Pharmaleaders Magazine

THE MAGAZINE FOR THE PHARMA LEADERS
The Real-Time Insights to Thought Leaders
VOL 1 NO. 1 MAR-APR 2010 www.pharmaleaders.in
Exclusive!!!
The changing social media landscape in healthcare
Rethinking patient noncompliance
Is pharma doing enough to understand compliance?
What Are IDEAs Made Of: Thinking ahead
Twitter use in pharma: valuable or time sinkhole?
How to create enough noise…with fewer reps?
Is the role of the medical rep doomed?
Difficult issues in pharma going global !!!. Doctors reach online
tipping point: is pharma ready to respond?
Market access challenges driving pharma change?
Malvinder Mohan Singh
aiming for a Billion Empire$
Tapan Ray
on why indian pharma industry
needs a roboust policy
Kiran M. Shaw
On the Mazumdar- Shaw
Cancer Centre (MSCC)

EDITORIAL
Healthcare policy in
an Obama administration
What are we getting?
As we welcome in a new year after a tough 2009, I see
2010 as the beginning of an exciting new decade
with the potential to greatly impact how businesses grow,
thrive and survive in the future. Recent entrepreneurial
activity I've seen, in addition to looking back at history,
convinces me that this upcoming decade will be
remembered years from now as a period of ingenuity and
adaptability. As Indian Pharma businesses get ready to
start writing that history, I invite you to explore the
concept I believe makes it all possible: that despite poor
economic conditions – there will never be a downturn of
ideas.
Looking ahead to the new decade on our horizon,
we foresee that there will be no recession of ideas because
no economic condition has the ability to stop an engineer
from working to solve a problem or an entrepreneur from
adapting to changing conditions.
The unstoppable power of human innovation, combined
with a current business climate that has lowered the cost
for entrepreneurs to launch their ideas into actual market-supported
ventures, has created what we see as an exciting
time to formalize that idea you always had for a business!
If history ever indicated when the time for a new idea was
right, it's that the time is now.
President Obama has
indicated that his administration will reform the American
health system to expand access and make health care more
affordable. However, his administration will need to
address how these programs will be paid; the impact of
expanding health insurance coverage; and the potential
shortages or strains these reforms could pose for the
existing health care system.
Editorial Board
Editor-in-Chief Satya Brahma
Editor & Publisher Ruth Desouza
Editor – Medical Dr Deven Parmar
Editor – Global Strategy Prof R.D.joshi
Executive Editor Abidali Dossa
Editorial Cordinator Kirti Wadekar
Manager Business P.R.Patil
Executive – Business Smruti R Khuntia
Editorial Advisory Board
Interlink
Dr R.B.Smarta, Managing Director,
Ajit Singh, Chairma,
Tapan Ray, Director General,
Kiran Majumdar Shaw,
Prof B.Suresh,
Samprada Singh,
Dilip Surana,
Narayan Gad,
Dr. Ramakanth Panda,
Huzaifa Khorakiwala,
ACG Worldwide.
OPPI
CMD – Biocon Ltd.
Vice-Chancellor, Mysore University
Chairman, Alkem Labs Ltd.
MD, Microlabs Ltd.
Chief Executive – Formulations,
Panacea Biotec Ltd
Vice Chairman, Asian Heart Institute
Executive Director & CEO, Wockhardt Ltd &
Wockhardt Foundation
President OPPI &Vice Chairman & Managing
Director, Novartis India Limited
Executive Director, Serum Institute of India Ltd
Chairman, Elder Pharmaceuticals Ltd.
Ranjit Shahani,
Dr Suresh Jadhav,
Jagadish Saxena,
Pharma Leaders, a bi-monthly publication of
Integrral Media Pvt Ltd (IMPL), brings to you
regular updates on World healthcare business
and economy: corporate news, trends, strategic
business issues, and opportunities for business
across industry-sectors. In short, it brings you the
India Growth Story and how you can leverage it to
your advantage.Copyright © 2010, Integrral
Media Pvt Ltd. All rights reserved.No part of this
publication may be reproduced, stored in a
retrieval system or transmitted in any form or by
any means electronic, mechanical, photocopying,
recording or otherwise, without the prior written
permission of the author.
Address all editorial related queries to
editor@pharmaleaders.in
Integral Media Pvt Ltd., 3A, Central Plaza,
166 C.S.T. Road,Kalina, Santacruz (E),Mumbai,
Maharastra,Pin : 400 098,India. 91-22-2666 6611 / 44
VOL 1 NO. 1 MAR-APR 2010 www.pharmaleaders.in 5

EDITORIAL
A close scrutiny will examines the challenges the President faces,
explains how these reforms may be enacted, the potential impact for
employers as well as those in the health industry and provides five ideas
for making health care more affordable. I feel that that President Obama's
plan would provide coverage for two-thirds of the uninsured; costing $75
billion if it were enacted in 2009. Forty percent of the estimated 30 million
Americans who would gain health insurance would obtain this through
their employers reversing a critical trend in the erosion of employer-based
coverage.
Many of the reforms proposed have been tested at the state level in
Massachusetts, which enacted universal healthcare legislation in 2006.
The state now has the nation's lowest uninsured rate in what had been the
most costly healthcare state. Approximately one-third of the cost of
Obama's plan could come from existing funding for the uninsured. The
remaining amount will have to be raised through repealing tax cuts,
raising taxes or other limitations in spending. Reforms are aimed at
providing tax subsidies for the healthcare disenfranchised which includes
the estimated 15% of uninsured Americans and those small businesses
that cannot afford to offer coverage. Expanding coverage will exacerbate
current deficiencies in the health system, such as labor shortages. Without
successful cost containment strategies, growing healthcare costs would
increase the costs of the Obama plan dramatically over time and reduce
the effectiveness of mandates - making federal costs unsustainable.
In this inaugural issue, Pharma Leaders has attempted to take a complete
stock of the Industry in its various features as you read.Looking forward
to hear from you.
Happy Reading……
Satya N Brahma
Editor-in-Chief
Satya.brahma@pharmaleaders.in

CONTENTS
CONTENTS

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INSIGHT
INSIGHT
Ms. Anju Gupta Kaudanya,
Managing Director, VHB Medi
Sciences Limited
“VHB is poised to grow phenomenally both
organically & inorganically
as a robust player in Indian
Pharma Sector. Contract
Manufacturing business &
Domestic Business will
fuel our Growth”
India's growing pharmaceutical
industry is expected to touch $20
billion by 2015 and feature among the
global top 10, a joint report published by
the Federation of Indian Chambers of
Commerce and Industry (FICCI) and
Ernst & Young said. According to the
report, with over $90 billion patented
drugs are going off-patent in the near
future, the Indian pharmaceutical
market, which will treble to $20 billion
by 2015 from $7.1 billion in 2007 with a
compounded annual growth rate
(CAGR) of 12.3 percent, will be a
potential hunting ground for Indian
companies that are increasingly focusing
on India's generic drug industry and are
either acquiring stakes or are entering
into agreements for working on
developing new drugs, typically under
licensing deals, to cut down on costly
and lengthy research. Companies are
increasingly restructuring their
operations with global parents
increasing their equity stakes in their
Indian affiliates," said Ms Anju Gupta
Kaudanya, dynamic &
ever smiling MD of VHB Medisciences
Ltd in an exclusive interview with Mr
Smruti Ranjan Khuntia, Associate
Editor of Pharma Leaders.
India has a significant cost advantage in
the conduct of clinical trials, including
infrastructure, operational, patient
recruitment, drug, manpower, data
management and processing costs, she
said. The report also said that patented
drugs will account for 8-10 percent of
the total market and the affordability of
high-patent drugs will be driven by the
population in the highest income class,
which is expected to grow to 25 million by
2015 from the present 10 million.
The story goes that the reason MsAnju
Gupta decided to manufacture
medicines for injectables, when she set
up her first ambitious unit at Rudrapur
in Uttarakhand, was that the number of
patients was few and so it would be
easier to reach out to them rather than
sell to a whole lot of general physicians,
which would
require a large field force. Whatever the
reason, VHB, from the very beginning,
has focussed on the high-margin chronic
care therapy products that have made the
company very profitable. Together with
a head for numbers, Bhagats -- who
started life as a wholesaler of
pharmaceutical products in Mumbai
where the Founder Mr Ramesh C Bhagat
ran a business -- has a knack for turning
around companies. Most of her
achievements have been of great assets.
Known to be extremely aggressive, with
her feet firmly on the ground, 34-year-old
India’s arguably youngest Pharma
CEO, Ms Anju her desisted from
overpaying for assets or getting carried
away by bids from peers, preferring
instead to bide her time. Industry
watchers are convinced that VHB's
more recent hi-tech manufacturing
facility at Rudrapur, too will soon turn
profitable as the contract manufacturing
business grows up. Rudrapur Facility is
strategically a good fit for VHB because,
as the soft-spoken and down

to earth Anju says, it will help VHB
tap into the customer base in
Canada, Europe and US and sell
existing portfolio of products to them.
When VHB Pharma first started
selling its products on a national
scale, way back in 2002, it ranked a
low on the ORG list. Today, with a
domestic market share of 1.2 per
cent, it is ranked in top 100
Companies in volume & financial
figures.. The numbers tell the story:
whether it's building a profitable
business or creating wealth for her
shareholders, Anju has done a great
job.
I n d u s t r y wa t c h e r s a r e
convinced that VHB's more
recent hi-tech manufacturing
facility at Rudrapur, too will
soon turn profitable as the
cont ract manufactur ing
business grows up.
VHB Life Sciences Limited has taken
b i r t h s i x d e c a d e s b a c k ,
Rudrapur Facility is strategically a good fit for VHB because, as the soft-spoken
and down to earth Anju says, it will help VHB
tap into the customer base in Canada,
Europe and US and sell existing portfolio of
products to them. When VHB Pharma first
started selling its products on a national
scale, way back in 2002, it ranked a low on
the ORG list. Today, with a domestic market
share of 1.2 per cent, it is ranked in top 100
Companies in volume & financial figures..
The numbers tell the story: whether it's
building a profitable business or creating
wealth for her shareholders, Anju has done
a great job.
marketing of wide range of
therapeutic formulations year after
year. It has emerged as India’s
fastest growing and most reputed
pharma company. VHB Life Sciences
Limited has to its credit 6 integrated
independent SBU’s. History has a
special mention of VHB Group, for
over six decades now since its
inception in 1946, it has to its credit
the introduction of a wide range of
highly specialized innovative
formulations 15 of which hold the
Numero Uno position in India and
globally. Currently VHB Group. is
rated as the fastest growing
pharmaceutical organization. The
vision that it has believed in "to Save
Lives Through Life Saving Drugs"
has earned it tremendous goodwill of
being a respected and reputed name
in India since 1946... History has a
special mention of VHB Group, for
over six decades now since its
inception in 1946, it has to its credit
the introduction of a wide range of
highly specialized innovative
formulations 15 of which hold the
Numero Uno position in India and
globally.Currently VHB Group. is
rated as the fastest growing
pharmaceutical organization. The
vision that it has believed in "to Save
Lives Through Life Saving Drugs"
has earned it tremendous goodwill of
being a respected and reputed name
in India since 1946. Over 21 Branch
Offices, 3500 Distribution Centers
having the most Ultramodern Cold
Chain Maintenance infrastructure
and a field force of over 2500
dedicated professionals covering
over 2,00,000 doctors has earned
the highest accolades from the
medical fraternity and institutions
across the globe. Ms. Anju Gupta
Kaudanya ,Managing Director, VHB
Medi Sciences Limited Technically
was also facilitated Most Advanced
Pharmaceutical Manufacturing
Unit of the year Award The
Pharmaceutical Leadership
Summit 2009
INSIGHT
.......INSIGHT

THE BIG INTERVIEW
THE BIG INTERVIEW
Kiran Majumdar Shaw shares
her opinion on the emergence
of world's largest Cancer
Hospital….the queen of
biotech is thrilled & passionate
to spread its services to the
patients through worldclass
treatment in collaboration with
Dr Devi Shetty of Narayana
Hridalaya.
The Mazumdar-Shaw Cancer Centrer is an integral part best hundreds of patients a day, the costs can be radically
of the Naraya Hrudayalaya Health City in Bangalore. I reduced. We are even able to cross subsidize treatment
have partnered Dr. Devi Shetty in the health city project by having differential charges between prime time
wherein I will financially support cancer hospitals across during the day and night time.
the country the first of them having been established in
Bangalore. MSCC is also conceived as a research driven cancer
centre where we propose to participate in clinical trials
The operations and management of the MSCC will be involving new therapies as well as pursue our own
done by The Narayana Hrudayalaya Hospitals. Dr. Shetty research in cancer through our own medical
has successfully demonstrated affordable cardiac care investigators.
based on economies of scale. Narayana Hrudayalaya
performs 30 heart surgeries per day and is the lowest cost Today Biomarkers in cancer is a very hot area and MSCC
cardiac care hospital globally. I believe that by using a plans to start an initiative in this area by creating a
similar template for cancer, affordable cancer care can tumour bank that will provide a rich platform for
also be provided. That is the underlying rationale for research. MSCC also plans to focus on cancers that affect
building a 1400 bed hsopital. Just as cardiac care was the lower economic strata of our society: Head & Neck
beyond the reach of the common man and where cardiac cancers and Cervical cancer which account for nearly 40%
treatment was only available to affluent patients, cancer of all cancers. This is largely attributable to tobacco
has a similar profile today. consumption in the case of H&N cancers, and poor living
and sanitary conditions when it comes to cervical
Dr. Shetty has brought cardiac treatment and now cancer cancers.
treatment within the reach of the common man which is
what we mean by decoupling affluence from healthcare. MSCC will also focus on Breast cancer in women and
We believe that it is the cost of Scans and other Lymphomas that require specialized Bone marrow
diagnostics as well as Radiotherapy that makes cancer a transplantation expertise. MSCC also plans to focus on
very expensive disease to treat. By amortising the large awareness campaigns and pursue screening and
investment costs of expensive equipment across early detection strategies to reduce the cost of cancer
thousands of patients per day as opposed to tens or at care.

MAZUMDAR SHAW CANCER
CENTER AT NARAYANA
HRUDAYALAYA HEALTH CITY
arayana Hrudayalaya, the world
renowned, Bangalore based,
N
specialty cardiac care hospital has
established the world's largest cancer
hospital with 1,400-beds. Built as a 5
lakh sq ft facility, this state of the art
hospital called The Mazumdar- Shaw
Cancer Centre (MSCC) has been
conceived to provide comprehensive
cancer treatment for all forms of the
disease. Research will also be a strong
focus with emphasis on head and neck
cancer, breast cancer and cervical
cancer which form the largest
segments in India.
The MSCC, which has the active support
of India's well known woman
entrepreneur and Biocon founder Kiran
Mazumdar-Shaw, has been set up to
bring about a discernable change in the
treatment and management of Cancer.
Based on the philanthropic ideas
institutionalized by Dr Devi Shetty in
the Narayana Hrudayalaya, this cancer
hospital aims to decouple cancer
healthcare from affluence. Thus, its
guiding principle is providing world-class
affordable cancer care to the
masses.
Apart from being the largest such
facility in the world, MSCC will also
function as a world-class research hub
and training college in oncology. The
center plans to harness the full
potential of state-of-the-art
diagnostic and radiation technology
to benefit the masses. Moreover, it
aims to leverage technology to
develop tai lored t reatment
strategies for individual cases.
A primary enabler in this endeavour is
the Tumor Board which facilitates
collaboration among medical
oncologists, surgeons, radiation
oncologists and other specialists. The
Board will discuss and review the
medical history and condition of all
patients to determine the best
THE BIG INTERVIEW
Narayana Hrudayalaya, the world renowned, Bangalore
based, specialty cardiac care hospital has established
the world's largest cancer hospital with 1,400-beds.
Built as a 5 lakh sq ft facility, this state of the art hospital
called The Mazumdar- Shaw Cancer Centre (MSCC) has
been conceived to provide comprehensive cancer
treatment for all forms of the disease. Research will also
be a strong focus with emphasis on head and neck
cancer, breast cancer and cervical cancer which form the
largest segments in India.

THE BIG INTERVIEW
available treatment option. The MSCC, the approach to affordable
technology adopted enables the cancer care is through creating
doctors to have access to a data cancer awareness and encouraging The Narayana Hospitals
base of cases around the world, the routine diagnosis to catch the endeavour to play a key
treatment protocol and the results disease early so that treatment can role in providing both
are at the click of a mouse. Thus not be effective and lower cost. access and affordability
only will patients get standardized to quality healthcare for
care of an international level, but Affordable high tech cardiac care the common man
they also need not expend time and has already been demonstrated by through their health
money looking for a second opinion. Narayana Hrudayalaya which was cities.
established ten years ago by a group
The MSCC is also committed to a of Health professionals led by Dr. Today Narayana Hrudayalaya
policy of “Healthcare for all” and Devi Shetty to bring cardiac care to has a 3000 bed health
thereby offers a ray of hope for the common man. Over a period of city at Bangalore.
patients who can confidently say time Narayana Hrudayalaya
that they will not be refused realised that the only way cost of 750 beds in Calcutta,
treatment because of their health care can be brought down is Eastern India's largest
financial condition. by economy of scale. heart hospital, which
will be expanded to 2000
Cancer is a disease that is on the Based on this assumption The beds.
rise both globally and especially in Narayana Hrudayalaya Hospital
India. It is estimated that the Group started building health cities A 500 bed health city in
Hyderabad in 40 acres to incidence of cancer will rise from with 3000 to 5000 beds as the only scale up to 5000 beds.
the current levels of 10-12 million solution to offer affordable health
world wide to 20-25 million cases in care. A 1400 bed health city in
2030. Annual mortality rates are Jaipur in 47 acres of land
estimated at 6.5 million which are Narayana Hrudayalaya pioneered to expand to 3000 beds
expected to rise to as much as 13-16 the concept of telemedicine and in in Phase II.
million per year by 2030. Each year association with ISRO, Narayana
India bears a burden of 2.5 to 3 Hrudayalaya has treated over A 1500 beds health city is
53,000 heart patients in remote being built in million cancer patients of which Ahmedabad to be nearly a million cancer cases are locations of India entirely free of commissioned in 6 diagnosed each year with an annual cost. Narayana Hrudayalaya does months.
mortality rate of 30%. Survival the largest number of heart
outcomes are grim and the cost of surgeries in the world. A 350 beds heart hospital in
cancer treatment is beyond the Jamshedpur and health Narayana Hrudayalaya attracts city projects coming up reach of most cancer patients in children suffering from complex in Bhuvaneshwar, Siliguri
India. heart disease from 65 countries. and Mysore
The most common cancers in India Narayana Hrudayalaya is an
are oral, oesophageal, lung and academic institute conducting over
stomach cancers in men and breast 60 training programs.Narayana
and cervical cancers in women. Hrudayalaya believes in women
Head and neck cancers and lung empowerment and over 93% of our
cancers are directly linked to employees are women.If India has
tobacco and alcohol consumption in to build a reliable National
men whilst infection and poor Healthcare System for its billion
sanitary conditions are often linked plus people, such a system will have
to cervical cancer in women. Over to have inbuilt into it both
70% of the cases that report for accessibility and affordibility. This
diagnosis and treatment are in will call for large scale hospital
advanced stages of the disease infrastructure operated by the
resulting in poor survival outcomes requisite professional and trained
and expensive treatment costs. At manpower.

“I am still spending some time to study the details of the bill. However,
my first reaction is that there is nothing major for the generic industry as
far as the bid is concerned, except for the fact that there is certainly
going to be a trickle effect of larger coverage of about 30 million extra
people and also not acceptance of the provision of pay-for-delay
probably benefits the generic and the branded companies.”
Dr Kamal Sharma,
MD, Lupin Ltd
INTERVIEW
INTERVIEW
The US House of Representatives has products.
approved the Senate version of the
Healthcare Bill. The Obama administration is Many pharma majors have been anticipating this
attempting to reduce healthcare costs and extend move by the Obama administration for a while.
insurance coverage for Americans. The Bill is There have been a slew of significant deals
seen to be beneficial to formulation companies. closed in the recent past between large US
pharmas and Indian companies in preparation
The legislation is a clear signal by the US for the healthcare legislation, with the one
government that it intends to bring down between Pfizer and Dr Reddy's and GSK
healthcare costs and the main objective seems to Pharma and Strides Arcolab being the notable
be introduce generic version of drugs wherever ones.
possible to cut cost of medication.
Pharma Leaders posed this questions to Dr
With the Indian pharma industry fundamentally Kamal Sharma, MD, Lupin Ltd on the
based on generics, India stands to be the most repercussions of the effect. Excerpts from the
obvious choice for US pharmaceutical Interview.
companies when they look outside for generic
PL: You have got a bunch
of a generics that have been
approved by the USFDA in
the past eight weeks. What
does all this mean to your
revenues if this is going to
be a PLuantum leap in
terms of revenues?
g e n e r i c b u s i n e s s ,
launching new products is
something which ensures
revenues and bottomlines.
So in some way it is a key to
the business.
PL: Will the recent US
healthcare Bill make a big
difference in the next
couple of years? Are you
expecting that? A market
over there is waiting to
bloom.
Dr Kamal Sharma: This
is a normal product
pipeline pending for
approvals. As of this
moment, 105 submissions
have been made to the Dr Kamal Sharma: I am
USFDA, 40 have been
still spending some time to
approved and 60 are still
study the details of the bill.
awaiting approval. So we
However, my first reaction
do expect to launch 10-12
is that there is nothing
products next year. In the
This is a normal product pipeline pending for approvals. As of this moment, 105
submissions have been made tothe USFDA, 40 have been approved and 60 are
still awaiting approval. So we do expect to launch 10-12 products next year. In
the generic business, launching new products is something which ensures
revenues and bottomlines. So in some way it is a key to the business

INTERVIEW
major for the generic industry as far as the bid is slightly much longer view starting 2003 has
concerned, except for the fact that there is certainly always been there.
going to be a trickle effect of larger coverage of The disappointments in specific challenge with
about 30 million extra people and also not regards to execution, compliance standards and
acceptance of the provision of pay-for-delay companies going and misjudging the size of
probably benefits the generic and the branded opportunity is available. This is clearly lesson of
companies. Beyond that, I cannot see anything that have been incorporated by some of them, but
major for the generic pharmaceutical. we have to be careful while analyzing is how does
PL: What is your take on the landmark Healthcare
Bill will was passed in the US on Sunday? Do you
think it translates into some kind of opportunity for
the Indian Pharmaceutical companies or is it not
that big a material positive? PL: You are also foraying into the biological space.
this broader favourable macro translate into
revenue numbers for specific opportunities and
companies. We think that there will be winners and
there will be losers.
Dr Sharma : I would be less sanguine about this
Give us an idea of what kind of investments and
issue because if you look at the big picture it's all
growth you are expecting from that space and also
about lowering costs for the US government. From
general growth in revenues that you are seeing in
that perspective, we are brining the price line
FY11 itself?
down. We are talking about possibly some kind of Dr Kamal Sharma: With regard to biological
deals happening in the manufacturing space where space, people are talking about a patent cliff on
people with manufacturing cost advantages in smaller molecules commencing 2011. It is just so
India could do more deals as you have seen with happens that the biological molecules the
big pharma in the past. Apart from that, we would blockbusters are going to see patent expiration
have to wait for the dust to settle down on this issue thereafter, specially some of the major monoclonal
before we can really make great statements out antibodies are going to lose patent. Therefore, it is
there on what this could mean. time that some of the strong companies took on
this particular task.
We have also started work about three years ago in
this area. Currently, we have about eight proteins
in various stages of development. Some of them
are now entering clinical trials in India. To that
extent, US bill indicating creating a pathway for
biologicals is indeed heartening. Europe already
has some kind of a pathway and there are a couple
PL: Beyond the US bill, one has seen this
substantial improvement in pharma, the out
performance of the phamra index itself. Would you
say that industry or the environs in the industry is
changing? Does it mean greater acceptance of
Indian generics, greater outsourcing by
multinational companies? Are we in for a kind of
secular growth in the pharma space itself?
Dr Sharma: You are not off the mark as far as the of approvals which have happened. So for a
assessment of the broader environment goes, but company like Lupin, which has been aggressive
from a stock selection standpoint we have to and has been growing at the rate of about 32% in
always be cognizant of the fact that pharma topline and 53% in the bottomline net income, we
headline opportunity as a story gets repeated every certainly believe that it will be an opportunity that
five years. This time it could be no different. The must not be lost sight of and we are all prepared to
fact remains that the headline opportunity for most cease it at an appropriate time.
of the Indian pharma companies if you take a

NEWS MAKER
INTERVIEW
OPPOURTUNITIES
DELIVERED...........
Pravin Iyer
Managing Director
Medreich Saimirra Ltd.
World today is a new battle ground, Muscle and might no
longer count, With grit and brain, you win today, And that’s
the power of MSL’s way!!!
Pravin Iyer, CEO , Medreich Ltd & Managing areas. They each have unique attributes and
Director,Medreich Saimirra Ltd outlines how challenging it requirements, so we’ve tried to keep the best of both
is to compete in a generic branded market & casually says organizational structures and created a hybrid structure.
it is all about Innovation in Strategies & Sinserity in efforts.
Saimirra is the creation of an ideology that Global Reach
Q: What does Medreich bring to Medreich Saimirra in the
throuch through Local Partnership & we have a winning
area of specialty care? How has the pipeline grown from
Formula.
the acquisition?
A: Medreich Saimirra is the domestic marketing Company
with a strong basket of product portfolios. As I mentioned
Q: What is your vision/goal for the Medreich Saimirra?
A: We want to be a major value driver for Medreich before, we have 7 different therapeutic categories, we
Saimirra, and in order to do that, we want to make a have 50 significant products on the market, so it was an
significant impact on serious medical conditions. So we’re expansion in the overall portfolio of products into a
committed to things like the eradication, remission, and number of new therapeutic areas, but also contributed in
relief of serious medical conditions, which generally areas where complementary activities. Now we have a
require specialist care. more significant presence and we have the ability to
leverage a stronger portfolio in some of those areas where
we both participated before.
Q: What changes have been made in the Medreich
Saimirra ?
Q: How is the transition going?
A: With the combination of some of finest professionals
and Medreich’s robust technical expertise, we’ve created A: I think the transition is going pretty well. The building up
a new organization and a new organization structure. exercises are challenging, but I would say that at this point
What we’ve tried to do is to focus on minimizing business we’ve really met our goals in terms of where we wanted to
disruption, because most of the business was actually in be at this point. The organization is formed, operating
pretty good shape prior to the integration and our goal was effectively, and we have clear goals and objectives. We
to preserve the things that were working well. In specialty have alignment across the business unit on what our
care there’s quite a diverse product portfolio; we have priorities are. We have people in place and we’ve done a
7different therapeutic areas that we are in and are thorough portfolio review and made decisions on the
managing the business across all 7 of these therapeutic portfolio.

The New Age CEO...
NEWS MAKER
Mr. Pravin Iyer is a Cost Accountant with over performance of Medreich Group year after
20 years of experience in the field of Finance & year by focusing on improving productivity as
Accounts. He has over 20 years of well well as optimizing cost structures across the
rounded experience in the pharmaceutical entire value chain. With a strong hold on
industry including 10 years at Strides Arcolab Finance, he also guides the various activities of
as Vice President Commercial. He joined Merger & Acquisition Department Besides
Medreich as the Chief Operating Officer to heading the Finance function, he also
head the supply chain and systems and has spearheads the Secretarial, Global Taxation,
taken on the role of the Chief Financial Officer Global Treasury & Insurance and Forex
from 2008. Pravin has presented a paper on operations.
the Harmonization of Regulatory requirements
in the ASEAN 'countries in the Asia Business The Indian pharmaceutical industry grew at
Forum in Singapore in October 2003. During 13% during 2003-07 and the market size is
the last 8 years at Medreich he has estimated to be US$ 9.77 billion in 2007-08.
spearheaded the companies various Joint Exports constitute a significant part of the
Ventures, Strategic Marketing tie-ups and pharmaceutical industry. Pharmaceutical
successful M&A's besides Financial exports from India are expected to grow at a
Management. He has worked in various CAGR of 18.5% during FY08-FY12,
capacities as head of Finance, Operations, particularly driven by multibillion dollar patent
Supply Chain Management and International expirations and growth in global generics
Marketing. Pravin is on the Board of Medreich's market. Many big pharmaceutical companies
Joint Venture Manufacturing enterprise with have recently acquired overseas companies to
Adcock Ingram South Africa and on the Board tap the potential generic market; consolidation
of the Company's R&D JV with Substipharm in the industry is expected to happen in a big
France.Pravin heads the Medreich's domestic way. While the growth path of pharmaceutical
marketing enterprise as it Managing Director. industry is well defined, it is important to know
how the industry needs to be managed. An
this dynamic young designated CEO of industry, which is driven by global demand, has
Medreich Group, started his career with couple more reasons to adopt smart and efficient
of Pharma Companies through his hardwork management practices. Examples are galore
and dedication earned the highest position in in India where many Indian pharmaceutical
the organisation. His leadership witnessed companies are known to be multinationals,
dramatic growth and through his aggressive f o l l o w i n g t h e b e s t ma n a g eme n t
positioning and strategy the organisation won practices.Pravin is confident that with the
many laurels and awards. As Group CFO of technical expertise & marketing strengnth,
Medreich Group, Pravin spearheads Medreich Group will be the force to recon
Medreich's's aggressive game plan to with…as he says I believe in “People
accelerate growth and take advantage of the Empowerment & Oppourtunities Delivered”
changing business dynamics that emphasize
equally, aspects of product portfolio, quality, Pravin is a prolific orator & has presented
global footprint and cost efficiency. Pravin has papers in many National & International
a meritorious track record, and the experience Co n f e r e n c e s i n c l u d i n g p r e s t i g i o u s
of managing large business operations earlier, Pharmaceutical Leadership Summit 2009
with similar responsibilities. In Medreich organised by Indian Express & UTV & at highly
Group, he has commendably spearheaded acclaimed India Leadership Conclave 2009 at
business growth, and effectively led the Delho organized by ASSOCHAM, DNA &
support functions. Pravin has made a NDTV PROFIIT on Challenges & Opportunities
significant contribution to improve the financial of Mid-Sized Pharma companies in 2020.

NEWS MAKER
We’re starting a new year, so we have a budget in place with 3) Pain Management : We are coming up with first time in
people focused on the right things. While I still say we’re India with Ezyflex & will do brand extension in our existing
going through a transition, all the fundamentals are in products.
place and we’ve taken great pains to ensure we maintain
business continuity. I think we’re pretty satisfied with 4) Gynaecology : Arginitric has made its mark in this
where we are at this point. segment, this will be a booster for us to enter into the field
of Infertility.
5) Nutrition/vitamins : Our existing products like
Natoz,Metacrome,Frutcee will help as a launching pad for
Medvite,Natolac FM , Fracture support nutritional
supplement,memory support,cardiac support & diabetic
Q: What did you learn from your career at Medreich Ltd as a
Global CFO to CEO – Designate ( As you will be taking over in
April First week) that has helped you transition into your
new role at Medreich Saimirra?
A: I ran the Financial Portfolios at Medreich Worldwide for support.
seven years ago and the journey has been very successful.
We have a commitment to the Nation to supply quality
Q: What specialty care drugs are a high priority for
medicines at affordable rates. Saimirra knows the pulse &
Medreich Saimirra now?
we don’t want to be a me-too-product marketing Company.
We are introducing new molecules as we have strong R&D A: Right now, Arginitric,l and Duorandi are certainly the
back-up . Healthcare in general across the board now is largest products and probably the ones with the strongest
much more government controlled and there is a growth potential, but they stand out for the meaningfulness
consolidation of stakeholders. Some of the things that I of what they can contribute. The beauty of our business
learned and the dynamics that I was involved with in unit is that in each one of these different disease areas, we
vaccines years ago are actually helping me now manage have groups with expertise and knowledge in the ability to
some significant, pretty important medicines across the bring our medicines to patients and physicians that can
remainder of the portfolio. use them in the most optimal way they know how.
We are at present present in 9 States with a Field Force of There’s opportunities across infectious disease. We have a
more tha 250 & we will strengthen our presence in group focused on peripheral vascular diseases, where we
Northen states like UP, Punjab, J & K, Haryana/Himachal & have a portfolio of products for very specialized conditions.
in Eastern states like Bihar, Jharkhand, Assam by 2010. We Each one of those teams is highly motivated and inspires to
have a reasonably a well developed organization & within a do the best with the assets that they have, and to them,
period of 1 yea, Saimirra has become a 300 Mn what they’re working on is the most important thing.
organization & growing at the rate of 180%.Products like
Arginitric,Duorandil,Benzoclav,Axacef,Ferolac,Trabical are
Q: What is the company’s specialty unit’s strategy in
the ones who have been at the top with outstanding
emerging markets?
growth. We will focus on following therapeutic areas :
A: Many of the products that we're marketing in the
1) Anti-infectives : We will strengthen our presence by developed world have application in the emerging markets,
launcing cepahlosporins & parenteral preparations. and we work very closely with our colleagues in emerging
markets. We have a specialist for some of our larger
2) Cardiology : Since we are already having a good equity businesses, like in Contract Manufacturing with Leading
with physicians we will take advantage of the same by Companies like Pfizer, GSK etc are done by our Medreich
launching Exogenous nitrates,Beta-blocker combination & Ltd..
innovative products like nifedipine SR.

NEWS MAKER
We’ve made great inroads in domestic marketing , in We currently have huge research based products in
particular, where we have a nice business in 9 States that pipelines that will be introduced for trhe first time in India.
is growing rapidly. We’re pretty heavily engaged and
ultimately we want to be able to optimize each of the assets
Q: With a strong focus on niche diseases, are you confident
we have within the specialty care business unit where
your pipeline will keep Saimirra well positioned beyond the
there’s a market or an opportunity to grow the business.
patent cliff?
A: If I look at the pipeline – of course, it’s always projections
because you still need approval – if things come to be
realized as we believe they will, we should be fine. We can
manage this transition rather well. And with that, we should
Q: Innovation in Product range have been become
increasingly important. How crucial is it for companies to
focus in those areas?
A: At Medreich Saimirra, we base the scientific hypothesis continue to gain market share. The other thing to look at is
on an increasingly better understanding of the signaling what is the percentage of sales for products which have
pathways which exist in the body and pathways which have been launched in the last two years? It’s a growing
sometimes multiple functions. On one side, you want to be percentage and they are growing very dynamically. We
very specific because you want to be very targeted. Then, measure the sales of the young products very carefully.
sometimes, you want a better pathway and a target that
has multiple bifurcations of signaling. If you take a
Q: Do you think the blockbuster drug model is dying?
signaling pathway in cancer where the pathway says
cancer cell divide, you would like that it works in a number A: What would be more accurate to say is that a model
of cancers. If you go after disease where one single which runs after blockbusters through a “me-too”
pathway is really relevant, you would like it to be as specific approach is not working as it was working before. Before, if
to that one single pathway, able to avoid side effects that you had a good me-too and you put the resources behind it,
are due to other things. you’d do well. In the last three to four years, we have seen a
shift in the market where me-too’s have much less returns
The essence of what I’m saying is we are going in a more than the really differentiated products. That to me is a good
targeted way than historically, and we use more biologics sign. It means that if a product offers incremental benefit,
than we used historically. Our approach has worked and we than you can make a good profit. You can be as profitable
have focused more on disease and medical need rather with a smaller product as one was with a larger one before.
than the market size. That maybe differentiates us from
others. One must look at the pipeline, but, of course, also look at
the bottom line. Tendency wise, the products are more
targeted, more focused, and smaller.
Q: So, is it fair to say your management philosophy is
valuing proven science over purely financial drivers?
Q: Speaking of targeted therapies, what is Saimirra’s’
stance on personalized medicine?
A: Yes, the philosophy is really to look first at where do you
have the need; what is this level of satisfaction or
dissatisfaction with a current therapy that is available? A: There is an increasing utilization of molecular
Once we have that, [then] looking at science. If you don’t diagnostics to really understand which patient profits from
have good science, then the likelihood of success and a therapy and which patients may have side effects
sustainable success is very limited. In fact, We have seen because of a therapy. This reason has made us decide to
not only an increasing number, but also the quality of the create a molecular diagnostics unit, which first will be
compounds is good. I’m very confident that the approach linking the efforts to our own existing products, but,
we started to take about one year ago is working out well. secondarily, will be a real independent business.

Low awareness of health issues. The Indian
The first therapeutic area where this will work is in Anti- population is “theoretically unprepared” in terms of
Infectives. We understand quite a bit already from a point healthcare. Prior to launching a specific drug it may be
of a view of the pathways more than in many other necessary to educate the people about the disease itself –
diseases. causes, consequences, and treatment methods.
Price vs. quality. A commonplace argument in India is
that the more expensive a drug is, the more efficient it is.
Some medications may be perceived as under-valued, not
Q: Do you see the adoption of personalized medicine
approaches becoming more common across the industry?
A: It will be increasingly penetrating. We have for a number expensive enough to justify their application. But, on the
of years felt, “No, that’s not really our field.” But now that other hand, price concerns are indeed in place, and it is
we have very good hypotheses and good tests, we felt, important not to cross the threshold when the drug would
“Well, what the heck, why won’t we do it?” We now are become too expensive.
investing in this area.
Celebrity-factor Even more so than in the West, Indian
consumers are willing to rely on famous people advertising
particular medications. Advice from famous actresses or
sportsmen substantially boosts market potential of a drug
Q: Do you feel leading drug developers share a
responsibility to bolster their in-house R&D capabilities?
A: We do partner. We have a number of agreements with among consumers.
academic institutions and biotech companies. But we have
strong belief that you need to have a very good internal Country of origin. This may prove to be crucial for a
capability, because innovation is basically the lifeblood of consumer’s choice of a drug in India. Traditionally, German
the company. If you rely too much on the outside, you loose and Swiss drugs enjoy a high degree of trust.
the capabilities, and with that, you also lose the ability to Pharmaceuticals from Poland, Hungary, and the former
absorb the knowledge which is coming from the outside. Yugoslavia also fare well – bearing a long history back from
That creates a very significant competitive disadvantage. the Soviet times. Chinese or Indian products fare less well
One needs to have contacts with the outside but also have at the moment. Companies may also exploit stereotypical
these qualities and capabilities inside. Then you can really knowledge about certain countries to their advantage. For
optimize what you can do. I strongly believe in maintaining example, a successful marketing campaign of a
and fostering the internal capabilities. contraceptive drug from a French manufacturer was
followed by slogan, “Pharmaceutical from the country
where they know everything about Love…”
Q: Will you expand drug-development opportunities in
emerging markets?
A: I would say there are two aspects. First of all, it’s a
research strategy question, which turns around to the core
question: Where do you get the best talent, and will the
talent come to you or do you have to go to the talent? Our
experience has been and our decision has been when we
decided to build the R & D Centre, we need to go where the
talent is because the talent will not come to us in numbers
which are large enough if we are not where they want to be.
Researchers and scientists want to be in places where
there is a buzz, where they bump into interesting people,
where there’s a lot of academic action around. The big
emerging knowledge center in the world now is China with
the Chinese government having invested very substantially
over a very extended period of time now, maybe 20 years,
into bringing more people into natural sciences,
engineering, biology, medicine, pharmacy, chemistry. So
we came to the conclusion that in order to optimally tap the
human resources, we need to be there.
Pravin Iyer outlines distinguishing characteristics of the
Indian marketplace from a pharmaceutical marketing
perspective.
Efficiency vs. convenience. In the West consumers pay a
great deal of attention to convenience of certain
medication – dosage, taste, form of delivery etc., while in
Indian conditions, drug efficiency is the foremost concern;
for example transdermal patches popular in the United
States are still treated with suspicion in India..
NEWS MAKER

INTERVIEW WITH TAPAN IYER
INTERVIEW

COVER FEATURE
COVER FEATURE-PHARMA LEADERS

NEWS MAKER
FOCUS
DIRTY GAMES OF
SPURIOUS BUSINESS
PHARMA LEADERS EXPOSE!!!
Twenty Per Cent Of Drugs Sold In India Are Fake.
Current estimates of fake drugs
put the prevalence between 0.5%
and 30% of all the Rs34,000
crore-worth drugs sold in India
Imagine administering a paracetamol tablet to a near and dear one who is
down with fever only to find that the medicine is having no effect. This
scenario sounds scary, but it could be actually be happening to a lot of
people as it has been recently revealed that about 20 per cent drugs sold in
India are fake. As per ASSOCHAM's estimation, the market for spurious
drugs in India is growing by 25 per cent each year.
Infact the latest figures released
by the Organization for
Economic Cooperation and
Development's state that almost
75 per cent of fake drugs
exported the world over accrue
from India. The emerging picture
of the spurious drugs market in
India has put the drug controller
general's office on alert, which is
now planning to undertake the
world's biggest ever study to
determine the size of this deadly
domain. The study of Indian
spurious medicine market is
scheduled to kick off soon. It will
be headed by drug controller
general of India, Surinder Singh
and should continue for about six
months. In a one of its Kind
shocker, various Drugs made in
China with “Made in India”
labels have been impounded in
Africa (Nigeria and other places)
as well as in some ports in India.
Thus, leading up to an
international racket of the worst
kind.If these drugs had been used
with terrible effects, the Blame
would have been posted on India,
effectively listing it as Rouge in the
Pharmaceutical World. China
has now officially for the first time
admitted that some of its
companies were involved in this
dastardly deed, surprising indeed
when everything is so tightly
controlled.It's well known that
nothing can be done on this scale
and magnitude without official
blessings. So where does this
lead us to? Similar incidents such

as melamine in the milk powder and
other stuff as well as the lead
contamination in the paint used in
toys to the dumping of various
electronic items including mobile
hand sets without IME numbers or
multiple hand sets with the same IME
numbers everything is Passé.It brings
one to the simple conclusion that the
Chinese State cannot and will not
accept the Indian Nations rise as a
Global Power and will rather try their
best to discredit us as International
forums as well as restrain us at the
Regional levels.We are already
seeing them continuing with the
Border incidents….and as an
aggressive push other than the Rail to
Tibet as well as the Aksai chin
road…they have embarked on their
string of pearls whereby they have
bases and port access in our
neighborhood vis a vis ports being
built in Myanmar, Sri Lanka,
Maldives, and others.With a strong
Naval Presence and Participation by
Pakistan, India faces a real threat of
encirclement, by Land, Water and
Non Friendly neighboring Nations.
How many “Made In India” Labels
with produce of China has reached
undiscovered is still unknown.India
has always been perceived as a
Paper Tiger – a Tiger that will only
roar but lacks the Bite. its high time
that we understand that there are
times for peace, but it cannot be
without war on all fronts, whether the
Economic Front, in Cyber Space, in
International Forums or in the High
seas and on Our Borders.
India's drugs quality regulator is
readying a survey to map the
prevalence of counterfeit drugs in the
country with a smaller sample size
but with a wider range of product
categories compared with an earlier
proposal for such a study. The survey,
in its new form, will pick up 31,000
samples of 62 top-selling medicines
across nine therapeutic categories
and will cover products of 29
manufacturers. The samples will cut
across medicines administered for
cardiovascular ailments, pain,
infections, tuberculosis and even
steroids, putting a diversified basket
of drugs under the scanner. This is in
marked contrast to the way the study
was originally fashioned under M.
Venkateswarlu, the previous drug
controller general of India, or DCGI,
who retired on 30 January. That plan
was to cover 50,000 samples each
of five-six large volume brands,
making for a sample size of up to
300,000 medicines. The aim then
was to restrict the number of brands
but cast the net deep. The premise of
the new survey, redesigned by the
office of the current DCGI, Surinder
Singh, is to cover the drug market as
widely as possible. The first-of-its-kind
survey is expected to throw up a
robust official estimate of the
prevalence of spurious and fake
drugs in the country. Current
estimates put the prevalence between
0.5% and 30% of all the Rs34,000
crore-worth drugs sold in India.
Countries in Europe and Africa have
complained of Indian exports of
counter feit drugs into their
rarkets.“We have developed the
study design with the help of Indian
Statistical Institute (in Hyderabad) to
ensure the results from the current
sample size are statistically
significant. Once we have the data,
we will know where we stand,” said
DCGI Singh, who expects a realistic
estimate to emerge from the survey.
The survey would not only give clarity
on the true extent of menace in the
country but also help India face up to
international criticism “from a
position of strength”, said Singh.A
senior official in the DCGI's office,
who preferred anonymity, said the
survey would also help identify
“geographical pockets” where the
problem of fake drugs is rampant.
“We will collect two strips of each
drug. One will be retained with us
and the other sent to the drug makers.
The companies will have to give in
writing if the sample is original,
made by them or not. If not, we will
call it counterfeit,” said the official,
explaining the methodology of the
proposed survey. The other strip with
the drug authorities could then be
used for laboratory testing to check
the quality of the drug. The survey
would be launched as soon as the
financial grant of Rs50 lakh is
sanctioned. Amendments to the
Drugs and Cosmetics Act, 1940, are
being finalized by the Union ministry
of health and family welfare, as part
of legislation that will levy hefty fines
and puni shment up to l i fe
imprisonment for offenders caught in
the fake drugs trade. An expert
warned that while spreading out was
a vital survey component, the
sampling should cover rural areas,
pockets of which are notorious for
such activities and include medicine
godowns as well. “The surveyors
should definitely take as many
samples as possible from the dealers
(and) localities that have been
identified as being notorious over the
years. The pharmacies in rural areas
and resettlement colonies are
another important link,” said P.N.
Bhargava at the drug anti-counterfeiting
cell of Indian
Pharmaceutical Alliance, an industry
lobby. “In fact, large-scale godowns
should also be in the survey as a lot of
counterfeit drugs find their way into
the system and are transacted in at
that point.” A study funded by the
World Health Organization and
carried out by global policy think
tank International Pharmaceutical
Federation found 3.1% of the more
than 10,000 samples of 56 top-selling
brands that it picked up to be
counterfeit.
Ministry of Health & family Welfare
Reward Scheme for whistleblowers in
the fight against the menace of
spurious or fake drugs, cosmetics and
medical devices.
FOCUS
FOCUS

Public Health is one of the major
objectives of Government of India.
Drugs / Medicines are the most
essential component to fight various
diseases prevalent in the country. It is,
however, important that the drugs so
available are not only of standard
quality but are safe, potent and
efficacious also. Drugs is in the
concurrent list of Constitution of
India. Regulatory control over the
quality of drugs in the county is
exercised by both the Central and
State Governments through the
provisions of the Drugs & Cosmetics
Act, 1940 and the Drugs &
Cosmetics Rules, 1945 made
thereunder. The manufacture and
sale of drugs is looked after by the
State Drugs Control Authorities
appointed by the State Governments
while imports, market authorisation
and new drugs are the responsibility
of the Central Government. The
Central Drugs Standards Control
Organisation (CDSCO) with the
Drugs Controller General (India)
[DCG(I)] as its head is the Central
regulatory body for enforcing the
quality standards of drugs, cosmetics
and medical devices in the Central
Government.
2. International ranking of the
country in pharmaceutical sector has
improved enormously with the sector
growing at 12-14% per annum. The
country now accounts for about 8%
of global production and 2% of the
world pharmaceutical market. The
country meets 95% of its domestic
demands through indigenous
production covering almost all
therapeutic categories and imports
only a few high technology products.
The size of Indian pharma industry is
about Rs.85000 crores, with about
40% i.e. Rs. 35000 crores worth of
pharma products being exported. It
is among top 20 countries if the
world exporting pharma products.
Vaccines and bio-pharma products
are exported to about 151 countries.
Further in the segment of Active
Pharmaceutical Ingredients (APIs),
India ranks third in the world
providing over 400 APIs.
3. The country's hold on international
pharmaceutical market, especially
the status enjoyed by it in providing
high quality drugs on cheapest prices
invited some unhealthy competition
from various quarters. Internationally,
the vested interests are supplying
spurious medicines manufactured by
them but with 'Made in India' label.
Allegations of marketing and
circulation of spurious or fake drugs
within the country also are raised
from time to time by the media,
consumer associations, NGOs as
well as in legislative forums. The
volume of the pharmaceutical market
and stakes involved in it makes it easy
for the people to fall prey to the lures
of money and indulge in various
malpractices. The manufacture and
sale of spurious drugs is a
clandestine activity generally
indulged in by anti-social elements
and carried out by unlicensed
manufacturers which exploit the
confidence enjoyed by certain fast
selling drugs by making their
imitations.
4. The Drugs & Cosmetics Act, 1940
and Drugs & Cosmetics Rules, 1945
contain comprehensive penal
provisions which act as sufficient
deterrent for those intending to
indulge in the malpractices relating
to drugs/medicines. Since the Drugs
& Cosmetics Act, 1940 is a Central
enactment, the core concept of
implementat ion of deterrent
measures with respect to countering
the menace of spurious drugs is better
coordinated between states as well
as the centre. Despite these deterrent
provisions of law, availability of
spurious drugs in market is a fact
which cannot be denied altogether.
The Drugs Controller General (India)
has been in continuous touch with the
state drug control authorities, the
FOCUS
revenue intelligence authorities, the
custom authorities and all port
officials for keeping a close watch on
such clandestine activities to check
the menace of spurious drugs.
5. The CDSCO is conducting an all
India survey to assess the extent of
availability of spurious drugs in the
country by drawing samples from
different regions and different strata
in the country on the basis of
statistical principles provided by the
I ndian Stat i s t i cal I n s t i t u t e,
Hyderabad. The samples are being
analysed and action would be taken
as per the provisions of the law. This
would help in identifying the
geographical areas where spurious
drugs are available so that a
focussed monitoring is done by the
concerned authorities in these areas
for eliminating the menace of
spurious drugs. Assistance has also
been provided under the World Bank
assisted Capacity Building Project to
upgrade testing facilities and to
es tabl i sh new drug tes t ing
laboratories so as to enhance the
capacity of laboratories to test large
number of samples. Under the
project, 23 States' and 6 Central
Drug laboratories have been
strengthened through renovations,
extensions and equipments. Further,
Schedule M of the Drugs and
Cosmetics Rules, 1945 pertaining to
Good Manufacturing Practices
makes it mandatory, at par with the
international standards, for the
manufacturers of drugs to comply
with the requirements for the
Schedule for quality control of the
drugs manufactured by them.
Detailed guidelines have been
issued to the State Governments to
undertake focussed surveillance over
possible movement of spurious drugs.
Specific training programmes have
been conducted for regulatory
officials of State Governments on
logistics of intelligence work,
prosecutions, etc with the assistance
FOCUS

of FDA, Maharasht ra. The
pharmaceutical industry and the
trade have been motivated to fight
the menace of spurious drugs as a
share responsibility.
6. The Drugs & Cosmetics Act, 1940
has recently been amended by the
Drugs & Cosmetics (Amendment) Act,
2008 for providing more stringent
penalties to those involved in the
t r a d e o f s p u r i o u s d r u g s .
Representations were received from
various stakeholders on difficulties in
the implementation of these
amended provisions and the
concerned expressed at their misuse.
A committee under the Drugs
Controller General (India) was,
therefore, set up to look into the
matter to frame suitable guidelines
for the purpose. As per the
recommendation of the committee,
guidelines were framed and
thereafter the provisions of the
amended Act have been enforced
w.e.f. the 10th August, 2009.
7. Since spurious or fake drugs is a
sensitive issue affecting the health of
the citizens as well as the prestige of
the country's pharmaceutical trade
interests, there is a sense of urgency
in taking on the menace on priority
basis. There is no dearth of good
intentioned people who may wish to
work for the country's interests as the
whistle blowers in eradicating the
menace. People's participation is
imperative in this regard and would
be a highly effective step in
augmenting the efforts of taking on
the elements engaged in such illicit
trade of spurious drugs. With this aim
in view, a scheme has been devised
by the Central Government for giving
mo n e t a r y r ewa r d s t o t h e
whistleblowers who can take risk of
providing the information about the
perpetrators of such crime. Such
scheme is already operational in
other enforcement departments of
Government which pays good
dividend also in terms of voluminous
catches / seizures. The Reward
scheme provides for giving
handsome rewards to the informers
who provide specific information to
the designated authorities leading to
the seizures of spurious, adulterated,
misbranded and not of standard
quality drugs, cosmetics and medical
devices. This reward scheme will be
applicable to both the informers as
well as the officers of the CDSCO. In
the fight against the menace of
spurious or fake drugs, cost of such
social participation will be minimal
given the proportion of damage
inflicted by the perpetrators of the
crime on the health of the society and
the economic progress of the country.
8. The salient features of the
aforesaid reward scheme are as
follows:-
(I) The reward scheme shall be
applicable for whistleblowers in the
area of drugs, cosmetics and medical
devices.
(ii) Reward is to be given to the
whistleblowers i.e. the informers /
officials only when there is a
confirmation of the seizure of
s p u r i o u s , a d u l t e ra t e d a n d
misbranded drugs, cosmetics and
medical devices by the designated
officers of the CDSCO.
(iii) The reward of maximum of upto
20% of the total cost of consignments
seized will be payable to the informer
/ officials which should not in any
FOCUS
case exceed Rs 25 Lakh in each case.
(iv) In respect of an officer of the
Government / CDSCO, the reward
should not in any case exceed Rs 5
Lakh for one case and a maximum of
Rs 30 Lakh in his / her entire service.
(v) With a view to ensure that the
informers are not made to wait till the
final disposal of the matter, 25% of
the amount will be given at the time of
filing of the charge sheet in the court
of Law.
(vi) Further, with a view to ensure that
the informers do not turn hostile
during the trial of the case and
continue to assist the court in
deciding the matter in favour of the
Government, 25% of the amount will
be given to them at the time of
disposal of the case in favour of the
Government in the first court of law.
(vii) The remaining 50% amount will
be paid only when the case has been
finally disposed of in favour of the
Government and no appeal with
respect to the matter is pending in
any other Court of Law in the country.
(viii) The eligibility of the informer
and the quantum of cash rewards
would be decided by a Committee,
which will consist of officials from
different departments / offices. The
Committee will consist of the
following persons:
(a) Director General Health
ServicesChairman (ex-officio)
FOCUS

(b) Director / Deputy Secretary
(Drugs), Ministry of Health & Family
Welfare Member (ex-officio)
© Chief Controller of Accounts or
Director, Internal Finance Division,
Ministry of Health & Family
Welfare Member (ex-officio)
(d) A Representative of the respective
zonal / sub-zonal office of CDSCO
nominated by DCG(I) Member
(e) Drugs Controller of the concerned
State / Union Territory Member
(f) A Representative of social groups /
NGOs nominated by the Ministry of
Health & Family Welfare Member
(g) A legal representative nominated
by the Ministry of Health & Family
Welfare in consultation with the
Ministry of Law & Justice Member
(h) A representative of the Customs
Department in case of international
movement of spurious drugs only
Member
(I) DCG(I) or his nomine M e m b e r
Secretary
(ix)The eligibility of Government
servants for the rewards shall be
decided by the Commi t tee
depending upon the final outcome of
the case only.
(x) The Government will engage
senior advocates who have sufficient
experience of the cases relating to
Drugs as its counsel in the cases.
(xi) To ensure speedy trials of the
cases, these cases will be filed before
the Designated / Special Courts set
up for the purposes of drugs related
issues as per the provisions of the
Drugs and Cosmetics (Amendment)
Act, 2008.
(xii) Special instructions are to be
given to the Drug testing laboratories
to send their reports at the earliest,
within the minimum time possible, so
that the matter is disposed of
expeditiously.
(xiii Drug Controller General (India)
along with other officials will be the
FOCUS
FOCUS
nodal authority who will inter alia oversee the functioning of the Reward
Scheme as proposed herein above.
(xiv) The zonal and sub-zonal officers of the CDSCO will act as the nodal officer
to whom the whistle blower / informer can provide the information about the
manufacture / movement of spurious / adulterated drugs.
(xv) The identity of the whistle blower / informer will be kept secret and will be
known only to the concerned zonal and sub-zonal officers of the CDSCO, the
DCG(I) and the Director General Health Services. It will be the responsibility of
the concerned officials to keep the details of the whistle blower / informer
secret.
(xvi) The identity of the whistle blower / informer will not be disclosed to the
committee.
(xvii) On receipt of the information from the whistle blower / informer, the
concerned officers will organize immediate and systematic investigation in co-ordination
with the State Drugs Control Administration to unearth the spurious
drugs racket.
(xviii) As the Licenses are granted by the State Drugs Control Authorities, they
will take suitable action like prosecution etc depending upon the evidences
available in the case.
(xix) The details of the investigations will then be forwarded by the concerned zonal
/ sub-zonal officer to the DCG(I) for the consideration of the committee to decide
about the merit of the case for reward and the quantum of reward to be given to the
whistle blower / informer.
(xx) The details of the nodal authority and the zonal / sub-zonal officers of the
CDSCO for the purposes of this reward scheme, to whom the concerned
information may be given by the whistle blower / informer, are as follows:
Name Addresses and phone number, mobile number, fax number
Dr. Surinder
Singh, Drugs
Controller
General (India),
Central Drugs Standard Control Organization, Directorate
General of Health Services, Ministry of Health and Family
Welfare, Government of India, FDA Bhavan, ITO, Kotla Road,
New Delhi -110002;
Phone: +91-11-23236965 / 23236975;
Fax: +91-11-23236973E-mail address: dci@nb.nic.in

FOCUS
FOCUS
Dr. D. Roy, Deputy
Drugs Controller (India)
(For the states Haryana, Himachal Pradesh, Jammu & Kashmir, Punjab, Rajasthan, Uttaranchal,
Uttar Pradesh, N.C.T. of Delhi & Union Territory of Chandigarh)
Central Drugs Standard Control Organization (North Zone), CGO Building – I, Kamla Nehru Nagar,
Hapur Chungi,
Ghaziabad- 201002 (U.P.)
Phone: +91-120-2719483 / 2750013 / 2701927;
Mobile Number: +919811203186Fax: 0120-2701927
E-mail address:cdsconz@gmail.com
Dr. R. Ramakrishna,
Deputy Drugs
Controller (India)
(For the states Chattisgarh, Goa, Daman & Diu, Madhya Pradesh, Maharashtra, Dadar & Nagar
Haveli andLakshadweep)
Central Drugs Standard Control Organization (West Zone), 4th Floor, FDA Bhavan, GMSD
Compound, Bellasis Road, Mumbai Central,
Mumbai-400008 (Maharashtra)
Phone: +91-22-23002279 / 23002215;
Mobile Number: +919820256032
Fax: 91-22-23002271 E-mail address:cdscowz@gmail.com
Dr. A. Ramakishan
( For the state Gujarat)
Central Drugs Standard Control Organization (Sub-Zonal Office), Air Cargo Complex, Old Terminal
Building, Airport,
Ahmedabad-380016 (Gujarat)
Phone: +91-79-22865244;
Fax:079-22865244 E-mail address:cdscosbz@gmail.com
Shri ACS Rao
(For the state Andhra Pradesh)
Central Drugs Standard Control Organization (Sub-Zonal Office), Unit No.18, Second Floor, Cargo
Satellite Building, RGI Airport Shamshabad,
Hyderabad (Andhra Pradesh)
Phone: +91-40-24008270 / 24008236;
Mobile Number: +919440115452 / +919618727439Fax:040-24008270
E-mail address:adchyderabad@gmail.com
Smt Shanty
Gunashekharan
(For the states Karnataka, Kerala, Pondicherry and Tamil Nadu)
Central Drugs Standard Control Organization (South Zone), 2nd Floor, Shastri Bhavan, Annexe 26,
Haddows Road, Chennai – 600006 (Tamil Nadu)
Phone: +91-44-28278186 / 25610402 / 25610906;
E-mail address:ddcsz@tn.nic.in
Shri Souman
Mukhopadhyay
(For the states Andaman and Nicobar Island, Arunachal Pradesh, Assam, Bihar, Jharkhand,
Manipur, Meghalaya, Mizoram, Nagaland, Orissa, Sikkim, Tripura & West Bengal)
Central Drugs Standard Control Organization (East Zone), CGO Buildings, Nizam Palace West,
2nd Floor, 234/4, Lower Circular Road, Kolkata – 700020 (West Bengal)
Phone: +91-33-22470513;
E-mail address:cdscoez@gmail.com
9. Any clarification / information in respect of the scheme may be had from the undersigned:
Dr. V.G. Somani,
Deputy Drugs Controller (India),
Central Drugs Standard Control Organization,
Directorate General of Health Services,
Ministry of Health and Family Welfare,
Government of India,
FDA Bhavan, ITO, Kotla Road,
New Delhi -110002;
Phone: +91-11-23236975 / 23236976;
Fax: +91-11-23236973
E-mail address: drvgsomaniddci@gmail.com

Top 100 Sales Drugs Worldwide Brands
BRANDS 2010

TAKING GUARD
Booming Indian Pharma Industry : The State of Affairs

OVER VIEW
On the growth path-Diagnostics and Pathological
Testing Market in India

PMT Focus
PMT FOCUS

MANAGEMENT
MANAGEMENT STYLES OF
INDIAN PHARMA LEADERS
There are many facets of approaches, our Leaders
deal while taking tough decisions. In an elaborate
feature, Dr R.B.Smarta, Managing Director, Interlink
Consultancy highlights the changing approaches
our leaders follow to deal with complex issues
Although Indian Pharma has the business Models are not Government initiatives. It will
occupied 3 rd position in the adding and creating value for the propel us to deliberate on new
th world by volume and 13 position entire world, due to market business models to give that
by value, are there chances for conditions and regulatory lead. Obviously, business and
Indian Pharma to lead the restrictions as well as pricing. revenue models need to be driven
world. Whether they will lead by powerful leaders. As a result,
the world is a debatable question During last year 2008, USA and even the Leaders will need
and a subject of speculations! UK has just grown by 1% and 2% supportive styles. So new
respectively. However, Europe, management styles need to
Indian Pharma market and rest of the world has grown at emerge!
marketing strategies are full of 18% and 19% respectively.
tactics so far and they are very Among rest of the world Ov e r t ime new s t y l e s o f
distinct and different in nature emerging markets grew by managing pharma business
as Patents have just arrived in 24%. US and UK captures have emerged on the basis of
2005! Impact of Patents would around 42.9%. Pharmaceutical m a i n e l e m e n t o f
mould Indian Pharma Industry market needs a support from entrepreneurship!
overtime. But the environment Europe and rest of the world to
of Global pharma has changed so maintain even 10% growth. Leadership Role & Styles:
fast that the value-migration Partly, last year and this year In this context. It is worthwhile
model of pharma (a blockbuster peptides have given growth to to explore India's earl ier
model ) has faced severe the industry by targeting it on leadership styles and their roles
limitations and it needs support different diseases. They are to unleash this leadership
of new thoughts Amino Acids. Part of Nutrition! potential.
Situational context: Imagine Pharma may change its While managing any industry in
There is a better level playing course of direction from serving India, entrepreneurs endowed
field now for Indian Pharma in not only to sick to serving with their skills are on the verge
the world as on one hand many healthy through nutrition!! of creating new processes to lead
patented products are expiring the world. Mr.Narayan Murthy,
their patents and US, UK, do not Next 4 to 5 years do provide Mr .Ratan Tata, Mi t tal s ,
have more promising new golden opportunities where-by Ambani's, Goenkas, Birla's are a
product pipeline to maximize Indian Pharma can initiate few names who have developed
their potential in next 10 years. actions on sick and healthy of empires on such integration of
So on the front of New products society to lead, provided all processes. Pharmaceutical
t h e s i t u a t i o n i s h i g h l y forces and actions work together industry should not be an
competitive. On the other hand a l o n g wi t h emp owe r i n g exception.

MANAGEMENT
In Indian pharma industry, one of Mankind gives us a clear picture themselves.
the most valuable contributions of what an entrepreneur does to
last 3 to 4 decades is detailed change the market rules in India
2. Brand Franchise Led:
understanding of this and can capture enormous market This opportunity could allow
entrepreneurship! It is the share! Our Indian Pharma even multinationals to come to
recognition of a particular process Entrepreneurs have taken up a India by franchising them to
in the minds of Entrepreneurs!! leap forward on the basis of India. Entrepreneurs who
Research shows that it generally perceived opportunities. In last ½ thought and who led industry
consists of the following six decade, the successful (nationally through popularizing those
stages: and internationally) took up brand through their selling
strategic view of the situation and and market ing acumen.
Identifying an charged a bit! Wallace was the first one to
opportunity bring brands in India. Chemo
During last 4 to 5 decades, Pharma, TTK even Elders
µ
Defining a business following opportunities have could real ly start their concept shaped entrepreneurs in India. leadership stance through
Assessing resource They do display a distinct style. brand building and brand
requirements franchisee.
1. Reverse 100 Engineering
Acquiring those
Led: 3. Distribution Led:
resource As in India, we had and have This opportunity of essential
an excellent organic chemist, marketing infrastructure such
µ
µ
µ
Implementing and process of reverse engineering as distribution was looked at
managing the was followed up as there were very differently to have
concept n o p r o d u c t p a t e n t s . forward integration to process
Companies started patenting patented products and brand
µ
Harvesting the their processes and over time franchisee availability to the
concept or venture they mastered this art of patient was an important
reverse engineering and given aspect and hence, after
µ
It has been observed that all lot of new molecules to India as understanding the touch of
entrepreneurs have an innate soon as they were available in patient, they took up this
strength to unleash or / uncover / the western world. This distribution led trading and
or perceive opportunities in opportunity gave birth to the selling style to really establish
diversity. Their belief in their l eade r ship po s i t i on f o r themselves as leaders. Alkem,
dreams and scope of opportunity Dr.Reddy's, Cipla and as a Aristo, Frank Ross etc. are
decides the risk and rewards of g o o d s c i e n t i s t t h e part of that particular breed
the situation! All are perhaps first Entrepreneurship got evolved where they could establish
generation entrepreneurs!! through the process of reverse themselves and lead Indian
Second generation today needs a engineering and they kept it market through their innate
different style and energy!!! following in such a way that selling trading aptitude.
over time they could establish
Pharma Industry has undergone a
themselves as leaders in no.of
4. Manufacturing led:
metamorphosis, as in the 70's first As India has been an excellent therapeutic areas definitely in
10 companies had 8 MNCs while in in Active Pharma Ingredients India as well as in the world.
80's, 90's, 2000 and now you (API's) manufacturing. Those This leadership was science
observe that a space has been who were in supply side to the based and creating branded
created by Indian companies pharma indus t r y , the y g ene r i c s o f r eput e f o r
aggressively! Latest additions of realized the for forward
Strategic
Surprises
Reverse
Engineering
Manufac tur ing Brand
F ranchising
Exports
APIs
Ma nufac turing
Generic Brand
Building
Distribution
Intensity
Technology

integration to their business them to cast carving the niche Mr.Vikram Tannan, Mr.Ajit
and they took the led through in international markets Singh, Mr.Glenn Saldanhna,
establishing their own generic starting with not so regulated Mr.Malvinder Singh, Mr.
API as well as specialized APIs markets towards regulated Habi l Khorakiwala, Mr.
as the market was demanding. markets and improving their Pankaj Patel etc. have been
Kopran, Hetero and such learning curve by competing in s h a p e d b y d i f f e r e n t
companies who made a name t h e ma r k e t s a n d a l s o opportunity and a few of them
in APIs gave a birth to a improving their qual ity. adopted strategic route. Some
d i f f e r e n t k i n d o f Almos t al l top leading of the industry leaders who
entrepreneurship which was companies, today have that have both processes and road
most cost ef fect ive and leadership slant towards those map to carve out a dominant
efficient. international markets. Some role for Indian companies on
the global map!
have gone far ahead to make
5. Technology led :
A few who were in drug the niche in the existing US
d e l i v e r y s y s t e m a n d generic market as well as
specifically multi-nationals as generic market of the world.
well as national companies E v e n t o d a y , a f e w
such as Smithkline (SKF) as organizations have kept their
well as Raptakos Brett could focus of the leadership styles of
take a lead from their own trading, selling, branding only
delivery systems as well as on export markets such as
made it known to the industry Flamingo etc. Government has
as well as competition unique further given impetus to this
drug system can differentiate style through its specific
yourself as a leader. There are policies.
many examples where you find
US Vitamins, SKF, Raptakos
7. Strategic surprise led:
and if you look at even now is This opportunity was captured
Modi Mundi Pharma they by Dr.Reddy's, Torrent ,
h a v e c r e a t e d t h e i r Wockhardt, Zydus Cadila and
differentiation from drug all multinationals either by
del ivery system. Reckitt surprising the customers by
Benckiser is not an exception only strategic initiatives on
to them. new therapies, new products,
cost leadership etc. The styles
of entrepreneurship have been
6. Exports led:
This opportunity was provided shaped by these opportunities
t o m a r k e t I n d i a n when you look at the leaders
entrepreneurs as they grew like Dr.Anji Reddy, Mr.Dilip
and tried to develop that there Shanghvi, Mr.Y.K. Hamied,
are regulated and not so Mr. (late) Parminder Singh,
regulated markets in the world Mr. I.A. Modi, Mr.Samprada
h a v i n g q u a l i t y A P I s , Singh, Mr. Shyam Ruia, Mr.N.
manufacturing facilities of H. Israni, Mr.Suresh Kare,
reputed approvals, investment Mr.B.K. Mody, Mr.Jagdish
and manufacturing plants led Saxena, Mr .C.R. Amin,
MANAGEMENT
Process
Technology
Mode
Manufacturing
Mode
Brand
Building
Mode
Exports/
International
Markets
Building
Drug Delivery
Mode
Strateg
y Mode

Perspectives
PERSPECTIVES

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