Pharmaleaders Magazine

THE MAGAZINE FOR THE PHARMA LEADERSThe Real-Time Insights to Thought Leaders

The changing social media landscape in healthcare

Rethinking patient noncompliance

Is pharma doing enough to understand compliance?

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?

What Are IDEAs Made Of: Thinking ahead

Exclusive!!!

Malvinder Mohan Singhaiming for a Billion Empire

$

Tapan Ray

on why indian pharma industry

needs a roboust policy

Kiran

M. S

haw

On

the

Maz

umda

r- S

haw

Can

cer C

entre

(MSCC)

VOL 1 NO. 1 MAR-APR 2010 www.pharmaleaders.in

THE MAGAZINE FOR THE PHARMA LEADERS

EDITORIAL

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.

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.

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.

Healthcare policy in an Obama administration

What are we getting?

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

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.

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,

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

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

[email protected]

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 BrahmaEditor-in-Chief

[email protected]


mailto:[email protected]


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. ContractManufacturing business &

Domestic Business willuel our Growthf ”

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

operat ions 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


I n d u s t r y w a 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

con t rac t manufac tu r ing

business grows up.

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.

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 ,

market ing 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 special ized 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

udrapur Facility is strategically a good R 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.


INSIGHT

.......INSIGHT



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.

THE BIG INTERVIEW


MAZUMDAR SHAW CANCER

CENTER AT NARAYANA

HRUDAYALAYA HEALTH CITY

arayana 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 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

deve lop ta i lo red 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

N

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 The Narayana Hospitals doctors to have access to a data cancer awareness and encouraging

endeavour to play a key base of cases around the world, the routine diagnosis to catch the role in providing both treatment protocol and the results disease early so that treatment can

access and affordability are at the click of a mouse. Thus not be effective and lower cost.

only will patients get standardized to quality healthcare for Affordable high tech cardiac care care of an international level, but the common man has already been demonstrated by they also need not expend time and through their health Narayana Hrudayalaya which was money looking for a second opinion. 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

heart hospital, which financial condition. by economy of scale. will be expanded to 2000 beds.Cancer is a disease that is on the Based on this assumption The

rise both globally and especially in Narayana Hrudayalaya Hospital A 500 bed health city in India. It is estimated that the Group started building health cities

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

Narayana Hrudayalaya pioneered to expand to 3000 beds estimated at 6.5 million which are the concept of telemedicine and in in Phase II.expected to rise to as much as 13-16 association with ISRO, Narayana million per year by 2030. Each year

A 1500 beds health city is Hrudayalaya has treated over India bears a burden of 2.5 to 3 being built in 53,000 heart patients in remote million cancer patients of which Ahmedabad to be locations of India entirely free of nearly a million cancer cases are commissioned in 6

cost. Narayana Hrudayalaya does diagnosed each year with an annual months.the largest number of heart mortality rate of 30%. Survival surgeries in the world. A 350 beds heart hospital in outcomes are grim and the cost of

Jamshedpur and health cancer treatment is beyond the 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

Narayana Hrudayalaya is an The most common cancers in India academic institute conducting over are oral, oesophageal, lung and 60 training programs.Narayana stomach cancers in men and breast Hrudayalaya believes in women and cervical cancers in women. empowerment and over 93% of our Head and neck cancers and lung employees are women.If India has cancers are directly linked to to build a reliable National tobacco and alcohol consumption in Healthcare System for its billion men whilst infection and poor plus people, such a system will have sanitary conditions are often linked to have inbuilt into it both to cervical cancer in women. Over accessibility and affordibility. This 70% of the cases that report for will call for large scale hospital diagnosis and treatment are in infrastructure operated by the advanced stages of the disease requisite professional and trained resulting in poor survival outcomes manpower. and expensive treatment costs. At


THE BIG INTERVIEW


Dr Kamal Sharma, MD, Lupin Ltd

INTERVIEWThe US House of Representatives has products.

approved the Senate version of the Many pharma majors have been anticipating this Healthcare Bill. The Obama administration is move by the Obama administration for a while. attempting to reduce healthcare costs and extend There have been a slew of significant deals insurance coverage for Americans. The Bill is closed in the recent past between large US seen to be beneficial to formulation companies.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

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

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?

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.

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.

Dr Kamal Sharma: This

is a normal product

pipel ine 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

“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.”


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

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

issue because if you look at the big picture it's all

about lowering costs for the US government. From

that perspective, we are brining the price line

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

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

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.

Give us an idea of what kind of investments and

growth you are expecting from that space and also

general growth in revenues that you are seeing in

FY11 itself?

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?


INTERVIEW


INTERVIEW

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 IyerManaging Director

Medreich Saimirra Ltd.

areas. They each have unique attributes and Pravin Iyer, CEO , Medreich Ltd & Managing requirements, so we’ve tried to keep the best of both Director,Medreich Saimirra Ltd outlines how challenging it organizational structures and created a hybrid structure.is to compete in a generic branded market & casually says

it is all about Innovation in Strategies & Sinserity in efforts. Saimirra is the creation of an ideology that Global Reach throuch through Local Partnership & we have a winning Formula.

A: Medreich Saimirra is the domestic marketing Company with a strong basket of product portfolios. As I mentioned before, we have 7 different therapeutic categories, we A: We want to be a major value driver for Medreich have 50 significant products on the market, so it was an Saimirra, and in order to do that, we want to make a expansion in the overall portfolio of products into a significant impact on serious medical conditions. So we’re number of new therapeutic areas, but also contributed in committed to things like the eradication, remission, and areas where complementary activities. Now we have a relief of serious medical conditions, which generally more significant presence and we have the ability to require specialist care.leverage a stronger portfolio in some of those areas where we both participated before.

A: With the combination of some of finest professionals A: I think the transition is going pretty well. The building up and Medreich’s robust technical expertise, we’ve created exercises are challenging, but I would say that at this point a new organization and a new organization structure. we’ve really met our goals in terms of where we wanted to What we’ve tried to do is to focus on minimizing business be at this point. The organization is formed, operating disruption, because most of the business was actually in effectively, and we have clear goals and objectives. We pretty good shape prior to the integration and our goal was have alignment across the business unit on what our to preserve the things that were working well. In specialty priorities are. We have people in place and we’ve done a care there’s quite a diverse product portfolio; we have thorough portfolio review and made decisions on the 7different therapeutic areas that we are in and are portfolio.managing the business across all 7 of these therapeutic

Q: What does Medreich bring to Medreich Saimirra in the area of specialty care? How has the pipeline grown from the acquisition?

Q: What is your vision/goal for the Medreich Saimirra?

Q: What changes have been made in the Medreich Saimirra ?

Q: How is the transition going?


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OPPOURTUNITIESDELIVERED...........


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

The Indian pharmaceutical industry grew at in the ASEAN 'countries in the Asia Business 13% during 2003-07 and the market size is Forum in Singapore in October 2003. During estimated to be US$ 9.77 billion in 2007-08. the last 8 years at Medreich he has Exports constitute a significant part of the spearheaded the companies various Joint pharmaceutical industry. Pharmaceutical Ventures, Strategic Marketing tie-ups and exports from India are expected to grow at a successful M&A's besides Financial CAGR of 18.5% during FY08-FY12, Management. He has worked in various particularly driven by multibillion dollar patent capacities as head of Finance, Operations, expirations and growth in global generics Supply Chain Management and International market. Many big pharmaceutical companies Marketing. Pravin is on the Board of Medreich's have recently acquired overseas companies to Joint Venture Manufacturing enterprise with tap the potential generic market; consolidation Adcock Ingram South Africa and on the Board in the industry is expected to happen in a big of the Company's R&D JV with Substipharm way. While the growth path of pharmaceutical France.Pravin heads the Medreich's domestic industry is well defined, it is important to know marketing enterprise as it Managing Director.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 m a n a g e m e 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

Pravin is a prolific orator & has presented equally, aspects of product portfolio, quality, papers in many National & International global footprint and cost efficiency. Pravin has C o 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 a meritorious track record, and the experience Pharmaceutical Leadership Summit 2009 of managing large business operations earlier, organised by Indian Express & UTV & at highly with similar responsibilities. In Medreich acclaimed India Leadership Conclave 2009 at Group, he has commendably spearheaded Delho organized by ASSOCHAM, DNA & business growth, and effectively led the NDTV PROFIIT on Challenges & Opportunities support functions. Pravin has made a of Mid-Sized Pharma companies in 2020.significant contribution to improve the financial

The New Age CEO...


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

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 medicines at affordable rates. Saimirra knows the pulse & 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 the ones who have been at the top with outstanding 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.

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?

Q: What specialty care drugs are a high priority for Medreich Saimirra now?

Q: What is the company’s specialty unit’s strategy in emerging markets?


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 we have within the specialty care business unit where there’s a market or an opportunity to grow the business.

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

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 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.

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.

Q: With a strong focus on niche diseases, are you confident your pipeline will keep Saimirra well positioned beyond the patent cliff?

Q: Innovation in Product range have been become increasingly important. How crucial is it for companies to focus in those areas?

Q: Do you think the blockbuster drug model is dying?

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?


NEWS MAKER


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

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

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…”

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..

Q: Do you see the adoption of personalized medicine approaches becoming more common across the industry?

Q: Do you feel leading drug developers share a responsibility to bolster their in-house R&D capabilities?

Q: Will you expand drug-development opportunities in emerging markets?


NEWS MAKER


INTERVIEW WITH TAPAN IYER


INTERVIEW


COVER FEATURE-PHARMA LEADERS


COVER FEATURE



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FOCUS

DIRTY

GAME

S OF

SPUR

IOUS B

USINE

SSPH

ARMA

LEAD

ERS E

XPOS

E!!!

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, l ead ing 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 fei t drugs in to thei r

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 statist ically

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 punishment 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.


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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

implementa t 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

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 nd ian S ta t i s t i ca l 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 tab l 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


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of FDA, Maharash t 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

m o n e t a r y r ewa rd 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

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



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

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:


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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: [email protected]



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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: 0120-2701927E-mail address:[email protected]

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:[email protected]

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; Mobile Number: +919723398877Fax:079-22865244 E-mail address:[email protected]

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:[email protected]

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; Mobile Number: +919841181929Fax: 044-28213079E-mail address:[email protected]

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; Mobile Number: +919432104906Fax: 033-22813806E-mail address:[email protected]

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;

Mobile Number: +9109969252768

Fax: +91-11-23236973

E-mail address: [email protected]



FOCUS

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BRANDS 2010


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TAKING GUARD


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OVER VIEW


PMT Focus


PMT FOCUS


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 rdoccupied 3 position in the adding and creating value for the propel us to deliberate on new

thworld 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,

During last year 2008, USA and the world is a debatable question even the Leaders will need UK has just grown by 1% and 2% and a subject of speculations! 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 O v e r t i m e n e w 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

Leadership Role & Styles:of Global pharma has changed so maintain even 10% growth. In this context. It is worthwhile fast that the value-migration Partly, last year and this year to explore India's earlier model of pharma (a blockbuster peptides have given growth to leadership styles and their roles model ) has faced severe the industry by targeting it on to unleash this leadership limitations and it needs support different diseases. They are potential.of new thoughts Amino Acids. Part of Nutrition!

While managing any industry in Situational context: Imagine Pharma may change its India, entrepreneurs endowed There is a better level playing course of direction from serving with their skills are on the verge field now for Indian Pharma in not only to sick to serving of creating new processes to lead the world as on one hand many healthy through nutrition!!the world. Mr.Narayan Murthy, patented products are expiring Mr .Ratan Tata , Mi t ta l s , Next 4 to 5 years do provide their patents and US, UK, do not Ambani's, Goenkas, Birla's are a golden opportunities where-by have more promising new few names who have developed Indian Pharma can initiate product pipeline to maximize empires on such integration of actions on sick and healthy of their potential in next 10 years. processes. Pharmaceutical society to lead, provided all So on the front of New products industry should not be an forces and actions work together t h e s i t u a t i o n i s h i g h l y exception.a l o n g w i t h e m p o w e r i n g competitive. On the other hand


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

This opportunity could allow understanding of this and can capture enormous market even multinationals to come to entrepreneurship! It is the share! Our Indian Pharma India by franchising them to recognition of a particular process Entrepreneurs have taken up a India. Entrepreneurs who in the minds of Entrepreneurs!! leap forward on the basis of thought and who led industry Research shows that it generally perceived opportunities. In last ½ through popularizing those consists of the following six decade, the successful (nationally brand through their selling stages: and internationally) took up and marketing acumen. strategic view of the situation and

Identifying an Wallace was the first one to charged a bit!opportunity bring brands in India. Chemo

Pharma, TTK even Elders During last 4 to 5 decades, Defining a business could really start their following opportunities have

concept leadership stance through shaped entrepreneurs in India. brand building and brand They do display a distinct style.

Assessing resource franchisee.

requirements

Acquiring those As in India, we had and have This opportunity of essential

resourcean excellent organic chemist, marketing infrastructure such process of reverse engineering as distribution was looked at Implementing and was followed up as there were very differently to have managing the n o p r o d u c t p a t e n t s . forward integration to process conceptCompanies started patenting patented products and brand

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 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 eadership pos i t ion for 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 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 ry , they g e n e r i c s o f r e p u t e f o r aggressively! Latest additions of realized the for forward

µ

µ

µ

µ

µ

µ

2. Brand Franchise Led:

1. Reverse 100 Engineering Led: 3. Distribution Led:

4. Manufacturing led:


MANAGEMENT

Str ategic Su rp rises

Rev erse En gin eering

M an u fac tur ing Bran d

F ran ch isin g Exp o rts

AP Is M a nu fac tu ring

G en eric Bran d Bu ild ing

D istrib u tio n In ten sity

Tec hn o lo gy


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 Habil 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 m a 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 quality. adopted strategic route. Some d i f f e r e n t k i n d o f Almost a l l top leading of the industry leaders who entrepreneurship which was companies, today have that have both processes and road most cost effective 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 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

This opportunity was captured and if you look at even now is by Dr.Reddy's, Torrent, Modi Mundi Pharma they Wockhardt, Zydus Cadila and h a v e c r e a t e d t h e i r all multinationals either by differentiation from drug surprising the customers by delivery system. Reckitt only strategic initiatives on Benckiser is not an exception new therapies, new products, to them.cost leadership etc. The styles of entrepreneurship have been

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,

5. Technology led :

7. Strategic surprise led:

6. Exports led:


MANAGEMENT

Process Technology

Mode

Manufacturing Mode

Brand Building

Mode

Exports/ International

Markets Building

Drug Delivery Mode

Strategy Mode


Perspectives


PERSPECTIVES
