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Pharma Spectrum Organisation of Pharmaceutical Producers of India Volume 6 Issue 10 October 2013 INDEX

Pharma Spectrum

Organisation of Pharmaceutical Producers of India

Volume 6 Issue 10 October 2013 INDEX INTERNATIONAL 1. IPR / Innovation 1 2. Regulatory/
Volume 6
Issue 10
October 2013
INDEX
INTERNATIONAL
1. IPR / Innovation
1
2. Regulatory/ Medical / Biotech
1
3. New Products
2
4. R&D / Clinical Trials
2
5. Mergers & Acquisitions / Collaborations
3
6. Access & Pricing
4
7. Trade
4
8. Ethics & Compliance
5
9. New Appointments
6
DOMESTIC
1. IPR / Innovation
6
2. Regulatory / Medical / Biotech
8
3. New Products
10
4. R&D / Clinical Trials
10
5. Mergers & Acquisitions / Collaborations
12
10 5. Mergers & Acquisitions / Collaborations 12 6. Access & Pricing 13 7. Trade 15

6. Access & Pricing

13

7. Trade

15

8. Ethics & Compliance

16

9. New Appointments

16

10. OPPI Related News / Events

16

Organisation of Pharmaceutical Producers of India

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Pharma Spectrum International IPR / Innovation to data released last week by the Indian Patent

Pharma Spectrum

International

IPR / Innovation

to data released last week by the Indian Patent Office (IPO).

September 11, 2013, Fierce Pharma

Big Pharma has fought bruising battles in India over intellectual property. China has added compulsory licensing to its bag of tricks for dealing with costly drugs. Now drugmakers can add South Africa to the list of countries that are looking askance at unimpeded patents.

September 24, 2013, Pharmabiz The US District Court for the District of New Jersey has
September 24, 2013, Pharmabiz
The US District Court for the District of New Jersey has
issued a favourable ruling in the Teva Pharmaceutical
Industries' patent infringement lawsuit against Mylan
regarding an Azilect (rasagiline tablets) patent which
covers methods of treating Parkinson’s disease (PD). The
Court has upheld the validity of Teva’s patent.
The South African government is asking for comments by
Oct. 4 on a proposed National Policy on Intellectual
Property, PharmaTimes reports. It would raise the bar on
innovation, striking a blow at what critics consider
"evergreening" by drug companies to extend patent
protection.
Teva anticipates the Court will enter Judgment that
prevents Mylan from launching its generic version of
Azilect until Teva’s patent expires in 2017. Teva filed a
lawsuit suit against Mylan in October 2010. Similar
lawsuits were filed against Watson and Orchid in October
2010, Apotex in May 2011 and Sandoz in April 2012.
Regulatory /
Medical / Biotech
Watson Sends Patent Challenge Notice
To Ranbaxy For Acne Drug
September 22, 2013, Hindu Business Line
GSK Gets Double Dose Of Good News
For Breo Ellipta
September 20, 2013, Fierce Pharma
Ranbaxy Laboratories has said its U.S. arm has received a
notice from Watson Laboratories Inc, challenging the
patent of acne treatment drug Absorica. The drug is
licensed to Ranbaxy Laboratories from Cipher
Pharmaceuticals Inc of Mississauga, Ontario.
It is now protected by two issued patents listed in the
U.S. Food and Drug Administration’s (USFDA) approved
drug products list, which expire in September, 2021, the
company said in a statement. “Ranbaxy Laboratories Inc,
the wholly-owned subsidiary of the company, has
received a Paragraph IV certification
GlaxoSmithKline got a double dose of good news today
about its respiratory drug Breo Ellipta, known as Relvar
Ellipta in other markets. Regulators in Europe
recommended the potential blockbuster be approved
there for COPD and asthma, while regulators in Japan
gave it the OK for asthma.
Breo was approved in May by the FDA for two uses in
COPD. The respiratory drug is one that GSK is leaning
heavily on to pick up some of the sales vacuum that will
come when generics of Advair finally take on the nearly
$8 billion a year powerhouse.
Foreign Drug Makers Won 77% Of All
Patents Granted In Last 3 Years

September 16, 2013, Livemint

More than two-thirds of the pharmaceutical patents awarded by India in the last three years were granted to foreign drug makers such as Pfizer Inc., Novartis AG and F Hoffmann La Roche Ltd , which have been critical of India’s intellectual property rights (IPR) regime.

The country issued 1,001 drug patents between April 2010 and March 2013, of which 771 were given to foreign drug makers, mainly from the US and Europe, according

September 16, 2013, Fierce Pharma

Roche's blockbuster Xeloda went off patent in December, so it was inevitable that a generic would hit the market at some point. It just wasn't known when. Well, that when is now. The FDA Monday said it had approved a generic from Teva Pharmaceutical Industries.

Organisation of Pharmaceutical Producers of India

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Pharma Spectrum Teva has been approved to market generic capecitabine in 150 and 500 milligram

Pharma Spectrum

Teva has been approved to market generic capecitabine in 150 and 500 milligram strengths, the agency said. "Generic drugs are important options that allow greater access to healthcare for all Americans," said Dr. Kathleen Uhl, acting director of the Office of Generic Drugs in the FDA's Center for Drug Evaluation and Research.

September 17, 2013, The Economic Times

the contents could not be determined, according to a July 18 letter from the U.S. Food and Drug Administration to Wockhardt, which makes sterile injectable drugs and various forms of insulin.

August 27, 2013, Fierce Pharma

Bayer's Nexavar is one big step closer to a thyroid-cancer approval. The FDA put the drug on the priority-review fast track, which means Nexavar could have its new indication by February. It's a timely win for Bayer's development partner, Onyx Pharmaceuticals, which just agreed to a $10.4 billion buyout by Amgen.

Ranbaxy's regulatory ailments are threatening to become chronic. Months after it agreed to pay $500
Ranbaxy's regulatory ailments are threatening to become
chronic. Months after it agreed to pay $500 million to
settle charges, the US Food & Drug Administration issued
an import alert against its factory in Mohali (Punjab),
sending the stock tumbling 30%.
While Ranbaxy doesn't export any drugs to the US from
the plant, the move could delay plans to start selling
several generics in the world's biggest drug market. "I
think there are some 17 generic drug filings that Ranbaxy
has done from the Mohali plant that might get delayed,"
said Surjit Pal, an analyst with brokerage firm Prabhudas
Lilladher.
It's not a huge new market--analysts see $200 million in
additional sales--but it's a needy one. Nexavar would be
pointed toward patients whose cancer has returned after
surgery and radiation--patients whose treatment options
are limited, and prognosis poor.
New Products
FDA Turbocharges GlaxoSmithKline's
Bids For New Cancer Drug Uses
September 16, 2013, Fierce Pharma
Eisai Launches Anticancer Agent
Halaven In Russia
September 13, 2013, Pharmabiz
With two back-to-back decisions, the FDA is revving up
GlaxoSmithKline's cancer prospects. Friday, the agency
dubbed Arzerra a "breakthrough therapy," a coveted
designation that puts the leukemia drug into the fast
lane for first-line use. And today, the FDA put GSK's new
melanoma duo, Tafinlar and Mekinist, on its priority
review track as a combination cocktail.
Eisai Co., Ltd., a Japanese pharmaceutical company, has
launched anticancer agent, Halaven (eribulin mesylate)
in Russia, making it the first product to be marketed in
Russia by the company. Halaven is a novel anticancer
agent discovered and developed in-house by Eisai and is
currently approved in more than 50 countries, including
Japan, the United States and in Europe.
Developed with Genmab, Arzerra is not a big seller; it
brought in less than $100 million last year. But the
breakthrough designation gives it a chance to do much
better. The drug is now approved for chronic
lymphocytic leukemia patients whose disease has
progressed despite previous therapy.
In Russia, Halaven was approved in July 2012 for the
treatment of locally advanced or metastatic breast
cancer previously treated with at least two
chemotherapy regimens including an anthracycline and a
taxane. The Russian pharmaceutical market constitutes
the 11th largest in the world and is expected to continue
to achieve double-digit growth going forward.

September 12, 2013, Reuters

U.S. inspectors visiting a factory in India owned by drugmaker Wockhardt Ltd in March found torn data records in a waste heap and urinals that emptied into an open drain in a bathroom six meters from the entrance to a sterile manufacturing area.

R&D/Clinical Trials

September 24, 2013, The Times of India

And when an inspector asked about the contents of unlabelled vials in the laboratory glassware washing area, a plant worker dumped them down a sink and said

A team led by a scientist of Indian origin has made a

"blueprint" for a universal flu vaccine. The influenza

Organisation of Pharmaceutical Producers of India

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Pharma Spectrum virus that causes flu is known to be one of the world's most

Pharma Spectrum

virus that causes flu is known to be one of the world's most rapidly changing organisms. Flu vaccines become redundant after every season and aren't effective against every strain causing cough, cold and other complications. So, scientists have to create new vaccines with new strains of the virus each year.

Now, a team led by professor Ajit Lalvani from the National Heart and Lung Institute at Imperial College London has used a 2009 pandemic virus strain to study why some people seem to resist severe illness, thereby stumbling upon a recipe to create the world's first universal flu vaccine.

Even the smallest biotech company can benefit when it thinks--and acts--globally. And a biotech startup that was able to grab a promising therapeutic asset from Pfizer as it shuttered much of its work in the U.K. has pieced together a global virtual organization that illustrates just how effective that can be.

Mergers & Acquisitions / Collaborations

UK Committee Urges Transparency In Clinical Trials September 17, 2013, Pharma Letter Otsuka To Buy
UK Committee Urges Transparency In
Clinical Trials
September 17, 2013, Pharma Letter
Otsuka
To
Buy
Astex
Pharma
For
$886m
The UK Parliament’s Science and Technology Committee
has described the current lack of transparency of many
clinical trials as “unacceptable,” adding that it has not
been impressed with government efforts to tackle the
problem to date.
September 6, 2013, Financial Express
Committee chairman Andrew Miller MP said: “Many of
the trials taking place today are unregistered and
unpublished, meaning that the information that they
generate remains invisible to both the scientific
community and the public.
Japanese drugmaker Otsuka Holdings said on Thursday
that it had agreed to buy Astex Pharmaceuticals for close
to $900 million to tap cancer drugs under development
by the US company. The move comes as Otsuka seeks to
increase revenue streams as patents for its mainstay
Abilify schizophrenia treatment will begin to expire.
On
A
Roll, Boehringer Wins
'Breakthrough' Status For Pioneering
Otsuka said in a statement through the Tokyo Stock
Exchange that it would launch a tender offer beginning
within the next 10 days that would run for 20 days. The
company has set aside $886 million to cover the
purchase of Astex at $8.50 a share.
Leukemia Drug
September 17, 2013, Fierce Biotech
India Receives Highest FDI Worth $1b
In Pharma In Apr-Jun
When Boehringer Ingelheim took volasertib into a Phase
III study for acute myeloid leukemia earlier this year, the
pharma company claimed a pioneering role in advancing
a promising cancer therapy that inhibits polo-like kinase-
-or Plk. Today, the company said that the FDA agreed,
offering to help speed development with its
"breakthrough" therapy designation.
September 1, 2013, Financial Chronicle
India's pharmaceuticals sector has received FDI of $ 1
billion, the highest among the top 10 segments, during
the April-June period this year amid concerns over
increasing acquisitions of domestic firms by
multinationals. Foreign Direct Investment (FDI) in drugs
and pharmaceuticals during April-June 2012 stood at $
465 million, according to the latest data of Department
of Industrial Policy and Promotion (DIPP).

The BTD announcement marks another step forward in Boehringer's considerable effort to push a small group of late-stage cancer therapies into the market. In July the FDA approved afatinib for non-small cell lung cancer for patients with EGFR mutations.

September 10, 2013, Fierce Biotech

The DIPP is working on a cabinet note to include major changes in the FDI policy in the sector to protect domestic generic (off-patent) firms. "The DIPP is concerned that an overwhelming majority of foreign direct investment in pharma is coming only in existing (brownfield) units," an official said.

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Pharma Spectrum Access & Pricing corporations to bypass the Supreme Court and sue the government

Pharma Spectrum

Access & Pricing

corporations to bypass the Supreme Court and sue the government for millions of dollars in foreign tribunals.

The 'investor-state dispute settlement', a key element of the bilateral investment pact, will arm foreign investors operating in India with a slew of rights. Biswajit Dhar, director general of the Research and Information System for Developing Countries told TOI:

Of

September 16, 2013, Pharma Letter

The Japanese Ministry of Health, Labor and Welfare (MHLW) reported approximate medical expenditure (AME) for the fiscal year 2012 that ended in March. Although costs for work-place injuries and some out-of- pocket items are yet to be included, the AME - accounting for 98% of the National Health Expenditure (NHE) - is a quick and accurate indicator of trends in the NHE, which takes a year and a half to be finalized, reports The Pharma Letter’s local analyst.

September 24, 2013, Fierce Pharma The AME increased by 640 billion yen ($6.44 billion) or
September 24, 2013, Fierce Pharma
The AME increased by 640 billion yen ($6.44 billion) or
1.7% to 38.4 trillion yen in 2012. Payments for elderly
patients (aged above 70) accounted for 75% or 480 billion
yen of the total increase. For the age bracket, daily
medical cost per patient increased 2.6% to 14,800 yen in
2012 and annual medical….
Which sort of pharma rep would a doctor prefer to see--a
live rep, in the flesh, possibly carrying an iPad? Or an
electronic version, piped in via Skype at the physician's
convenience? Pfizer aims to find out, with its latest foray
into e-detailing.
U.K. Groups Want Drugmakers To
Guarantee Supplies When Prices Are
Reduced
As Pharmafile reports, the U.S.-based pharma giant has
been promoting a new service in the U.K. called
Pfizerline, which allows primary care doctors to book
time with reps. Ads in the BMJ (formerly the British
Medical Journal) tout the convenience of anytime,
anywhere contact with Pfizer reps bearing info about the
company's products.
September 13, 2013, Fierce Pharma
Pharma Suffers In China As Widening
Scandal Spooks Docs, Reps
September 18, 2013, Fierce Pharma
The Pharmaceutical Services Negotiating Committee
(PSNC) in the U.K. is afraid impending price reductions
will lead to drug shortages. It has asked the government
to require drugmakers meet certain supply levels,
according to PharmaTimes.
The PSNC and the British Association of Pharmaceutical
Wholesalers (BAPW) have said the price cuts slated for
January might make it more attractive for some
wholesalers to export drugs to countries with higher
prices. They contend price cuts also might lead them to
reduce stocks of some drugs.
There's no doubt the pharma bribery scandal has been
bad for business in China. Just how bad? That remains
to be seen. But in the meantime, Reuters reports that
drugmakers are struggling to push their products--and
explores how those problems might affect third-quarter
results.
Fearful doctors, who have grown more cautious with the
widening scandal, pose a major hurdle to pharma sales
efforts. As one former sales rep told Reuters, some
doctors accustomed to seeing upwards of 10 sales staff
per day have slashed visits altogether.
Trade

September 25, 2013, The Times of India

There is growing pressure on the Indian government to incorporate a provision in an investment agreement with the US, which if invoked will have far-reaching implications in that it will allow multinational

September 5, 2013, The Economic Times

India is considering joining a global forum that prescribes standards for medicine manufacturing to safeguard its drug exports to the member countries. Called the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S), it currently comprises 43 drug importing countries.

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Pharma Spectrum The move assumes significance in the backdrop of Indian drugmaker Ranbaxy being recently

Pharma Spectrum

The move assumes significance in the backdrop of Indian drugmaker Ranbaxy being recently penalised $500 million (aboutRs3,350 crore) by the US government for shoddy manufacturing practices. The United States and the European Union are among the key members.

September 5, 2013, Fierce Pharma

In 2012, the Russian market of drugs and dietary supplements totaled 818 billion roubles ($24.8 billion) by value, of which 80% was accounted for by imports. According to state plans, by 2020, the share of domestically produced drugs should be no less than 50%, and in the segment of essential drugs even 90%.

Ethics & Compliance

European business leaders are taking up Pharma's case in China. Foreign drugmakers have been singled out unfairly in Chinese investigations into bribery and anticompetitive pricing, the European Union Chamber of Commerce says. Fighting corruption is great--but the crackdown has to extend to domestic drugmakers, too.

September 17, 2013, BioSpectrum Asia In fact, one official says, it's the very companies with
September 17, 2013, BioSpectrum Asia
In fact, one official says, it's the very companies with the
strongest compliance procedures that are attracting the
most government scrutiny. Foreign multinationals have
been "at large" very responsible, the chamber's top
pharma official, Bruno Gensburger, told Reuters.
With the Chinese getting tough on the pharmaceutical
sector in the country, reports of both foreign
multinationals and domestic companies making amends
to their operations are coming to light. Swiss
pharmaceutical major Novartis has now released a
statement claiming that it has started an internal inquiry
following Chinese press accusations of corruption at its
Alcon eye care division.
Novartis Can't Get Past Foul-Ups At
Consumer Plant; Recalls 4.4 Million
Bottles Of Maalox
August 29, 2013, Fierce Pharma
"Alcon does not tolerate activities that are not in
compliance with the laws and regulations in the markets
where we operate. When any inappropriate activities are
identified, we take swift remedial action," Novartis said
in a statement.
Novartis can't catch a break with its troubled U.S. OTC
plant that has been a source of frustration for CEO
Joseph Jimenez. The Swiss drugmaker has recalled 4.4
million bottles of its popular Maalox products due to
manufacturing problems that predate Jimenez's recent
decision to strip the facility down to the most basic
operations.
'Zorro' Claims Novartis' Alcon Unit
Faked Trials To Bribe Chinese Docs
September 17, 2013, Fierce Pharma
Several weeks ago, Novartis began recalling the Maalox
products from the U.S. and Canada because of packaging
issues. The recall encompasses 9 different types of its
Maalox chewable tablets, including more than 3.4 million
bottles of Maalox Advanced Maximum Strength Antacid &
Antigas.
The bribery allegations in China just keep on coming.
Novartis' Alcon eyecare division now says it will
investigate claims it used fabricated clinical trials to
bribe doctors. The news is none too welcome for
Novartis, which has already faced a set of bribery
accusations in China.

August 27, 2013, Pharma Letter

The Russian pharmaceutical market will continue to focus on imports during the next several years, despite all the attempts of the state to improve the situation and to increase the share of domestic producers, according to results of a recent study conducted by Deloitte, titled Trends and practical aspects of the development of the Russian pharmaceutical market -

2013."

China's 21st Century Business Herald publicized whistleblower allegations against Alcon on Tuesday, the Financial Times reports. Citing an Alcon employee codenamed Zorro, the Chinese newspaper reports that Alcon used a middleman to pay doctors for working on non-existent post-marketing clinical trials.

September 13, 2013, Fierce Pharma

Add Bayer to the list of companies Chinese authorities are investigating. Friday, a Bayer spokeswoman told The Wall Street Journal China's probe has reached the German pharma for a "potential case of unfair

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Pharma Spectrum competition" as the country's government continues its industry-wide crackdown. According to the

Pharma Spectrum

competition" as the country's government continues its industry-wide crackdown.

According to the Journal, a representative from China's corporate registry, the State Administration for Industry and Commerce (AIC), visited an unspecified Bayer office in China at the end of August, the spokeswoman says. "We are fully cooperating with the authority," she told the WSJ without providing further details.

Domestic

IPR / Innovation

September 22, 2013, Business Standard

September 10, 2013, Fierce Pharma Once again, GlaxoSmithKline has the U.S. Justice Department on its
September 10, 2013, Fierce Pharma
Once again, GlaxoSmithKline has the U.S. Justice
Department on its tail. Prosecutors are investigating
bribery allegations that Glaxo faces in China, trying to
determine whether the drug maker violated U.S. law.
First reported by Reuters, the news of the U.S.
investigation illustrates the Justice Department's
renewed zeal about Corporate America's operations
overseas.
Genzyme Corporation, a fully-owned subsidiary of drug
major Sanofi-Aventis, has filed a suit against Dr. Reddy's
Laboratories alleging that the Indian drug maker
infringed patents of its blockbuster cancer drug Mozobil
on three counts.
Mozobil (plerixafor injection) is a hematopoietic stem
cell mobiliser indicated to patients with non-Hodgkin's
lymphoma (blood cancer) and multiple myeloma. In its
petition filed in the District Court of Delaware, Genzyme
alleged that DRL intimated though a letter that it had
submitted
Prosecutors have been eyeing pharma (and other
industries) for violations of the Foreign Corrupt Practices
Act (FCPA), and several drugmakers have paid millions of
dollars to settle corruption probes. Though Glaxo is
based in Britain, its shares are listed in the U.S., making
it vulnerable to FCPA prosecution.
Bristol-Myers Misleading HC In Patent
Case
September 14, 2013, The Times of India
New Appointments
Roche Names Lufthansa CEO Franz to
Replace Humer
The struggle for introducing an affordable version of an
anti-cancer drug in the domestic market has taken an
interesting turn. Even as the patent regulator is yet to
allow BDR Pharma a licence to manufacture a generic
version of cancer drug, dasatinib, drug MNC Bristol-Myers
Squibb has told the Delhi high court that the generic
company's application for compulsory licence has been
rejected.
September 16, 2013, Bloomberg.com
Roche Holding AG (ROG), the world’s biggest maker of
cancer medicines, named Deutsche Lufthansa AG (LHA)
Chief Executive Officer Christoph Franz to replace
Chairman Franz Humer next year. Roche will propose his
nomination to the annual shareholder meeting on March
4, the Basel-based company said today in a statement.
Franz’s term at Lufthansa expires May 31.
BDR Pharma's application seeking compulsory licence on
exorbitantly priced anti-cancer drug is still pending with
the Patent Controller with the related hearings still on, a
company official said. The innovator, BMS is believed to
be "misleading" the court which may "influence the final
order", a lawyer with the law firm, Gopakumar Nair
Associates, which represents BDR Pharma, told TOI.
BDR Pharmaceutical's
Plea
For

Humer, who led Roche for more than a decade, is credited as an architect of Roche’s strategy of yoking its diagnostics and drugs units together to create medicines targeted at individual patients. Humer, 67, was CEO when Roche bought a 30 percent stake in U.S. biotechnology company Genentech Inc. in 1999….

September 12, 2013, The Economic Times

The Indian Patent Office has rejected Mumbai-based BDR Pharmaceutical's application for compulsory licence on cancer drug Dasatinib, according to an affidavit filed by Bristol Myers Squibb, the patent holder for the drug. Compulsory licensing is a provision provided by international intellectual property protection

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Pharma Spectrum agreements under which governments can allow companies to produce generic versions of patent-

Pharma Spectrum

agreements under which governments can allow companies to produce generic versions of patent- protected drugs under certain conditions, including if they are found to be out of reach of the public.

Dasatinib, which Bristol-Myers Squibb sells as Sprycel, is used in the treatment of chronic myeloid leukaemia. In India, a month's dose of this drug costs about Rs 1 lakh. BDR Pharmaceutical had applied for a compulsory licence (CL) on this drug in March and said its version will cost Rs 8,100/month.

The recent crises highlight the weaknesses of the global economic model. As former Federal Reserve chairman Paul Volcker observed on December 11, 2009, "We have another economic problem which is mixed up in this of too much consumption, too much spending relative to our capacity to invest and to export."

Traditional sources of growth include increasing population, sustainable and affordable resources, new markets as well as improved productivity and innovation. Environmental and resource constraints limit the potential for large increases in population. The population in more affluent developed nations is shrinking, with birth rates falling below replacement levels.

Mylan Will Not Shy Away From Pursuing ‘Frivolous’ Patents September 12, 2013, Hindu Business Line
Mylan Will Not Shy Away From Pursuing
‘Frivolous’ Patents
September 12, 2013, Hindu Business Line
Multinational drug-maker Mylan has hinted that it is
willing to get its hands dirty in India, even if this meant
pursuing “frivolous or invalid patents” to bring in less-
expensive generic medicines. “There is a clear
distinction between large brand pharmaceutical
multinationals and Mylan,” said President Rajiv Malik.
Govt Refutes Novartis' Allegations On
Patents
August 29, 2013, Indian Express
Mylan is a multinational, but it is also a generic and
specialty company focused on improving access to
quality, affordable medicines, he clarifies. And to
enhance access, “we will pursue patents we believe are
frivolous or invalid in order to bring generic versions of
products to market sooner and create more affordable
access to these products,” he said, adding that Mylan’s
generic Herceptin programme is a case in point.
Tearing into the allegations made by Novartis on India's
'discriminatory' patent practices, the government has
said global firms, including the Swiss drug major, have
benefited more from the country's rules cornering over
80 per cent of the patents granted.
"You would appreciate that more than 80 per cent of
patents registered in India are attributed to non-
Indians," Commerce Secretary S R Rao has said in a letter
to Novartis AG CEO Joseph Jimenez. Responding to a
letter sent by Jimenez to Commerce and Industry
Minister Anand Sharma, Rao further
Panel
Backs
Compulsory
Licence
On
Cancer Drug
September 11, 2013, Mint
Indian Patent Regime A Thorn In The
Flesh Of Global Drug Makers: Arun
Narasani
An expert committee on compulsory licensing has
recommended that the department of industrial policy
and promotion (DIPP) issue a compulsory licence for the
manufacture of Bristol-Myers Squibb Co.’s anti-cancer
drug Dasatinib to two companies.
August 29, 2013, Pharmabiz, Nandita Vijay
Brain League IP Services and Origiin IP Solutions LLP have
expressed that India needs to be taken seriously by
global pharma majors when it comes to revoking of
patents. This goes by the developments in the last few
months proving that process of getting patent is tough in
India and those granted are extremely prone to
revocation.

If the department approves the recommendation, it will be India’s second compulsory licence and a significant blow to the New York-based drug maker. A compulsory licence would allow the government to produce a generic version of the patented medicine and sell it at a cheaper price.

September 10, 2013, The Economic Times

These included the recent Roche’s Herceptin application. In 2012, India retracted patents granted to Roche's hepatitis C drug Pegasys, Pfizer Inc.'s cancer drug Sutent and Merck's asthma aerosol suspension formulation. While Roche’s Pegasys invention was seen to be not efficient compared to non-pegylated version,

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Pharma Spectrum Regulatory / Medical / Biotech DCGI May Look Into Fresh Quality Complaints Against

Pharma Spectrum

Regulatory / Medical / Biotech

September

24,

2013,

Pharmabiz,

Joseph

Alexander

Ranbaxy's newest facility at Mohali was put under an import alert by US FDA earlier this month after the company had failed to correct violations from prescribed good manufacturing practices noted by US drug regulatory investigators in September 2012 and December 2012.

September 20, 2013, Livemint

Ranbaxy Laboratories, which is facing heat from the US Food and Drug Administration (FDA) over
Ranbaxy Laboratories, which is facing heat from the US
Food and Drug Administration (FDA) over the quality of
products from its Mohali plant, is still under the scanner
of Indian regulatory authorities also and the Drug Control
India’s drug regulator on Thursday said it found no major
discrepancies at Ranbaxy Laboratories Ltd’s
manufacturing plant in Mohali, after the US drug
regulator earlier this week banned imports from the
facility citing irregularities.
General of India (DCGI) said his office will look into the
fresh complaints, if required.
“The investigation is still going on,” DCGI Dr G N Singh
informed about the status of the review of GMP
compliance of Ranbaxy facilities as ordered by the
Health Ministry. “It is an ongoing process as we want to
ensure the safety and efficacy of drugs marketed in the
domestic market,” he added.
“We had carried out inspections of products and services
in the concerned manufacturing units of Ranbaxy, and
have found no major discrepancies. Hence there are no
violations by the company under the Drugs and
Cosmetics Act and Ranbaxy operations will continue in
India as usual,” said G.N. Singh, India’s Drugs Controller
General of India (DGCI).
Indian Drug Regulator Reaches Out To
Other Countries As Issues Mount
46 Habit-Forming Drugs To Be Sold
Only On Doc's Prescription
September 17, 2013, The Economic Times
September 23, 2013, Fierce Pharma
The top drug regulator in India has decided it is time to
confer with some of his peers around the world after a
run of tough regulatory actions by Western countries
against Indian drugmakers. Just last week the FDA issued
Habit-forming anti-biotics, anti -TB and other such drugs
like diazepam sleeping pills will not be freely available
at chemists from March 1 next year, as government has
notified a list of 46 such medicines to regulate their use.
a new import ban against yet another plant of the
country's largest generic drugmaker, Ranbaxy
Laboratories.
According to the Business Standard, with problems for its
drugmakers mounting, Drug Controller General of India
G. N. Singh is confabbing with regulators in Europe this
They will no longer be over-the-counter drugs and will
be sold only through a doctor's prescription. Chemists
will have to record the names and addresses of
prescriber and buyer of all such drugs in a separate
register. As per the notification, such records will have
to be maintained for a period of three years….
week about the cGMP standards that they expect. His
agency might invite officials from the U.S. for discussions
as well.
Expert Panel On FDC Issues Draft
Policy Guidelines For Approval Of FDCs
In India
September
16,
2013,
Pharmabiz,
Ramesh

September 23, 2013, The Economic Times

After the US Food and Drug Administration barred products from Ranbaxy Labs' Mohali plant earlier this month, other global drug regulators from the UK and Australia said that they are seeking information from the US regulator to check the impact on the company's drugs marketed in their respective countries.

Shankar

The Prof C K Kokate-headed expert committee, constituted by the Union health ministry in February this year, to formulate policy guidelines and procedures for approval of fixed dose combinations (FDCs) has issued draft policy guidelines for approval of FDCs in India.

The guidelines apply to the manufacture/ import and marketing approval of any FDCs in the country. As per the guidelines, a clear justification with a valid

Organisation of Pharmaceutical Producers of India

8

therapeutic rationale of the particular combination of active substances proposed along with the appropriate data will be the basis for approval.

To

Not

Neglected Tropical Diseases Govt Asks Pharma Industry Not Pharma Spectrum and includes DNA vaccines and vaccines

Pharma Spectrum

and includes DNA vaccines and vaccines containing living genetically engineered organisms, toxins, antigens and anti-toxins, antibiotics

September 11, 2013, Pharmabiz

September

2,

2013,

Pharmabiz,

Joseph

Alexander

Pointing out that the pharmaceutical industry was ignoring the neglected tropical diseases (NTDs), the Centre has asked the industry to chip in by manufacturing required drugs to combat these NTDs which impact millions of 'faceless and nameless' downtrodden people in India.

Union Health Ministry is planning to make amendment to the Drugs and Cosmetics (D&C) Rules
Union Health Ministry is planning to make amendment to
the Drugs and Cosmetics (D&C) Rules to increase the
period of retention of documents from the
manufacturers and also the control of samples for a
greater time as part of tightening the monitoring quality
of drugs.
“Pharmaceutical industry has been neglecting the NTDs
and there is not sufficient number of drugs and enough
supply to treat these diseases impacting the millions. For
Kala-azar, there is only one company that supplies drugs
for our national programme.
DCGI Asks Clinical Trial Sponsors To
Furnish Details Of Payments To
Investigators Along With Applications
The proposal, which is now under the consideration of an
expert panel, is to amend the rule 65 (7) of the D&C
Rules to increase the period of retention of documents,
registers etc., for a period from two years to five years
in line with the provision for maintaining manufacturing
records.
September
6,
2013,
Pharmabiz,
Joseph
Industry Urges DCGI To Give Deadline
Of March 2014 For Submitting Efficacy
Data Of FDCs Approved By SLAs
Alexander
August 30, 2013, Pharmabiz, Ramesh Shankar
The Drugs Control General of India (DCGI) has asked the
sponsors of clinical trials to furnish details of the
contracts with the investigators with regard to the
financial support, fees and payments in kind, while
making the applications for trial permissions.
The DCGI, in an order, pointed out that good clinical
practice guidelines provide that the sponsor should enter
into a formal and legal agreement/ contract with the
investigators and the institutions before the start of the
trial on various terms of the trial.
Even as the last date for submitting the efficacy data of
FDC drugs approved by the state drug controllers before
October 1, 2012 to the Drug Controller General of India
(DCGI) ends on August 30, the pharma industry in the
country has urged the DCGI to extend the last date of
submission till March 31, 2014 as proposed earlier.
Central Drug Authority To Centralise
Licensing In 17 Critical Categories
The industry has pointed out that the extension of last
date for submission of safety and efficacy data for SLA-
approved FDCs is necessary in view of the extensive
nature of effort and time required in compiling and
submitting the necessary details.
September
3,
2013,
Pharmabiz,
Joseph
Govt Moves Bill To Regulate Drugs,
Cosmetics
Alexander

August 30, 2013, The Times of India

The proposed Central Drug Authority (CDA), though with diluted powers as compared to the original proposal and recommendations, will centralise the licensing in respect of 17 categories of very critical drugs, as per the Drugs and Cosmetics (amendment) Bill, 2013 recently introduced in Parliament.

The government on Thursday introduced a bill in Rajya Sabha that provides for setting up of a Central Drugs Authority as an overarching body for regulation of drugs and cosmetics and seeks to bring 17 critical drugs under central licencing.

The categories of drugs which the central licensing authority is empowered to issue licenses will be sera, solutions serum proteins intended for injection vaccines;

The bill also contains a separate chapter for regulatory provisions for medical devices and for regulating clinical trials and export of drugs and cosmetics. While no person can conduct any clinical trial for a new drug or medical

Organisation of Pharmaceutical Producers of India

9

Pharma Spectrum device or cosmetic, the bill contains severe penal provisions for its violations that

Pharma Spectrum

device or cosmetic, the bill contains severe penal provisions for its violations that include imprisonment of maximum 10 years and penalty of up to Rs 30 lakh.

August

Shirodkar

28,

2013,

Pharmabiz,

Suja

Nair

We are through with clinical trials and have received the necessary approvals. We hope to launch it by the end of this year," Novo Nordisk India Managing Director Melvin D'souza told reporters here. Tresiba is a once-daily basal insulin with a duration of action beyond 42 hours, allowing for flexibility

R&D/Clinical Trials

Understanding woes of the pharma manufacturers in travelling all the way to Delhi to submit
Understanding woes of the pharma manufacturers in
travelling all the way to Delhi to submit the applications
for the FDCs to prove their safety and efficacy, the Drug
Controller General of India (DCGI) informed the
manufacturers that they can file application for the
same, before the deadline, in the nearest zonal or sub
zonal offices.
September
24,
2013,
Pharmabiz,
Ramesh
Shankar
Through this initiative, the DCGI hopes to encourage
more manufacturers to follow the mandate passed by
the Centre which requires all the companies to submit,
Form 44 along with other requisite supporting documents
to prove the safety and efficacy of the FDC on or before
The Department of Biotechnology (DBT), under its Small
Business Innovation Research Initiative (SBIRI) scheme,
has invited proposals from Indian biotech companies for
funding of research and development in the field of
biotechnology. Under this SBIRI scheme, the DBT will
provide support for innovation research in biotech
companies including start-ups and small and medium
enterprises.
August 31.
New Products
Zydus
Launches
Diabetes
Treatment
Drug Lipaglyn
Under this flagship public-private partnership
programme, the DBT will support early stage and proof-
of-concept for innovations based on valid hypothesis,
R&D aimed at affordable product development, lab-scale
technology refinement, validation of a technology at
pilot scale, platform technologies/ prototype
development, etc.
September 17, 2013, The Economic Times
Pharmaceutical entity Zydus group on Monday said it has
launched Lipaglyn, its patented new drug for treatment
of diabetes. Lipaglyn will be available across India and is
priced at Rs 25.90 per tablet. It is recommended for
BA/BE Studies Of New Drugs
Discovered Abroad & Not Marketed In
India Should Not Be Approved To Be
Conducted In India: Panel
once administration of once day as a 4mg tablet, the
company said in a statement.
September
23,
2013,
Pharmabiz,
Ramesh
Shankar
Commenting on the launch of the drug, Zydus Cadila
Chairman and Managing Director Pankaj R Patel said: "It's
a great milestone for Indian pharmaceutical research
today as Lipaglyn completes its journey from the lab to
the market."

September 3, 2013, The Economic Times

World's largest insulin player Novo Nordisk today said it is launching long-lasting insulin injection Tresiba in the country soon. "Tresiba (insulin degludec)-- a new basal insulin for adult patients with type 1 and type 2 diabetes

to be available in India as a new treatment option.

The Prof. Ranjit Roy Chaudhury expert committee, constituted by the union health ministry to formulate policy, guidelines and SOPs for approval of new drugs including biologicals, clinical trials and banning of drugs, has recommended that bioavailability (BA) and bioequivalence (BE) studies of new drug substances discovered abroad and not marketed in India should not be approved to be conducted in India.

If new chemical entities (NCEs), new drug substances or their generic drugs are to be introduced in India, BA/BE studies in patients should be done as a part of the clinical trials, the panel in its recommendations said. However, the expert committee recommended that a generic drug produced in India for the first time should

Organisation of Pharmaceutical Producers of India

10

Pharma Spectrum undergo BE studies in comparison with the innovator molecule. ministry will present details

Pharma Spectrum

undergo BE studies in comparison with the innovator molecule.

ministry will present details of the new regulatory regime for clinical trials.

September 18, 2013, The Times of India

Giving crowd sourcing a whole new meaning, scientists at the Council for Scientific and Industrial Research (CSIR) have initiated a country-wide venture to build a chemical library with diverse compounds that will successfully drive drug discovery programmes, particularly for neglected diseases like tuberculosis and malaria.

September 12, 2013, The Economic Times

An expert panel set up by the drug regulator has recommended a minimum compensation of Rs 2 lakh for the family of 'most serious, terminally ill' patients who die because of drug study-related injuries. The recommendation is part of a government move to address concerns raised by health activists that pharmaceutical companies do not always adequately compensate volunteers for clinical trials who end up with injuries.

CSIR had launched the Open Source Drug Discovery (OSDD) in 2008 with the objective of
CSIR had launched the Open Source Drug Discovery
(OSDD) in 2008 with the objective of discovering drugs
for neglected diseases like TB, malaria and others
through open innovation and sharing of research that has
been lauded across the globe.
New
Law
To
Regulate
Biomedical,
Health Research
The expert committee, set up by the Drug Controller
General of India (DCGI), has also set a range of Rs 4 lakh
to Rs 74 lakh as payout, depending on age and health
risks of volunteers at the time of enrollment. These
figures are significantly higher than what some drug
makers pay to trial victims in India.
September 16, 2013, The Economic Times
In the absence of any law to deal with biomedical and
health research, government has decided to regulate all
such activities in medical colleges, universities, hospitals
and public and private organisations. The Ministry of
Health has proposed the Biomedical and Health Research
Bill to ensure ethical research in all institutions with
proper care and compensation policy for human
participants in such task.
Health Panel Wants Legal Action
Against US Agency
September 3, 2013, Hindu Business Line
The Standing Committee on Health and Family Welfare
has instructed the Centre to take legal action against a
US agency, Programme for Appropriate Technology in
Health (PATH), for violating clinical trial norms in India.
The proposed law will ensure compulsory registration
and evaluation of ethics committees set up in all kinds of
research institutions and provide for penal provisions
against those engaged in unauthorised research, officials
told. The law will also cover institutions and sponsors
undertaking unethical biomedical research at places with
inadequate facilities.
In its report about the deaths of some female children
and adolescents in Khammam district of Andhra Pradesh
after being administered Human Papilloma Virus (HPV)
vaccines by PATH in 2010, the committee observed that
the agency showed gross violation of the concept and
legal requirement of consent from study subjects for
clinical trials.
Clinical Trials Of New Drugs Get Fresh
Impetus As Govt Clears 55 Proposals
DNA
Editorial:
Safeguard
Patients’
Interests
September 13, 2013, Financial Express
September 2, 2013, DNA

In a move that will provide a big impetus to India's $500- million clinical trial industry, which has of late seen stunted growth, the government on Thursday cleared around 55 trials proposed by pharma firms and clinical research organisations, including Dr Reddy's, Eli Lilly, MSD Pharma, Cadila Healthcare, Quintiles.

The approvals are for trials regarding new drugs (including new chemical entities) and new fixed dose combinations. The approvals, given by the health ministry’s apex committee, come ahead of a September 24 hearing by the Supreme Court where the health

The current problems affecting clinical trials in the country a critical component of the $18 billion pharma sector and essential for developing affordable medication are following a familiar pattern. There are certain commonalities in the manner in which regulatory oversight functions in various sectors in the Indian economy.

The guidelines that seem adequate on paper turn out to be lacking in practice not because there is something fundamentally wrong with them but because of flawed implementation. This could be due to corruption,

Organisation of Pharmaceutical Producers of India

11

Pharma Spectrum inefficiency or a lack of resources. In an effort to plug the gaps,

Pharma Spectrum

inefficiency or a lack of resources. In an effort to plug the gaps, harsher guidelines are instituted.

August 31, 2013, The Times of India

In a further indication of the rot in the country's healthcare system, a parliamentary panel has rapped the government for gross irregularities in drug trials, under- reporting and lapses in monitoring serious adverse events and lethargy in safeguarding health, in studies on cervical cancer prevention vaccine by a US-based non- governmental agency.

circulated a draft Cabinet note that seeks to bring down FDI limit in brownfield pharma and calls for putting foreign investment in drug facilities defined as "critical" on the approval route, industry experts advocate the need to clear ambiguities in the current FDI policy to give the much required boost to the Indian pharma industry. Experts argue that there is a need for a sustainable policy as dilly dallying in terms of Greenfield and Brownfield projects makes the investment climate unpredictable.

September 16, 2013, Indian Express Charging the government for inaction, the parliamentary committee on health
September 16, 2013, Indian Express
Charging the government for inaction, the parliamentary
committee on health says in a report that the issue has
been diluted with no accountability fixed on erring
officials for serious violations committed in the studies
which led to the death of hapless tribal children three
years back.
The Health Ministry may have to reconsider its stand that
all foreign direct investment (FDI) in existing
pharmaceutical companies should continue to be routed
through the Foreign Investment Promotion Board (FIPB).
Both the Prime Minister's Office and the Planning
Commission are inclined towards opening up FDI across
sectors.
Mergers &
Acquisitions /
Collaborations
The Health Ministry has been opposed to the idea of
including pharmaceutical companies in the automatic FDI
list since its inception. In fact, the Parliamentary
standing committee in a report tabled in the recently-
concluded Monsoon Session called for a blanket ban on
FDI in brownfield pharma companies.
DIPP
Seeks
To
Restrict
FDI
In
Brownfield Pharma Projects
Cap On FDI: Health Ministry To Identify
‘Critical’ Pharma Sectors
September 12, 2013, Hindu Business Line
September 19, 2013, Hindu Business Line
Restrictions on Foreign Direct Investment (FDI) in
existing pharmaceutical projects will apply on drugs that
are identified as ‘critical’ by the Health Ministry. The
Industry Department, in its draft Cabinet note, has
placed the responsibility of identifying the sectors where
takeovers would not be permitted on the Health
Ministry.
The Department of Industrial Policy & Promotion (DIPP)
has floated a Cabinet note seeking restrictions on foreign
direct investment (FDI) in existing pharmaceutical
projects in specific areas, such as vaccines, injectibles
and oncology medicines.

It has also proposed that foreign investors be mandated to create at least 25 per cent additional capacity and generate additional employment in the critical pharma projects they are investing in, a Department of Industrial Policy and Promotion (DIPP) official told Business Line.

For

FDI

In

September

19,

2013,

Pharmabiz,

Shardul

Nautiyal

“Once we have incorporated the comments of all ministries (Finance and Health) and departments in the note, we will send it to the Cabinet for approval,” a DIPP official told Business Line. The Government allows 100 per cent FDI in pharmaceuticals, but while investments in new projects are allowed automatically, investments in brownfield or existing pharmaceutical companies are required to be routed through the Foreign Investment Promotion Board (FIPB) since late last year.

September 5, 2013, Financial Express

Even

Promotion (DIPP), the nodal body for FDI policy, has

and

as

the

Department

of

Industrial

Policy

In a case similar to the Vodafone group’s $2-billion tax dispute, the Supreme Court on Wednesday asked French drug major Sanofi SA to explain why it should not pay tax

Organisation of Pharmaceutical Producers of India

12

Pharma Spectrum to the tune of around R1,058.07 crore on a cross-border merger involving Indian

Pharma Spectrum

to the tune of around R1,058.07 crore on a cross-border merger involving Indian assets of Hyderabad-based Shantha Biotechnics (SBL).

A bench headed by Justice AR Dave sought reply from

the French firm after the income-tax department challenged the Andhra Pradesh high court's February 15 order that ruled in favour of Sanofi Pasteur Holding SA. It also posted the matter for further hearing on January 14 and asked the parties to file short notes.

Mukherjee today said there is a need to increase spending in the key sector to provide better health and nutritional security to the people.

"Public expenditure on health in India is 1.2 per cent of GDP. This is much lower than the 4 per cent plus levels in countries like US, UK, Australia, Norway and Brazil," Mukherjee said after inaugurating the new hospital building of Jagadguru Sri Shiva-rathreeshwara (JSS) Maha-vidya-peetha here.

September 4, 2013, The Economic Times September 24, 2013, The Times of India The government
September 4, 2013, The Economic Times
September 24, 2013, The Times of India
The government today cleared the Rs 5,168-crore deal of
the US-based Mylan Inc for acquiring Bangalore-based
pharma firm Agila Specialties, a subsidiary of Strides
Arcolab. The decision was taken at a meeting of the
Cabinet Committee of Economic Affairs (CCEA) held
here, Information and Broadcasting Minister Manish
Tiwari told reporters.
Perturbed by reports of shortage of essential medicines
on retail shelves after the implementation of new
pharma policy, the government has sent out a sharp
message to drug companies and trade channels to ensure
their availability across the country.
The acquisition, however, is subject to certain
conditions. After the completion of acquisition process,
Mylan has to maintain the investment level in R&D in
value terms for five years at absolute quantitative level
Supplies of widely used medicines such as pain relievers
paracetamol and diclofenac, treatment for worms
albendazole and those used in chronic ailments like
cholesterol-lowering drug atorvastatin, diabetes drug
metformin and blood pressure drug enalapril have been
affected.
at the time of induction of FDI, according to sources.
Recovery Of Arrears
By
NPPA
In
Overcharging
Cases
Picks
Up
Access & Pricing
Momentum
September
20,
2013,
Pharmabiz,
Joseph
NPPA
Fixes
Prices
Of
43
More
Alexander
Formulation Packs As Per New DPCO
September 25, 2013, Pharmabiz
The National Pharmaceutical Pricing Authority (NPPA),
continuing its exercise of revising the prices of essential
medicines under the new Drug Price Control Order, 2013,
has fixed the prices of 43 more formulation packs.
Spurred by intensive efforts like defending the court
cases and issue of revenue attachment notices, the
recovery of overcharging amount by the National
Pharmaceutical Pricing Authority (NPPA) from defaulting
companies has picked up momentum this year, after a
sluggish phase in the last few years.

The formulations are based on the bulk drugs of allopurinol, dexchlorpheniramine maleate, promethazine, phenobarbitone, piperazine, dapsone, ethambutol, isoniazid, acyclovir, didanosine, stavudine, diltiazem, nifedipine beclomethasone dipropionate, hydrocortisone sodium succinate, ipratropium bromide,

September 24, 2013, The Economic Times

Observing that the country's public expenditure on health is only 1.2 per cent of GDP, President Pranab

In the first eight months of this year, the total recovered amount stood at Rs.19.17 crore whereas the total recovery during 2012-13 was Rs.14.97 crore. After Rs.51.41 crore collected during 2008-09 and Rs.35.41 crore during 2009-10, the recovery had gone slow. During 2010-11, the total amount stood at Rs.17.26 crore

September 11, 2013, The Economic Times

With government spending on health less than two per cent of GDP, President Pranab Mukherjee today expressed concern over the low expenditure and

Organisation of Pharmaceutical Producers of India

13

Pharma Spectrum advocated universal healthcare as a plausible solution. Inaugurating a meeting of Ministers of

Pharma Spectrum

advocated universal healthcare as a plausible solution. Inaugurating a meeting of Ministers of Health and a Session of WHO Regional Committee for South-East Asia at Rashtrapati Bhavan, Mukherjee noted with concern that 46 per cent people in the region lived below poverty line and asked nations to build an environment for quality health.

led to de-stocking by companies and retailers which was compounded by the retail traders strike in Maharashtra.

In terms of overall performance, multi-national drug companies were more severely hurt in the quarter compared to their Indian peers. That is because unlike Indian companies which earn a bulk of their revenues from exports, much of the revenues of multinational drug companies are accounted

September 6, 2013, Livemint

Agrowing number of private companies are trying to tap Big Data—analysing large amounts of information
Agrowing number of private companies are trying to tap
Big Data—analysing large amounts of information to
detect and forecast trends and patterns—to serve
healthcare, as the government moves to set up an
electronic medical record system that will hook up
25,000 villages across the country.
August 28, 2013, The Economic Times
“How to put Big Data to its fruitful logical conclusion is
the challenge that is faced by the country today,” N.K.
Dhamija, deputy commissioner and nodal officer of tele
medicines at the health ministry, told a conference of
government health officials and private sector
entrepreneurs looking to utilize Big Data in healthcare.
The Delhi High Court on Tuesday extended relief for
pharma firms, including Sun Pharma and Cipla, on
relabeling of their existing stock under the new drug
pricing regime on the condition that they comply with
the interim order and posted the case for next hearing
on September 23.
The two companies along with a dozen other drug firms
had challenged the government on specific provision
under Drug Price Control Order 2013 which makes it
mandatory upon the companies to label revised prices
within 45 days of the price notification.
Panel Asks DoP To Identify Pharma Cos
Changing Compositions To Dodge Price
Control Provisions
NPPA
Revises
Price
Of
Nine
Formulation Packs
August 28, 2013, Pharmabiz
August
29,
2013,
Pharmabiz,
Joseph
Alexander
The Parliamentary Standing Committee attached to the
Chemicals Ministry has asked the Department of
Pharmaceuticals (DoP) to identify the pharmaceutical
companies which are circumventing price control
mechanism by changing the composition and strength of
their formulations.
The panel also asked the DoP to take up the matter with
the ministry of health and family welfare for further
action. In its recent recommendation, the Committee
once again took up the issue of pharma companies
dodging the provisions of the price control mechanism
and asked the Department to follow up the matter.
The National Pharmaceutical Pricing Authority (NPPA)
has fixed/ revised the prices in respect of nine
formulation packs, in accordance with the provisions of
the new Drug Price Control Order (DPCO), 2013. The
formulations are based on the bulk drugs including
pyrazinamide, propranolol hydrochloride,
cyclophosphamid, oxaliplatin, diazepam, cefixime
trihydrate with ofloxacin, according to a notification by
the agency. The NPPA also issued correction orders with
regard to its earlier three orders.
Health Ministry Launches Rs. 2550-Cr
NACSP To Accelerate AIDS Prevention
Programme

August 28, 2013, The Economic Times (epaper page 7)

The quarter to June was a bad one for most pharma companies with a slowdown in growth for over a year now, weighing heavily on their performance. To add to their woes, the implementation of the new drug policy

August 28, 2013, Pharmabiz

The Union health ministry has launched the Rs.2,550- crore National AIDS Control Support Project (NACSP) which is aimed to help and accelerate the country’s AIDS prevention programme by targeting high risk groups like Female Sex Workers, men who have sex with men and Injecting Drug Users.

The World Bank is supporting this project with an interest-free loan of Rs.1,275 crore. The project would

Organisation of Pharmaceutical Producers of India

14

Pharma Spectrum also support the planned expansion and consolidation of tailored interventions for other at-risk

Pharma Spectrum

also support the planned expansion and consolidation of tailored interventions for other at-risk populations, including migrant workers and truckers, which play a critical role in the transmission dynamics of HIV in the country.

Trade

However, the move which was keenly awaited by the small and medium scale units for long, will not do any good to the very small generic manufacturers as the government will buy medicines from firms which have an average annual turnover of Rs.10 crores in the last three years.

September 5, 2013, Financial Express

September 24, 2013, Livemint Sales of drugs in India grew at a tepid 4.9% in
September 24, 2013, Livemint
Sales of drugs in India grew at a tepid 4.9% in August, the
slowest pace in at least eight months, mainly due to
lower stock intake by distributors and retailers,
favourable weather conditions and weakening of the
rupee against the US dollar.
To curb the growing menace of counterfeit brands, FMCG
companies ITC and Coca-Cola India, along with the
Federation of Indian Chambers of Commerce and
Industry (Ficci), are planning to take stringent steps in
the next few months.
The Rs.75,933-crore local drug market grew at an
average 12-13% pace in January-July, according to the
latest data by pharma market researcher IMS Health
India. August also saw dramatic changes in the rankings
of leading drugmakers and their top-selling brands, IMS
Health said.
To start with, Ficci’s committee against smuggling and
counterfeiting activities destroying the economy
(CASCADE) has initiated a pan-India movement against
smuggling and counterfeiting amongst youth and
consumers.
Medicine Shortage Being Felt Across
The Country
September 4, 2013, Hindu Business Line
Drug
Companies
To
Raise
Trade
Margins
September 21, 2013, The Times of India
Shortage of essential medicines on retail shelves may be
over soon with major companies like Cipla, Mankind
Pharma and Torrent deciding to give in to the demand of
higher trade margins and hoping to end the stalemate
between the industry and chemists.
Shuba’s father-in-law had carried only a limited stock of
his asthma medicine when he travelled from Payyanur
(Kerala) to Mumbai to spend time with his children. After
all, the medicine could be bought at pharmacies
anywhere in the country.
Drug major Cipla and Mankind Pharma decided on Friday
to increase the trade margins to 10% to stockists and 20%
to retailers on the price-controlled basket of drugs, as
against the earlier offered 8% and 16% respectively,
while others like Torrent and Eris Lifesciences are doling
out a 5% special discount'' on these medicines to
stockists.
But that was not to be, as the family found out when he
exhausted his stock. The medicine was not available with
chemists in Mumbai, Payyanur or Chennai and Shuba had
to call the doctor in Kerala to get an alternative to this
asthma medicine.
Drug Price Order – Gain For Patients,
Pain For Retailers
September 3, 2013, Hindu Business Line

September

18,

2013,

Pharmabiz,

Joseph

Alexander

Some 350 drugs are set to become cheaper in the weeks ahead thanks to the Drug Price Control Order 2013. The Order mandated reduction of prices of the medicines within 45 days of the notification being issued and that the reduced prices apply to drugs already being sold in the market.

After toying with the idea for several years, the department of pharmaceuticals (DoP) has finally decided to source generic drugs from private sector manufacturers and initiated the steps in this regard, as part of the new attempt to revive the Jan Aushadhi programme with a new business plan.

Manufacturers were to replace existing stocks with the new price mentioned on labels. The Order officially came into effect from end July. This move will bring relief to lakhs of patients. But pharma manufacturers and the 7.5 lakh chemists and druggists in the country are unhappy as this order will erode their margins.

Organisation of Pharmaceutical Producers of India

15

Pharma Spectrum Number Of Spurious Drugs Comes Down Significantly During 2012-13 August 29, 2013, Pharmabiz,

Pharma Spectrum

August 29, 2013, Pharmabiz, Ramesh Shankar

There has been a remarkable reduction in the number of drug samples declared spurious or adulterated by the drug control authorities in the country during the year 2012-2013 compared to the previous year. The number of drug samples declared spurious or adulterated has come down drastically from 133 in 2011-12 to just 70 in

2012-13.

As the Regional Director, Dr Khetrapal Singh brings a vast repertoire of experience, having worked in the health sector for over three decades at both national and international levels. She served with WHO for the past 15 years. She is the first woman to be nominated to this post in the Region, according to a release here on Thursday.

OPPI Related News / Events

According to official data, the drug control authorities in different states in the country had
According to official data, the drug control authorities in
different states in the country had collected and tested
a total 57,351 random drug samples during the year
Targeting Neglected Diseases
2012-2013 in which 2327 samples were declared not-of-
standard quality drugs while a total of 70 drug samples
September 11, 2013, Indian Express
were declared spurious or adulterated.
Ethics & Compliance
No Relevant News
New
Appointments
/ Transfers
Dr Poonam Khetrapal Singh Nominated
WHO Regional Director
September 13, 2013, Pharmabiz
Dr Poonam Khetrapal Singh has been nominated as
Regional Director for the WHO South-East Asia Region,
involving 11 countries. She will become the first woman
International experts and representatives of the Indian
government, along with global health organisations,
recently gathered in Delhi for a conference titled
"Partnering for Success – Reducing India's Burden of
Neglected Diseases." Experts from various fields of
medicine comprised panels that examined the need to
understand the economic and social burden of neglected
disease, how to reach the poorest and most
marginalised, and how to increase research and
development capacity. In 2012, the World Health
Organisation established targets for the control and
elimination of 10 neglected tropical diseases by 2020.
Governments around the world — working in partnership
with civil society organisations and the pharmaceutical
industry — have joined in a global coordinated effort to
meet this challenge. The conference on Reducing India's
Burden of Neglected Diseases is being convened by
Global Health Progress (GHP), Organisation of
Pharmaceutical Producers of India (OPPI) and
International Federation of Pharmaceutical
Manufacturers & Associations (IFPMA).
to hold this post. The 32-member Executive Board of the
World Health Organisation (WHO) is expected to appoint
Dr Khetrapal Singh as Regional Director in January 2014,
in Geneva for a five-year period and she will assume
charge in February at the regional office in New Delhi.

Organisation of Pharmaceutical Producers of India

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