THE EDITORIAL

Address,
CONTENTS
The rising cost of medicines has been a major concern
to consumers and health groups worldwide in recent
years. There also has been an ever increasing demand
for low cost medicines. Thus, for many Big Pharma • Cover Story
companies the way ahead now seems to be ‘GENERIC’. --Generics- The Way Ahead…
Also many pharmaceutical companies are now
collaborating with the companies manufacturing generic
drugs, to expand their share in this segment. Thus, we • Articles/Analysis
have decided to take up the generic drugs industry as --Merge & Emerge
the subject matter for this issue.
• BT News
An intensive study has been done by the students to
analyze the global generic pharmaceutical industry, its --Africa- Anti-Counterfeit or Anti-Generics?
rapidly changing battle lines and India’s position in the
same.
• Candid Talk
We also bring to you the second part of the Mergers & --An Interview with Mr. Sameer Kolhe, A.G.M –
Acquisitions series, this time featuring Indian companies International Business, Indoco Remedies Ltd.,
Mumbai
and cross border deals.

In the BT news section we have taken up the issue of the • PUMBA News
Indian generic drugs facing problems in the African market --Achievers ‘09
and the Indian government’s move against the same.

On the same lines we bring to you an exclusive interview

with Mr. Sameer Kolhe.

Also, a section to keep you updated on the latest

happenings at PUMBA.

Your feedback and suggestions are welcome at:

thepumbagazette@gmail.com

The past belongs to us, but we don’t belong to

the past. We belong to the present. We are the

‘MAKERS’ of the ‘FUTURE’ - M.K.Gandhi

Wish You A Happy Reading!!

Sincerely Yours,

Chief Editor: Tejaswini Lunkad, MBA-BT

(Semester- II) (The PUMBA Gazette Team)

Generics- The Way Ahead…
The term “generics” rings in the boardrooms of most big
and small pharmaceutical companies, dominating most
talks, strategies and deals. Generic, the non patented
version of a patented drug can be of two types – When a
company selling a copy of an established product decides
to give it a brand name, it becomes a branded
generic. However, if the generic company opts to sell the
product on the basis of the molecule name alone, it
becomes a generic generic.
Generic drugs now account for more than $40 billion in
prescription sales worldwide. Although the amount seems
very small as compared to the global revenue of $730
billion at the end of 2008, generics still form a major volume
of drugs being sold. It is due to their low prices that their
share in revenue is less. According to analyst reports, the
global generic industry is expected to grow 10-12% over the
next five years due to a number of drugs going off patent.
The number of new launches, IND applications and
approvals is also coming down each year. And with the
rising number of patented drugs going off protection every
year, the revenue from innovative drugs will grow very
slowly.
A number of players are now entering the generic market to
win back revenues that would otherwise be lost due to
patent expiry. Given the astronomical cost of launching a
new product, companies have slowed down new launches.
An ever increasing pressure on companies to bring down
the costs is another reason to enter the generic market. A
generic launch drastically brings down the cost of a
particular therapy, which it remains quite profitable till
competition is low enough. Also there is increasing
consolidation among generic manufacturers to achieve
greater vertical integration, scales and R & D. The number
of legal proceedings involving generic companies and
innovators is rising rapidly. Global pharma giants have been
filing cases against generic companies for attempting to
manufacture generic versions of their patented products.
The legal complications are due to Para IV filing of
Waxman-Hatch law in USA. Under this, a generic company
is granted permission to market a patented molecule before
its patent expires, under the stipulation that it does not
infringe upon the existing patent. It also gives the generic
company exclusive 180 day marketing rights; during which
no other generic company can enter the market. In a
successful case profits of millions of dollars can be made in
this span.
India has also achieved a strong foothold in the global
generics market. In 2002 Indian companies accounted for
less than 7% of all generic drugs approved for marketing by
the US FDA; however they accounted for over 20 % in
2006. India's share in the total DMF filings has increased
from a mere 14% in 2000 to about 50% in 2007 .In terms of
ANDA approvals as well, India's share has gone up from
15% in 2005 to about 25% in 2007 (Jan-Jun).It is predicted
that by 2020 India will become one of the top three generics
drug makers in the world. The fact that India has a large
number of FDA approved manufacturing facilities outside
the US is the biggest advantage to India.
Governments of the world are also taking measures to
reduce the ever rising health costs, one of them being
promoting generics. The US president Barrack Obama is a
staunch supporter of generic drugs. He seems likely to
allow for the re-importation of drugs, with a caveat that the
prices of the re-imported drugs should be lower than their
cost in the US. Allowing re-importation would provide Indian
manufacturers an increased access to the profitable US
market. The Indian government has plans to set up ‘generic
drugstores’ across the country to facilitate access to
affordable medicines. Under the proposal, the government
expects to open generic stores, through NGOs, Red Cross
and hospitals that are willing to work on a no-profit basis.
Companies participating in this program are expected to
operate on very low margins but bank on high volumes.
This is expected to boost the domestic generic market.
In rest of the world too generics forms a major part of the
drugs. With generic competition intensifying in USA,
companies are now focusing big time on the European
market. Analysts at Frost & Sullivan say that French
generics market is currently growing with the fastest rate
among the EU 5; Italy is the slowest among the top 5.
Japan with annual sales of $58 billion constitutes
approximately 11% of the world's pharmaceutical market.
But unlike in the US or in Europe, generic drugs in Japan
are still perceived as inferior to the branded
ones. However, as the country's healthcare bills soar, the
government is increasingly encouraging the use of
generics. Ranbaxy was the first Indian company to enter
this massive market, followed by Lupin, Cadila and
Dr.Reddys.
With all this happening the big companies have also
decided to safeguard themselves. The originator companies
have developed “life-cycle management plans” composed
not only of patent strategies, but an entire range of
practices aimed at limiting or delaying the entry of a generic
product into the market. Licensing of “authorized generics”
to maximize their profit potential, at the same time
preventing the entry of other generic players is practiced.
Pfizer’s tie-up with Greenstone to market a generic version
of Zoloft is an example. In an attempt to maximize the
product life cycle and delay the entry of generic
competition Innovator companies routinely file applications
seeking approvals for new indications of existing products
facing patent expiry.
The next frontier in this battle would be in the field of
biotechnology. It will comprise biopharmaceuticals, stem
cell therapy, gene therapy, novel vaccines etc. The unique
feature of these products is that they are extremely difficult
to copy or make a generic of. Companies that succeed in
the endeavor to launch biosimiliars will have struck a
jackpot. Realizing this, Roche spent over $40bn to purchase
one of the world’s largest biotech companies, Genentech.
This segment has so much of potential that all major
pharma companies have taken large steps to capitalize on
it. This presents enormous future potential for the generic
players too.
Compiled by: Kiran Dond, Queeny Bubna, Vishakha Laddha (MBA-BT)
(Sem II)
Mentor: Amit Sasmal (MBA-BT, Sem IV)
Merge & Emerge
The first part of this issue dealt with M&As with both the
companies being international in the deal. Top generic
companies worldwide have used M&A as a major tool for
both growth and expansion. Indian companies are also not
in the rear in acquiring companies overseas. Merger and
acquisition activity in the pharma industry involving Indian
players has recently become more commonplace as the
country's large firms have begun to push harder for a more
global presence. Presently, most M&A featuring Indian
companies have been cross border deals.
Ranbaxy-Daiichi
This deal was the most talked amongst all those in the year
2008-09, which would change the face of the generic
industry at home and away. Japan based Daiichi-Sankyo
acquired a controlling stake of about 64% in India’s largest
pharmaceutical company, Ranbaxy Laboratories Ltd. The
deal was worth $4.6 bn and the combined company will be
worth $300 bn. The deal was a shock for most of the
corporates as Malvinder Singh, the then CEO & MD,
Ranbaxy sold 34.8% share which was owned by the Singh
family. Ranbaxy will operate as a subsidiary of Daiichi-
Sankyo.
Both the entities will gain a lot from this deal. Daiichi-
Sankyo will take a huge leap of 7 positions in the global
pharmaceutical sector to number 15. Also Daiichi will be
able to exploit the presence of Ranbaxy in the worldwide
generic market. Daiichi has also put a strong foot in the
Indian sub-continent along with other nations where
Ranbaxy has dominated. These include emerging markets
like Russia, Mexico and East European countries, which
Daiichi has not penetrated so far. Daiichi will also gain
access to low cost manufacturing facilities of Ranbaxy and
to its supply chain network. The deal has also extended the
combined entity’s reach to proprietory as well as non
proprietory drugs.
Ranbaxy, on the other hand, will gain an entry in the closed
economy of Japan which has very strong norms as far as
the safety & testing requirements are concerned. Ranbaxy
has also become a debt free company after the deal.
Ranbaxy also gains an access to Daiichi’s R&D expertise to
advance in the branded drug business. However, it is
unfortunate that an Indian MNC has become a Japanese
subsidiary.
Post deal Daiichi Sankyo reported a loss of about $ 3.45 bn
in the fiscal 2008-09 blaming on the nose diving shares of
Ranbaxy, the reasons being weak global market &
regulatory setbacks faced in the US.
Dr. Reddy’s-BASF & Dow Chemicals
DRL is also not far behind in acquiring companies. It
acquired pharmaceutical contract business & manufacturing
facility of the world’s biggest chemical group BASF, a US
based company in May 2008. The deal was signed with an
agreement that DRL would acquire contract manufacturing
of generic prescription and OTC products for branded and
generic companies in US. The deal would also bring other
tangible and intangible assets under DRLs control. The
funds for the transaction would come from the internal cash
reserves and other credit sources. The amount for the deal
was kept undisclosed. This acquisition will help DRL
expand its portfolio of prescription and OTC drugs. The deal
also includes tolling and supply agreement which would
strengthen the supply chain and logistics facilities in North
America.
Another deal which strengthens DRLs dream of becoming a
giant player in contract manufacturing was the purchase of
US based Dow Chemical’s small molecules business, Dow
pharma. In this case also the amount for the deal was kept
confidential. Along with customer contracts, process
technologies, intellectual property and trademarks, Dr.
Reddy would also gain access to Dow’s Pfenex Expression
Technology for biocatalysis development. This also means
that it would be easy for DRL to manufacture biotechnology
products like prostraglandins and other carbohydrates.
Piramal-Minrad
Piramal Healthcare Ltd., one of India’s largest
pharmaceutical and healthcare companies, acquired Minrad
International Inc., a US based generic anaesthetic
manufacturer for $40 million (about Rs. 196 crore) in a cash
and debt form, thus strengthening its global presence in the
critical care. The deal was signed in the last week of
December 2008.
Piramal produces halothane and isoflurane, both inhalation
products while Minrad’s product portfolio consists of
isoflurane, enflurane and sevoflurane. The merger will
expand the product portfolio of inhalation anesthetics of
Piramal as well as help it to penetrate the US market for
sevoflurane, the largest selling inhalation anesthetic in the
US. Piramal will also have an access to key intellectual
property for the manufacture of inhalation anesthetics,
including process-based intellectual property for both
sevoflurane and desflurane. Apart from this, it can also
exploit well equipped R&D facilities of Minrad. The
combined company will have an access to more than 100
countries.
The company had bought Rhodia’s Inhalation Anesthetics
business in December 2004 for $14 million (about Rs. 61
crore). By merging with Minrad it has gradually consolidated
its presence in the Critical Care business. Another move
towards strengthening its hold over the critical care sector
was the acquisition of the ‘Haemaccel’ brand of blood
plasma products from Germany’s PlasmaSelect AG for a
cash of about Rs 53 crore in 2008.
The company expects a 4 fold rise in the revenue by 2009-
10 from the critical care business, major contribution
coming from Minrad.
Sun Pharma-Chattem Chemicals
Sun Pharmaceutical Industries, a subsidiary of Sun
Pharma, has acquired 100% ownership in US based
Chattem Chemicals Inc. in November 2008. This is another
example of a cross border deal in which an Indian company
has gone global to acquire companies from overseas. It
was taken over from Elcat Inc., a US based drug firm, which
had acquired it in the mid 1990s. Chattem is registered with
the US Drug Enforcement Administration (DEA) & US-FDA
as a narcotic raw material importer. The deal holds the
import licenses for controlled substances like concentrated
poppy straw (CPS), along with phenyl acetone,
methamphetamine and raw opium, which are listed in
schedule-II. Moreover, DEA has also approved the
manufacturing of Schedule-I to V controlled substances.
Apart from the narcotic import registration Sun Pharma will
also get access to a fully operational US-FDA & DEA
approved Active Pharmaceutical Ingredients (API) facility
located at Hungary and ten active Drug Master Files
(DMFs). This acquisition has allowed Sun Pharma to
strengthen its foot in the pain management space. It had
completed two acquisitions on same lines in 2005. It had
acquired a well equipped controlled substances
manufacturing facility at New Jersey; the deal also included
the rights to product dossiers that were being marketed by
Able. Also, a plant in Hungary authorised to make
controlled substance APIs, was bought from Valeant
Pharmaceuticals.
Cadila-Etna Biotech
Cadila Healthcare Ltd. (Zydus Cadila), one of India’s
leading healthcare companies, acquired Etna Biotech, the
wholly owned subsidiary of the Dutch biopharma company,
Crucell N.V. in the month of November 2008. This was
Zydus Cadila’s first acquisition in the research space. This
provides the company a research platform for developing
new vaccines & technology.
Etna Biotech headquartered in Italy, has various vaccines
at different developmental stages in the pipeline. These
include vaccines against Hepatitis, Malaria and Measles.
Zydus Cadila, by aquiring Etna Biotech, has tightened its
hold in the vaccine market which would otherwise be quite
difficult to enter. Also the vaccine industry is forecasted to
grow at about 18% by 2010 which provides an edge to the
company over the other competitive companies. Acquisition
of the Italian firm will also help Cadila Healthcare to tighten
its grip over the European market which has low generic
penetration, thus providing Zydus ample opportunities to
grow.
In the first quarter, the company had acquired 100% stake
in Laboratories Combix, based at Spain. It had also
acquired 70% stake in South Africa based Simayla
Pharmaceuticals in the month of June, thus expanding its
horizon in Africa. Earlier in 2007, it had acquired Brazil
based Quimica e Farmaceutica, which is in line with the
company’s objective of increasing its customer base in
African countries.
Lupin-Hormosan
Lupin Ltd. acquired Germany based Sales & Marketing
company Hormosan Pharma in the month of July last year.
This was Lupin’s first acquisition in the European market.
Hormosan markets a range of generic drugs in Germany
however it specializes in drugs related to Central Nervous
System which are complementary to Lupin’s product range.
This helps Lupin to expand its horizon to European
countries as well as increases its product portfolio for the
CNS and cardiovascular therapeutics. The acquisition will
also strengthen the R & D division of Lupin.
Lupin has also bought a 60 % stake in the South African
firm Pharma Dynamics in September 2008. The deal was
worth $24 million. Pharma Dynamics markets
cardiovascular drugs in SA, it has strengthened the product
portfolio of cardiovascular segment of Lupin Ltd. Also it
gives Lupin an access to the South African generic market
and it is now aiming for a 50-60 % share. On the other
hand, the product folio of Pharma Dynamics will expand as
it already has a JV with Aspen for anti-tuberculosis drugs.
Lupin is recognized to be the largest producer of anti-
tuberculosis drugs. In the same month, Lupin had also
acquired a minority stake, 35% to be precise, in an
Australian firm Generic Health which markets prescription
and OTC drugs. The generics business in Australia is
growing at a rapid pace and is close to $2.6 billion. Thus,
Lupin is squeezing in steadily in the overseas generic
market through an inorganic route.
Dabur-Fem
New Delhi based Dabur India Ltd., one of the leading
FMCG companies in India, acquired a controlling stake of
72.15 % in Fem Care Pharma in an all-cash deal of $41.23
mn (Rs. 203 crore). It will also seek to buy another 20% in
the near future. This strategy of Dabur will give it an entry in
a lucrative skin care market as Fem Care caters products
like fairness bleaching creams, hair removing creams and
liquid soaps. The other products which Dabur will have an
access to are anti-ageing creams, hair conditioners, fabric
softners and men’s bleaching creams. These are
complementary to the already marketed products like
Vatika & Gulabari, which have their own niche markets.
Dabur will also gain access to the research facilities of Fem
Care and also be able to expand its reach to the Asian
Subcontinent and Gulf countries, where Fem already has a
substantial presence. This deal strengthens Dabur’s
presence in the FMCG business, where it can compete with
the giants like Hindustan Uniliver, P&G, Marico, etc. Dabur
had previously acquired Balsara’s hygiene and home
products businesses and is planning to launch an ayurvedic
skin care product at the start of fiscal 2010-11. This makes
evident it that the company wishes to consolidate its
presence in the FMCG business. Fem is also in a win-win
situation as it can exploit Dabur’s strong distribution
network to expand its brand across India. Though, experts
comment that the deal was slightly at an expensive side, it
is certainly going to help the parent company in a long run.
The current economic downturn and the volatility of the
stock markets may have taken a toll on the number of M&A
taking place in the year of 2009 but it is definitely true that
Indian companies are trying to expand their presence
abroad. Some major deals like Sun Pharmaceuticals &
Taro, Fresenius – Dabur Pharma, Emami & Zandu
Pharmaceutical works will not only strengthen the position
of the parent company but also open various segments for
them in the industry. A notable but strong trend of
companies trying to invest & grow as R&D based
companies, along with their already established generics
and contract manufacturing business, has been observed.
Compiled by: Kanika Goyal, Ruchi Bharadwaj, Vandita
Javali, Vijendra Agarwal (MBA-BT, Sem-II)
Mentor: Priyanka Jamenis ( MBA-BT, Sem IV)

Africa- Anti-Counterfeit or Anti-Generic?
Propaganda claiming that the Indian generic drugs are
spurious and only the patented drugs are good for
consumption, has been spreading in the African countries
for sometime now. Hence, a number of African countries
are apprehensive about the quality of medicines the Indian
companies export and are allegedly seeking to enact
legislation which would ban generic drugs. In December
2008 the Kenyan parliament passed the anti-counterfeit
legislation which lays down that generics having patent
protection anywhere in the world can be considered
counterfeit in case of an intellectual property dispute with
the patent holder. This means that in case a drug company,
which does not hold a patent for a medicine in India but
holds a US patent, challenges the generic version sold by
an Indian company in Kenya, it will be classified as a
counterfeit. The critics of this law say that the definition of
‘counterfeits’ does not distinguish between mechanical
details of Intellectual Property Rights (IPRs), such as
trademarks, copyright, patents and data protection from
quality control issues related to medicines, which basically
revolve around formulation. They affirm that the provisions
in Kenya’s anti-counterfeit law are contrary to the country’s
Intellectual Property Act 2001 it and doesn’t distinguish
between different categories of goods such as counterfeit
trademark goods and pirated copyright products, as is done
in Trade-Related aspects of Intellectual Property Rights
(Trips) protocol of the World Trade Organization (WTO).
Some critics also argue that it is improper to freeze parallel
imports that benefited the Kenyans, since they were cheap
and easily accessible. In the Kenyan case, it appears more
likely that the proposed protection is aimed at allowing big
multinational pharmaceutical companies to protect their
monopolies by strong-arming the weaker governments via
their own.
Any type of barriers on generic drugs will result in a huge
loss to the Indian pharmaceutical companies as African
countries account for 14% of India’s $8-billion
pharmaceutical exports. Kenya is the third largest African
market for Indian drugs, many of them generics. The
country is estimated to have imported drugs worth more
than $70 million last year. This ban will also severely affect
the generic industry in African countries which is still in the
nascent stage. Also in the current slowdown it will affect the
purchasing power of patients who will be compelled to
purchase 10 times expensive drugs. It could threaten the
flow of much needed medicines for public health problems
such as HIV/Aids and malaria. In late August, a new $32
million pharmaceutical factory owned by India’s Cipla and a
local group called Quality Chemicals (Cipla’s local
distributor) is expected to start commercial production of
ARVs and a treatment for malaria, another big killer
throughout sub-Saharan Africa. The factory will have a
capacity of 6 million tablets per day when operating full-tilt,
or enough to treat some 3 million patients.
As an answer to the propaganda, earlier this year, the
Indian High Commissioner Mr. Rajiv had called on South
Africa to assist India in the fight against major
pharmaceutical companies which are trying to get generic
medicines classified as counterfeit drugs. Later in April, the
government gave a presentation to the ambassadors and
high commissioners of African countries on the scientific
way in which generic drugs are manufactured in India, to
ensure that its genuine pharmaceutical exports to African
countries do not get rejected as fakes. The presentation
also stressed on the need for the African countries to
differentiate between spurious and generic drugs and frame
laws to check the fakes. This move by the government will
safeguard the interest of the Indian pharmaceutical
companies as most of them are generic based.
To secure the future of generic drugs, there is a need for
better understanding of national as well as other
international pharmaceutical related laws. This will grant an
easy access for affordable medicines to African countries
and other emerging markets. Recently, World Health
Organization (WHO) provided a definition for ‘counterfeit
drugs’ which covered generic drugs under its warp.
Considering the representation from India and other South
East Asian nations, WHO has put defining counterfeit drugs
on hold, while agreeing to modify the same in their favor.
This issue of distinction between spurious and generic
drugs needs to be addressed more intently, as many drugs
are coming off patent by 2010-2015 which would then be
open for production in the generic version. Also there
should be strict regulations against spurious drugs
worldwide. Any move to restrain the free flow of lawfully
produced generic medicines would undermine the
production and trade of good quality generic medicines and
consequently the access to affordable medicines.
Compiled by: Pritesh Shetty, Tejaswini Lunkad (MBA-BT,
Sem-II)
‘Generation Generics’
Mr. Sameer Kolhe, an alumnus of PUMBA is working as an
A.G.M – International Business, with Indoco Remedies Ltd.,
Mumbai.
The PUMBA Gazette Team exclusively interviewed him on
the global generic market.
1) According to a recent report by the Generic Pharma
Association in US, generic drugs saved the healthcare
system more than $734bn in the last decade. How vital
is the role of generics in the healthcare policy of a
country and do you think this is a good news for Indian
generic players?
One has to look at US$ 734bn from a point of view that the
global pharmaceutical market is worth roughly US$ 750
Billion in 2008 of which generics is less than 18% of the
value (though 50% of the volumes). The savings would now
look huge. The generics component in the Health Care
policy of a country is critical. It can change the industry’s
outlook, impetus on the industry’s potential and channelize
the innovative culture in the industry which is more critical it
being a Techno-Bio-Manufacturing industry. There are
hundreds of Innovator companies focusing on Research of
new molecules in US and Japan and even at 1/40th of the
cost India utilizes all its energy in ‘development’ part of R&D
which only focuses on generics.
The Generic trend is good for the Indian Manufacturers for
the short future but they have to regularly upgrade and
innovate to sustain. So I say, for India it is ideal that we
have generics policy ingrained in our system which keeps a
perfect control on the prices and makes medicines available
and affordable to the needy ones. Yes, it does not give our
industry the required momentum to work harder on the
research front but it’s too late and could be wrong to shift
the focus now.
2) According to you what is the major factor driving the
high growth rate of Pharma industry? How much in it is
the contribution of the overall increase in the generic
utilization or the loss of patent protection by several
brand name blockbusters?
I believe it has got nothing to do with Genericizing or Not
Genericizing the market. Few reasons why the global
pharmaceutical market is growing (even though the growth
rate is declining continuously for the last 5 years) could be:
- The value / volume of medicine per prescription
have gone up substantially with more and more
adjutant drugs becoming part of the same. This
has led to increase in per capita spending on the
health care by the affordable strata.
- Increasing awareness on categories like nutritional
medicines, which as a sector is pouring in both
profits and volumes to the industry
- Most of the under developed countries have either
started affording medicines or getting funds from
WHO and other organizations which in turn floats
tenders and has hence come under the organized
section of the Pharmaceutical Industry.
- Pharmaceutical being a core sector is least
affected by recession and to the contrary has
affected in increase in the prices of the medicines
all over and hence the growth seen more robust in
value terms.
Yes, I am compelled to give some credit to the “gone
Generics” blockbusters off lately in the overall growth of the
pharma sector but more in the volumes than in the value.
Please note that the biggest regulated markets like US,
Japan and few others are de-growing or surely the growth
rate has been declining. And last but not the least, the
global population is growing and unhealthy population is
growing even faster.
3) Pfizer has plans of introducing generic products in
various categories and has also struck a deal with
Aurobindo pharma to extend its generic arm. So, big
MNCs, rather than being innovators and patent holders,
are now getting into generics to maintain their position
in the market. What is your opinion about this?
Well this was ought to happen. Please note few facts –
- New Chemical Entities launched globally in 2008 is
a mere 25 (12 in the primary driven areas and 13 in the
specialist driven areas) in contrast to the average of 38
in the period of 1998 to 2006. So to say not many
NCEs are in the pipeline for the innovators (especially
in the primary driven areas)
- Contribution to the Global Pharmaceutical growth
from Pharmerging markets is 35% in 2008 (up from
14% in 2001).So now no player can put Generics out of
their strategy while wanting to make an impact in these
Pharmerging makets.
- Sanofi started it in a big way and showed others
how to do it. Others are just following it. However
MNCs can, on their own never ever become a
successful generic company. It’s a completely different
ball game and requirements in terms of infrastructure
(Distribution Channels for Generics are different),
psyche to compete in a price sensitive environment and
 very high technical abilities to cut down cost (which in
true sense the Innovator companies doesn’t posses)
makes it difficult for the Innovators companies to adopt
that mode completely.
I believe these innovator companies will surely come into
the generic arena. Infact this is already happening. The only
thing to be seen is the strategy these big fishes adopt to be
there. I don’t have an iota of doubt that Indian pharma
companies will be a part of their strategies and this will
boost the sector. Contract Research for Generic
Development, Re-Validation of Old registrations, Contract
Manufacturing, Bio-Studies, Stability Studies and IT
enabled services will be the ones that will get a major
boost.
Very importantly you might even see Indian companies
getting the slots for an ‘Authorized Generic’ for few
patented products and if this happens, there might be an
exponential rise the industry’s growth prospects.
4) Globally, the generic drug market is growing, is been
promoted to a large extent and this is affecting
pharmaceutical innovation to a large extent. What is
your opinion about it?
Well as explained earlier yes the change in the focus might
change the attitude towards research for now but then there
is not enough scope as well remaining in the new research
of the conventional products (NCEs). The focus had shifted
to Biotechnology for some time but that sector has badly
been affected for want of funds globally. May be that sector
revives and you can see the focus shifting to research
again.
5) The pharmacists’ right to generic substitution” is a
policy adopted by various countries but at the same
time is prohibited in other countries. What is your
opinion about this policy?
Well first, you need to have a robust and accurate system
to have this policy in, which many countries do not posses
(including India). Please note that Generic substitution was
a result of Insurance Players coming into the markets. The
reimbursement system in these countries have forced to
give Pharmacists that power to decision making to be able
to substitute prescriptions to match the reimbursed price by
the insurers to the patients who are insured.
So in my opinion, countries like India, China, Russia and
Brazil will take long time before the insurers would have a
substantial market here and pharmacy (medical stores) will
be an organized sector. Imagine a country like South Africa
(Population of 4.5 Million) has 3500 Pharmacy Shops,
Netherlands (population of 4.8 Million) has 2800 Pharmacy
Shops and in contrast, alone Mumbai has 32,000
registered pharmacy shops. Do we really believe we can
have it here in India!!??
6) Countries, such as Germany, Austria, Switzerland
& Italy operate numerous regional courts that
maintain equal jurisdiction over patent related
matters. Don’t you think this leads to forum
shopping and possibility of inconsistent decision
making? Will it in a way affect the prospects of
generic drugs and what can be done about it?
Those days are fast passing by and legal systems can’t
have partisan outlook for generics for foreign countries.
This is temporary and I don’t think so it is an important
challenge for generic players.
7) The Obama Govt. is planning to pass a bill on
biogenerics (The Bipartisan Biogenerics Consensus
Bill: Promoting Innovation and Access to Life-
Saving Medicine Act) How will the Indian biogeneric
players mainly the insulin and vaccine
manufacturers benefit from it?
Well, innovation is not a product of policies or bill passed
in parliament. This step is only a way to give an impetus
to Biotech Industry which has struck a pause. One
should not look at it more seriously than it being a help
to Bio-Pharmaceutical companies who had poured in a
lot of money with out getting good return on the same.
Well as far as India is concerned, in this sector believe
me we will not remain a generic country and will have
mix of innovation and generics manufacturing.
8) Recently, there has been a case of pandemic
disease called ‘Swine flu’. Do you think India has an
appropriate stock pile to deal with it? Are the Indian
generic companies well equipped to deal with such
an outbreak?
On the lighter side, we Indians are so immune to any
‘FLU’ kind of a thing to get to us especially which has
originated in Europe, that I personally believe that it will
never enter India. India is well equipped to face the
pandemic if at all there is such an outbreak. We provide
vaccines and antibiotics to the whole world and there
shouldn’t be a single doubt on our capacities to cater to
our own people.
Compiled by: The PUMBA Gazette Interview Team
PUMBA News and value the family. Women should never give up and
always be ready for whatever destiny offers”, she added.

Mr. Kedia (27) was awarded PUMBA's annual award,

Achievers ‘09-An ode to excellence…
Achievers, for his entrepreneurial spirit. At 25, he started his
company Mobitrail. His technical skills include working on
mobile platforms including j2me, brew, iphone, multiplayer,
GPS and motion gaming. His company focuses on
development and distribution of mobile games and game-
based brand marketing solutions catering to the fast
expanding market of mobile and web games for the casual
gamer. "The entrepreneur should be an expert, but he also
needs to have knowledge about each and every aspect of
business," Mr. Kedia said. He also emphasized on
choosing the right mentor.

Nutan Mumbai Dabbawala’s association, an unique service

Every year in an event known as ‘ACHIEVERS’ the
Department of Management Sciences, University of Pune
(PUMBA) felicitates achievers in varied fields. The occasion
this year was scheduled on 25th April. The department
felicitated personalities like the innovator of Touch Magix
Media Pvt. Ltd., Mr. Anup Tapadia; the Executive Vice-
President of National Securities Depository Limited, Mr.
Chandrashekhar Tilak; the President of Foundation For
Liberal And Management Education (FLAME) Mrs. Indira
Parikh; the architect of Mobitrail, Mr. Vikas Kedia and the
President of Nutan Mumbai Dabbawalas, Mr. Raghunath
Medge.
industry whose primary business is collecting the freshly
cooked food in lunch boxes from the residences of the
office workers, delivering it to their respective workplaces
and returning the empty boxes to their homes. The
association has achieved six sigma with the error rate of 1
in every 6, 00,000 deliveries. Mr. Raghunath Medge was
venerated for this achievement. He said that customer is
their God and they believe that serving the customer is
serving God. They in no ways compromise in their work
then may it be for Prince Charles or Richard Branson.
Prince Charles had to fit in with their schedule, since their
timing was too precise to permit any flexibility! Mr. Medge
thus stressed on dedication and team work.

Mr. Anup Tapadia (23) bagged two masters’ degrees in

computer science at the young age of 21. He is an alumnus
of University of California, San Diego. At the tender age of
14 he became the world's youngest professional to pass
the Microsoft certifications (MCSD, MCSE,
MCDBA).Microsoft chairman Bill Gates, Azim Premji of
Wipro Technologies and several others have appreciated
his achievements. Mr. Tapadia recently returned to India
from Silicon Valley to start Touch Magix Media Pvt. Ltd., a
company that manufactures advertising, branding, gaming
and entertainment products.

Mr. Chandrashekhar Tilak was lionized for his remarkable

contributions to the Indian capital market during his 22-year
career. So far he has handled activities like stock exchange Overall the event was a huge success and left our students
settlements, surveillance, participant interface, marketing highly inspired. Each of the guests set an excellent example
for the students.
and corporate communications. He was also the chief
investigating officer of the capital market scam involving
Harshad Mehta and Ketan Parekh. He advised students to
focus on practical knowledge as it was instrumental in
achieving success. He has been delivering lectures on
annual budgets presented by the union government for the
past 22 years.

Mrs. Indira Parikh was lauded for her contribution in the

field of education. She was the Dean of Indian Institute of
Management, Ahmedabad (IIM-A) from 2002 to 2005 and
professor of organisational behaviour at the institute. She
said, "While achieving success, everyone needs to respect