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CONTENTS

Vol.13 No.3 December 1-15, 2017 PG 44-57

Chairman of the Board As we near the end
Viveck Goenka of yet another year,
a retrospective
Sr Vice President-BPD coverage of our
Neil Viegas stories that
reflected the trends,
Editor strategies, policies,
Viveka Roychowdhury* challenges and
aspirations of
Chief of Product the pharma
Harit Mohanty industry | pg 58-74

BUREAUS Express Pharma®
Mumbai
Usha Sharma, Raelene Kambli, Regd. With RNI No.MAHENG/2005/21398. Postal Regd.No.MCS/164/2016-18.
Lakshmipriya Nair, Sanjiv Das, Printed and Published by Vaidehi Thakar on behalf of The Indian Express (P) Limited and Printed at
Mansha Gagneja, Swati Rana The Indian Express Press, Plot No.EL-208, TTC Industrial Area, Mahape, Navi Mumbai-400710 and Published at 2nd floor, Express Towers, Nariman Point,
Mumbai 400021. Editor: Viveka Roychowdhury.* (Editorial & Administrative Offices: Express Towers, 1st floor, Nariman Point, Mumbai 400021) *
New Delhi Responsible for selection of news under the PRB Act. Copyright © 2017. The Indian Express (P) Ltd. All rights reserved throughout the world.
Reproduction in any manner, electronic or otherwise, in whole or in part, without prior written permission is prohibited.
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Asst. Art Director
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Chief Designer
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MARKETING
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To subscribe: [email protected] 39EXPRESS PHARMA

December 1-15, 2017

EDITOR’S NOTE

Time for a new strategy?

According to a recently released CII Are continued Thus, are continued investments in the US market
report, “Indian Roots, American Soil,” investments justified, given that the opportunities seem to be
the life sciences, pharmaceuticals, drying up? Of course, these companies cannot
and healthcare sector is the second in the ignore the largest pharma market in the world, but
largest group of Indian companies in US market maybe it is time for moderation and re-thinking
the US, in terms of FDI, jobs created and saved, justified, given strategy. The good news is that the domestic
R&D, skills training and local CSR initiatives. While market is showing signs of revival from the effects of
IT and IT-es tops at 28 per cent, lifesciences, that the GST. AIOCD PharmaTrac data for October shows
pharma, and healthcare is a close second at 25 per opportunities that four months after the roll out of GST, growth
cent. during October was 6.5 per cent, compared to just
seem to be 2.4 per cent in August. Pharma pundits are
Obviously targeted to play to US President drying up? assuming that this upward trend will continue and
Trump's call to action, To Make America Great the industry will achieve double digit growth again,
Again, the biannual “Indian Roots, American Soil” in the next few months.
survey showed that 100 companies with origins in
India are responsible for creating more than In contrast, pharma exports dropped in October.
100,000 jobs and $17.9 billion in investments across In fact, the country's overall exports contracted for
the US. The average investment received from the first time in 13 months in October. As per a
Indian companies per state/territory is $187 million. CARE Ratings report, pharma/drugs is one of the
President Trump will be pleased to know that 85 top five industries, dominating India's exports
per cent of these companies plan to make more basket, which together contribute a little over 60
investments in the US while 87 per cent plan to hire per cent of total exports. Of these five sectors, two
more employees locally in the next five years. i.e. gems and jewellery (14.5 per cent share of the
total exports pie) and pharma (5.7 per cent share)
How do we interpret investment flow to the US at showed a decline which contributed to the overall
a time when the first anniversary of fall in exports in October. As per data from the
demonetisation saw fiery TV debates blaming the Ministry of Commerce, pharma/drugs share of the
government for continuing jobless growth? In fact, total exports pie was $9.8 billion in 2016, which
four Indian pharma companies with sizeable registered a negative growth of -2.1 per cent in 2017.
investments in the US (Dr Reddy’s Laboratories, Though the slip is small, it is a cause for concern.
Glenmark Pharma, Sun Pharma and Emcure One hopes that this is an aberration and the graph
Pharma), are reportedly among the 18 companies turns upward again over the next few months.
accused by a consortia of US states of colluding to fix
prices of generic medicines. In the final 18 months of his term, Prime
Minister Modi finds himself with so much to do, and
Secondly, most of India's pharma majors so little time. Of course, there have been gains, like
investing in the US continue to be in the cross hairs the country moving up 30 places in the World
of the US FDA for not following mandated cGMP Bank's Ease of Doing Business Index. More
norms at their manufacturing plants. Most recently, recently, Moody's Investors Service upgraded the
in a Warning Letter 320-18-06 dated November 6, Government of India's local and foreign currency
the US FDA warned Lupin that ''repeated failures issuer ratings to Baa2 from Baa3 and changed the
at multiple sites demonstrate that your company’s outlook on the rating to stable from positive. Let us
oversight and control over the manufacture of drugs hope that as the country moves into election mode,
is inadequate''. The WL stated that the US FDA had health and associated policies once again become a
reviewed Lupin’s response to concerns highlighted key part of the political debate.
during previous inspections at the company’s Goa
and Indore plants but deemed the response It is against this backdrop that we bring to you
inadequate and not addressing all the issues raised in our annual CPhI India and P-mec India special issue.
sufficient detail. Over analyst calls, Lupin officials Do read the in-depth coverage of our first Pharma
expressed surprise over the US FDA's stance, not CXO Summit, focussed on leveraging serialisation
expecting the regulator to reject their response and and traceability for business growth. All experts at
pick holes in the remedial actions outlined in its the Pharma CXO Summit agreed that investment in
response. Clearly, the US regulator is not letting such technologies is crucial to future global growth of
companies off the hook until it is satisfied that the the sector and CXOs will have to strategise to
root causes have been sufficiently addressed. achieve long term sustainability rather than quarter
to quarter P&L goals. Hopefully, the interactions at
Just a couple of days later, on November 13, Sun CPhI India and P-mec India 2017 will inject new
Pharma's Baska plant reportedly had a surprise vigour into India Pharma Inc’s growth trajectory.
visit from US FDA inspectors. Given that the plant
is close to its Halol facility, which still has ongoing VIVEKA ROYCHOWDHURY Editor
unresolved issues as there has been a delay in re- [email protected]
inspection, this news is particularly significant.

40 EXPRESS PHARMA

December 1-15, 2017

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28.S-t3an0d.1J1.322017







PHARMA CXO SUMMIT

DAY 1 - NOVEMBER 9, 2017

INAUGURAL CEREMONY

L-R: Dr Ajit Dangi, CEO, Danssen Consulting; Bejon Misra, Founder, PSM India; Daara Patel, Secretary, IDMA; Ravi Uday Bhaskar, Director General – Pharmexcil; Shaunak J Dave, CEO & MD,
OPTEL Group India, VP (Asia), OPTEL Group and Viveka Roychowdhury, Editor, Express Pharma

AGENDA

◗ Lamplighting Ceremony Viveka Roychowdhury, Editor, Express Pharma giving the Welcome Address
◗ Welcome Address by Express Pharma
◗ Welcome Address by Optel The event got off to an auspicious start busy schedules to attend the Summit. She also
◗ Putting the Patient First with the lamp lighting ceremony fol- elaborated on the vision of the event and
◗ Serialisation and traceability based on lowed by a Welcome Address, wherein pointed out how pertinent it was to discuss on
GS1 standards Viveka Roychowdhury, Editor, Express this year’s theme, given that countries across
◗ PANEL DISCUSSION: Leveraging Global Pharma addressed all the delegates at the the globe are already implementing or set to
Traceability for Sustainable Business & Growth event. She extended her heartfelt thanks to the enforce track & trace and serialization man-
esteemed delegates for making time in their dates by 2018.
OPTEL FACILITY VISIT
45EXPRESS PHARMA
AWARDS NITE
December 1-15, 2017
◗ Video Address from OPTEL
◗ Welcome Address by Express Pharma
◗ Launch of Pharma Export Excellence Handbook
◗ Express Pharma Exports Excellence Awards
◗ PANEL DISCUSSION: CEO Think Tank: Strategies
for the next decade
◗ Gala Dinner

To subscribe: [email protected]

PHARMA CXO SUMMIT Welcome Address
by Optel
Shaunak J Dave, C EO & MD, OPTEL Group India, VP (Asia), OPTEL Group
Shaunak J Dave, CEO & lated markets like the US where
MD, OPTEL Group India, India has 30 per cent of the
VP (Asia), OPTEL Group , market share in volumes and 10
welcomed the audience on be- per cent in value. In 2018
half of the OPTEL Group. He branded drugs worth $50 billion
threw more light on the current will become off patent, which is
scenario in the pharma industry a tremendous opportunity. He
and the challenges faced by it, said, “We need to become more
especially in exports. He pointed innovative and do more
out that the pharma industry investment in research. We need
accounts for 20 per cent in terms to establish Brand India as a
of volume but only 1.4 per cent of leading destination for quality
value, in the global market. By medicine at affordable prices.”
2020, it is estimated to reach $55 Dave also highlighted the impor-
billion, where one third of the tance of traceability in achieving
revenue will come from exports. sustainable business and growth
He also drew attention to the and how OPTEL can partner
growth opportunities in regu- companies in this intitative.

Putting the Patient First

Bejon Misra, Founder, protect Indian brands and
PSM India set the medicines are protected.
context for the whole
summit by pointing out the He informed, “We are on
need to keep the patients first the final stage of drafting a
on all initiatives by the life- regulation for sale of medi-
sciences industry. cines within the country and
there is a large element of
Misra spoke on the need to tracking and traceability in
assure quality and safety of that.”
drugs for patients’ benefits
and the role of technology in He also urged the regula-
doing so. Rooting for trace- tors to offer more clarity on
ability adoption he said, the laws to ensure easy imple-
“There is a need for traceabil- mentation and compliance.
ity and the Ministry of Com-
merce needs to mandate Misra also recommended
traceability for atleast ex- collaborations between the
ported medicines.” He said industry stakeholders to come
that this move will up with affordable traceability
solutions to enable their
wide-spread adoption.

KEY TAKEAWAYS

◗ Traceability in the pharma supply chain is a right step
towards ensuring wellbeing of the most important stakeholder
in this sector – the patient

◗ Technology will empower organisations to build their capac-
ity and compete at the market place on quality and efficacy

◗ There is a need for acceptance of tracebility solutions within
the industry to drive progress. Collaborations can help come up
with affordable solutions to enable wide-spread adoption

Bejon Misra, Founder, Partnership for Safe Medicines (PSM) India

46 EXPRESS PHARMA

December 1-15, 2017

PHARMA CXO SUMMIT

Serialisation and traceability
based on GS1 standards

Subrato Dey, Head, West- the risk of counterfeiting and
ern Regional Office, GS1 lost business opportunities. An-
India addressed the audi- other reason for the need of
ence and informed them about global standards in healthcare is
GS1 standards and elaborated because of diverging regulatory
on serialisation and traceability requirements of each country.
based on them. Emphasising on Different countries have differ-
the need for global standards in ent encoding requirement.”
healthcare supply chain, he He also informed that GS1 is
explained how these standards working towards harmonising
help ensure efficiency, safety, regulatory requirements across
collaboration and sustainability. multiple countries. He further
He said, “GS1 provides the plat- stated, “Traceability is the need
form on which a solution can be of the day and that's why
built to address challenges of we want to engage with the
medication errors, counterfeit- industry and bring out the best
ing and traceability. Global stan- practices which can be used
dards eliminate inefficiencies in by the industry and develop the
the supply chain and it reduces solution.”

KEY TAKEAWAYS

◗ Unique identification is the first step towards building
serialization
◗ Data communication is important in sharing and moving the
data in the entire supply chain
◗ harmonisation with global standards is a must for progress.

Subrato Dey, Head, Western Regional Office, GS1 India

Glimpses of Pharma CXO Summit 2017

An enrapt audience Industry veterans in deep discussion Browsing through Pharma Exports Excellence Handbook

Interactive sessions galore at the inaugural edition of Pharma CXO Summit 47EXPRESS PHARMA
To subscribe: [email protected]
December 1-15, 2017

PHARMA CXO SUMMIT

Panel Discussion: Leveraging Global
Traceability for Sustainable Business & Growth

(L-R): Viveka Roychowdhury, Editor, Express Pharma (Moderator); Ravi Uday Bhaskar, Director General, Pharmexcil; Dr H G Koshia, Commissioner, Food & Drugs Control Administration,
Gujarat; Daara Patel, Secretary General, Indian Drug Manufacturers Association; Shaunak J Dave, CEO & MD, OPTEL Group India, VP (Asia), OPTEL Group

The next session was a KEY TAKEAWAYS implement it. He also argued these solutions more cost-ef-
panel discussion on that India’s drug quality is fective. Dave emphasised that
the theme of the event, ◗ Technology can be of help in not only tracking wrong doings very superior and the fact thought these is cost involved
‘Leveraging Global Traceabil- but also in preventing them that a big part of the world in adopting serialisation, the
ity for Sustainable Business & looks at it to supply medi- move will prove to be very
Growth’. Moderated by ◗ There is a need for affordable solutions to encourage cines is an evidence of this beneficial in the long course
Viveka Roychowdhury, Edi- serialisation in India fact. Dr Koshia was in favour of time. He also highlighted
tor, Express Pharma, the emi- of measures to constantly im- that the OPTEL Group can
nent panel comprised Ravi ◗ There is a need to educate the SMEs in pharma to improve prove the standards of India help companies smoothen
Uday Bhaskar, Director Gen- and accelerate adoption of serialisation in India Pharma Inc and highlighted their serialisation journey
eral, Pharmexcil; Dr H G the various initiatives imple- and make it more affordable
Koshia, Commissioner, Food cluding the need for it in the serialisation effective and ef- mented in his state to im- as well as effective.
& Drugs Control Administra- first place, implementation ficient etc., during the course prove quality and safety of
tion, Gujarat; Daara Patel, strategies if it becomes of the discussion. drug. Roychowdhury summed
Secretary General, IDMA; mandatory in all global mar- up the discussion very well
Shaunak J Dave, CEO & MD, kets, the various opportuni- The panelists were divided Bhaskar also reiterated and pointed out that like it or
OPTEL Group India, Vice ties and challenges it unfolds, in their opinions. Patel was that there is a need for the hate it, serialisation is here to
President (Asia), OPTEL dealing with cost concerns, opposed to making serialisa- industry to constantly evolve stay. She also said that it is
Group. technology’s role in making tion compulsory as SMEs do and urged the companies to time all stakeholders came to-
not have the funds needed to take steps towards progress, gether to make this journey
The panelists debated of which one is serialisation. simpler and efficient, thereby
and deliberated on different At the same time, he also enabling the sector to embark
aspects of serialisation, in- urged the providers to make on the next phase of growth.

48 EXPRESS PHARMA

December 1-15, 2017

PHARMA CXO SUMMIT

AWARDS

Export excellence awarded
at Pharma CXO Summit 2017

The maiden Express Pharma Export Excellence Awards recognise and honour the
resounding successes of Indian pharma companies and their untiring efforts in
establishing India as a leading export destination

Express Pharma Ex- Winners of Express Pharma Export Excellence Awards 2017
port Excellence
Awards 2017 was one informative and insightful – Pharmexcil; and Shaunak J Next, Express Pharma Ex- MD, MSD India; and Hitesh
of the key highlights of address, he informed the Dave, CEO & MD, OPTEL port Excellence Awards were Sharma, Partner & National
the Pharma CXO Summit, or- delegates about the conducive Group India, VP (Asia), OPTEL given away by Kuncalienkar, Leader - Life Sciences, EY were
ganised by Express Pharma and business climate in Goa and Group to launch the Pharma Ex- Roychowdhury, Bhaskar, Dave the panelists. The session was
OPTEL Group. Held on pointed out that the state is port Excellence Handbook. It and Dr HG Koshia, FDA Com- aimed at giving CEOs in the audi-
the eve of the first day of already a thriving pharma hub sought to encourage Indian missioner, Gujarat. (Check the ence - past, present and future -
the Summit, it sought to with over 78 companies. He also pharma companies to evolve award winners in the consecutive cause for introspection on their
acknowledge and celebrate the appreciated Express Pharma and their export strategies to stay at pages. ) The final part of the blueprint to confront a world
resounding successes of Indian OPTEL Group for organising the top of the game and acknowl- evening was a panel discussion filled with unprecedented
pharma companies, and the the Pharma CXO Summit edge the players who are already called, ‘CEO Think Tank: Strate- challenges and opportunities.
vital roles they have played in to discuss pivotal issues in expanding India Pharma Inc’s gies for the next decade’.
establishing India as a leading the industry. He recommended reach to all corners of the world. Utkarsh Palnitkar, Partner & Thus, the first day of Pharma
export destination. meaningful collaborations as the Therefore, it featured company National Head - Infrastructure, CXO Summit gave ample oppor-
way forward to drive progress. profiles and insights from Government & Healthcare, Na- tunities for both, celebration
It commenced with a pharma professionals in key tional Head - Life Sciences Prac- and contemplation. After a lot
Welcome Address by Viveka After his address, Kun- roles, who have steered compa- tice, KPMG India; Dr Ajit Dangi, of food for thought, the delegates
Roychowdhury, Editor, Express calienkar joined Roychowdhury, nies to global leadership posi- CEO, Danssen Consulting; KG ended the evening with a gala
Pharma. She explained the Editor, Express Pharma; Ravi tions. Ananthakrishnan, Former VP & dinner.
vision and mission of the Uday Bhaskar, Director General
endeavour and explained the [email protected]
methodology of the awards. She
also thanked the Presenting
Partner, OPTEL Group and the
Knowledge Partner, Pharmexcil
for their support and guidance
in building this platform and
choosing the deserving winners.

Next, Louis Roy, President,
OPTEL Group gave a video mes-
sage wherein he expressed his
best wishes for the Summit and
the Awards. He also gave the au-
dience a very thorough under-
standing of OPTEL Group’s op-
erations across the world, and
conveyed its vision and mission
to the audience.

The Guest of Honour,
Sidharth Sripad Kuncalienker,
the present MLA of Goa State
and Chairman of Economic
Development Corporation of
Goa was the next speaker. In his

To subscribe: [email protected] 49EXPRESS PHARMA

December 1-15, 2017

PHARMA CXO SUMMIT

WINNERS OF EXPRESS PHARMA EXPORT EXCELLENCE AWARDS 2017

Glenmark Pharmaceuticals in Formulations - Large Enterprise Category Cipla in Formulations - Large Enterprise Category

Eisai Pharmaceuticals, India in Formulations – Mid-sized Enterprise Category Indoco Remedies in Formulations – Mid-sized Enterprise Category

50 EXPRESS PHARMA

December 1-15, 2017

PHARMA CXO SUMMIT

WINNERS OF EXPRESS PHARMA EXPORT EXCELLENCE AWARDS 2017

ZIM Laboratories in Formulations – Emerging Enterprise Category Rusan Pharma in Formulations – Emerging Enterprise Category

Shantha Biotechnics in Vaccines Category Launch of Pharma Export Excellence Handbook
To subscribe: [email protected]
51EXPRESS PHARMA

December 1-15, 2017

PHARMA CXO SUMMIT

Panel Discussion: CEOThinkTank:
Strategies for the next decade

Utkarsh Palnitkar,Partner & National Head – Infrastructure, Government & Healthcare, National Head - Life Sciences Practice, KPMG India; Dr Ajit Dangi, CEO, Danssen Consulting; KG
Ananthakrishnan, Former Vice - President & Managing Director, MSD India; and Hitesh Sharma,Partner & National Leader - Life Sciences, EY

The final part of the 1st with unprecedented chal- will not be sustainable. He ad- rience and strengths to create novation. Dr Dangi spoke on
day of the Pharma CXO lenges and opportunities. vised that we will have to a win-win situation. the need for skill building in
Summit evening saw move up the value chain to the sector to gear up for the
an interesting panel discus- Palnitkar set the context continue its growth momen- Sharma said that the future. Palnitkar emphasised
sion titled, ‘CEO Think Tank: for the discussion by giving an tum. He recommended mov- pharma industry is brimming on the necessity of de-stigma-
Strategies for the next understanding on the current ing from cost arbitrage to in- with potential. Funding is not tising failures to nurture inno-
decade’. Moderated by scenario in the pharma sector tellectual arbitrage. Dr Dangi the challenge but strategic vi- vation while Sharma advised
Utkarsh Palnitkar, Partner & and its growth story over the also said that the intellectual sion. The sector should be everyone to not be afraid of
National Head - Infrastruc- past couple of decades. Then pool in India is deep and we more focussed on its growth experimenting as innovation
ture, Government & Health- he spoke that the panel will just need to make optimal use path and invest wisely to en- is often born from the lessons
care, National Head - Life Sci- discuss and deliberate on what of it to change the game in able its progress. Newer tech- learnt from failures.
ences Practice, KPMG India, the future beholds for this sec- pharma from volumes to nologies, untried ideas etc are
an eminent panel comprising tor and the strategies it needs value. the need of the hour for India The other suggestions
Dr Ajit Dangi, CEO, Danssen to look at to ensure continuous Pharma Inc's progress. He were creating a BIRAC-like
Consulting; K G Ananthakr- growth. In the course of the Ananthakrishnan high- spoke on how tech companies institution for the pharma in-
ishnan, Former VP & MD, discussion, he touched upon lighted that there are chal- are partnering with pharma dustry and utilising IT effec-
MSD India; and Hitesh several pivotal issues ranging lenges but the opportunities companies to embark on the tively to enable and inspire
Sharma, Partner & National from the existing business too are huge. He emphasised next phase of growth. originality and out-of-the-box
Leader - Life Sciences, EY, this models in the sector, strate- on the need to identify and ideas.
session was aimed at giving gies to create and protect in- leverage newer and unex- The panelists were unani-
CEOs in the audience - past, tellectual property, plored growth opportunities. mous in their view that India The discussion concluded
present and future - cause for He also advised the domestic Pharma Inc should invest in with the panelists reiterating
introspection on their blue- Dr Dangi pointed out that and MNC pharma companies innovation to accelerate its that investing in innovation is
print to confront a world filled all these years, India's com- to get into strategic partner- progress. Ananthakrishnan a long-time strategy and this
petitive advantage has been ships to pool their skills, expe- recommended creating an would be key to success in the
cost but in times to come, this ecosystem that encourages in- next decade.

52 EXPRESS PHARMA

December 1-15, 2017

PHARMA CXO SUMMIT

DAY 2 - NOVEMBER 10, 2017

AGENDA VideoAddress: Critical Importance of Global
Traceability in the Experience Economy
◗ Networking Breakfast
◗ Welcome Address The first session of the second day Dr Ajaz S Hussain, Founder Insight, Advice & KEY TAKEAWAYS
◗ Video Address: Critical at Pharma CXO Summit 2017 was Solutions, LLC and former Deputy Director
Importance of Global on 'Critical Importance of Global of Pharmaceutical Science, US FDA ◗ Assurance, be it of quality, safety
Traceability in the Traceability in the Experience Economy'. or outcomes, is a growing need and
Experience Economy A global pharma expert, Dr Ajaz S Hus- He advised the pharma industry veterans the pharma industry should work
◗ OPEN Serialization sain, Founder Insight, Advice & Solutions, to have an open mind towards serialisa- towards enhancing its ability to
Standard Released: Why LLC and former Deputy Director of Phar- tion and devise their strategies for its deliver it
it’s needed and why you maceutical Science, US FDA, spoke to the adoption with care.
should join? audience at the event through a video ad- ◗ Value-based pricing will be the trend
◗ Serialization: 2017 & dress. He emphasised that we are in an of the future. Soon pay-for-perform-
Beyond age of experience and meeting patients’ ance may be the norm in healthcare
◗ Networking Tea Break expectations is going to be paramount. He
◗ Panel discussion: The explained that the need for experience is ◗ Pharma players need to move
Serialization Journey growing exponentially but our ability to beyond compliance when it comes to
in India provide assurance is not growing at the serialisation and look for ways to
◗ Valedictory Address: Make same pace. Dr Hussain also gave insights improve their systems and become
in India, Export to the World on how serialisation will help improve future-ready
◗ Vote of thanks patient experience in times of outcome-
based pricing and help the industry avail
manifold benefits and accelerated growth.

OPEN Serialization Standard Released: Why
it’s needed and why you should join?

Marcel de Grutter, Executive Marcel de Grutter, Executive Director, OPEN-SCS and Liaison Regulatory & Government
Director, OPEN-SCS and Liai- Affairs, Abbott
son Regulatory & Government
Affairs, Abbott, an OPEN-SCS expert, stones of various packaging serialisation GMAP development process of PSS. He
gave an understanding on the vision and specification 1.0 use cases which his com- said that with implementation of seriali-
scope of these standards and explained pany has already implemented such as sation, companies can also train their peo-
how they offer manifold benefits to PSS 1.0 and 2.0 deliverables and agile ple to apply GAMP.
streamline and improve the supply chain,
aid in GAMP-compliant change and
lifecycle management, spur innovation,
improve quality and performance etc. He
also informed how global companies are
already part of this initiative and urged
the rest of them to follow suit to increase
their competitiveness in the global arena.

He strongly recommended serialisa-
tion for countries like India and opined
that it will help improve quality processes.
He also advised training people to use
electronic systems to ensure easy imple-
mentation. He mentioned that quality will
be a huige determinant of success in times
to come and Indian pharma companies
could use serialisation as an oppurtunity
to increase exports. In his presentation,
he also explained the criticality of a
standard data exchange specification
for healthcare packaging serialisation.

He also shared achievements and mile-

To subscribe: [email protected] 53EXPRESS PHARMA

December 1-15, 2017

PHARMA CXO SUMMIT

Serialisation: 2017 & Beyond

Jean Pierre Allard, CTO, OPTEL Group made a Jean Pierre Allard, CTO, OPTEL Group
presentation on the impact of serialisation in the
pharma industry. He revealed that recorded inci-
dences of counterfeiting in 2014 stood at 2177. Caution-
ing that counterfeiting is not a myth but a reality, he
also said that this number does not represent the real
number of counterfeit and this could be tip of the ice-
berg! He informed that in the world, 15,000 packaging
lines need serialisation and stressed on the point that
unless we do something on a urgent basis, an unprece-
dented dilemma is on its way. On the plus side, he said
that India is one of the country which has started its
serialisation journey.

He also spoke on how serialisation mandates are
being adopted in countries across the world and gave an
overview on the laws in different developed markets
such as the US and the EU. He also laid emphasis on
the need to comply with these laws.

He also spoke on the global regulations already im-
plemented in India, China, South Korea, Turkey and
Argentina. He also said that serialisation is here to stay
and each company needs to create to blueprint for em-
bracing serialisation. He also spoke on OPTEL’s readi-
ness and ability to be a great partner to pharma compa-
nies in their efforts to adopt serialisation processes.

ValedictoryAddress: Made in India, Export to the World

Dr Sanjit Singh Lamba, MD, Eisai Pharmaceuti-
cals India, in his valedictory address, spoke
on Make in India, Export to the World. He also
briefed the audience on the journey of Eisai Pharma
and shared the key learnings of the company while
dealing with different markets globally. He said that
after the success of Eisai in India we have seen a num-
ber of investments coming from major Japanese
pharma companies coming to India.

He also highlighted the various challenges faced
by the Indian pharma companies. He pointed out that
on one side we talk about being the ‘Pharmacy of the
World’ and on the other side we are faced with issues
of infrastructure, compliance and regulation. How-
ever, he also said that with technology adoption, the in-
dustry is undergoing a huge change since the in past 10
years.

Speaking on exports, he said, “The major chal-
lenge is the quality issue that is affecting the reliabil-
ity. We are doing a lot more on that, for instance, seri-
alisation to ensure that we have full control on our
supply chain.”

He also advised, “We need to have continuous in-
vestment in technologies and people.” Thus it was a
very befitting conclusion to two days of knowledge
sharing at Pharma CXO Summit 2017.

Dr Sanjit Singh Lamba, MD, Eisai Pharmaceuticals India

54 EXPRESS PHARMA

December 1-15, 2017

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PHARMA CXO SUMMIT

Panel Discussion:The SerialisationJourney in India

The last panel discussion (L-R) SM Mudda, Director – Global Strategy (Technical), Micro Labs; Prabir Das, VP, Mylan Laboratories; Shivaji Chakraborty, Assistant GM,
at Pharma CXO Summit Packaging Development, Fresenius Kabi Oncology; and Vardhaman Jain, Marksans Pharma
2017 was on The Serial-
ization Journey in India. The KEY TAKEAWAYS old and their speed is very low
panel discussion was and changing to updated
moderated by SM Mudda, ◗ There is need to work with the government to find solutions for SMEs to reduce the cost bur- machinery involves cost. In
Director – Global Strategy den of serialisation implementation India, we have unskilled, un-
(Technical), Micro Labs. Prabir ◗ The government should document a common standard for the industry for the better implemen- trained manpower in the pack-
Das, VP, Mylan Laboratories; tation of serialisation aging line so handling the new
Shivaji Chakraborty, Assistant ◗ Lack of understanding about technology and its potential, high initial cost of implementation are equipment is a big challenge for
General Manager, Packaging some of the major reasons for the slow adoption of serialisation them. Accommodating text on
Development, Fresenius Kabi small cartons is a challenge for
Oncology; and Vardhaman Jain, automation. We are still work-
Marksans Pharma were the ing on to deal with challenges.”
panelists. The discussion began
with a very important question: Jain elaborated on how the
Why there has been a reluc- barcodes need to be integrated
tance to accept serialisation? in the quality system. He said,
Lack of understanding about “The complexity is very high.
technology and its potential, However, today, people under-
high initial cost of implementa- stand that track and trace is
tion were some of the major rea- not required only for the DAVA
sons which emerged as the an- portal but also falls under the
swer to the question. FDA enforcement, US as well
as EU.”
The discussion also touched
upon varied topics ranging from Concluding the panel dis-
India’s standing in the global cussion, Mudda said, “It is a
pharma industry, rising threat difficult journey and there is a
of counterfeit medicines, and long way to go before we stan-
global track and trace regula- dardise the requirements
tions, to India’s regulations for globally to find workable solu-
the export market, as well as se- tions. We should be looking
rialisation compliance and chal- forward to better solutions
lenges and more. and compliance.”

Das informed that serialisa-
tion is the most discussed topic
in the pharma industry these
days. He also spoke on the basic
challenges faced in packaging.
One of them is accommodating
the additional barcode which is
relatively smaller to our conven-
tional barcode. He said that at
various levels of packaging, we
face different challenges. Elabo-
rating on them he said, there are
no harmonised standards
across the globe which can be
easily integrated in a common
system. It is a challenge for the
packaging industry to keep
evolving complying with the
new regulations coming up in
different countries.

Speaking on operational
challenges faced in serialisation,
Chakraborty said, “Serialisation
looks simple but its not that sim-
ple. The few challenges which is
very common in the industry is
integration with the existing
packaging line. It is really diffi-
cult keeping in mind the Indian
scenario. Most of the lines are

56 EXPRESS PHARMA

December 1-15, 2017

PHARMA CXO SUMMIT

Glimpses of Pharma CXO Summit 2017

57EXPRESS PHARMA

December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

As we near the end of
yet another year, a retrospective

coverage of our stories that
reflected the trends, strategies,

policies, challenges and
aspirations of the pharma industry

EXPRESS PHARMA (JANUARY 16-31, 2017)

cover ) (T H E M A I N F O C U S EXPANDING ACCESS

T here is no doubt that the pharmaceutical industry 21EXPRESS PHARMA Express Pharma has always
has a social commitment to public health. Many taken a keen interest in
pharma companies do take this commitment seri- January 16-31, 2017 India’s progress in the public
ously enough to invest considerable resources to re- welfare.Ascertaining that
duce disease burden by increasing access to doc- commitment to public health,
tors, diagnostics, medication and a host of interventions. this story covered a crucial issue
— Access to health.
Their access strategies most often take the form of patient
It examined an often
outreach programmes and health awareness campaigns overlooked aspect, the efficacy
of pharma companies’access
through which they identify a health need and try to address strategies to identify a health
need and address gaps in current
gaps in current healthcare systems. Pharma companies have healthcare systems.

been part of global and national campaigns aimed at achieving It highlighted the challenges
and recommended that the
public health goals, be it eradicating infectious diseases like po- industry will have to evolve its
access strategies, specifically for
lio, TB or HIV, or managing NCDs like diabetes. India, and in some cases, state by
state.
But how effective are such interventions? Can they be
The measures in the article ,
replicated? Are they sustainable? And above all, are they if implemented, will enable
better access to medicines and
above the needle of suspicion that they are but a means to ac- also help pharma companies in
their endeavour to tap rural
cess and penetrate new markets? markets.

Since 2008, the Netherlands-based Access to Medicine

Foundation's Access to Medicine Index has evolved into a

barometer of effectiveness of these access programmes, at

least for the 20 research-based pharma companies tracked

by the Index. The Index analyses these companies on how

they make medicines, vaccines and diagnostics more accessi-

ble in low- and middle-income countries. It also highlights

best and innovative practices, and areas where progress has

been made and where action is still required. Published every

two years, the latest report

6 released in December 2016
received financial support
from the UK Government,
the Bill & Melinda Gates

COMPANIES Foundation and the Dutch BY VIVEKA ROYCHOWDHURY
GSK, ABBVIE, J&J, Ministry of Foreign Affairs.
SANOFI, NOVARTIS
AND MERCK GSK leads the 2016 In-
ACCOUNT FOR NEARLY dex, for the fifth time, ahead
of Johnson & Johnson
(which improved its ranking

75% by one place), Novartis (also
up one rank) and Merck (up
two places). Companies
which showed maximum im-

OF PROJECTS provement in their rankings
TARGETING were AstraZeneca (up eight
HIGH-PRIORITY, places from 15 to 7) and
LOW-INCENTIVE Takeda Pharmaceutical (up
GAPS five places from 20 to 15).
Novo Nordisk slipped eight

places from second to 10th

rank while Roche slipped seven places from 12 to 19.

But many would consider GSK's top rank ironic since the

company was pulled up by the Chinese government for ethical

breaches. In fact, many big names in the pharma firmament

have faulted on the ethics side. Which is probably why for the

first time, the 2016 edition of the Index analysed pharma com-

panies’ compliance performances alongside their systems

and strategies for improving access to medicine.

Jayasree K Iyer, Executive Director, Access to Medicine

Foundation acknowledges this “central tension” saying, “The

social contract that companies have with the people is that

the companies have the responsibility to provide quality, af-

fordable and effective health products to people, who are ulti-

mately their customers. However, there is a central tension

between shareholder profits and stakeholder needs, exacer-

bated by poverty, inequality, and such.”

Explaining the methodology followed by the ranking she

20 EXPRESS PHARMA To subscribe: [email protected]

January 16-31, 2017

58 EXPRESS PHARMA

December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

INTERVIEWS WITH INDUSTRY LEADERS AND GAME CHANGERS

In the first interview, GSK’s AVaidheesh talks about increasing access to medicines through meaningful
collaborations and digital technologies.The second one features the founder of a promising start-up,
Locus Technologies which is transforming the logistics space.The third interview with KPMG is on the
changing business dynamics of the pharma industry in increasingly volatile conditions.

cover )

INTERVIEW

Increasing access to medicines
via collaboration and digitisation

A Vaidheesh, VP, South Asia and MD, India, GlaxoSmithKline Pharmaceuticals, in an exclusive
interaction with Prathiba Raju mentions that in 2017 and beyond, the pharmaceutical sector
will witness partnerships with governments to increase access to a broad range of innovative
medicines, vaccines and foresees a transformational role of digital in the next few years

What will be the most the power of emerging new industry are adjusting their makers. For example, in a products such as The Next-Gen, Best-in-Class
dominant business trends in technologies. We have digitised sails to adapt to an critical ecosystem of pneumococcal conjugate
2017 in the Indian our entire field force of over increasingly VUCA world healthcare, industry is made up vaccine (PCV) Synflorix Cole-Parmer®
pharmaceutical industry? 3000 sales reps with iPads for where volatility, uncertainty, of 6Ps – Patients, Payers, vaccines and Seretide, our
I foresee a trend of instant detailing and real-time complexity and ambiguity are Providers, Policy makers, leading respiratory offering. Latex & Nitrile Gloves
collaboration between reporting. We have invested in the only constants. So, what Physicians and Play makers. In
government and pharma Veeva a CRM tool for our sales defines the leadership in a every country, VUCA is created We do believe that a large Perfectly Engineered for
companies to further increase force with an integration of all VUCA pharma scenario? by any one of them in some number of people need to get Pharmaceutical Applications
access to medicines and the digital channels such as It is not just the pharma form or the other. For example, these vaccines and medicines
vaccines in the coming years. websites, emails, webinars, industry but the entire world in India, this whole focus from the private market. If you
The evolution of digital tele-detailing so that they can that is in VUCA right now. First towards accessible and want to play for the long term
technologies will further aid communicate easily with and foremost, we need to affordable medicine has then you need to start looking
this development. In fact, GSK doctors and offer real-time recognise the fact that we are in created volatility. Now talking at price volume equations.
India is already making big information. This ensures a a volatile ever-changing of volatility, I believe that the There are some categories
investments on the digital seamless and transformational environment and one of the key government is very much where you may not have
front, to deliver growth while customer experience and factors that are likely to face justified in stepping up and volume headroom and that is
remaining committed to serve makes GSK future ready. more scrutiny in the pharma trying to find a way to reach where you need to seek
patients with futuristic quality industry is the increasing role healthcare to over 1.2 billion government intervention. So,
standards. Apart from Titans of the pharma of regulators and policy people in this country. we need to develop an
partnerships, digitisation will innovative method of engaging
see a major leap in the sector. The pharma industry with the government on ways
Digital disruption is should also play a huge role as and means to subsidise our
transforming every industry one unified voice and discuss price decrease otherwise
globally. At GSK, we believe with policy makers ways and business becomes non-viable.
that the time has come for the means to drive the agenda of VUCA is all about how we
pharma industry to leverage accessible and affordable engage with the entire
technology to improve real- medicine. Though the ecosystem proactively.
time flow of information and government and private
ride the digital revolution to players strategies might differ, How have pharma leaders
fast forward the future. With a coalition is necessary. Even and corporations in the
increased Internet penetration industry associations such as established markets like the
in India and more digital-savvy OPPI (Organisation of US, EU etc. changed their
healthcare professionals Pharmaceutical Producers of strategies?
(HCP’s) GSK is leading this India) are working towards the From a GSK perspective, we
transformation with a vision of same goal. Moreover, we as have always been focussed on
an integrated solution that will sensible business leaders, must access to medicines to patients
increase the quality of in-clinic recognise our own at large. We differentiate IP and
interactions. In fact, in a single responsibility of ensuring the pricing. IP has to get protected
quarter in 2016, GSK reached affordability and accessibility of and pricing is a function of
over 400,000 HCPs through the medicines. For example, at affordability of that particular
digital route. GSK is also GSK India, we have made our country.
investing in communications vaccines and medicines more
with the doctors and leveraging accessible by voluntarily As far as the US is
reducing the prices of our key concerned, we know a new
president has been elected. He,

22 EXPRESS PHARMA

January 1-15, 2017

Express Pharma
(January 1-15, 2017)

LOGISTICS SPECIAL

INTERVIEW

‘Locus aims to be a market leader in
the healthcare services domain’

Locus, a machine learning start-up, is helping companies across sectors automate their
intra-city scheduled and on-demand delivery, thereby ushering a new paradigm in logistics
solutions. Nishith Rastogi, Co-Founder and CEO, Locus, talks about the differentiators that
his company offers, the challenges it seeks to address and changing trends in pharma
logistics, in an interview with Lakshmipriya Nair Excerpts

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platform that focusses on resource costs, which is an reduce costs type of service has ended. pharma player. Can you  Manufactured under strict GMP, complying with
decision making. We are not alarming sign. The product and Nowadays, logistics solutions share more details about ISO, EN and ASTM standards
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as per the industry's wants. create customer loyalty. them optimise their deliveries
Customer experience is a key How are you geared to by enabling efficient
Our routing technology is lever for Locus. serve the healthcare sector automation and optimisation
easily adaptable to several which has very peculiar using our route planning
verticals and use cases, right There is a huge reliance on demands when it comes engine. The average distance
from moving people to humans for decision making to logistics? travelled per rider for every
packages. From cement to (the question that the When it’s healthcare, time is task completed was reduced
FMCG and the pharma operations head always asks the most critical factor that is by 50 per cent by following
industry where time is of is - Manoj kahaan hai?) and stressed upon by the industry. the routes planned by Locus’
essence, our platform can hence issues with consistency In services like diagnostic optimisation engine.
easily be scaled for cross- are very big. Analytics and sample collections and
industry disruption. reporting day-to-day delivery of medicines at We are at various stages
operations remain patients’ doorstep, time of discussions and pilots with
Locus’ planning engine unanswered. Locus helps in sensitivity play a vital role. some of India's largest
concocts highly optimised addressing these challenges. The underlying prescription diagnostics labs and other
routing while it envisages for today's advanced medicine delivery
constraints like time, volume, Why is automation the healthcare supply chain companies.
etc., taking into account need of the hour in approaches—regardless of the
several variables, including logistics? healthcare organisation's What are your growth
real-time gridlock Let's take the planning scope and scale—is plans for the sector this
conditions. process as an example. Even technology, with a strong dose year?
now, a large number of of data and analytics. We The healthcare industry has
What are the most pressing traditional companies use enhance these service levels realised that it's time to bridge
challenges that you seek to excel sheets and paper-pen to and ensure that the customer the gap between technology,
overcome in the logistics plan their routes. Also, in is catered to on-demand and data, and analytics to truly
arena through your order to keep up with on-the-go. transform supply chain into a
solutions? customer requirements, the strategic business asset.
Let’s categorise these approach they use is to deploy At Locus, we help our Various companies have now
challenges to decipher them an over-supply of resources. customers increase the
better. Productivity vs time is serviceability quotient by Continued on Page 32
a major challenge that needs One small change in the increasing the utilisation of
direction of automation holds

30 EXPRESS PHARMA

February 1-15, 2017

Express Pharma
(February 1-15, 2017)

MARKET

INTERVIEW

‘Differentiation through quality
needs to be the success mantra’

Utkarsh Palnitkar, Partner, KPMG in India, National Head – Infrastructure, Government &
Healthcare; and National Head – Life Sciences and Christopher Stirling, Global Chair, KPMG
Life Sciences, KPMG International speak on trends driving the pharma sector in India and
globally, emerging revenue and business models in volatile market conditions, growing role of
R&D in Indian pharma and more, in an interaction with Viveka Roychowdhury. Excerpts

How will President Trump companies have slowly begun looked at by other EU states
impact India’s pharma to deploy technology to engage seeking to cut their drug
sector? more with patients. Sooner expenditure. Going forward, life
Palnitkar: The US is the single than later, a ‘patient-centric sciences companies need to
largest export destination for healthcare’ approach is focus on new drugs to shore up
India; out of the total $15.2 expected to shape up as the growth, embrace technology to
billion pharma exports from driver of the life sciences increase efficiency and
India, the US share was $4.2 industry where quality and compliance, emphasise on
billion (27.9 per cent). From affordability of care remain collaboration and partnerships,
FY13 to FY15, exports to the US fundamental. and focus on patient-centric
has increased by 15 per cent. business models. Life sciences
Utkarsh Palnitkar Christopher Stirling How do quality and pricing companies that manage to
The Indian pharma industry issues impact the revenue embrace the evolving
is aligned with President and other stakeholders to the life sciences business and business models of life regulatory environment, and
Trump’s vision of containing reassess and redesign the model, globally and in India? sciences companies? What master disruption, will likely
drug costs and making current healthcare system. Stirling: Considering that should be the top five focus have the greatest chance to
healthcare affordable. India is the new patient pool is areas of growth for life deliver real value.
expected to remain a preferred While the government has well-informed about sciences CEOs ?
source of safe, effective and always had positive intentions treatments and medicines, in Stirling: The pharma sector is Many of the bigger Indian life
affordable medicines to millions for healthcare in India, the developed countries such as the at crossroads. In a heavily sciences companies have
in the US, notwithstanding the missing pieces around US and the EU – payers disrupted marketplace, invested in R&D. Are these
recent comments of Trump’s implementation; effective (insurance companies) are characterised by shifting payer viable bets?
administration on high drug oversight; competent policy looking forward to ink different attitudes and patient Palnitkar: The top 25 Indian
prices and a new proposed framework and pertinent healthcare plans with an empowerment, neither companies increased their
process for bidding which could regulations to meet our outcome/value-based pricing incremental adjustments nor R&D expenditure from 7.1 per
indicate a challenging national health goals and build model, especially for high- steady evolution are likely to cent in 2014-2015 to almost 7.8
environment for all generic UHC, need to be tackled priced and specialty drugs — halt the decline of the per cent of their consolidated
players exporting to the US, without further delay. oncology drugs, Hepatitis C traditional pharma business net sales in 2015-16, however
including India. Stirling: The Netherlands treatment, etc. Enhancing the model. With rising demand for this is still low compared to
model of mandatory health patient experience via better healthcare and falling budgets, global life sciences companies
These are however early insurance has demonstrated efficacy of drugs drives value- governments and payers are who spend over 17 per cent of
days to comment on how the that providing guaranteed based pricing instead of exerting pressure to drive their net sales on R&D.
new US administration will quality and affordable volume-based pricing. down prices. One bold example
impact the sector. healthcare is possible – an involves the Netherlands; not With enablers such as
effort which has been praised These market dynamics content with striking volume access to skilled manpower,
Comment on PM Modi's around the globe. This model have led global life sciences deals with the major pharma presence of quality technical
approach to healthcare can stimulate Indian companies to think of players, it is looking to utilise institutes, and exposure to
initiatives like UHC. policymakers to embrace a transformative ways that could the power of the EU to create global multinationals, the
Palnitkar: Evident challenges health security model that replace traditional blockbuster even greater economies of journey from generic to
around high out-of-pocket aspires to deliver healthcare drugs, incremental innovation scale. At the moment, several innovator has only just begun in
spending, inequality of services without having to suffer any and physician-preferred member states are pooling India. This journey is expected
and fragmented social and fiscal hardship. models to patient-centric together into a single to help Indian companies in an
regulatory standards are How is the patient impacting models. In India, life sciences procurement machine with environment where there is
forcing stakeholders back to much greater bargaining high competition in generics,
the policy drawing board. power. This initiative, in its tighter scrutiny by drug
Further, with the voice for UHC early stages, is also being regulators, higher usage of
gaining traction, it is becoming biologics drugs, and budget
imperative for the government

10 EXPRESS PHARMA

February 16-28, 2017

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59EXPRESS PHARMA 022-6139-4444 [email protected]

December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

cover ) EXPRESS PHARMA (FEBRUARY 1-15, 2017) RISE OF PHARMA HUBS

(T H E M A I N F O C U S Express Pharma has been
chronicling the happenings
RESURRECTING of the pharma industry for over
two decades.This story trained
BRAND AP its focus on how Andhra Pradesh
Visakhapatnam and Nellore to play pivotal roles in rebuilding is rebuilding itself as a pharma
Andhra Pradesh's reputation as a leading pharma hub hub post-bifurcation.

BY PRATHIBA RAJU Visakhapatnam will be
the nucleus of this new hub,
Andhra Pradesh, gearing to the Andhra Pradesh government is further progress in the pharma sector. Laboratories have also made which has four facilities in measures to expand the from these, major companies striving to be a preferred desti- given its advantages of being a
enter a new orbit of contemplating to set up two big Lured by the incentives offered by inroads in the state. Visakhapatnam. pharma industry’s base in AP. such as Hetero Drugs which nation for the pharma sector.” flourishing port. It also examined
growth, is set to revive its pharma clusters, one in Visakhapat- Chief Minister of Andhra Pradesh, As of today, the North Andhra has a huge plant near Nakka- the opportunities that the state
IT and pharma sectors nam and the second one in Nara Chandra Babu Naidu, multina- Thus, the industry too is Citing that the sunrise in- region of pharma industry is palli and Divis Pharma also “In the coming years, offers to entice major pharma
which took a hit post bi- Nellore district of the state. These tionals such as Mylan, Eisai, Johnson keen to leverage the opportuni- dustry has a bright future in worth nearly $2 billion.” have their expansion plans exports are expected to have a players to the state.
furcation. A major chunk of the upcoming new clusters are expected & Johnson, Hospira have set to make ties being offered by Andhra AP, SV Krishna Prasad, CEO charted out for the state. quantum jump, as the state
pharma industry’s base remained in to be crucial connecting points for significants investments in the state. Pradesh. and Director, Cito Healthcare Adding to the state's advan- government is adding another Challenges and bottlenecks
Hyderabad and its surrounding dis- the East and Far Eastern countries. Major domestic players such as Dr says, “The Andhra Pradesh tage is the Jawaharlal Nehru Also, Lupin Pharma has cluster in the JNPC region. that could hinder the rise of the
tricts of Ranga Reddy, Mahabubnagar, Located in the middle of coastal Reddy’s Laboratories, Aurobindo Teeming with government is taking proactive Pharma City (JNPC) built over plans to invest nearly `500 This would give a double boost state as a pharma was also
Medak and Nalgonda which became a Andhra with well-developed infra- Pharma, Hetero Drugs, Divis Labora- opportunities steps to develop the pharma in- 2,200 acres at Parawada near crores while Biocon also to the new investors as most analysed to find solutions.The
part of Telangana. structure, an international airport and tories, SMS Pharmaceuticals, Cipla, dustry in the state. In the re- Visakhapatnam, has 600 acres plans to revive its Parawada fa- of the ancillary units required pharma industry received a
good rail connectivity, among other Ranbaxy, Laurus Labs, Lee Pharma, The US-India Business cent bifurcation, the state had under SEZ. This has attracted cility. Johnson & Johnson has will be in the same vicinity. thorough understanding of this
The state has plans to become to advantages, Visakhapatnam is well Sionc Pharma, Pharmazell, Raks Council, during a meeting with lost a major chunk of pharma major investments from Hos- shown interest in setting up a With this, VisakHAPAtnam burgeoning market and
regain its position as a major pharma positioned to take on a pivotal role in Pharma, Natco, Granules, Neuland the Chief Minister, had dis- industry to Telangana. So, the pira, Mylan, Eisai, Reddy’s Lab greenfield project, So, these in- will have two pharma clusters, hopefully will be able to leverage
hub and is beckoning investors Now, cussed investment plans worth state government has taken and Aurobindo Pharma. Apart dicate that Andhra Pradesh is one at Parawada and the other it to expedite their progress.
around $5 billion by Mylan,

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MANAGEMENT instance, in October 2006, the next decade. onco injectables (18 per cent) segments, drug-device combina- rency fluctuations. The market COMPANY WATCH
The change in the distribu- and oral hormones (15 per cent). tions (16 per cent) and controlled is cautious about Glenmark's
BETTING Glenmark had out-licensed mel- substances (seven per cent) are strategic blueprint. With a Neu- Express Pharma the pharma
tion of ANDAs across segments Contrast this with the pro- sure to play a significant role. tral rating, an HDFC Securities industry and its progress
onBEAT ogliptin for type-2 diabetes to also give a hint of Glenmark's jected picture for FY17-21, when Institutional Research report in very closely. So obviously,
Bouyed up with promising research results, Glenmark seems chosen path. In FY12-16, the oral solids will shrink to 22 per Muted market reaction response to Glenmark's strategy when Glenmark Pharma, a
to be revving up for some major out-licensing deals. Do they Merck. But less than two years “ANDAs were distributed across cent, topicals grow to 35 per But Glenmark's R&D play in the says, "Although we believe leading pharma
finally have a blockbuster waiting in the wings? just four segments: the bulk cent, onco injectables reduce to last 16 years, has taken a toll on Glenmark's strategy to invest in major unveiled its strategic
Will their bets pay off? later, in February 2008, the of 46 per cent in oral solids, 12 per cent, hormones reduce to the balance sheet, as had cur- three lucrative therapies blueprint for the next decade, it
By Viveka Roychowdhury followed by topicals (21 per cent), eight per cent with two new couldn’t have gone uncovered.
MNC decided to refocus its Bouyed up with promising
research results, Glenmark
portfolio and stop further invest- seems to be revving up for some
major out-licensing deals. Do
ments in diabetes R&D. This, in they finally have a blockbuster
waiting in the wings? Will their
turn, led to R&D on Glenmark's bets pay off? These were some of
the major pegs covered in the
molecule being terminated. story.

Coming after these disap- It also covered their growth
strategy in detail and traced its
pointments, the Sanofi deal progress in the 16 years since its
IPO in 2000. It also featured the
in 2011 for one of Glenmark's market’s predictions on
Glenmark’s blueprint and the
first monoclonal antibodies, possibility of its success.

vatelizumab (GBR 500) was

seen as a major positive for Glen-

mark, but Sanofi too decided to

return the molecule in 2016.

But Glenmark has not given

up. It is very clear from the

strategic blueprint released in

December that going forward,

the engine of the next level of

transformation will clearly be

the R&D pipeline, which seems

to have three main areas of

focus: oncology (the company

has four NOEs from preclinical

to Phase 1), dermatology (one

NME in Phase 2) and respira-

tory (four NOEs, in preclinical

to Phase 3). The 10th molecule is

for pain and is in the Phase 2.

Any one of these 10 NOEs are

potential candidates for out-

licensing deals in addition to four

NOEs which have been classified

as non-core assets.

The market is already sniff-

ing out the molecules with prom-

ise. The HDFC Securities report

says that the company believes

that GBR8383 (which is in pre-

clinical phase) is going to be a

groundbreaking product and is

showing better efficacy than

L ast December, Glen- able as a sole business and out-licensing deals since 2004, Russian roulette at best. And current treatments.
mark Pharma unveiled hence took the first steps into with the likes of global majors Glenmark has been one of many
its strategic blueprint new molecular entity (NME) like Forest Laboratories and Tei- hopefuls, chasing dreams of a Glenmark's earliest
for the next decade. In research in 2000. The an- jin (2004-05) , Eli Lilly and blockbuster, only to have them
the 16 years since its IPO nouncement in December was Merck (2006-2007), and Sanofi turn to dust. In October 2008, NDA/BLA filings, as per
in 2000, the Mumbai-headquar- a reaffirmation of this stance, (2010-11). In fact for 2011, a year Eli Lilly stopped clinical trials of
tered company has achieved even though the company today after the IPO, the company won Glenmark's pain drug molecule currently planned studies, is
many milestones. It has grown is a leading player in the generic two awards from the London- after adverse findings. In August
into a global entity, from two dermatology space in the US based SCRIP as the 'Best Com- 2009, Glenmark's first out- in 2019, for two respiratory
formulation facilities in 2000 and has filed approximately 200 pany in Emerging Markets' and licensed molecule, oglemilast,
to 17 facilities across four conti- drug master files (DMFs) in 'Best Overall Pipeline'. Even was terminated by Forest as molecules in the speciality
nents, seven of which are ap- various markets in the API though all three out-licensed Phase IIb dose range studies on
proved by the US FDA. Interna- business segment. molecules ultimately suffered the COPD molecule were not area, GSP301, currently in
tional revenues have grown from setbacks before the Sanofi deal successful enough. Glenmark's
eight per cent to 70 per cent of Its three business segments too fell through, Glenmark had deal on oglemilast with Teijin phase 3 and GSP304 currently
total revenues. Consolidated clocked healthy CAGRs over clocked cumulative revenues of Pharma for the Japan market
revenue went from $31 million in the past five years, with APIs at over $20 million. also met the same fate. in phase 2.
2000 to $1.2 billion in 2016. 21 per cent, followed by generic
formulations (20 per cent) R&D roulette Not all of the out-licensing With a mission statement to
But more importantly, the and branded formulations (19 Pharma R&D has always been a deals were terminated because
management realised that the per cent). high risk-high reward game, a the molecule was snuffed out "transition into an innovation-
generics game was not sustain- due to unimpressive data. For
There have been seven led global pharmaceutical organ-

Products derived isation over the next decade, the
from the BEAT
identified focus 'growth cata-
platform have the
highest potential lysts' besides NOEs, are filing

Dr Kurt Stoeckli as many as nine new drug appli-
President and CSO,
Glenmark Pharmaceuticals cation (NDA)/biologic license

application (BLAs) in the next 10

years and targeting 30 per cent

of total revenues from specialty

and innovation segments over

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