Organisation Of Pharmaceutical Producers of India

Issue 12 , June 2009

INTERNATIONAL

1. IPR 1
2. Regulatory 2
3. New Products 5
4. R&D / Clinical Trials 6
5. Mergers & Acquisitions / Collaborations 8
6. Pricing 10
7. Trade & Others 10
8. Biotechnology 13
9. New Appointments 14

DOMESTIC

1. IPR 15
2. Regulatory 17
3. New Products 21
4. R&D / Clinical Trials 21
5. Mergers & Acquisitions / Collaborations 22
6. Pricing 23
7. Trade & Others 25
8. Biotechnology 26
9. New Appointments 27
10. OPPI Related News 28
11. OPPI Forthcoming Events 29

International
IPR
Judge Fends Off Generic Pulmicort, for
Now
http://www.fiercepharma.com/story/judge-fends-
generic-pulmicort-now/2009-05-21?utm_medium=nl&
May 21, 2009, Fierce Pharma
Apotex is out of luck. AstraZeneca has won an injunction
against the generics maker's launch of copycat Pulmicort
Respules, at least until the federal court can hear a
patent-infringement trial. As you know, Apotex already
has FDA approval for its version of the asthma drug, but
AstraZeneca says it's patent-protected through at least
2018.
Blair Hains, a spokesman for AstraZeneca, told Bloomberg
that the company is pleased with the decision. "We
continue to have full confidence in the strength of the
intellectual property rights protecting Pulmicort
Respules," he said. A date for the trial has not yet been
set.
Genzyme Sues Lupin for its ANDA Filing
for Phosphate Binder Product, Renvela
May 19, 2009, Pharmabiz
The US-based Genzyme Corporation has filed a patent
infringement suit against the Mumbai-based Lupin Ltd and
its US subsidiary against the latters' Abbreviated New Drug
Application (ANDA) filing for manufacturing and marketing
of generic version of Genzyme's Renvela (sevelamer
carbonate) used for the control of serum phosphorus in
chronic kidney patients on dialysis.
In a petition filed in the District Court of Maryland, US, on
May 14, 2009, Genzyme alleges that by attempting to
manufacture and market the generic form of the product,
Lupin has tried to infringe six patent claims of the
company. Genzyme holds US Patent Nos. 5,496,545
(`545), 5,667,775 (`775), 7,014,846 (`846) and 7,459,151
(`151) for phosphate-binding polymers for oral
administration issued on 1996, 1997, 2006 and 2008
respectively. Another two patents, Patent Nos 6,509,013
(`013) and 6,858,203 (`203), for the method of making
phosphate-binding polymers for oral administration issued
on 2003 and 2009 respectively, were also questioned by
Lupin.
Organisation of Pharmaceutical Producers of India
Pharma Spectrum
P&G Wins Patent Infringement Lawsuit
against Teva Pharma
May 15, Pharmabiz, Cincinnati, USA
http://www.pharmabiz.com/article/detnews.asp?articleid
=49730
United States Court of Appeals for the Federal Circuit
ruled in favour of the Procter & Gamble Company (P&G) in
the patent infringement lawsuit filed by P&G against Teva
Pharmaceuticals USA, Inc. The positive ruling protects
P&G's rights in the US to exclusively market the
osteoporosis therapy Actonel (risedronate sodium) tablets.
Actonel is commercialised through a collaboration
between Procter & Gamble Pharmaceuticals and sanofi-
aventis.
On August 13, 2004, P&G filed a patent infringement
lawsuit against Teva to enforce P&G's US composition of
matter patent for risedronate, the active ingredient in
Actonel. Teva sought to market a generic version of
Actonel in the United States under the assertion that the
Actonel patent was not valid due to obviousness of the
invention. On February 28, 2008, the Court ruled in favor
of P&G, expressly rejecting Teva's validity challenge.
Shortly afterwards, Teva filed an appeal of the decision.
Oral arguments for the appeal were heard in December,
2008.
Wyeth Sues Sun and its US Subsidiary
over Protonix Drug
May 7, 2009, Mint
http://www.livemint.com/2009/05/07220031/Wyeth-
sues-Sun-and-its-US-subs.html?h=B
US-based Wyeth Pharmaceuticals has sued Mumbai-based
Sun Pharmaceutical Industries Ltd. and its US subsidiary
Caraco Pharmaceutical Laboratories Ltd. for claiming that
their heartburn drug was a generic version of its Protonix
drug. The complaint, filed on 5 May in the US district
court for the Eastern District of Michigan, claims false
advertising by Sun and Caraco under the Lanham Act,
according to two law journals—Law 360 and Justia.
“Wyeth is seeking its damages caused by Sun and Caraco’s
false advertising,” said Gwen Fisher, a Wyeth
spokesperson. “We are not making any statement on this,”
said a Sun spokesperson. The Lanham Act prohibits a
number of activities, including trademark infringement,
trademark dilution and false advertising.
1

Abbott Sues J&J over New Humira Rival
May 5, 2009, Fierce Pharma
http://www.fiercepharma.com/story/abbott-sues-j-j-
over-new-humira-rival/2009-05-
05?utm_medium=nl&utm_source=internal
Get ready for a battle in the rheumatoid arthritis
segment. Johnson & Johnson's Centocor unit is prepping
for a launch of its new Humira competitor Simponi, and
Abbott Laboratories is not amused. So unamused, in fact,
that Abbott slapped J&J with allegations of patent
infringement.
All in a day's work for the folks who defend Big Pharma
intellectual property, right? Yes and no. Abbott's suit
follows up a set of reverse accusations: Last year,
Centocor and NYU sued Abbott, saying that they were
entitled to patent royalties on Humira. And that case is
still pending.
Wockhardt Settles Patent Dispute with
Orion
April 29, 2009, Business Standard
http://www.business-
standard.com/india/news/wockhardt-settles-patent-
disputeorion/59835/on
Drug maker Wockhardt today said it has settled a patent
dispute with European pharmaceutical firm Orion
regarding the generic versions of the latter's two products
used in the treatment of Parkinson's disease. The company
has executed a settlement and licence agreement with
Orion Corporation regarding Wockhardt's application
before the US drug regulator for the generic version of
European firm's Comtan and Stalevo products, the
Mumbai-based drug major informed stock exchanges.
Under the terms of settlement agreement, Wockhardt
would be able to launch generic versions of the both drugs
"on September 30, 2012, or possibly even earlier," the
company further said.
Judge Gives Lilly a Generic Reprieve
April 24, 2009, Fierce Pharma
http://www.fiercepharma.com/story/judge-gives-lilly-
generic-reprieve/2009-04-
24?utm_medium=nl&utm_source=internal
Eli Lilly execs are high-fiving now that a district judge has
blocked Teva Pharmaceutical's launch of an Evista
copycat. True, the block is only temporary, until the
companies' patent fight is resolved in court, probably later
this year. But Judge Sarah Evans Barker, who gave Lilly
the reprieve, will also decide the patent case. And in her
ruling, analysts say, Barker left some clues that could
make Lilly very happy.
Organisation of Pharmaceutical Producers of India
Pharma Spectrum
In explaining her decision to prevent generic Evista's
launch, Barker rejected some important building blocks in
Teva's case for selling the drug ahead of its official patent
expirations (which start in 2012). For one, Barker didn't
agree that Evista's invention was just an obvious extension
of previously known work, saying that the company is
likely to "prevail in demonstrating the non obviousness" of
the patent.
Regulatory
Bayer's Nexavar gets Japanese Nod for
Advanced Liver Cancer Treatment
May 22, 2009, Pharmabiz, Berlin
In Japan Bayer received approval for Nexavar (sorafenib)
tablets for the treatment of unresectable hepatocellular
carcinoma (HCC) from the Ministry of Health, Labour and
Welfare (MHLW). Nexavar, an oral anti-cancer drug,
jointly developed by Bayer HealthCare AG and Onyx
Pharmaceuticals Inc, is the only drug therapy shown to
significantly improve overall survival in patients with the
disease. The product is already marketed in Japan as a
therapy for unresectable or metastatic renal cell
carcinoma (RCC).
"Liver cancer is one of the leading causes of cancer-
related deaths in Japan, and the incidence is continuing to
rise," said Gunnar Riemann, member of the executive
committee of Bayer HealthCare. "We expect that this
approval will provide patients a new option for improved
treatment and we are pleased that with our MRI liver
contrast agent Primovist we contribute to early diagnosis
of HCC. We will make further efforts to contribute to
patients and medical experts both in fields of diagnosis
and treatment of HCC in Japan and worldwide."
Janssen Gets FDA Nod to Use
Risperidone as Monotherapy, Adjunctive
Therapy in Bipolar I Disorder
May 20, 2009, Pharmabiz, Titusville, New
Jersey
Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals
Inc has received US Food and Drug Administration (FDA)
approval for Supplemental New Drug Applications (sNDAs)
for the use of Risperdal Consta (risperidone) Long-Acting
Treatment as both monotherapy and adjunctive therapy to
lithium or valproate in the maintenance treatment of
Bipolar I Disorder.
Bipolar Disorder is a brain disorder that causes unusual
shifts in a person's mood, energy and ability to function. It
is often characterized by debilitating mood swings from
extreme highs (mania) to extreme lows (depression). Type
2

I Bipolar Disorder is characterized based on the
occurrence of at least one manic episode, with or without
the occurrence of a major depressive episode, and affects
approximately one per cent of the American adult
population in any given year.
UCB gets FDA Nod for Cimzia to Treat
Rheumatoid Arthritis
May 18, Pharmabiz, Brussels
UCB announced that the US Food and Drug Administration
(FDA) approved Cimzia, the only PEGylated anti-TNF
(Tumour Necrosis Factor), for the treatment of adult
patients with moderately to severely active rheumatoid
arthritis (RA). Cimzia can be dosed at 400 mg initially and
at weeks two and four, followed by 200 mg every other
week; for maintenance dosing, 400 mg every four weeks
can be considered.
In clinical trials with Cimzia, together with methotrexate
(MTX), patients experienced a significant reduction in the
signs and symptoms of RA at week 24 with some showing
clinical responses within one to two weeks, compared with
MTX alone. Additionally, radiographic data showed Cimzia,
together with MTX, inhibited progression of joint damage,
with a significantly smaller change from baseline in
modified Total Sharp Score (TSS) at 24 and 52 weeks of
treatment, compared with MTX alone (p<0.001).
Novartis Bags FDA Nod to Market
Prevacid 24HR
May 15, 2009, Pharmabiz, Basel, Switzerland
http://www.pharmabiz.com/article/detnews.asp?articleid
=49729&sectionid=43
Novartis announced that Prevacid 24HR (lansoprazole
delayed-release capsules 15 mg) has been approved by the
US Food and Drug Administration (FDA) as the first over-
the-counter (OTC) Proton Pump Inhibitor (PPI) for the
treatment of frequent heartburn since 2003. Prevacid
24HR is expected to be available over-the-counter in 2009.
Once-daily Prevacid 24HR is the first OTC PPI approved in
its original prescription formulation. It is the only PPI
containing the active ingredient lansoprazole to be
approved for OTC treatment of frequent heartburn, which
is defined as heartburn that occurs two or more days per
week. In three clinical studies, Prevacid 24HR
demonstrated significantly better efficacy in treating
frequent heartburn than placebo.
US FDA Grants Orphan Drug Status for
Pervasis' Vascugel
May 12, 2009, Pharmabiz, Cambridge,
Massachusetts
Organisation of Pharmaceutical Producers of India
Pharma Spectrum
Pervasis Therapeutics Inc, a biotechnology company
pioneering biologically active cellular therapies to treat
vascular and other serious diseases, has received orphan
drug designation for Vascugel, a novel allergenic cell
therapy product that may restore natural repair and
regeneration pathways in the vasculature, from the US
Food and Drug Administration (FDA).
The orphan drug designation is granted for the prevention
of arteriovenous fistula or arteriovenous graft failure in
patients with end-stage renal disease (ESRD) receiving
haemodialysis or preparing for haemodialysis.
Roche's Avastin Gets US FDA
Accelerated Nod for Brain Cancer
May 7, 2009, Pharmabiz, Basel
Roche has received accelerated approval for Avastin
(bevacizumab) from the US Food and Drug Administration
(FDA) for people with glioblastoma with progressive
disease following prior therapy.
The new indication for Avastin was granted under the
FDA's accelerated approval programme that allows
provisional approval of medicines for cancer or other life-
threatening diseases. It follows the unanimous vote by the
FDA Oncologic Drugs Advisory Committee (ODAC) on March
31.
Jubilant Gets USFDA Nod to Market
Cardiac Drug
May 4, 2009, Business Standard
http://www.business-
standard.com/india/news/jubilant%5Cs-us-arm-gets-
usfda-nod-to-market-sestamibi/60376/on
Pharmaceutical firm Jubilant Organosys today said its
American arm has got a nod from the USFDA to market the
generic drug Sestamibi in the US.DRAXIMAGE LLC, the US
subsidiary of BSE-listed Jubilant, received approval from
the US Food and Drug Administration (FDA) for it's
Abbreviated New Drug Application (ANDA) for DRAXIMAGEs
generic Sestamibi, Jubilant said in a press release.
Sestamibi is used in Myocardial Perfusion Imaging (MPI),
which evaluates the flow of blood to the heart. The MPI
market size is currently estimated at $400 million.
US FDA Asks OTC Drug Makers to Revise
Labelling to Include Warning on Pain &
Fever Drugs
May 2, 2009, Pharmabiz, Maryland
The Food and Drug Administration issued a final rule that
requires manufacturers of over-the-counter (OTC) pain
relievers and fever reducers to revise their labelling to
3

include warnings about potential safety risks, such as
internal bleeding and liver damage, associated with the
use of these popular drugs.
Products covered by the FDA action include
acetaminophen, and a class of drugs known as the
nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs
include aspirin, ibuprofen, naproxen, and ketoprofen.
Acetaminophen is in a class by itself. The revised labelling
applies to all OTC pain relievers and fever reducers,
including those that contain one of these ingredients in
combination with other ingredients, such as in cold
medicines containing pain relievers or fever reducers.
Bial, Eisai Get European Marketing Nod
for Once Daily Anti-Epileptic Zebinix
May 2, 2009, Pharmabiz, London
http://www.pharmabiz.com/article/detnews.asp?articleid
=49510&sectionid=43
Bial-Portela & CA, SA, and Eisai Europe Limited, the
European subsidiary of Eisai Co, Ltd, announced that the
novel once daily anti-epileptic Zebinix (eslicarbazepine
acetate) received marketing authorisation from the
European Commission as adjunctive therapy in adults with
partial-onset seizures, with or without secondary
generalisation.
Epilepsy is one of the most common neurological diseases,
affecting approximately one in 100 people. Treatment of
partial-onset seizures, the most common type of epilepsy,
remains a constant challenge and up to 40 per cent of
patients with partial seizures do not achieve seizure
control with current anti-epileptics.
Strattera Approved For Paediatric ADHD
in Japan
May 1, 2009, SCRIP
Lilly’s Strattera (atomoxetine) has been approved in Japan
for attention-deficit hyperactivity disorder (ADHD) in
paediatric patients aged six to 18 years.
The formal clearance from the Ministry of Health, Labour
and Welfare endorses a positive recommendation from
anadvisory committee earlier this year (scripenews.com,
February 5th, 2009). Strattera has been on the US market
since early 2003 but was not submitted until mid-2007 in
Japan, where it received a priority review.
Tykerb and Clozaril among Formal
Japanese Approvals
May 1, 2009, SCRIP
Japan’s Ministry of Health, Labour and Welfare has
formally approved a number of products given positive
recommendations by an advisory committee last month,
Organisation of Pharmaceutical Producers of India
Pharma Spectrum
inclduign GalxoSmithKline’s Tykerb and Novartis’s
Clozaril.
Tykerb (lapatinib) was given final regulatory clearance for
use in combination with capecitabine (Chugai/Roche’s
Xeloda) in patients with recurrent or non-operable
metastatic HER2-positive breast cancer who have received
previous treatment containing Chuggai/Roche’s Herceptin
(tratuzumab).
World Prepares for a Swine Influenza
Pandemic
May 1, 2009, SCRIP
As global authorities prepare for a possible swine influenza
pandemic, the Pharma industry is poised to develop a
vaccine.
The World Health Organisation this week raised the level
of influenza pandemic alert from phase three to phase
five, just one step from a global pandemic. The move
comes after the WHO declared a “public emergency of
international concern” following a number of confirmed
cases of swine influenza A (H1N1) in Mexico and the US.”
All countries should immediately activate their pandemic
preparedness plans, “said Dr. Margaret Chan, Director
General of WHO.
India Angry Over Drug Seizure Issue
April 30, 2009, Asian Age
India has complained the World Trade Organisation against
come of the European nations confiscating Indian generic
drugs being shipped to South America and Africa via
Europe.
“We have taken it up in the WTO”, said the joint secretary
in the department of industrial policy and promotion N.N.
Prasad.
Glenmark Receives US FDA Nod for
Ezetimibe
April 28, 2009, Business Standard
http://www.business-
standard.com/india/news/glenmark-receives-us-fda-nod-
for-ezetimibe/59483/on
Drug firm Glenmark Generics Ltd today said it has
received tentative approval from the US Food and Drug
Administration (FDA) for the generic version of cholesterol
lowering drug Ezetimibe, sold under the brand name
'Zetia' in 10 mg strength.
Glenmark has got the tentative approval for the generic
version of Schering Plough and MSP Singapore Company
LLC's anti-cholesterol compound Ezetimibe, which has
4

received sales of 1.5 billion dollars in 2008, the company
said in a statement.
J&J, Schering Biologic Wins FDA
Approval
April 24, 2009, Fierce Biotech
http://www.fiercebiotech.com/story/breaking-news-j-j-
schering-biologic-wins-fda-approval/2009-04-
24?utm_medium=nl&utm_source=internal
Johnson & Johnson and Schering-Plough have won FDA
approval for Simponi (golimumab), an injectable biologic
drug for the treatment of rheumatoid arthritis, psoriatic
arthritis and ankylosing spondylitis. These chronic
inflammatory diseases, which plague roughly 3 million
Americans, result in pain and inflammation--and in some
cases, joint destruction and disability. The drug was also
approved in Canada earlier this week.
Simponi is an update to the $5 billion-a-year blockbuster
drug Remincade and will compete with Amgen;s Enbrel
and Abbott Laboratories' Humira. Simponi's biggest
advantage? It requires only injections rather than in-office
infusions, and is the first monthly subcutaneous anti-TNF-
alpha therapy.
New Products
Generex Launches Oral Insulin in
Lebanon
May 18, 2009, Pharmabiz, Worcester,
Massachusetts
Generex Biotechnology Corporation, the leader in drug
delivery for metabolic diseases through the inner lining of
the mouth, together with Benta s.a.l., the company's
importation, marketing, distribution and sales sub-
licensee in Lebanon, launched the commercial retail sales
of Generex Oral-lyn in Lebanon.
The launch was announced at a press conference in Beirut
with Lebanese minister of Health H E Muhammad Jawad
Khalifah.The product has been approved for importation
and commercial marketing and sale in Lebanon by the
Ministry of Public Health, and will be marketed and sold
for the treatment of patients with type-1 and type-2
diabetes in Lebanon.
Bayer Schering to launch Oral
Contraceptive Qlaira in Europe
May 16, 2009, Pharmabiz, Berlin
Bayer Schering Pharma AG, Germany, has launched its
new oral contraceptive Qlaira (estradiol
valerate/dienogest) in Europe. Qlaira will be available in
several European countries, including Germany. More
Organisation of Pharmaceutical Producers of India
Pharma Spectrum
European countries will follow from autumn 2009 onwards,
a company press release said.
Qlaira is the first in a new class of oral contraceptives to
deliver estradiol, the estrogen identical to the one
produced by the female body. Over the past 50 years,
many new progestins have been developed for use in oral
contraceptives, but the estrogen component remained the
same - ethinylestradiol. The introduction of Qlaira thus
offers women a new choice in oral contraception
Abbott Launches Two New Products for
Peripheral Artery Disease Treatment
May 11, 2009, Pharmabiz, Abbott Park, Illinois
http://www.pharmabiz.com/article/detnews.asp?articleid
=49652&sectionid=43
Abbott launched two new products - FoxCross PTA
Catheter and HI-TORQUE Versacore .035 Guide Wire - for
the treatment of peripheral artery disease (PAD), a
condition that occurs when the vessels supplying blood to
the legs, arms, stomach or kidneys become narrowed or
blocked by plaque, restricting normal blood flow.
The FoxCross PTA Catheter is a next-generation .035
balloon dilatation catheter and is now available in the
United States and Europe. The HI-TORQUE Versacore .035
Guide Wire is a peripheral guide wire for delivery of
catheters, balloons and stents and is now available in the
United States.
Lundbeck Launches ATryn in US
May 8, 2009, Pharmabiz, Framingham,
Massachusetts
ATryn (antithrombin [recombinant]) is now available
commercially through Lundbeck Inc of Deerfield, Illinois, a
wholly owned subsidiary of H Lundbeck A/S in Denmark,
GTC Biotherapeutics, Inc's commercialization and
development partner in the United States. GTC is due to
receive a total of $1 million from Lundbeck for its initial
inventory of ATryn.
"We are delighted to have reached this important
milestone with the launch of ATryn in the US, which is the
first transgenically produced therapeutic product to reach
the marketplace," stated Geoffrey F Cox, GTC's chief
executive officer and chairman of the Board. "We look
forward to working with Lundbeck to deliver this
important new product."
Watson Launches BPH Drug Rapaflo in
the US
April 17, 2009, SCRIP
Watson Pharmaceuticals has launched its orally active
alpha la-adrenoceptor selective antagonist Rapaflo
5

(silodosin) in the US for the treatment of benign prostatic
hyperplasia (BPH) following an FDA approval last October.
“We are confident that the proven rapid efficacy and
safety of Rapaflo will provide BPH patients and their
physicians an important treatment option. We expect our
three-day sample packs to clearly demonstrate their rapid
tolerability of Rapaflo,” said Paul Biasro, President and
Chief Executive of Watson.
First Launch for Minodronic Acid in
Japan
April 17, 2009, SCRIP
Astellas and Ono have launched the oral bisphosphonate
minodronic acid bydrate in Japan, its first market
worldwide, for the treatment of osteoporosis. The product
is being co-marketed by the two firms as Bonoteo and
Recallbon respectively.
Osteoporosis affects an estimated 10 million people in
Japan, where a number of other bisphosphonates are
already on the market. Several of these, including
Takeda/Ajinomoto’s Benet/Actonel (risedronate), are
available in once-weekly formulations.
R&D/Clinical Trials
Glaxo Forges $370M Pact with Oxford
Biotherapeutics
May 18, 2009, Fierce Biotech
http://www.fiercebiotech.com/story/glaxo-forges-370m-
development-pact-oxford-biotherapeutics/2009-05-
18?utm_medium=nl&utm_source=internal
GlaxoSmithKline has committed up to $370 million for a
new deal designed to bolster its presence in the cancer
market. The pharma giant announced a drug development
pact with Oxford BioTherapeutics to discover, develop and
commercialize new therapeutic antibodies for the
treatment of primary, metastatic and recurring forms of
cancer. OBT gets an undisclosed upfront and the rest in
milestones.
"We are extremely pleased to be collaborating with GSK
given their proven commitment to innovation and their
expertise in the development and commercialization of
novel oncology medicines," said Christian Rohlff, CEO of
OBT.
Organisation of Pharmaceutical Producers of India
Pharma Spectrum
Europe Awards $331M to Accelerate
Drug Research
May 18, 2009, Fierce Biotech
http://www.fiercebiotech.com/story/europe-awards-
331m-accelerate-drug-research/2009-05-
18?utm_medium=nl&utm_source=internal
Europe’s Innovative Medicines Initiative has handed out
$331 million to back 15 cutting-edge research projects
designed to make the continent more competitive with
the United States when it comes to drug development.
Academic groups and small companies alike competed for
the support--a combination of €110 million in cash from
the European Union and €136 million in kind from the
continent's pharmaceutical industry. That money will go to
back "pre-competitive" work that will provide solutions to
common problems in drug development.
Regulus Therapeutics gets Initial
Milestone from GSK Collaboration
May 16, 2009, Pharmabiz, Carlsbad, California
Regulus Therapeutics Inc announced that it achieved the
initial milestone from GlaxoSmithKline (GSK) as part of
their ongoing worldwide strategic alliance established to
discover, develop and market novel microRNA-based
therapeutics to treat inflammatory diseases. The two
companies are working to identify drugs directed at four
different microRNA targets related to inflammatory
disease.
Regulus has now reached an important discovery
milestone, which triggered a payment, concurrent with
the first demonstration of a pharmacological effect in
immune cells by specific microRNA inhibition. Scientists
successfully delivered specific microRNA inhibitors, known
as anti-miRs, to mice and clearly identified changes in
expression of the genes regulated by the microRNA in
immune cells.
Lilly to Present Above 50 Studies at
ASCO 2009
May 15, 2009,Pharmabiz
http://www.pharmabiz.com/article/SectionWiseArchive
News.asp?id=4
Eli Lilly and Company will unveil data from more than 50
studies at the 45th Annual Meeting of the American
Society of Clinical Oncology (ASCO) in Orlando, Fla. from
May 29 to June 2, 2009. Majority of the presentations are
learnt to support Lilly's leadership in thoracic cancer
research. The company will present the latest research
findings on Alimta (pemetrexed for injection), as well as
Gemzar (gemcitabine HCl for injection), and enzastaurin,
an investigational, oral, targeted therapy.
6

This year's ASCO also marks the first time Lilly will
feature the newest molecules in its portfolio resulting
from Lilly's recent acquisition of ImClone Systems.
Roche Ties Up with Tekmira Pharma to
Advance RNAi Product Candidates
Thursday, May 14, 2009, Pharmabiz,
Vancouver, BC
Tekmira Pharmaceuticals Corporation has entered into a
product development agreement with global healthcare
company Roche to advance Roche's first two RNA
interference (RNAi) product candidates into human clinical
testing. Both of the product candidates will be based on
Tekmira's stable nucleic acid-lipid particle (SNALP)
technology.
Under the terms of the product development agreement,
Roche will pay Tekmira up to US$ 18.4 million to support
the advancement of the product candidates to the filing of
Investigational New Drug (IND) applications. Tekmira is
also eligible to receive up to US$ 32 million in milestones
plus royalties on product sales as the first two products
are advanced through development and commercialization
based on Roche's access to Tekmira's intellectual property
under previously announced agreements.
Pfizer's Kindler Lays Out His Vision for
R&D Teams
May 12, 2009, Fierce Bioresearcher
http://www.fiercebioresearcher.com/story/pfizers-
kindler-lays-out-his-vision-r-d-teams/2009-05-
12?utm_medium=nl&utm_source=internal
Takeda isn't the only big pharma company looking for ways
to push scientists into a new, more productive groove.
Pfizer CEO Jeff Kindler has made R&D productivity a key
theme. And he sat down with the Wall Street Journal
recently to review how R&D teams need to be
structured in order to be successful.
First, he said, the teams have to be a manageable size.
Say, no bigger than 100 to 150, so they can all fit into one
cafeteria. Second, the team leaders, the CSOs, need to be
at the top of their field. And, third, they need to be left
alone to create a distinctive culture, being evaluated
based on their success demonstrating proof of concept.
Exelixis, Boehringer Ingelheim
Collaborate to Develop Autoimmune
Disease Therapies
May 11, 2009, Pharmabiz, South San
Francisco, California
http://www.pharmabiz.com/article/detnews.asp?articleid
=49654&sectionid=20
Organisation of Pharmaceutical Producers of India
Pharma Spectrum
Exelixis Inc and Boehringer Ingelheim, a global
pharmaceutical group of companies headquartered in
Germany, have established an exclusive, worldwide
collaboration with the aim to discover, develop and
commercialise autoimmune disease therapies. The
collaboration is focused on the discovery of sphingosine-1-
phosphate type-1 receptor (S1P1) agonists. The S1P1
receptor is a central mediator of multiple pathways
implicated in a variety of autoimmune diseases.
Under the terms of the agreement, Exelixis will receive a
$15 million upfront payment. In addition, Exelixis will
potentially receive up to $339 million in milestone
payments dependent on the successful achievement of
development, regulatory and commercial programme
goals and royalties on sales of potential products
commercialized under the collaboration.
Jubilant In R&D Deal with AstraZeneca
May 6, 2009, Hindu Business Line
http://www.thehindubusinessline.com/2009/05/06/storie
s/2009050650540200.htm
Jubilant Organosys Ltd announced that its Bangalore-
based subsidiary, Jubilant Biosys Ltd, has signed a
research collaboration agreement with AstraZeneca,
which is focused on developing new drugs to add to the
international pharmaceutical company’s pre-clinical
pipeline.
Jubilant Organosys is expected to earn $220 million in
research and milestone fees through this deal. Of this, it
will get about $20 million as definite payment from
AstraZeneca, with an annual payment of about $3 million
coming in during the first two years. It could also
potentially earn up to $200 million as and when it meets
certain targets in developing drugs under the deal. The
two firms will work on neuroscience-related drugs.
Oxford Biomedica, Sanofi-Aventis Enter
Pact to Develop Gene-Based Medicines
for Ocular Diseases
May 4, 2009, Pharmabiz, Oxford, UK
http://www.pharmabiz.com/article/detnews.asp?articleid
=49540&sectionid=20
Oxford BioMedica announced that it has entered into a
new collaboration with sanofi-aventis to develop novel
gene-based medicines, utilising the company's LentiVector
gene delivery technology, for the treatment of ocular
diseases.
Oxford BioMedica will receive an upfront payment of
US$26 million (£18 million) and committed funding of up
to a further US$24 million (£16 million) over three years.
In addition, sanofi-aventis has an exclusive option for a
worldwide licence to develop and commercialise four
ocular products. If successful, Oxford BioMedica will
7

receive further undisclosed license fees, milestone
payments and royalties on product sales, the terms of
which are consistent with other deals of this size and
scope.
Pfizer, MMV Ink Pact to Fight against
Malaria
April 25, 2009, Pharmabiz, New York
http://www.pharmabiz.com/article/detnews.asp?articleid
=49413&sectionid=6
Pfizer Inc and Medicines for Malaria Venture (MMV) have
signed an agreement that is designed to facilitate
advancements in the battle against malaria, a disease that
afflicts vulnerable populations in the developing world
each year. Under the agreement, MMV will have access to
the Pfizer library of novel chemical entities, in order to
screen it for compounds that have the potential to be
developed into new treatments for malaria.
Malaria causes an estimated 881,000 deaths each year, of
which over 90 per cent are in Africa and 85 per cent are
children under five years of age.
Arzoxifene Shown to Increase Bone
Mineral Density
April 17, 2009, SCRIP
A study of Lilly’s investigational selective oestrogen
receptor modulator (SERM) arzoxifene showing it to
increase lumbar spine and total hip bone minderal density
(BMD) in postmenopausal women with normal or low bone
mass, has been published in the Journal of Endocrinology
& Metabolism.
In addition, arzoxifene, dosed at 20mg/day, decreased the
biochemical markets of bone turnover, and showed a
neutral effect on the uterus and endometrium.
Mergers &
Acquisitions/Collabo
rations
J&J Buys Cougar Biotech for $1B
May 22, 2009, Fierce Biotech
http://www.fiercebiotech.com/story/breaking-news-j-j-
buys-cougar-biotech-1b/2009-05-
21?utm_medium=nl&utm_source=internal
Johnson & Johnson has snagged a biotech with a late-
stage oncology drug in its pipeline. J&J will pay $1 billion
cash for Los Angeles-based Cougar Biotechnology, which is
developing drugs for prostate cancer, breast cancer and
Organisation of Pharmaceutical Producers of India
Pharma Spectrum
multiple myeloma. Cougar will work with Ortho Biotech
Oncology R&D, a unit of Centocor R&D.
Cougar is conducting two Phase III trials for abiraterone
acetate for prostate cancer. The first
study involves patients with metastatic, castration-
resistant prostate cancer who have progressed after
docetaxel-based chemotherapy has failed. The second
trial is testing patients who have not receive
chemotherapy.
Aurobindo, Pfizer Expand Product
Portfolio
May 21, 2009, Pharmabiz
Aurobindo Pharma has expanded its partnership with
Pfizer Inc, a global leader in pharmaceuticals, by
executing licensing and supply agreements for several
solid dosage and sterile products for a number of emerging
markets.
Under the terms of the agreement, Pfizer has acquired
rights to 55 solid oral dose products and five sterile
injectable products for several countries throughout Asia,
Latin America, Africa and the Middle East. These products
fall under a broad range of some important therapeutic
segments such as anti infectives, cardiovascular (CVS) and
central nervous system disorders (CNS).
Claris Partners Pfizer to Strengthen
Regulated Market Presence
May 21, 2009, The Hindu Business Line
http://www.thehindubusinessline.com/2009/05/21/storie
s/2009052150490200.htm
Pharmaceutical major Claris Lifesciences Ltd today
announced a partnership with global giant Pfizer Inc. to
commercialise sterile injectable drugs that are off-patent
and have lost market exclusivity in the US, Canada,
Europe, Australia and New Zealand.
Pfizer, with a turnover of $10 billion in established
products annually, had a similar licensing agreement with
Aurobindo Pharma Ltd.
Sanofi-Aventis, DNDi Tie Up For
Sleeping Sickness Drug Fexinidazole
May 19, 2009, Pharmabiz, Paris
http://www.pharmabiz.com/article/detnews.asp?articleid
=49791&sectionid=14
Sanofi-aventis and the non-profit Drugs for Neglected
Diseases initiative (DNDi) have signed an agreement for
the development, manufacturing and distribution of
fexinidazole, a promising new drug for the treatment of
human African trypanosomiasis, also known as sleeping
8

sickness, a fatal disease that threatens 60 million people
in Sub-Saharan Africa.
Fexinidazole will enter clinical development in the first
half of 2009 and is the only new drug candidate in clinical
development for sleeping sickness. Under the terms of the
agreement, DNDi will be responsible for preclinical,
clinical and pharmaceutical development. Sanofi-aventis
will be responsible for the industrial development,
registration, and production of the drug at its
manufacturing sites. Considering their respective
commitments to fight sleeping sickness, sanofi-aventis and
DNDi have decided to combine their expertise to making
fexinidazole available on a non-profit basis to all patients
who need it.
Sanofi Inks $315M Inflammation Pact
with Kyowa
May 14, 2009, Fierce Biotech
http://www.fiercebiotech.com/story/sanofi-inks-315m-
inflammation-pact-kyowa/2009-05-
14?utm_medium=nl&utm_source=internal
Now that Sanofi-Aventis has finished trimming some of its
marginal drug development programs, the French pharma
is reloading its pipeline with a licensing deal for a
preclinical antibody advanced by Japan's Kyowa Hakko
Kirin. Sanofi says that the inflammation deal will be worth
up to $315 million in upfront fees and milestones for
Kyowa. The companies didn't break that number down.
Sanofi snared worldwide rights to the anti-light fully
human monoclonal antibody, with a co-promotion pact in
place for Japan and Asia. The program will initially test
the antibody's effectiveness against ulcerative colitis and
Crohn's disease and, depending on the data, could be
further pursued into rheumatoid arthritis.
UCB to Acquire Schwarz Pharma Shares
May 13, 2009, Pharmabiz, Brussels, Belgium
http://www.google.co.in/search?hl=en&q=PharmabizUCB+
to+acquire+Schwarz+Pharma+shares&btnG=Search&meta=
&aq=f&oq=
UCB is seeking to acquire the Schwarz Pharma shares held
by minority shareholders - representing approximately 0.4
per cent of stock capital - by way of a so-called 'squeeze-
out' procedure. In accordance with the legally stipulated
procedure (under Sections 327a ff. of the German Stock
Corporation Act [AktG]), the Schwarz Pharma shares held
by minority shareholders are to be transferred to UCB and
in return for an appropriate cash compensation, by way of
a resolution still to be passed by the Annual General
Meeting of Schwarz Pharma AG.
UCB SP GmbH, Monheim, as the principal shareholder of
Schwarz Pharma, informed the Executive Board of Schwarz
Pharma AG in a letter that it had set the cash
compensation for the transfer of the shares held by
Organisation of Pharmaceutical Producers of India
Pharma Spectrum
minority shareholders in Schwarz Pharma to UCB SP
GmbH, as the principal shareholder, to EUR 111.44 per
share.
GSK Extends Strategic Collaboration
with Aspen
May 13, 2009, Pharmabiz, London
http://www.pharmabiz.com/article/detnews.asp?articleid
=49696&sectionid=14
GlaxoSmithKline plc (GSK) has agreed to extend its
strategic relationship with Aspen Pharmacare Holdings
Limited (Aspen) and to acquire a 16 per cent shareholding
in the South African based pharmaceuticals company. This
is part of a wide ranging agreement which includes
combining commercial activities in sub-Saharan Africa and
the divestment of several assets to Aspen.
Abbas Hussain, president Emerging Markets,
GlaxoSmithKline said, "Extending our strategic relationship
with Aspen supports GSK's strategy to accelerate sales
growth in emerging markets. The combination of our
commercial activities in Sub-Saharan Africa is highly
complementary and will mean that together we can
provide more medicines of value to more patients in these
countries. At the same time, GSK will also benefit from
investing in one of Africa's leading healthcare companies
with a formidable track record of delivery."
Merck Buys Clostridium difficile
Combination Rights
May 1, 2009, SCRIP
Merck & Co. has acquired the worldwide rights to a
biologic treatment for Clostridium difficile infection in
a $ 225 million deal with Medarex and Massachusetts
Biologic Laboratories (MBL) of the University Of
Massachusetts Meidcal School.
Merck will pay $ 60 million up front for the licence to
develop and commercialise CDA – 1 and CDB-1, which was
being developed by Medarex and MBL, and could pay a
further $ 165 million in milestones, as well as double-digit
royalties on sales.
BMS and Ensemble in $249 Million Drug
Discovery Deal
April 17, 2009, SCRIP
Bristol-Myers Squibb and Ensemble Discovery are to
discover and develop novel drug candidates in a deal
worth up to $248.5 million.
Ensemble is developing Ensemblins, a new class of oral
drug molecules for targets that cannot be modulated
effectively by traditional small-molecule pharmaceuticals.
The deal will aim to develop Ensemblins for up to eight
targets.
9
 Pharma Spectrum

INTERNATIONAL ACQUISITIONS - April ‘09

Listed below are some of the acquisitions that happened in the Pharmaceutical and Biotechnology domains in
the month of April, 2009. The list below mentioned the company acquired, and its country, bidder company
and value of the acquisition (where available).

Pharmaceutical
Date Target Company Bidder Value Country Type of Deal
(USD
mn)
Clinical Data Inc Beckman Acquisition, Cross border,
01/04/2009 USA
(Cogenics division) Coulter Inc 18 Private
Tongjitang
Anhui Jingfang
Chinese
02/04/2009 Pharmaceutical Co China Acquisition, Domestic, Private
Medicines 9
Ltd
Company
Piedmont Charles River
03/04/2009 Research Center Laboratories USA Acquisition, Domestic, Private
46
LLC International Inc
Gainbridge
SSL Acquisition, Cross border,
07/04/2009 Investments Cyprus
International Plc 27 Private
(Cyprus) Limited

Beleggingsmaatsch
SSL Acquisition, Cross border,
07/04/2009 appij Lemore B.V Netherlands
International Plc 93 Private
(34.50% stake)

Medley S/A
Sanofi-Aventis Acquisition, Cross border,
09/04/2009 Industria Brazil
SA 658 Private
Farmaceutica
Cipla Medpro Adcock Ingram
09/04/2009 South Africa Acquisition, Domestic, Public
South Africa Ltd Limited 266
Oktogon Acquisition, Cross border,
16/04/2009 Torfarm SA Denmark
Investment ApS 14 Private
Pfizer
16/04/2009 Pfizer Ltd Investments India Acquisition, Cross border, Public
27
Netherlands BV
Stiefel GlaxoSmithKline Acquisition, Cross border,
20/04/2009 USA
Laboratories, Inc. Plc 3,300 Private

Biotechnology
Magen BioSciences
03/04/2009 PPD Inc USA Acquisition, Domestic, Private
Inc 15
Rosetta Genomics Prometheus
13/04/2009 Israel Acquisition, Cross border, Public
Ltd (16.43% stake) Laboratories Inc 8
British
Genetel Biotech HD Global Acquisition, Cross border,
17/04/2009 Virgin
(BVI) Limited Limited 36 Private
Islands
Korea Bone Bank Acquisition, Buy & Build, Cross
21/04/2009 Endotec Inc. USA
Co., Ltd. 20 border, Private

For further information please contact Yes Bank Ltd. Deal values approximated to nearest million.

Organisation of Pharmaceutical Producers of India 9A


Pricing
Colombia Sets Kaletra Price Ceiling
13 May 2009, SCRIP, Francesca Bruce
"The Colombian government has set a maximum price for
Abbott's Kaletra (lopinavir plus ritonavir), reducing the
private sector price by around 55%. However, civil society
is still pushing for the government to issue a compulsory
licence.The national medicine pricing commission has set
the maximum public sector price at $1,067 (down from
$1,683) per patient per year, and $1,591 for the private
sector (down from around $3,500).
The move follows talks with Abbott after the government
called for the firm to match the prices charged elsewhere
in the region (scripnews.com, April 22nd, 2009). Local
media reports suggest that Abbott refused to lower its
prices, prompting the government to take action. The firm
was unable to comment, but it stated earlier that it had
already lowered its prices three times over the past two
years.Nevertheless, the price ceiling still means that
Kaletra is not subject to competition from generics. Many
groups are therefore still arguing for the Colombian
government to declare lopinavir plus ritonavir of public
interest, which would allow it to issue a compulsory
licence for the drug. The health ministry should make a
decision on this at the end of the week.
Inaccurate: GSK Launches 50% Discount
for Uninsured
May 7, 2009, Fierce Pharma
http://www.fiercepharma.com/story/glaxo-launches-50-
discount-uninsured/2009-05-
07?utm_medium=nl&utm_source=internal
Andrew Witty puts charity to work again. The
GlaxoSmithKline CEO, who's already pledged to slash
prices for drugs sold in poor countries, now is offering a 50
percent discount on meds for U.S. patients who are
uninsured. The discount-card program applies to anyone
under 65 who doesn't have insurance, and patients will
have access to it until they get employer-sponsored
coverage or until health reform takes care of their
insurance problems, whichever comes first. No income
restrictions apply, either.
Deirdre Connelly, Glaxo's U.S. pharma president, explains,
"We feel this is simply the right thing to do, especially in
this economy." Apparently, "the right thing to do" has been
much on Witty's mind; as you know, he's has been on
something of a good-boy binge. He's pledged to disclose
payments to doctors and to limit them, too, and also
promised to publish info on Glaxo's support for medical
Organisation of Pharmaceutical Producers of India
Pharma Spectrum
societies. Then there was the push for price cuts in poor
countries. And now this.
Trade & Others
Hetero Readies Drugs for Treating
'Swine Flu'
May 13, 2009, Hindu Business Line
http://www.thehindubusinessline.com/2009/05/13/storie
s/2009051350710200.htm
Hetero Drugs, the lead supplier of ‘Tamiflu’, which is
considered the best bet to treat ‘swine flu’, has lined up
supply of nine million capsules to the Centre, as part of
the national preparedness to tackle a possible pandemic.
“We have already supplied two million capsules, by end of
May another three-four million would be sent and by June
10, 2009 will complete the entire supply,” Mr Srinivas
Reddy, Director (Marketing) of the Hyderabad-based drug
major, said.
Immediately after reports of detection of swine flu cases
in Mexico and other parts, the Centre had sounded Hetero
Drugs for an immediate supply of 10 lakh doses of generic
versions of Roche’s anti-influenza drug Tamiflu.
Trend: Hospitals Mounting Attack on
Retail Clinic Business
May 11, 2009, Fierce Healthcare
http://www.fiercehealthcare.com/story/trend-hospitals-
mounting-attack-retail-clinic-business/2009-05-
11?utm_medium=nl&utm_source=internal
For a while, it was beginning to look like the retail clinic
phenomenon was peaking or perhaps even petering out,
with a handful of clinics even being forced out of business.
But maybe the truth is that the battleground is shifting--
from growth fueled by pharmacy chains and independent
operators to a gradual encroachment by hospitals.
While hospitals have been dabbling in the retail clinic
market for years, a growing number are dipping their oar
in. For example, the Cleveland Clinic has lent its
impeccable brand and services to several CVS clinics in
Ohio, and the Mayo Clinic is operating two clinics in
Rochester, MN supermarkets.
Big Pharma Grows Online, Slowly
May 11, 2009, Fierce Pharma
http://www.fiercepharma.com/story/big-pharma-grows-
online-slowly/2009-05-
11?utm_medium=nl&utm_source=internal
Welcome to the revolution--the social media revolution,
that is. Big Pharma is finally joining the party, AdAge
reports, with a 36 percent increase in internet-media
10

spending in 2008. Though plenty of folks consider
drugmakers' arrival to be too little, too late--even after
that 36 percent hike, pharma still spent only $137 million
online--the trade pub allows that FDA regulation makes it
tough for them to be early adopters.
Some of the mag's examples of pharma's forays online:
Johnson & Johnson has a blog; AstraZeneca, Boehringer
Ingelheim and Novartis send out company news via
Twitter; Sanofi-Aventis and AstraZeneca have relatively
new YouTube channels. We'd add that Pfizer and Roche
both tweet news, too. You pharma-marketing experts
know of more examples, few and far between though they
are.
Dutch Body Lures IT, Pharma Companies
May 9, 2009, Hindu Business Line
http://www.thehindubusinessline.com/2009/05/09/storie
s/2009050951021700.htm
Having assisted around 80 Indian companies establish
offices in the Netherlands, the Netherlands Foreign
Investment Agency (NFIA) in India is luring companies here
to look at Europe. According to NFIA, in the last two years
alone nearly 25 companies have established their presence
in the Netherlands.
“Opportunities exist during these recessionary times. An
investment in Europe would be a profitable strategy for
Indian companies in today’s economic context. When
growth returns to the world economy, as it inevitably will,
the companies that have established their presence in
Europe will have the first-mover advantage,” says Mr
Robert Schipper, Executive Director, NFIA-India.
Ranbaxy to Sell Generics Medicines
under AOK Agreement in Germany
May 6, 2009, Pharmabiz
http://www.pharmabiz.com/article/detnews.asp?articleid
=49594&sectionid=5
Ranbaxy Laboratories' German subsidiary Basics GmbH
(Basics) has concluded new discount agreement with AOK
Baden Wurttemberg, biggest health insurance group, for
providing Cefaclor Basics and Tamsulosin Basics during the
year 2009 and 2010. The agreement will come into effect
from June 1, 2009.
Cefaclor Basics product will be exclusive for all 15 AOK
regional associations and five zones. Similarly, Tamsulosin
Basics will be exclusive for 13 AOK regional associations
and four zones.
US Trade Pacts Could Harm Indian
Pharma
May 6, 2009, Financial Express
Organisation of Pharmaceutical Producers of India
Pharma Spectrum
http://www.financialexpress.com/news/us-trade-pacts-
could-harm-indian-pharma/454952/
Concerned over certain clauses in the free trade
agreements (FTAs) of the US that could potentially curb
Indian pharmaceuticals exports, New Delhi has decided to
take up the matter with Washington soon. India’s concerns
about the FTAs of the US — for instance the one which the
US has with Morocco — stem from certain provisions in
such trade pacts that aim at increasing the duration of
drug patents.
Usually, a patent is meant to last only for 20 years.
However, these FTA clauses ensure the ‘patentability of
new uses of discovered inventions’ (meaning even minor
changes of an existing drug can be patented). The
provisions are also aimed at increasing duration of the
patent monopoly (a strategy called ‘ever-greening’ of
patents) by taking into account the time taken to process
patent claims.
Glaxo, Roche Combat Antiviral Hoarding
May 4, 2009, Fierce Pharma
http://www.fiercepharma.com/story/glaxo-roche-
combat-antiviral-hoarding/2009-05-
04?utm_medium=nl&utm_source=internal
GlaxoSmithKline and Roche have been reduced to playing
flu-drug traffic cop. Because the worried well are
snapping up drugs all over the world, prompting shortages
in some places, the drugmakers are strategically allocating
their stocks. Glaxo says it's sending its antiviral Relenza to
areas of the U.S. and elsewhere in the world that need it
most. Roche has actually cut off French pharmacies
because of a run on its Tamiflu drug; it's only supplying
Tamiflu to hospitals in France.
The number of daily prescriptions for antiflu drugs
skyrocketed last week to nine times previous April levels,
the New York Times reports. To help keep up with
demand, Roche and Glaxo quickly jacked up production:
Glaxo now has 6 million Relenza treatments in stock and
plans to boost production to 5 million treatments per
month.
Ranbaxy Forced to Recall Drug from US
May 3, 2009, Business Standard
http://www.business-standard.com/india/news/ranbaxy-
forced-to-recall-drugus-mkt/356916/
Withdrawal of nitrofurantoin capsules in coordination with
the US FDA and will be at retail level. Ranbaxy
Laboratories is facing more trouble in the US. Quality
issues have forced the company to withdraw all batches of
a generic urinary infection antibiotic drug.
Ranbaxy Pharmaceuticals Inc (RPI), the US subsidiary of
Ranbaxy, today said it was conducting a voluntary recall of
11

all lots of nitrofurantoin (monohydrate/macrocrystals) 100
mg capsules currently in the market in the US.
Novo Nordisk Among World's Most
Ethical Companies: Ethisphere Study
May 2, 2009, Pharmabiz
Novo Nordisk, the world leader in diabetes care is
recognized as one among the top ethical companies in the
world according to Ethisphere study. The analysis is based
on the sustainable and ethical leadership of the Denmark
drug major.
More than 10,000 of the world's leading companies were
analyzed for a period of six months in six continents,
across 35 industries before arriving at the final list. These
companies were evaluated on seven key parameters which
included corporate responsibility, governance, innovation
leadership, integrity track record, internal systems
programme before deciding on the final list.
Indian Pharma Emerges Big Plan in
Japan
May 2, 2009, Business Standard
http://www.business-
standard.com/india/storypage.php?autono=356834
Leading Indian drug makers such as Ranbaxy, Lupin, Zydus
Cadila and Dishman, which forayed into Japan in the past
three years, have emerged as important players in the
generic or copycat drug business of patented medicines in
that market, the second largest in the world.
The Japanese drug market, second after the US with a size
of $74 billion, has a small generic segment, worth 5
percent of the total in value terms and 17 percent in
volume terms.
Biocon Taps German Market through
Axicorp
April 30, 2009, Pharmabiz
http://www.pharmabiz.com/article/detnews.asp?articleid
=49535&sectionid=50
The Bangalore-based leading biotech player Biocon's
moves to tap growing business opportunities in Germany
has achieved further momentum as its German subsidiary
AxiCorp bagged a tender offer from AOK, Germany's
largest health insurer, to supply Metformin, a key diabetic
generic drug in Germany. The AOK tender is valued at
Euro 13.5 million.
The contract is planned to be awarded for the entire
German territory over the next 2 years and is subject to
review in accordance with the German tender regulations.
The tender is expected to strengthen the market presence
of AxiCorp in the booming generic business.
Organisation of Pharmaceutical Producers of India
Pharma Spectrum
Docs Like E-Promos
April 28, 2009, Fierce Pharma
http://www.fiercepharma.com/story/news-flash-docs-e-
promos/2009-04-28?utm_medium=nl&utm_source=internal
Look no further for more evidence that humanity is
getting a little too, er, enamored with the internet.
According to a study of pharma e-promotions, almost
three-fourths of doctors said they'd just as soon talk with
a computer than with a drug rep--and some even
preferred the computer.
If this study is to be believed, it's clear why e-promotion is
on the move. More than two-thirds of physicians said they
had a positive attitude toward this type of interaction
with drugmakers. Perhaps that's because they could do so
at their leisure. Almost 70 percent said they did their e-
promos in the evenings. Or perhaps it's just because they
don't have to make conversation.
Institute of Medicine: Time to Nix
Pharma Gifts
April 28, 2009, Fierce Pharma
http://www.fiercepharma.com/story/institute-medicine-
time-nix-pharma-gifts/2009-04-
28?utm_medium=nl&utm_source=internal
The government's top medical advisers are now
putting their two cents into the conflict of
interest debate. The Institute of Medicine says that
collaborations between medical professionals and
drugmakers can benefit society, but financial ties are
getting in the way. In the 353-page report, IOM's
Committee on Committee on Conflict of Interest in
Medical Research, Education, and Practice warns that
current industry practices are negatively influencing
research and patient care.
The Committee calls on medical professionals to cut or
restrict many practices that have now become a common
part of the pharma-doctor relationship, including
the elimination of free meals, gifts and travel
arrangements. Drug samples? Only for those who can't
afford the meds. Meetings with sales reps? Restricted.
Pharma-sponsored presentations and ghost-writing
articles? Out. And researchers are being advised not to
sign on for studies if they have a financial stake in the
outcome.
Cipla Ready to Supply Generic Drug to
West
April 28, 2009, Financial Express
http://www.financialexpress.com/news/cipla-ready-to-
supply-generic-drug-to-west/451953/0
12

As worries about a possible swine flu outbreak in the West
spread, pharma major Cipla Ltd on Monday said it is ready
to supply 1.5 million doses of oseltamivir, the generic
version of the bird flu drug, Tamiflu, which can be
effective for swine flu.
Cipla, which had challenged multinationals with its cheap
versions of AIDS drugs for a Medecins Sans Frontieres
programme in Africa years ago, said it can deliver the drug
in a month. “Cipla has the capacity to supply the drug
within 4-6 weeks,” Amar Lulla, joint managing director,
Cipla, said on Monday.
$1b Drug Market in Africa at Stake
April 26, 2009, Financial Chronicle
http://www.mydigitalfc.com/news/1b-drug-market-
africa-stake-625
India has charged the European Union (EU) with working
against its drug exports to Africa and South America. The
Indian pharmaceutical industry’s exports to Africa are
worth $1,065 million a year, a market that will be lost if
the EU, prodded by multinational companies, succeeds in
convincing African nations to not import Indian medicines.
Kenya has already issued a notification saying that generic
drugs – the Indian industry’s strong point -- patented
elsewhere cannot be sold in that country. The law, in
fact, classifies generic drugs as spurious.
Genentech Withdraws Raptiva in the US
April 17, 2009, SCRIP
Genentech is to withdraw its psoriasis therapy Raptiva
(efalizumab) in the US based on its association with an
increased risk of developing progressive multifocal
leucoencephalopathy (PML), a rare and potentially fatal
brain infection.
Three patients taking the monoclonal antibody therapy
were diagnosed with cases of PML, two of which were
fatal. A fourth patient developed progressive neurological
symptoms and died of an unknown cause (scripnews.com;
November 18th, 2008).
Merck & Co Taps Mylan for Japanese
Promotion
April 17, 2009, SCRIP
Banyu, Merck & Co’s subsidiary in Japan, has tapped the
generics company Mylan to promote two of its key
cardiovascular products in the country.
From May 1st, the US generics firm will begin providing
information to hospitals and other medical facilities for
the ACE-inhibitor Renivac (enalapril) and the hypolipaemic
Organisation of Pharmaceutical Producers of India
Pharma Spectrum
Lipovas (simvastatin). Banyu will continue to produce,
distribute and sell the products.
Global $225 Million Malaria Drug
Scheme Launched
April 17, 2009, SCRIP
A global scheme to subsidise newer medicines for malaria-
endemic countries has been finally launched, costing
$225-233 million in the first two years.
Most of the funding will come from UNITAID, an
international drug purchasing facility (which has more
than 25 donor nations), and the UK government. Other
countries, including the Netherlands, are considering a
financial contribution to the scheme.
Move to Publish “Secret” Anti-
Counterfeiting Treaty “Modest Step”
April 17, 2009, SCRIP
Following mounting pressure, the Office of the US Trade
Representative (USTR) has published a six – page summary
on the “secretive” anti-counterfeiting trade agreement
(ACTA) that it is negotiating with major trading partners
including the EU and Japan. Essential Action, which has
being calling for its publication with more than 100 other
public interest groups around the world, told Scrip that
the move was a “modest step forward”.
Its Director, Robert Weissman said he hoped the move
signaled the beginnings of a new progressive policy on
transparency at the USTR.
Biotechnology
Sanofi-Aventis Builds $350m Dengue
Fever Vaccine Plant
May 13, 2009, Financial Chronicle
Sanofi-Aventis began work on Tuesday on a €350 million
($477 million) plant that is to be devoted to production of
the world’s first vaccine against dengue fever, a public
health threat for some two-fifths of the world’s
population.
The company says its vaccine plant in this town north of
Lyon is the largest single industrial investment it has ever
made. By 2013 it is hoped the plant will begin turning out
a dengue vaccine that the company is, at present, testing.
13

Pfizer, WARF Sign License Agreement
for Human Embryonic Stem Cell Patents
May 7, 2009, Pharmabiz, Madison, Wisconsin
http://www.pharmabiz.com/article/detnews.asp?articleid
=49602&sectionid=3
Pfizer Inc, the world's premier biopharmaceutical
company, and the Wisconsin Alumni Research Foundation
(WARF), the private, non-profit patenting and licensing
organisation for the University of Wisconsin-Madison, have
signed a license for human embryonic stem (hES) cell
patents for the development of new drug therapies.
The WARF license provides Pfizer the rights to work with
hES cells for drug research and discovery. Securing
appropriate licenses, in an area as broad and rapidly
moving as regenerative medicine, helps ensure rapid and
efficient utilization of the many existing discoveries and
inventions in this field and allows for the efficient transfer
of information for development of future inventions
Big Pharma Swallows Billions in Biotechs
May 5, 2009, Fierce Pharma
http://www.fiercepharma.com/story/big-pharma-
swallows-billions-biotechs/2009-05-
05?utm_medium=nl&utm_source=internal
Megamergers may have grabbed most of the headlines of
late, but drug makers snapped up plenty of small firms
last year, Ernst & Young points out. In 2008, pharma
swallowed some $28.5 billion worth of U.S. biotech
companies, just a few billion short of a $33 billion record
in 2007. And if you back out AstraZeneca’s 2007 buyout of
vaccine maker MedImmune--a whopping $15.6 billion deal-
-then 2008 totted up the highest biotech M&A total ever.
The 2008 deal roster includes TakedTakeda’s $8.8 billion
acquisition of Millennium Pharmaceuticals, which makes
the multiple myeloma treatment Velcade, and Eli Lilly’s
$6.5 billion deal for ImClone Systems, maker of cancer-
fighter Erbitux. Meanwhile, pharma took some $5 billion in
European biotechs under its wing last year, including
Novartis’ purchase of the Swiss firm Speedel for $932
million
Pharming Group's Prodarsan Product
Gets Orphan Drug Status from US FDA
April 30, 2009, Pharmabiz, Leiden, The
Netherlands
Biotech company Pharming Group NV announced that its
wholly-owned subsidiary DNage BV has received a notice
from the US Food and Drug Administration that its product
Prodarsan has been awarded an orphan drug designation
for the treatment of Cockayne Syndrome. Prodarsan is a
Organisation of Pharmaceutical Producers of India
Pharma Spectrum
combination of two small molecules, formulated for oral
use, which are believed to reduce the accumulation of
DNA-damage, the underlying biochemical cause of
Cockayne Syndrome.
Cockayne Syndrome, the initial target of Prodarsan, is a
rare genetic disease in which children suffer from
accelerated (or premature) aging, while developing severe
aging diseases. Progeria diseases are a group of genetic
premature aging diseases which manifest in several forms
that are genetically and clinically similar although not
identical. Depending on the specific form of the disease,
patients have a significantly reduced life expectancy and
exhibit many aging-related symptoms early on in their
lives. Quality of life for these patients is seriously
impaired. Cockayne Syndrome is one of the more common
forms of progeria and is characterized, among others, by
growth failure, mental retardation, hearing and sight
problems and a reduced life expectancy. Currently, no
effective therapy for Cockayne Syndrome is available.
New Appointments
IFPMA New Appointment
April 29, 2009, IFPMA
Ms. Alicia Greenidge, IFPMA’s Director General, is
resigning her position in order to pursue other
opportunities. Ms. Greenidge came to IFPMA in 2008 after
a distinguished career in the United State Government.
During the search for a successor, Laurent Renaud,
Director of Administration and Finances, IFPMA will take
on the day-to-day administrative operations of the
organisation under the direction of Michael Boyd, Vice
President of Public Affairs International for Schering-
Plough Corporation, who will be serving as Acting Director
General.
14

Domestic
IPR
22 Patent Department Officers
Transferred
May 18, 2009, Mint
http://www.livemint.com/2009/05/18001429/22-patent-
department-officers.html
The New Controller General of India’s patents, designs and
trademarks office, Mr. P.H. Kurian, has transferred at
least 22 officers in its four regional offices. It is the first
time, in at least a decade that transfers have taken place
on this scale.
Kurian, the first Indian Administrative Service officer to
head the patents office, said on Tuesday that the transfers
were aimed at a more equitable distribution of skilled
officers and group leaders at the right places.
India Needs its Hatch-Waxman Act for
Healthcare
May 15, 2009, DNA Money
http://www.dnaindia.com/report.asp?newsid=1256132
The Hatch-Waxman Act, a legislation that transformed the
American drug industry, completed 25 years last week.
Over those years, the American healthcare system saved a
whopping $734 billion due to increased use of generic
pharmaceuticals.
While the opening up of the American drug industry to
generics did lead to the growth of generic giants like
Teva, Sandoz, Mylan and Ranbaxy, large innovators like
Pfizer, GSK and Merck have been forced to come out of
their safety zones of unending patent protection of
blockbuster drugs and see the world differently.
Vulnerability grew and so the desire to take
unprecedented steps for continuous innovations.
Govt Accepts Satwant Reddy
Recommendation on Data Exclusivity
May 13, 2009, Pharmabiz
http://www.pharmabiz.com/article/detnews.asp?articleid
=49689&sectionid=44
After almost two years of discussions with various
stakeholders, the Centre is learnt to have accepted the
recommendations of Dr Satwant Reddy committee on data
exclusivity and may offer 'protection against disclosure' to
the pharma companies. However, the government may
take some more time to announce its decision on
Organisation of Pharmaceutical Producers of India
Pharma Spectrum
'Protection against unfair commercial use' as the Union
ministry of health and the department of pharmaceuticals
wanted stakeholders to get further engaged in a dialogue
before final details are worked out.
According to sources, the government has accepted the
recommendations of Dr Satwant Reddy committee as far
as 'protection against disclosure' is concerned and may
announce the same soon. "Government should take
adequate steps to ensure that specified undisclosed data
submitted for seeking marketing approval for
pharmaceutical products is not disclosed to any third
party. Officials in the office of Drug Controller General of
India should be under obligation to keep secret the
undisclosed information submitted to Drug Regulator for
approval of new drug," the Dr Reddy committee had
recommended.
US Rakes up Counterfeit Drugs Issue
again by Charging Indian IPR Protection
as Weak
May 12, 2009, Pharmabiz
Even as the indirect attempts by the multinationals to
equate Indian generics with counterfeit drugs failed at
WHO, the United States has once again raised the issue by
expressing concern on the 'weak intellectual property
rights protection and enforcement' in India.
The 'Special 301' Report by the Office of the United States
Trade Representative (USTR), which placed India on the
priority watch list, has called for better and effective
system to check counterfeit drugs.
Lupin Settles Venlafaxine XR Capsules
Litigation with Wyeth
May 11, 2009 Pharmabiz
http://www.pharmabiz.com/article/detnews.asp?articleid
=49661&sectionid=44
Lupin, the sixth largest Indian pharma company with net
sales of over Rs 2,700 crore, has settled all ongoing Hatch-
Waxman litigation relating to venlafaxine extended
release capsules, a generic version of Wyeth's
antidepressant 'Effexor XR' capsules. These capsules had
US sales of $3.01 billion for the year 2008 (IMS) and
accounted for 17 per cent of the Wyeth's net revenue in
2008.
As per the terms of the settlement, Lupin will be licensed
under the relevant patents and would be free to
commercially launch its generic product on or after June
1, 2011, or earlier in certain limited circumstances, but in
no event earlier than January 2011.
15

Dr Reddy's Files Post-Grant Opposition
against Pfizer
May 9, 2009, Financial Express
http://in.biz.yahoo.com/090508/203/batjqw.html
Pharmaceutical giant Pfizer is facing a post-grant
opposition from Dr Reddy's Laboratories for its anti-
smoking drug, Chantix (Champix in India). The latter has
resisted against the Indian patent (the '091 patent) for the
usage of the tartrate salt of varenicline, the active
ingredient of Chantix. Last year in February, Pfizer
launched the varenicline prescription drug in India under
the brand name Champix (Chantix in US).
Recently, the Delhi patent office had rejected a patent
application for Caduet, a high cholesterol and blood
pressure drug, filed by Pfizer while considering a pre-grant
opposition by Torrent. Post-grant opposition allows a
company to challenge the validity of the patent of a drug
which has been already launched. A similar post-grant
opposition filed by Wockhardt against Roche's hepatitis C
drug, Pegasys, was rejected by Indian patent office
recently.
Indian Patent Office Set for Total
Revamp, Most Backlog Files to be
Cleared by June End
May 6, 2009, Pharmabiz
http://www.pharmabiz.com/article/detnews.asp?articleid
=49581&sectionid=44
The Intellectual Property Office (IPO) of India is all set to
revamp its entire operations in the country by clearing all
the possible backlog files before July 1, 2009, by more
efficient deployment of its available human resources.
The IPO is in a process of rationalising the allotment of
patent applications for examination by creating four
groups based on subject expertise to handle the cases
promptly. The groups, Chemistry and allied sciences,
Biotechnology and microbiology, Mechanical and allied
subjects, Electrical, electronics and related subjects, will
be operational soon to handle the files more promptly
with the available human resource, informed P H Kurian,
controller general of patents, designs and trademarks and
geographical indications (CGPDTM).
Pfizer Sues 3 Indian Cos for Patent
Infringement of its Pain Drug, Lyrica
May 5, 2009, Pharmabiz
Pfizer Inc has filed patent infringement suit against three
Indian companies, namely Sun Pharma, Wockhardt Ltd and
Lupin Ltd to block marketing generic equivalents to its
blockbuster neuropathic pain management drug, Lyrica, in
US.
Organisation of Pharmaceutical Producers of India
Pharma Spectrum
The law suit against Lupin pharma is on the allegation that
the company has infringed US Patent No 6,001,876 for
isobutylgaba and its derivatives for the treatment of pain
issued in December 1999, Patent No 6,197,819 for gamma
amino butyric acid analogs and optical isomers, issued in
March 2001, and Patent No 5,563,175 GABA and L-glutamic
acid analogs for anti-seizure treatment, issued in October
1996.
SC Dismisses Plea against Sun Pharma
May 5, 2009, manoramaonline.com
http://week.manoramaonline.com/cgi-
bin/MMOnline.dll/portal/ep/contentView.do?contentId=54
34451&programId=1073754912&pageTypeId=1073754893&c
on tentType=EDITORIAL&BV_ID=@@@
New Delhi: The Supreme Court has dismissed the Central
Excise Department's plea alleging that pharma major Sun
Pharmaceuticals Ltd was undervaluing its physician's
samples and thus paying lesser duty.
It alleged that the pharma major, which manufactured
both commercial packs and the physician's sample packs,
was clearing the latter at a lower assessable value than
the pro-rata value of the sale packs of the same
medicines.
Will Compulsory Licensing Hit Roche,
Glaxo?
April 30, 2009, Fierce Pharma
http://www.fiercepharma.com/story/will-compulsory-
licensing-hit-roche-glaxo/2009-04-30-
0?utm_medium=nl&utm_source=internal
The World Health Organization's hike in pandemic threat
level triggers certain pharma-related events, particularly
the release of antivirals from government stockpiles
around the world. And with those stockpiles being
deployed, naturally FDA et al are coordinating with Roche
and GlaxoSmithKline to get replacement stocks of their flu
meds Tamiflu and Relenza.
Another less-appetizing prospect, for the two drugmakers
anyway, is the fact that with a public health emergency
underway, the World Trade Organization allows various
countries to buy from low-cost suppliers, a.k.a. generics
firms, despite the fact that both meds are still under
patent. This "compulsory licensing" process allows poor
nations to gain access to meds they can afford, in the
event of an epidemic. Intellectual property protections
can quickly be trampled by officials aiming to protect
their citizenry--and by politicians looking to score some
points in the process.
16

Govt to Create 1,380 Patent Examiners
Posts
April 27, 2009, Hindu Business Line
http://www.thehindubusinessline.com/2009/04/27/storie
s/2009042750770300.htm
The Centre plans to create 1,380 patent examiners posts
during the 11th Plan period, of which 414 will be filled up
this year alone.Stating this at a function organised by the
Confederation of Indian Industry (CII) in partnership with
the Department of Industrial Policy and Promotion (DIPP)
here on Sunday, the Joint Secretary in the DIPP, Mr N.N.
Prasad, said that the Centre has spent around Rs 500 crore
in the last five-six years towards the development of hard
and soft intellectual property (IP) rights infrastructure.
Between 1999-200 and 2006-07, the number of patent
applications filed in the country has increased from 4,824
to 28,882, with the number of patents granted rising from
1,881 to 7,359. The number of patent applications filed is
projected to jump to about 72,000. The present level of
manpower in the IP offices is said to be insufficient to
handle the workload.
Delhi HC Scraps Roche's Plea
April 25, 2009, The Times of India
http://timesofindia.indiatimes.com/Business/HC-scraps-
Roches-plea/articleshow/4445931.cms
In a ruling that might spell relief for lakhs of lung cancer
patients, the Delhi High Court on Friday allowed Cipla to
manufacture and sell the generic version of lung cancer
drug `Erlotinib' of Swiss pharma firm Hoffman La Roche
Ltd.
Vacating its previous stay order on the generic
manufacturer, a division bench also removed all restraints
on Cipla, while exporting the life saving drug to other
countries in which La Roche has patent rights. The court
dismissed the plea of the Swiss company and also imposed
a cost of Rs 5 lakh on it.
Regulatory
Over 44 Fixed-Dose Combination Drugs
Clear DGCI Tests
May 25, 2009, The Economic Times
http://economictimes.indiatimes.com/News/News-By-
Industry/Healthcare--Biotech/Over-44-fixed-dose-
combination-drugs-clear-DGCI-
tests/articleshow/4573397.cms
The government may give permission to 44 more
combination drugs — a formulation of two or more active
ingredients combined in certain fixed doses - for treating
Organisation of Pharmaceutical Producers of India
Pharma Spectrum
diarrhoea, fever, pain and hypertension, said a health
ministry official.
Known as fixed dose combination (FDC) drugs in
pharmaceutical industry parlance, these will help reducing
the number of pills in a single dosage, and consequently
the expenses incurred. For instance, doctors usually
prescribe three to four medicines to patients suffering
from common cold or diarrhoea. With FDCs, this could be
cut down to just one.
DCGI Calls Second Meeting of Expert
Panel on FDCs on June 4
May 25, 2009, Pharmabiz
http://www.pharmabiz.com/article/detnews.asp?articleid
=49878&sectionid=19
The Drug Controller General of India (DCGI) has called the
next meeting of the expert panel on fixed dose
combination (FDC) on June 4. The meeting will decide the
fate of another 28 FDC drugs.
This is the second meeting of the panel which was formed
last year to resolve the vexed FDC issue. The first meeting
of the expert panel was held on January 23 and 24 this
year in which a total of 48 FDC drugs were examined.
DCGI Asks State Drug Authorities to
Disallow Cos Altering Compositions
without Changing Brand Names
May 25, 2009, Pharmabiz
http://www.pharmabiz.com/article/detnews.asp?articleid
=49880&sectionid=19
The office of the Drug Controller General of India has
directed the state drug authorities to keep a track of
companies indulging in the practice of changing the
compositions of products after getting the approval but
retaining same brand names. Pharma companies have
been doing this to take advantage of the brand value of
the product and at the same time to escape price control
by substituting decontrolled drugs in the formulation, it is
learnt.
State drug authorities usually do not verify such changes in
the composition in the formulations once the product
licenses are issued. Several medium and small pharma
companies have been taking advantage of this lack of
monitoring by the state drug authorities for some time
now.
17

Investors at Risk as US FDA Gets Tough
with Drug Cos
May 25, 2009, The Economic Times
http://economictimes.indiatimes.com/News-by-
Industry/Investors-at-risk-as-US-FDA-gets-
tough/articleshow/4573303.cms
The recent warning letters issued by the US Food and Drug
Administration (FDA), to manufacturing units of Indian
pharmaceutical companies have significantly raised
investors risk. With the FDA getting more stringent with its
quality inspections and upcoming approvals for companies
put on hold, investors are the ones who could lose out in
the long-run, said analysts.
"Companies need to put things in place. Once the US FDA
issues inspectional observations or '483' concerns and if it
goes to the next level of warning letters, it will take a
couple of quarters for things to get sorted out," said
Abhishek Singhal, an analyst with Macquarie.
FDA-Approved Inspectors Plan Short-
Notice Audit of Trials
May 23, 2009, The Economic Times
http://economictimes.indiatimes.com/Pharmaceuticals/F
DA-approved-inspectors-plan-short-notice-audit-of-
trials/articleshow/4567501.cms
Drug Controller General of India (DCGI) is planning random
audit of clinical trial sites across the country on a regular
basis by this June and will suspend any human experiment
if the research organisation is found violating the
guidelines. The move comes in the wake of successful
audits over the last few months that enabled the drug
regulator to efficiently monitor the human trials, a health
ministry official said.
Under the scheme, a team of drug inspectors will walk
into clinical trial centres at short notice and audit the
internal processes and the clinical trials data.
Drug Regulator to expand Survey on
Fake Medicines
May 22, 2009, The Hindu Business Line
The Drug Controller General of India plans to widen the
survey to map the prevalence of counterfeit drugs in the
country with larger number of samples. The regulator,
which is examining 26,500 samples of 62 top-selling
medicines, is planning to pick up one lakh samples for the
next survey. The first report on counterfeit drugs is
expected in June.
Speaking to Business Line, Mr. Surinder Singh, DCGI, said,
“We want to put to rest all the speculation about the
extent of fake drugs prevalent in the Indian market.
Organisation of Pharmaceutical Producers of India
Pharma Spectrum
Drug Export Quality Certificate to be
Issued Only by DCGI
May 21, 2009, The Hindu Business Line
The Drug Controller General of India (DCGI) has decided to
withdraw the powers given to State-level regulators to
issue export quality licence, technically called Certificate
of Pharmaceutical Products (CoPP). The move is to
centralize pharmaceutical sector regulating.
Speaking to Business Line, Dr. Surinder Singh, DCGI, said,
“The power to issue CoPP was given to the State
regulators earlier outside the Concurrent List. Therefore,
now we are going to take it back to bring uniformity in
regulations. We will notify this in over the next month or
so.”
Karnataka Drugs Control Dept Issues
Over 3000 Show Cause Notices,
Suspends 1,000 Licenses
May 20, 2009, Pharmabiz, Bangalore
http://www.pharmabiz.com/article/detnews.asp?articlei
d=49802
Karnataka drugs control department has issued a total of
3,768 show cause notices, suspended 1,398 licenses and
cancelled 921 licenses of both manufacturers and the
pharmacy outlets during the period ending March 31,
2008-09.
During the year a total of 88 prosecution cases were filed
in the court. In addition, there were 69 cases disposed and
50 convictions carried out. Around 178 complaints
received from the public are being investigated. In the
government drug testing lab, a total of 3,311 samples
were analyzed of which 240 were declared not-of-standard
quality and investigations are being carried out.
Pharma Policy to be Delayed As New
Minister May Take Fresh Look at
Industry
May 19, 2009, Pharmabiz
http://www.pharmabiz.com/article/detnews.asp?articleid
=49787&sectionid=19
Though the same Manmohan Singh government is all set to
continue in the office after its thumping victory, the much
awaited national pharmaceutical policy which has been
pending since 2002 will have to go through another full
circle of process and all progress made so far will have
little impact.
With Ram Vilas Paswan, who has been pressing for the
policy for long, is most unlikely to stay as chemicals
minister under the new dispensation, the note on policy
should be prepared by the department again under the
18

new minister and be forwarded to the cabinet for
consideration.
US FDA Office in India May Not Speed Up
Certifications, Approvals for Domestic
Cos
May 18, 2009, Pharmabiz
http://www.pharmabiz.com/article/detnews.asp?articleid
=49768
Although the US FDA office in India may start its
operations in the next few months, that is unlikely to
expedite the disposal of approvals of Indian companies as
expected, it is learnt. Indian office of US FDA at New
Delhi, will have local drug inspectors within three months
from now and the country director will take charge in
September 2009.
However, the move may not help the Indian companies to
get approvals of Abbreviated New Drug Applications
(ANDAs) and good manufacturing practice (GMP)
certificates faster than now as every decision will have to
be cleared by the FDA office in Washington, informed a
senior official with US FDA.
MNC Units Abroad to Come Under Drug
Regulator Scanner
May 17, 2009, Hindu Business Line
The Drugs Controller General of India (DCGI) will soon
start sending its officers to foreign countries to inspect
the manufacturing facilities of multinational
pharmaceutical companies importing drugs into India. The
move is in line with the processes followed by the drug
regulators of other countries.
Speaking to Business Line, Dr. Surinder Singh, DGCI, said
“Inspectors from other countries, from Nepal to the US,
come to India to check manufacturing facilities of Indian
drug companies. We also get drugs imported from many
countries such as Taiwan and China for which we will start
sending our inspectors to examine whether they are
following good manufacturing practices.”
Commerce Ministry Tightens Procedures
for Export of Drugs to Ward off EU
Allegations
May 15, 2009, Pharmabiz
http://www.pharmabiz.com/article/detnews.asp?articleid
=49727&sectionid=11
The Union commerce ministry has asked the pharma
exporters to comply with more stringent quality guidelines
to ensure that no counterfeit drugs are exported from the
Organisation of Pharmaceutical Producers of India
Pharma Spectrum
country. India has been facing unfair criticism in this
regard from the European nations for some time.
As per the new notification issued by the directorate
general of foreign trade (DGFT),every exporter of drugs
and pharmaceuticals at the time of shipment shall submit,
along with other required documents, a copy of
Certificate of Analysis issued by the manufacturer for the
subject product; or a copy of Certificate of Analysis issued
by approved laboratory of the importing country/US FDA:
or a copy of Certificate of Analysis issued by a laboratory
approved by Drugs Controller under Drugs and Cosmetics
Act, 1940 and the rules made thereunder.
Dept. of Pharma asks Industry to
Provide Detailed Data of Units Wanting
to Avail of CLCSS
May 12, 2009, Pharmabiz
In view of the extremely poor response from the
industry to the Credit Linked Capital Subsidy Scheme
(CLCSS) during the last eight years, the pharmaceutical
department has asked the industry to provide a
comprehensive data about the probable SSI units which
may avail the revamped scheme which is being tweaked
by the government to make it more attractive and
beneficial to the pharma units to upgrade their units as
per the revised Scheduled M.
According to sources, the pharmaceutical department is
apprehensive about the response of the industry to the
tweaked CLCSS as a mere 200 pharma units availed the
scheme during the last eight years. As the government is
working on a revamping the scheme, it wanted to ensure
that the scheme has enough takers. So, the government
has asked the industry to provide a list of the probable
number of units who might avail of the facility.
Centre Plans Health Management
Information System to Monitor Demand
& Supply of Drugs
May 11, 2009, Pharmabiz
During the current XIth Plan period, the Centre will be
giving emphasis to e-Health by using IT in healthcare
segment and plans to set up a national grid to share
information among the healthcare providers, trainers,
beneficiaries and the society.
The Centre is also planning to launch a Health
Management Information System (HMIS) which will help
eventually to track the demand and supply of drugs and to
curb wastage of drugs due to date expiry. When fully
developed, it will work as a demand-driven management
system to track and monitor the drug situation across the
country and channelise the supply as per the demand in
particular places.
19

Health Ministry Redrafting ART Bill to
Regulate Thousands of Infertility Clinics
May 11, 2009, Pharmabiz
http://www.pharmabiz.com/article/detnews.asp?articleid
=49649&sectionid=13
The Union health ministry is re-drafting the Assisted
Reproductive Technology (Regulation) Bill, 2008 (ART Bill)
which will be introduced to regulate thousands of
infertility clinics that have mushroomed over the years in
the country. The Bill will define the establishment and
functioning of these clinics.
The ministry has received a large number of suggestions
and comments from foreign countries, embassies, legal
institutions, international institutions, experts and others
on the draft bill. The government had late last year
published the draft bill and had invited suggestions and
comments from the public on the proposed bill. The Bill,
drafted by an 11-member expert committee appointed by
the health ministry, proposes to establish a National
Advisory Board and state Boards to regulate and supervise
the establishment and functioning of the infertility clinics
in the country.
Pharma Port Office Opened in Bangalore
May 7, 2009, Hindu Business line
http://www.thehindubusinessline.com/2009/05/07/storie
s/2009050751191700.htm
The Health Ministry has opened a new port office for
pharma exports and imports at the Bengaluru International
Airport. Bangalore, a hub of biotechnology, clinical trials
and pharma research, will also have a sub-zonal office of
the Ministry’s drug quality arm, the Central Drugs
Standard Control Organisation, the Drugs Controller-
General of India, Dr Surinder Singh, said on Wednesday.
The port facility is part of the ongoing exercise to build
capacity and recruit more people at the CDSCO, Mr
Debashish Panda, Joint Secretary, Union Department of
Health & Family Welfare, said. Dedicated pharma zones
equipped with cold rooms would come up at the Delhi and
Mumbai airports by March 2010; the stakeholders and
operators of the two airport were meeting in Mumbai on
May 8.
Task Force Prescribes Policy Change to
Help Pharma SEZs
May 7, 2009, Financial Express
http://in.biz.yahoo.com/090506/50/batjaa.html
In a booster dose to the growing Indian pharmaceutical
industry, an inter-ministerial task force has mooted
several changes in the Special Economic Zones (SEZ) policy
in favour of the sector allowing it to focus more on the
Organisation of Pharmaceutical Producers of India
Pharma Spectrum
booming domestic market rather than on exports during
the initial phase of running a pharma SEZ.
Recommending special treatment to the pharma sector,
the report of the 'task force on pharmaceuticals' said the
year of commencement of the tax holiday period for
pharma SEZs should be computed from the year of profits
and not as per the existing SEZ norms that calculates the
tax holiday period from the year of setting up an SEZ.
DCGI Calls Govt-Industry Meet to
Finalise Guidelines on Spurious Drugs
Act
May 2, 2009, Pharmabiz
http://www.pharmabiz.com/article/detnews.asp?articleid
=49507&sectionid=19
The Drugs Controller General of India (DCGI) Dr Surinder
Singh has called an industry-government meeting on May
19 to finalise guidelines to safeguard the interests of
genuine drug manufacturers from misuse of recently
amended spurious drugs Act. The DCGI has asked the
industry to come out with its own specific suggestion in
this regard.
The Drugs and Cosmetics (Amendment) Act 2008,
stipulating stringent penalties for manufacturing and
marketing spurious drugs, was passed by Parliament last
year and the President gave her assent in last December.
The only formality left on the Bill is its notification which
the ministry will be doing soon.
WHO Auditors Inspect Indian Regulatory
Authority Again, Gives 100 Score
April 28, 2009, Pharmabiz
http://www.pharmabiz.com/article/detnews.asp?articleid
=49447&sectionid=19
WHO inspectors along with drug control officials from
other countries, held a comprehensive audit of the
national regulatory authority (NRA) in India and gave a
high score of 100, reversing its earlier adverse
observations about the bad plight of regulatory system in
the country two years ago.
"As many as 13 auditors from the WHO and other nations
held a week-long audit in different aspects and carried out
on-site inspections to assess the performance of the
regulatory mechanism recently. We got a 100 score on all
specific six indicators this time, whereas in the previous
similar assessment held in late 2007, we had been given
just around 40 score," DCGI Dr Surinder Singh told
Pharmabiz.
20

Govt Nod Must for Drug Cos to Rejig
Combination
April 27, 2009, The Economic Times
Drug makers changing the composition of existing
formulations to escape price cap will now have to come to
the centre for a fresh approval. In a move to keep a check
on companies which replace price control, the centre has
directed state drug regulators not to allow them to sell
such medicines with their old brand names. Instead, such
drugs will be treated as new ones and the companies will
have to go through the Centre’s scrutiny before it gets a
fresh approval, a government official said.
The move is significant as companies are now likely to
think twice before they make change in the existing
composition and approach the centre for a fresh approval.
This would also mean that companies will have to
subscribe to a new brand name.
New Products
Piramal Healthcare Launches Actipatch
for Pain Therapy
May 14, 2009, The Economic Times
http://economictimes.indiatimes.com/News/News-By-
Industry/Healthcare--Biotech/Pharmaceuticals/Piramal-
Healthcare-launches-ActiPatch-for-pain-
therapy/articleshow/4531084.cms
Piramal Healthcare on Thursday announced the launch of
BioElectronic's ActiPatch, a product in pain management.
"ActiPatch is a medical device that utilises pulsed electro-
magnetic frequency (PEMF) to accelerate healing of soft
tissue injuries. Patients suffering from pain and swelling in
conditions ... can benefit from this product," Piramal
Healthcare Director Swati Piramal told reporters.
Its unique delivery system using patented technology,
provides a cost-effective patient-friendly method to
reduce soft tissue pain and swelling, Piramal said.
Intas Bio Introduces Bortezomib in
Indian Market to Treat Multiple
Myeloma
May 11, 2009, Pharmabiz
http://www.pharmabiz.com/article/search.asp
Intas Biopharmaceuticals Limited has launched bortezomib
injection, under the brand name Borviz, in the Indian
market. The new drug offers effective treatment for
'multiple myeloma', the second-most common cancer of
plasma cell (blood).
Organisation of Pharmaceutical Producers of India
Pharma Spectrum
As part of company's sales strategy to provide cost-
effective novel therapies & oncology drugs, the company
has launched new sales division Bridge to strengthen its
new brands of drugs and focus on specific therapeutic
areas. With growing product portfolio, new sales division
will now focus on drugs that cater to non small cell lung
cancer (NSCLC) and multiple myeloma.
Shantha’s Oral Cholera Vaccine Launch
on April 26
April 25, 2009, DNA
http://www.dnaindia.com/report.asp?newsid=1250444
Hyderabad-based Shantha Biotechnics Ltd is all set to
launch an oral vaccine for preventing cholera. The first
bivalent oral cholera vaccine, it will be called Shanchol.
The company plans to officially launch the vaccine on
April 26; it will be available through commercial channels
from June.
"It's almost 38 years the world has been waiting for a
vaccine to prevent cholera. There was one vaccine before
that. But, it was withdrawn due to efficacy issues,"
Shantha managing director Varaprasad Reddy said.
R&D/Clinical Trials
NACO Ties Up with 26 Research
Institutions for NIIHAR Network
May 20, 2009, Pharmabiz
The National Aids Control Organisation (NACO) has tied up
with 26 research institutions across the country to
undertake operational, epidemiological and bio-medical
research in the field of HIV/AIDS. NACO had earlier
constituted a consortium Network of Indian
Institutions/Organizations for HIV/AIDS Research (NIIHAR)
for the purpose.
Sources in the NACO said that it has already roped in 26
research institutions under the network and more will be
added as the NACO is screening the other institutions in
the panel of institutions which have shown interest in
joining the network. This consortium will pool resources
and expertise to conduct high quality, collaborative,
multi-centric research that will help evidence based
decision making on policy, management and evaluation of
interventions. This consortium will have linkages with
universities, ICMR, CSIR, DST, ICSSR and others
stakeholders including donor organizations.
21

Ban on Clinical Trials for Wyeth Vaccine
Lifted
May 15. 2009, The Mint
http://www.livemint.com/2009/05/14233904/Ban-on-
clinical-trials-for-Wye.html
The drug controller general of India (DCGI) earlier this
week lifted a temporary ban on clinical trials for a vaccine
by US drug maker Wyeth Inc., allowing the drug company
and the Hyderbad-based clinical research organization
GVK Biosciences Pvt. Ltd to go ahead with the trials.
The ban had been imposed following the death of a baby
that was less than a year old due to lapses in standard
operating procedures while conducting clinical trials for
the vaccine in St John’s Hospital, Bangalore, in November.
However, the ban on trials has been removed only for 11
of the 12 hospitals where they were being carried out. It
stays in St John’s, said Surinder Singh, drug controller
general.
Piramal Life Gets Nod for Cancer
Molecule Trials
May 13, 2009, Financial Chronicle
http://www.mydigitalfc.com/knowledge/piramal-life-
gets-nod-cancer-molecule-trials-007
Mumbai-based Piramal Life Sciences on Wednesday said it
had received regulatory approval for initiation of phase-I
& II combination studies of its cancer molecule P276 for
pancreatic, head and neck cancer.
Having received the go-ahead from the Drug Controller
General of India (DCGI), Piramal Life Sciences, which is
part of the Piramal Group, will now initiate phase I and II
clinical trials at various locations to assess and identify
right doses of the molecule to be used in combination with
chemotherapeutic drugs, a company statement said.
India, Norway to Collaborate in
Promoting Human Vaccination Research
Projects
May 11, 2009 PHARMABIZ
http://www.pharmabiz.com/article/search.asp
The Department of Biotechnology (DBT) and the Research
Council of Norway (RCN) will collaborate to promote
research in the field of human vaccination through joint
projects, spanning for three years, as part of the
programme for global health and vaccination research.
The programme, carrying a total fund of 10.5 million
dollars, will aim at strengthening and expanding research
that can contribute to sustainable improvements in health
in low and middle-income countries. This will include
development of knowledge and tools to combat the major
Organisation of Pharmaceutical Producers of India
Pharma Spectrum
disease burden in these countries and strengthening
international collaborations.
Ranbaxy Close to Completing Trials for
New Malaria Drug
May 5, 2009, Hindu Business Line
http://www.thehindubusinessline.com/2009/05/05/storie
s/2009050551830100.htm
Ranbaxy Laboratories Ltd on Monday announced the
commencement of the third phase clinical trials for its
new anti-malaria combination drug in India, Bangladesh
and Thailand. The drug, Arterolane maleate + Piperaquine
phosphate, is targeted at patients in developing countries
with the aim of significantly improving upon the
conventional options available for the treatment of
malaria.
According to Dr Sudershan Arora, President-R&D
(Generics, NDDS, Clinical & Drug Development), Ranbaxy,
the company will strive to successfully complete the trial
and apply for marketing authorisation by late 2010.
Mergers &
Acquisitions /
Collaborations
Malvinder Singh Steps Down, Sobti New
Ranbaxy CEO
May 25, 2009, Financial Express
http://www.financialexpress.com/news/malvinder-singh-
steps-down-sobti-new-ranbaxy-ceo/465223/
Nearly a year after selling his family’s entire 35% stake in
the country’s largest drug manufacturer, Ranbaxy
Laboratories Ltd, to Japanese firm Daiichi Sankyo,
Malvinder Singh on Sunday stepped down as the company’s
chairman, CEO and managing director. Daiichi Sankyo
director and Ranbaxy board member, Tsutomu Une, has
been appointed as the executive chairman of the company
while, Atul Sobti, the current COO has been appointed the
new CEO. The changes were announced after the
company’s board meeting on Sunday.
With this the Singh family’s association with the company,
which his grandfather Bhai Mohan Singh founded in 1961,
comes to an end. Singh had joined Ranbaxy in 1998 and
became CEO in 2006.
22

Ranbaxy Acquires Skin Care, Lifestyle
Range
May 22, 2009, Business Standard
Ranbaxy Laboratories, the second largest drug company in
India in terms of market share after Cipla, has acquired
the entire range of skin care and lifestyle products of
Ochoa Laboratories, a small to medium sized
manufacturer located on the outskirts of New Delhi.
The Company did not disclose the terms of the
transaction. Sources said Ranbaxy acquired about 80
products of Ochoa Laboratories and many are established
brands in the domestic market.
Elder Health Care Looks at Buying Two
Indian Brands
April 25, 2009, The Economic Times
http://economictimes.indiatimes.com/News/News-By-
Industry/Cons-Products/FMCG/Elder-Health-Care-looks-at-
buying-two-Indian-brands/articleshow/4446127.cms
Elder Health Care, the FMCG arm of the Rs 560-crore
pharma major Elder Group, is evaluating two Indian
brands for acquisition. The two potential targets are in
the areas of oral care and body care, and will help Elder
consolidate its presence in the personal care segment.
Elder expects to close each of the deals at a valuation of
Rs 5-10 crore.
The company wants to complete the acquisitions soon as it
wants to capitalise on the present moment, when
valuations are low. “We are looking at acquisitions to
consolidate our presence in the personal care segment.
We soon plan to appoint a merchant banker for reviewing
the deals,” Elder Health Care managing director Anuj
Saxena told ET.
Pricing
Pharma Industry to Oppose Price
Control
May 24, 2009, Financial Chronicle
http://www.mydigitalfc.com/economy/pharma-industry-
oppose-price-control-932
The pharmaceutical industry has upped the ante against
the move to put 356 medicines under price control. The
industry is also pushing for early passage of the proposed
legislations on clinical trials and biotech.
The pharma industry is hoping that the new government
would rescind the proposal of earlier incumbent Ram Vilas
Paswan to bring back pricing controls on the sector.
Organisation of Pharmaceutical Producers of India
Pharma Spectrum
Paswan lost the Hajipur seat in Lok Sabha elections. The
industry feels that the government needs to focus on
bigger problems such as availability of drugs in remote
areas rather than pressuring companies to cut down on
margins. “There are more than 10,000 pharma firms in
India and for every branded drug there are at least 80-100
cheaper alternatives available. Pricing is not an issue here
as cheap drugs are available, so the government has to do
away with these proposals,” AV Dangi, president and chief
executive officer at Danssen Consulting (a consultancy
firm specialising in pharmaceuticals, life sciences and
healthcare) said.
Cancer Drugs May Come Under NPPA
Lens
May 20, 2009, The Economic Times
http://www.immservices.net:80/view/view_clip.php?vid=
1480514&cnm=T3IxOTk1NjE2MzAw
Cancer drugs may soon come under the purview of India’s
drug price regulatory, as they have become too expensive
for the common man to afford, according to Drug
Controller General of India (DCGI), Mr. Surinder Singh.
The move could hurt the margins of multinational
companies, such as Sanofi-Aventis, Pfizer, Roche,
GlaxoSmithKline and Eli Lilly, who enjoy a near monopoly
in the category, also populated by Indian Drug makers Dr.
Reddy’s, Natco and Dabur.
Mr. Singh told ET on Tuesday that he has recommended
that cancer drugs be brought under the National
Pharmaceutical Pricing Authority (NPPA). “As the DCGI, I
have outlined the technical inputs and rationale, behind
the suggestion for the inclusion of new drugs. Cancer
drugs, in particular, should be included, since they are
expensive and beyond the means of the common man,” he
said. A final decision on this will have to be taken by the
department of pharmaceuticals. According to a Pharma
analyst, oncology is still a small segment for Indian firms,
but they have a number of products in the pipeline over
the next two to three years.
Anti-Asthma Drugs to be 90% Cheaper
May 11, 2009, Financial Chronicle
http://www.mydigitalfc.com/news/anti-asthma-drugs-be-
90-cheaper-748
ANTI-ASTHMA medicines are expected to cost less than a
tenth of their prices now after the regulator, the National
Pharmaceutical Pricing Authority (NPPA), brought the bulk
drug, doxofylline, under price control. Ranbaxy and Dr
Reddy’s Laboratories (DRL) are among over a dozen
companies that produce these medicines. NPPA found that
doxofylline is a derivative of theophylline, which was
already under price control.
Brands of medicines produced from the bulk drug include
Synasma (Ranbaxy), Doxobid (Dr Reddy’s), Doxflo (Lupin),
23

Zordox (Cipla) and Doxolin (German Remedies). Prices of
all these will drop sharply to just Rs 5.74 per strip of 10
tablets. This is just a fraction of the Rs 78 that Dr Reddy’s
now charges for Doxobid (400 mg) and Rs 75 Ranbaxy
charges for Synasma. An NPPA official told Financial
Chronicle that there was no point controlling theophylline
and not doxofylline.“The companies were making use of
the loophole,” he said.
NPPA Fixes, Revises Prices of 296
Formulations
May 6, 2009, Pharmabiz
http://www.pharmabiz.com/article/detnews.asp?articleid
=20815&sectionid=19
The National Pharmaceutical Pricing Authority (NPPA) has
fixed or revised prices of 296 formulations, including nine
imported drugs from global majors like Pfizer, Aventis
Pharma, Novartis and Novo Nordic. And many of these
imported formulations went costlier, while a couple of
them registering a hike of over 12 per cent.
According to the notification issued by the NPPA, prices of
mono-component insulin formulations -- Lantus 100 IU/ML
catridge and Lantus 100IU/ML solostar -- imported by
Aventis Pharma were revised with the former one going up
by 12.83 per cent (up from Rs 481 to Rs 543.12 per 3ml
catridge). Three formulations by Pfizer Products India,
containing methyl prednisolone also became costlier.
Among them, price of Solu Medrol AOV 125mg was revised
from Rs 252.46 per 2ml vial to Rs 290.34, up by a
whopping 15 per cent.
Working of NPPA-CIFG at Chennai
Disappointing Even After 8 Months
May 5, 2009, Pharmabiz
http://www.pharmabiz.com/article/detnews.asp?articleid
=49554&sectionid=19
Working of the Centre for Information Facilitation and
Grievances (CIFG) at Chennai is disappointing as it is not
able to attract any major complaints on drug prices and
quality of products. The centre was set up by National
Pharmaceutical Pricing Authority with the help of a local
NGO a few weeks ago.
The NPPA has started a new initiative in six places across
the country, including Chennai, to disseminate
information on drug prices and their availability.
Cure Against Costly Drugs on Way
May 5, 2009, The Economic Times
The government is laying ground rules for negotiating drug
prices with multinational companies to ensure that costly
patented drugs are provided at 40-70% lower prices
Organisation of Pharmaceutical Producers of India
Pharma Spectrum
through the public health system, compared with those
prevailing in the private health care system.
This will ensure that patented drug sold in India – through
public as well as private health systems-will be at their
lowest international prices, said a government official who
asked not to be named.
NPPA Hikes Price of Rifampicin, Cut
Prices of Two Other Bulk Drugs
April 29, 2009, Pharmabiz
http://www.pharmabiz.com/article/detnews.asp?articleid
=49467&sectionid=19
The National Pharmaceutical Pricing Authority (NPPA) has
cut the prices of two bulk drugs including tolnaflate,
which became cheaper by around 40 per cent, and
increased the prices of two other bulk drugs.
The price of topical antifungal agent tolnaflate came
down from Rs 4121 to Rs 2500 per kg, as per a recent
notification by NPPA. The price was earlier fixed on
February 13, 2007. And the prices of a number of
formulations used to treat fungus and skin infections will
come down with the huge reduction in the bulk drug cost.
The price of glipizide, used in the anti-diabetic
therapeutic area, came down from Rs 29,244 to Rs 26,114
per kg. The price was revised almost after three years.
Drugs with Composition Change Need
Fresh Okay
April 27, 2009, The Economic Times
http://www.pressdisplay.com/pressdisplay/viewer.aspx#
DRUGMAKERS changing the composition of existing
formulations to escape price caps will now have to come
to the Centre for fresh approvals. In a move aimed at
keeping a check on companies, which replace price-
controlled ingredients with ones outside price control, the
Centre has directed state drug regulators not to allow
them to sell such drugs with their old brand names.
Instead, such drugs will be treated as new ones and the
companies will have to go through the Centre’s scrutiny
before it gets a fresh approval, a government official said.
The move is significant as companies are now likely to
think twice before they make any change in the existing
composition and approach the Centre for a fresh approval.
This would also mean that companies will have to
subscribe to a new brand name. The decision comes in the
wake of the National Pharmaceutical Pricing Authority
(NPPA) seeking action from the Drug Controller General of
India (DCGI) against companies that dodge price control by
tweaking ingredients of medicines and then misguide
consumers by retaining the original brand name. “We have
been receiving cases from NPPA for some time now where
companies have altered the composition and retained the
brand names. This amounts to misleading consumers. We
24

have, therefore, asked all state drug regulators to treat
such drugs as new drugs and not give approvals to sell
under the same brand name,” DCGI Dr Surinder Singh told
ET.
Trade & Others
FAKE DRUGS
May 25, 2009, Financial Express
http://www.financialexpress.com/news/Fake-
drugs/465221/
Much to the chagrin of the Indian pharmaceutical industry
and patients alike, fake drugs are everywhere. Successful
brands are being faked and sold on an unprecedented
scale in India. So much so that fake allopathic as well as
homeopathic medicines are estimated to occupy between
15 to 20% of the Rs 40,000 crore Indian pharmaceutical
market.
Originally, fake drugs were confined to lifestyle drugs such
as Viagra or conventional medications for cold, cough and
fever. Nowadays, they have made a smooth transition to
lifesaving drugs as well. Their presence spans across a
wide spectrum—AIDS/HIV therapy, antibiotics, insulin,
cholesterol drugs, hormone replacement therapy, cancer
drugs and many more.
Drug Inspector in Pondicherry Pulled Up
for Not Clearing Drug License
Applications for 2 Yrs
May 23, 2009, Pharmabiz
http://www.pharmabiz.com/article/detnews.asp?articleid
=49863&sectionid=19
Director of Medical Services in the Union Territory of
Pondicherry has issued a show cause notice to a drug
inspector at the General Hospital at Karaikal for not acting
on several applications for drug licenses submitted to him
by traders.
The action was taken after receiving complaints from
Chemists and Druggists of Karaikal in Pondicherry. In the
complaint, chemists said that the official was keeping
many applications for licenses in his custody for more than
two years without recommending them to the Directorate
of Drugs Control. The director has asked the drug
inspector to explain the cause of this delinquency in ten
days.
Jan Aushadhi Stores Make Progress,
Average Weekly Sales at Rs 64,552
May 18, Pharmabiz
Organisation of Pharmaceutical Producers of India
Pharma Spectrum
http://www.pharmabiz.com/article/detnews.asp?articleid
=49766
The seven generic drug stores under the Jan Aushadhi
Scheme, launched by the Department of Pharmaceuticals
to ensure quality medicines at affordable prices, has
reported an average weekly sales worth Rs 64,552 from
the time of their launch, according to the latest report.
The report, published by the Dept of Pharmaceuticals
lately, takes an account on the performance of the Jan
Aushadhi stores for 23 consecutive weeks from November
25, 2008 to May 3, 2009. According to the report, the first
Jan Aushadhi store set up in Amritsar in November 25,
2008 has reported average weekly sales of Rs 38,859 in 23
weeks. The drug store at Gurgaon set up 11 weeks ago has
sold Rs 7,449 worth drugs even as the 10-week-old Mohali
and Panchkula stores dispensed Rs 7,180 and Rs 9,094
worth drugs, respectively, average in a week.
Jan Aushadhi Stores Cause Credibility
Crisis for Pharma Traders
May 14, 2009, Pharmabiz
http://www.google.co.in/search?hl=en&q=Jan+Aushadhi+s
tores+cause+credibility+crisis+for+pharma+traders&btnG=S
earch&meta=&aq=f&oq=
Pharmaceutical traders are asking the government to fix
trade margins for the generics-generic products in the
country to ensure uniformity in prices in the market place.
The demand has come in the wake of the government plan
to sell unbranded generic products through Jan Aushadhi
stores at lower prices than market rates. Traders fear that
the government move will affect the credibility of the
local chemists in the minds of consumers.
Currently, the unbranded generic drugs which are not
promoted ethically and sold by the chemist over the
counter, does not have any fixed margin for the trader
and are sold at different prices. Many of the products are
sold at lower prices than the branded product of the same
drug. The products, which are not having any promotional
costs, are also priced high although their manufacturing
costs are much low.
Banned From Chemists, Tamiflu Goes at
Rs 2,000 for 10 Tablets
May 6, 2009, Express Newsline
http://www.expressindia.com/latest-news/banned-from-
chemists-tamiflu-goes-at-rs-2-000-for-10-tablets/455009/
The government may have banned the distribution of
Tamiflu and Relenza, two options available to battle the
H1N1 influenza (or swine flu), but chemists say they are
running out of stock despite selling Tamiflu at Rs 2,000 for
10 tablets.
The enterprising chemist who arranged the drug for
Newsline, despite a ban on procurement and sale through
25

private channels, said with a touch of pride: “We have got
scores of calls for Tamiflu since morning. We will ask for
fresh stock tomorrow.”
GSK Winds Up Actifed Range of Cough
Drugs
May 2, 2009, The Economic Times
GlaxoSmithKline Pharmaceuticals (GSK) India has stopped
manufacturing its cold and cough drugs sold under the
brand name Actifed and Actifed Plus after it was found
that some people were illegally extracting
pseudoephedrine, a narcotic chemical, from the medicines
to sell overseas.
In January, the Mumbai wing of India’s Food and Drugs
Administration (FDA) busted a racket which included two
GSK officials, who used to extract pseudoephedrine and
sell it overseas. The FDA officials reportedly seized
Actified and Actified Plus tablets worth Rs 67 lakh during
the raid.
Local Drug Cos May Chip in to Treat
Swine Flu
April 28, 2009, The Economic Times
http://economictimes.indiatimes.com/News/News-By-
Industry/Healthcare--Biotech/Pharmaceuticals/Local-
drug-cos-may-chip-in-to-treat-swine-
flu/articleshow/4457204.cms
The swine flu outbreak, classified by the World Health
Organisation as a “public health emergency of
international concern”, may see Indian drug makers
pitching in with the generic version of the antiviral
Tamiflu as the world looks for quick, affordable options to
counter the infection.
“We have already received proposals from people on
behalf of countries in Latin America, Mexico and Israel.
We have the capability to supply 1.5 million dosages of
the drug within 4-6 weeks,” said Amar Lulla, joint MD,
Cipla.
Wholesalers Suspend Drug Supplies to
Apollo Pharmacy for Unhealthy Trade
Practice
April 28, 2009, Pharmabiz
http://www.pharmabiz.com/article/detnews.asp?articleid
=49446&sectionid=22
Pharmaceutical wholesalers have suspended medicine
supplies to more than 100 Apollo Pharmacy shops in
Mumbai and Thane in protest against the unhealthy trade
practices indulged in by the Apollo stores. Apollo
Pharmacy is the largest pharmacy chain in the country
Organisation of Pharmaceutical Producers of India
Pharma Spectrum
with over 300 outlets spread over 17 states across India. It
has been offering 10 per cent discount to its customers
under the loyalty programme.
Pharmaceutical Wholesalers Association (PWA) president
Dilip Mehta said that the wholesale dealers are agitated
over the unhealthy practice of offering 10 per cent
discount on medicines by the Apollo Pharmacy chains in
Mumbai. There are more than 100 Apollo pharmacy shops
in Mumbai and retail traders in the surrounding vicinity of
these Apollo Pharmacy shops are getting adversely
affected by this unhealthy trade practice, he said.
Sales Promotion Staff of Organon,
Fulford Protest against Unfair Labour
Practices
April 28, 2009, Pharmabiz
http://www.pharmabiz.com/article/detnews.asp?articleid
=49444&sectionid=5
About 700 sales promotion employees of Organon India
Limited and Fulford India Limited struck work nationally in
the first week of April, in protest against the Companies'
violation of certain provisions of Sales Promotion
Employees Act, 1976. Both these companies are now under
the control of Schering-Plough Corp of the US.
Secretary of the Federation of Medical and Sales
Representatives' Associations of India (FMRAI) Tamil Nadu
branch said the field work of these two companies had
paralyzed in India on that day. In Tamil Nadu these
companies have 70 sales promotion employees. Their
Union is affiliated to FMRAI.
Biotechnology
Indian Pharma Cos Upbeat on
Biogenerics
May 8, 2009, Business Standard
http://www.business-standard.com/india/news/indian-
pharma-cos-upbeatbiogenerics/357461/
Even as the substitutability of biogeneric or biosimilar
medicines with their original patented counterparts
continues to be a matter of debate world over, Indian
drug companies, which have introduced biogeneric
products or copies of biotechnology drugs in the country,
are bullish over the marketing prospects of “biogenerics"
after patents expire in developed markets. Companies
such as Dr Reddy’s, Biocon, Reliance Life Sciences and
Ranbaxy etc. are all in the process of strengthening their
biogeneric portfolio to cater to future global demand.
“The biogeneric market in India is pegged at Rs 600 crore,
while the US and EU market for biosimilars is estimated to
26

reach $ 21 billion by 2015”, said KV Subramaniam,
president and CEO, Reliance Life Sciences (RLS). RLS
launched three biosimilars - ReliPoietin (Erythropoietin
(EPO), ReliGrast (Granulocyte Colony Stimulating Factor
(G-CSF), and ReliFeron (Interferon Alpha 2b) in the
domestic market in 2008 and is working on a range of
biosimilars, which are at different stages of development
viz clinical trials, pre-clinical studies, process
development and molecular biology.
INDUSTRIAL BIOTECHNOLOGY:
Drug Making Made Easier
April 30, 2009, Pharmabiz
Industrial biotechnology (IB), the third wave of
biotechnology, uses biological systems for the production
of chemicals, materials and energy. This technology is
mainly based on biocatalysis (the use of enzymes to
catalyse chemical reactions) and fermentation technology
(directed use of microorganisms), in combination with
molecular genetics, enzyme engineering and metabolic
engineering. It enables to bring down (reduce) material
and energy consumption, as well as pollution and waste
generation for the same level of industrial production.
Technologies include the use of plants and enzymes to
generate industrial products.
Currently, IB exhibits the maximum extent of penetration
in the pharmaceutical sector (15 per cent). New
technologies have proven to be a boon for the
pharmaceutical industry in the use of better biological
production methods. Since the pharmaceutical products
are of high value, added inputs in research and
development (R&D) can easily be recovered. The
pharmaceutical sector is thus proving to be the model for
the industrial development of biotechnology.
ABLE to Address Issues of Bio-Similar
Regulations, VC Funding: Dr. Vidyasagar
April 28, 2009, Pharmabiz
http://www.pharmabiz.com/article/detnews.asp?articleid
=49445&sectionid=3
Association of Biotechnology Led Entrepreneurs (ABLE) is
concerned about the regulatory environment existing for
bio-similars in the country. Inadequate venture funding to
this sector is yet another disincentive.
The regulations governing bio-similars impose high barriers
for Indian companies. "We need to make sure, by lobbying
both Indian and foreign governments to ensure that these
barriers are lowered", Dr. M Vidyasagar, president
Association of Biotechnology Led Entrepreneurs and
executive vice president, Tata Consultancy Services told
Pharmabiz in an email interaction.
Organisation of Pharmaceutical Producers of India
Pharma Spectrum
Indian Pharma-Biotech R&D
Consolidating & Downsizing to Maintain
Productivity: Expert
April 27, 2009, Pharmabiz
The pharmaceutical and biotechnology industry is in the
process of consolidating and down-sizing while trying to
maintain R&D productivity. Small and medium-sized
companies are trying to make the most of available
opportunities in niche segments.
While we see an extremely cautious approach to new R&D
spending plans, the silver lining for Indian companies
providing research services to big pharma is that the
emphasis on controlling costs is leading to an increasing
number of proposal requests, Dr Shoibal Mukherjee, senior
vice president - Clinical Development, GVK Biosciences
Private Limited told Pharmabiz in an email interaction.
New Appointments
Mr. Om Prakash, New Member
Secretary, NPPA
The Appointment Committee of the Cabinet has approved
the proposal to appoint Mr. Om Prakash, CSS (77)as
Member Secretary, in the National Pharmaceutical Pricing
Authority (Joint Secretary level) under the Department of
Pharmaceuticals. He has worked with the Ministries of
Environment & Forests, Department of Industrial Policy &
Promotion and Finance. Before his appointment as MS,
NPPA, he was holding the post of Director, Department of
Expenditure, Ministry of Finance.
Ms Aparna Sharma, Has Been Given
Additional Director, Department of
Health, Ministry of Health & Family
Welfare,
Ms Aparna Sharma, Director, Department of Health,
Ministry of Health & Family Welfare, has been given
additional charge of Food and Drugs, which was earlier
handled by Mr. A M Prasad, Director, who has been
promoted as Joint Secretary. She will continue holding this
additional portfolio till the time a full time Director is
appointed.
27

Mr. N N Prasad Appointed as Chief of
Staff to WIPO DG
May 6, 2009, Spicy IP
http://spicyipindia.blogspot.com/2009/05/nn-prasad-
appointed-as-chief-of-staff.html
In a momentous development for India, NN Prasad, Joint
Secretary at the DIPP (Department of Industrial Policy and
Promotion, Ministry of Commerce) has been selected as
the Chef De Cabinet to the Director General of WIPO, Dr.
Francis Gurry. This is a very high profile appointment, as
the post of Chef De Cabinet is akin to the Principal
Secretary to the Prime Minister of India.
As many of you may be aware, NN Prasad has been
instrumental in changing the face of Indian IP
administration. And more importantly, in increasing the
influence that India has on the international IP arena.
Under his stewardship, India has carved out a nice for
itself as a balancer of sorts at international negotiations
involving the developed and the developing world.
Illustratively, India hosted a development agenda meeting
in 2006, where Prasad played a key role in getting the two
sides to agree on common themes. Naturally, this is all
very close to the middle path approach that this blog has
been advocating for a while now.
Dr. Eswara Reddy Takes Charge as
Deputy Drugs Controller (NZ)
April 30, 2009, IDMA Bulletin
Dr. S. Eswara Reddy, M. Ph, Ph.D has taken charge as
Deputy Drugs Controller, North Zone, and Ghaziabad. He
was Drugs Inspector in West Zone, Mumbai for over 10
years. He has also been given some additional
responsibilities at FDA Bhavan, New Delhi. Dr. Reddy has
been awarded as the ‘Best Drugs Inspector’ in 2005 by All
India Drugs Control Officers Confederation. He has been
associated with IDMA and has actively participated in our
Seminars and Conferences such as IDMA-APPA PAC. He has
been involved in GMP, GLP and GCP inspections. He has
published papers in journals including Indian Drugs.
OPPI Related News
When we Think Of Pharmaceutical and
Biotechnology Industry One Issue that
Comes to Our Mind is Patent Protection.
How Are Companies Coping with
Evolving Patent Laws? Ms. Suja Nair
Reports…….
May 16, 2009, Express Pharma
Organisation of Pharmaceutical Producers of India
Pharma Spectrum
Is Protectionism a matter? ………
In both cases, the ruling was against the MNCs and in
favour of generic companies. Both cases have been high-
profile cases where landmark decision was given. Is this a
show or protectionism on the part of Indian Judicial
system towards generics?
Expressing his views, Mr. Tapan Ray, Director General,
OPPI, opines, “In its current form the patent laws
appear to be somewhat protective in nature towards
the domestic generic companies. Absence of data
protection and less than adequate patent enforcement
mechanism within the country will bear testimony to this
fact. Probably because of all such reasons, in the Pharma
space, India is attracting much lesser foreign direct
investments than China, in the post IPR regime.”
It seems that at present India needs a robust enough
patent management systems and procedures within the
country, for the countries own interest. Such world class
patent management systems will be able to protect the
long term interest of the innovators of India and not just
for the acceptability by the West. Ray points out.
Take on patent law in India………
Mr. Tapan Ray informs, “The patent management
strategies in our country are evolving and may be for that
reason, are not robust enough, as yet. When we compare
India with China, it can be noticed that there is still some
work needed to be done. For instance there is a big gap
within the patent management system which undoubtedly
shows the absence of regulatory data protection.
Dept of Pharma to Organise
International Meet on Pharma Industry
in Mumbai in Nov.
May 16, 2009, Pharmabiz
The Department of Pharmaceuticals, in association with
FICCI and other pharma organisations, is organising an
international conference on pharmaceuticals in Mumbai on
November 30, ahead of the proposed CHI happening from
next day, to showcase strength of Indian companies.
A meeting, called by Pharma secretary Ashok Kumar
recently, decided to organise the event in a bid to lure
the big traders from the developed countries and thereby
giving a fillip to the exports from the country by
showcasing the strengths of the domestic industry. The
meeting was attended by joint secretary Arun Jha, deputy
secretary Paresh Johri, representatives from organisations
like SPIC, IDMA, BDMA and OPPI, experts from UNIDO,
Pharmexcil and CPhI organisers to chalk out the detailed
plan for the event.
28
 Pharma Spectrum

OPPI Calls Meeting of Pharma Bodies on

May 12 to Evolve Code of Ethics for OPPI Forthcoming
Marketing
May 4, 2009, Pharmabiz
http://www.pharmabiz.com/article/detnews.asp?articleid
Events
=49518&sectionid=43
OPPI Seminars:
As desired by the Department of Pharmaceuticals, the
Organisation of Pharmaceutical Producers of India (OPPI) • HRD Seminar on “HRx: Adopt, Align,
will hold a brainstorming session in Mumbai on May 12 with Deliver” on 16th June, 2009, Mumbai
other pharma associations to evolve a joint code of ethics
for the industry in a bid to curb the growing unethical • Technical Seminar on “Consumer Safety
trade practices. Through Anti-Counterfeiting Technologies
The joint meeting is expected to be attended by different on 3rd July, 2009
organisations representing small and large pharma sectors • Annual General Meeting on Saturday, 8th
and it will work out a common code of ethics to be
submitted to the department for final clearance and August, 2009, at ‘Ball Room’ The ITC
implementation with a view to reign on the sales Grand Central, Parel, Mumbai 400 012.
promotions and increasing unethical practices like
inducing doctors, sources said. Invitations have been sent
to all the concerned associations.

The department wanted the associations to bridle own

members and warned that the department would
intervene if the organisations failed to do so. Two
meetings were already held by pharma secretary Ashok
Kumar with the pharma associations and finally entrusted
the job of compiling the common code with OPPI which
was one of the pioneers to introduce guidelines to its
members

DCGI, Ranga Iyer, Anji Reddy Among 40

Most Powerful Pharma People
April 30, 2009, Pharmabiz
http://www.pharmabiz.com/article/detnews.asp?articleid
=49490&sectionid=17

DCGI Dr Surinder Singh, OPPI President Ranga Iyer, and

Reddy's Laboratories chairman Dr Anji Reddy have been
selected as among the 40 most influential personalities of
the global pharma industry by the World Pharmaceutical
Frontiers.

The annual list of 2009, judged by their contributions to

the pharma industry, is led by US president Barak Obama.
It also has some other well-known names like Bill and
Melinda Gates, former US president Bill Clinton, WHO
director general Margaret Chan among others including
the heads of a number of global pharma majors. But there
are only a very few from Asian region and all the three
Indians in the list have made it this time as new entrants,
while many of others were there in the previous list also.

Organisation of Pharmaceutical Producers of India 29