Number 40 - 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
Volume: 06 Number: 40 12 th January 2013
Content
• DCGI approves Itolizumab for Psoriasis treatment
• USP Monograph of Butylparaben updated on 11 th January 2013
• Clarithromycin use may be linked to increased risk of miscarriage
• Supreme Court notice to Government on PIL over marketing of Gardasil and
Crevarix vaccines
• Indian Government plans new legislation to take DPCO out of Essential
Commodities Act ambit
• US FDA approves Bedaquiline for Resistant TB Treatment
• Forthcoming Event
DCGI approves Itolizumab for
Psoriasis treatment
It as been reported that the Drugs
Controller General of India (DCGI) has
approved its novel biopharmaceutical for
treating psoriasis, itolizumab (anti-CD6
molecule). The Bangalore, India-based
Biotech Company said it expects to
launch the monoclonal antibody on the
market some time this year, after which it
will file an investigational new drug
application with the US Food and Drug
Administration. The Journal points out
that itolizumab is the second monoclonal
antibody drug developed by Biocon. The
other drug is a cancer treatment called
Nimotuzumab (bioMab EGFR).
For details:
http://online.wsj.com/article/SB10001424
127887323482504578228801388202138.
html
USP Monograph of Butylparaben
updated on 11 th January 2013
A harmonized standard for Butylparaben
has been approved by the Pharmacopeial
Discussion Group (PDG) as described in
its PDG Sign-Off Cover Page. Having
reached Stage 6 of the PDG process, the
Butylparaben monograph has been
formally approved by the USP
Monographs—Excipients
Expert
Committee in accordance with the Rules
and Procedures of the 2010–2015 Council
of Experts.
Changes from the existing USP–NF
monograph include:
• Replacing the current TLC method for
Related Substances and titration
method for Assay with one HPLC
method for both tests
For details:
http://www.usp.org/sites/default/files/us
p_pdf/EN/USPNF/butylparaben.pdf
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Clarithromycin use may be linked to
increased risk of miscarriage
MedPage Today reports, "Use of the
antibiotic clarithromycin (Biaxin) in the
first trimester of pregnancy is associated
with an increased risk of miscarriage,"
according to a study published online in
PLOS ONE. Researchers found, "in a large
cohort study," that women "who took the
drug in the first trimester were 56% more
likely to miscarry than those who did not
take the drug." However, there was "no
increase in the risk of birth defects."
treatment or monitoring, resulting in
fatalities.
The drugs have been used on thousands
of adolescent girls in Gujarat and Andhra
Pradesh, they said. "These vaccines had
not been assessed with respect to safety
and efficacy for the Indian population,
where adolescent girls are
overwhelmingly anemic and
malnourished. No steps were taken to
ensure the health and safety of the girls,"
the petitioners said.
Supreme Court notice to
Government on PIL over marketing
of Gardasil and Crevarix vaccines
The Supreme Court has issued a notice to
the government on a plea that licences
for sale and marketing of Gardasil and
Crevarix, vaccines for prevention of
cervical cancer, should be revoked as the
drugs are "unsafe" and the permits were
granted without adequate research.
Gardasil and Crevarix, both human
papilloma virus (HPV) vaccines, are being
marketed in India by MSD
Pharmaceutical, a subsidiary of Merck,
and GlaxoSmithKline, respectively.
"Both vaccines were licensed in India
without sufficient clinical trials in
appropriate age groups to determine their
safety and efficacy," the public interest
litigation (PIL), filed on behalf of an
Andhra Pradesh-based women's
organisation, said.
Seeking a ban on their sale and use,
petitioners Kalpana Mehta, Nalini Bhanot
and V Rukmini Rao alleged that the
drugmakers were "conducting trials" on
unsuspecting women from vulnerable
sections of the society without follow-up
The PIL claimed that the Parliamentary
Standing Committee for Health and
Welfare had sought a probe into the
approval for marketing of these vaccines
but "this was not done". According to the
PIL, the Indian Council for Medical
Research had entered into an MOU with a
US-based NGO to execute a project to
test the drugs.
Source: Economic Times
Indian Government plans new
legislation to take DPCO out of
Essential Commodities Act ambit
The government is planning to bring a
new legislation to modify and place the
Drugs Price Control Order (DPCO)
separately from the ambit of the Essential
Commodities Act.
However, the new legislation is unlikely to
be presented in the Budget session of
Parliament and the Department of
Pharmaceuticals (DoP), hence, would
notify the revised DPCO before the
session, it is learnt. The new DPCO will
lay out the retail price of over 640 packs
of 348 essential medicines.
“The National Pharmaceutical Policy was
already notified and to define the
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mechanism of price control, the DPCO will
have to be modified. Later, a special
legislation will be brought to take out
DPCO from the ambit of the Essential
Commodities Act and place it separately,”
sources said.
The special legislation will thus give a
regulatory framework, covering price
control and monitoring of drugs by the
National Pharmaceutical Pricing Authority
(NPPA), based on the policy announced
already. The NPPA however will
implement the policy once the DPCO is
notified.
The DoP also has to ensure provisions for
organisational and financial support to
enable the NPPA to implement the new
policy in an effective and transparent
manner. Hence, the policy may finally
come into effect only from the next
financial year.
The US Food and Drug Administration
(FDA) approved bedaquiline on 31 st
December 2012 as part of the treatment
regimen for multidrug-resistant
tuberculosis (MDR-TB) when other agents
are unavailable.
Bedaquiline, to be sold under the brand
name Sirturo by Janssen Therapeutics, a
division of Janssen Products LP, was
approved under the FDA's accelerated
approval program on the basis of phase 2
efficacy and safety data that used the
surrogate study endpoint of sputum
culture conversion rather than clinical
cure. The FDA had allowed the company
to move forward with the phase 2 data to
support its new drug application for
accelerated approval because of the
unmet need. However, as a condition of
submission under accelerated approval,
the company is obligated to conduct a
confirmatory phase 3 trial.
According to the new pricing policy,
prices of 348 essential drug formulations
(or over 640 packs of medicines
containing these drugs in various
strengths and dosages) will be fixed at
the arithmetic average of prices of all the
drugs in that segment with a minimum of
one per cent market share.
According to the existing DPCO, the
pricing regulator so far used to fix prices
of 74 bulk drugs, and all medicines
containing one or more of these bulk
drugs, based on a cost-plus formula. For
all medicines, companies were allowed to
increase prices by up to 10 per cent
annually, and for anything beyond that
they were required to seek permission
from the regulator.
US FDA approves Bedaquiline for
Resistant TB Treatment
Bedaquiline is the first new TB drug since
the introduction of rifampin in 1970.
"Multi-drug resistant tuberculosis poses a
serious health threat throughout the
world, and Sirturo provides much-needed
treatment for patients who...don't have
other therapeutic options available,"
Edward Cox, MD, MPH, director of the
Office of Antimicrobial Products in the
FDA's Center for Drug Evaluation and
Research, said in an FDA news release.
"However, because the drug also carries
some significant risks, doctors should
make sure they use it appropriately and
only in patients who don't have other
treatment options."
Bedaquiline works via a novel mechanism
of action — inhibition of a mycobacterial
enzyme that is essential to the bacteria's
action — and will be indicated as part of
combination therapy for the treatment of
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pulmonary TB caused by MDR
Mycobacterium tuberculosis in adults, to
be administered under directly observed
therapy.
The approval comes after an FDA
advisory panel endorsed the efficacy of
the drug at a hearing on November 28,
2012, although many panel members had
expressed safety concerns. The vote was
unanimous (18 to 0) in supporting
bedaquiline's efficacy, but the panel had
split 11 to 7 on safety in support of
accelerated approval.
Janssen had presented data from 2
studies involving a total of 440 patients
with MDR-TB, defined as TB that is
resistant to at least rifampin and
isoniazid. In a study that was placebocontrolled,
bedaquiline resulted in a
significant 33% faster culture conversion
within 24 weeks, with approximately 79%
of those taking bedaquiline converting at
24 weeks in both the placebo-controlled
and an open-label trial.
At the advisory committee hearing, Fred
Gordin, MD, chief of infectious diseases at
the Veterans Affairs Medical Center,
Washington, DC, who voted yes on the
efficacy but no on the safety of
bedaquiline, had said he still supported
the drug's approval "with the caveat that
we need much more safety data....
There's clearly a role for this drug, but in
many patients who have other options, I
think it has to be very clear to providers
that there are long-term safety issues."
Janssen's phase 3 trial is planned for
2013. It is designed as a double-blind
study comparing 9 months of treatment
with bedaquiline with treatment with
placebo, both with a background
regimen.
Ref.
http://www.medscape.com/viewarticle/77
6901
Forthcoming Event
Safety concerns reported by both Janssen
and the FDA included signals for
increased risks for QT interval
prolongation, hepatotoxicity, and a
greater number of deaths in the
bedaquiline group compared with in the
placebo group. The number of deaths
was small, and at least half were deemed
to be related to the TB itself, but the
difference between bedaquiline and
placebo (12.7% vs 2.5%) was statistically
significant.
The drug will carry a boxed warning
alerting patients and healthcare
professionals that it can affect QT
prolongation. The warning also notes
deaths in patients treated with
bedaquiline.
Annual
Picnic
IPA Bengal Branch
20 th January 2013
Venue:
“Babusahar Bagan”
Karna Madhabpur
Contact:
Ashok K. Maity: 9433579919
Madhab Banerjee: 9748674625
Pradip K. Mallik: 9830574612
Indrajit Kar: 9874782277
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