Drug Information Bulletin, 36 _4_ - Indian Pharmaceutical Association

Drug Information Bulletin
(Electronic)
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: 4 Number: 36 18 December 2010
Content
• DCGI to introduce “Preliminary Scrutiny” for approval of FDCs from January 2011
• Pfizer Pulls PAH Drug Due to Liver Toxicity
• Reckitt Benckiser Group buys India’s Paras Pharmaceuticals Ltd
• Healthcare Industry Now Offering Improved Diagnoses, Earlier Interventions, and
Better Medical Outcomes with Personalized Medicine
• Supreme Court directs Universal Access to Second Line ART in a phased manner
• Forthcoming Events
DCGI to introduce “Preliminary
Scrutiny” for approval of FDCs from
January 2011
Aiming to streamline the submission of
application for approval of Fixed Dose
Combination (FDC) drugs and their review by
the drug authorities, the Drug Controller
General of India (DCGI) has introduced a
system of 'preliminary scrutiny' of such
applications while receiving them to
determine the acceptability for review by the
DCGI office. This will come into effect from
January 1, 2011.
The new system is intended to avoid
unnecessary delays in approvals of FDC
applications. So far, the applicants have used
many different approaches in organizing the
information and the differences in
organization of data in each application has
made reviewing more difficult and can also
lead to omission of critical data or analyses
which could result in unnecessary delays in
approvals.
The preliminary scrutiny of the applications
will be done by CDSCO officers based on
checklists prepared for each of the several
categories of FDC. During the preliminary
examination, the CDSCO officers will
scrutinize the applications to ensure that it
contains all the required administrative as
well as technical information in proper
manner as per the checklist. If application
submitted is not in accordance with the
format and the checklist, it will not be
accepted by CDSCO.
Once an application is accepted, the
adequacy of the data will be reviewed by
CDSCO as per the specified requirements and
guidelines. In case the data submitted is not
adequate or satisfactory, applicant will be
requested to generate/submit adequate data
for consideration and approval of the FDC.
The proposed fixed dose combination should
be based on therapeutic rationale. The
applicant is required to justify the
combination based on the rationale. While

submitting the rationale for a FDC, the
applicant must address the issues like drugdrug
interaction between the ingredients,
food effects and dosage schedule of
individual active ingredients vis-a-vis that of
the FDC. Further, the indication/claim for the
FDC should be such that the individual active
ingredients makes a contribution to the
claimed effect and the product should be
formulated so that the dose and proportion
of each substance in the FDC is appropriate.
Trial batches of new drugs for test and
analysis/clinical trial/BE study purpose should
be manufactured after obtaining Licence in
Form 29 from the concerned State Licensing
Authority and copy of the licence should be
submitted along with the application. While
submitting reply to a query, the applicant
should always enclose with the reply, a copy
of query letter issued by CDSCO.
The applicant should submit stability data
generated on 3 trial batches manufactured
by them under Licence in Form 29 issued by
State Licensing Authority (SLA). The stability
data and the clinical trial protocol should be
submitted as per the CDSCO format. In case
of clinical trial/ bioequivalence study NOC,
the applicant should submit the adequate
chemical and pharmaceutical information.
The applicant should always submit
certificate of analysis, dissolution data (in
case of oral dosages form, as appropriate),
stability study data etc. in respect of
formulation, duly signed by the Incharge/Manager
QC.
Before preparing the application, the
applicant must categorise their proposal and
submit information as per the checklist for
that category. Application in Form 44 should
be complete in all respects and signed by the
authorized person of the firm with name and
designation. The TR challan receipt
submitted by the applicant should mention
the name of the FDC including correct head
of the account, payable at, bank clearance,
2
etc. The documents must be submitted with
indexing and page number. Without indexing
or page number, no application will be
accepted. Clear and unequivocal information
should be provided along with the
application.
Source: Pharmabiz
Pfizer Pulls PAH Drug Due to Liver
Toxicity
Pfizer is to voluntarily withdraw sitaxentan
(Thelin), a drug for pulmonary arterial
hypertension (PAH), following two cases of
fatal liver toxicity [1]. The drug has been
marketed in 16 countries in the European
Union and in Australia and Canada; clinical
trials with the compound will also be
discontinued, and the company no longer
plans to file a US new drug application.
Pfizer says its decision is based on "a review
of emerging safety information from clinical
trials and postmarketing reports." While liver
toxicity is a known complication of the class
of drugs to which sitaxentan belongs, the
company says a new potentially lifethreatening
idiosyncratic risk of liver injury
has been observed. "Given the availability of
alternative treatments, Pfizer has concluded
that the overall benefit of Thelin no longer
outweighs the risks in the general population
of PAH patients," the company says in a
statement.
Alternative treatments for PAH include the
dual endothelin antagonist bosentan
(Tracleer, Actelion Pharmaceuticals), the
endothelin A receptor antagonist ambrisentan
(Letairis, Gilead Sciences), and two
phosphodiesterase type-5 inhibitors better
known for their treatment of erectile
dysfunction but repackaged with new brand
names for PAH, sildenafil (Revatio; Pfizer)
and tadalafil (Adcirca, United Therapeutics).
Source: Medscape Pharmacist

Reckitt Benckiser Group buys India’s
Paras Pharmaceuticals Ltd
Reckitt Benckiser Group plc (RB) announces
that it has agreed to buy Paras
Pharmaceuticals Limited (Paras) for INR 32.6
billion (Indian Rupees) (approximately GBP
460 million) from the current shareholders,
including the Patel family and Actis, the
emerging markets private equity investor. RB
will finance the transaction from existing
facilities.
Paras is a privately-owned Indian company
with a portfolio of leading Indian over the
counter Health and Personal Care brands
including:
• Moov, the No 2 topical analgesic pain
ointment,
• D’Cold, the No 2 cold & flu remedy,
• Dermicool, the No 2 for prickly heat,
• Krack, the No 1 medicated skin
treatment for cracked heels and
• Itch Guard and Ring Guard anti fungal
creams.
In addition, Paras has a personal care
business led by Set Wet, a leading hair gel
and deodorant brand.
In the fiscal year ending March 2010, Paras
generated net sales of INR 4,014 million,
representing a mid-teens average growth rate
over the last four years, and operating
EBITDA for the same year of INR 1,083
million (approximately GBP 56 million and
GBP 15 million respectively).
The company has a brand new state of the
art and GMP compliant manufacturing plant
located at Baddi in Northern India, which
employs around 700 people.
Commenting on the acquisition, Reckitt
Benckiser CEO, Bart Becht, says, “The
acquisition of Paras is another step forward in
RB’s growth strategy in consumer health care.
It creates a material health care business in
India, one of the most promising health care
3
markets in the world with the addition of a
number of strong and leading brands.”
“We believe the Paras business has not only
extremely good growth potential, when
supported by RB’s investment and innovation
strength, we also expect to realize material
synergies as a result of the integration of
Paras into Reckitt Benckiser.”
“The growth potential of the business, the
creation of a material health care business in
India’s large and growing health care market
and the global synergies available make Paras
an exciting addition to our portfolio and
attractive opportunity for our shareholders.”
RB was advised by J P Morgan. Actis and the
other Paras shareholders were advised by
Morgan Stanley.
Source: www.rb.com
Healthcare Industry Now Offering
Improved Diagnoses, Earlier
Interventions, and Better Medical
Outcomes with Personalized Medicine
The success of personalized medicine
depends on accurate diagnostic tests. Experts
believe that personalized medicine will
eventually become the standard of care, but
advancements in science and diagnostic
technology, regulatory frameworks, and
insurance reimbursement are required. Once
the groundwork is laid, the benefits will be
many, including reduced costs of healthcare
by eliminating ineffective treatments, faster
approvals due to predictable safety and
efficacy, lower rates of adverse reactions,
earlier detection, and prevention.
Within the next few years, genomic
information will prevent disease and more
effectively treat and diagnose disease.
PharmaLive's Personalized Medicine and
Orphan Drugs Review & Outlook report
examines the personalized medicine and
orphan drug sectors, companies involved, as
well as the drugs, technologies, and business
strategies that are driving growth. DX
Directions' IVDs for Personalized Medicine

eport provides a comprehensive review of
technology issues in developing companion
IVDs, demonstrating clinical utility in
personalized healthcare, reimbursement and
regulatory issues, as well as consumer
engagement in personalized medicine.
Source: Pharmalive.com
Supreme Court directs Universal Access
to Second Line ART in a phased manner
Sankalp Rehabilitation Trust had filed an
application in the above petition
in the Supreme Court challenging the
constitutionality of NACO's criteria
for second line ART and seeking a direction
that second line be made
available to all those who need it, irrespective
of any other criteria.
Under Indian law, commenting on the merits
of a case which is pending before
a court amounts to contempt. The update
below is a fair reporting of the
proceedings before the Supreme Court in this
matter.
The Petitioner argued that limiting access to
2nd line was violative of
fundamental right to life of PLHIV. Taking a
serious view of the situation,
the Hon'ble Supreme Court made it clear to
the government that access to
second line must be universalized. On 16th
December, the following
statement, appended below, was endorsed as
an order of the Hon'ble Supreme
Court.
As per the order, second line ART will be
provided to all PLHIV who need it,
whether they were in the private or public
sector or on rational or
irrational treatment. In the first phase (3
months), universal access to
second line treatment would be started at
four Centres of Excellence (JJ
Hospital in Mumbai, GHTM Tambaram,
4
Maulana Azad Medical College (MAMC), New
Delhi and Calcutta School of Tropical
Medicines, Kolkata) with immediate
effect. This pilot initiative would be studied
over a period of three
months, after which it will be scaled up to
more ART Centres.
Lawyers Collective HIV/AIDS Unit will
organize a meeting in January 2011
with PLHIV and NACO to further explain the
order and discuss the remaining
issues in the ART Rollout Programme.
Forthcoming Events:
National Seminar on:
“Chemical & Pharmaceutical Industries in
India - Present Scenario & Future Prospects”
to commemorate the 150th Birth Anniversary
of Acharya Prafulla Chandra Roy, to be held
on 21st & 22nd January, 2011
Jointly organized by:
Indian Institute of Chemical Engineers
(Calcutta Regional Centre)
&
Alumni Association, Jadavpur University
National Conference on:
“Emerging Trends in Natural Product
Research”
February 12-13, 2011
Pre conference workshop on
‘Quality Evaluation of Natural Products’
February 11, 2011
Organized by:
School of Natural Product Studies
Jadavpur University, Kolkata
Website: www.jaduniv.edu.in;
www.aptiindia.org