This summary provides the key details from the document in 3 sentences: The document is an index from the July 2012 issue of Pharma Spectrum, which reports on news in the pharmaceutical industry. It covers topics such as international and domestic regulatory issues, new products, mergers and acquisitions, pricing, and appointments. The index lists over 10 stories in each of the international and domestic sections covering a range of pharmaceutical industry topics from that month.

1. Pharma Spectrum
Organisation of Pharmaceutical Producers of India
Volume 5 Issue 7 July 2012
INDEX
INTERNATIONAL
1. IPR 1
2. Regulatory 2
3. New Products 3
4. R&D / Clinical Trials 4
5. Mergers & Acquisitions / Collaborations 5
6. Pricing 6
7. Trade & Others 7
8. Biotechnology 10
9. Medical Diagnostics / Devices 10
10. New Appointments 10
DOMESTIC
1. IPR 10
2. Regulatory 11
3. New Products 14
4. R&D / Clinical Trials 14
5. Mergers & Acquisitions / Collaborations 16
6. Pricing 18
7. Trade & Others 19
8. Biotechnology 22
9 Medical Diagnostics / Devices 23
10. New Appointments 24
11. OPPI Related News 24
Organisation of Pharmaceutical Producers of India 0

2. Pharma Spectrum
International But as EvaluatePharma reminds us in its latest World
Preview report, released at this week's BIO conference,
2012 is far from the end of pharma's patent woes. Next
IPR year provides something of a respite, with only $29
billion's worth of drugs losing exclusivity.
As Compulsory Licensing Spreads, Merck Loses A Patent Ruling On
Drugmakers Adapt Blockbuster Nasonex
June 22, 2012, Fierce Pharma June 18, 2012, Fierce Pharma
There is the concept associated with evolution that you Even as the clock is ticking down on the patent for its
must adapt or die. Now some experts are suggesting the super blockbuster Singulair, Merck got smacked Friday
same thing for drugmakers when it comes to the growing with a negative decision in its battle with genericmaker
threat of compulsory licensing. Now that China is Apotex over Merck's blockbuster Nasonex spray. A
following India into this realm, which allows countries to federal judge in New Jersey ruled against Merck, saying
essentially strip companies of patents if they deem it in Apotex's generic did not step on Merck's patent, then
the public interest, the tension among big drug separately ruled against Apotex, throwing out its claim
developers is rising. that Merck's patent on the nasal spray is invalid.
LiveMint quotes a research company in the U.K. saying Merck's general counsel Bruce Kuhlik tells Reuters it may
the research-oriented companies "will have to appeal the decision, while Merck spokesman Ron Rogers
restructure their business plans in emerging markets," to tells Bloomberg, "As far as we know, the FDA has not
compete. Strategies will include making their drugs approved Apotex's application. We do not expect generic
cheaper themselves in the countries where the threat of competition near-term." Apotex declined comment.
compulsory licensing exists and making sure they are
available to more poor patients to cut off the incentive China Now Carries A Big Compulsory-
to invoke the maneuver. Licensing Stick
June 11, 2012, Fierce Pharma
Big Pharma Firms May Learn To Live
With Compulsory Licensing Drugmakers can count compulsory licensing among the
June 22, 2012, Livemint new pitfalls of China's huge-and-growing drug market.
Thanks to amended intellectual property laws, the
With China amending its patent law on compulsory Chinese government can now force generic drugs onto
licensing soon after India granted the first such permit in the market before branded meds lose patent protection.
the country, innovator pharmaceutical firms that bank
on patent protection for growth are under pressure to China isn't alone in this, of course; India recently caused
revamp sourcing, distribution and pricing strategies, a dust-up by compelling Bayer to license its cancer drug
industry experts said. Nexavar to Natco Pharma, which promised to sell its
copycat version for $176 per month, compared with
“The research-oriented companies, which mostly focus Bayer's $5,600 monthly price.
on the patented technologies that give them an edge,
will have to restructure their business plans in emerging US Firm Sues Zydus Cadila Subsidary
markets now as local governments are taking all possible For Infringement Of Patents
measures to lower the healthcare cost,” said a London-
based life sciences partner at a global consultant.
June 12, 2012, Business Standard
A complaint for infringement of patents with regard to
Beware: Patent Losses To Climb Back drug for treatment of acne has been filed against Zydus
To $56B By 2015 Pharmaceuticals USA, Inc, a fully owned subsidiary of
June 20, 2012, Fierce Pharma Ahmedabad-based pharma major Cadila Healthcare Ltd
(Zydus Cadila) in a district court of US.
For years we've been anticipating 2012 as the steepest
patent cliff, the year when the world's biggest drugs This complaint petition has been filed by one Arizona-
would be slammed with generic competition. No doubt based Medicis Pharmaceutical Corporation (MPC). Zydus
about it, $67 billion in drug sales at risk from patent USA has been accused of seeking approval from the
expirations is a whopping big figure. United States Food and Drug Administration (FDA) to
commercially manufacture, use, and selling of a generic
Organisation of Pharmaceutical Producers of India 1

3. Pharma Spectrum
version of Solodyn minocycline hydrochloride and system of Swiss drug major Roche (ROG: SIX), the world’s
extended release tablets, before the drug’s patents biggest producer of cancer drugs.
which is with MPC, expires.
The EMA says this includes looking at whether the
China Amends Patent Law In Fight For deficiencies have an impact on the overall benefit-risk
profile for any of the products involved. However, it
Cheaper Drugs points out that there is at present no evidence of a
June 8, 2012, Moneycontrol.com negative impact for patients and, while the
investigations are being conducted, there is no need for
China has overhauled parts of its intellectual property patients or health care professionals to take any action.
laws to allow its drugmakers to make cheap copies of
medicines still under patent protection in a move likely US To Charge Fee On Generic Drug Sale
to unnerve foreign pharmaceutical companies. The
Chinese move comes within months of a similar move by Application
India to effectively end the monopoly on an expensive June 21, 2012, Business Standard
cancer drug made by Bayer AG by issuing its first so-
called "compulsory licence". All generic pharmaceutical companies, including Ranbaxy
Laboratories, Cipla, Dr Reddy’s Laboratories, Lupin,
Similar action by China will ring alarm bells in Big Glenmark and Torrent Pharma, might soon have to pay a
Pharma, since the country is a vital growth market at a fee to the US drug regulator when they seek its
time when sales in Western countries are flagging. The permission to sell their products there.
amended Chinese patent law allows Beijing to issue
compulsory licences to eligible companies to produce America is the world’s largest drug market. A Generic
generic versions of patented drugs during state Drug User Fee Act is on the way, to enable the US Food
emergencies, or unusual circumstances, or in the and Drugs Administration (FDA) to levy a user fee of
interests of the public. around $100,000 on each generic drug application filed
for approval, it is learnt. The new norms are likely to be
Cipla Losses Appeal In US Court For introduced from October.
Animal Healthcare Product FDA Panel Turns Thumbs Down On
June 8, 2012, The Economic Times
Sanofi's Anti-Clotting Drug
Drug firm Cipla today said it has lost an appeal in a US June 20, 2012, Fierce Biotech
court over a patent case against Merial Ltd regarding an
animal healthcare product. The company had moved the Sanofi's attempt to gain its first new drug approval in
US Court of Appeals in Washington against a ruling by two years experienced another setback today as a
District Court Georgia that held that the company's sales committee of external experts decisively voted against
of animal healthcare product, PetArmor Plus infringed a an OK for semuloparin, a treatment designed to prevent
patent held by Merial Ltd, a subsidiary of Sanofi-Aventis, blood clots among patients receiving chemotherapy.
and suspended sales of the product in the US.
The advisers concluded that Sanofi didn't proffer a clear
"Company has now received an order from the Federal picture of who would benefit from the treatment,
Circuit wherein it has affirmed the order of the District particularly worrying given their risk of bleeding. The 14
Court with two judges ruling against the company and to 1 landslide likely buried any remaining chance of a
one judge in favour of the company," Cipla said in a near-term approval for the treatment.
filing to BSE.
AstraZeneca’s Obesity Drug Study
Regulatory Stopped After Adverse Event
June 20, 2012, Fierce Biotech
EMA Investigating Deficiencies In Score one against AstraZeneca in the obesity drug game.
Safety reviewers called a stop to the London-based drug
Roche's Drug Safety Reporting giant's Phase I study of an experimental obesity
June 22, 2012, Pharma Letter treatment after a man on the injected drug became sick.
The European Medicines Agency revealed yesterday that The drug, code named AZD2820, is a peptide
it is working with national medicines agencies to melanocortin-4 receptor partial agonist from AZ's
investigate deficiencies in the medicine safety reporting collaboration with the Cranbury, NJ-based biotech
Palatin Technologies. The potential bad reaction hit one
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4. Pharma Spectrum
of the 72 obese men that AZ had planned to enroll in the international reference pricing system that links the
trial, and the man might have suffered from an allergic price of medicines in Germany to those in countries like
reaction to his first shot of the drug. Greece; and a medicines assessment system that links
the price of new medicines to generics.
US FDA Calls For More Efficacy Data On
Pfizer's Tafamidis NDA Following US Senate And House Pass Of
June 19, 2012, Pharma Letter FDA Reforms, Now Comes The Detail
June 5, 2012, Pharma Letter
The US Food and Drug Administration yesterday issued a
complete response letter regarding drugs behemoth Now that the US House of Representatives and the
Pfizer’s New Drug Application for tafamidis meglumine, Senate have passed HR 5651 and S 3187 (the FDA Safety
requesting the completion of a second efficacy study to and Innovation Act), respectively, focus will move to a
establish substantial evidence of effectiveness prior to conference committee, which will iron out differences
an approval. between the bills and reach a compromise, comments
Karl Karst on law firm Hyman, Phelps & McNamara’s FDA
The Agency has also asked for additional information on Law Blog.
the data within the current tafamidis NDA. Tafamidis is a
novel, investigational medication for the treatment of Both bills reauthorize and amend old (PDUFA and
transthyretin familial amyloid polyneuropathy (TTR-FAP) MDUFA) and establish new (GDUFA and BsUFA) user fee
in adult patients with symptomatic polyneuropathy to statutes, permanently reauthorize the Best
delay neurologic impairment. Pharmaceuticals for Children Act and the Pediatric
Research Equity Act, and create several new provisions
FDA Approves Glaxosmithkline's New of law, among other things, he notes.
Combo Vaccine MenHibrix
June 18, 2012, Pharma Letter
New Products
The US Food and Drug Administration has approved US
pharma giant GlaxoSmithKline’s MenHibrix
(meningococcal groups C and Y and Haemophilus b
Dr Reddy’s Laboratories Launches
tetanus toxoid conjugate vaccine), a combination Parkinson’s Drug In US
vaccine for infants and children aged six weeks through May 8, 2012, The Economic Times
18 months, for prevention of invasive disease caused by
Neisseria meningitidis serogroups C and Y and Dr Reddy's Laboratories has launched in the US market
Haemophilus influenzae type b. ropinirole hydrochloride XR (extended release) tablets
used to treat the signs and symptoms of Parkinson's
The basis for FDA approval of MenHibrix included data disease. Ropinirole hydrochloride XR tablets are the
GSK submitted from clinical trials conducted in the USA, bioequivalent generic version of Requip XL tablets, a
Mexico, Australia, Belgium and Germany over seven registered trademark of pharma giant SmithKline
years in which 7,521 infants and toddlers received at Beecham.
least one dose of MenHibrix.
The Indian company has obtained the approval of the
German Model For Assessment Of New United States Food and Drug Administration for its
abbreviated new drug application for ropinirole
Medicines Slammed By EU Pharma hydrochloride XR tablets to launch a generic product.
Leaders Requip XL had reported sales of around $58 million for
June 11, 2012, Pharma Letter the 12 months period ended March 2012 in the US market
according to IMS Health.
Leading pharmaceutical companies in Europe,
represented in the European Federation of Ranbaxy To Relaunch Bessling Brand
Pharmaceutical Industries and Associations (EFPIA), May 29, 2012, The Economic Times
meeting in Berlin last Friday, called on the German
government for urgent action to protect patient access Ranbaxy Laboratories has received US drug regulator's
to new medicines and ensure that Germany remains a approval to relaunch one of its best selling brand in the
home for pharmaceutical innovation. US after being banned for nearly four years. US Food and
Drug Administration (FDA) has approved Absorica, a
“Recent years have seen the introduction of a series of novel, patented brand formulation of isotretinoin that is
punitive measures in Germany. A 16% rebate; an used to treat acne.
Organisation of Pharmaceutical Producers of India 3

5. Pharma Spectrum
Health and Human Services during the bilateral meeting
The drug has been developed by its Canadian partner between India and the US.
Cipher Pharmaceuticals to whom Ranbaxy will pay
royalties on net sales of the drug, Ranbaxy said in a The primary aim of this collaboration is to initiate a
release. "Absorica will be the flagship brand for health research relationship between the two countries
Ranbaxy's specialized dermatology sales force," said to generate a better understanding of the molecular and
Ranbaxy's Americas senior VP and regional director biological mechanisms underlying diabetes, to
Venkat Krishnan said. characterize the genetic, social and environmental
determinants, and to identify innovative approaches for
improving prevention and treatment of diabetes.
R&D/Clinical Trials Hit By Red Tape, Clinical Trial
Companies Eye South-East Asia For
Global R&D Spending Rises 8.2% In Expansion
FY11 June 13, 2012, The Economic Times
June 22, 2012, Hindu Business Line
Pushed to the wall by an overly cautious drug regulator
Global R&D spending, after witnessing a decline in fiscal and an alarmist Indian government, clinical trial
2010, has grown by 8.2 per cent in FY2011, according to companies are looking at South East Asian countries to
a Zinnov study. India’s prominence as an R&D hub is expand their business and escape the red tape of Indian
growing with the likes of IBM, SAP, Oracle and others authorities.
setting up R&D centres and currently, 30 per cent of the
top 1000 R&D spenders across verticals have a presence Clinical research companies (CROs), that were aspiring
here. to become billion- dollar companies by 2010, had to
rework their plans after a Parliamentary Standing
This growth has been primarily driven by organisations in Committee report questioned the allegedly unfair and
the semiconductor, industrial and consumer hardware unethical trials conducted on Indian patients .
and electrical and electronic sectors.
Alzheimer’s Vaccine Trial Proves
Researchers At CCMB Make Successful
Breakthrough Discovery To Contain June 8, 2012, Zee News
Diabetes By Deactivating A Gene
June 21, 2012, Pharmabiz, A Raju Scientists have found a new vaccine to be effective
against Alzheimer’s disease. The vaccine, CAD106, can
A team of researchers at the Centre for Cellular and prove a breakthrough in the search for a cure for this
Molecular Biology (CCMD) in Hyderabad have come out seriously debilitating dementia disease. Alzheimer’s
with a major breakthrough discovery to contain diabetes disease is a complex neurological dementia disease that
by successfully deactivating a gene to regulate the is the cause of much human suffering and a great cost to
functioning of beta cells in pancreas. society.
The malfunction of these beta cells leads to non- According to the World Health Organisation, dementia is
production of insulin or production of ineffective insulin. the fastest growing global health epidemic of our age.
The research team conducted the experiments on the The prevailing hypothesis about its cause involves APP
mouse model. In this model, the researchers could (amyloid precursor protein), a protein that resides in the
successfully regulate the mass of beta cells in pancreas outer membrane of nerve cells and that, instead of being
of the mouse. broken down, form a harmful substance called beta-
amyloid, which accumulates as plaques and kills brain
cells.
India And US Sign Agreement On
Collaboration In Diabetes Research India, US To Begin Collaborative
June 19, 2012, The Economic Times
Research On Tuberculosis Soon
Indian and US have signed an agreement on collaboration June 5, 2012, PharmaBiz
in Diabetes Research. The agreement was signed
between Ghulam Nabi Azad, Union Minister for Health Even as tuberculosis (TB) continues to threaten the lives
and Family Welfare and Kathleen Sebelius, US Secretary, and wellbeing of thousands of people each year in India
and several other countries, India and the US will soon
Organisation of Pharmaceutical Producers of India 4

6. Pharma Spectrum
begin collaborative research on TB under the Indo-US The topical drug is a non-steroidal treatment in Phase II
vaccine action programme (VAP). development for psoriasis and atopic dermatitis,
Research Triangle Park, NC-based Stiefel said in a
The main aim of this initiative is to build and enhance statement. Welichem ($WBI.TSX), headquartered in
biomedical and clinical research capacity in India by Burnaby, British Columbia, has gathered safety and
establishing long term longitudinal cohorts of TB patients efficacy evidence on the drug...........
and their contacts (or other high TB risk patients) for
studies using state of the art research tools.
Zerhouni Trumpets New R&D Mindset Mergers &
At Sanofi
June 1, 2012, Fierce Biotech Acquisitions /
Sanofi has reorganized its research and development
over the past couple of years, and R&D chief Elias
Collaborations
Zerhouni offered up some insights about the new
mindset at the French drug giant. For example, the India, Norway To Extend Partnership In
company has emphasized a focus on results of clinical
programs over the scientific bureaucracy that has been
Healthcare Sector
implicated in the industry's lack of R&D productivity. June 21, 2012, The Economic Times
"The project is what matters, not people's titles,"
Zerhouni said, as quoted by Bloomberg. "The least India and Norway have decided to extend by five years
hierarchical the model is, the better." its partnership in healthcare sector after the success of
their joint efforts in delivering child and maternal health
services. At a meeting in Oslo on Monday between Health
Eli Lilly Opens Diabetes R&D Center In Secretary P K Pradhan and Norway's Secretary General
China from the Ministry of Foreign Affairs Bente Angell-Hansen
June 1, 2012, BioSpectrum Asia signed a letter of intent to initiate Phase II of the
Norway India Partnership Initiative (NIPI) on reducing
Eli Lilly officially opened the Lilly China Research and child and maternal mortality.
Development Center (LCRDC) on May 30, keeping with its
commitment towards China. The center will focus on NIPI is a partnership between India and Norway to
discovering innovative diabetes medicines with novel improve delivery of child and maternal health services in
mechanisms that can be tailored for the Chinese select states under the National Rural Health Mission
population to delay the progression of the disease. (NRHM). The partnership was initiated in 2006 by the
Prime Ministers of India and Norway Manmohan Singh and
Affecting nearly 90 million Chinese people, diabetes is a Jens Stoltenberg.
significant national public health problem, due in part to
longer life expectancies, dietary changes and a Piramal In Talk To Buy US Contract
sedentary lifestyle emerging in China. Differences in the
genetic makeup of Asian patients may also play a role in
Drug Maker Cambridge For $200 M
diabetes development and progression, and exploring June 16, 2012, Financial Express
these differences is a priority for the LCRDC.
Piramal Healthcare (PHL) is in talks to buy US contract
drug manufacturer Cambridge Major Laboratories (CML)
GSK Unit Stiefel Snags Rights To Skin for around $200 million, a person with direct knowledge
Drug For CAD$35M of the development said. “Early stage negotiations are
May 31, 2012, Fierce Biotech on and it will take a while to conclude the deal,” he
said.
Stiefel Laboratories has injected a new drug in mid-stage
development into its dermatology pipeline. The PHL is the flagship company of the Ajay Piramal-owned
company, a unit of GlaxoSmithKline, has ponied up Piramal Group while the Wisconsin-based unlisted CML
CAD$35 million ($33.9 million) in an upfront payment to makes pharmaceutical intermediates and active
Welichem Biotech for rights to an experimental anti- pharmaceutical ingredients (APIs) used in drugs.
inflammatory compound dubbed WBI-1001 for markets
outside of China, Taiwan, Macao and Hong Kong.
Organisation of Pharmaceutical Producers of India 5

7. Pharma Spectrum
GSK Unit To Buy Basilea Eczema Drug India Firm Shakes Up Cancer Drug
For $227m Market With Price Cuts
June 13, 2012, Financial Express (epaper June 16, 2012, The Economic Times
page 10)
Indian pharmaceutical tycoon Yusuf Hamied
GlaxoSmithK.ine is to buy Basilea’s new eczema drug revolutionised AIDS treatment more than a decade ago
Toctino for an initial 146 million pounds ($227 million) to by supplying cut-price drugs to the world's poor -- and
boost its Stiefel dermatology business, the two now he wants to do the same for cancer. Hamied,
companies said on Thursday. The Swiss biotech company chairman of generic drugs giant Cipla, last month slashed
is also entitled to further payments of up to 50 million the cost of three medicines to fight brain, kidney and
pounds if the drug is approved in the United States, as lung cancer in India, making the drugs up to more than
well as double-digit percentage payments o US sales four times cheaper.
begning three years after launch.
"I hope we'll cut prices of many more cancer drugs," he
told AFP, adding that he wants to supply the cheaper
Pricing drugs to Africa and elsewhere.
Drugmakers Warn German Pricing Is
Roche Slashes MabThera Price In S. Killing Innovation
Africa To Drive Sales June 14, 2012, Fierce Pharma
June 20, 2012, Fierce Pharma
As economies have wilted in Europe, Germany has been
Drugmakers are chafing under European price cuts. But all about austerity and how that is the only way to cure
more and more, they're cutting prices on their own in the E.U.'s financial woes. But the backlash from
the developing world. It's part of the strategy to increase drugmakers to German drug pricing has become so
emerging markets sales, a recognition of the fact that significant that, for its own consumers, drugmakers warn
developing countries, a., can't afford drugs at the prices the cure may be becoming worse than the disease.
charged in U.S. and Europe, and b., present very
different tactical challenges. Novartis pulled its blood pressure medication Rasilamlo
from the German market three months after introducing
Roche is the latest mover: The Swiss drugmaker has cut it to Germany. Eli Lilly simply bypassed Germany with its
the price on its MabThera cancer treatment by one-half launch of Trajenta, the diabetes drug it's launching in
in South Africa. The move will immediately increase Europe with Boehringer Ingelheim.
volume, Business Day says. The government hasn't been
able to afford routine use of the pricey drug, which MNCs Get Flexibility In Transfer
treats lymphoma, leukemia and rheumatoid arthritis. Pricing; Move Will Dispel Fear Among
Now, more patients can get it.
Foreign Companies
Pharma Herd Faces Hurdles With June 11, 2012, The Economic Times
Pricey New Drugs The government has allowed multinationals flexibility in
June 20, 2012, Fierce Pharma valuing their transfer of intangibles such as brand to
their Indian subsidiaries without any fear of the tax
There was a time when specialty care drugs for diseases department. The government hopes it will dispel the
such as multiple sclerosis, cancer and rare genetic fears that India was gunning for foreign companies after
disorders flew under the radar of payers, as the it changed income tax law retrospectively and
treatments gobbled up a modest piece of the overall announced tough tax avoidance rules.
prescription-drug spending pie.
The new rule will allow multinationals to use any arms-
That time is over. With drugmakers flocking to these length methodology to value intangibles such as brand
lucrative drug markets, the bar has risen to get name, goodwill, and dealer network that are transferred
reimbursement and physician uptake of the expensive to their Indian subsidiary, withdrawing any discretion to
products. But there are ways to hedge bets in the the tax officer to question the value so determined.
specialty care game.
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8. Pharma Spectrum
U.K. Pharma Balks At Value-Based Trade Organisation, resisting attempts by the US, Japan
and some other developed countries to club counterfeits
Pricing Ideas or copies of patented drugs with fake or spurious ones.
June 7, 2012, Fierce Pharma
"The cases of seizure of high quality generic or off-
Drugmakers are squaring off against the U.K.'s price- patent drugs by third countries that hold patents for
setting proposals. As Britain approaches its new value- these could gain legitimacy if counterfeits are confused
based pricing system--set to come into effect in 2014--an with fakes," an Indian official told ET. "We cannot allow
industry association warns that the government's… this as it could seriously hinder access to cheap drugs by
the poor."
ACTA Will Make Life Saving Drugs
Costlier For The Poor Anti-Overtime Ruling A Disguised
May 31, 2012, The Economic Times Blessing For Reps, Recruiters Say
June 21, 2012, Fierce Pharma
Joseph Munyi, a Kenyan citizen, has been living with HIV
for 8 years and, much like other HIV patients, is The Supreme Court denied pharma sales reps their
unemployed. He has been receiving his medication free overtime. But it may have saved many of their jobs--not
of charge on account of government programmes and to mention their bonuses, industry recruiters say. If the
outreach programmes of Medicine Sans Frontieres. His ruling had gone in the reps' favor, drugmakers would
medication comes in the form of generic drugs. have been on the hook for billions in back pay--and that
outlay could have triggered another round of salesforce
However, this situation may not last long as economic layoffs, Dow Jones reports.
interests of few may end up impeding many a public
spirited citizen of the world from executing her bounden The ruling came in GlaxoSmithKline's ($GSK) overtime
duty as a human to ameliorate the conditions of the case, and it likely saved the company hundreds of
underprivileged. millions, if not billions. Other companies with pending
suits would have faced similar liabilities. Plus, the ruling
would have inspired other reps to sue their companies
Trade & Others for back pay. Voilá, billions in immediate costs.
Indian Drug Outlook Favourable: ICRA
MSF Appeals European Nations Not To & Moody’s
Ratify Anti-Counterfeiting Trade June 21, 2012, The Economic Times
Agreement
June 25, 2012, Pharmabiz, Ramesh Shankar Outlook on the Indian pharmaceutical industry remains
favourable, says ICRA & Moody report released on
Even as the European Parliament is meeting in July to Wednesday. Domestic formulation market grew by 13-
give its final voting on the proposed Anti-Counterfeiting 16% per annum in last five years. According to the
Trade Agreement (ACTA), the international medical report, domestic formulation market size stood at Rs
humanitarian organization Médecins Sans Frontières 58,300 crore, ranked third in terms of volume and tenth
(MSF) has appealed to the contracting states not to sign in terms of value, globally.
and ratify the Agreement unless all concerns related to
access to medicines are fully addressed. The domestic growth was driven mainly by expansion in
volumes and new introductions. Lifestyle-related
Terming the Agreement as a 'Blank Cheque for Abuse', disorders are driving growth at faster pace in chronic
MSF said that the Agreement is flawed and should not be segments along with increasing healthcare spending.
accepted in its current form. Enlisting the concerns, the
international NGO said that ACTA is not restricted to Pfizer Expects To Wrap Up Prempro
trademark counterfeiting. Suits For $1.2B Total
June 19, 2012, Fierce Pharma
India, Brazil & China Defend Generic
Drugs At WTO The price tag Pfizer's Prempro settlements is now in. The
June 25, 2012, The Economic Times drugmaker has paid $896 million to wrap up about 60% of
the patient lawsuits, Bloomberg reports. That's about
India, Brazil and China have defended the right of poor 6,000 cases, all alleging that its hormone-replacement
countries to access cheap generic medicines at the World drugs caused breast cancer.
Organisation of Pharmaceutical Producers of India 7

9. Pharma Spectrum
Pfizer has also set aside more money--$330 million--to Australia’s PIC Reports To Ministers On
cover the rest of its Prempro liability. That's for about
4,000 suits still outstanding. Total: $1.226 billion for Treatment And Reimbursement Of
10,000 cases, or a little more than $120,000 per case, on Similar Biologics
average. June 14, 2012, Pharma Letter
Drug Export Up 27% At Rs 60,000 Crore The Australian Pharmaceuticals Industry Council (PIC),
In FY 12 with industry group members AusBiotech, Medicines
Australia and the GMiA (representing generic
June 19, 2012, The Economic Times drugmakers), has today reported to the federal
government on the preferred treatment of follow-on
India's exports of drugs, pharmaceutical & fine chemicals biologics for reimbursement.
grew 27% to Rs 60,000 crore for the year ended March
2012, according to data compiled by Pharmaceutical The PIC has been considering the issue of regulation of
Exports Council of India (Pharmexcil). The export figure similar biologic medicinal products (SBMPs) - also known
is now close to the size of the Indian formulations as biosimilars - and specifically their treatment for
market which currently stands at around Rs 62,000 crore, reimbursement, following a request by the former
which is growing at 15-20% annually. Minister for Health and Aging for the PIC to try to reach
a sector-wide consensus on a policy for managing the
However, the exports and the local formulations listing and pricing of biosimilars on the Pharmaceutical
numbers are not comparable as the exports data include Benefits Scheme (PBS).
sale of active pharmaceutical ingredients or basic raw
materials used to make drug. The revenues of the
domestic market takes into account only branded Drugstores Accuse Pfizer, Teva Of
finished medicines. Blocking Effexor Generics
June 14, 2012, Fierce Pharma
Takeda To Stop Selling 13 Pfizer Drugs
In Japan CVS Caremark and Rite Aid have signed on to the Effexor
XR conspiracy theory. In an antitrust lawsuit, the
June 16, 2012, Reuters drugstore chains allege that Pfizer's ($PFE) Wyeth unit
and Teva Pharmaceutical Industries ($TEVA) colluded to
Takeda Pharmaceutical Co, Japan's biggest drugmaker, delay generic versions of the blockbuster antidepressant.
said on Monday it will stop distributing 13 Pfizer Inc
drugs it now sells in Japan at the end of this year and As Reuters points out, it's just the latest accusation of
Pfizer itself will begin selling them from 2013. The 13 generic-blocking shenanigans boosting sales of Effexor
drugs include antibiotic Minomycin, anticancer agents XR, the extended-release version of venlafaxine. Back in
Torisel and Mylotarg, and depression treatment Amoxan. December, Walgreen, Kroger, Safeway, Supervalu and
The list did not include Viagra. HEB Grocery together filed a similar suit against the two
drugmakers. Both companies have denied the
Takeda said it will continue to distribute Prevenar, a allegations.
pneumococcus vaccine for children, and the haemophilia
B drug BeneFIX. It also said it and Pfizer will continue to
work together on the arthritis drug Enbrel. Indian Companies Eye $1billion
Generic Opportunity
Lipitor Generic’s Mkt Shrinks 96% In US June 13, 2012, The Times of India
On Over-Crowding
It's literally a billion-dollar opportunity. In the wake of
June 16, 2012, The Economic Times patent expiries on three blockbuster drugs over the last
six-seven months, an opportunity worth nearly $1.3
A higher-than-expected price erosion of cholesterol- billion is up for grabs for domestic generic players. With
lowering Lipitor, the world’s best selling drug, is set to three drugs - Lipitor, Zyprexa and more recently Plavix -
affect the earning of Indian drug makers Ranbaxy going off-patent, along with a sharp rupee depreciation,
Laboratories and Dr. Reddy’s. The market of a significant revenue upside has emerged for players like
atorvastatin, the generic version of Lipitor, shrunk 96% in Ranbaxy, Dr Reddy's and others.
the US on May 30-the first day after expiration of
Ranbaxy Laboratories’ 180 day marketing exclusivity – as Of this, Ranbaxy is believed to have mopped up an
several new players entered the market estimated $600-million revenue already from generic
Lipitor since it was launched in December last year,
analysts say.
Organisation of Pharmaceutical Producers of India 8

10. Pharma Spectrum
CRAMS Holds Big Opportunity For The mere passage of a law that requires drug companies
to disclose how much money they pay doctors may not
Indian Generic change physician prescribing practices, suggests a new
June 8, 2012, The Times of India study. In two states that passed so-called sunshine laws
requiring drugmakers to disclose payments, doctors'
A global study has resized worldwide market for contract choices of which drugs to prescribe for their patients did
research and development services, with pharmaceutical not differ much from those of peers in states without
industry increasing its reliance on outsourcing to such a law.
accelerate development of new medicines. A host of
domestic companies- Jubilant, Piramal, Divis Labs, However, since the disclosure of information was to
Quintiles, Biocon and Syngene- offering businesses like state agencies, not the general public, the state laws
manufacturing, custom research and clinical trials, are were less likely to influence doctors' behavior, one
trying to catch a piece of the action. expert not involved in the research noted. "It was a way
of doing a quick analysis to even see if there was an
India To Take Up With Brazil Issues impact we could measure," said Kavita Nair, the study's
senior author and a associate professor at University of
Faced By Pharma Cos Colorado School of Pharmacy in Aurora.
June 8, 2012, Hindu Business Line
WHO Will Set Generics Apart From
India will take up with Brazil the barriers faced by Indian
pharmaceutical companies, including procedural delays, Counterfeits
and the consequent increase in costs of exports. The June 4, 2012, DNA
procedural delays happen during inspections, clearances
and registration by the Brazilian authorities. World Health Organisation (WHO) has adopted a
resolution to clearly define counterfeit medical products
The issue is part of India's campaign in Latin America to (CMP) so as to set them apart from genuine generic
boost its pharma exports, including generic drugs, as the drugs. The resolution follows intense lobbying by India at
sector also faces similar non-tariff barriers in other Latin the World Health Assembly (WHA) last week and is seen
American countries. This will be high on the agenda at as a major diplomatic win.
the bilateral discussions during the June 9-15 visit to
Brazil by the Commerce Minister, Mr Anand Sharma, The country has worked through back-channel ways at
official sources said. the inter-governmental level for almost two years to
pressurise the international organisation. This also means
US Regulator Calls For Action On Fake WHO will limit its role to public health issues and not get
into the debate of intellectual property rights (IPR).....
Drugs
June 7, 2012, Financial Times Memos Show PhRMA, Pfizer Led Big
Laws to combat counterfeit drug trafficking are toothless Pharma Support For Healthcare Bill
and need to be toughened, Margaret Hamburg, June 1, 2012, Fierce Parma
commissioner of the US Food and Drug Administration,
said on Wednesday. In an interview with the Financial The cat is out of the bag so to speak with the disclosure
Times, Ms Hamburg said current penalties for peddling of memos today detailing the level of drug industry
fake prescription medicines were the same as those for support for passage of President Obama's prized
selling fake Gucci handbags and weaker than healthcare reform. It was never a secret that Big Pharma
punishments for people selling illicit drugs. came on board to support the legislation, but memos
released today by a Republican committee show that its
“We need legal authorities to give teeth to our actions,” key trade association PhRMA, led by Pfizer, elicited
Ms Hamburg said. “We are increasingly concerned that industry support and agreed to pay for advertising
this is becoming an attractive area for bad guys, campaigns to boost its chances of passage.
including organised crime.” Her remarks came after two
recent high-profile cases of fake drugs circulating In return, the administration agreed to stand in the way
through the US supply chain. of provisions the industry didn't like, Bloomberg reports.
The memos show that drugmakers were most concerned
Do Doctor-Payment Sunshine Laws about price controls from Medicare and the consumers
getting access to cheaper drugs in other countries.
Work?
June 5, 2012, Reuters
Organisation of Pharmaceutical Producers of India 9

11. Pharma Spectrum
US FDA May Impose Huge Drug User
Fee On Generic Imports Soon, India To New Appointments
Hit Badly
May 28, 2012, Pharmabiz, Suja Nair No Relevant News
Shirodkar
The US FDA may introduce a Generic Drug User Fee Act
(GDUFA) soon to curb import of cheap generic drugs into
that country. The proposed Act empowers the US
government to fix an exorbitant fee on the import of
each generic product category coming from any overseas
sources.
The US currently imports about 80 per cent of APIs and
Domestic
40 per cent of generics made in the overseas locations.
The US Food and Drug Administration (FDA) recently
completed and submitted its recommendations for the
IPR
proposed Generic Drug User Fee Act (GDUFA) to the
Congress. Nexavar Licence Does Not Violate
Trade Pact: Sharma
June 15, 2012, Indian Express
Biotechnology Commerce and Industry Minister Anand Sharma on
Thursday said that issuance of compulsory licence to
Abbott Stands Alone In Challenge To anti-cancer drug Nexavar by India is not violative of any
provision of multi-lateral trade agreement. “We have not
Biosimilars Law violated of any WTO agreement...this (invoking CL) is
June 22, 2012, Fierce Pharma very much in conformity with the international
agreement under the WTO,” Sharma said while
So far Abbott Laboratories is having to fly solo in its addressing industry leaders of the pharmaceutical
challenge to the legality of the biosimilar provision in sectors in Sao Paulo, Brazil.
the Affordable Healthcare Act. In a citizens petition filed
with the FDA in April, the biologicsmaker claimed that In March, Hyderabad-based Natco Pharma was allowed to
its rheumatoid arthritis drug Humira cannot be copied manufacture and sell cancer-treatment drug Nexavar at
because it would be illegal to require Abbott to cough up a price over 30 times lower than charged by patent-
the trade secrets that it has spent "massive amounts of holder Bayer Corporation, under compulsory licensing
money" to develop, The Wall Street Journal reports. (CL).
Further, it contends that no biologic drug approved
before passage of the law should be considered for
Patents: A Prize For Inventors Will
biosimilar approval. There has been plenty of opposition Help
from those groups that want to see consumers benefit June 2, 2012, Hindu Business Line
from cheaper biologic drugs coming to market sooner
and are concerned the challenge will hold up a new A potentially game-changing idea is that if an inventor is
market for biosimilars. rewarded with a huge cash award upfront in exchange
for his invention becoming available immediately for
public use, unseemly patent battles waged across
Medical Diagnostics continents will be a thing of past.
/ Devices
Patents are country-specific, so much so that a person
registering one in his home country has no choice but to
also register it in all the countries where the product or
process is likely to be used. Under WTO norms, dictated
No Relevant News by the powerful Western world, the patent-holder enjoys
monopoly rights over his invention for 20 years.
Organisation of Pharmaceutical Producers of India 10

12. Pharma Spectrum
Scientists Float Group To Protect medicines. The department of pharmaceuticals had set
up a committee on price negotiations of patented
Intellectual Rights medicines and there has been no substantial outcome on
June 2, 2012, Indian Express the committee,” the commerce ministry said in a note to
the group of ministers on pharma pricing policy.
Invoking the case of Binayak Sen, four senior scientists
have formed a pressure group of “elder scientists” that
will take up issues related to “rights of scientists and
other intellectual workers”. The group announced its Regulatory
formation in the latest issue of Current Science, jointly
published by the Indian Academy of Sciences and the
Current Science Association, and invited opinions.
We Will Prove The Poor Can Access
Healthcare: Dr Devi Prasad Shetty,
“Some time ago, when Binayak Sen, an eminent health Narayana Hrudayalaya
activist and vice-president of the People’s Union for Civil
Liberties, was sentenced by a Chhattisgarh court to life
June 25, 2012, The Economic Times
imprisonment for sedition..., nine former presidents of
the three principal Academies of science in India If Dr Devi Prasad Shetty's vision comes true, most Indians
endorsed an appeal by more than 50 Nobel laureates..., will have access to quality healthcare. Dr Shetty says the
supporting Sen and urging immediate release,” the group cost of healthcare in India can come down by 50% in the
wrote. next 5-10 years, and this will be forced on the hospitals
by the government if service providers do not get their
act together.
How P H Kurien Took On Global
Patents System To Make Very Costly "If you are going to say the cost of a heart surgery is 3
lakh for a rich man, it is fine. But for somebody who has
Drug Affordable For Poor sold his house, it is unacceptable," he says. Shetty, who
May 30, 2012, The Economic Times pioneered the low-cost treatment model, said the lower
cost is achievable if hospitals increased the number of
It is said that only God and a few good men and women procedures by 1,000 times.
run India. One such man is P H Kurien. For readers
unfamiliar with his name, Kurien was India's Controller
General of Patents, Designs & Trade Marks until March
NRHM Funds To Be Linked To States’
12, 2012. On March 9, 2012, just three days before he Performance
left office, he issued the first-ever compulsory licence in June 25, 2012, The Times of India
India for the manufacture of a drug still under patent.
For the first time ever, funds allocated to states under
The licence authorized Indian company Natco to the country's flagship National Rural Health Mission
manufacture drug Naxevar for which Bayer, a German (NRHM) will be cut by almost 15% if they fail to place
multinational company, holds the patent. This was an doctors and health workers (even on contractual basis)
act of major significance for India's health. Since March to districts with the worst health index.
3, 2008, when it got the Indian patent, Bayer has
imported Naxevar, selling its monthly dose at the States will also have to post performance audits of
whopping price of 2,80,428 or $5,420. Unsurprisingly, health facilities online, failing which up to 7.5% of their
only 2% of Indian patients have been able to afford it. total outlay will be deducted. For the first time, NRHM's
programme implementation plan (PIP) for the year 2012-
Commerce Ministry Locks Horns With 13 has put in place incentives to reward high performing
states and also punish those who fail.
Pharma Dept Over Patented Medicines
May 29, 2012, Financial Express
Pharma Units In Himachal Under
Commerce ministry has locked horns with the Scanner For Spurious Drugs Production
department of pharmaceuticals for the latter’s alleged June 22, 2012, The Times of India
inaction on the plan to bring patented drugs under a
price negotiation system. There is no provision for any Seeing around 25000 crore pharmaceutical industry of
regulation on patented drugs in the proposed new pricing Himachal Pradesh facing credibility crisis due to the
policy for drugs. production of sub standard drugs, state government has
finally started acting against the drug manufacturing
“The National Pharmaceutical Pricing Policy is restricted units by suspending their licenses. Recently the licences
to generics alone and does not cover patented
Organisation of Pharmaceutical Producers of India 11

13. Pharma Spectrum
of seven companies were suspended after drugs approvals given by the competent authority so far were
manufactured by them failed the test. 'in order' and there was no need to re-examine the
approvals given or recall any particular drug from the
Considering the fact 600 pharmaceutical industries market on the grounds of errors in approval process,
located in Himachal Pradesh caters to around 50% highly placed sources confirmed.
demand of country, over the years Himachal Pradesh has
become the largest suppliers of drugs and almost all the Improving The Picture Of India’s
states in India are getting supplies from Himachal.
Healthcare
India In Race To Contain Untreatable June 18, 2012, Business Standard
Tuberculosis In the din of a slowing economy, falling rupee,
June 21, 2012, Livemint rampaging inflation, and incessant political
manoeuvrings, India’s list of challenges continues to
India’s slow response to years of medical warnings now grow. Of all these challenges, there is one that seems
threatens to turn the country into an incubator for a insurmountable already, and worse, could soon end up
mutant strain of tuberculosis (TB) that is proving becoming a calamity, aggravating the suffering of
resistant to all known treatments, raising alarms of a hundreds of millions of Indians.
new global health hazard.
This challenge relates to the provision of affordable,
“We finally have ended up with a virtually untreatable accessible, and accountable healthcare to every single
strain” of TB in India, said Dr Zarir Udwadia, one of the citizen of India. On just about every single measurable
country’s leading TB authorities. In December, Dr indicator of healthcare infrastructure, India is rapidly
Udwadia reported in a medical journal that he had four deteriorating.
TB patients resistant to all treatment. By January, he
had a dozen cases, then 15. Pharma Cos Sell Drugs 10 Times Cost:
CCI Seeks Partnership Agreements MCA
June 16, 2012, Financial Express
With Global Counterparts
June 20, 2012, Livemint Leading pharma companies, including GlaxoSmithkline,
Pfizer and Ranbaxy, sell commonly used drugs at a rate
To strengthen its extra-territorial jurisdiction, the 10 times the cost of production, a study by the
Competition Commission of India (CCI) is entering into Corporate Affairs Ministry has found. A study by the Cost
cooperation agreements with its counterparts in other Audit branch of the MCA found drugs like Calpol
nations. Extra-territorial jurisdiction relates to acts that manufactured by Glaxosmithkline, Corex Cough Syrup by
take place outside the country but have an effect on Pfizer, Revital by Ranbaxy Global, Omez by Dr Reddy's
competition in India. Labs, Azithral by Alembic and several others were being
sold at a mark up of up to 1,123 per cent over the cost
India’s competition watchdog is close to signing a of production.
memorandum of understanding (MoU) with the US
Federal Trade Commission’s Bureau of Competition, said Worried over the findings of the study, Corporate Affairs
a CCI official with direct knowledge of the development. Minister M Veerappa Moily has written to the ministers of
A draft MoU was prepared in November and is awaiting Chemical and Fertilizers M K Alagiri and Health Ghulam
the foreign ministry’s approval. Nabi Azad seeking appropriate action on curbing this
practice of pharma companies.
CDSCO Rules Out Review Or Recall Of
33 Drugs Approved Between Jan 2008 Parliamentary Panel Sceptic About
To Oct 2010 Physical Targets For Improving Human
June 18, 2012, Pharmabiz, Joseph Alexander Resources In Health
June 15, 2012, Pharmabiz, Joseph Alexander
Central Drugs Standard Control Organisation (CDSCO) will
not review or recall the 33 controversial drugs which The Parliamentary Standing Committee on Health has
were reportedly cleared without clinical trials on Indian expressed apprehension on achieving the physical targets
patients during the period of January 2008 to October set for the current Five Year Plan for improving the
2010. human resources in the health sector and called for more
allocation to paramedical sectors including pharmacists.
The regulatory authorities are of the view that all
Organisation of Pharmaceutical Producers of India 12

14. Pharma Spectrum
The Department of Health has set physical targets set to Amravati, 46 in Aurangabad and 29 in Mumbai received
be accomplished in Twelfth Five year Plan which notices. "Our drive exposed how many chemists were not
includes training capacity of 80,000 MBBS doctors and following any norms.
45,000 specialists per annum by 2020 and bringing down
the doctor: population ratio from 1:2000 to 1:1000. FIPB To Continue As Gate-Keeper On
Azad Visits US FDA; Stresses On Pharma Mergers For Now
June 7, 2012, Business Line
Importance Of Collaboration With US In
Food And Drug Regulation Who will be gate-keeper for the pharmaceutical
June 14, 2012, PharmaBiz industry, watching over local companies being acquired
by foreign owners? The Foreign Investment Promotion
The Union minister for health and family welfare, board (FIPB), the Competition Commission of India (CCI)
Ghulam Nabi Azad has stressed on the importance of or both? Until a final call is taken by the ministries
collaboration with the USA in food and drug regulation as involved, the FIPB is set to continue as gate-keeper, said
this will provide exposure to the Indian regulators to a source, after a meeting on the issue convened by the
international best practices in this area. Finance Ministry, on Wednesday.
Azad was speaking at the headquarters of the US Food Addressing public health concerns raised by the Health
and Drug Regulatory Administration (FDA) at Maryland. Ministry, and to streamline investment in local drug
Azad is member of the high level Indian delegation companies, guidelines will be outlined on the FIPB Web
visiting the USA. site, the source said. For instance, companies looking for
local acquisitions will have to ensure they continue to
manufacture essential medicines (if the acquired entity
CSR A Must In Cos Bill was making them); and not discontinue ongoing research
June 13, 2012, The Economic Times (epaper in critical areas.
page2)
FDA Foresees Jump In Apps For Cancer
Decks have been cleared for reintroduction of the
Companies Bill,2011,in the monsoon session. If the bill is
Drugs
passed after endorsing all the suggestions made by the June 6, 2012, Fiercer Biotech
Parliamentary Standing Committee on Finance,
corporate social responsibility (CSR) would, for the first U.S. regulators expect to review lots of cancer drugs this
time in the world, become mandatory. year. With developers finding ways to get early readouts
on efficacy, companies are expediting programs to set
The report recommends that companies with net worth the stage for rapid development and speedy approvals of
above.500 crore, or an annual turnover of over.1,000 new anti-cancer therapies.
crore, earmark 2% of average net profits of three years
towards CSR. In the draft Companies Bill,2009,the CSR In an interview with Reuters, FDA oncology chief Dr.
clause was voluntary though it was mandatory for Richard Pazdur predicts that the agency will receive 20
companies to disclose their CSR spends to shareholders. submissions for cancer drugs in 2012. It's too early to tell
whether that will lead to an increase in approvals this
year, but the number says a lot about intense
35% Chemists In Maharashtra Flout participation in cancer drug research around the
Abortion Drug Norms: Food And Drug biopharma industry.
Administration
June 13, 2012, The Times of India DCGI Asks State Drug Controllers To
Keep Tab On Trials To Wipe Out Illegal
Nearly 35% of drug retailers and wholesalers in the state
were found flouting norms claims the Food and Drug
Practices
Administration, which launched a crackdown following June 6, 2012, PharmaBiz
cases of female feticide in Beed. Out of the 954 retailers
and wholesalers inspected in the last six days, 340 were With reports of illegal trials affecting public safety, the
served show-cause notices for irregularities in Central drug authorities have asked all the State drug
maintaining records and selling abortion drugs without a controllers to keep a close tab on the clinical trials
prescription. happening around and stop illegal trials especially those
done individually by the doctors without due permission
Eighty-eight chemists in the Konkan region were served from the Central Drugs Standard Control Organisation
show-cause notices. Sixty-five chemists in Pune, 50 in (CDSCO).
Organisation of Pharmaceutical Producers of India 13

15. Pharma Spectrum
Talking to Pharmabiz, Drug Controller General of India Eli Lilly and Co. focusing on the growing diabetes market
(DCGI) Dr G N Singh admitted that there could be is likely to set a new trend in the highly competitive
individual cases of doctors carrying out trials on their local drug market, where foreign drug makers are
own for some companies, Indian or foreign, without aggressively taking on entrenched generic rivals.
informing the authorities. Such cases lead to unethical
practices and cause troubles, he added. The global collaboration combining the portfolio of the
two to address a particular disease segment and selling
Industry Leaders Call For Overhauling the products through a common team in various markets
is the first such alliance in the drug industry.
Of CDSCO For Better Efficiency,
Transparency GSK Launches Metered-Dose Inhalers In
June 4, 2012, Pharmabiz, Nandita Vijay India
Even as The Lancet report exposes the inadequacies of
June 7, 2012, Business Line
the functioning of Central Drugs Standard Control
Organization (CDSCO), industry stakeholders have called Asthma patients will now be able to buy the enhanced
for an overhaul of India's regulatory machinery on a version of a Metered Dose Inhaler (MDI) with a dose
priority basis including staffing policy of the counter, from their local chemists. Multinational drug-
organization. maker GlaxoSmithKline Pharmaceuticals has launched
the product with this new technology in the country, a
According to a stakeholder, “A competent CDCSO is of first of its kind, company officials said.
utmost importance and requires a leader who is
conversant with the nuances of this highly technical and The inhaler has an innovative dose counter that keeps
research-driven business.” Further, he added, the track of number of doses left. This helps the patients to
regulator should have a formal pharmacy education, to take the right number of drug doses. The inhaler also has
discharge duties efficiently. a locking system which prevents drug wastage when the
inhaler is not in use.
Dr G N Singh's Term As DCGI Extended
For Another 3 Months
May 31, 2012, Pharmabiz
R&D/Clinical Trials
The health ministry further extended the tenure of Dr G Doctors Discuss Problems Related To
N Singh with the additional charges of the Drug
Controller General of India (DCGI) by three more months
Clinical Act
effective from May 22. The order announcing the same June 22, 2012, The Times of India
was issued by the health ministry on May 29 and comes
as a great relief to the industry which has been A meeting of city doctors under the banner of Allahabad
demanding for some stability in the position of the drug Medical Association(AMA) was held on Thursday where
regulator of the country. the speakers discussed problems arising after the
passage of Clinical Establishment Act by the government.
Dr Singh informed that now with this order he will be
able to bring in stability to his position by enacting and Addressing the gathering, state president Indian Medical
working on the mission of the CDSCO to safeguard and association (IMA) Dr Ashok Agarwal said: "the government
enhance public health by assuring safety, efficacy and is making medical facilities expensive for the common
quality of drugs, cosmetics and medical devices in the man in the same manner as it is increasing the prices of
country. essential commodities including sugar, onion, petrol,
pulses, rice and green vegetables.
New Products Six New AIIMS Will Give Fillip To
Medical Research: Ghulam Nabi Azad
June 21, 2012, The Economic Times
Boehringer-Lilly Alliance Likely To Set
Trend Admitting that inadequate number of doctors has
June 15, 2012, Livemint affected medical research in the country, Union Health
Minister Ghulam Nabi Azad today expressed hope that
The business alliance between German drug maker the sector would get a fillip with the coming up of six
Boehringer Ingelheim GmbH and US biotechnology firm new AIIMS from next year.
Organisation of Pharmaceutical Producers of India 14

16. Pharma Spectrum
"Six new AIIMS in the country will start functioning by caused by invasive non-typhoidal Salmonella (NTS). This
April next year in different states, including Jodhpur in strain is most common in the sub Saharan African regions
Rajasthan. This will ease pressure on AIIMS Delhi and among malnourished children. About 20-30% of the
research work will get momentum," he said at a press children are known to die because of this infectious
conference here. disease each year.
Pharma Industry Urges Govt To Woo Lab- Grown Vein Transplant Milestone
Back Scientists In Stem Cell Research
June 20, 2012, Financial Express June 15, 2012, Indian Express
As the government begins to correct deficiencies in the In a first, doctors in Sweden have transplanted into the
drug regulatory process brought forth by a parliamentary body of 10-year-old girl a vein grown in the laboratory
panel, the industry has urged it to woo back Indian from her own stem cells. The core team that performed
scientists working with reputed global drug regulatory the procedure was led by Dr Suchitra Holgersson, a
agencies of US and UK. transplant medicine specialist originally from Mumbai,
and included four other doctors from India. The
In a letter to union health minister Ghulam Nabi Azad, landmark transplant was published in the British medical
pharma sector captains through the auspices of industry journal The Lancet on Thursday.
body Assocham, have said, “It is fortunate that a pool of
Indian origin scientists populate the world’s leading The procedure “could offer a potential new way for
regulators like US FDA (Food and Drug Administration) patients lacking healthy veins to undergo dialysis or
and UK MHRA (Medicines and Health products Regulatory heart bypass surgery without the problems of synthetic
Agency). grafts or the need for lifelong immunosuppressive
drugs”, The Lancet said.
Indian Platform For Sharing, Viewing
Research Available For Foreign Health Min To Notify Procedures And
Institutes Quantum Of Compensation To Victims
June 20, 2012, Business Standard Of Trials Soon
June 13, 2012, Pharmabiz, Joseph Alexander
Knimbus, an India-based global search and collaboration
platform for researchers, is set to offer its services in The Health Ministry will soon formally notify the
foreign varsities. A platform that connects creators and procedures and amount of compensation to be paid by
users of scientific, technical and medical knowledge to the pharmaceuticals companies, if a volunteer dies or
online content and peer groups, Knimbus is in the gets injured during a clinical trial. “The Government has
process of extending services to institutes in the United already published the draft rules for the new schedule
States and some European countries. Y1 under the Drugs and Cosmetic Rules, 1945 and it is
under the stipulated process of examination before the
It has also tied up with a partner in Germany and is in final notification.
the process of forging ties with about 25 universities in
Bangladesh. Knimbus was co-founded by Rahul Agarwalla However, with a view to tighten the norms on clinical
and Tarun Arora in November 2010, and the service went trials, several sections of the amendment have already
live in September 2011. been implemented,” Drug Controller General of India
(DCGI) Dr G N Singh said. “We are in the process of
Bharat Biotech Receives $ 4 Million finalising the detailed procedures and amount of
compensation and on making the companies liable for
Award From The Wellcome Trust For causes of damages during the trials. This will be notified
Development And Clinical Trials within a couple of months,” he said.
June 19, 2012, The Economic Times
Pharma Companies Need Aggressive
Vaccine manufacturer Bharat Biotech and The University R&D And Patent Filing: Experts
of Maryland Center for Vaccine Development (CVD) have
received $ 4 million from The Wellcome Trust for clinical
June 11, 2012, The Economic Times
development of a new conjugate vaccine for treating an
infectious disease. Indian pharmaceutical companies need to go for
aggressive research and patent filing like China and
The Trust will also fund clinical trials beginning in three Japan and unless spending on R&D is scaled up, it would
years to prevent the potentially lethal infectious disease be difficult to create new molecules, industry experts
Organisation of Pharmaceutical Producers of India 15

17. Pharma Spectrum
said. "Our Indian companies are just beginning to realise After keeping it dormant for many years, the
that they also need an R&D Department, as merely Department of Health Research is fast-tracking for the
quality control would not help. final approval from the Cabinet a comprehensive bill to
regulate and monitor the entire research on the human
Unless spending on R&D is scaled up, it will be difficult subjects in the country.
to create new molecules. It is time to go for aggressive
research and patent filing just like China and Japan," Sources said the modified Biomedical Research on Human
Deputy Controller of Patents & Designs, Intellectual Subjects Bill is in the final stages. “The Cabinet note is
Property Office K S Kardam said at a workshop on being prepared for submission and approval. The plans
'Patenting Pharmaceuticals in India'. are afoot to place it before the Parliament this year
itself and put into effect,” sources said.
R & D in India
June 5, 2012, Indian Express University Of Pune With Serum
Institute Complete Animal Study On
Foreign direct investment may have slowed, but India
still has a vibrant, sophisticated and rapidly evolving
Herbal Vaccine, Adjuvants
R&D sector. India should be a compelling proposition for May 30, 2012, Pharmabiz, Nandita Vijay
multinational companies seeking an emerging market
R&D location. The country’s large educated population, University of Pune’s Interdisciplinary School of Health
its low labour costs and its huge and rapidly emerging Sciences and Serum Institute of India, in a collaborative
middle class suggest the ideal environment for global research programme, have completed animal study on
R&D investment. herbal vaccine, adjuvants. The project was supported by
Department of Science and Technology.
And back in the heady days of 2006, the country was
certainly living up to that potential. FDI in R&D India was In another study, the Pune University along with US-
$3.8 billion, more than in China and Eastern Europe based BioVed Pharmaceuticals Inc. went on to research
combined. on blood disorder properties in cancer bearing animals
which is ready for commercialization.
Abbott To Strengthen Its Research
Capability In India, Also Scouts For
University Partner To Spur Innovation Mergers &
June 5, 2012, PharmaBiz
Abbott has now commenced its advanced nutrition
Acquisitions /
research in collaboration with Syngene. The
multinational drug major has set up the Abbott Nutrition Collaborations
R&D Centre in the Biocon Park which houses the Biocon
Biopharmaceutical Research Centre (BBRC). The
company is also in the process of scouting for a
PMO Seeks Legal Opinion On Pharma
University partner to spur its innovation in research in FDI Issue
the country. June 25, 2012, Financial Express
The company has already tie-up with the University of The Prime Minister’s Office (PMO) has sought a legal
Illinois where it has set up a Centre for Nutrition and opinion on whether the Competition Commission of India
Cognition. In India, Abbott is looking not just to tap the (CCI) can have the mandate of clearing or halting
talent of young researchers but also look at a similar approvals of proposed brownfield pharma FDI deals on
initiative to advance its research and comprehension on the grounds of public health. In a recent letter sent to
the needs of the Indian nutrition market, said Dr Robert the law ministry, the PMO has sought its views on the
H Miller, divisional vice president, Global R&D and matter.
Scientific Affairs for Abbott Nutrition.
This comes after the multiple arms of government -
Dept Of Health Research Fast-Tracking ministry of health and ministry of commerce and
industry as well as a section of the domestic industry -
Cabinet Nod For Bill To Regulate put up sustained resistance to an earlier decision taken
Clinical Research in October last year to empower the CCI to assume the
May 30, 2012, Pharmabiz, Joseph Alexander role of the filter of brownfield pharma deals.
Organisation of Pharmaceutical Producers of India 16

18. Pharma Spectrum
Ministries Oppose PMO View On GSK Extends $2.6 Billion Bid For
Pharma Deal Rules Human Genome Sciences
June 14, 2012, Business Standard June 8, 2012, Fierce Pharma
The ministries of finance, commerce and health appear GlaxoSmithKline said it would and now it has. It
to have locked horns with the Prime Minister’s Office extended its $2.6 billion hostile bid for shares of its
(PMO) over the regulation of cross-border deals for partner Human Genome Sciences by three weeks. The
expansion in the pharmaceutical sector. original offer from GSK of $13 a share was set to expire
last night, and since GSK has made it clear that it does
The Indian Pharmaceutical Alliance (IPA), an association not intend to just fold on this proposal, it pushed the
representing the domestic industry, had also recently deadline for investors to tender shares to June 29, the
written to the PMO suggesting joint clearance of company says in an announcement today.
brownfield FDI proposals for expansion in pharma by the
Foreign Investment Promotion Board (FIPB) and Human Genome opposes the deal, saying it values the
Competition Commission of India (CCI). company far too cheaply, and has been urging
shareholders to hold out until it can find a more
Pharmabiz Editorial: Brownfield rewarding alternative, even asking GSK to participate,
The Wall Street Journal reports.
Projects & FDI
June 13, 2012, Pharmabiz, P.A. Francis Why Fear FDI In Pharma?
In October last, at a high level meeting convened by the
June 6, 2012, Business Line
Prime Minister, it was decided that India will continue to
allow foreign direct investment in drugs and It would soon be time for the government to review its
pharmaceuticals sector through automatic route for 2011 policy decision on foreign direct investment in the
greenfield projects and in case of brownfield pharma sector. The occasion is ripe to consider
investments, FDI will be allowed through the Foreign perceptions on the impact of FDI on the industry. The
Investment Promotion Board (FIPB) for six months. FDI policy for the pharma sector was revised on
November 8, 2011, essentially shifting the FDI(in relation
These acquisitions will, however, be routed through the to the brownfield investments) from the automatic to
Competition Commission of India for the six months approval route. FDI in the sector is permitted up to 100
period. During this period, when the FIPB clears the per cent.
acquisitions, necessary enabling regulations will be put
in place by the CCI for effectively overseeing mergers The decision was a sequel to the acquisition spree by
and acquisitions so as to ensure a balance between multinational corporations — notably Matrix by Mylan
public health concerns and flow of FDI into the pharma (2006), Ranbaxy by Dai-ichi Sankyo (2008), Shanta
sector. Biotechnics by Sanofi Aventis (2009), Orchid Chemicals
by Hospira (2009), and Piramal Healthcare by Abbott
Laboratories (2010).
Empower Competition: Need To Have
Better Coordination Between Sector FDI In Drug Firms Resumes
Regulators And CCI June 1, 2012, The Economic Times (epaper
June 12, 2012, The Economic Times page 24)
The corporate affairs ministry has reportedly sought to The Foreign Investment Promotion Board (FIPB) has
bring all sectors including telecom and banking under the resumed clearing investment proposals in Indian drug
ambit of the Competition Commission of India (CCI). This companies, a move that will revive deal flow in the.
is a good idea. The CCI's remit is to oversee competition, 62,000-crore domestic pharma sector.
check abuse of monopoly power and curtail unfair trade
practices. The board has cleared four proposals of foreign financial
investors, but again deferred a decision on stake buys by
The job cannot be left to sectoral regulators. This is not multinational drug companies, extending uncertainty
to say that the CCI should become a super-regulator. over new rules to check rising cases of promoters of
Instead, it should help sectoral regulators - be it the RBI domestic drug companies selling out to foreign players.
or the telecom regulator - to arrive at informed decisions
in cases where there is a violation of fair play. At its meeting on May 9, the FIPB cleared Pethico
Pharmaceuticals proposal to raise.490 crore by selling a
22% stake through the foreign currency convertible bond
Organisation of Pharmaceutical Producers of India 17