for     ―The acquisition of Baxa demonstrates Baxter‘s long-
distribution," Cigna International President William        term commitment to nutrition and patient safety and it
Atwell said.                                                allows us to offer a broader range of solutions for the
                                                            safe preparation and delivery of IV medications,‖ said Mr
Sanofi    Pasteur     And      CureVac                      Robert M Davis, president of Baxter‘s Medical Products
Collaborate On A $33.1 Million Project
On Vaccines For Infectious Diseases                         Mylan To Acquire Pfizer Generic
November 16, 2011, Pharma Letter                            Respiratory    Delivery Platform;
pasteur-and-curevac-collaborate-on-a-331-million-           Challenge To GSK
project-on-vaccines-for-infectious-diseases.html            November 10, 2011, Pharma Letter
Germany‘s CureVac says it has signed several agreements     to-acquire-pfizer-generic-respiratory-delivery-platform-
with Sanofi Pasteur, the vaccines division of French drug   challenge-to-gsk.html?utm_source=2009_11_06-
major Sanofi under which the companies will further         Pharma+Clean&utm_campaign=46b90a4bb6-
develop and apply CureVac‘s proprietary RNActive            RSS_EMAIL_CAMPAIGN&utm_medium=email
technology platform to the development of vaccines
against several infectious diseases.                        US generic drug major Mylan has entered into an
                                                            agreement with global pharma behemoth Pfizer for the
A research proposal with total funding of $33.              exclusive worldwide rights to develop, manufacture and
                                                            commercialize       Pfizer's  generic    equivalent     to
Signum      Biosciences    Announces                        GlaxoSmithKline's blockbuster salmeterol and fluticasone
                                                            brands Advair Diskus and Seretide Diskus incorporating
Collaborative      Agreement    With                        Pfizer's proprietary dry powder inhaler delivery platform.
November 15, 2011, BioSpectrum Asia                         The two GSK products bought in sales of £1.22 billion           ($1.96 billion) in the third quarter of this year. In
7475.asp?nl=[[forstats                                      addition, Pfizer will grant Mylan rights to its dry-powder
                                                            delivery platform to develop and commercialize
Signum Biosciences, a privately held biotechnology          additional brand and generic pharmaceutical products,
company from New Jersey, has entered into an                including rights of negotiation for certain existing Pfizer
agreement with GlaxoSmithKline R&D Company Limited          compounds currently in various stages of development.
(China) to collaborate on Signum's phosphatase screening
technology and Phosphoprotein Phosphatase 2A (PP2A).

                                    Organisation of Pharmaceutical Producers of India                     7
                                                                                                Pharma Spectrum

28 Pharma Companies In USA Entered                  
Potential Pay-For-Delay Deals In FY                           over-tpp.html?utm_source=2009_11_06-
2011, Says New FTC Report                                     Pharma+Clean&utm_campaign=56c52744cf-
October 26, 2011, Pharma Letter                               RSS_EMAIL_CAMPAIGN&utm_medium=email
pharma-companies-in-usa-entered-potential-pay-for-            Japan‘s former Health Minister, Yoichi Masuzoe, and
delay-deals-in-fy-2011-says-new-ftc-                          current leader of the New Renaissance Party, alluded to
report.html?utm_source=2009_11_06-                            the drug pricing system during intensive deliberations at
Pharma+Clean&utm_campaign=ccc769e898-                         the Upper House Budget Committee held on November
RSS_EMAIL_CAMPAIGN&utm_medium=email                           11 on Japan‘s participation in the Trans-Pacific Trade
                                                              (TPP) accord, reports Pharma Japan.
In the 2011 fiscal year (12 months to September 30)
pharmaceutical companies in the USA continued a recent        In the course of the free trade talks, as one rule for
anticompetitive trend of paying potential generic rivals      which reform would be sought, Mr Masuzoe gave an
to delay the introduction of lower-cost prescription drug     example of drug re-pricing for market expansion, saying:
alternatives for American consumers, according to an          ―The USA is probably likely to seek a reevaluation
overview of industry data released yesterday by the staff     (abolishment and/or reform of re-pricing rules).
of the US Federal Trade Commission, the competition
agency whose chairman has been fiercely critical of the       Aggressive Pricing Tarnishes China's
so called ―pay-for-delay‖ deals.
                                                              Promise To Pharma
The FTC staff report found that drug companies entered        November 11, 2011, Fierce Pharma
into 28 potential pay-for-delay deals in FY 2011.   

Pricing                                                       Drugmakers are coming to realize that China's growth is a
                                                              mixed blessing. There's no question that projections for
                                                              Chinese drug sales are much more promising than the
Pfizer May Cut Price Of Drug To Retain                        numbers in most other countries. But with the
Mkt Share                                                     government's new focus on affordability--read price-
November 25, 2011, The Economic Times                         cutting--the margins on those sales aren't likely to be as
(epaper page 5)                                               large as Big Pharma might have hoped.
d=7&pagesize=&edid=ET&edlabel=ETM&mydateHid=25-               As Bloomberg reports, it's not just the central
11-2011&pubname=Economic+Times+-                              government driving prices down. Provincial policies have
+Mumbai&edname=Mumbai&publabel=ET                             resulted in big cuts for hundreds of drugs. So, domestic
                                                              drugmakers are already feeling the pinch. One Chinese
Pfizer has offered to deliver Lipitor at a cut-price of $4    pharma exec told the news service that he'd be better
directly to patients in its fight to retain market share of   off investing in real estate.
the worlds largest selling drug just days before the US
patent for the medicine is due to expire. The move is         Pharma Group                Protests        European
expected to hit Ranbaxy Pharma, which has the                 Pricing Pain
exclusive rights to sell the generic version for three
months, beginning November 30.
                                                              November 10, 2011, Fierce Pharma
However, the Indian company has remained silent on the        protests-european-pricing-pain/2011-11-10
US FDA clearance for its banned plants and it is not clear
if it would launch its generic version as scheduled.          Forget worries about access to credit. The euro crisis
Ranbaxy did not respond to ETs email queries. Lipitor is      continues to affect pharmaceutical companies in far
the brand name for atorvastatin, a cholesterol lowering       more direct ways--and the pain isn't expected to taper
drug with annual sales of over $10 bullion.                   off soon, Reuters reports. In fact, drugmakers have
                                                              grown so worried about continued price cuts, they're
                                                              asking European officials to take a hard look at drug-
Japanese Drug Re-Pricing Issues Raised                        payment policies regionwide.
By Former Health Minister Over TPP
November 15, 2011, Pharma Letter                              In his capacity as president of the European industry
                                                              association, GlaxoSmithKline CEO Andrew Witty wrote

                                     Organisation of Pharmaceutical Producers of India                     8
                                                                                               Pharma Spectrum

two top European health officials to warn about the
unintended consequences of ongoing price cuts.               d=7&pagesize=&edid=ET&edlabel=ETM&mydateHid=25-
Countries both rich and not-so-rich have slashed their       11-2011&pubname=Economic+Times+-
spending on pharma products……                                +Mumbai&edname=Mumbai&publabel=ET

South Korean Govt To Slash Drug Prices                       Ranbaxy Laboratories and the American authorities are
                                                             inching towards a settlement over the Indian drug
14%                                                          makers regulatory troubles in the worlds largest drug
November 8, 2011, Pharma Letter                              market, brightening its prospects of launching the low-            cost version Lipitor, the blockbuster cholesterol lowering
korean-govt-to-slash-drug-prices-                            drug, on schedule in the US next week.
Pharma+Clean&utm_campaign=91cd0563af-                        An agreement between Pfizer and Ranbaxy in June 2008
RSS_EMAIL_CAMPAIGN&utm_medium=email                          allows the Indian drugmaker to launch its atorvastatin
                                                             drug on November 30.In 2008,the US Food and Drug
South Korea‘s Ministry of Health and Welfare has issued      Administration (FDA) had banned Ranbaxy from selling 30
an advance notice of the legislation of detailed             drugs in the US and stopped approving fresh products
regulations to reform the drug-pricing system, which         from its two Indian plants...........
includes proposals to cut the prices of a wide range of
pharmaceutical products by an average of 14%.                Merck Paying $950 Million To Settle US
The price cuts, if approved by the Prime Minister‘s          Vioxx Criminal, Civil Charges
Office in December, will be the largest since the            November 23, 2011, SCRIP, Donna Young
government took away drug sales rights from doctors and
gave them exclusively to pharmacists in 1999, notes the      950-million-to-settle-US-Vioxx-criminal-civil-charges-
local Korea Herald.                                          323969

Roche Offers Money-Back Deal On                              Merck has agreed to plead guilty to violating the Food,
                                                             Drug and Cosmetic Act (FDCA) and pay $950 million to
Avastin In Germany                                           settle US criminal charges and civil claims for off-label
October 25, 2011, Fierce Pharma                              promotion of its cyclooxygenase-2-selective nonsteroidal              anti-inflammatory drug Vioxx (rofecoxib), the US
money-back-deal-avastin-germany/2011-10-                     Department of Justice (DOJ)...
                                                             Unregistered     Drugs                   Considered
When pricing gets tough, it's time to get creative. Facing
unprecedented pressures in Germany, Roche is offering a      Counterfeit – DOH
pay-for-performance deal on its cancer drug Avastin. If      November 22, 2011, Philippine Information
patients don't respond, hospitals and public insurers that   Agency
sign up for the deal will get their money back.    

The offer is valid for initial treatment of advanced cases   Health Secretary Enrique Ona during today's edition of
of colorectal, breast, lung and kidney cancers. The offer,   Communications and Exchange (CNEX) forum said that
while unusual, isn't unique. Drugmakers have used            under Philippine law, drugs that are not registered in the
similar patient-access schemes to persuade U.K.              Food and Drug Administration (FDA) are considered
gatekeepers to accept pricier treatments.                    counterfeit.

                                                             ―Many of the drugs being brought to the country by
Trade & Others                                               overseas Filipino workers (OFWs) particularly in the rich
                                                             countries in the Middle East, where drugs or medicines
                                                             are given for free and are considered legal for
Ranbaxy’s Lipitor Clone May Hit US                           distribution in their respective country, when brought
                                                             here in the Philippines are already considered
Soon                                                         counterfeit.‖ Ona added.
November 25, 2011, The Economic Times
(epaper page 5)

                                     Organisation of Pharmaceutical Producers of India                    9
                                                                                               Pharma Spectrum

China Seen Opening Doors To Generic                           suppliers, with most of the scarce meds made by only
                                                              one or two manufacturers.
November 22, 2011, DNA Money                                  That's the assessment of IMS Institute for Healthcare              Informatics, which has turned its magnifying glass onto
opening-doors-to-generic-companies_1615756                    the drug-shortage problem. IMS Institute called the
                                                              problem "highly concentrated," product-wise; the drugs
Next thing you know, El Dorado has moved to China for         represent just a small part of the overall pharma
local drug makers. The country, a fierce competitor in        market.
the global arena, could soon open its doors to Indian
generics makers, if the government‘s diplomatic               Public Health Groups Launch Global
machinations hit home.
                                                              Campaign    Against    Abbott    Labs’
―The generic sales revenue contribution from the              Monopoly On Critical AIDS Medicine
Chinese market to Indian companies is extremely               November 11, 2011, Pharma Letter
negligible now. But we are hoping to see a significant
change in the situation in a couple of years,‖ said P V       health-groups-launch-global-campaign-against-abbott-
Appaji, executive director of the Pharmaceutical Export       labs-monopoly-on-critical-aids-
Promotion Council (Pharmexcil).                               medicine.html?utm_source=2009_11_06-
Bipartisan Bill Introduced In USA To                          RSS_EMAIL_CAMPAIGN&utm_medium=email
Increase Penalties For Counterfeit
                                                              A global campaign to challenge US health care major
Drugs                                                         Abbott Laboratories‘ monopolistic hold on Kaletra
November 21, 2011, Pharma Letter                              (lopinavir+ritonavir), a critical HIV/AIDS medicine, was          launched yesterday by public health groups in a dozen or
n-bill-introduced-in-usa-to-increase-penalties-for-           so countries.
Pharma+Clean&utm_campaign=25291e6ea6-                         The goal is to spur competition by generic drugmakers
RSS_EMAIL_CAMPAIGN&utm_medium=email                           and thereby lower the medicine‘s price, as well as to
                                                              free up its components for new and improved
Bipartisan, bicameral legislation was introduced in the       combination treatments. In countries from the USA to
USA last week by Senators Patrick Leahy (Democrat,            Vietnam, Brazil to Indonesia, health groups are aiming to
Vermont), Chuck Grassley (Republican, Iowa), Michael          break Abbott‘s monopoly control over Kaletra.
Bennet (Democrat, Colorado), and Richard Blumenthal
(Democrat, Connecticut) and US Representatives Patrick        Japanese Pharma Companies Set To Go
Meehan (Republican, Pennsylvania) and Linda Sanchez
(Democrat, California) to increase penalties for              Global - By P Reed Maurer
trafficking counterfeit drugs.                                November 10, 2011, Pharma Letter
The legislation responds to recommendations made by           -pharma-companies-set-to-go-global-by-p-reed-
the US Intellectual Property Enforcement Coordinator          maurer.html
and the administration‘s Counterfeit Pharmaceutical
Inter-agency Working Group. The Counterfeit Drug              In a short time much can change in Japan. A striking
Penalty Enhancement Act will increase penalties for the       example is the move by Japanese pharmaceutical
trafficking of counterfeit drugs to reflect the severity of   companies to acquire assets outside Japan. Not too long
the crime and the harm to the public.                         ago Western observers considered local companies as
                                                              very provincial, protected and strong in Japan but non-
IMS Advises 'Early Warning System' On                         competitors in the rest of the world.

Drug Shortages                                                Today, four Japanese firms realize over 50% of their
November 14, 2011, Fierce Pharma                              revenue outside Japan. Reed Maurer recently met face          to face with the senior executives of 20 Japanese
warning-system-drug-shortages/2011-11-14                      pharma/health care companies, much like similar
                                                              meetings in 2005.
The drug-shortage problem is concentrated in one way,
and widespread in another. More than 80% of the scarce
meds are generics, and more than 80% are injectables.
The shortages are spread across a large number of

                                     Organisation of Pharmaceutical Producers of India                     10
                                                                                                 Pharma Spectrum

India Pharma Exports To Double                                 Glenmark Pharmaceuticals SA, a wholly-owned subsidiary
                                                               of the company has received from Sanofi a $5 million
November 9, 2011, Hindustan Times                              milestone payment related to the successful completion                        of the Phase I clinical study of GRC 15300, Glenmark said
news/WorldEconomy/India-pharma-exports-to-                     in a filing to BSE.

India is expected to double pharmaceutical exports in          Baxter Recalls 300K Flu Vaccines
the next two years, with the Pharmaceutical Export             November 3, 2011, Fierce Vaccines
Promotion Council (Pharmexcil) eyeing overseas sales 
worth Rs 1,22,500 crore ($25 billion) by the end of 2013-      300k-flu-vaccines/2011-11-
14. The figure stood at around $10 billion in 2010-11.         03?utm_medium=nl&utm_source=internal

To achieve this ambitious target, exports would need to        Baxter International has issued a voluntary recall of
grow at a compounded annual growth rate (CAGR) of              300,000 doses of its popular flu vaccine Preflucel after a
around 34%, which is much above the 15% growth rate in         higher-than-expected number of side effects were
the last five years. "We will have to explore new              reported in those who got the vaccine. The side effects
markets other than US and Europe to meet the $25-              were the type usually associated with flu vaccines, such
billion export target," said NR Munjal, chairman,              as fatigue, muscle pain and headache.
Pharmexcil and president, Indian Drug Manufacturers'
Association.                                                   Most of the vaccines were distributed in Ireland and
                                                               Scotland. Preflucel is a low-egg-content vaccine
AstraZeneca Launches New Crestor                               designed for those who are allergic to eggs, which are
                                                               used to produce vaccines. "The vaccine should no longer
Savings Card In USA, As Generic Lipitor                        be used and any remaining stock [of the recalled
About To Debut                                                 batches] should be returned to the original supplier for
November 7, 2011, Pharma Letter                                credit.
eca-launches-new-crestor-savings-card-in-usa-as-generic-       Brazil Pharma Market                     Driven       By
lipitor-about-to-debut.html?utm_source=2009_11_06-             Generic Medicines
                                                               October 31, 2011, Pharma Letter
The US subsidiary of Anglo-Swedish drug major                  pharma-market-driven-by-generic-medicines.html
AstraZeneca yesterday launched a new savings card
which allows eligible patients to get their prescription       According to the Ministry of Health, the Brazilian
for the firm‘s cholesterol lowerer Crestor (rosuvastatin)      pharmaceutical market has grown to $28 billion
for just $8 more than the average co-pay of a generic          annually, backed strongly by the sale of generics
statin.                                                        medicines. It is noted that, since 1999, Brazil has
                                                               accelerated its growth in the production of generic
Eligible patients can pay just $18 for a prescription of       medicines as a result of a government program with this
Crestor (up to 30 tablets), noted AstraZeneca. The move        aim.
comes just ahead of US patent loss for Pfizer‘s all-time
blockbuster statin Lipitor (atorvastatin) at the end of        Currently,    there   are    about  540   registered
this month which, as was the case when simvastatin lost        pharmaceutical companies in Brazil, 90 of which are
exclusivity, is expected to impact on sales of other – still   producers of generic medicines.
patent-protected -cholesterol lowering drugs.
                                                               Chinese Pharma Eyes Opportunity In
Glenmark Gets $5 Mn Payment From                               U.S., U.K.
Sanofi-Aventis                                                 October 28, 2011, Fierce Pharma
November 8, 2011, Hindu Business Line                           eyes-opportunity-us-uk/2011-10-
e2606681.ece?homepage=true&ref=wl_home                         28?utm_medium=nl&utm_source=internal

Drug firm Glenmark Pharmaceuticals on Monday said it           Big Pharma's stampede into China is well documented.
has received a payment of $5 million (over Rs 24 crore)        Most recently, Novartis made headlines with plans to cut
from Sanofi-Aventis on completion of Phase I study of          2,000 jobs in the U.S. and Switzerland, while pumping up
molecule ‗GRC 15300‘ being developed for treatment of          operations in China with several hundred new jobs. Of
                                      Organisation of Pharmaceutical Producers of India                     11
                                                                                             Pharma Spectrum

                                                           Animal Health
course, China's projected growth rate looks much
better than anything in the U.S. or Europe these days.

But Chinese drugmakers appear to have an appetite for
sales in Big Pharma's home markets. As China Daily         Pfizer Invests $7m In US Global Equine
reports, a group of Chinese pharma executives and
industry investors made a foray into the U.S. to check
                                                           Research Center
out the prospects. They met with Amgen, Pfizer, Ernst &    November 9, 2011,           Animal Pharm , Jamie
Young's pharma group and healthcare-investment             Day
specialist Warburg Pincus.                       
Abbott Honoured With Asian CSR                             center-
Award For Leadership In Science                            /830c7dd3-0ace-11e1-bbe6-4d8e6a53eb99.xml
October 25, 2011, Pharmabiz, Manila                        Pfizer Animal Health has opened a new equine research         center in the US which it says will become the worldwide
3&sid=2                                                    hub for the research and development of equine
                                                           vaccines and novel therapeutics. The $7 million Pfizer
Abbott, a global health care company and its               Animal Health Equine Research Center is located in
philanthropic foundation the Abbott Fund were honoured     Richland, Michigan, within the ...
at the 10th Asian Forum on Corporate Responsibility in
the Philippines with an Asian CSR Award for educational    US Generics Hit Merial Q3
improvement for advancing science education in the         November 4, 2011,           Animal Pharm , Jamie
region.                                                    Day
Abbott Science Education Programmes reached                /US-generics-hit-Merial-Q3-
thousands of children in 2010-2011 through creative,       323247?autnRef=/contentstore/animalpharmnews/codex
innovative events designed to spark an interest in life-   /056dfb9b-0636-11e1-bbe6-4d8e6a53eb99.xml
long science learning. A critical part of the Abbott
Science Education Programmes in China, Korea and           Merial, the animal health division of Sanofi, has reported
Singapore was the involvement of more than 500 Abbott      a 5.2% fall in revenues in the third quarter, which it
scientists, engineers and other employee volunteers,       attributes to generic antiparasitic competition in the US
lending their expertise to introduce children to the       companion animal market. The division has reported net
wonders of science.                                        sales of €470 million ($647.4m) in the three months to
                                                           September ...
15 Top Blockbuster Contenders
October 25, 2011, Fierce Biotech
blockbuster-contenders/2011-10-25                          Biotechnology
Divining the future sales for any drug in development      GAVI To Bring HPV Vaccines To Poor
requires some finesse. You first must see how the
experimental therapy shapes up against the current slate   Countries
of marketed drugs, then add in what the competition is     November 17, 2011, Fierce Vaccines
likely to do as they pursue their own approvals. 
Looking over our slate of 15 of the biggest blockbusters   17?utm_medium=nl&utm_source=internal
now in late-stage development, it's clear the big
developers are often attracted to the same                 The Gavi Allaince has started a new program to get
megablockbuster markets. Two big cholesterol drugs are     cervical cancer vaccines to girls in poor countries. The
in the works, and Alzheimer's is huge.                     alliance is in talks with Merck and GlaxoSmithKline,
                                                           which make the HPV vaccines Gardasil and Cervarix
                                                           respectively, to "secure a sustainable price from
                                                           manufacturers," according to a release.

                                   Organisation of Pharmaceutical Producers of India                    12
                                                                                               Pharma Spectrum

The alliance says that up to 2 million women and girls in
nine countries could be protected from cervical cancer        vaccines-market-set-to-see-change-will-grow-to-over-9-
by 2015 if a deal with drugmakers can be reached. ―The        billion-by-2018.html?utm_source=2009_11_06-
HPV vaccine is critical to women and girls in poorer          Pharma+Clean&utm_campaign=b7c2a0c775-
countries because they usually do not have access to          RSS_EMAIL_CAMPAIGN&utm_medium=email
screening to prevent cervical cancer and treatment
taken for granted in richer nations.                          The global cancer vaccines market in seven key markets
                                                              (the USA, France, Germany, Italy, Spain, UK and Japan)
GSK Taps Alnylam Tech For Faster                              was worth $3.48 billion in 2010, after increasing at a
                                                              compound annual growth rate (CAGR) of 63.7% during
Vaccine Production                                            2006-2010, notes a new report from GlobalData. Over
November 3, 2011, Fierce Vaccines                             the 2010-2018 period, the market is expected to record         a CAGR of 12.7%, to reach $9.08 billion by 2018. This
tech-faster-vaccine-production/2011-11-03                     high growth is attributed to the increasing patient
                                                              population of cancer.
GlaxoSmithKline is tapping Alnylam Pharmaceutical's RNA
interference technology to speed production influenza         The prophylactic cancer vaccines market experienced
and other vaccines cell culture systems. Financial details    high growth in the historic period due to the launch of
of the deal weren't disclosed, though the release notes       Merck & Co‘s Gardasil (human papillomavirus
that Alnylam will get funding and milestone payments as       quadrivalent (types 6, 11, 16, and 18) vaccine,
part of the deal, as well as royalties on any products that   recombinant) and Cervarix (human papillomavirus
emerge from the partnership.                                  bivalent (types 16 and 18) vaccine, recombinant) from
Alnylam's VaxiRNA technology uses small interfering RNAs
(siRNAs) to shut off genes that limit the growth viruses
used for vaccine production, according to Xconomy. The
company says the technology stems from previous work          Medical Diagnostics
applying RNAi technology to improve biotherapeutic
manufacturing, such as recombinant proteins and
monoclonal antibodies.                                        / Devices
10 Promising Therapeutic Vaccines                             Medtronic Starts Landmark Study Of
October 27, 2011, Fierce Vaccines                             Hypertension Treatment             October 27, 2011, BioSpectrtum Asia
Scientists have long figured it should be possible to rev
up the immune system on command, to give the body's           Medtronic announced the start of SYMPLICITY HTN-3, the
own natural defenses an extra surge of power to attack        company‘s US clinical trial of the Symplicity Renal
tumors and fight diseases. But decades of working on the      Denervation       System      for    treatment-resistant
challenge have seen many promising clinical trials of         hypertension. The first patient in this landmark study
potential "immune modulators," "immune stimulators"           was enrolled at the Prairie Heart Institute at St. John‘s
and "therapeutic vaccines" end in disappointment.             Hospital in Springfield, Ill.
Now there is evidence that therapeutic vaccines actually      Treatment     resistant    hypertension,    defined    as
can work. Therapeutic vaccines are meant to combat            persistently high blood pressure despite three or more
existing disease rather than offer lasting protection         antihypertensive medications of different types, puts
against infection, as traditional vaccines do. The FDA        approximately 120 million people worldwide at risk of
approved the first therapeutic vaccine in April 2010.         premature death from kidney disease and cardiovascular
Dendreon's Provenge (sipuleucel-T) was shown to extend        events such as stroke, heart attack and heart failure.
life about four months in men with a certain type of
metastatic prostate cancer.

Cancer Vaccines Market Set To See                             New Appointments
Change, Will Grow To Over $9 Billion
By 2018                                                       No Relevant News
October 24, 2011, Pharma Letter

                                     Organisation of Pharmaceutical Producers of India                     13
                                                                                             Pharma Spectrum

                                                           Robert Holleyman, president and chief executive of

Domestic                                                   Business Software Alliance, which represents the global
                                                           software industry, spoke in an interview on how strong
                                                           laws on intellectual property and software piracy can

IPR                                                        strengthen India‘s software industry, create more jobs
                                                           and increase tax revenues. Edited excerpts:

                                                           Is the lack of a strong regime on software piracy and
Bayer Withdraws Writ Petition Against                      intellectual property (IP) hurting the Indian information
Natco                                                      technology (IT) industry in terms of attracting business?
November 25, 2011, Mint                                    The challenge India faces is on its domestic            infrastructure in terms of broadband capability,
withdraws-writ-petition.html?atype=tp                      availability of PCs (personal computers), etc…..

In a new twist to the ongoing legal battle between         India Can Boast Of Healthy Patent
German drug multinational Bayer Healthcare AG and          Pipeline
Hyderabad-based cancer drug maker Natco Pharma Ltd
over the compulsory licensing of Bayer‘s cancer drug
                                                           November 15, 2011, Hindu Business Line
Nexavar, the Delhi high court last week dismissed the
foreign company‘s writ petition as withdrawn.              economy/economy/article2627425.ece?homepage=true&
Bayer had in the writ petition challenged the Indian
patent office‘s decision to publish Natco‘s compulsory     Though the corporate world might be circumspect of
licensing application for public review as a part of       India's capability to recognise intellectual property, the
proceedings. With this, the patent office can now go       award of 4,000 product patents in the last six years and
ahead with the hearing of the compulsory licensing         more than an equal number in the pipeline is ample
application involving both parties.                        proof of the country's capabilities.

                                                           ―Only a couple of cases are stuck in court while most
Bayer Joins List Of Multinational Cos                      have actually been awarded patents,‖ said Mr P.H.
Wary Of Indian Patent Law                                  Kurian, Controller General of Patents, Designs and
November 18, 2011, Financial Express                       Trademarks and Geographical Indications, department of     industrial policy and promotions, Government of India.
laws/877308/0                                              Utility Patenting: India’s Next Move?
                                                           November 14, 2011, Mint
Multinational pharmaceutical companies continue to be
wary of the alleged ‗loopholes‘ in India‘s patent laws,    patenting-India8217.html
when it comes to launching their patented products in
the country. Bayer, the 35-billion euro German chemical    India‘s rating on the Global Innovation Index (GII) slipped
and pharma company, is the latest to join others like      to 62 in 2011—a sign that recent reforms in economic
Novartis and Pfizer to call for strengthening India‘s      policy, education and intellectual property protection
patent laws to protect their intellectual property (IP).   aren‘t helping boost innovation, say experts.
                                                           India stood at 56 on the index in 2010 and at 45 in the
―For a company like Bayer, which is modelled on            year before.
innovation, IP is very important, and is a key mechanism
to protect our rights,‖ said Marijn Dekkers, chairman of   Key reasons for the fall, the experts point out, include a
Bayer, which makes painkiller Aspirin and heart medicine   lack of transparency in policy implementation, political
Avanta, among other drugs.                                 instability and, importantly, the absence of a connecting
                                                           link in the innovation ecosystem. The index
Intellectual Property Protection Is Key                    acknowledges the need for a broader vision of innovation
                                                           that is applicable to both developed and emerging
For Investment In India                                    economies, and recognizes the role of innovation as a
November 15, 2011, Mint                                    driver of economic growth.

                                   Organisation of Pharmaceutical Producers of India                     14
                                                                                                Pharma Spectrum

Piramal Healthcare Settles                       Patent
Litigation With Baxter
November 2, 2011, Business Standard                           After a two-year wait, the revamped and slimmer version              of the Companies Bill is ready to be tabled before
healthcare-settles-patent-litigationbaxter/150077/on          Parliament during the ongoing winter session. The
                                                              Companies Bill 2011, with tighter disclosure norms,
Piramal Healthcare today said it had settled a patent         stricter penal provisions, greater shareholder democracy
litigation over Baxter Healthcare's anesthetic drug           and introducing the concept of Corporate Social
Suprane and could now launch its product in the US            Responsibility, for the first time, was cleared by the
market from January 1, 2014. Piramal Critical Care Inc, a     Cabinet on Thursday.
subsidiary of the company, announced that patent
litigation with Baxter Healthcare Corporation regarding       The Bill will replace the existing Companies Bill 2009,
generic Suprane has been dismissed by the Delaware            which will be subsequently withdrawn. The reforms in
District Court in US pursuant to a settlement between         the Companies Act, 1956 were initiated after a series of
the parties, Piramal Healthcare said in a filing to the       white-collar crimes, including the Satyam accounting
Bombay Stock Exchange (BSE).                                  fraud.

As per the terms of the agreement, both parties agreed        National     Manufacturing  Policy
that Piramal may launch its generic Desflurane in the US
as of January 1, 2014 subject to regulatory approval, it      Expected To Enhance Indian Pharma
added. "Piramal has agreed not to make, use, sell or          Production Prospects
offer for sale in the United States, or import into the US,   November 23, 2011, Pharmabiz, Nandita
this product prior to January 1, 2014," the company said.
Govt To Fund Awareness Programmes                             0&sid=1
October 26, 2011, The Economic Times                          The Union government‘s National Manufacturing Policy       (NMP) is viewed to promote the productivity of the
=yes&pageid=17&edlabel=ETM&mydateHid=26-10-                   pharmaceutical sector. The policy was devised with the
2011&pubname=&edname=&articleid=Ar01701&format=&              objective to enhance the share of manufacturing in gross
publabel=ET                                                   domestic product (GDP) to 25 per cent from the current
                                                              15 per cent within a decade and create a 100 million
The government will provide financial support to              jobs.
educational institutes and industry associations for
conducting programmes to create awareness on                  The government brought out the policy because it has
Intellectual Property Rights. Under the 'IP Awareness         recognized that the manufacturing sector has a
Programme for Electronics and Information Technology          multiplier effect on the creation of jobs even in the
sector', the Department of Information Technology is          allied sectors. It has also announced the identification of
seeking application from educational institutes and           National Investment Manufacturing Zones (NIMZs) which
recognized industry associations to organise such             will support the expansion efforts of the small and
programmes.                                                   medium enterprises.

The government has earmarked.1.37 crore for this              Commission Goes Into Overdrive,
programme for two years, said Ajai Garg, Additional           Verdict On Drug Cartel Soon
Director, Department of IT. The support for awareness
programmes in educational institutes will be limited to.1
                                                              November 22, 2011, Business Standard
lakh per programme,.2 lakh for awareness programmes 
for working professional and IPR professionals,and.5 lakh     goes-into-overdrive-verdictdrug-cartel-soon/456246/
for conducting only one international workshop that will
be organised with global experts.                             The Competition Commission of India (CCI) is also seeing
                                                              action in its role as an anti-cartelisation watchdog. It is
                                                              widely expected to take a final view on whether

Regulatory                                                    restrictive trade practices are prevalent in the Rs
                                                              60,000-crore domestic pharmaceutical market.

                                                              The All India Organisation of Chemists and Druggists, the
Companies Bill Cleared                                        pan-India body that represents a majority of the 550,000
November 25, 2011, Hindu Business Line                        retail chemists, has been enjoying a near-veto power on

                                     Organisation of Pharmaceutical Producers of India                      15
                                                                                                 Pharma Spectrum

medicine trade issues for decades. Another verdict of          With the Department of Pharmaceuticals (DoP) failing
significant public interest, on the alleged.............       continuously to utilise the funds effectively for many
                                                               years, the Parliamentary Standing Committee attached
Corporate   Affairs   Ministry  Plans                          to the Ministry of Chemicals has registered its strong
                                                               reservation on the trend.
Tighter Norms For Private Placement
November 22, 2011, Hindu Business Line                         ―The Committee are perturbed to note that there has           been a trend that the allocated money under various
647648.ece                                                     schemes is underutilized and that too is not being
                                                               properly and evenly spent by the Department,‖ said the
Norms on private placement of shares are likely to be          recent report by the panel headed by Gopinath Munde.
tightened soon to make the practice more transparent
and free of misuse. A notification has been prepared by        Health Spend Set To Double In 12th
the Ministry of Corporate Affairs that makes it
mandatory for companies to file each placement                 Plan
individually with the registrar of companies (RoC).            November 19, 2011, The Times of India
This will help enforce the upper limit of 49 individuals or    19/india/30419399_1_health-sector-12th-plan-universal-
entities who can be issued shares through private              health-coverage
placement, an official said. If the number of individuals
or entities is 50 or above, it is considered a public          India's allocation for health is all set to double. The
placement and will have to be carried out under relevant       Planning Commission has decided to increase its
Securities and Exchange Board of India (SEBI) provisions.      spending on health to 2.5% of the GDP in the 12th Five
                                                               Year Plan that starts next year. This is in accordance
NBRA Bill May Be Introduced                              In    with the recommendation made by the High Level Expert
                                                               Group on universal health coverage that was constituted
Parliament In The Winter Session                               by the Commission.
November 22, 2011, Pharmabiz, Ramesh
Shankar                                                        Syeda Hamid, member of the Planning Commission, said,             "Nearly 2.5% of the GDP will be used in health sector
4&sid=1                                                        during the next plan period. This will be a big jump." The
                                                               expert committee, headed by Dr K Srinath Reddy, had
The Biotechnology Regulatory Authority of India Bill           recommended that India should more than double its
(NBRA Bill), which could not be introduced during the          public spending on health by 2017 to reduce the
last session as the corruption related issues took             tremendously high private out-of-pocket spending on
precedence over other issues, is likely to be introduced       medical bills.
in the winter session of Parliament which begins today as
it has found a place among the tentative list for              DoP Seeks Active Role Of Private
transaction of business for the winter session.
                                                               Sector To Ensure Access To Healthcare
Even though several important Bills related to pharma          November 19, 2011, Pharmabiz
and health sectors are waiting in the wings to be    
introduced in Parliament for its final nod, only one major     8&sid=1
Bill, NBRA Bill, has found a place among the tentative
list for transaction of business for the winter session. A     Department of Pharmaceuticals (DoP) has sought the
total of 24 new bills have been listed in the tentative list   active support of the private partners to increase
for transaction for this session.                              healthcare access to the bottom of pyramid in rural India
                                                               even as experts called for new models and products
                                                               backed up by strong government drive.
Parliamentary Panel Raps DoP For
Underutilisation Of Funds                                      Addressing the partners from healthcare sector including
November 21, 2011, Pharmabiz, Joseph                           the industry leaders as part of a recent summit, DoP
Alexander                                                      joint secretary Devendra Chaudhary said the best             working solution is not to leave everything to the
9&sid=1                                                        government.

                                      Organisation of Pharmaceutical Producers of India                     16
                                                                                              Pharma Spectrum

Health Ministry Plans Robust Policy To                      The officer added that five companies - including the
                                                            one that uses the image of a snake inappropriately -
Recall Faulty, Banned Drugs                                 changed their promotional campaign altogether. FDA
November 18, 2011, Business Standard                        commissioner    Mahesh     Zagade    confirmed    the             development. "It is a continuous process and we do it
ministry-plans-robust-policy-to-recall-faulty-banned-       very seriously.
                                                            DBT, CDSCO To Release Final Draft
The health ministry is planning to develop a foolproof
mechanism to ensure recall of all faulty and banned         Guidelines Of Similar Biologics 2011 By
drugs from the Rs 60,000-crore domestic pharmaceutical      December End
market. The move will strengthen the existing recall        November 16, 2011, Pharmabiz, Suja Nair
provisions under the Drugs and Cosmetic Rules.
The current law, however, fails to prescribe time-bound
recall formats. Although India has so far banned around     7&sid=1
90 products, mostly fixed dose combinations that were
found to be irrational, it had never attempted to enforce   The Department of Biotechnology (DBT) and the Central
it with a strict mechanism.                                 Drugs Standard Control Organisation (CDSCO) may
                                                            release the final draft guidelines for similar biologics by
                                                            December end. To discuss the guidelines and finalise it,
DoP Launches Steps To Frame An                              the DBT is going to meet the CDSCO officials by end of
Overarching   Pharma      Policy To                         November, so that they can proceed with the formalities
                                                            of getting stakeholders view on the same.
Complement Pricing Policy
November 17, 2011, Pharmabiz, Joseph                        The Drug Controller General of India's (DCGI's) office
Alexander                                                   recently submitted the draft notes on clinical trials for          these products titled Similar Biologics India September
2&sid=1                                                     2011, to the DBT for its review and approval. The draft
                                                            guidelines contains requirements of data for both pre-
The Department of Pharmaceuticals (DoP), which              clinical trial (which was done by the DBT earlier) as well
recently drafted a new policy to control the pricing of     as clinical trail data done by the CDSCO.
drugs, has initiated steps to frame an overarching
Pharma Control Policy as part of the system of providing    Govt Plan To Screen 150m                             For
affordable healthcare to the public.
                                                            Diabetes Fails To Take Off
The DoP said it was taking up the matter with other         November 14, 2011, The Times of India
concerned departments like Health and take the              (epaper page 21)
initiative to frame a comprehensive policy to     
complement the Pharmaceutical Pricing Policy drafted        d=23&pagesize=&edid=TOI&edlabel=TOIM&mydateHid=14
and released by the department recently.                    -11-2011&pubname=Times+of+India+-
FDA Cracks Down On 14 Firms For
                                                            India looks unlikely to be able to screen over 150 million
Misleading Ads                                              people for diabetes and hypertension by March 2012.The
November 16, 2011, Hindustan Times                          health ministrys plan to screen all adult males above 30                        years of age and pregnant women of all age groups for
news/Mumbai/FDA-cracks-down-on-14-firms-for-                diabetes and hypertension in 100 districts across 21
misleading-ads/Article1-769797.aspx                         states has failed to take off so far.

In a major crackdown on misleading advertisements for       Only a few cities like Bangalore, Chennai and
aphrodisiacal drugs, the Maharashtra Food and Drugs         Ahmedabad      have     rolled out     the   screening
Department has asked around 14 companies to correct         programme.Alarmed at the progress, health secretary P
their promotional campaigns. A senior Food and Drug         K Pradhan has called a review meeting on November 17.
Administration (FDA) officer, on condition of anonymity     A ministry official said, We will review the progress
because he is not authorised to speak to the media. said    made by states and help them with some models which
officials from across the state seized stocks worth Rs 5    they can work on.
lakh of the five alleged aphrodisiacs.

                                    Organisation of Pharmaceutical Producers of India                     17
                                                                                               Pharma Spectrum

Planning Commission Calls For More                           The new Companies Bill,finalized by the ministry of
                                                             corporate affairs,has decided to dilute the proposed
Capital Investment In Health Under                           mandatory CSR spending provision due to the corporate
12th Plan                                                    sectors serious objections to it. However,the pitch of the
November 14, 2011, Pharmabiz, Joseph                         draft new bill appears to be making it obligatory for the
                                                             companies having net worth of Rs 500 crore or more or
Alexander                                                    turnover of Rs 1,000 crore or more or net profit of Rs 5           crore or more during any financial year to spend 2% of
7&sid=2                                                      their net profits on charitable and philanthropic works.
The Planning Commission has called for more capital
investment in health for a prolonged period of time and
a health policy that would address the special needs of      New Products
different groups during the next five year plan period.

One of the major reasons for the poor quality of health
                                                             Ranbaxy Gets Nod For First Drug
services is the lack of capital investment in health for     Developed By Indian Pharma Co
prolonged period of time. The National Rural Health          November 1, 2011, The Economic Times
Mission had sought to strengthen the necessary     
infrastructure in terms of Sub-Centres, Primary Health       industry/healthcare/biotech/pharmaceuticals/ranbaxy-
Centres and Community Health Centres.                        gets-nod-for-first-drug-developed-by-indian-pharma-
Indians' Growing Healthcare Expenses
                                                             The country's drug regulator has given conditional
Concern WHO                                                  market approval for Ranbaxy Laboratories' anti-malaria
November 2, 2011, The Times of India                         drug, paving the way for the launch of the country's first            privately-developed medicine and ending more than a
growing-healthcare-expenses-concern-                         decade of failures or near misses for India's drug makers
WHO/articleshow/10574237.cms                                 While the domestic drug industry has been successful in
                                                             making generic versions of drugs as well as new drug
The World Health Organization (WHO) is worried about         delivery systems, this is the first time that a new
Indians' high out-of-pocket (OOP) expenses to buy            molecule discovered and patented by a home grown
medicines. WHO says, 3.2% Indians will fall below the        company will be sold commercially, plugging a big hole
poverty line because of high medical bills. About 70% of     in the R&D credentials of the country.
Indians spend their entire income on healthcare and
purchasing drugs, WHO suggests.                              There are a few companies whose molecules have
                                                             reached the last phase of clinical trials. But, on the
Dr Kathleen A Holloway, regional adviser of WHO, said,       whole, Indian drugmakers have had very limited success
"About 70% Indians are spending their out-of-pocket          with their drug discovery programmes because of
income on medicines and healthcare services in               inadequate funding and lack of proper skill sets," says
comparison to 30%-40% in other Asian countries like Sri      Sujay Shetty of PricewaterhouseCoopers.
Lanka, and are still suffering from infected diseases due
to lack of best quality drugs and healthcare facilities."

Centre Gives Corporates Breather On                          R&D/Clinical Trials
Social Spend
October 30, 2011, The Times of India                         Alagiri Seeks Extension Of Tax Benefit      For Research
es=yes&pageid=9&max=true&articleid=Ar00901&sectid=3          November 25, 2011, Financial Express
2011&pubname=Times+of+India+-+Mumbai+-                       extension-of-tax-benefit-for-research/880215/0
on+social+spend&edname=&publabel=TOI                         The chemicals and fertilisers ministry has asked the
                                                             finance ministry to extend the income tax concession for
The Centre has decided to take a middle-path in              companies that are spending on research and
enforcing corporate social responsibility (CSR) by giving    development (R&D) for another 10 years beginning April
the companies the option to either spend 2% of their net     1. The benefit allowed under section 35 (2AB) of the
profits on philanthropic activities,or mandatorily explain   Income Tax Act, which lowers any manufacturer‘s
why they could not.

                                     Organisation of Pharmaceutical Producers of India                    18
                                                                                               Pharma Spectrum

taxable income by twice the amount spent on research,        November 24, 2011, The Economic Times
is set to expire at the end of this financial year.          (epaper page 19)
Drug companies are the main beneficiaries of the             d=19&pagesize=&edid=ET&edlabel=ETM&mydateHid=24-
scheme. ―This is the only investment-linked tax benefit      11-2011&pubname=Economic+Times+-
allowed under the existing Income Tax Act and retaining      +Mumbai&edname=Mumbai&publabel=ET
it fits into the finance ministry‘s plans in the proposed
new direct tax code (DTC) to replace investment-linked       Innovation is the secret of India‘s growing success and it
tax      breaks     with   profit-linked     ones,    said   is this innovation that should make the developed world
Lakshminarayanan, leader, Tax in India, Deloitte Touche      sit up and take note of, say management experts Prof.
Tohmatsu India.                                              Nirmalaya Kumar and Prof. Phanish Puranam.

ICMR To Begin Research On The 'Effect                        Innovation Council Has Some Good
Of Mental Health Disorder And                                Ideas, But Financial Sector Growth Is
Substance Use On Maternal And Child                          Key
Health'                                                      November 18, 2011, The Economic Times
November 24, 2011, Pharmabiz, Ramesh               
Shankar                                                      /innovation-council-has-some-good-ideas-but-financial-           sector-growth-is-key/articleshow/10775663.cms
                                                             The Sam Pitroda-led National Innovation Council has
The Indian Council of Medical Research (ICMR) will soon      completed one year and published a report about what it
begin research on the 'Effect of mental health disorder      has achieved. There's a lot to be said for its efforts. It
and substance use on maternal and child health'. The         plans to support, with technology, innovators and
broad areas of the study include socio behavioural and       finance, skill clusters like the auto components belt at
mental health consequences of drug use/abuse among           Faridabad or Agartala's bamboo industry.
women of reproductive age group (15-49); socio
behavioural and mental health consequences of alcohol        It plans to map local cultures, histories and ecologies,
use/abuse among women of reproductive age group (15-         give fellowships and promote new thinking in schools and
49); effect of post natal depression (PND) among young       colleges. Connecting India's 2,50,000 panchayats with
mothers; HIV/AIDS and common mental disorder (CMD)           high-speed fibre optic and a broadband network is a
among women; effect of substance/alcohol use/abuse on        good idea, as is the plan to allow India's nearly 800 MPs
foetal growth; and gynaecological morbidity and              to use part of their area development funds to award
psychological disorder.                                      local innovators.

Betting On Innovation                                        Innovation Tool To Fight Downturn:
November 24, 2011, Business Standard                         Pitroda                 November 17, 2011, Hindustan Times
How important is innovation in sustaining economic           Pitroda/Article1-770136.aspx
growth and boosting greater connectivity between
markets across the globe? A recent report by the World       Innovation can be a game changer when worrisome
Intellectual Property Rights (WIPO) – ―The Changing Face     inflation, costlier borrowings, falling rupee, industrial
of Innovation‖ – provides some interesting insights to       production haunts the economy. ―There is an urgent
answer this question.                                        need to rethink and redefine innovation to fight the
                                                             shrinking profit margins and strengthening slowdown,‖
The report clearly states that in high-income countries,     said Sam Pitroda, Chief of National Innovation Council
estimates show that innovation accounts for as much as       (NIC) during a news conference on ―Decade of
80 per cent of economy-wide productivity. Though no          Innovation-India@year1‖, an event jointly organised by
data is available for the medium- and low-income             Confederation of Indian Industry (CII) and the NIC.
countries, evidence shows that companies with higher
levels of innovation outperform companies with little or     Pitroda also proposed setting up of 100 sectoral
minimal level of innovation.                                 ―innovation councils‖ along with the transformation of
                                                             existing industry clusters into innovation clusters by
Inside India To Change The World                             mentoring and networking them with knowledge

                                     Organisation of Pharmaceutical Producers of India                    19
                                                                                                Pharma Spectrum

CROs Annoyed Over Continued Delay In                         various disciplines with stress on designing commercial
                                                             products based on indigenous technologies.
Giving Approvals For Clinical Trials By
DCGI                                                         Earlier this week, Prime Minister Manmohan Singh
November 11, 2011, Pharmabiz, Ramesh                         approved the establishment of CICs in Mumbai, Kolkata
                                                             and Chennai within the next two years, CSIR Director-
Shankar                                                      General Samir Kumar Brahmachari said.
                                                             Pharmabiz Editorial: Role Of Ethics
The clinical trial industry in the country is annoyed over   Committees
the continued delay in giving approvals for the clinical     November 2, 2011, Pharmabiz
trials, including the bioavailability and bioequivalance
(BA/BE) studies, by the office of the Drug Controller        44&sid=3
General of India (DCGI).
                                                             The most costly part of new drug discovery is the three
Industry sources said that ever since the controversy        phase clinical research lasting for three to four years
surrounding the Hyderabad-based CRO Axis Clinicals hit       involving thousands of human volunteers and
the headlines, the DCGI office has virtually stopped         investigators in multi locations. Any of these potential
giving clearance to clinical trials including the BA/BE      drug candidates can be abandoned during the trial
studies and ordered auditing of all the Clinical Research    period if their adverse drug events are beyond the
Organisations (CROs) in the country to ensure that these     acceptable limits.
studies are performed strictly in accordance with the
applicable regulatory provisions and prescribed              It is certainly a high risk activity involving millions of
guidelines in the country.                                   dollars and pharmaceutical companies usually make sure
                                                             that trial reports reaching the regulatory authorities are
Azad Asks ICMR To Speedily Work Out                          favourable. No new drug can be approved for marketing
Affordable Diabetes Screening Strips                         without submission of trial reports and their scrutiny by
                                                             the regulatory authorities. Because of these reasons, the
November 10, 2011, Pharmabiz                                 whole operation of clinical research is highly secretive.
                                                             Registration Of BA/BE Studies With
Union Minister for Health and Family Welfare Ghulam          CTRI To Become Mandatory Soon
Nabi Azad has asked the Indian Council of Medical            November        1,   2011,      Pharmabiz,       Ramesh
Research (ICMR) to speedily work out an economic
solution for diabetes screening strips so that the goal of
screening at least 150 million people under the National
Programme for Prevention and Control of Diabetes,            5&sid=1
Cardiovascular Disease and Stroke can be achieved.
                                                             After more than two years since the registration of
He made this plea while flagging off the centenary           clinical trials was made mandatory in the country, the
celebrations of the ICMR here on Tuesday, in the             Union health ministry will soon make the registration of
presence of Union minister for communications and IT         bioavailability and bioequivalance (BA/BE) studies
Kapil Sibal and ministers of state for health S              mandatory with the Clinical Trial Registry of India
Gandhiselvan and Sudip Bandyopadhyay.                        (CTRI).

                                                             According to sources, the Union health ministry has
CSIR To Develop                   12      Innovation         already taken the decision in-principle to make the
Complexes                                                    registration of BA/BE studies mandatory, on the same
November 7, 2011, Financial Express                          lines of the other clinical trials in the country. The drugs        controller general of India (DCGI) Dr Surinder Singh has
complexes-1320320267                                         already directed the senior officials in the CTRI to make
                                                             the necessary changes in its web network to incorporate
Seeking to boost inventions, the Council of Scientific and   the BA/BE features, sources said.
Industrial Research will establish 12 innovation
complexes across the country, with the first three
coming up at Mumbai, Kolkata and Chennai. The CSIR
Innovation Complexes (CIC) will house scientists from

                                     Organisation of Pharmaceutical Producers of India                      20
                                                                                                Pharma Spectrum

Mergers &
                                                              Decline in R&D productivity, diminished pipeline for new
                                                              drugs, increased drug discovery costs and stringent
                                                              regulatory     measures       dominate     the     current

Acquisitions /                                                pharmaceutical industry scene. This is where acquisitions
                                                              and alliances widen growth opportunities for
                                                              international pharma along with Indian companies to tap

Collaborations                                                opportunities in Brazil, Russia India and China along with
                                                              the established markets in the West and Far East which
                                                              covers Japan.

Biocon Says Will Find Insulin Partner                         Companies are looking at buyouts and partnerships to
By Mar                                                        capture potential opportunities. Between January 2010
November 24, 2011, DNA Money                                  and October 2011, some of the mergers and acquisitions           were Abbot buyout of Piramal domestic formulation
24/2011&pageno=15&edition=9&prntid=155091&bxid=92             business, Reckitt Benckiser‘s purchase of Paras
4&pgno=15                                                     Pharmaceuticals and the acquisition of the nutrition
                                                              business of Wockhardt by Danone.
Biocon Ltd, India‘s largest listed Biotechnology company,
expects to find a deep-pocketed global partner for its        DIPP Amends FDI Policy On Options In
experimental oral insulin pill by end March, its top          Equity Instruments By Deleting Clause
executive said on Wednesday, ―e are in advanced
discussion with potential partners‖ Biocon‘s managing
director Kiran Mazumdar-Shaw said, without naming             November 7, 2011, PharmaBiz, Suja Nair
them. In January, Biocon has said it was looking for a        Shirodkar
partner after its oral insulin, IN-105, failed to meet the
main goal of an Indian late-stage trial in patients with      1&sid=1
type 2 diabetes.
                                                              Reacting to the strong disapproval from the industry, the
FDI Curbs In Pharma Could Deter MNCs:                         Department of Industrial Policy and Promotion (DIPP)
                                                              recently amended the New FDI Policy by deleting the
Kewal Handa, Pfizer India MD                                  contentious Clause of the Policy within thirty
November 17, 2011, The Economic Times                         days of its introduction.
industry/healthcare/biotech/pharmaceuticals/fdi-curbs-        The decision to scrap the clause was taken by the DIPP
in-pharma-could-deter-mncs-kewal-handa-pfizer-india-          following strong opposition from all the sectors over the
md/articleshow/10763168.cms                                   severe implications of such a provision on legitimate
                                                              foreign investments in India. The amendment which was
India's attempts to check foreign investment in pharma        made by way of a corrigendum on October 31, came as a
and expand drug pricing control could force                   great relief for many.
multinationals to exit the country, the head of Pfizer
India has warned. "India might not become attractive
market if we have such controls, you will see companies
                                                              Pharma MNCs Eye Indian Companies To
pulling out of India," Kewal Handa, the managing              Collaborate On Drugs, Molecules
director of the Indian unit of the $67-billion Pfizer, said   November 6, 2011, The Economic Times
in an interview at his office.                      
"It's the attractiveness of the domestic business that        pharma
attracts investment. All global companies have their
options open. You will not put money where the                To take advantage of the robust growth of the domestic
opportunity is less, and we do not have the right             pharma industry, MNCs are looking at alliances and
ecosystem for investments in pharma," he added.               partnerships for not only sourcing out products, but also
                                                              to expand R&D, says a report. The domestic pharma
Acquisitions, Alliances Widen Growth                          market is expected to grow at a CAGR of 15 to 20
                                                              percent to reach a value anywhere between USD 50 and
Opportunities For Indian Pharma,                              74 billion by 2020, says a PwC report titled `India
Reports PwC And CII                                           Pharma Inc: Enhancing Value through Alliances &
November 8, 2011, Pharmbiz                                    Partnerships.'

                                     Organisation of Pharmaceutical Producers of India                     21
                                                                                            Pharma Spectrum

International pharma companies have acquired domestic       Sources in the department said the committee would
companies to maximise their capabilities in serving the     hold a meeting soon to decide the further course of
global markets in the recent past. Earlier, alliances       action as it would be a crucial element of the proposed
would be formed to source out products, today it has        National Pharmaceutical Pricing Policy that was drafted
expanded into R&D. Pharma MNCs are looking for              and published by the DoP recently.
opportunities to co-develop drugs, buy or in-licence
molecules from domestic companies.                          New Pharma Pricing Policy To Cost
                                                            Manufacturers Rs 1,500 Crore: Study
Pricing                                                     November 22, 2011, The Economic Times
Drug Price Control Hurts R&D Potency                        crore-study/articleshow/10823963.cms
November 24, 2011, The Economic Times
(epaper page 15)                                            The proposed national drug pricing policy will cost      drugmakers close to 1,500 crore and stockists and
d=15&pagesize=&edid=ET&edlabel=ETM&mydateHid=24-            traders collectively over 2,500 crore in revenue loss
11-2011&pubname=Economic+Times+-                            when it comes into effect, a study shows. While
+Mumbai&edname=Mumbai&publabel=ET                           drugmaker GlaxoSmithKline Pharmaceuticals' loss has
                                                            been pegged at 137 crore, that of Ranbaxy Laboratories
It is incredible how the right ambience can make all the    is estimated to be 115 crore, according to the study by
difference between success and failure or boom and          pharmaceutical market research company AWACS.
gloom. Service sectors such as advertising have creative
people who can absorb all the pressure of tight deadlines   Other big drugmakers such as Abbott India, Zydus Cadila
and yet deliver excellent campaigns provided their          and Sanofi Aventis are projected to lose over 50 crore
ambience offers the right stimulation.                      each. Under the draft national pharmaceutical pricing
                                                            policy released by the Department of Pharmaceuticals
Similarly, industry arms such as R&D thrive in an           (DoP) last month, the ceiling price of 348 drugs under
atmosphere devoid of controls and constraints.              price control....
Creativity and innovation suffer with controls. The
pharmaceutical industry is one such sector where the        Overcharging Instances Come Down
R&D section could deliver a pipeline of innovative drugs
,despite legendary difficulties in making new               Slightly As Per NPPA Latest Statement
breakthroughs.                                              On Arrears
                                                            November 22, 2011, Pharmabiz, Joseph
DoP Looks To Speed Up Functioning Of                        Alexander
Panel On Patented Drug Pricing Ahead              
Of Pharma Policy
November 23, 2011, Pharmabiz, Joseph                        The instances of overcharging by pharmaceutical
Alexander                                                   companies seem to be on a slow patch and the recovery          rate also continued to be sluggish during the last few
2&sid=1                                                     months, if the latest statement by the National
                                                            Pharmaceutical Pricing Authority (NPPA) is any
After toying with the idea of fixing the prices of          indication.
patented drugs through negotiations before marketing
them in the country for nearly five years, the              The price regulator sent a total of 812 notices on the
Department of Pharmaceuticals (DoP) now wants to            grounds of overcharging beyond the permissible limits of
speed up the working of the expert committee set up to      10 per cent annual increase for formulations by the
suggest a mechanism in this regard.                         companies till October 31, 2011 since its inception to
                                                            claim a total amount of Rs.2357.95 crore. The total
                                                            recovery stood at Rs.216.77 crore so far, according to
                                                            the statement.

                                    Organisation of Pharmaceutical Producers of India                   22
                                                                                             Pharma Spectrum

Inject Sanity Into                Draft      National       In a bid to make affordable healthcare a reality, the
                                                            ministry of health and family welfare (MFHW) has
Pharma Policies                                             mooted a proposal to regulate the prices of more
November 21, 2011, The Economic Times                       essential drugs through the drugs price control order
(epaper page 14)                                            (DPCO). At present, only 74 drugs are listed under the      DPCO.
11-2011&pubname=Economic+Times+-                            In an affidavit before the Supreme Court, the ministry
+Mumbai&edname=Mumbai&publabel=ET                           said it had recommended a list of 348 drugs in the
                                                            DPCO. It also acknowledged the fact that there was a
If failed mortality ratio targets make you morbid, a        huge difference between the manufacturing cost of
revisit to 1946 and 1948 panel reports suggests that we     drugs and their maximum retail price (MRP). The
had a better handle on our public health policies 65        ministry said it had already written to the Department
years ago. There is a new draft National Pharmaceuticals    of Pharmaceuticals to take a final decision on the issue.
Policy, 2011. Here is a quote from that: In the new
policy, the span of control is likely to go up to 60%.      DoP, Health Ministry To File Separate
Details of the policy deserve a separate column.
                                                            Affidavits In SC On Bringing Down
However, the thrust is more price control. For the 12th     Prices Of Essential Drugs
Five-Year   Plan    (2012-17     ),Planning  Commission     November       8,    2011,     Pharmbiz,       Ramesh
constituted an expert committee on health. I havent         Shankar
been able to find the report in public domain, but media
has told us that this committee wants to scrap user         7&sid=1
charges in public hospitals, even for patients who can
pay.                                                        The Department of Pharmaceuticals (DoP) and the Union
                                                            ministry of health will file separate affidavits in the
New Drug Price Control Will Pull                            Supreme Court on the issue of bringing down of prices of
Pharma Sector Into Semi-Recession                           medicines included in the National List of Essential
                                                            Medicines (NLEM). The issue will come up for hearing on
November 17, 2011, Hindu Business Line                      November 17 in the Supreme Court.
e2636324.ece?homepage=true&ref=wl_home                      According to sources, both the health ministry and the
                                                            DoP are viewing the issue from two different viewpoints.
The Government's move to control prices of all 348          While the health ministry, which is primarily concerned
essential drugs will push the pharmaceutical sector into    about the quality of the drugs available in the country,
a semi-recession according to the biggest drug maker        will have a social approach and will push for bringing
Pfizer. Speaking to Business Line, Mr Kewal Handa,          down the prices of drugs, the DoP which is the
Managing Director of Pfizer India, said that the focus on   administrative ministry for the pharma industry will have
domestic pricing and uncertainty around the FDI rules       a commercial approach to the issue.
was making India an unattractive destination for
multinational pharmaceutical companies.

―If you look at the growth of the pharmaceutical sector
in 2010, we were at a peak around April-May, growing at
                                                            Trade & Others
around 20 per cent. It has now come down dramatically
to 13 per cent. So, as it is we are seeing a low growth     MNC Monopoly Mars Critical Drugs
phase and with coming National List of Essential            November 25, 2011, Business Standard
Medicines (NELM), the industry would slip into a semi-
recession stage,‖ Mr Handa said.                            monopoly-mars-critical-drugs/456650/

Centre Plans To Regulate Prices Of                          Study says formulation for some critical ailments
                                                            enormously priced.Six years into the product patent
Essential Drugs                                             regime, foreign multinational companies have monopoly
November 17, 2011, Hindustan Times                          over at least 33 medicines they import and market in                        India, a recent study by a Kolkata-based researcher says.
essential-drugs/Article1-770208.aspx                        The    study,    ‗Multinationals     and    monopolies,
                                                            pharmaceutical industry in India after TRIPS‘, is part of
                                                            the working paper series published from that city by the

                                    Organisation of Pharmaceutical Producers of India                    23
                                                                                             Pharma Spectrum

Indian Institute of Management, early this month. Sudip     The Indian vaccine market is currently estimated to be
Chaudhuri, the researcher, claims at least 10 of these      worth around $900 million and targets $4.6 billion
medicines, mostly among the highest priced patented         revenue by 2017. It is poised to grow 23% during 2011-
drugs, for which there are no generic alternatives, are     2012. Vaccines are the most cost-effective public health
for the treatment of cancer.                                products known to us and they are a means to prevent or
                                                            the potential to develop preventive solutions, according
States’ Views On Competition Policy                         to India Infoline.
Sought                                                      India has made a significant contribution to vaccine
November 25, 2011, Hindustan Times                          development, said Ashwani Kumar, Minister of State for                     Science and Technology, and Earth Sciences, noting that,
news/WorldEconomy/States-views-on-Competition-              India produces 60% of the world‘s vaccines and account
Policy-sought/Article1-773586.aspx                          for 60%-80% of annual UN vaccine purchases.

Corporate affairs minister M Veerappa Moily has written
to all chief ministers seeking their opinion on the
                                                            Decisive Change For Bayer Pharma
proposed National Competition Policy, slated to be sent     Came Only In 2005
to the Cabinet in February. The state governments have      November 17, 2011, Mint
been asked to send in their inputs by the end of  
December.                                                   change-for-Bayer-phar.html?atype=tp

The policy seeks to promote fair competition among          Stephan Gerlich, German drug maker Bayer AG‘s India
firms while nurturing smaller companies and those           head, spoke in an interview about the way forward for
related to agriculture marketing societies. The move is     its businesses in the country in line with its new Asia
expected to ease supply-side constraints and help           focus. Edited excerpts: On higher investment in the
control inflation in the long run, Moily said. “Our aim   chemicals business versus crop sciences, healthcare:
is to create one national market......
                                                            While the investment required for a chemical plant is
Referral Fees, Or Bribes?                                   huge, it is relatively small in the other areas... So you
November 22, 2011, Hindustan Times                          can‘t really come to that conclusion. We have been                        investing lately in downstream activities in Bayer
news/Maharashtra/Referral-fees-or-bribes/Article1-          Material Science (chemicals) because the customer
772340.aspx                                                 needs, and such custom-made products can only be
                                                            produced locally.
Dr Kiran Bhosale (name changed), an orthopedic
surgeon, was surprised when marketing professionals of      Pharmabiz Editorial: MNCs & Unethical
a tertiary care hospital in Andheri visited him eight       Practices
months ago. ―This was their second visit and they were
again offering me money to send patients to them. I told
                                                            November 17, 2011, Pharmabiz
them I don‘t indulge in such malpractices,‖ said Dr
Bhosale.                                                    95&sid=3

According to Dr Bhosale, the hospital was giving him Rs     Last week Wall Street Journal reported that
11,000 for referring patients requiring a minor             GlaxoSmithKline PLC would have to pay the US
procedure, and Rs 20,000 for those undergoing major         government a sum of $3 billion to settle some of the
procedures. He, however, declined to name the               criminal and civil investigations into whether the
hospital, saying: ―Everyone in the industry indulges in     company marketed some drugs illegally and defrauded
this practice.‖                                             the Medicaid program.

                                                            The settlement would also resolve a Justice Department
Indian Vaccine Market Targets $4.6                          probe into GSK‘s development and marketing of the
Billion Revenue By 2017, Up From                            diabetes drug Avandia, linked to heart attack risks in
                                                            several patients across the US. The drug was withdrawn
Current $900 Million                                        from all over the world last year.
November 17, 2011, Pharma Letter

                                    Organisation of Pharmaceutical Producers of India                    24
                                                                                              Pharma Spectrum

Pharma Brand Launches Slump This                             manufacturing companies for supplying drugs to the
                                                             members of the opposite group.
November 16, 2011, Business Standard                         Following the recent restraint order by the Punjab and          Haryana High Courts to AIOCD branches operating in
brand-launches-slump-this-year/455655/                       Punjab and Amritsar, in last week, the High Court of
                                                             Orissa,   restraining  AIOCD,     has   directed   two
Brand launches in the Indian pharmaceutical sector have      manufacturing units to resume supplies to a member of
dipped by more than half in 2011. On an average,             AICDF hails from Kendrapara in Orissa.
pharma companies have launched 4,000 brands a year
over the past four years but these have come down to         Delivering High Quality,                 Low       Cost
1,400-1,500 in the calendar year till September this
year. Even if only the trends so far were annualised,        Healthcare
there is a fall of 53 per cent.                              November 13, 2011, Hindu Business Line
Sujay       Shetty,        executive       director–India,   corporate/article2622459.ece
PricewaterhouseCoopers, says the decline is due to
increased competition. ―Every molecule has 30-40             ―Innovation has been integral to business and economic
competitors. Unlike the situation a few years ago, there     growth in India across many industries – not least so
is no market for me-too products. Companies will have        healthcare. Indian innovators in healthcare are leading
to focus on differentiated products. Smaller players, who    the world in new business models and ways of delivering
lack product development capability, are likely to be        high quality and low cost care.
                                                             At the India Economic Summit in Mumbai, the
Pfizer The Times Of India                        World       International Partnership for Innovative Healthcare
                                                             Delivery (a new organisation launched through the World
Diabetes Initiative Launched                                 Economic Summit) will convene to discuss how these
November 15, 2011, The Times of India                        successful innovations can be scaled further in India and      made more relevant to the rest of the world.
launched/articleshow/10733405.cms                            Competition Policy Awaits Cabinet Nod
The Pfizer and The Times of India diabetes initiative was
                                                             November 11, 2011, Hindustan Times
launched in 60 different locations across India, including
Kolkata, on Monday. Among the programmes organized in        Feed/Business/Competition-policy-awaits-cabinet-
Kolkata were a walkathon, nutrition workshop and an          nod/Article1-767460.aspx
interactive session with doctors.
                                                             A final draft of the National Competition Policy is ready
Three monuments in Kolkata - Victoria Memorial,              for the Union cabinet‘s nod to unleash the next wave of
Vidyasagar Setu and Rabindra Setu - have already been        reforms in India by ensuring the vast government
decorated with blue lighting as part of this initiative.     apparatus doesn‘t restrict market activity beyond a
Over 400 school children, doctors, diabetics, health         certain point. That certain point is going to be the
workers, pharmaceutical company executives and others        government‘s social and other goals.
participated in the Walkathon from Victoria Memorial to
Rotary Sadan in the morning.                                 It will usher the next wave of reforms, said corporate
                                                             affairs minister Veerappa Moily, whose ministry recently
                                                             received the final draft. The need for National
Courts Issue More Retraining Orders To                       Competition Policy has been felt for a long time, going
AIOCD For Issuing Threats To Cos For                         back to 1997, and has been endorsed by several
                                                             committees, panels and the planning commission.
Supplying Drugs To AICDF Members
November     15,    2011,                  Pharmabiz,
                                                             Competition Impact Study On 14 Core
Peethaambaran Kunnathoor           Sectors
9&sid=1                                                      November 5, 2011, Times of India
Even as the trade war between the two associations,          45.cms
AIOCD and AICDF, is getting harder, restraining orders
are being issued by various courts in the country to the     In order to strengthen the proposed National
biggest trade body, AIOCD, for its alleged threats to        Competition Policy(NCP) and the functioning of the

                                     Organisation of Pharmaceutical Producers of India                    25
                                                                                                 Pharma Spectrum

Competition Commission of India(CCI), the Committee on         Sanofi Pasteur India Gets Nod For
National Competition Policy (CNCP) has subjected 14
core sectors to a rigorous 'Competition Impact                 Import Of Dengue Vaccine
Assessment' (CIA) survey. The CIA is designed to               October 29, 2011, Hindu Business Line
accurately assess the impact of conditions like abuse of
dominance, market power, choice to consumers, supply,          e2574042.ece
as well as pricing of goods and services.
                                                               The Genetic Engineering Approval Committee (GEAC),
The CIA addresses public procurement policies and other        which works under the Union Ministry of Environment
sticky issues that distort markets and encourage graft in      and Forests, has granted permission to Sanofi Pasteur
sectors like railways, road transport, civil aviation,         India Private Ltd to import tetravalent dengue vaccine.
electricity, real estate, health services and education as     The vaccine division of the global therapeutics solutions
well as how a single national market could create more         major Sanofi approached the GE regulator for the import
efficiency and transparency.                                   of dengue vaccine for phase-2 clinical trials from Sanofi
                                                               Pasteur's headquarters at Lyon in France.
GST May Bring Down Supply Chain
                                                               While it is referred to as CYD dengue vaccine, it is
Costs                                                          globally known as tetravalent dengue vaccine. Dengue, a
November 4, 2011, Hindu Business Line                          viral disease that spreads through mosquito bites, kills              about 21,000 annually. Currently a major threat in India,
economy/logistics/article2595194.ece                           dengue starts with flu-like symptoms and drastically
                                                               reduces platelets that help blood clot. Left untreated, it
Industrial and trading houses were advised by experts to       leads to death.
start aligning their operations, especially in the area of

                                                               Animal Health
supply chain management, in tune with the new Goods
and Service Tax (GST) regime that is likely to be in place
by October 2012 or April 2013.

The tax experts, addressing representatives of business        No Relevant News
houses at a seminar organised by the CII here, felt that
companies should set up their internal GST steering
committees to study the impact of the new tax regime
on their operations.                                           Biotechnology
Gujarat FDCA Launches NSQ Drug Alert                           DBT May Amend Protocol 5 Of
System For Faster Recall
                                                               Mashelkar Committee Report To
October 31, 2011, Pharmabiz, Suja Nair
Shirodkar                                                      Provide Level Playing Field To All             Players
5&sid=1                                                        November 17, 2011, Pharmabiz, Suja Nair
The Gujarat Food and Drug Control Administration     
(FDCA) recently launched a not-of-standard quality (NSQ)       1&sid=1
drug SMS alert system through which all the stakeholders
in the state will now be notified of the recalled NSQ          The Department of Biotechnology (DBT) is seriously
drugs at the earliest.                                         contemplating to amend and modify the Protocol 5 of
                                                               the Mashelkar committee report which was adopted by
The latest addition which is the part of the E-governance      the government in 2005. The provisions of the Protocol 5
initiative taken by the state drug authority is specifically   allow the traders to market imported biotech products in
dedicated to address and protect the patients from             India without undertaking any clinical studies in the
administering NSQ drugs. Guj FDCA is the first drug            country.
authority in the country to have this SMS alert system for
the benefit of the patients.                                   The Protocol 5 of the Mashelkar committee which was
                                                               jointly formulated by the DBT and the Ministry of
                                                               Environment & Forests enables all the traders to import
                                                               and market any biotech products into the country
                                                               without undergoing any clinical trials or studies in the
                                                               Indian population.

                                      Organisation of Pharmaceutical Producers of India                     26
                                                                                              Pharma Spectrum

In Hunt For New TB Vaccine, India Is                         person‘s breath is being developed by a four-member
                                                             research team at the Delhi-based International Centre
One Of The Trial Sites                                       for Genetic Engineering and Biotechnology (ICGEB) to
October 27, 2011, Indian Express                             produce a faster diagnosis of the deadly but curable           disease.
                                                             Late detection of this infectious illness means most
A global initiative to develop new tuberculosis vaccines     patients are treated at advanced stage. Available tests
to supplement the now 90-year-old Bacille Calmette-          take days, sometimes weeks, to show results. Early
Guérin (BCG), commonly administered to infants as part       diagnosis and timely treatment could potentially save
of vaccination protocols, will feature India as one of the   lives, reduce medical costs and prevent the spread of
sites for trials.                                            infection.

The first TB vaccine trials in India in over four decades,
funded by the global tuberculosis vaccine initiative
Aeras, will be conducted by the Bangalore-based St           New Appointments
John‘s National Academy of Health Sciences at a site at
Palmaner, Andhra Pradesh.
                                                             / Transfers
Medical Diagnostics                                          New    Secretaries
                                                             Pharmaceutical Deptt
                                                                                                 for           MSME,

/ Devices                                                    November 8, 2011, iGovernment
Giving DNA Nano devices A New Role
                                                             Loretta Mary Vas IAS UP (1977 batch) presently serving as
Inside Living Systems                                        Special Secretary Department of Economic Affairs, has
November 14, 2011, Financial Express                         been appointed as the new Secretary, Department of             Pharmaceuticals. Loretta would replace Mukul Joshi who
nanodevices-a-new-role-inside-living-systems/875447/         superannuated on October31 this year.

Over the past couple of decades, scientists have been        Pradeep Kumar Chaudhery Appointed
toying with the versatility of Deoxyribonucleic acid (DNA)
— the material that carries the genetic code of              As Secretary In The Department Of
organisms — in constructing minuscule objects of various     Industrial Policy And Promotion (DIPP)
shapes in a field of research known as Structural DNA        November 1, 2011, Babus of India
Now, researchers at Bangalore‘s National Centre for          Pradeep Kumar Chaudhery, a 1977 batch Haryana cadre
Biological Sciences (NCBS) have shown that these nano-       IAS, presently special secretary in the department of
structures can play a role inside a living organism as       commerce, has been appointed as secretary in the
devices that perform specific tasks. Their findings          department of industrial policy and promotion (DIPP) in
potentially open the door to a variety of applications,      place of Rajinder Pal Singh, a 1976 batch AP cadre IAS,
such as bio-imaging, by using the nano-objects to carry      who retired on October 31, 2011.
sensors, or using them as compartments to study
enzymes‘ activity.
                                                             Dr V G Somani Given Additional Charge
Breath Test By Indian Scientists                             As DCGI
Promises Faster Diagnosis Of TB                              November 1, 2011, Pharmabiz
November 8, 2011, Livemint                                   2&sid=2
test-by-Indian-scientis.html?atype=tp                        Dr V G Somani, currently the Deputy Drugs Controller of
                                                             the East Zone, has been given the additional charge as
Indian scientists are working on a device to detect          the Drug Controller General of India (DCGI) after the
tuberculosis (TB) in the early stage of the disease by       extension given to Dr Surinder Singh ended on October
trapping human breath in air-tight plastic jars. An          31.
electric nose that would sniff out sick molecules in a
                                     Organisation of Pharmaceutical Producers of India                    27
                                                                                               Pharma Spectrum

Dr Somani, who took over as the Deputy Drug Controller       subsidiary of Swiss drug major Novartis and president of
of India in December 2010, in Kolkata, has been given        the Organisation of Pharmaceutical Producers of India
the charge for three months or 'until further orders',       (OPPI), shares his views with Joe C Mathew on the issue.
according to the office order he received from the
Ministry of Health and Welfare.                              Edited excerpts: How industry-friendly is the proposed
                                                             national pharmaceutical pricing policy? OPPI supports the
                                                             government‘s efforts to improve access to health care

OPPI Related News                                            and is happy to partner with it towards this end. The
                                                             national pharmaceutical pricing policy, which has been
                                                             long in the making, is misguided in the belief that pricing
                                                             equals affordability equals access. Access goes far
MNCs Move SC Over Drug Price Control                         beyond pricing and the government needs to work with
November 23, 2011, The Times of India                        all stakeholders to improve access to quality health care.           Further efforts to bring over 60 per cent of the Indian
business/MNCs-move-SC-over-drug-price-                       pharmaceutical market under price control will only
control/articleshow/10836944.cms                             impede the industry‘s growth and development, with a
                                                             long-term negative impact on the nations‘ health care
Till now, pharma companies, opposing price control,          goals.
have been trying to make their voices heard in the
corridors of power. With the courts recently stepping in
to bring essential medicines under a price control
                                                             Setting New Standards
regime,     multinational-led    industry   body      OPPI   November 1-15, Express Pharma
(Organization of Pharmaceutical Producers of India)
has moved the Supreme Court seeking to be heard on the       ement01.shtml
drug pricing issue. OPPI through an application seeking
"impleadment" in the ongoing public interest litigation on   "The main challenge of the DoP would be to ensure that
the drug pricing issue in the Supreme Court, wants to be     all companies across the pharma industry follow the
a formal party in the case. Sources said that the OPPI       same standards in their marketing practices and
filed the application to engage with the government          interactions with the healthcare practitioners" Tapan
"more actively'', and wanted to ensure that its case is      Ray, Director General, The Organisation of
heard.                                                       Pharmaceutical Producers of India. Reactions to the
                                                             Department of Pharmaceutical's recently introduced
The PIL was filed by health groups led by All India Drug     draft code on pharma marketing practices range from
Action Network, seeking essential drugs to be regulated      resigned acceptance, uncertainity on its clauses,
under a price control regime in 2003. The "impleadment"      cynicism that it will only increase corruption in the
application was filed on November 12, and later              system to a call for a Jan Lokpal for the pharma
admitted by the court. "The OPPI moved the Supreme           industry. More discussion and debate on the draft code
Court to get impleaded as a party in the ongoing PIL         will be required to find a win-win solution for all
because the drug pricing issue affects our industry's        stakeholders, writes Viveka Roychowdhury......
ability to sustainably provide medicines-both innovative
and generic-to the population in India, and, hence will      ....Indeed, India is now globally the third largest market
have an effect on public health and access to medicines,     in terms of volume of production and not having such a
as well as the economic development of the pharma            regulation in place could spell disaster. In India the
industry," OPPI president Ranjit Shahani told TOI.           Organization of Pharmaceutical Producers of India (OPPI)
                                                             issued a Code of Pharmaceutical Marketing Practices
                                                             2010 (called the ―OPPI Code‖), based on the IFPMA
Q&A: Ranjit Shahani, President, OPPI                         Code. The Indian Drug Manufacturers' Association (IDMA)
November 11, 2011, Business Standard                         also released another set of guidelines for its members.           Tapan Ray, director general, OPPI points out that the
shahani-president-oppi/455085/                               decision of the Government is the culmination of a series
                                                             of events, covered widely by the various sections of the
Eight years after the national pharmaceutical policy was     media, at least since 2004. He quotes from the January–
struck down by the judiciary, the Department of              March, 2004 issue of The Indian Journal of Medical Ethics
Pharmaceuticals, under the chemicals and fertilisers         (IJME) which in context of marketing practices for
ministry, has attempted to re-frame a pricing policy for     ethical pharma products in India had commented: ―If the
medicines sold in the country. The new policy draft          one who decides, does not pay and the one who pays,
attempts to suggest a model that brings in all essential     does not decide and if the one who decides is ‗paid‘, will
medicines under price control, as the Supreme Court          truth stand any chance?‖
suggested. There are differing views on the efficacy of
this attempt too. Ranjit Shahani, chief of the Indian

                                     Organisation of Pharmaceutical Producers of India                     28
                                                                                               Pharma Spectrum

Industry Bodies To Jointly Examine                           The costs of production, one of the key determinants to
                                                             arrive at the market price of any drug, is significantly
Merits Of New Draft Of Pharma Policy                         more in western countries due to various factors, he
November        8,    2011,     Pharmbiz,        Joseph      says. Ray says it is not practical for the association's
Alexander                                                    member companies to have manufacturing plants in each           country they operate. All international players, local or
6&sid=1                                                      global decide manufacturing locations based on overall
                                                             business requirements, he says.
The major industry associations in the pharmaceutical
sector are planning to hold joint deliberations on the       New Pharmaceutical Policy Has Drug
merits and demerits of the new draft of the National
Pharmaceutical Pricing Policy prepared and released by
                                                             Makers Worried
the Department of Pharmaceuticals (DoP), and report to       November 2, 2011, Livemint
the department. The associations including Organisation
of Pharmaceutical Producers of India (OPPI), Indian          pharmaceutical-policy-has.html?atype=tp
Drug Manufacturers Association (IDMA), Federation of
Pharma Entrepreneurs (FOPE), and Confederation of            India‘s new pharmaceutical policy that aims to bring
Indian Pharmaceutical Industry (CIPI) are likely to join     more essential drugs under the price control regime has
for the common meeting being planned for November 18         drug    makers      worried.     The    department      of
here to take a close look at the policy draft, sources       pharmaceuticals, which put out a draft policy last week,
said.                                                        suggests a system to limit prices to increase the access
                                                             and availability of essential drugs. The policy will
Apart from sending independent remarks about the             regulate the prices of at least 400 drugs, against 34 now.
policy, the stakeholders will also prepare a common set      Industry is likely to resist its implementation as an
of recommendations to be submitted to the DoP which          impact analysis on the policy shows the prices of drugs
has invited comments from the industry and other             could be reduced by up to 30%...............
concerned sections on the draft, sources said. This is
expected to make the procedure easier for the                …………..The Organisation of Pharmaceutical Producers
department too. The new draft that seeks to replace the      of India (OPPI), which represents the foreign drug
now aborted National Pharma Policy 2006 aims at              makers present in in the domestic market, is silent on
controlling the prices of 60 per cent of formulations,       the issue. Abbott India Ltd and Aventis Pharma Ltd, the
based on the national list of essential medicines            Indian units of US drug maker Abbott Laboratories and
prepared by the Union ministry of health. The draft says     French drug maker Sanofi Group, respectively, said their
the policy, to be finalized in a month, will cover nearly    responses will be in line with that of OPPI. A
all the 348 medicines in the list. Based on updated data,    questionnaire sent to OPPI’s director general Tapan Ray
the list will be expanded to cover about 400 drugs to        remained unanswered.
increase access and availability of essential medicines.
                                                             We Must Get The Balance Right: Witty
New Policy To Force Cut In Imported                          At OPPI AGM
Drug Prices                                                  October 16-31, 2011, Express Pharma
November 3, 2011, The Economic Times                           t18.shtml
policy-to-force-cut-in-imported-drug-                        An agenda setting address by chief guest Andrew Witty,
prices/articleshow/10588233.cms                              global chief executive officer, GSK, was the highlight of
                                                             the recently held 45th AGM of the Organisation of
A key clause in the government's draft drug pricing policy   Pharmaceutical Producers of India (OPPI), reports Viveka
has raised the hackles of foreign drugmakers who fear it     Roychowdhury. With 'encouraging innovation for
could force them to sharply reduce prices of several         inclusive growth' as part of the Organisation of
imported medicines by up to 90%...............Since there    Pharmaceutical Producers of India (OPPI) declared
is no separate price determination (formula) for             mission, each annual general body meeting is but
imported brands, their ceiling price has been linked to      naturally a reinforcement of this ideal. But this year's
the cost of brands made locally," says Manoj Tongra, a       AGM saw a new pragmatism and acknowledgement of
drugs control officer in Rajasthan. The condition has left   India's role in the pharmaceutical industry. And each
foreign drugmakers enraged. "The proposal is unfair and      speaker in their own way gave their perspective on the
unreasonable," says Tapan Ray, director general of the       role India was expected to play.
Organisation of Pharmaceutical Producers of India, the
association of global drugmakers in India.                   The mood was set by Ranjit Shahani, president, OPPI
                                                             and vice president and managing director, Novartis India
                                     Organisation of Pharmaceutical Producers of India                    29
                                                                                                Pharma Spectrum

in his presentation on the 'Opportunity for Innovation'       Encouraging        Innovation                          In
when he predicted, "There is a great re-balancing and as
the economic centre of gravity shifts, there will be the      Pharmaceuticals      Through                       Public
emergence of new centres of innovation. Can we could          Private Partnerships
look afresh at the mode of research to decrease the cost      October 2011, IFPMA Newsletter, Issue 26
of    innovation,     without   compromising      patient
safety?."......... Having defined the new brand of            To encourage innovation in the area of pharmaceutical
innovation required to succeed in the pharma industry of      research and development in India, the Organisation of
today, Witty gave away the OPPI Excellence Awards and         Pharmaceutical Producers of India (OPPI) has
the Scientists and Young Scientists Awards. Explaining        collaborated with two premier R&D focused institutions,
the rationale of the Awards, Tapan Ray, director              National Institute of Pharmaceutical Education &
general, OPPI said, "Every year OPPI presents awards of       Research (NIPER) and Council of Scientific & Industrial
excellence to scientists and young scientists of the          Research (CSIR) as part of its Public Private Partnership
country to recognise, honour, and encourage innovation        (PPP) initiative. OPPI, in 2009, instituted ―Scientists and
in the pharma sector of India.                                Young Scientists Awards‖ at both the institutes. In
                                                              addition, the Award is extended for scientists from
Going the R&D way: TRIPS tale                                 Pharmaceutical Research Centres/ Academic Institutions.
October 16-31, Express Pharma                                 The selection of the awardees is based on the            recommendation of an independent panel of juries—
ch01.shtml                                                    experts in the field. The Award carries a trophy, a
                                                              citation and a cash prize of Rs.1 lakh each.
"I think it is a fallacy to say that money is not a problem
for MNCs. Businesses around the world are feeling the         In a recent OPPI Annual Award Function for ―Scientists
pressures of a declining world economy, and the pharma        and Young Scientists‖ in Mumbai, Mr. Andrew Witty,
industry is no different." Ranjit Shahani, Vice Chairman      CEO, GlaxoSmithKline plc., who graced the occasion as
& Managing Director, Novartis India                           Chief Guest, said, ―the efforts taken by the OPPI to
                                                              acknowledge the work of these young talents is really
In 1995 India signed the Trade Related Intellectual           appreciable. As the industry, it is our responsibility and
Property Rights (TRIPS) agreement so have these               duty to provide them with the inspiration so that they
amended laws done the trick for pharma MNCs' R&D              can continue doing the good work.‖
plans for the Indian market and made India more
attractive? Not so, say some. "The innovative
pharmaceutical industry is greatly attracted to the
Indian market, but the roles of TRIPS and improved
patent laws have been over-emphasised. In truth, India's
economic growth and the growing desire among Indians
for quality healthcare, including quality medicines, have
played a much greater role. At the moment, less than
one per cent of the Indian pharma market consists of
patented medicines," Ranjit Shahani, vice chairman and
managing director, Novartis India, explains.

                                      Organisation of Pharmaceutical Producers of India                     30

Shared By: