Drug Information Bulletin - Indian Pharmaceutical Association

Drug Information Bulletin
Drug Information Centre (DIC)
Indian Pharmaceutical Association
Bengal Branch
Tele fax: 033 24612776, E-mail: ipabengal.dic@gmail.com
Web Site: http://www.ipabengal.org
Contact: 09830136291
5 th
Year
Volume: 05 Number: 46 25 th February 2012
Content
• MSF urges company to drop court case in India at Novartis shareholders meet
• USP monograph of Meloxicam updated
• New excipient monographs official in the second supplement of USP 34–NF 29
• FDA panel recommends Aclidinium Bromide for COPD
• Europe's spending cuts limit pharmaceutical profits
• Dr G N Singh appointed as new DCGI of India
• One step closer to blocking the transmission of malaria
• IPA Bengal Branch collaborated with 12 th Congress of International Society of
Ethnopharmacology at Kolkata during 17 th -19 th February 2012
MSF urges company to drop court case in
India at Novartis shareholders meet
BASEL, 23 February 2012 – As
shareholders of Swiss pharmaceutical
company Novartis meet today in Basel,
Switzerland, the international medical
humanitarian organization Médecins Sans
Frontières (MSF) called on shareholders to
urge the company to drop its ongoing
court case against the Indian government.
MSF is concerned that the case could have
a severe impact on access to affordable
medicines for people across the developing
world.
'Shareholders at this meeting need to know
what the stakes are on this case and what the
consequences will be,' said Dr. Unni
Karunakara, MSF's International President. 'We
are asking Novartis once and for all to stop this
legal battle in India that is a direct attack on the
pharmacy of the developing world. We will not
stand by silently and watch our source of
affordable medicines dry up in the future'we
rely on these drugs to do our work in more
than 60 countries today.'
The hearing is scheduled to take place before
India's Supreme Court in March, and India's
Attorney General has just been appointed to
defend the case for the government.
'The implications of this case reach far beyond
India and far beyond this particular cancer
drug,' said Leena Menghaney, Manager for
MSF's Access Campaign in India. 'Novartis
shareholders need to question the company's
attempt to break a system on which millions of
people in developing countries rely on for
affordable treatment. We urge Novartis
investors to tell the company to drop the case.'
Novartis first sued the Indian government in
2006, after a patent the company was seeking
for the cancer drug imatinib mesylate was
rejected. India grants product patents in line
with international trade rules since 2005, but in
the interest of public health, India's law is strict
about what does and does not deserve a

patent. Patents are not granted on
modifications of drugs that already exist.
Because Imatinib mesylate was the salt form of
imatinib, the original invention behind the
cancer drug, it was not granted a patent.
Since then, Novartis has been attacking this
part of India's patents law -called Section 3(d) -
in the courts. After losing a legal battle to have
Section 3(d) removed from Indis;s patent law
in 2007, the company is now trying a new legal
tactic to weaken it.
A Novartis win will lead to Indian patent offices
granting patents on modifications to drugs
which would otherwise remain off-patent in
India. This would take the substance out of a
public health provision which has already
demonstrated its importance in securing
affordable access to key HIV, TB and cancer
medicines.
MSF has launched a Stop Novartis social media
campaign to draw attention to the implications
of the case and to call on the company to back
down. Alongside other civil society
organizations including Act Up, Oxfam and the
Berne Declaration, MSF is protesting against
the company's actions outside the shareholder
meeting in Basel and outside of Novartis
headquarters in New York.
Generic medicines produced in India make up
80% of the HIV drugs MSF uses to treat
170,000 people in 19 countries.
Source: E drug
USP monograph of Meloxicam
updated
Meloxicam
Type of Posting: Revision Bulletin
Posting Date: 24–Feb–2012
Official Date: 01–Mar–2012
Expert Committee: Monographs—Small
Molecules 2
Reason for Revision: Compliance
2
In accordance with the Rules and
Procedures of the 2010-2015 Council of
Experts, the Monographs—Small Molecules
2 Expert Committee has revised the
Meloxicam monograph. The purpose for
the revision is to eliminate the use of USP
Meloxicam Related Compound D RS under
the test for Organic Impurities, Procedure
2. Recent evaluation of the current lot of
USP Meloxicam Related Compound D RS
by USP scientific staff has determined that
it is not suitable for its compendial usage
as described in USP 34–NF29.
The Organic Impurities Procedure 2 is
revised as follows:
System suitability stock solution and
System suitability solution are deleted from
the monograph, and the resolution
requirement between meloxicam related
compound D and meloxicam under System
Suitability is deleted.
Meloxicam related compound D is no
longer listed in Table 4 as a specified
impurity eluting at the relative retention
time of 2.4. An impurity eluting at this
relative retention time is now controlled as
an individual unknown impurity. The limit
of this impurity remains unchanged at NMT
0.1%.
The Meloxicam Revision Bulletin
supersedes the currently official
monograph and will be incorporated in the
Second Supplement to USP 35–NF 30.
Should you have any questions, please
contact Clydewyn Anthony, Ph.D. (301-
816-8139 or cma@usp.org).
Download the Meloxicam Revision Bulletin
New excipient monographs official in
the second supplement of USP 34–NF
29
• Chitosan
• Polyglyceryl 3 Diisostearate
• Racemethionine

• Hydroxypropyl Corn Starch
• Hydroxypropyl Pea Starch
• Hydroxypropyl Potato Starch
www.uspnf.com
FDA panel recommends Aclidinium
Bromide for COPD
Dow Jones Newswires reports an advisory
panel to the US Food and Drug
Administration recommends the approval
of aclidinium bromide, a drug made by
Forest Laboratories Inc, intended to treat
chronic obstructive pulmonary disease
(COPD).
"The 12-2 vote of the Pulmonary-Allergy
Drugs Advisory Committee on Thursday
came with calls for a post-marketing study
to determine the risk of cardiovascular side
effects," MedPage Today explains. The
company "is seeking approval to market
the drug -- inhaled at a dosage of 400 mcg
twice a day -- for long-term treatment of
bronchospasm associated with COPD,
including chronic bronchitis and
emphysema." The piece adds, "Aclidinium
is a newer type of anticholinergic known as
a long-acting M3 muscarinic antagonist."
Europe's spending cuts limit
pharmaceutical profits
The New York Times reports, "Profits at
pharmaceutical companies have been
declining or showing little growth for the
last year as austerity measures across
Europe lead to cuts in health care
spending. Some analysts say this trend
could continue until at least 2014."
Because of budget constraints, some
European governments are adopting laws
that put "pressure on companies to prove
their drugs are effective or risk having
them dropped from the coverage list, or
covered at a lower rate." The price
slashing can impact emerging markets
because less wealthy nations "refer to the
prices set in Europe to determine their
own." Due to reduced spending from
3
governments, European drug companies
are being focused to draw back research
funds and develop new strategies for
marketing medicines.
Dr G N Singh appointed as new DCGI
of India
Dr G N Singh was today appointed and
given additional charges of the Drug
Controller General of India (DCGI). Apart
from handling the responsibilities as the
DCGI of the country, he will also handle
responsibilities of his previous office as the
secretary-cum-scientific director of the
Indian Pharmacopoeia Commission (IPC).
He has been discharging the functions and
duties of chief scientific and executive
officer in the IPC since January, 2009.
Dr Singh did his Master’s and Doctorate
degrees in Pharmaceutical Sciences from
Banaras Hindu University and has an MBA
from University of Hull, UK. At his credit,
he has a long research and administrative
experience of 22 years and has authored
and published about 70 research papers.
His scientific achievements are reflected in
publishing Addendum 2002 to IP 1996 and
Addendum 2005; fifth edition of IP in the
form of IP 2007; Addendum 2008 of IP
2007 and sixth edition of IP 2010. He has
also played a vital role in the publication of
Addendum 2011 to IP 2010, National
Formulary of India (NFI) 2010 and
ensuring availability of IP Reference
substances.
One step closer to blocking the
transmission of malaria
*Geneva, 21 February 2012. *Today, the
first comparative analysis of all currently
available and in-development antimalarials
in terms of the steps they target in the
malaria parasite’s lifecycle has been

published in *PLoS Medicine. *This
research, carried out on 50 anti-infective
molecules by Medicines for Malaria Venture
(MMV) and partners, provides the missing
pieces of the puzzle needed to develop
future medicines able to block transmission
of the parasite from person to person.
Current medicines mostly target the
malaria parasite at the blood stage in its
lifecycle, because this is the step that leads
to clinical symptoms. However, to block
transmission of the parasite, a critical
strategy of the malaria eradication agenda,
we need to be able to kill the parasite at
the sexual and vector (mosquito) stages of
its lifecycle.
Research teams from Imperial College
London, Genomics Institute of the Novartis
Research Foundation, Swiss TPH,
University of Basel, Scripps Research
Institute and MMV were able to reproduce,
in the laboratory, the complex biology of
the malaria parasite throughout its
lifecycle. This then allowed them to test
the activity of the 50 molecules against
each
‘laboratory-produced step’ to determine
exactly where they act.
4
complete data provides us with a
benchmark against which to assess any
newly discovered molecules.”
The original research article entitled: ‘The
Activities of Current Antimalarial Drugs on
the Life Cycle Stages of Plasmodium: A
Comparative Study with Human and
Rodent Parasites’, can be accessed free of
charge via the following link:
www.plos.org/media/press/2012/plme-09-
02-leroy.pdf
IPA- Bengal Branch collaborated with
12 th Congress of International Society
of Ethnopharmacology held at
Kolkata during 17 th -19ih February
2012.
The research revealed a number of
interesting findings. Specifically, some
already available antimalarials, such as
pyronaridine and atovaquone, can target
the liver and sexual stages of the parasite
in addition to the blood stage. The
endoperoxide OZ439, currently in Phase II
clinical trials in MMV’s pipeline, and a new
8-aminoquinoline, NPC-1161B, also
demonstrated transmission-blocking
potential.
“These specific findings will be critical in
guiding the selection and combination of
next-generation molecules to succeed
artemisinin combination therapy and will
support the drive to eradicate malaria,”
said Tim Wells, CSO of MMV, “while the
Dr. A. P. J. Abdul Kalam, His
Excellency, Former President of
India delivering inaugural address of
12 th Congress of International
Society of Ethnopharmacology at
Kolkata on 17 th February 2012.