Healtcare A Review

BINISH CHUDGAR OF INTAS GUJARAT STATE: BIG-TICKET US FDA WARNING
ON BIOSIMILAR STRATEGY INDIA’S PHARMA HUB INTERNATIONAL LETTERS AND QUALITY

PAGE 12 PAGE 15 INVESTMENTS COMPLIANCE
PAGE 34 PAGE 35
STANDING OUT FROM THE CROWD
INDIA
PAGE 21
JULY 2018
Acknowledgements
PharmaBoardroom is profoundly grateful to…
Suresh Prabhu, Minister of Commerce and Industry of India
Hemant Koshia, commissioner of FDCA Gujarat
Dilip G. Shah, secretary general of Indian Pharmaceutical Alliance (IPA)
for their continuous support, enthusiasm and encouragement in the

compilation of this report.
2 Healthcare & Life Sciences Review: India www.pharmaboardroom.com

HEALTHCARE & LIFE SCIENCES REVIEW
INDIA
Binish Chudgar,
vice-chairman and
managing director of
Intas
Interview
12
CONTENTS
— July 2018
2 ACKNOWLEDGEMENTS
5 PREFACE
6 FOREWORDS
Standing Out 8 SNAPSHOT IN FIGURES
From the Crowd
Cover story 12 BIOSIMILAR STRATEGY INTERVIEW
21 Binish Chudgar, Intas
14 REGULATORY ALIGNMENT INTERVIEW
Hemant Koshia, FDCA Gujarat
15 GEOSTRATEGIC FOCUS FEATURE
Gujarat State
16 CEO PROFILE FEATURE Vivek Sharma, Piramal
Pharma Solutions
18 APIS INTERVIEW Satyanarayana Chava,
Laurus Labs
21 STANDING OUT FROM THE CROWD
COVER STORY
22 Scaling the Value Chain
24 Outsourced Services: Credible Partners
The African 27 The Only Way Forward
Launchpad for 28 Adjusting to a New Normal
Indian Pharma
Feature 32 Surviving the Raw Materials Rollercoaster
47 35 No Mistakes Allowed!
37 A Top-Down Endeavor
38 No Better Place than Home?
42 The Right Focus: Partnerships
The Healthcare & Life Sciences Review was produced 43 Leveraging the Past to Build the Future
by PharmaBoardroom. 44 INDIAN R&D INTERVIEW Sharvil Patel,
Report Director: Laurent Pichotzki Libano Zydus Cadila
Report Coordinator: Magdalena Anna Kantor
Report Assistant: Mathilde Humbert
45 CRMO PARTNERSHIPS INTERVIEW
Senior Editor: Louis Haynes Jonathan Hunt, Syngene International
Editor: Patrick Burton 46 MEDTECH INTERVIEW Randolph Alves, Alves
Report Publisher: Diana Viola Group
Graphic Design: Miriam León, Irene de Aza
47 EXPORT STRATEGIES FEATURE Emerging
For exclusive interviews and more info, please log onto Markets
www.pharmaboardroom.com or write to contact@focusreports.net.
48 DOMESTIC MARKET STRATEGIES
Copyright: All rights reserved. No part of this publication maybe reproduced in any
form or by any means, whether electronic, mechanical or otherwise including photo-
INTERVIEW Nitin and Bhagyesh Shah, Unison
copying, recording or any information storage or retrieval system without prior written Pharmaceuticals
consent of Focus Reports. While every attempt is made to ensure the accuracy of the
information contained in this report, neither Focus Reports nor the authors accept any 50 COMPANY SPOTLIGHT FEATURE Athena
liabilities forerrors and omissions. Opinions expressed in this report are not necessarily
those of the authors. 51 IMMUNIZATION AND VACCINES INTERVIEW
Jean-Pierre Baylet, Sanofi Pasteur
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Preface
The latest edition of HCLS Review India builds on the March 2018 report from the country
which painted a picture of the South Asian nation as the ‘pharmacy of the world’ – able
to supply affordable generic drugs to global markets and with an increasingly advanced
footprint in R&D intensive niches such as biologics.
Through interviews with the heads of some of India’s leading domestic pharmaceutical
companies, this report delves into the biologics, biosimilars and new chemical entities
being developed in India and taken abroad; the nation’s hubs of development and inno-
vation, notably the northern state of Gujarat; and how Indian companies have stepped up
their quality compliance game following a spate of US FDA warning letters.
Other key topics covered in this report include the startling growth of the contract
research and contract manufacturing sectors as pharma companies divest an ever-increas-
ing number of non-core activities; the enduring importance of the domestic market, of
which Indian companies hold a 77 percent market share; and how Indian organizations
are consolidating their presence abroad through a series of acquisitions and tie-ups with
international entities.

STRAP IN HERE PLEASE
Strap subhead in here please
Dear members of the international pharmaceutical industry,

As Minister of Commerce and Industry of India, I am proud to introduce the 2018
edition of the India Healthcare & Life Sciences Review, which I consider an excellent
opportunity to showcase the very real progress of Indian companies in this field.
Over the past few decades, the Indian pharmaceutical industry has established itself as
a global powerhouse for the production of bulk drugs and generics which have gained
dominant market shares in the world’s most strategic markets and tremendously bol-
stered healthcare affordability and accessibility on all continents. Furthermore, India
already has the largest number of FDA-approved plants outside the US, domestic phar-
ma companies received an all-time high number of drug approvals in 2017 and continue
to tirelessly increase their R&D investments to take advantage of new technology and
changing demographics.
As part of its commitment to support the growth of this flourishing sector, India’s
government is intensifying its efforts to improve the ease of doing business in India and
incentivize both R&D and manufacturing investments to the pharmaceutical industry.
While India has proudly become the “world’s pharmacy”, the strength and the growth
potential of its domestic market should not be overlooked either. As a matter of fact,
the latter is set to reach over USD 27 billion by 2021 and should benefit from the recent
increase of public health spending announced as part of the Union Budget 2018-19.
Additionally, India accounts for almost 20 percent of the global disease burden. Moving
forward, India is set to stand as the world’s fastest growing large economy for the rest
of the decade, and the dynamism of our country’s economy and pharmaceutical market
have undoubtedly cemented the crucial importance of India in the overall operations of
all pharmaceutical companies with global ambitions.
With the India Healthcare & Life Sciences Review 2018, I invite all members of the
global pharmaceutical community to take a closer look at the promising opportunities
India has to offer, and to consider how they can strategically leverage the unique exper-
tise and capabilities of our thriving pharmaceutical companies, which already contribute
to placing India at the forefront of the pharmaceutical industry globally.
Warm regards,
Mr. Suresh Prabhu

Minister of Commerce and Industry of India

Distinguished members of the healthcare and pharmaceutical sectors,

As the Commissioner of the FDCA–Gujarat, I am particularly proud to introduce this 2018
edition of the India Healthcare and Life Sciences Review, which I consider to be a formidable
opportunity to display the capabilities of the sector in the country as well as abroad.
Over the past decade, Gujarat has truly emerged as a pharmaceutical hub of international
reference, as our state’s pharmaceutical exports have skyrocketed from USD506 million in
2006 to over USD3.06 billion in 2016, making up over 28 percent of India’s pharmaceutical
exports. Despite accounting for only five percent of the population and six percent of the coun-
try’s area, Gujarat is today responsible for almost a third of the country’s pharmaceutical pro-
duction, displaying a total turnover of over USD7 billion in 2017. It makes no doubt that this
eye-catching and on-going success takes its roots in our ecosystem’s shared commitment to
tirelessly raising the bar in terms of quality, efficiency, innovation, compliance and transparen-
cy. While FDCA-Gujarat emerges as a key driving force behind Gujarat’s healthcare sector, my
fundamental objective is therefore to ensure that these values become more deeply entrenched
in our processes and requirements every day.
Looking forward, critical challenges still lie ahead and the FDCA-Gujarat does not plan to
rest on its laurels, especially when it comes to designing strategies that aim to simplify approv-
al processes without ever compromising on our quality, safety, and efficacy standards. In this
endeavor, nurturing FDCA’s relationships across the local and international value chains will
stand as a critical success factor, and we will continue to favor a collaborative approach encom-
passing the Indian population as well as the regulated sector.
India in general and Gujarat in particular are not only strengthening their positioning as
one of the most attractive pharmaceutical and healthcare industries in the world; Gujarat also
demonstrates a true leadership in building a modern, safer, and more responsive healthcare
environment. As Commissioner of the FDCA-Gujarat invite you and the international com-
munity at large to take a look at the exciting developments that the healthcare and life sciences
industries in Gujarat and India are making through this in-depth report.
Warm regards,
Mr. Hemant Koshia

Commissioner – FDCA Gujarat

SNAPSHOT IN FIGURES
Macroeconomy
INDIA SNAPSHOT
POPULATION: 1.28 BILLION (2ND IN WORLD)

MEDIAN AGE: 27.9 YEARS (139TH OLDEST IN WORLD)
POPULATION GROWTH RATE: 1.17% (96TH IN WORLD)
HEALTH EXPENDITURE: 4.7% OF GDP (2014)
GDP (PPP): USD 9.447 TRILLION (2017)

GDP PER CAPITA (PPP): USD 7,200 (2017)
GDP REAL GROWTH RATE: 6.7% (2017) Source: CIA World Factbook
GDP GROWTH RATES
(YEAR-ON-YEAR IN %) Source: IMF; Livemint

8
EUROPEAN
CHINA UNION WORLD USA
INDIA
4
0
2016 2017 2018 2019
WAGES IN ASEAN (2014)
ANNUAL MINIMUM HOURLY TOTAL COST OF LABOR

COUNTRY WAGE (USD) MINIMUM WAGE (USD) (MINIMUM WAGE PLUS WELFARE, USD)
CHINA 2,472 1.19 3,337.20
INDIA 689 0.28 740
INDONESIA 1,087 0.52 1,187
MALAYSIA 3,107 1.24 3,534.20
PHILIPPINES 1,515 0.73 1,648.30
THAILAND 3,012 1.21 3,168.60
VIETNAM 1,296 0.64 1,581.10

Source: China Briefing

SNAPSHOT IN FIGURES
Domestic market
TOP 15 PHARMA COMPANIES IN INDIA (2017) INDIA’S PHARMACEUTICAL SALES AND

Source: AIOCD Awacs
FORECAST (2013-2021F)
MARKET GROWTH
COMPANY SHARE (%) RATE (%) IN USD BILLION
INDIAN PHARMA
9-10%
# MARKET (TOTAL) 100 5.5 CAGR
1 SUN PHARMA 5.5 7.0 27
25
2 CIPLA 4.6 3.2 23
19 21
3 ZYDUS CADILA 3.9 9.8 17 18
15 16
4 MANKIND 3.6 5.4
5 LUPIN 3.3 7.9
6 TORRENT 3.2 5.9
7 ALKEM 3.1 3.9
8 ABBOTT 3.1 4.7
9 RANBAXY 3.1 4.1
10 GLAXO 3.0 7.6
11 MACLEODS 2.8 6.1
12 INTAS 2.8 5.9
2013 2014 2015 2016E 2017F 2018F 2019F 2020F 2021F
13 GLENMARK 2.4 9.3
14 ARISTO 2.4 3.5
Source: India Pharmaceutical & Healthcare report - Q2 2017, BMI Research, via
15 PFIZER 2.4 -3.5 ISI Emerging market database, accessed July 2017
INDIA BIOTECHNOLOGY MARKET SIZE INDIA BIOSIMILARS MARKET
(USD BILLION) (USD MILLION)
11.6
11
6%
33% 14 -1
20. CAG
R 658
GR
CA
578
7 507
5 444
4.3 4.3
3.8 390
3 342
2.6 2.6
1.5 1.9
1.1
05 20 06 20 07 0 08 20 09 2010 2011 2012 2013 2014 2015 2016 17F

20 2 20
2016 2017E 2018F 2019F 2020F 2021F
Source: ABLE - Biospectrum Industry Survey, Makeinindia, Ministry of External Affairs,
TechSci Research, Global Industry Analysts Report (GIA) Source: Business standard, Beroe Analysis

SNAPSHOT IN FIGURES
Manufacturing
PHARMACEUTICAL CLUSTERS
Source: Invest India
Captive R&D Units

Contract R&D Units
Established Bulk Drug Cluster
Established Formulation Cluster
BADDI
Emerging Bulk Drug Cluster PANTNAGAR
Emerging Formulation Cluster HARIDWAR
NCR
SIKKIM
AHMEDABAD
ANKLESHWAR
VAPI
BARODA
MUMBAI
TARAPUR
AURANGABAD HYDERABAD - MEDAK
PUNE
VISHAKHAPATNAM
BENGALURU CHENNAI
MYSORE
PONDICHERRY
RELATIVE COST OF PRODUCTION WITH US COST AS BASE (%)
USA EUROPE INDIA
100 85 40
Source: Frost and Sullivan Report on Indian Generic Pharmaceuticals Market, BMI, Financial Express, TechSci Research (March 2014)

SNAPSHOT IN FIGURES
Exports
DESTINATION OF INDIAN PHARMA PRODUCTS EXPORTS
Almost a third of Indian exports find a home in United States
OTHER
44.8% 1.4% BRAZIL
1.6% AUSTRALIA
1.7% NETHERLANDS
1.9% KENYA
2.0% GERMANY
RUSSIA 4.8% 3.0% NIGERIA
SOUTH
AFRICA 4.3%
30.9% USA
UK 3.6%
Source: Ministry of commerce,
Gol; breakup for FY2014
EXPORTS OF PHARMACEUTICAL PRODUCTS FROM INDIA TO THE WORLD
EXPORTED VALUE (USD ‘000) Source: Eurasia Review
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
0 2,000,000 4,000,000 6,000,000 8,000,000 10,000,000 12,000,000 14,000,000

BIOSIMILAR STRATEGY
Binish Chudgar, Intas
FULL SPEED
AHEAD!
Binish Chudgar, vice-chairman and managing di-

rector of Intas, the largest privately-owned Indian
pharmaceutical company with sales of over USD
1.7 billion during the last financial year, provides in-
sights into the company’s growth model, biosimilar
strategy, M&A approach, as well as his objectives
with regards to a large-scale acquisition in the US.
most resources at the moment. Biosimilars are also
part of our AVP operations.
Binish Chudgar
HCLS: Intas has so far chosen to market its bio-
INTAS similars in Europe by itself rather than partnering
with multinational companies, unlike other Indi-
an companies, such as Biocon and its partnerships
HCLS: In 2018, Intas proudly stands as India’s with Mylan and Sandoz. What are the rationales
largest privately owned pharmaceutical company, behind this strategy?
although the company was posting revenues of BC: Multinational companies such as the one you
only USD 100,000 when you took over in 1994. How just mentioned are typically multi-billion-dollar busi-
would you characterize the Intas business model? nesses. Our feeling is that they may not do justice to a
BINISH CHUDGAR (BC): Our growth matrix is product with a sales potential ranging from USD 50 to
based on various geographies and product baskets. In USD 100 million, as the latter would not be particular-
terms of geographies, Intas has historically been very ly substantial with regards to the overall operations of
strong in India, while we started exporting to Europe these companies. As a result, we will continue market-
in 2001, thereby becoming one of the first Indian ge- ing by ourselves all our current and upcoming oncol-
neric companies to tap developed markets, and we ogy products, because we have a long-term interest in
initiated our US operations five years after. In terms this strategic therapeutic area.
of geographic expansion, we truly look at building a
balanced footprint, where the varying performances of HCLS: How do you balance the high develop-
our different markets compensate each other. ment costs of biosimilars with the ever-increasing
Our products model is threefold. First comes our competition in Europe?
me-too, vanilla generics division which we started BC: When we started working on our first biosimi-
over two decades ago and – second – our oncology lars, the development costs were indeed phenomenally
and parenteral business, in which we have developed a high, as we did not know exactly the expectations of
remarkable expertise. In international markets we are the regulators. Today, European regulatory authori-
mostly known as an oncology company. Added-Value ties have started establishing clearer and more precise
Products (AVPs), i.e. branded products requiring mar- guidelines, and – as a result – the R&D cost for biosimi-
keting capacities and a dedicated field force to propel lars has been substantially decreasing over recent years.
market penetration, stands as our third business divi- The context is still completely different in the US,
sion as well as the one in which we are investing the where receiving a Biologics License Application (BLA)

BIOSIMILAR STRATEGY
Binish Chudgar, Intas
generics businesses; product wise, these portfolios will

therefore not bring Intas to new heights. However,
when combining Actavis’ manufacturing basis in the
UK and Ireland with the quality of their management
teams, it is easy to understand how this acquisition has
improved the company’s relationship with the market,
while providing us with a better understanding of the
countries’ sales and distribution channels. These two
aspects – the company’s management teams and man-
ufacturing assets – will definitely better position Intas
for future growth, while it would have taken us a lot
of time to assemble such quality assets by ourselves.
Today, our heightened strength allows us to better ser-
vice our European markets, while we will generate reve-
nues of around USD 425 million in the UK and Ireland
is required. Moving forward, it nonetheless seems that post acquisition, with an additional EUR 200 million
the US FDA’s development guidelines will also become [USD 245 million] coming from the rest of Europe.
clearer, while the most challenging costs to control for
the US market relates to the manufacturing of biosim-
ilars, rather than to their development. INTAS STARTED ITS BIOSIMILAR
Overall, Intas started its biosimilar program around PROGRAM AROUND 12 YEARS
12 years ago, and we have already launched 12 biolog- AGO, AND WE HAVE ALREADY
ics in India. Furthermore, with filgrastim, Intas became LAUNCHED 12 BIOLOGICS IN
the first ever Indian company to launch a biosimilar
INDIA
in Europe [approved in February 2015 and marketed
under the name Accofil™ – Ed.]. Moving forward, we Regarding the Mallinckrodt acquisition, Intas is
would like to bring one or two of these biosimilars onto so far not active in the opioid segment, but the latter
the global stage each year. Furthermore, we are cur- displays a strategic complementarity with our main
rently running six biosimilar programs at the moment, area of focus, as pain management is a key aspect of
mainly in oncology and also for autoimmune diseases. oncology treatments. However, as opioids can only be
manufactured in the continent of destination of the
HCLS: Although negotiations recently stopped, products, acquiring Mallinckrodt’s US specialty gener-
Intas emerged as the frontrunner in the acquisi- ics business emerged as the perfect opportunity for us,
tion of Mallinckrodt’s US specialty generics busi- as it would directly establish Intas as market leader in
ness. However, filings show that sales for the nine the US opioid business. Furthermore, Mallinckrodt is
months to September 2017 declined by 16 percent a US-focused company which we could have developed
and the US contributed to nearly four-fifths of this in Europe, so Intas stood as the perfect exit strategy
division’s sales. After having acquired Actavis/Te- for Mallinckrodt’s specialty generics business, and the
va’s UK and Ireland businesses – one of the best company’s management and employees truly acknowl-
performing companies in these two countries – edged it.
why did you change your M&A approach to target However, given the US opioid crisis, the significant
an underperforming asset? resources required to advance such a large acquisition
BC: Our vision is to only go for M&A deals that will and the extensive due diligence processes it implies,
– above all – strengthen our company’s structural ca- negotiations could not be extended ad vitam aeter-
pacities and give us an edge in the mid- or long-term. nam. Looking forward, I however consider that the lat-
Although they were posting margins of over 40 ter could resume within a few years, when the opioid
percent, Actavis UK and Ireland were purely vanilla crisis will be better controlled.

REGULATORY ALIGNMENT
Hemant Koshia, FDCA Gujarat
PAVING THE WAY

Dr. Hemant Koshia, commissioner of the FDCA Gujarat, the regulatory author-
ity of the state of Gujarat – India’s leading hub for the production of pharma- Hermant Koshia
ceutical and healthcare products – provides insights into the collaboration
initiatives bolstered by the FDCA and the agency’s endeavour to operate as a FDCA GUJARAT
front runner among India’s regulatory landscape.
HCLS: How do you ensure that Gujarat’s regula- The FDCA Gujarat also launched India’s first
tory framework is aligned with those of the most ad- mobile testing lab in June 2017. The latter is able to
vanced markets in the world? test 450 molecules and is equipped with handheld
HEMANT KOSHIA (HK): We closely and regularly instruments that enable on-site testing, and it also
interact with our peers from the US FDA, UK MHRA, stands as an initiative that is meant be more widely
Health Canada and the WHO among others. For exam- developed in the future.
ple, with the US FDA we are closely working on capacity
building, training, networking and knowledge sharing HCLS: What types of challenges are you facing
through regular one to one meetings. in your mission of protecting the health and well
To ensure transparency, traceability, simplicity, effec- being of the Indian population?
tiveness, efficiency, accuracy and accountability in var- HK: On the operational level, regulation enforce-
ious G2G (government to government), G2C (government remains a key area of focus for the FDCA. We
ment to consumers), G2B (government to business) must ensure that no manufacturer overlooks the reg-
ways, the FDCA has undertaken many innovative initi- ulations laid down by the different regulatory agen-
atives encompassing e-governance, collaborative part- cies, which stand as building blocks to guarantee the
nerships and knowledge sharing platforms gathering quality, safety and efficacy of pharmaceutical prod-
together international regulators, the pharmaceutical ucts manufactured and consumed in Gujarat. Strict
industry and the academia. As a matter of fact, a large actions, including license cancellation, have been
number of these initiatives have been pioneered by the implemented in the past against companies that are
FDCA and replicated by other state’s regulatory agencies now abiding by the FDCA’s requirements.
across the country. Another aspect that should not be overlooked
relates to the FDCA’s commitment to combating
HCLS: Can you highlight some of these initiatives? substandard, spurious, and counterfeit medicines.
HK: Gujarat was the first state in India to set up a pio- According to the World Customs Organization
neering, cloud-based e-governance system which has since (WCO), the fake drug market is estimated at USD
been rolled out across 16 states, covering 70 percent of 200 billion, and the Gujarat FDCA pays the utmost
the country’s population. All 3,000 pharmaceutical com- attention to this phenomenon through our post-mar-
panies across these states are thereby linked through this keting surveillance program, which notably allows us
digital, cost and time saving platform, thereby enhancing to assess drug quality directly from retail chains.
a direct dialogue between the industry and the regulators.
To give you a better idea of its mind-blowing comprehen-
siveness, this unique database encompasses 250,000+ GUJARAT WAS THE FIRST STATE IN
pharmaceutical and healthcare products. This initiative INDIA TO SET UP A PIONEERING,
and the tremendous improvements it allowed prompted CLOUD-BASED E-GOVERNANCE
the Government of India to award the National e-Govern- SYSTEM WHICH HAS SINCE BEEN
ance Gold Award to the FDCA Gujarat. ROLLED OUT ACROSS 16 STATES

GEOSTRATEGIC FOCUS
Gujarat State
MADE IN GUJARAT
The state of Gujarat proudly stands as India’s main pharmaceutical
hub, accounting for over 33 percent of the country’s pharmaceutical
turnover and 28 percent of its pharmaceutical exports. Given the
tremendous importance of the Indian industry globally, this state
G
therefore emerges as a pharmaceutical hub of global importance.
“ ujarat’s history of manufacturing fine

chemicals and pharmaceutical prod-
ucts actually goes back more than 110
establishment of three pharmaceutical and healthcare
clusters in our state: an API-Active Pharma Ingredients
Park, a formulations hub and a medical devices cluster.
years. Furthermore, the LM College of Furthermore, India’s first national government medical
Pharmacy in Ahmedabad was established in 1947 – the devices laboratory will also be established in Gujarat,”
year marking the independence of India – and there- reveals Dr. Hemant Koshia, commissioner of the FDCA
fore stands as the oldest pharmacy institute in the Gujarat.
country,” posits Dr. Hemant Koshia, commissioner of Another important factor in Gujarat’s success is the
the FDCA Gujarat, the state’s regulatory authority. It fact that between 2001 and 2014, the state had a very
is also the home of the Sarabhai Group, one of the first dynamic chief minister – Narendra Modi – who ascend-
integrated pharmaceutical giants in India. ed to the position of prime minister in 2014. This has
“For Gujarati people, pharmaceuticals are in their contributed to raising the state’s international pro-
DNA. People who have grown up in our state are file and attractiveness through the biennial investors’
very familiar with the pharmaceutical sector, which summit, ‘Vibrant Gujarat,’ which makes it easier for
stands as one of Gujarat’s main industries,” explains Gujarati entrepreneurs and CEOs to convince interna-
Nitin Shah, founder and chairman of Unison tional partners of their state’s investment potential.
Pharmaceuticals. The numbers speak for themselves: Finally, one should not overlook Gujarat’s
Gujarat today gathers together over 4,000 manufac- long-standing experience in business and international
turing licensees and industry heavyweights such as trade. “Gujarati are reputed across India for their busi-
Torrent Pharmaceuticals, Zydus Cadila, Intas, and ness mindset and their entrepreneurial drive – whether
Dishman are headquartered in the state. Furthermore, it relates to the pharma industry or to any other indus-
Gujarat alone accounts for over 40 percent of the countries. An eye-catching number of India’s entrepreneurs
try’s CRAM companies and CROs. are actually Gujarati,” explains Unison’s Nitin Shah.
In terms of the reasons for this clusterization, “From my perspective this aspect has been nurtured by
Mohal Sarabhai of ASENCE Group notes that “First historical factors: most of North Gujarat is very arid, to
and foremost, Gujarat holds extremely good univer- the difference of the rest of the country where the won-
sities, especially in the pharmaceutical and medical derful climate has favored the development of agricul-
fields, and infrastructure as well as a great labor force. ture. This scarcity of natural resources in that part of
Furthermore, it has become increasingly difficult for our state has historically strengthened the importance
company heads to bolster a healthy dialogue with labor of trade as a mean of survival, forcing Gujaratis to
unions in the state of Maharashtra (where Mumbai is become entrepreneurs and outstanding businessmen
located) and in Northern India (where Delhi is located). to sustain their families,” considers Mohal Sarabhai of
Moreover, land is easily available and reasonably priced ASENCE Group. “Business is part of our culture, and
in Gujarat, which marks a true advantage in compar- this is a great asset in driving our state’s pharmaceuti-
ison to the aforementioned states.” “In this vein, the cal industry to new heights,” concludes Nitin Shah of
government of India announced in October 2016 the Unison Pharmaceuticals.

CEO PROFILE
Vivek Sharma, Piramal Pharma Solutions
CEO PROFILE
A DIFFERENT PERSPECTIVE
U
nlike many of his phar- we divested assets that were not This aspect is particularly impor-
ma peers, Vivek Sharma perfectly aligned with our devel- tant in a regulated industry like the
worked in operations opment vision while integrating pharmaceutical sector, where com-
and finance for two new capabilities through a hand- pliance and reliability are absolute-
decades before joining ful of acquisitions. In the mean- ly paramount. “The service industry
the life sciences industry as head of time, we re-organized our teams is above all a relationship business:
Piramal Pharma Solutions (PPS) in with the objective to increase our customers choose and remain loy-
2011. Already established as one of commercial performance, and I al to a given partner because the
the world’s leading CDMOs with a truly believe that my background latter have earned their trust. To
presence in North America, Europe, has helped me successfully driving be a successful service provider in
and Asia, Sharma has helped take our company through these struc- the pharmaceutical sector implies
PPS to new heights. The company tural changes,” he continues. fostering a subtle chemistry both
doubled the size of its business over PPS has conducted several stra- internally and externally – that’s
the past three years and added more tegic acquisitions under his tenure the main driving force behind cus-
customers during this period than - including those of Coldstream tomer acquisition and retention,”
over the preceding eight years, while Laboratories and Ash Stevens - he concludes.
Sharma was recognized as “CEO of and the CDMO industry at large
the Year” at the CPhI awards in 2015. has been particularly active in
“In the grand scheme of things, terms of M&A deals over the past
PPS’s eye-catching performance is years. Leveraging his expertise
above all due to the outstanding in finance and M&A, in terms of
efforts of our 4,000+ employees. My what Sharma looks for in poten-
role is to steer our people’s energy tial acquisitions, “Targeted capa-
and expertise in the right direction, bilities emerge as a key parameter
so we present a united front when to look out for, but I believe that
pursuing our main goal: ensuring human capital is the most crucial
patients can benefit from medicines aspect to consider. In this context,
developed and manufactured by I assess if the mindset of the peo-
Piramal,” humbly highlights Vivek ple heading the targeted company
Sharma. From an executive stand- could fit within Piramal’s custom-
point, holding a different back- er centric model, so we can operate
ground has seemingly revealed in as one single organization moving
itself a very precious advantage: “I forward. At the end of the day, in
was able to assess our operations terms of operations, the capabil-
VIVEK SHARMA
from a different standpoint than if ities you may acquire are just as
PIRAMAL PHARMA SOLUTIONS
I had always worked in this indus- good as the people that have been
try,” he explains. “Since I took over, managing these assets…” he says.


APIS
Satyanarayana Chava, Laurus Labs
BROADENED
REACH
Dr. Satyanarayana Chava, founder and CEO of

Laurus Labs, one of the world’s leading API com-
panies after only 13 years of existence, outlines his
expectations for the development of the company’s
different verticals, which follows Chava’s vision to
establish Laurus as a leading player in offering in-
tegrated solutions for global pharmaceutical needs.
Satyanarayana Chava entered the ARVs field through products in which we

held a technological and technical edge, such as EFV-
LAURUS LABS based combinations. In this regard, one of our main pri-
orities has been to enrich our portfolio – for example,
by developing a full basket of second-line products –
HCLS: For the 2016-17 financial year, APIs were while remaining consistent with the concept of unique-
still driving around 91 percent of Laurus’ revenues, ness I mentioned earlier. This stands as a challenging
with ARV drugs making up around 65 percent of and time-consuming endeavor, but I believe we have
the total API business. Given the strategic impor- already consolidated our leadership in the HIV field;
tance of these products, how do you see the demand looking forward, we are better positioned than ever to
for ARVs evolving in the coming years? meet increasing and evolving demand for these crucial
SATYANARAYANA CHAVA (SC): According to products.
UNAIDS, there are 36.7 million people living with HIV
worldwide, and only 70 percent of them know that HCLS: One of your key success factors on the API
they are HIV positive. More than half have access to side has been its focus on building a large, prod-
antiretroviral therapy, but only 44 percent have viral uct-specific capacity. As Laurus is currently expand-
suppression. ing its reach to new therapeutic areas such as oncol-
In this context, UNAIDS set up the 90-90-90 HIV ogy, CVC, anti-diabetic, and ophthalmology, isn’t
treatment targets, with the objective that – by 2020 it a risk of dispersing Laurus’ capacities over too
– 90 percent of all people living with HIV are aware broad a range of products?
of their status, 90 percent of those diagnosed receive SC: Although Laurus today stands as a Top 5 API
sustained antiretroviral therapy, and 90 percent of company globally in terms of sales, we are not even in
those receiving antiretroviral therapy achieve viral the global top 20 with regards to the overall number
suppression. As awareness around the disease keeps of DMFs that our company holds. This means that we
on improving, the fulfillment of these targets will nur- still hold some potential to further expand our portfo-
ture an increasing demand for HIV products to treat lio, without losing sight of our historical objective to
patients and prevent new infections. reach a leadership position globally for the products
As per Laurus, we are very happy to be a part of that we manufacture.
market growth and we have been tirelessly working on In this regard, one will notice that all new APIs we
addressing remaining gaps in our HIV offering. We have been developing are aligned with a very clear

APIS
Satyanarayana Chava,
Laurus Labs
formulations and CDMO business-

es will be our main growth drivers
in the long term.
HCLS: As you are significant-

ly investing in the development
of Laurus’ formulation arm, you
will eventually end up competing
against some of your API cus-
tomers – isn’t it a problem for
your API business?
SC: This assessment of the sit-
uation might have been relevant
a decade ago, but the industry has
changed: stakeholders do not recog-
nize the same boundaries as before,
where companies used to stick to
strategy: to the exception of oncol- their areas of expertise. To give you
ogy, our new APIs target chronic OUR STRATEGY FOR OUR a concrete example, the number
diseases with huge patient pools, in FORMULATION ARM IS TO of legal actions between two origi-
areas where the patients use prod- GAIN A DOMINANT POSITION nators today are significant when
ucts over several decades. Finally, IN A FEW, WELL-IDENTIFIED compared to the number of trials
these new APIs operate in areas PRODUCT CATEGORIES between originators and generics
with little product obsolescence, RATHER THAN BUILDING A companies. In the same way, gener-
which will allow us to maximize our HUGE PRODUCT PORTFOLIO ics companies are trying the climb
development investments. up the value chain, while originators
process which truly requires sub- have been expanding their business
HCLS: Given the prominent stantial CAPEX and may take five to model to the generics field. There is
position that Laurus has already seven years, the threshold associat- not a single company operating at
reached within the global API ed with formulations is much larger the global scale that is not diversify-
industry, what will be your main than APIs and the opportunities are ing its business model and ventur-
growth drivers in the coming much greater. In the grand scheme ing into new verticals to better ben-
years? of things, our strategy for our for- efit from emerging market trends.
SC: Historically, API companies mulation arm is to gain a domi- I believe that our API customers
have not been able to surpass a cer- nant position in a few, well-identi- understand these dynamics, as they
tain threshold. Moving forward, we fied product categories rather than follow the same approach when it
may be able to grow our API busi- building a huge product portfo- comes to the diversification of their
ness to reach USD 500 or USD 600 lio. In the meantime, we want to own revenue stream.
million, but it will be extremely dif- increase our presence across the At the end of the day, if Laurus is
ficult to go beyond this level. globe, while we just started selling able to offer a better API at a low-
In this context, we started Laurus’ HIV formulations in the US. er price and with a greater capacity
formulation arm in 2014 as another In the meantime, our CDMO than a given competitor exclusively
growth driver which will propel the business for Big Pharma companies focused on APIs, I have no doubts
company to new heights once our has increased from USD5 million in that our customers will remain loy-
API business’s growth will be chal- 2012 to over USD 25 million dur- al to our offering – even if we even-
lenging. Although the development ing the latest financial year. Moving tually become one of their competi-
of a formulation arm is an extended forward, the development of our tors on the formulation side.

COVER STORY
Standing Out From the Crowd

INDIA STANDING OUT
FROM THE CROWD
“Over the past few decades, the Indian pharmaceutical industry has established itself as a global powerhouse for the production
of bulk drugs and generics which have gained dominant market shares in the world’s most strategic markets and tremendously
bolstered healthcare affordability and accessibility on all continents,” states Suresh Prabhu, India’s Minister of Commerce & Industry
and Civil Aviation. “India is undoubtedly a significant player in the global marketplace, representing an important source of FDA-
regulated products,” confirms Dr. Letitia Robinson, director of the India Office of the US FDA, which was set up in New Delhi in 2008.
Though perhaps lesser heralded, India’s critical role on the global pharmaceutical stage echoes the country’s ever-increasing
significance in many other regards: to name only a few examples, the Center for International Development (CID) at Harvard University
predicts that India will be the fastest growing country in the world for the coming decade, at 7.9 percent GDP growth, and its population
could surpass that of China around 2024, according to the UN’s 2017 World Population Prospects. When it comes to the fine chemical
and pharmaceutical industries, numbers are equally impressive: “with 573 approved facilities, India continues to have the highest
number of US FDA-registered manufacturing facilities outside the US, while over 800 are UK MHRA approved and approximately 1,400
manufacturing units are WHO GMP (Good Manufacturing Practices) certified,” highlights Dilip G Shah, secretary-general of the Indian
Pharmaceutical Alliance (IPA).

COVER STORY
Thanks to the Indian ecosystem’s oncology but also for autoimmune

remarkable expertise in reverse diseases. Overall, a large share of
engineering and its unrivalled our resources are allocated to new
capacity to provide health systems chemical entities (NCEs) and bio-
around the world with large vol- similar programs, as we want to
umes of affordable generic drugs, ensure our Added-Value Products
Indian pharmaceutical exports division makes up over 30 percent
SURESH have skyrocketed from USD 3.9 of our revenues within the next five BINISH
PRABHU CHUDGAR
billion in 2004 to around USD years,” he adds.
minister of commerce 17 billion today according to the In addition to biosimilar pro- vice-chairman and
and industry managing director,
Pharmaceuticals Export Promotion grams, prescient Indian lead- Intas
Council of India (Pharmexcil), ers have not shied away from the
while Indian companies make up development of novel drugs and
25 percent of the US generic market new biologicals either. “Lipaglyn –
share. “From an Indian pharmaceu- India’s first NCE – has been grant-
tical perspective and as a country, ed investigational new drug status
we have shown a very high degree with the US FDA. Currently we
of capability to attain such market have three Phase II studies in the
share. A question that I have asked US and another four in India. Non-
DR LETITIA
ROBINSON
myself is where do we go from here? alcoholic steatohepatitis (NASH), SHARVIL PATEL
Is it better to be growing by 45-55 which is the indication for Lipaglyn managing director,
director, US FDA India Zydus Cadila
office percent or be entering other areas as we are currently working on, is an
well – such as the development of area of unmet healthcare need as
new molecules, biosimilars and bio- there are currently no drugs approved for the treatment
technology. I believe this is the next wave of the Indian of the disease in both emerging and developed mar-
pharma industry,” reckons Murtaza Khorakiwala, man- kets,” stresses Sharvil Patel, managing director of Zydus
aging director of homegrown entity Wockhardt. Cadila’s, India’s fifth largest pharmaceutical company.
While Biocon recently made global headlines when
the US FDA approved its trastuzumab-dkst (co-devel-
oped with US-based Mylan), the Indian company is also
SCALING THE VALUE CHAIN pushing the development of groundbreaking biologi-
cals. “Biocon’s itolizumab, specifically, is a very unique
As a matter of fact, pioneering domestic companies molecule as it is a ‘first in class’ biologic, a humanized
triggered this diversification phase more than a decade recombinant anti-CD6 monoclonal antibody for the
ago, and frontrunners have already begun reaping the treatment of patients with active moderate to severe
rewards of their bold investments. “Intas actually started chronic plaque psoriasis. It harnesses a very different
its biosimilar program around 12 years ago, and we have treatment pathway and boasts a novel mechanism of
already launched 12 biologics in India. With the approv- action. While India is not well known for novel drugs, we
al of filgrastim in February 2015, we moreover became are trying to change that,” highlights Kiran Mazumdar-
the first ever Indian company to launch a biosimilar in Shaw, chairwoman and managing director of Biocon.
Europe,” proudly documents Binish Chudgar, vice-chair- In the meantime, Bharat Serums & Vaccines (BSV), a
man and managing director of Intas, the largest privately biopharmaceutical company with R&D units in USA,
owned Indian pharmaceutical company with sales of over Germany and India, decided to develop the world’s first
USD 1.7 billion during the last financial year. “Moving recombinant product in fertility, which would enable
forward, we would like to bring one or two of our bio- the elimination of variations typically encountered
similars onto the global stage each year, while we are cur- in urine-derived fertility injectable drugs, as all prod-
rently running six programs at the moment, mainly in ucts will originate from the same cell line. “We are still

COVER STORY
TREATMENT & THERAPIES MEDICAL DEVICES
THE ONE STOP-

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COVER STORY
KIRAN BHARAT V. MURTAZA

MAZUMBAR DAFTARY KHORAKIWALA
SHAW
chairman and managing director,
chairwoman and managing director, Wockhardt
managing director, Bharat Serums and Photo courtesy of Bharat Serums and Vaccines
Biocon Vaccines
enrolling patients for our Phase I clinical trials, which this regard, I am particularly confident in the skills and
have been advancing at a very good pace. Leveraging creativity of our California-based R&D center, where we
recent technological advancements, I believe this first- develop all our cell lines before transferring them to and
of-its-kind product could moreover be reasonably priced scaling up in India,” he relates.
and more consistent than urine-derived fertility prod-
ucts,” explains Bharat V. Daftary, chairman and manag-
ing director of BSV, which has also started the pre-clini-
cal phase for two highly needed biologicals in the critical OUTSOURCED SERVICES: CREDIBLE PARTNERS
care arena. “I am terribly excited about these two prod-
ucts, which could save a large number of lives and have a In the meantime, India-based companies have secured
game-changing impact in ICUs all around the world. In a place under the sun for themselves by partnering
EVOLVING BUSINESS MODELS
EXPORT ORIENTED LICENSING PARTIALLY OR WHOLLY OWNED SUBSIDIARIES

BUSINESS-CRAMS
IN-LICENSING OUT-LICENSING INTO INDIA FROM INDIA
DRL
JOINT VENTURES FRANCHISING
ETI
KLINICAL

COVER STORY
with leading American, European, and Japanese phar- and faster go-to-market model,” documents Vivek
maceutical companies for the discovery, development, Sharma, CEO of Piramal Pharma Solutions (PPS), one
and manufacturing of their products, including inno- of the world’s leading CDMOs with a presence in North
vative drugs. “When looking at the macro environment, America, Europe, and Asia.
all Big Pharma companies want to increase the speed- “In the meantime, the overall number of biotech com-
to-market of their life-changing products while at the panies operating worldwide has increased tremendously
same time reducing development and manufacturing over recent years, and the majority of them do not hold
costs. They strive to apply this approach to an ever-in- in-house development and manufacturing capacities
creasing number of products in the pipeline but they either,” he adds. Again, the recent achievements of India-
do not hold the in-house capacity to reach this objec- based Indian Contract Research and Manufacturing
tive. In this context, they are left with no choice but to (CRAM) companies and CDMOs are particularly
look for external partners that can enable a streamlined impressive: for example, in 2017, the US FDA granted
Piramal PS: Redefining the CDMO Relationship

As a leading player in a global CDMO solutely crucial, and both sides must acknowledge that we
industry shaped by a frenzy of M&A depend on each other. My perception is that only greater
deals over recent years, the first and integration can usher in better outcomes for both parties.”
foremost objective of Vivek Sharma,
CEO of Piramal Pharma Solutions Despite increasing price pressure, it moreover seems that
(PPS), is to develop the company to pharma companies do not disregard the added value ge-
make it as customer-centric as possi- nerated by their partners either. “In some situations, we
ble – and to be recognized by their even could increase our prices because – as part of our
VIVEK SHARMA customers for this commitment – ra- company’s continuous improvement process – we proved
— ther than instinctively building up pro- ourselves as able to generate a higher value for our custo-
CEO, Piramal duction capacities and capabilities. mers, which they fully acknowledged,” he reveals.
Pharma Solutions “Large or small, we look for acquisi-
tions that fit well with our needs: these However, capital constraints, reduced internal bandwidth
would include expanding our geogra- to drive development projects, and a need for reducing
phical footprint, complementary or new capabilities that costs and clinical timelines are realities in the new phar-
are synergistic, and technologies that fit well with our ma world which partners like PPS also strive to address.
customers’ future requirements, to name a few. Overall, “As a CMO we continue to look at creative alliances and
all our investments are conducted in a way that can bring innovative business models, which may include: pharma
more added-value to our partners,” he explains. site divestiture to a CMO with committed volumes for a
set number of years, risk-share models that reduce upfront
Besides guiding the company’s inorganic development, costs, with potential for a higher payout for the CMO, on
this overarching vision truly trickles down to all of its pro- success tied to milestone events, and fixed price early de-
cesses. “Some of our customer-centric initiatives have velopment projects,” he concludes.
even inspired our current partners, who look at replicating
these processes within their own operations. For example,
we have set up a unique model to collect, analyse, and in-
tegrate customers’ feedback. As part of this program, the
performance of our different sites is measured according
to feedback given by our customers, which allows me to
closely monitor our strengths and areas for improvement,”
explains Sharma, who was named ‘CEO of the Year’ at the
CPhI Awards in 2015.
Sharma assesses the evolving relationship between phar-

ma companies and service providers thusly: “First of all, I
want to highlight that the quality of this relationship is ab- Photo courtesy of Piramal

COVER STORY
approval for Tesaro’s ovarian can- from lab chemistry to scale-up and chemical process
cer drug, which Dishman will pro- development to plant design, construction, and oper-
duce at its Bavla facility in Gujarat. ation conforming to world class GMP standards,” he
“When the clinical trials of this explains. “In the meantime, several companies outside
drug were happening, Dishman was India have already shown a great interest in partnering
the API supplier alongside being a with us, as they want to leverage our expertise in scaling
key supplier to Tesaro; now that up technology and efficiently designing/constructing
JANMEJAY VYAS
this cancer drug has been approved state-of-the-art world-class automated manufacturing
the volume will jump significant- capacities. As part of these potential partnerships, we
chairman, Dishman
Group ly. Given the relationship and the would still own these upcoming plants, but they would
trust that we have established over be the main investors in these projects. For us, this kind
the years with the US FDA, they of agreement represents a smart way to increase our
allowed us to start the supply of overall production capacity without having to allocate
APIs to Tesaro already,” remarks substantial resources to this effort,” he stresses.
Dishman’s chairman JR Vyas.
“We have been working with the
world’s leading innovators for over SEVERAL COMPANIES OUTSIDE INDIA
a decade, although currently most WANT TO LEVERAGE OUR EXPERTISE
of our CDMO efforts are centered IN SCALING UP TECHNOLOGY AND
DR. DEEPAK on innovators’ mature products,” EFFICIENTLY DESIGNING/CONSTRUCTING
BIREWAR adds Dr. Deepak Birewar, found- STATE-OF-THE-ART WORLD-CLASS
founder and er and chairman of the dynam- AUTOMATED MANUFACTURING
chairman, Inventys
Research ically growing CDMO Inventys CAPACITIES JR Vyas DISHMAN
Research. “For a few of our prod-
ucts, we started cooperating with Over the past decade, India also witnessed the rise
our customers even before these products’ introduc- of niche, specialized service providers, which share the
tion into the market: we therefore developed the labo- same focus on the most stringent pharma ecosystems
ratory samples and are now about to enter the launch in the world as their glorious predecessors. “I realized
and growth phase for those products. As we own an that there was no contract manufacturer dedicated to
integrated site, we can offer full gamut of services effervescent products based out of India or the US,

COVER STORY
which prompted me to found Vovantis in 2008. Today, up our own scientific talent pool
50 percent of our revenues come from the US, where we at an eye-catching pace,” stresses
manufacture private labels for the main retail chains, Jonathan Hunt, CEO of Syngene
and we can produce all effervescent products commer- International, one of the fast-
cialized in the US market,” explains ASENCE Group’s est-growing CRAM organizations
managing director, Mohal Sarabhai. in the world, which has forged stra-
“In the meantime, we just started registering our tegic partnerships based on dedi-
effervescent products in the UK and expect to have our cated, India-located R&D centers JONATHAN
HUNT
facility inspected by the MHRA shortly; once approved, with BMS, Abbott, Baxter, Amgen
we will use this UK base to expand into other European and – more recently – GSK. In the CEO, Syngene
International
markets, while we are about to double our production same vein, Sharma of PPS confirms
capacity to sustain this vision,” adds Mohal Sarabhai, that his company is “today able to
grandson of the illustrious scientist and industrialist deploy cost competitive R&D-driven projects in India,
Vikram Sarabhai, whose company Sarabhai Group was because talent and structural resources are more largely
one of the first integrated pharmaceutical giants in India and easily available than some years ago.”
and the country’s market leader until the mid-1980s. “In this regard, we would like to see a better alignment
between the government’s R&D vision and the concrete
tools and means that it brings to the table, especial-
ly when it comes to dedicated incentives. As a matter
THE ONLY WAY FORWARD of fact, the government recently reduced the weighted
tax deduction on R&D expenses from 200 percent to
India-based service providers are also aiming to fully 150 percent as part of the Budget 2018, which is dif-
leverage the country’s R&D potential. “While we are a ficult to understand given our country’s ambitions in
US-centric service provider, the fact that we are domi- the high-tech field,” bemoans Sameer Hiremath, CEO
ciled in India affords us a number of advantages - access and joint-MD of the CDMO Hikal, whose R&D center
to a rich pool of scientific talent, a relatively younger was built under the supervision of Lonza’s former chief
English-speaking work force and lower operating costs. technology officer, Dr. Helmut Rupp who joined Hikal
For example, the rate at which India produces gradu- before retiring.
ates with master’s degrees and PhDs in chemistry and “In a global context marked by increasing price pres-
biology is astounding, and it has allowed us to build sure and decreasing margins, we foresee that companies
Corporate Headquarters
DORIZOE LIFESCIENCES LTD.
Old Premchandnagar Road, Tel: +91-79-66197777
Development | Services | Delivery Bodakdev, Ahmedabad-380054, Gujarat (INDIA) www.dorizoe.com
GLOBAL CONTRACT
DEVELOPMENT ORGANISATION

COVER STORY
of our competitors. If we actually consider the resources

WITHOUT INNOVATION, YOU ARE channelled to Inventys’ new R&D & Pilot plant facilities
NOT EVEN A CONTENDER IN TODAY’S over the past three years, those investments equal to our
FAST CHANGING WORLD OF GLOBAL one year’s revenue! As a matter of fact, almost all our
profits (and some more) of the last ten years have been
COMPETITION Deepak Birewar
INVENTYS RESEARCH invested in R&D & related facilities,” he concludes.
holding basic technologies and still focusing on low

added-value products will struggle to comply with ris-
ing quality standards. In this regard, the only way for- ADJUSTING TO A NEW NORMAL
ward is to continue climbing up the value chain and
stimulate companies’ innovation drive - and we are Indian pharmaceutical exports have grown more than
doing this with over 20 percent of our employees who five-fold over the past two decades, but the increase
work in Research & Technology,” reveals Hiremath. only reached 2.5 percent during the fiscal year ending
“Without innovation, you are not even a contender in March 31 2018, according to Pharmexcil. More wor-
today’s fast changing world of global competition,” con- ryingly, the value of Indian pharma exports to North
firms Inventys Research’s Dr. Deepak Birewar. “In 2017, America dropped by 8.04 percent to USD 4.83 billion
we invested more than seven percent of our revenues in during the 11 months up to February 2018. North
our R&D, which represents a remarkable commitment America, including the US, contributes to over 30 per-
for a company of our size and sets us on top of the list cent of the India’s overall exports in terms of value.

COVER STORY
Carving out a Niche

Jai and Sameer Hiremath of Hikal docu- like Hikal, which aims to position itself as one of the leading
ment the company’s specialty focus in companies in the world in its own areas of expertise, clearly
the consolidating CDMO industry and holds opportunities for growth moving forward.
articulate how Hikal is reinventing itself In the meantime, we decided to increase the R&D efforts
and climbing up the value chain. conducted in Hikal’s R&D center, with the objective of de-
veloping our own generic AI and API portfolio, both in
Given the on-going consolidation sha- crop sciences and the pharmaceutical business. Since 2015
ping the CDMO industry, what makes we have filed a substantial amount of Drug Master Files
JAI HIREMATH you believe that a large mid-size com- (DMFs) with the US FDA, while we follow a life cycle exten-
— pany like Hikal can continue thriving in sion strategy, where we focus on products that are about
founder and an industry context increasingly domi- to go off patent.
managing nated by huge players?
director, Hikal
Jai Hiremath (JH): The consolidation
shaping the CDMO sector will undoub- Where would you like to see Hikal in the next five years?
tedly continue in the coming years, as JH: We want to maintain an annual growth rate of 15 to
these companies look at generating 20 percent, in line with our performance over the past five
economies of scale. As per Hikal, we are years. Fuelling our R&D pipeline will be absolutely crucial
not particularly worried by this industry to fulfilling this objective, which will require more and more
trend, as the demand for our products investments dedicated to this specific field. To ramp up this
and services is still particularly strong. process and increase our chances of success, we look at joi-
ning forces with companies that can help us improve our ca-
SAMEER Sameer Hiremath (SH): Economies of pacities and strengthen our company’s knowledge in some
HIREMATH scale do matter, but one should not over- specific areas, such as continuous manufacturing.
— look the importance of specialty compa-
CEO and joint nies holding differentiated technologies. SH: Our ambition is also to come closer to our customers:
managing In this regard, we see some Europe-ba- leveraging our strength in APIs & AIs. As you know, acti-
director, Hikal
sed, mid-sized CDMO companies with a ves make up a large share of finished products’ costs, and
specialty focus that have been doing rea- some customers have been asking us for quite a long time
lly well, so it also proves that there is a room for niche players already to cover the entire value chain including formula-
like us with a unique expertise and technology. Customers tions. At this time, we have ample opportunities to support
are becoming more and more demanding, and the latter our customers on the development and supply of actives in
aim to partner with the world’s best providers for a very pre- both our businesses while we continue to evaluate oppor-
cise part of the development and manufacturing process of tunities on a select basis for adding further value to our
a given molecule. In this context, we believe that a company products.

COVER STORY
“The last two years have been why Indian companies have been badly hit by erratic
slightly turbulent because of policy pricing in the US, the number one export market for
changes and the pricing challenges the Indian pharmaceutical industry,” adds Chudgar.
which caused a certain level of dis- In the meantime, prices of raw materials (including
ruption,” confirms Zydus Cadila’s APIs and intermediates) from China have been skyrock-
Sharvil Patel. “With regards to price eting over recent years, thereby generating an even more
erosion in the US generics business, complex equation to solve for domestic generics compa-
SATYANARAYANA I believe that the latter follows a nies, which are over-dependent on imported raw mate-
CHAVA
cyclical model and will therefore be rials, especially from China. “The prices of API interme-
CEO, Laurus Labs corrected within three to four years, diates have been increasing substantially, which created
based on a supply and demand log- a supply crunch for API intermediates. The latter has
ic. As prices continue to decrease, manufacturing plants automatically impacted the price of pharma APIs, which
shut down, which nurtures the drive for M&A deals,” will – ultimately – increase generics prices in the US mar-
notes Chudgar of Intas. While price erosion in the US ket,” highlights Chudgar, before warning: “Looking for-
generics market was in excess of 15 percent in 2017 and ward, I nonetheless believe that the margins that Indian
will perhaps be at similar levels in 2018, it is particular- manufacturers enjoyed before the beginning of the cur-
ly difficult for Indian companies to cope with current rent cycle are definitely gone.”
price erosion, as they have to ship their products from In this ‘new normal,’ Indian formulation compa-
India to the US. “Making this model sustainable and nies are left with no choice but to rationalize their US
competitive requires large inventories, which explains portfolios, further streamline their operations and
The Global
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Speaks The International Language... Products
Of HealthTM
Finished Dosage Fermentation API Synthetic API
www.asence.com www.vovantis.com
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Group Companies

COVER STORY
Maneesh: Ahead of Its Time

In the early 2000s Maneesh Pharma- ghts in terms of forging competitive, cross-border allian-
ceuticals engaged in a series of more ces; setting up, acquiring and running overseas plants;
than ten joint ventures and acquisi- defining joint ventures’ structures and business models;
tions in strategic markets - including and protecting ourselves from variations of foreign cu-
the US, the UK and Brazil - at a time rrencies,” he continues. As a matter of fact, all joint ven-
where most Indian manufacturers tures set up by Maneesh around a decade ago – such as
contented themselves with more Tillomed, a Top Ten generics player in the UK market -
basic export strategies. Interestingly have been flourishing, although Maneesh was eventually
VINAY SAPTE enough, an ever-increasing number forced to divest its stakes along the way because of the
— of Indian exporters are now aiming financial turbulences generated by the GFC.
managing direc- to replicate Maneesh’s pioneering
tor, Maneesh approach. “Indian exports have been “We are now on the brink of kick-starting a new interna-
Pharmaceuticals recently plateauing – especially in tional phase for Maneesh, while two of our Indian plants
key markets, while very few domes- were successfully inspected and approved by the US
tic companies’ plants have been spared US FDA warning FDA in 2016. In the meantime, we are putting a special
letters or export bans. When adding these aspects to emphasis on our R&D strategy and look at developing
increasing competition and foreign governments’ push products specifically targeting the US market, as well
to foster the local production of medicines, one unders- as in licensing branded products with a high potential
tands that Indian exporters are left with no choice but in developed markets,” he adds. While Maneesh is now
to evolve their international strategies,” explains Vinay looking for distributors to partner with for the marketing
Sapte, founder and managing director of Maneesh Phar- of these selected products, the company’s overarching
maceuticals. vision is to follow the way it paved ten years ago: to be-
come an integrated pharmaceutical company in strategic
“Although the 2008 Global Financial Crisis (GFC) and the foreign markets. “This approach clearly emerges as the
worldwide economic downturn it generated had a harsh only way to be profitable in today’s industry context,”
impact on our operations, we have gained crucial insi- concludes Sapte.
strengthen their vertical integration in parallel to the ability to respond to market needs faster than others
long-term development of more complex, higher mar- will be more important. While some of our compet-
gin products. “In the US and European markets, it itors in the US market operate with a 2000-product-
is not simply pricing that will increase market share; portfolio, a company like Laurus with strong R&D and

COVER STORY
manufacturing capacities but only 50 stock keeping India-based companies unable to

units (SKUs) stands as a very agile player. Furthermore, compete. “At some point, India’s
we plan to fully leverage our company’s vertical inte- power cost for the manufactur-
gration as well as our proven capacity to generate high- ing of fermentation products was
er margins than most of our competitors in the API roughly equal to the final selling
sphere to thrive in the highly competitive formula- price of Chinese fermentation
tion market, in spite of rapid price erosion,” explains APIs,” reveals Mohal Sarabhai,
Dr. Satyanarayana Chava, founder and CEO of Laurus managing director of the ASENCE MOHAL
SARABHAI
Labs, one of the world’s leading API companies, which Group and head of fermenta-
recently started selling HIV formulations in the US. tion-focused API manufacturer managing director,
ASENCE Group
Synbiotics.
This fierce competition has
shaped – in many product categories – a new global
SURVIVING THE RAW MATERIALS landscape where few intermediates and API producers
ROLLERCOASTER outside China have survived this spiraling price con-
text. “For example, only two companies based outside
The abovementioned price surge for raw materials China still supply Vitamin D3 in 2018, and India-based
actually came after a devastating phase of downward Fermenta is one of them,” reveals Satish Varma, man-
price pressure driven by China-based manufacturers aging director of Fermenta Biotech Ltd., one of the
which took over the global market and rendered many world’s largest producers of Vitamin D3. However, the
India-based companies that survived those years of
fierce price competition today are in a very interesting
position. “In this context, our company has emerged
as a very attractive partner for international customers
eager to diversify their sources of supply and not exclu-
sively rely on China-based producers,” confirms Satish
Varma of Fermenta Biotech, whose production volume
has increased 10 times from 2005 to 2017.
ONLY TWO COMPANIES BASED

OUTSIDE CHINA STILL SUPPLY
VITAMIN D3 IN 2018, AND INDIA-
BASED FERMENTA IS ONE OF
THEM Satish Varma FERMENTA BIOTECH
While intermediate and API prices have been surging

again recently as China strengthened its control of pol-
lutions norms, one might think that new Indian play-
ers will swiftly re-enter the global market and vie for a
piece of the pie held by Indian ‘survivors.’ “Although
India’s fermentation capacity is today clearly underde-
veloped as a large share of domestic companies could
not sustain the downward price competition triggered
by China-based companies, India’s stringent envi-
ronmental framework for fermentation-centered API

COVER STORY

COVER STORY
IPA’s India Pharmaceutical Forum 2017: CEO Forum (photo - from left to right):
Gautam Kumra, managing director, McKinsey & Company (Moderator); Umang Vohra, managing director, Cipla Ltd; Nilesh
Gupta, managing director, Lupin Ltd; Pankaj R Patel, chairman & managing director, Cadila Healthcare Ltd; Satish Reddy,
chairman, Dr Reddy’s Laboratories; Dilip Shanghvi, managing director, Sun Pharmaceutical Industries Ltd
companies has so far prevented new players from rap- ‘survivors’ still hold a true competitive advantage,”
idly entering this business again. As a result, Indian highlights Mohal Sarabhai.
RECENT INVESTMENTS
FEBRUARY 2016 MARCH 2016 JUNE 2016 NOVEMBER 2016
Cipla announced the Lupin acquired drug India’s second-largest drugmaker Sun Pharmaceuticals
completion of its USD formulation developer Dr Reddy’s Laboratories Ltd said Industries Limited plans
550 million acquisition of Gavis Pharmaceuticals in a it agreed to buy eight generic to acquire 85.1% stake in
US generic drug makers USD 850 million deal drugs from Teva Pharmaceutical Russian company Biosintez
InvaGen Pharma and that gives it its first Industries and Allergan Plc for for USD 24 mn for increasing
Exelan Pharm manufacturing site in the US USD 350 million in cash to its presence in Russia
bolster its U.S. business. through local manufacturing
capability.
NOVEMBER 2017 OCTOBER 2017 JANUARY 2017 JANUARY 2017
Piramal Enterprises Ltd acquired Sun Pharmaceutical Industries Aurobindo Pharma has Intas Pharmaceuticals, through its
a portfolio of spasticity and pain Ltd, India's largest drugmaker, bought Portugal based wholly owned subsidiary Accord
management drugs from UK- has entered into an agreement Generis Farmaceutica SA, Healthcare, has completed
based specialty biopharmaceutical with Switzerland-based Novartis a generic drug company, the acquisition of Actavis UK
company Mallinckrodt AG, to acquire the latter’s for USD 144 mn. & Actavis Ireland from Teva
Pharmaceuticals, in an all-cash deal branded cancer drug Odomzo Pharmaceutical Industries, for an
for USD 171 mn. for around USD 175 mn. enterprise value of £603 million.
Source: Invest India

COVER STORY
NO MISTAKES ALLOWED! India and Indian companies were

being targeted as we had a fairly pos-
Another issue that has been grinding the gears of the itive relationship with the US FDA.”
Indian industry over recent years concerns quality com- “Our risk-based site selection
pliance. “In India, pharmaceutical companies have had model focuses on drug manufac-
mixed success in upgrading their quality systems, and turing establishments, rather than
the number of warning letters from the US FDA to countries,” highlights Dr. Letitia
Indian manufacturing sites has increased in the last five Robinson, director of the US FDA DILIP G SHAH
years. While the proportion of official action indicated India Office, while stressing that the secretary general, IPA
(OAI) and voluntary action indicated (VAI) decisions in problems encountered by the FDA’s
US FDA inspections has remained the same (around 65 investigators in India are similar to
percent), the number of inspections increased by 30 per- those seen around the world in manufacturing: “com-
cent in 2015. That same year, when some of our mem- mon issues include inadequate or poor quality systems
bers received warning letters from the US FDA, it came implementation, data integrity issues, inadequate vali-
as quite a surprise,” relates Dilip G Shah of the IPA, dation of various processes used in manufacturing or
before adding: “we did not, however, take the view that testing, and product contamination,” she adds.
British Biologicals: Building, Consolidating, Expanding

Although India has today emerged latter’s guidance and prescriptions are strongly respec-
as a fast-growing nutraceutical mar- ted by patients.” He continues, “India’s physicians and
ket, the context was completely di- patients no longer accept products whose benefits are
fferent when VS Reddy first establi- not strongly supported by scientific evidence. Moreover,
shed British Biologicals – now India’s Indian regulators have become extremely stringent with
leading nutraceutical company – in regards to packaging and marketing standards, ruling
1988. At that time, the Indian mar- out nutraceutical products boasting unproven added va-
ket was still at a very nascent stage, lue from the market.”
DR. V S REDDY and the main challenge he faced
— not only concerned the limited pur- Leveraging its leadership in India and the uniqueness of
founder and chasing power of the Indian popu- the company’s brands, Reddy has initiated an aggressive
managing lation. “As one of the pioneers in internationalization strategy over the past two years and
director, British
the Indian nutraceutical market, we British Biologicals today exports its products to 35 coun-
Biologicals
truly had to educate the domestic tries. “We just opened an office in the US, where we
ecosystem and convey the crucial are already supplying vitamins to leading retailers such
role played by nutraceuticals as complements to allopa- as Amazon. Although the US probably stands as one of
thic treatments as well as powerful prevention means. the most competitive nutraceutical markets in the world,
Fulfilling this endeavor was no bed of roses: it took me it undoubtedly is a science-driven ecosystem, which
almost ten years before the Indian physician communi- should propel the growth of our portfolio,” he says, whi-
ty steadily began integrating our products in their daily le the company is ready to duplicate some of the clinical
practices,” explains Reddy, who is fondly known as ‘The trials already conducted in India to fully showcase the
Protein Man of India.’ added-value of its products to US stakeholders. “We
believe that our unique diabetic diet, hepatitis syndro-
Despite dealing in nutraceuticals, British Biologicals has me, and menopause syndrome products could rapidly
adopted a promotional approach similar to that of any conquer substantial market shares in the US, and we will
specialty pharmaceutical company selling science-ba- most likely concentrate our promotion efforts on die-
sed, prescription products. Reddy posits, “As we are ticians operating in private clinics to propel these pro-
above all a science-based company and all our products’ ducts’ market uptake,” he says, before stressing he is
benefits and innovations are scientifically proven and also considering several acquisition opportunities in the
evidence-backed, we have historically concentrated our US and the UK to access overseas manufacturing capaci-
efforts on general practitioners in a country where the ties and support British Biologicals’ marketing strategy.

COVER STORY
US FDA inspects one of our plants every six months

on average,” he adds. As part of the findings of IPA’s
THE LEVEL OF REGULATORY Quality Forum - set up in 2015 with the vision of help-
SCRUTINY THAT A PHARMACEUTICAL ing the Indian pharma industry achieve excellence
COMPANY HAS TO COPE WITH in quality - progress has evidently already been made
OFTEN DEPENDS ON THE over the past three years: while Indian manufacturers
SIGNIFICANCE OF ITS MARKET SHARE accounted for 50 percent of all warning letters issued
IN THE RELEVANT COUNTRY by the US FDA to non US-sites in 2015 – Chinese sites
Binish Chudgar INTAS making up only 13 percent of the total – this number
decreased to 29 percent in 2017 for India-based sites
“The level of regulatory scrutiny that a pharmaceuti- and grew to 35 percent for China-based sites.
cal company has to cope with often depends on the sig- In the meantime, regulatory and compliance issues
nificance of its market share in the relevant country – do not seem to have utterly cooled down the eagerness
especially when it comes to the US FDA. In this regard, of leading international companies to acquire India-
it truly makes a difference whether a company holds based manufacturers and/or service providers, espe-
only a handful of products or ships 50+ INNs from a cially in very sophisticated product areas. For example,
given plant; when holding a small market share, regula- Swedish CDMO Recipharm completed the acquisition
tors would typically not go into full details, but compli- of India-based CDMO Kemwell in 2016 and acquired
ance inspections suddenly reveal themselves extremely a majority stake in Nitin Lifesciences, an Indian ster-
stringent and in depth once a company has a substan- ile injectables CMO. In the same year Baxter agreed to
tial position,” considers Chudgar of Intas. In the mean- purchase India-based Claris Injectables (including its
time, recent inspections seem to indicate that stringent three Ahmedabad-based manufacturing plants) for
regulatory scrutiny has been broadened to encompass USD 625 million.
API manufacturing plants, in addition to the formula- “Looking forward, I however expect that Indian com-
tion plants primarily targeted in the first place. panies will continue suffering from increasing scruti-
“I see quality compliance as a learning curve, while ny pressure in the coming years, leading them to sig-
one should bear in mind that regulatory standards are nificantly step up their investments related to quality
also constantly evolving. Across our multiple manu- and regulatory controls. In the meantime, some var-
facturing plants, Intas has successfully passed 50+ US iable costs, such as electricity supply, are much more
FDA inspections over the past two decades, and the expensive in India than in Europe,” considers Alexandre
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COVER STORY
Williams, founder and managing director of Athena clearly become strategically important across all layers
DDS, an international company with an Indian man- of Indian organizations, including formulation and
ufacturing basis. “Taken all together, these factors will API companies as well as both B2B and B2C players.
accelerate the weakening of India’s manufacturing cost “My approach is extremely simple: quality is every-
advantage, which is already affected by Indian workers’ one’s responsibility. As a matter of fact, it has been
expectations to see their wages being increased by 10 integrated as a Key Result Area for all of our 4,000
percent a year – regardless of the inflation rate. As a employees, regardless of the function they hold. In my
matter of fact, India has already lost its manufacturing eyes, risk exposure in terms of quality compliance is
cost advantage vis-à-vis several European countries – actually the most crucial metric for our organization,
especially above a certain volume of goods – as export- and we have made huge investments to ensure our
ing from India moreover implies bearing higher logistic company remains ahead of the curve,” explains Vivek
and tariff costs,” he warns. Sharma, CEO of PPS, which displays one of the best
track records in this area. “You truly have to ensure that
from top to bottom everyone understands that integ-
rity, ethics and compliance are binary: they are either
A TOP-DOWN ENDEAVOR maintained or they are not. [Companies’ heads] have
to create a healthy paranoia in regard to these stand-
In a context where even well-established, multi-bil- ards and we build that into every individual job,” con-
lion-dollar domestic companies have received warn- firms Jonathan Hunt of Syngene International, one of
ing letters from the US FDA, quality compliance has the fastest-growing CRAM organizations in the world.
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COVER STORY
“In this regard, I believe that has been gaining traction across
quality compliance truly comes as the country’s pharma ecosystem.
a top-down endeavor, which has “We assist and train both Indian
to be generated by the company’s regulators and the Indian phar-
heads before flowing through- maceutical industry on developing
out all layers of the organization. and maintaining the quality, safety
Indian CEOs with global aspira- and effectiveness of medical prod-
SATISH VARMA
tions know that they cannot take ucts, which includes addressing HEMANT KOSHIA
any shortcuts when it comes to regulatory compliance issues. In commissioner, Food
managing director,
Fermenta Biotech quality standards and regulato- this regard, Indian regulators have and Drug Control
Administration Gujarat
ry compliance, but the trickiest become important strategic part-
part is to convey and nurture this ners for the US FDA, we regularly
approach to their teams: in a vast and highly populat- engage with them and also aim to build confidence in
ed country like India, the paramount importance of each other, develop quality standards and bilateral ini-
quality and regulatory standards might not be obvious tiatives,” reveals Dr. Letitia Robinson of the US FDA
to all layers of our population,” adds Satish Varma of India Office. “In an effort to adopt the best regulatory
Fermenta Biotech. practices implemented in the world’s most advanced
When it comes to the overarching goal of avoiding ecosystems, we closely and regularly interact with our
regulatory and compliance issues, Indian CEOs may peers from the US FDA, UK MHRA, Health Canada,
benefit from the cross-border, collaborative spirit that and the WHO – among others. We are closely working
towards capacity building, training, networking and
knowledge sharing with the US FDA through one-to-
one meetings conducted on a regular basis,” highlights
Dr. Hemant Koshia, commissioner of FDCA Gujarat,
the regulatory authority of the state of Gujarat.
NO BETTER PLACE THAN HOME?
In parallel to their astounding expansion on the inter-

national scene, domestic companies have also strength-
ened their grip within India and today enjoy a 77 per
cent share of the Indian pharma market, while only
18 multinationals emerge in the Top 100 ranking. In
the meantime, India has remained a critical market for
some of the most successful Indian players globally:
Sun Pharmaceuticals, the fifth largest global specialty
Global. Niche. Elite generic company, makes around 26 percent of its USD
4.5 billion gross sales in India, where it stands as the
• Two advanced manufacturing sites
• Global reach with products supplied to 40 countries market leader – and similar numbers apply to other
• Sterile and non-sterile fabrication
• Specialization in dermatology and ophthalmology domestic heavyweights. “There is a lot of energy being
• 23 years of operation spent in trying to make sure that the Indian market
lives up to its promise – as you know it is a USD 36
Galentic Pharma (India) Pvt. Ltd. info@galentic.com
4th Floor, Samruddhi Venture Park,
www.galentic.com
billion market and Cipla is aiming to reach USD two
MIDC Central Road, Andheri (East)
Mumbai 400 093. billion in terms of sales in the country,” testifies Umang
Vohra, managing director and global CEO of Cipla, the

COVER STORY
third largest pharmaceutical com- patients a day (versus ten to 40

pany in India. patients a day in most other coun-
In the meantime, India-centered tries), thanks to efficient organiza-
pharmaceutical companies in tion, anticipation, and adequate
the likes of Eris Life Sciences, La team structure,” adds Dr. Georges
Renon, and Oaknet Healthcare Jabre, the recently appointed CEO
have been flourishing over the of Serdia Pharmaceuticals (India)
UMANG VOHRA
past decade. “Two main market Pvt. Ltd. (an affiliate of the Servier VENU AMBATI
dynamics caught my attention: Group). “As very few external
managing director and managing director,
global CEO, Cipla first, I noticed that most domes- observers actually know this fact, Abbott India Ltd
tic companies were focused on the I would also highlight that Indian
global market while India was – to hospitals do offer holistic care:
some extent – a secondary priori- healthcare professionals typically provide chronic dis-
ty in these companies’ strategies,” eases patients with a basket of exams, treatments and
explains RS Raghav, former exec- follow-up options – at various levels of costs, which are
utive vice president of Lupin and calibrated to the patients’ ability to pay,” adds Jabre.
founder and managing director “Last but not least, there is a favorable environment
of Oaknet Healthcare, which is in terms of the policy context that generates access –
currently ranked 79 in India with- price controls are one way to generate greater coverage,”
GEORGES in only three years of existence. expresses Cipla’s Vohra, while about 20 percent of the
JABRE
“Second, I realized that the crowd-
CEO, Serdia
Pharmaceuticals
ed Indian industry and its 10,000+
(Servier India) companies would undoubtedly UNISON
experience significant consolida-
tion moving forward – whether
it relates to portfolio or company
acquisitions. Indeed, an incred-
ibly high number of small and
mid-size domestic companies with
turnover of USD 18-30 million
were founded by first-generation
RS RAGHAV entrepreneurs, and the latter may
be eager to sell their businesses at a
managing director of
Oaknet Healthcare premium price if such opportunity
MAKING QUALITY HEALTHCARE
arises. A rise in M&A deals would AFFORDABLE
further widen existing gaps in the
Indian market,” he highlights. Bhagyesh Shah - Managing Director
Unison House, Nr.Prernatirth Derasar, Jodhpur, Satellite,
“More and more Indians can afford medicines which, Ahmedabad - 380015, Gujarat, India
in turn, increases market penetration, while there is a +91-9909006464
more conspicuous amount of consumption that goes international@unisonpharmaceuticals.com www.unisonpharmaceuticals.com
into tier two, three and four cities. Hospitals have

reached a certain standard of care and we see patients
increasingly using hospitals to get treated,” highlights
Cipla’s Vohra. “I am positively impressed by the amount
of time that local medical doctors give to their patients
and to follow up. This is even more impressive as
Indian doctors manage to attend up to a hundred fifty

COVER STORY
INR 500,000 [USD 7,800] per family per annum and cov-
IN THE GRAND SCHEME OF THINGS, THE er more than 100 million vulnerable families, especially
MOST IMPORTANT ASPECT IS THAT ONE in rural areas. “This program, which is set to be imple-
HUNDRED MILLION FAMILIES WILL GET mented in October 2018, should increase the access
HEALTHCARE ACCESS THROUGH THE of the population to more sophisticated products and
NHPS incentivize physicians to prescribe branded products
RS Raghav OAKNET
to families covered by this new scheme,” expects Vinay
drugs manufactured in or imported to India are under Sapte of Maneesh Pharmaceuticals, a top 70 company
price control based on the National List of Essential in the domestic market. Although the government seem-
Medicines prepared by the Ministry of Health and ingly wants to put the emphasis on pure generics rather
Family Welfare. “Recent changes in pricing ensure that than branded generics, most voices among the industry
the market remains dynamic and the pressures on indus- seem to agree that the utmost priority is to give access
try are running high, but ultimately it is the patient that to quality healthcare to the largest share possible of the
matters and that is why we have made ‘going beyond the Indian population, while the main question at stake
pill’ a strategic priority for the future,” recounts Venu revolves around the quality of medicines accessed by the
Ambati, managing director of Abbott India. However, population.
he is quick to point out that ‘affordability’ should not “In the grand scheme of things, the most important
be dealt with in isolation, but rather as part of a com- aspect is that one hundred million families will get
prehensive, holistic strategy. “We also need to focus on healthcare access through the NHPS; moving forward,
improving the other ‘A’s of the system – that is ‘accessi- we can foresee that millions of Indians eligible to this
bility’ and ‘availability,’” he muses. scheme would steadily look for better products and
In this regard, Finance Minister Arun Jaitley recently services and slowly move to the branded market, espe-
announced a new, ambitious National Health Protection cially if their purchasing power keeps on increasing
Scheme, which will provide a health insurance cover of in the meantime. In a nutshell, in all cases, the NHPS
NATURE OF OBSERVATIONS RECEIVED BY INDIAN SITES INSPECTED BY THE US FDA

(IN % OF WARNING LETTERS & 483 OBSERVATIONS)
Others 10% 8% • Failure to establish laboratory controls that

3% 17%
include scientifically sound and appropiate
Facilities & Infrastructure 7%
14% specifications, standards, sampling plans
4%
Production systems 16%
13% • Failure to ensure that test prodecdures
11% are scientifically sound
Lab controls 8%
19% 17%
Investigations & • Failure to adequately investigate
root cause assessment 18%
– Deviations – Invalidated OOS
– OOS results – Customer complaints
28%
• Inadequate controls of computer % otrher
46% data systems
Data reliability & 41%
Good documentation • Gap in prevention of unauthorized access
practices 20% • Incomplete data in lab records
• Incomplete data in batch production records
2015 2016 2017
Source: US FDA Warning Letters & 483 observations in public domain, graph produced by IPA for Quality Forum

COVER STORY
will propel the growth of the entire market,” consid- pharmaceutical companies must be more precise when it
ers Oaknet’s Raghav, former executive vice president of comes to detailing the benefits of their medicines as well
Lupin and managing director of Oaknet. One still need as in their overall communication to external partners,”
to see how and at which pace this ambitious scheme will reveals Serdia’s Jabre. “Furthermore, operating in today’s
be put into motion, but the Indian Government has so environment implies being extremely focused, as the
far proven itself particularly reliable when it comes to time available for doctors’ visits is on average shorter as
reform implementation. “In this regard, we also hope compared to previous years. Indeed, as most patients are
that the government will set up dedicated purchasing favoring the private sector, doctors are giving us less time
schemes for essential products, including for biologicals. to develop our ideas and services – hence the importance
For example, some areas of India are particularly affect- of being sharper as a company if we want to convey our
ed by snakebites, but public hospitals do not have anti- undeniable expertise,” he continues. While affordability
dotes,” regrets BSV’s Bharat V. Daftary. Roughly 46,000 is first and foremost driving the Indian market, it none-
people die of snakebites in India every year, according to theless does not mean that physicians don’t acknowl-
the American Society of Tropical Medicine and Hygiene, edge the added value brought by pharmaceutical com-
accounting for nearly half of the 100,000 annual snake- panies. “We for example developed a new dosage form of
bite deaths the world over. enoxaparin enabling self-injection through a multi-dose
“As India remains essentially a self-pay market, pen and became the first company in India to market
patients are also much more demanding – towards the such technology in this product category. Although
doctors and the medicines prescribed – than in coun- competitors swiftly started copying our pen, gynecolo-
tries with established social security systems. Therefore, gists remained loyal to our product, because they trust
Oral Solid Lifecycle specialist

· Co-development
· Licensing out
o Oro-dispersible
o Sublingual
o Sustained Release/Enteric Coated
o Fixed Dose Combination
Address Email
France: Espace Arnold de Ville, 12 Rue Global: awilliams@ddsathena.com
Georges Blandon, 78430 Louveciennes, France Europe: patel.shradha@ddsathena.com
India: 602, Star Hub, Tower II, MENA: patil.amit@ddsathena.com
Sahar International Airport Road, South East Asia/NZ/Au: wasim.shaikh@ddsathena.com
Andheri East, Mumbai 400 069. India

Others 10% 8% • Failure to establish laboratory controls that
3% 17%
include scientifically sound and appropiate
Facilities & Infrastructure 7%
14% specifications, standards, sampling plans
COVER STORY 4%
Standing Outsystems
Production From the Crowd
16%
• Failure to ensure that test prodecdures
11% 13%
are scientifically sound
Lab controls 8%
19% 17%
Investigations & • Failure to adequately investigate
root cause assessment 18%
our company and value its expertise,” explains Daftary specialty focus, – Deviations
while we essential-– Invalidated OOS
– OOS
of BSV, which currently ranks third in India’s gynecol- ly look at underperforming assetsresults – Customer complaints
ogy market and aims to shortly reach second position. 28 %
that we could rapidly turn around
thanks to•aInadequate
heightened controls
focusofandcomputer % otrher
46% data systems
Data reliability & 41% support” explains Oaknet’s RS
Good documentation • Gap in prevention of unauthorized access
Raghav. Besides acquisitions,
• Incomplete lead-
data in lab records
practices 20%
THE RIGHT FOCUS: PARTNERSHIPS ing domestic companies
• Incomplete data also aimproduction records
in batch
at bringing new branded products, LUCA VISINI
2015 2016 2017
In the consolidating Indian market where the top three innovative delivery mechanisms managing director,
companies
Source: US hold a 19 percent
FDA Warning Letters market share andinthe
& 483 observations topdomain,
public 50 graph
and produced
technologies from
by IPA for abroad
Quality Forum to Eli Lilly and Company
companies make up 84 percent of the market, an ever-in- fully tap into the potential of the India
creasing number of players are embracing a specialty domestic market. “In this vein,
approach boosted by bold acquisition and partnership we have already signed in-licensing partnerships with
strategies. “We are a specialty pharmaceutical company European and US companies, and these products will
with three main areas of interest: dermatology, women’s most likely reach the Indian market within the next three
health, and cardiology/anti-diabetic segment”, reveals to five years,” reveals BSV’s Daftary.
Oaknet’s managing director RS Raghav. “While our goal While international companies may struggle to oper-
is to break into the Top 50 within the next five years, ate in a large country comprising 29 states and seven
our revenues grew 18 percent during the last financial union territories with many local languages and varying
years, and we largely owe this great performance to our regulations, the latter moreover seem increasingly eager
successful in-licensing and acquisition strategies: beside to leverage the exceptional coverage network of domes-
the acquisition of Adcock Ingram’s Indian footprint, we tic companies to expand access to innovative medicines.
also acquired seven brands from leading multinational “We have a commercial partnership with Lupin for the
companies in the likes of Sandoz to enrich our portfo- promotion and distribution of several Lilly products
lio. Moving forward, we will continue building up our in our diabetes portfolio. We initiated this partnership
THE INDIAN PHARMA INDUSTRY HAS MADE PROGRESS OVER THE LAST 3 YEARS
USFDA Warning letters for Non-US sites USFDA Import alerts for Non-US sites
29% 29% 35% 30%

39% 50%
INDIA
35%
22% 43% China
13% 50%
53%
RoW
39% 38% 37%
29% 20%
12%
2014 2015 2016 2017 2016 2017

Source: Open Web Search, produced by IPA for the Quality Forum 2018

COVER STORY
first for the promotion and distri- the operations of all pharmaceutical companies with
bution of one product and then global ambitions,” believes Minister of Commerce &
have expanded it in 2016 to include Industry Suresh Prabhu.
additional therapies,” highlights
Luca Visini, the recently appointed
managing director of Eli Lilly for
India, while similar partnerships OUR PREDECESSORS HAVE DONE
DEEPAK have been multiplying at an impres- AN INCREDIBLE JOB IN CONVINCING
SAWANT sive pace over the past months. LEADING MULTINATIONAL
minister of health “Although Cipla was one of the COMPANIES THAT THEY CAN
and family welfare for
Maharashtra state
companies that fought against RELY ON INDIAN PARTNERS AND
multinational patents in India, we SUPPLIERS Sameer Hiremath HIKAL
are today the preferred partner for
multinational companies,” explains Cipla’s Vohra to Whether it relates to the domestic stage – character-
illustrate the wind of change blowing through India’s ized by a huge growth potential but a limited pricing
pharmaceutical market. power – or to international markets shaped by soaring
“Finally, in our vision, partnerships will not only competition, sweeping trade policies, and regulatory
encompass the commercial sphere, and – given our huge scrutiny, the challenges that lie ahead for Indian com-
ambitions in India – we truly aim at embracing all layers panies are only matched by the bountiful opportuni-
of the country’s healthcare system, whether it concerns ties that are still yet to be seized. “I however believe it
medical universities, the union and state ministries of is clearly easier for businessmen of my generation to
health,” stresses Serdia’s Jabre, while India’s 29 states reach our growth objectives: our predecessors have
and seven union territories form a fragmented health- done an incredible job in convincing leading multi-
care reality with diverse epidemiological, cultural, cli- national companies that they can rely on Indian part-
matic, and economic profiles but a similar eagerness to ners and suppliers. A few decades ago, entrepreneurs
benefit from the industry’s expertise. “We look forward had to sell ‘Brand India’ even before selling their own
to partnering with pharmaceutical and healthcare com- company…” comments Hikal’s Sameer Hiremath. “In
panies and jointly shifting the healthcare paradigm in the meantime, the new generation will have to be more
India’s second most populated state, whether it relates innovative than ever, while reaching out to new geog-
to prevention, treatment or the management of our raphies – such as Latin America and South East Asia
healthcare capacities and centers,” concludes Dr. Deepak – and diversifying revenue streams,” assesses his father
Sawant, minister of public health and family welfare in Jai Hiremath.
the Government of Maharashtra, “a state where over half Finally, when it comes to further strengthening
of the 112 million inhabitants exclusively rely on the its significance within the global pharmaceutical
State Health Department to access healthcare services and healthcare landscapes in the years to come, the
and products,” he points out. Indian industry will undoubtedly be able to leverage
a particularly precious asset: experience. “Through
the challenging early years, we have learnt how to get
the best returns on investment, and this expertise will
LEVERAGING THE PAST TO BUILD THE FUTURE be extremely useful moving forward,” expects Binish
Chudgar of Intas, whose sales grew from USD 100,000
“Overall, India accounts for almost 20 percent of the in 1994 to over USD 1.7 billion in the last financial
global disease burden; moving forward, its thriving year. “This aspect actually does not exclusively apply
pharmaceutical market should benefit from the recently to me or to Intas, but to all Indian CEOs that success-
announced increase of public health spending, while the fully developed their companies before India became a
dynamism of our country’s economy will undoubtedly respected and dominant player in the global pharma-
contribute to cement the crucial importance of India in ceutical market,” he concludes.

INDIAN R&D
Sharvil Patel, Zydus Cadila
R&D DRIVE
As managing director of India’s fifth largest pharma-

ceutical company, Zydus Cadila’s Sharvil Patel docu-
ments the company’s NCE and biosimilar ambitions.
Sharvil Patel
ZYDUS CADILA
HCLS: Lipaglyn is India’s first new chemical en-

tity (NCE) and has investigational new drug status
with the USFDA. You have recently received per-
mission to conduct Phase II clinical studies in the successful as we have developed and commercialized
US. How is it going so far? nine products. Our global strategy is now to outlicense
SHARVIL PATEL (SP): In India we are doing very in many of the emerging markets to local large compa-
well so far with the launch of the brand and we are nies in countries such as Russia, Brazil and Colombia.
covering about 100,000 patients. Our aspiration is to Biosimilars are very interesting as access is very poor
have the drug registered in critical markets across the and prices are mostly high in many markets around
world. Currently we have three Phase II studies in the the world. Our mission is to enhance access and bring
US and another four in India. NASH, which is the indi- them at an affordable price.
cation for Lipaglyn we are currently working for, is an
area of unmet healthcare need as there are currently no HCLS: What are your strategic priorities at the
drugs approved for the treatment of the disease in both moment?
emerging and developed markets. We are planning to SP: In the first place, I would like to enhance our
launch the drug either through ourselves or by licens- vaccines and our biologics portfolio along with re-
ing it out. The product has significant and differenti- search and development. We currently have 18 vaccines
ated effect on hepatic steatosis, while it shows all other launched as well as nine prequalified WHO ones which
beneficial effects. We are very confident that we will be allows us to participate in the global tenders. Definitely
successful because of the current data and clinical lead- both the private and the public vaccines markets are
ership that we have in India. We are looking to launch within the scope of our strategic interests, as well as
it in 2019-2020. expanding to the US. Furthermore, special focus will
be given on compliance and enhancement of produc-
HCLS: The global biosimilars market is expected tivity in every area. To this purpose, we are looking to
to reach USD 10.9 billion by 2021 from USD 3.39 run programs on how to improve productivity across
Billion in 2016. What opportunities do you recog- the organisation. Our aspiration has always been to be-
nize for Zydus in particular? come a research driven pharmaceutical company and
SP: Biosimilars are at the core of our business and we stated this vision in 1995 with the aim of accom-
we started working on them in the early 2000s. As far as plishing our mission by 2020. I think that we have de-
the domestic market is concerned, we have been quite livered on the commitment that we made back then.

CRMO PARTNERSHIPS
Jonathan Hunt, Syngene International
UNLOCKING (GREAT)
POTENTIAL
Jonathan Hunt
Jonathan Hunt, CEO of Syngene International, one of the fastest-grow-
ing and leading contract research and manufacturing organizations in SYNGENE
the world, discusses the company’s partnership model with leading bi- INTERNATIONAL
otech and Big Pharma companies.
HCLS: What are the advan- biologics which is creating a strong, It is always good to be closer
tages of Syngene’s partnership local ecosystem for convergence of IT to your clients for engaging in a
model, where exclusive research and life sciences and innovative scien- more meaningful conversation.
infrastructure within Syngene’s tific research. However, it is also important
premises is set up for particular What we do well with many of our that we retain the vibrancy that
clients with a dedicated team of clients is that we integrate so com- currently defines us. While we
Syngene scientists? pletely into their own R&D organ- deal with many mega corporates
JONATHAN HUNT (JH): All ization that it is seamless. The best across the globe, we also have
of these partnerships have a dif- example of this is the integration smaller single asset, innovative
ferent focus and operating model; that has happened between BMS biotech startups in our client list,
while some of them are more fo- and us within BBRC, the dedicated for which our collaboration plays
cused towards chemistry, others R&D facility for BMS: we operate a much more critical role in their
are fully integrated across all as- on the BMS systems and from their overall R&D strategy. For them
pects of drug discovery. perspective we are simply their col- it is very critical that there is not
However, the primary advan- leagues in India. We have developed a only an element of cultural align-
tage in all of these strategic part- significant amount of trust through ment but also that we understand
nerships is that it allows them to a decade strong relationship and we the startup mindset.
access the very best of India, while are jointly committed to seeing this
having somebody else manage and carry into the future.
deliver the scientific outcomes for
THE PRIMARY
them. So they don’t have to worry HCLS: How do you see Syngene’s
about setting up the right infra- footprint evolving in the coming ADVANTAGE IN ALL
structure, having the right skill years? OF THESE STRATEGIC
sets and local talent pool, man- JH: We set up a US subsidiary, pre- PARTNERSHIPS IS
aging the regulatory compliance cisely to act as an interface and en- THAT IT ALLOWS
environment and the way of oper- sure that we have a local representa- THEM TO ACCESS
ating in India. We manage all this tion in close proximity to the largest THE VERY BEST
and deliver a range of integrated number of our clients. Besides in- OF INDIA, WHILE
drug discovery and development creasing our visibility, the subsidi-
HAVING SOMEBODY
services to them. ary will act as a front end for activ-
The second advantage is around ities related to project management,
ELSE MANAGE
the scale and size of our opera- alliance management, commercial AND DELIVER
tions here in Bangalore and the interactions; however all the science THE SCIENTIFIC
access to emerging technologies will continue to happen from here in OUTCOMES FOR
in AI, deep learning, informatics, Bangalore. THEM

MEDTECH
Randolph Alves, Alves Group
READY FOR THE

NEXT LEVEL
Randolph Alves, founder and chairman of Alves RANDOLPH

Group, provides insights into the company’s ex- ALVES
panding footprint overseas and documents its im-
founder and
pressive presence in India, where it is about to set chairman, Alves
up a comprehensive MedTech park in Goa. Group
HCLS: There are more than 35,000 factories in

India. How do you see the industry evolving in the
coming years? Alves moreover keeps growing in the Indian market,
RANDOLPH ALVES (RA): Around 25,000 of these building more manufacturing facilities in the country.
players are small and insignificant. The market also in- Finally, we are going to set up a MedTech park in Goa
cludes medium-sized players, such as Alves. Only then this year, featuring manufacturing of medical devices,
comes the 50 or so large players. The issue remains that pharmaceuticals, R&D, medical tourism and home-
smaller players are still focused on the less lucrative do- care. Needless to say, we will be bringing affordable and
mestic market instead of being internationally orient- international-standard treatments and therapies to the
ed. Our strategy is focused on the international market, table and therefore bring higher added value to hos-
and we have already set up joint ventures in five African pitals, doctors, and other key stakeholders among the
countries. Our internationalization strategy is mainly medical community. This platform will help us share
focused around medical devices as the global market new ideas and support our peers in the industry.
is worth USD 550 billion, in comparison to the USD Our first growth challenge to overcome will be our
five billion Indian market. Yet our vision remains to cash flow, which means that we need to raise funds for
offer end-to-end healthcare solutions within both the our international and domestic projects. For example,
medtech and pharma segments. our medical device expansion project in Goa – a turn-
ing point in our domestic development – will cost us
HCLS: Can you provide us with a breakdown of over five hundred crores (USD 76 million), a substan-
Alves Group’s revenues in terms of medtech and tial investment. We are therefore seeking to raise equi-
pharma? ty internationally. From there, foreign companies will
RA: Approximately 70 percent of our revenues come come and outsource from us.
from medical devices. As a hundred-crore company
(over USD 15 million), Alves is not a big player in terms HCLS: What sets Alves Group apart from other
of revenues yet. However, in terms of assets, we are players in the Indian market?
strong with seven factories in India, including five in RA: We are one of the most established medical de-
medical devices. In this field, we are manufacturing for vice players in India. I cannot see any serious interna-
the biggest companies such as J&J, 3M, BSN Medical, tional player investing in medical devices in India, as
Paul Hartmann and Smith & Nephew, and we also they are scared to invest in a technology they do not
supply government tenders all over India and abroad. trust. We do not have such fears because we have our
There is therefore a huge potential to grow. own expertise in developing technologies which are of
In parallel to setting up joint ventures in foreign international quality standards. That is how we have
countries, starting with Africa in the next five years, evolved as a leading player in the field.

EXPORT STRATEGIES
Emerging Markets
THE AFRICAN LAUNCHPAD

Although most industry observers expect that Indian pharma exports to the US will pick up again in the
P
coming years, Indian companies have – in the meantime – been rapidly increasing their efforts to develop
stronger footprints in strategic emerging market such as Brazil, Russia and some Asian and African countries.
harmexcil identifies that roughly 20 percent Randolph Alves. “The secret of a

of India’s pharma exports of around USD win-win joint-venture is to find
17 billion go to African countries; making a market that helps the compa-
these countries a launchpad in the inter- ny grow with a real market need,
national strategies of a significant number and to give back to the communi-
of Indian exporters. This aspect gained a higher signif- ty in return; the reason we set up
icance as Indian companies have steadily established joint ventures in Africa is because
RANDOLPH
themselves as partners of choice of international health- healthcare was virtually absent ALVES
care NGOs and aid agencies over the past decades. “Over over there, and manufacturing founder and
the past 16 years, we have been partnering with Europe- margins were higher in Africa chairman,
based NGOs such as MSF as well as aid and UN agencies than in India. In parallel, we want- Alves Group
including UNICEF. The latter notably rely on central- ed to bring down the healthcare
ized procurement to supply various emerging markets, costs of the continent, and train
notably in Africa,” explains Bhupendra Sangani, found- the community on how to manu-
er and managing director of Galentic, an Indian manufacture their own pharmaceuticals
facturer in the dermatology and ophthalmology arenas. and medical devices. Finally, I love
“These partnerships provided us with a great opportu- the spirit of Africa, a place rich
nity to increase our visibility in several African coun- in natural resources and not yet
tries. Consequently, we approached the relevant health commercialized,” he explains. In BHUPENDRA
SANGANI
authorities and started directly exporting our products terms of revenues, Alves is expect-
founder and
to Ethiopia, Tanzania, Uganda, Zimbabwe, Madagascar, ing at least a 100 million USD managing
Namibia, Kenya, Ivory Coast, and Botswana,” he reveals. from each African country, since director, Galentic
Building on its increasing strength in Africa, Galentic each is spending from 200 million
started registering products across the Middle East dollars to half a billion on healthcare
and in several Southeast Asian and Latin American “Our ambition is to become more than a large Indian
countries, and it is now awaiting US FDA approval for player. We are in fact aspiring to become the next Pfizer
a recently-built manufacturing plant in Gujarat. “In or J&J, with the goal of reaching at least half a billion
less than two decades, Galentic products are already dollars in five years, thanks to our joint ventures in
approved in 40 countries, and international markets Africa. Latin America will be the second region to invest
make up around 90 percent of our revenues,” highlights in. We will then eye South East Asia and finally consider
Sangani. the CIS countries,” he concludes.
Medtech and pharma player, Alves Group, is also
sharpening its ambitions for this promising continent.
OUR AMBITION IS TO BECOME MORE
“To enter the big league, we are to set up joint ventures
THAN A LARGE INDIAN PLAYER. WE
in foreign markets, starting with Africa in the next five
ARE IN FACT ASPIRING TO BECOME THE
years, where we have already set joint ventures in five
NEXT PFIZER OR J&J
countries,” explains the group’s founder and chairman
Randolph Alves ALVES GROUP
www.pharmaboardroom.com Healthcare & Life Sciences Review: Country 47

DOMESTIC MARKET STRATEGIES
Nitin and Bhagyesh Shah, Unison
Pharmaceuticals
MAKING QUALITY AFFORDABLE
Nitin Shah, founder and chairman of Unison Pharmaceuticals Pvt. Ltd., and Bhagyesh Shah, the company’s
managing director, provide insights into the unique positioning and development plans of this eye-catching
company, which has forged a great name for itself among India’s domestic industry by offering some of the
most affordable high-quality pharmaceuticals in the competitive Indian market.
HCLS: Could you please introduce Unison Phar- advantage: we only have two facilities in comparison
maceuticals to our international readership? with many of the bigger companies which may have
NITIN SHAH (NS): The company is now 37 years ten or more. Primarily our pricing is achieved through
old and ever since the point at which it was first con- our willingness to reinvest our profits and work with
ceived, our aim has been to provide high quality prod- low margins.
ucts at prices that are affordable to Indian patients. Due NS: Essentially, we work using a low-margin busi-
to the fact that public health spending in India is low, ness model with the objective to produce and sell high
the country’s healthcare is predominantly private in volumes of products at the lowest prices available. As
contrast with developed countries which generally either we are producing high quality products and selling
have government run healthcare systems or widespread these products at affordable prices, we are creating a
insurance programs. In this context, Unison has actually mutually beneficial situation for both our company
become a reference among the domestic pharmaceuti- and the patients.
cal industry when it comes to introducing high quality
products at the lowest price available in India.
BHAGYESH SHAH (BS): So far we have been fo-
cused entirely towards the state of Gujarat and its 60+
million inhabitants. In spite of this single-state focus
and the fact that Gujarat accounts for only five percent
of India’s total pharmaceutical market, we are among
the top 80 highest ranking companies in India in terms
of revenue and among the top 40 highest ranking com-
panies in relation to number of units sold.
UNISON HAS ACTUALLY BECOME A

REFERENCE AMONG THE DOMESTIC
PHARMACEUTICAL INDUSTRY WHEN
IT COMES TO INTRODUCING HIGH
QUALITY PRODUCTS AT THE LOWEST
PRICE AVAILABLE IN INDIA.
HCLS: What factors allow Unison to bring prod- NITIN SHAH

ucts to the market at such competitive prices? UNISON PHARMACEUTICALS
BS: Unlike the very large pharmaceutical compa-
nies, scale optimization is not our main competitive

DOMESTIC MARKET STRATEGIES
Nitin and Bhagyesh Shah, Unison
Pharmaceuticals
BS: While widespread acceptance may be slow at

first, eventually everyone realizes the advantages of
our products. Even if it takes a few months or even a
year, as long as quality and delivery remain consistent,
people are eventually drawn towards the medicines we
produce. As such the trend we have observed has been
that orders start out relatively small but grow expo-
nentially, as people come to appreciate the benefits of
our business model.
HCLS: After having been tremendously success-

ful in Gujarat, what are the next steps for Unison?
BS: Currently we aim to continue concentrating
our efforts towards Gujarat in India, while develop-
ing our abilities to expand into global markets. The
process through which we came to this decision pri-
marily centered around the development of our new
production facility which is four times larger than
our current manufacturing plant. While our old fa-
cility has had a World Health Organization (WHO) BHAGYESH SHAH
certificate for eight years, our new facility will be the UNISON PHARMACEUTICALS
WHO certified by September 2018 and we are expect-
ing to get UK MHRA certification by March 2019. As
such, this new facility allows us to export globally as
well as being able to create a stronger footing across
India; however, we aim to export for at least three AFTER THE COMPLETION OF THE WHO
years before eventually expanding throughout the INSPECTION, WE WILL START ACTIVELY
domestic market. After the completion of the WHO REACHING OUT TO INTERNATIONAL
inspection, we will start actively reaching out to in- PARTNERS, AND WE HOPE TO BE ABLE TO
ternational partners, and we hope to be able to enter ENTER THE UK AND OTHER EUROPEAN
the UK and other European markets in two to three MARKETS IN TWO TO THREE YEARS’ TIME.
years’ time.
HCLS: Will you still apply your ethos of supply- HCLS: What goals will Unison Pharmaceuticals
ing high quality products at affordable prices in Pvt. Ltd. have achieved in five years?
regulated markets in Europe? BS: In the next two to three years we aim to be an
BS: While we aim to remain true to our vision, we emerging company at a global level in terms of sales,
must look at the ways in which our ethos is received in while in the three years following that we aim to have
each country. In this regard, we may need to adapt our created a strong footprint in the markets that we have
strategy. While we know how the market in Gujarat entered. We intend to remain focused and have around
functions and the ways in which our products are 10 products registered across Europe, while being par-
received, we do not know how our products will be ticularly strong in a single country such as the UK in
received in markets in Europe. Nevertheless, social which we would have up to six products registered and
security systems and socialized healthcare systems in emerge as a top 10 player for these products. In relation
Europe will definitely work in our favor. However, we to the domestic market we aim to become a Top 60
must first prove the quality of our products in order company within the pharmaceutical industry within
for them to be widely adopted. the next five years.

COMPANY SPOTLIGHT
Athena
INDIAN BASE; GLOBAL

AMBITIONS
Alexandre Williams, founder and managing director of Athena, an international
company with an Indian manufacturing base, provides insights into the genesis
and development plans of this fast-growing company specialized in the devel-
E
opment and manufacturing of life cycle products for global partners.
“ ager to discover the world, I joined France’s Ethypharm in my

mid-twenties, which was at that time a B2B company specialized in
drug delivery systems. I then worked in several emerging countries,
including China and India between 2001 and 2006, two markets where
I had the mission to turn around the affiliates’ performances. In 2006, I was pro-
moted as Ethypharm’s VP Head of Business, before a private equity firm entered
Ethypharm’s capital. The latter however wanted to shift the company’s focus from
B2B to B2C and divest some assets, including the Indian operations. I seized this
opportunity, and this how Athena Drug Delivery System was actually born,” intro-
duces Alexandre Williams.
As some specialty pharma companies transfer the promotion of their mature
products to their generics arms in mature markets, Athena’s products can be pro-
moted by both specialty pharmaceutical companies and purely generics companies
looking for differentiated branded generics, i.e. generics molecules with a life cycle
that does not exist yet or that is still very rare on the global market. “We take care of
the product development and manufacturing, while our partners handle the mar-
keting of these products in targeted markets,” he adds.
Looking forward, Athena plans to launch more than 50 products in both mature
and emerging markets in the coming years, which will lead the company to double
or triple the production capacity of its Indian plant. “Leading pharmerging markets
are as attractive as mature markets for life cycle products. We have a solid strategy
for emerging markets, and – despite our smaller size – we actually follow the same
approach as some multinational companies,” he stresses, while some of Athena’s
Alexandre Williams
products are already registered in Russia, Indonesia, South Africa, Algeria, Egypt, ATHENA
and Athena recently inked a contract with a Nigerian company – among many other
international partners. “In Latin America, we are particularly focusing our efforts
on Brazil and Mexico, as well as Colombia and Chile,” he adds, before highlighting
LEADING
that the company is also active in Europe and Canada.
Nevertheless, some of the aforementioned countries have recently decided to boost PHARMERGING
the domestic production of locally consumed drugs, prompting Williams to consid- MARKETS ARE
er setting up a new manufacturing capacity in a strategic country - although Athena AS ATTRACTIVE
will continue servicing some markets from its Indian hub. “As a matter of fact, we AS MATURE
have already started transferring some manufacturing activities to France, where we
work with CMOs. Overall, our main objective will be have an FDA-approved factory,
MARKETS FOR
which will allow us to enter the US market and leverage the experience I have honed LIFE CYCLE
in this country for years when I was at Ethypharm,” concludes Williams. PRODUCTS.
50 Healthcare & Life Sciences Review: India

IMMUNIZATION AND VACCINES STRAP IN HERE PLEASE
Jean-Pierre Baylet, Sanofi Pasteur Strap subhead in here please
BUILDING UP
MOMENTUM
Jean-Pierre Baylet, country head for India and clus-

ter head for South Asia at Sanofi Pasteur, provides
insights into the progress and room for improvement
that lie ahead for India’s immunization program.
Jean-Pierre Baylet
SANOFI PASTEUR
coverage of the population is required for mass vac-
HCLS: India’s Universal Immunization Program cination to be effective; however, the immunization
(U.I.P.) is one of the most comprehensive in the rate for inactivated polio vaccines in India still hovers
world when it comes to the number of vaccines around 50 percent of the population, which is way too
used, the number of beneficiaries and immuniza- low to fulfill the government’s objective to reach polio
tion session organized, as well as with regards to eradication by 2022.
its geographical spread and the diversity of areas
covered. What is your assessment of India’s UIP? HCLS: How do you explain such a low coverage
JEAN-PIERRE BAYLET (JPB): The efforts of rate for vaccines that are freely available through
the government of India over the past few years are India’s UIP?
absolutely praiseworthy; as per today, 11 vaccines are JPB: India being the world’s seventh largest geog-
included in India’s UIP. Looking forward, the gov- raphy in the world, reaching out to the population in
ernment should aim at accelerating the inclusions of rural areas is no easy task, especially given the inher-
critical vaccines, while taking into account the specifi- ent challenges posed by vaccines in terms of cold chain
cities of the country’s epidemiological profile. For ex- management. Currently, the government of India
ample, there is still no routine immunization against moreover holds 30.000 vaccination centers scattered
flu in India while the country went through several across the country – and this is not enough to cater
outbreaks over the past 8 years. As we speak, govern- to the country’s demand while guarantying an utmost
ment is discussing the opportunity to integrate HPV quality of storage. In this context, additional invest-
vaccines into the UIP, which would emerge as a great ments are required to further densifying and develop
step forward [cervical cancer being the second leading the country’s distribution and storage network.
cause of cancer deaths among women in India – Ed]. In the meantime, education and awareness also
Nevertheless, this vaccine – which is typically admin- emerge as two pillars that must be tirelessly strength-
istrated to preteens, teens, and adolescents – still faces ened. This aspect notably entails convincing parents
social and cultural resistance in India. that they must bring their kids to vaccination centers
In parallel to the inclusion of new vaccines, another and ensure that the latter are up to date with routine
area of focus should be the improvement of vaccina- immunization. In this regard, healthcare providers play
tion coverage of the population for vaccines that are a crucial role in conveying to the parents how impor-
already available through the UIP. As you know, a large tant it is to get kids vaccinated.

INDEX
Including advertisers
Advertisers
COMPANY NAME PAGE
Abbott 27, 39, 40 Inventys Research 4, 26, 28, 36
Accord 20, 34, Intas 4, 12, 13, 15, 22, 30, 34, 36, 43
Alves Group 23, 46, 47 Laurus Labs 4, 18, 19, 30, 31, 32
ASENCE Group 4, 15, 27, 30, 32 Maneesh Pharmaceuticals 31, 40
Athena 37, 41, 50 Ministry of Commerce and Industry 2, 6, 21, 22, 43
Bharat Serums & Vaccines (BSV) 22, 24, 26, 41, 42 Ministry of Health and Family Welfare,
Maharashtra State 43
Biocon 22, 24
Oaknet Healthcare 4, 37, 39, 40, 41, 42
British Biologicals 28, 35
Piramal Pharma Solutions (PPS) 16, 17, 25, 27, 34, 37
Cipla 34, 38, 39, 43
Sanofi Pasteur 51
Dishman Group 15, 26
Sarabhai Group 15, 27
Dorizoe Life Sciences 27
Serdia Pharmaceutivals (Servier India) 32, 39, 41, 43
Eli Lilly 4, 42, 43
Syngene International 27, 37, 45
Fermenta Biotech 32, 38
Unison Pharmaceuticals 15, 39, 48, 49
FDCA Gujarat 2, 7, 14, 15, 38
US FDA India Office 21, 22, 35, 38
Galentic 4, 38, 47
Wockhardt 22, 24
Hikal 27, 29, 43
Zydus Cadila 15, 22, 30, 44
Indian Pharmaceutical Alliance (IPA) 2, 21, 34, 35, 36
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BINISH CHUDGAR OF INTAS GUJARAT STATE: BIG-TICKET US FDA WARNING

ON BIOSIMILAR STRATEGY INDIA’S PHARMA HUB INTERNATIONAL LETTERS AND QUALITY

STANDING OUT FROM THE CROWD

Suresh Prabhu, Minister of Commerce and Industry of India

Hemant Koshia, commissioner of FDCA Gujarat

Dilip G. Shah, secretary general of Indian Pharmaceutical Alliance (IPA)

for their continuous support, enthusiasm and encouragement in the

2 Healthcare & Life Sciences Review: India www.pharmaboardroom.com

www.pharmaboardroom.com Healthcare & Life Sciences Review: India 3

JOIN THE CONVERSATION

AMPLIFIED CONTENT IN BRIEF

Read the interview

Read the article

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Dear members of the international pharmaceutical industry,

Mr. Suresh Prabhu

6 Healthcare & Life Sciences Review: India www.pharmaboardroom.com

Distinguished members of the healthcare and pharmaceutical sectors,

Mr. Hemant Koshia

www.pharmaboardroom.com Healthcare & Life Sciences Review: India 7

POPULATION: 1.28 BILLION (2ND IN WORLD)

HEALTH EXPENDITURE: 4.7% OF GDP (2014)

GDP (PPP): USD 9.447 TRILLION (2017)

GDP GROWTH RATES

(YEAR-ON-YEAR IN %) Source: IMF; Livemint

WAGES IN ASEAN (2014)

ANNUAL MINIMUM HOURLY TOTAL COST OF LABOR

CHINA 2,472 1.19 3,337.20

INDIA 689 0.28 740

INDONESIA 1,087 0.52 1,187

MALAYSIA 3,107 1.24 3,534.20

PHILIPPINES 1,515 0.73 1,648.30

THAILAND 3,012 1.21 3,168.60

VIETNAM 1,296 0.64 1,581.10

8 Healthcare & Life Sciences Review: India www.pharmaboardroom.com

TOP 15 PHARMA COMPANIES IN INDIA (2017) INDIA’S PHARMACEUTICAL SALES AND

INDIA BIOTECHNOLOGY MARKET SIZE INDIA BIOSIMILARS MARKET

(USD BILLION) (USD MILLION)

05 20 06 20 07 0 08 20 09 2010 2011 2012 2013 2014 2015 2016 17F

www.pharmaboardroom.com Healthcare & Life Sciences Review: India 9

Captive R&D Units

RELATIVE COST OF PRODUCTION WITH US COST AS BASE (%)

USA EUROPE INDIA

10 Healthcare & Life Sciences Review: India www.pharmaboardroom.com

DESTINATION OF INDIAN PHARMA PRODUCTS EXPORTS

Almost a third of Indian exports find a home in United States

EXPORTS OF PHARMACEUTICAL PRODUCTS FROM INDIA TO THE WORLD

EXPORTED VALUE (USD ‘000) Source: Eurasia Review

www.pharmaboardroom.com Healthcare & Life Sciences Review: India 11

Binish Chudgar, vice-chairman and managing di-

12 Healthcare & Life Sciences Review: India www.pharmaboardroom.com

generics businesses; product wise, these portfolios will

www.pharmaboardroom.com Healthcare & Life Sciences Review: India 13

PAVING THE WAY

14 Healthcare & Life Sciences Review: India www.pharmaboardroom.com

“ ujarat’s history of manufacturing fine

www.pharmaboardroom.com Healthcare & Life Sciences Review: India 15

16 Healthcare & Life Sciences Review: India www.pharmaboardroom.com

www.pharmaboardroom.com Healthcare & Life Sciences Review: India 17

Dr. Satyanarayana Chava, founder and CEO of